SEPTEMBER 2008

WEEK ENDING SEPTEMBER 6

PRODUCT Pacific Consolidated Industries Mobile Oxygen Storage Tank, MOST 20-2B, Part Number: 793080-002, CODE Serial numbers: 6947-001 to 6947-546, 6968-001 to 6968-211, 6982-001 to 6982-134, C4340-24, C4340-25, 7224-001 to 7224-011, and 10001 to 10194
RECALLING FIRM/MANUFACTURER Pacific Consolidated Industries, LLC, Riverside, CA
REASON The recall was initiated after the firm received two customer complaints of ruptured bourdon tubes that had resulted in bellowed out face gauges.
VOLUME OF PRODUCT IN COMMERCE 1,032 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Nautica (GK) Mattress Stretcher. There are no serial numbers on the GK Mattress Stretchers. These mattress stretchers were sold for installation on or as a component of the following patient bath lifts: a) Nautica Bath Lift System, Part number 88004051; b) Nautica Bath Lift System, Part number 88004051.12, 
CODE
a) Serial number: NTCA-040;
b) Serial numbers: NTCA-0197, NTCA-0200, NTCA-0201, NTCA-0225, NTCA-0166, NTCA-0198
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arjo, Inc., Roselle, IL, 
Manufacturer: B. H. M. Medical, Inc., Magog, Canada. REASON Repeated use of the ratchets that lock the position of the back and leg rest of the stretcher may damage the retention pin that prevents the latch from disengaging from the anchor system. This would allow the backrest to pivot freely down to the floor.
VOLUME OF PRODUCT IN COMMERCE 7 units
DISTRIBUTION Nationwide

PRODUCT
a) Quickie Rhythm Power Wheelchair with QC (non-expandable) electronics, Model number EIPW10, 
b) Quickie Groove Power Wheelchair with QC (non-expandable) electronics, Model number EIPW13, 
CODE All wheelchairs with the QC Motor controller units with version 2.0 parameter or *.SUN file software.
RECALLING FIRM/MANUFACTURER rise Medical, Inc., Fresno, CA, 
REASON Product experiences a longer than expected stopping distance, which may cause injury to the user, objects, or the chair itself.
VOLUME OF PRODUCT IN COMMERCE 205 controller units (affecting 141 wheelchairs)
DISTRIBUTION Nationwide, Canada and Australia

PRODUCT
a) CareVue Chart Release C ,Versions C.00.00 through C.00.06 Product No. 862246. This device is a clinical information system intended for use in data collection, storage,
and management with independent bedside devices, and other systems that are connected either directly or through networks. It is used when there is a need for generating patient records and computation of drug dosage, 
b) IntelliVue Clinical Information Portfolio Critical Care Release D, Version D.00.00 Product Number: 865047. This device is a clinical information system intended for use   in data collection, storage, and management with independent bedside devices, and other systems that are connected either directly or through networks. It is used when there is a need for generating patient records and computation of drug dosage,
CODE
a) Software Versions: C.00.00 through C.00.06;
b) Software Version D.00.00
RECALLING FIRM/MANUFACTURER Philips Medical Systems, Andover, MA, 
REASON Medications prescribed for one patient were printed on the record of another patient.
VOLUME OF PRODUCT IN COMMERCE 138 units
DISTRIBUTION Nationwide and Internationally

PRODUCT 24mm Rotating C-Mount Coupler, Model Number 1088-020-121S2. The device is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope, endoscope or arthroscope is indicated for use, 
CODE
Lot Numbers: 07L046134, 07L046144, 07L046154, 07L046164, 07L046184, 07L046194, 07L046214, 07L046224, 07L046234, 07L046244, 07L046254, 07L046274, 07L046284, 07L046294, 07L046304, 07L046324, 07L046334, 07L046344, 07L046364, 07L046374, 07L046384, 07L046394, 07L046404, 07L046414, 07L046424, 07L046454, 07L046464, and 07L046474
RECALLING FIRM/MANUFACTURER Stryker Endoscopy, San Jose, CA, 
REASON The coupler on this device was manufactured without set-screws that are used to hold and center the rear assembly and the endobody. The coupler is part of the camera system and affects the ability to focus.
VOLUME OF PRODUCT IN COMMERCE 28 devices
DISTRIBUTION IA

PRODUCT
a) GE Healthcare Precision RXi 23A/ 32A Remote X-Ray Imaging R&F System. It is a remote analog R&F system consisting of a tilting table with integrated spot  film device, 65 kW pulsing generator and high heat capacity X-Ray tube. The
system can be configured to meet a wide variety of exams for various clinical applications with ether 23 cm image intensifier with 512x512 Image Chain or 32 cm Image intensifier with either 512x512 Image Chain or 1Kx 1K Image Chain, 
b) GE Healthcare Precision RXi Digital Remote X-Ray Imaging R&F System. It is a remote R&F system consisting of a tilting table with integrated spot film device, 65 or 89 kW pulsing generator and high heat capacity X-Ray tube. The system can  be configured to meet a wide variety of digital record and fluoroscopy exams for various clinical applications with either 32 cm or 40 cm image intensifier,
c) GE Healthcare Precision RXi version e Remote X-Ray Imaging R&F System.  It is a remote analog R&F system consisting of a tilting table with integrated spot  film device, and 50KW or 65 kW pulsing generator. The system is configured with  a 23 cm image intensifier and a 512x512 Image Chain, CODE
a) Units: 101 103 117 121 128 132 133 135 136 152 156 160 162 164 173 178 182 184 190 194 196 201 202 209 221 228 232 235 238 240 246 250 251 252 254 259 260  261 263 264 267 268 273 275 276 281 283 289 295 297 300 302 310 322 330 331  333 342 343 347 348 351 353 354 365 367;
b) Units: 100 102 104 105 106 107 108 109 110 111 112 113 114 115 116 118 119  120 122 123 124 125 126 127 129 130 131 134 137 138 139 140 141 142 143 144
145 146 147 148 149 150 151 153 154 155 157 158 159 161 163 165 166 167 168 169 170 171 172 174 175 176 177 179 180 181 183 185 186 187 188 189 191 192
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c) Units: 10805 10805 10805 10804 10804 10804
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Waukesha, WI, 
Manufacturer: General Medical Merate, Seriate, Italy. 
REASON GE Healthcare Precision RXi tilt joystick became stuck in the Trendelenburg direction causing the patient to slide off the table. Also recall conducted to investigate the possibility of accidentally activation of the remote console joystick where a fatal accident occurred on a non-GE Remote R&F System.
VOLUME OF PRODUCT IN COMMERCE 265 systems
DISTRIBUTION Nationwide

PRODUCT FASTPAK batteries are Nickel-Cadmium (NiCd) battery packs used to provide DC power to LIFEPAK 5, 10, 11, or 12 defibrillator/monitors. The FASTPAK battery has a capacity of 1 amp/hour (1.0AH). The battery can be charged in a Battery Support System, Battery Support System 2, Mobile Battery Service Station, or the LIFEPAK 10, 11 or 12 defibrillator/monitor when the device is powered by an external power adapter. The FASTPAK battery does not have a pushbutton fuel gauge like the LIFEPAK NiCd. The fuel gauge provides a visual indication of battery capacity. Battery part number 9-10424-18, sold with LIFEPAK defibrillators and also sold separately, 
CODE All batteries with lot code 0624
RECALLING FIRM/MANUFACTURER
Recalling Firm: Physio Control, Inc., Redmond, WA, 
Manufacturer: Micropower Electronics, Beaverton, OR. REASON Batteries mislabeled - batteries labeled as 2.4 amp/hour batteries; however they are 1.0 amp/hour batteries.
VOLUME OF PRODUCT IN COMMERCE 811 batteries
DISTRIBUTION Nationwide, Canada, Netherlands, Asia Pacific and Latin America

PRODUCT TomoTherapy Hi-Art System with software versions 3.0 and 3.1 - Radiation Therapy System. The device is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy, 
CODE
10002 10003 10007 10016 10019 10021 10028 10037 10044 10048 10050 10051 10056 10094 10165 10166 10168 10169 10174 10185 10186 10187 10188 10189 10190 10191 10192 10193 10194 10195 10196 10198
RECALLING FIRM/MANUFACTURER Tomo Therapy Inc., Madison, WI, 
REASON In certain cases of HI-ART Systems operating with 3.0 or 3.1 SW, the registration adjustment field numbers may appear as nonsense characters or values on printed pages of the Register Tab. These values may appear differently than those shown on the Operator Station (OS) display. For example, the number "8" may appear as the number "0" on the printed page. During the registration process, the HI-ART couch will achieve the accepted and approved registered position automatically. However, if the operator subsequently adjusts the couch position manually based on a printout with the anomaly, the patient may be in the incorrect position during treatment.
VOLUME OF PRODUCT IN COMMERCE 32 systems
DISTRIBUTION Nationwide and Internationally

PRODUCT Logix TPN Software Solution, catalog 2M8410, consists of the Logix Order Entry (OE) Installation CD, version 1.0.28 and Logix Compounder Manager (CM) Installation CD, version 3.1.8. The software is included in a number of Baxter's pharmacy compounders. The software assists the pharmacist in management of compounding, creating and authorizing nutritional solutions intended for IV administration, CODE Software version 1.0.2 (comprised of Logix OE version 1.0.28 and Logix CM version 3.1.8)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare, Corp., Round Lake, IL, Manufacturer: Baxter Healthcare Corp., Buffalo Grove, IL. REASON Software anomaly results in inaccurate information being printed out on the Delivery Report, even though the compounder performed the compounding correctly.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION AZ, MN, WI, PR and Canada

PRODUCT CADD-MS"3 Ambulatory Infusion Pumps, Model 7400, Rx only, CE 0473, SN 499000. The device is designed for subcutaneous, intravenous, epidural and intrathecal infusion of medication. Reorder Numbers 21-7401-51/49/00 & 21-7411-51, 
CODE
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RECALLING FIRM/MANUFACTURER Smiths Medical MD, Inc., Saint Paul, MN, 
REASON Smiths Medical has received reports that the device powers down without an alarm. Investigation concluded that if the battery cap is not fully tightened, the pump may power down and a brief "chirp" will sound. This may occur if the user has not sufficiently tightened the battery cap or if the battery cap is damaged. If a patient is asleep or does not regularly check their blood glucose, as trained, there is a potential risk of harm to the patient if the Pump's powering down goes unnoticed. When the Pump is powered down, delivery of insulin is interrupted.
VOLUME OF PRODUCT IN COMMERCE 2,303 devices
DISTRIBUTION Nationwide and Internationally

PRODUCT Syn go Imaging XS is a picture archiving and communication system intended to display, process, read, report, communicate, distribute, store and archive digital radiological images, including digital mammography images. Model number 7502029, 
CODE
Serial numbers: 9288, 9632, 9633, 9640, 9792, 10412, 10625, 11106, 11942, 12029, 12030, 12031, 12032, 12068, 12211, 12216, 12217, 12222, 12229, 12235, 12276, 12283, 12288, 12543, 12577, 12600, 12610, 12660, 12661, 12062, 12063, 12643, 12739, 12773, 12782, 12783, 12789, 13026, 13027, 13090, 13131, 13147, 13155, 13208, 13241, 13280, 13295, 13296, 13297, 13298, 13299, 13300, 13301, 13302, 13303, 13304, 13305, 13306, 13307, 13308, 13310, 13358, 13370, 13371, 13372, 13400, 13401, 13402, 13403, 13404, 13405, 13406, 13407, 13408, 13409, 13410, 13411, 13412, 13413, 13414, 13415, 13416, 13417, 13418, 13419, 13420, 13421, 13427, 13428, 13429, 13432, 13433, 13434, 13435, 13436, 13437, 13438, 13439, 13440, 13441, 13442, 13443, 13444, 13445, 13446, 13447, 13448, 13449, 13450, 13451, 13452, 13453, 13454, 13455, 13456, 13457, 13458, 13459, 13460, 13461, 13462, 13480, 13490, 13491, 13492, 13493, 13494, 13495, 13496, 13501, 13504, 13505, 13510, 13519, 13520, 13574, 13575, 13576, 13591, 13635, 13636, 13637, 13669, 13670, 13671, 13672, 13673, 13674, 13675, 13676, 13679, 13680, 13681, 13682, 13683, 13684, 13685, 13686, 13687, 13688, 13689, 13690, 13691, 13692, 13693, 13694, 13695, 13696, 13697, 13724, 13725, 13732, 13733, 13734, 13735, 13740, 13745, 13749, 13751, 13785, 13791, 13792, 13794, 13811, 13820, 13821, 13822, 13823, 13824, 13825, 13826, 13846, 13847, 13848, 13849, 13850, 13851, 13889, 13890, 13906, 13907, 13908, 13909, 13912, 13913, 13921, 13922, 13933, 13934, 13945, 13959, 13960, 13961, 13968, 13971, 13979, 13980, 13991, 13992, 13996, 13997, 13998, 13999, 14000, 14004, 14005, 14016, 14017, 14043, 14050, 14051, 14052, 14053, 14054, 14059, and 14066
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, 
Manufacturer: Siemens Medical Solutions Inc., Erlangen, Germany. 
REASON The selected patient images on the device may display an additional image from another patient or study.
VOLUME OF PRODUCT IN COMMERCE 236 units
DISTRIBUTION Nationwide

PRODUCT
a) Seprafilm Adhesion Barrier (chemically modified sodium   
    hyaluronate/carboxymethylcellulose absorbable adhesion barrier);  Product Number: 4301-02, 
b) Seprafilm Adhesion Barrier (chemically modified sodium
    hyaluronate/carboxymethylcellulose absorbable adhesion barrier).  Japan Distribution Only. Product Number: 4301-05, CODE
a) Lot Numbers: 07NP135 Exp Date: April 2010; 07NP177 Exp Date: May 2010; 07NP199 Exp Date: June 2010; 07NP216 Exp. Date: July 2010; 07NP311 Exp. Date: May 2010;
b) Lot number: 07NP181 Exp June 2010
RECALLING FIRM/MANUFACTURER Genzyme Corp., Framingham, MA, 
REASON Sterility may be compromised.
VOLUME OF PRODUCT IN COMMERCE 3,149 (10 packs)
DISTRIBUTION Nationwide, Korea, Taiwan and Japan

PRODUCT BCI Non Invasive Blood Pressure Monitor Product/Catalog number 6004, 
CODE
AJ07080009 AJ07080010 AJ07080041 AJ07080042 AJ07110027 AJ07110030 AJ07110031 AJ07080040 AJ07080043 AJ07110000 AJ07110001 AJ07110002 AJ07110003 AJ07110004 AJ07110026 AJ07080039 AJ07080004 AJ07080032 AJ07080033 AJ07080034 AJ07080044 AJ07080045 AJ07080056 AJ07080057 AJ07080058 AJ07110010 AJ07110047 AJ07110048 AJ07110049 AJ07080002 AJ07110009 AJ07110011 AJ07080003 AJ07080005 AJ07080011 AJ07080012 AJ07080013 AJ07080014 AJ07080015 AJ07080016 AJ07080017 AJ07080018 AJ07080019 AJ07080020 AJ07080021 AJ07080022 AJ07080023 AJ07080024 AJ07080025 AJ07080026 AJ07080027 AJ07080028 AJ07080029 AJ07080030 AJ07080031 AJ07080046 AJ07080047 AJ07080035 AJ07080059 AJ07100060 AJ07100073 AJ07110046 AJ07110012 AJ08010000 AJ08010001 AJ07110042 AJ07110043 AJ07110044 AJ07110045 AJ07080048 AJ07110018 AJ07110019 AJ07110020 AJ07110021 AJ07110040 AJ07100002 AJ07100004 AJ07100006 AJ07100009 AJ07100010 AJ07100011 AJ07100012 AJ07100013 AJ07100014 AJ07100015 AJ07100016 AJ07100017 AJ07100018 AJ07100020 AJ07100024 AJ07100025 AJ07100026 AJ07100028 AJ07100029 AJ07100030 AJ07100031 AJ07100034 AJ07100035 AJ07100036 AJ07100038 AJ07100039 AJ07100051 AJ07100058 AJ07100064 AJ07100065 AJ07100000 AJ07100001 AJ07100005 AJ07100007 AJ07100008 AJ07100019 AJ07100021 AJ07100022 AJ07100023 AJ07100027 AJ07100033 AJ07100037 AJ07100045 AJ07100046 AJ07100047 AJ07100048 AJ07100049 AJ07100050 AJ07100052 AJ07100053 AJ07100054 AJ07100055 AJ07100056 AJ07100057 AJ07100059 AJ07100061 AJ07100062 AJ07100063 AJ07100066 AJ07100067 AJ07100068 AJ07100071 AJ07100072 AJ07100003 AJ07100032 AJ07110014 AJ07110015 AJ07110038 AJ07080036 AJ07080053 AJ07080054 AJ07080055 AJ07100070 AJ07080006 AJ07080007 AJ08010004 AJ07110016 AJ07110017 AJ07110013 AJ07110039 AJ07110041 AJ07110022 AJ07110023 AJ07080051 AJ07100040 AJ07100041 AJ07100042 AJ07110024 AJ07110005 AJ07110006 AJ07110007 AJ07110008 AJ07080052 AJ07100069 AJ07100074 AJ07080008 AJ07100043 AJ07100044 AJ07110032 AJ07110033 AJ07110034 AJ07110035 AJ07110036 AJ07110037
RECALLING FIRM/MANUFACTURER Smiths Medical PM, Inc., Waukesha, WI, 
REASON Do to a component that may be installed backwards, the device may turn off or may immediately reset.
VOLUME OF PRODUCT IN COMMERCE 195 devices
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Ambulift, standard basic model manually powered patient lift. The Ambulift is used  to move and lift patients from their beds, transport them to the bathroom, and lift  them in and out of the bath. Model AB1102 - Standard basic model Ambulift with  chair and leg rest. Model AB1552 - Standard basic model Ambulift with chair and  leg rest and scales, 
b) Ambulift Classic, battery powered patient lift. The Ambulift is used to move and  lift patients from their beds, transport them to the bathroom, and lift them in and  out of the bath. Model KDB1890-04US - Ambulift Classic with chair and leg rest.  Model KDB1895-04US - Ambulift Classic with chair, leg rest and scale, 
CODE All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arjo, Inc., Roselle, IL, 
Manufacturer: Arjo Med. AB, Gloucester, UK. 
REASON The armrests of the lift chair may push up, allowing the patient to slip down and out of the seat. The resultant fall could result in serious or fatal patient injuries.
VOLUME OF PRODUCT IN COMMERCE 14 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Smash Balloon Dilatation Catheter- is intended for use in percutaneous dilation of the iliac, femoral, popliteal, tibial, renal, tibioperoneal vessels in whose lumens are obstructed by atherosclerotic plaque, 
CODE All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Natick, MA, 
Manufacturer: Boston Scientific Ireland, Ltd., Galway, Ireland. 
REASON Since July 2007, Boston Scientific has tracked an increasing trend in complaints regarding cracks and damage to the balloon inflation hub. The potential clinical effects related to these types of cracks and damage could include no inflation, difficulty inflating, slow deflation, partial deflation or, in a worst case scenario, no deflation of the balloon.
VOLUME OF PRODUCT IN COMMERCE 17,891 units
DISTRIBUTION Internationally

PRODUCT
a) Dental Cement-Bisco BISCEM® Dual-Cured Self-Adhesive Resin Cement,  Translucent; The product is intended to serve as a temporary tooth filling or  as a base cement to affix a temporary tooth filling, to affix dental devices such  as crowns or bridges, or to be applied to a tooth to protect the pulp, Item  numbers D-45011P, D-45001S and G-91700K, 
b) Dental Cement-Bisco BISCEM® Dual-Cured Self-Adhesive Resin Cement,  Translucent; The product is intended to serve as a temporary tooth filling or  as a base cement to affix a temporary tooth filling, to affix dental devices
such as crowns or bridges, or to be applied to a tooth to protect the pulp;  Item numbers D-45012P and D-45002S, CODE All lots
RECALLING FIRM/MANUFACTURER Bisco, Inc., Schaumburg, IL,
REASON During product stability testing, Bisco determined that after 15 months of storage, BISCEM® Self-Adhesive Luting Cement used in self-cure mode only without light-curing may take longer than specified to set, resulting in reduced bond strength. Bisco also determined that product component(s) may thicken slightly over time.
VOLUME OF PRODUCT IN COMMERCE 69,847 syringes
DISTRIBUTION Nationwide and Internationally

PRODUCT Opthalmic microsurgical system-AMO WHITESTAR SIGNATURE Phacoemulsification System, Product Number NGP680300. The device is a modular ophthalmic microsurgical system that facilitates both anterior segment (i.e., cataract) and posterior segment (i.e., vitreoretinal) ophthalmic surgery. Product Number: NGP680300, 
CODE
Lot Numbers: 200750010, 200750016, 200750017, 200750018, 200750019, 200750020, 200750021, 200750024, 200750025, 200750027, 200750028, 200750031, 200750037, 200750042, 200750045, 200750046, 200750051, 200750052, 200750055, 200750056, 200750058, 200750065, 200750067, 200750068, 200750074, 200750079, 200750080, 200750090, 200750094, 200750100, 200750102, 200750110, 200750113, 200750136, 200750137, 200750138, 200750139, 200750140, 200750154, 200750158, 200750159, 200750160, 200750161, 200750162, 200750164, 200750166, 200750167, 200750194, 200750196, 200750199, 200750205, 200750206, 200750209, 200750215, 200750216, 200750222, 200750224, 200750226, 200750229, 200750235, 200850064, 200850066, 200850069, 200850089, 200850092, 200850108, 200850109, 200850111, 200850112, 200750038, 200750040, 200750043, 200750049, 200750064, 200750066, 200750070, 200750085, 200750087, 200750088, 200750089, 200750091, 200750096, 200750097, 200750105, 200750106, 200750107, 200750112, 200750114, 200750115, 200750117, 200750118, 200750119, 200750122, 200750123, 200750126, 200750127, 200750142, 200750143, 200750144, 200750145, 200750146, 200750148, 200750150, 200750151, 200750152, 200750153, 200750155, 200750163, 200750168, 200750169, 200750170, 200750171, 200750173, 200750175, 200750176, 200750177, 200750178, 200750179, 200750184, 200750185, 200750187, 200750189, 200750190, 200750191, 200750192, 200750195, 200750232, 200750238, 200750239, 200750240, 200750242, 200750243, 200750244, 200850001, 200850002, 200850003, 200850015, 200850017, 200850018, 200850020, 200850021, 200850022, 200850026, 200850027, 200850028, 200850037, 200850040, 200850041, 200850043, 200850044, 200850045, 200850046, 200850047, 200850049, 200850050, 200850051, 200850052, 200850053, 200850055, 200850056, 200850057, 200850058, 200850059, 200850073, 200850074, 200850075, 200850076, 200850078, 200850079, 200850080, 200850081, 200850082, 200850083, 200850084, 200850085, 200850086, 200850098, 200850099, 200850100, 200850102, 200850103, 200850106, 200850114, 200850122, 200750047, 200750073, 200750095, 200750099, 200750156, 200850007, 200850060
RECALLING FIRM/MANUFACTURER
Recalling Firm: Advanced Medical Optics, Inc., Santa Ana, CA, 
Manufacturer: Visx, Incorporated, A Subsidiary of Amo, Inc, Santa Clara, CA. 
REASON AMO initiated this field correction event after becoming aware of a trend in complaints associated with AMO Vitrectomy Cutter used in conjunction with the Amo Whitestar Signature Phacoemulsification System. The physician may be unable to make a cut during cataract surgery.
VOLUME OF PRODUCT IN COMMERCE191 units
DISTRIBUTIONNationwide and Internationally

PRODUCT
a) Circular Mapping Catheter-Biosense Webster LASSO 2515 Variable Circular Mapping Catheter- The catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e.,  recording and stimulation only. The device is designed to obtain electro    grams in the Atrial regions of the heart,
b) Circular Mapping Catheter-Biosense Webster LASSO 2515 Variable Circular Mapping Catheter- The catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e.,  recording and stimulation only. The device is designed to obtain electrograms
in the Atrial regions of the heart. 20 Poles, US Catalog Number D7L202515RT, EU Catalog Number 35T2515R, CODE All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioSense Webster Inc., Diamond Bar, CA, Manufacturer: BioSense Webster, Inc., Chihuahua, Mexico. REASON This recall was initiated after the firm received several complaints reporting issues with deflection. The catheter may become caught in the mitral valve, requiring surgical procedures, valve may be torn while trying to dislodge, unable to retract the catheter through the sheath and require surgical intervention to remove, pulling on catheter to remove may lead to large atrial septal tear, and separation of the distal end of the catheter may occur. Also,the firm determined that when the catheter is fully deflected and the variable loop is fully contracted, it is possible that the catheter mechanism can become "locked" in position and cannot return to the un-contracted, un-deflected state. This could lead to damage to the device or limit the ability to withdraw the catheter safely.
VOLUME OF PRODUCT IN COMMERCE 14,295 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Generation 4 electronic liquid gauges used on the Caire Liberator, Stroller, Sprint, and Hi-Flow Portable oxygen unit, 
CODE
Liberator Base units - CBB300634XXXX - CBB300738XXXX. Includes units produced from week 34-2006 through week 38-2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Caire, Inc., Marietta, GA, 
Manufacturer: Caire, Inc., Ball Ground, GA. 
REASON Moisture ingress into the electronic liquid level indicator may cause inaccurate liquid oxygen level readings. The oxygen could run out without the patient knowledge.
VOLUME OF PRODUCT IN COMMERCE 3,470 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Hall Easy-Fit® Prosthetic Heart Valve - Aortic A7700. The device uses a single pyrolytic carbon disc occluder pivoting within a titanium housing. The housing is machined into final configuration from a single piece of solid titanium and has no
  welds or introduced bends. It is an open-member design in which all members   project centrally without distal attachment. A rotatable fabric sewing ring is affixed to the valve. The valve is provided on a holder (collect) to facilitate insertion and to provide protection during shipping and handling. The valve is
  sterile and non-pyrogenic if seal and package are not opened, damaged, or broken, 
b) Hall Easy-Fit® Prosthetic Heart Valve - Mitral M7700. The device uses a single pyrolytic carbon disc occluder pivoting within a titanium housing. The housing is machined into final configuration from a single piece of solid titanium and has no
  welds or introduced bends. It is an open-membered design in which all members project centrally without distal attachment. A rotatable fabric sewing ring is affixed to the valve. The valve is provided on a holder (collect) to facilitate insertion and to
  provide protection during shipping and handling. The valve is sterile and non- pyrogenic if seal and package are not opened, damaged, or broken, 
CODE

1. USA 19A554013J 19A554110J 19A554192J 19A554193J 19A554196J 19A554287J 19A554292J 19A554298J 21A553685J 21A553921J 21A553982J 21A553985J 21A554133J 21A554959J 21A555003J 21A555206J 21A555473J 21A555711J 21A555821J 21A555906J 21A555914J 23A553480J 23A553533J 23A553611J 23A553837J 23A553987J 23A554034J 23A554663J 23A555403J 23A555772J 23A556211J 23A556271J 25A554669J 25A555417J 25A556058J 25A556107J 27A549092J 27A549340J 27A553554J 27A554155J 27A554159J 27A554224J 27A554225J 27A554232J 27A554236J 27A554436J 27A554507J 27A555286J 27A555289J 27A556046J 27A559810J 27A559811J 27A559812J 27A559918J 29A549102J 29A549192J 29A549193J 29A549242J 29A551836J 29A551988J 29A554151J 29A554156J 29A554158J 29A554226J 29A554231J 29A554435J 29A554438J 29A554439J, and 29A554440J EUROPE 19A554058J 19A554109J 19A554126J 19A554201J 19A554289J 19A554290J 19A554604J 19A554654J 19A554749J 19A554754J 19A560318J 19A560981J 19A560992J 19A561161J 19A561162J 19A561172J 19A561230J 19A561233J 19A561237J 19A561246J 21A553907J 21A554016J 21A555382J 21A555395J 21A555637J 21A555719J 21A555723J 23A553121J 23A553122J 23A553200J 23A553412J 23A553478J 23A553531J 23A553539J 23A553605J 23A553616J 23A553838J 23A554137J 23A554331J 23A554493J 23A554658J 23A554709J 23A554716J 23A554720J 23A554843J 23A554965J 23A554968J 23A555025J 23A555251J 23A555263J 23A555516J 23A555519J 23A555523J 23A555524J 23A555527J 23A555531J 23A555532J 23A555613J 23A555622J 23A555623J 23A555675J 23A555681J 23A555735J 23A555773J 23A555775J 23A555915J 23A555917J 23A555922J 23A555924J 23A555926J 23A555927J 23A555928J 23A555929J 23A556008J 23A556011J 25A554042J 25A554044J 25A554047J 25A554139J 25A554144J 25A554217J 25A554220J 25A554221J 25A554425J 25A554426J 25A554428J 25A554429J 25A554431J 25A554432J 25A554503J 25A554554J 25A554556J 25A554557J 25A554558J 25A554561J 25A554562J 25A556030J 25A556035J 25A556038J 25A556101J 25A556116J 27A549104J 27A549189J 27A549194J 27A549245J 27A549339J 27A549341J 27A551835J 27A551989J 27A553552J 27A553553J 27A554157J 27A554223J 27A554230J 27A554237J 27A554976J 27A555291J, and CANADA 21A554071J 23A555518J 25A554143J 27A551991J, and 27A555283J OTHER 19A553455J 19A553748J 19A553881J 19A553901J 19A553998J 19A554000J 19A554001J 19A554010J 19A554059J 19A554063J 19A554064J 19A554108J 19A554113J 19A554122J 19A554194J 19A554202J 21A553173J 21A553181J 21A553405J 21A553466J 21A553525J 21A553598J 21A553687J 21A553790J 21A553825J 21A553828J 21A553832J 21A553905J 21A553910J 21A553913J 21A553920J 21A553977J 21A553981J 21A553983J 21A553984J 21A554089J 21A554131J 21A554308J 21A554309J 21A554311J 21A554312J 21A554313J 21A554314J 21A554320J 21A554607J 21A554702J 21A554703J 21A554706J 21A554758J 21A554793J 21A554794J 21A554797J 21A554800J 21A554837J 21A554839J 21A554840J 21A554841J 21A554887J 21A554889J 21A554893J 21A554895J 21A554896J 21A554899J 21A554954J 21A554962J 21A555002J 21A555004J 21A555005J 21A555006J 21A555007J 21A555014J 21A555203J 21A555205J 21A555375J 21A555378J 21A555385J 21A555386J 21A555388J 21A555397J 21A555477J 21A555478J 21A555483J 21A555494J 21A555496J 21A555499J 21A555500J 21A555504J 21A555507J 21A555580J 21A555581J 21A555583J 21A555584J 21A555626J 21A555627J 21A555630J 21A555633J 21A555634J 21A555673J 21A555674J 21A555706J 21A555708J 21A555709J 21A555716J 21A555717J 21A555726J 21A555806J 21A555909J 21A555913J 21A555992J 21A555993J 21A555994J 21A555995J 21A555997J 21A556053J 21A556085J 21A556151J 23A553484J 23A554024J 23A554027J 23A554028J 23A554031J 23A554136J 23A554206J 23A554208J 23A554213J 23A554329J 23A554334J 23A554339J 23A554340J 23A554344J 23A554383J 23A554384J 23A554386J 23A554488J 23A554489J 23A554612J 23A554657J 23A554661J 23A554664J 23A554711J 23A554717J 23A555027J 23A555529J 23A555680J 23A555732J 23A555738J 23A555916J 23A555918J 23A555923J 23A555925J 23A556005J 23A556006J 23A556009J 23A556013J 23A556015J 23A556019J 23A556021J 23A556023J 23A556024J 23A556096J 23A556206J 23A556208J 23A556210J 25A554563J 25A554666J 25A555279J 25A555280J 25A555282J 25A555419J 25A555428J 25A555826J 25A555939J 25A555940J 25A556039J 25A556112J 27A549240J 27A554506J 27A554977J, and 29A554434J
2. USA 23M546512J 23M547083J 23M547084J 23M547626J 23M547629J 23M547631J 23M547896J 23M547905J 25M553329J 25M553855J 25M554621J 27M555072J 27M555079J 27M555083J 27M555646J 27M555654J 27M555789J 27M555842J 29M554274J 29M560938J 29M561157J 29M561320J 29M561328J 29M561456J 31M552397J 31M553444J 31M553650J 31M553713J 31M553762J, and 31M555548J EUROPE 23M546513J 23M547076J 23M547088J 23M547195J 25M553559J 25M553640J 25M553854J 25M553931J 25M553946J 25M554246J 25M554629J 25M554858J 25M554910J 25M555060J 25M553850J 27M553375J 27M553383J 27M553562J 27M553570J 27M553572J 27M554161J 27M554172J 27M554173J 27M554176J 27M554181J 27M554182J 27M554185J 27M554187J 27M554189J 27M554260J 27M554262J 27M554263J 27M554264J 27M554265J 27M554267J 27M554269J 27M554271J 27M554351J 27M554354J 27M554358J 27M554450J 27M554454J 27M554458J 27M554511J 27M554518J 27M554642J 27M554643J 27M554645J 27M554646J 27M554810J 27M554863J 27M554870J 27M554923J 27M554992J 27M554993J 27M555069J 27M555315J 27M555330J 27M555333J 27M555341J 27M555342J 27M555347J 27M555350J 27M555353J 27M555439J 27M555440J 27M555441J 27M555442J 27M555443J 27M555444J 27M555538J 27M555540J 27M555541J 27M555543J 27M555545J 27M555546J 27M555641J 27M555642J 27M555644J 27M555647J 27M555652J 27M555691J 27M555743J 27M555744J 27M555745J 27M555746J 27M555754J 27M555755J 27M555763J 27M555787J 27M555791J 27M555852J 27M555858J 27M559405J 27M559440J 27M559448J 29M550088J 29M550209J 29M551061J 29M552565J 29M552612J 29M552648J 29M552649J 29M552717J 29M552722J 29M552922J 29M552927J 29M552937J 29M553239J 29M553240J 29M553289J 29M553295J 29M553353J 29M553355J 29M553442J 29M553763J 29M553857J 29M553858J 29M554079J 29M554080J 29M554369J 29M554400J 29M554578J 29M554679J 29M554680J 29M554683J 29M554684J 29M554734J 29M554736J 29M554737J 29M554744J 29M554783J 29M554871J 29M554872J 29M554874J 29M554875J 29M554877J 29M554879J 29M554929J 29M554930J 29M554931J 29M554932J 29M554933J 29M554935J 29M554936J 29M554937J 29M554939J 29M554940J 29M554941J 29M555095J 29M555099J 29M555101J 29M555107J 29M555110J 29M555153J 29M555154J 29M555158J 29M555556J 29M555560J 29M555561J 29M555656J 29M555657J 29M555665J 29M555984J 29M553354J 31M550204J 31M550207J 31M551255J 31M551256J 31M552714J 31M553351J 31M553443J 31M553446J 31M553576J 31M553657J 31M553711J 31M554466J 31M554471J 31M554577J 31M554876J 31M554880J 31M554934J 31M555371J 31M555372J 31M555549J 31M555980J, and 31M556181J CANADA 27M555436J 31M553577J, and 31M555160J OTHER 25M553700J 25M553796J 25M553798J 25M553799J 25M553841J 25M553933J 25M553943J 25M553948J 25M554348J 25M554565J 25M554619J 25M554626J 25M554633J 25M554721J 25M554729J 25M554731J 25M554733J 25M554775J 25M554803J 25M554804J 25M554805J 25M554806J 25M554856J 27M553374J 27M554676J 27M554922J 27M554926J 27M554989J 27M555001J 27M555084J 27M555313J 27M555314J 27M555316J 27M555317J 27M555331J 27M555332J 27M555337J 27M555338J 27M555339J 27M555340J 27M555343J 27M555345J 27M555348J 27M555349J 27M555430J 27M555433J 27M555437J 27M555542J 27M555643J 27M555645J 27M555649J 27M555687J 27M555689J 27M555690J 27M555741J 27M555748J 27M555749J 27M555751J 27M555752J 27M555759J 27M555786J 27M555790J 27M555843J 27M555846J 27M555851J 27M555854J 27M555945J 27M559304J 29M553712J 29M554078J 29M554085J 29M554086J 29M554087J 29M554784J 29M554928J 29M555098J 29M555108J 29M555159J 31M553761J 31M554280J 31M554465J 31M554468J 31M554685J 31M554735J 31M555370J 31M555373J 31M555547J 21A555222J 23A555240J 23A555676J 25A554043J 27M555544J 29A554153J 31M549988J, and 31M550134J

RECALLING FIRM/MANUFACTURER
Medtronic Heart Valve Division, Spring Lake Park, MN, by letter dated March 24, 2008. Firm initiated recall is ongoing.
REASON
The holder of the valve was incorrectly secured to the valve. This could potentially make it difficult to easily disengage the holder from the valve.
VOLUME OF PRODUCT IN COMMERCE
685 devices
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Q-Logic Controller Software used on the following power wheelchairs: Q6000, Q6000XL, Q6000Z, R4000, Q600, Q600XL, Q610, Q1107, Q600E, and Dynamo 1107, Recall # Z-1776-2008
CODE
Serial Numbers: J9602208233020, J5736007315020, J7526107036020, J9629207170020, J7501008030020, J5702908797060, J7529607010020, J9630907149020, J5704608254020, J9603908056020, J9603908056020, J5718007250020, J5723307144020, J5723207301020, J5723407136020, J7227507026020, J5728807092020, J7528907141020, J9629507111020, J7529907223020, J5730907096020, J9632007004020, J9635307146020, J5700308104020, J5726906070020, J5728606106020, J5711407229020, J5711607346020, J5717307078020, J5714307169020, J7219107157020, J5721507327020, J5716207521020, J5716507018020, J5732407100020, J5724107138020, J5725407048020, J5726707458020, J7529907221020, J5732307247020, J5705907063020, J5734507146020, J5735307331020, J5700808254020, J9600908175020, J9602508181020, J9402508170020, J5702508198020, J5702808845020, J5702908207020, J5704608142020, J9601808155020, J7225407065020, J5704208091020, J9622207232020, J9628207076020, J9621407082020, J9626407088020, J9600708204020, J5702508551020, J5710207395020, 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J5731807125020, J9630607246020, J5701008221020, J9632707074020, J8604308213020, J7212007001020, J5733907132020, J8633907299020, J5701608285020, J9633107003020, J5721307202020, J7225407201020, J5721207287020, J9634807194020, J9604608152020, J5701808118020, J5726207131020, J7536207185020, J5702908203020, J5734007020020, J9600308037020, J5702908204020, J5729107281020, J5728507137020, J9628507127020, J9630307007020, J5733107086020, J9633207200020, J5734107203020, J5704508261020, J5704508272020, J9604508273020, J5701508339020, J7505608116020, J9632707093020, J5711307155020, J5717907047020, J9605208059020, J5714207086020, J5719007155020, J7222907051020, J9601108299020, J9633207074020, J9634807123020, J9635207046020, J9601408076020, J9601108300020, J9623507028020,

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RECALLING FIRM/MANUFACTURER Pride Mobility Products, Corp., Exeter, PA, 
REASON Software - Watch dog timer feature was disabled.
VOLUME OF PRODUCT IN COMMERCE 4,129 units
DISTRIBUTION Nationwide and Canada

PRODUCT Hill-Rom Century+ Bed Model P1400 HBSW siderail upgrade kits; accessory model numbers: P9964-11, P9964-12, P9964-13, P9964-14, P9964-15, P9964-16, P9964-41 and /or P9964-42, 
CODE All MOD 376 HBSW Siderail Upgraded accessory kits shipped between 9/19/06 and 3/18/07.
RECALLING FIRM/MANUFACTURER Hill-Rom, Inc., Batesville, IN
REASON A risk of entrapment will exist between the head and foot rails if installation instructions are followed.
VOLUME OF PRODUCT IN COMMERCE 69 kits
DISTRIBUTION Nationwide

PRODUCT Xcelerate Patella System Reamer Shaft Assembly; Non-Sterile; Product no. 8001-1702, 
CODE Lots: MCYL30A, MCYL30B
RECALLING FIRM/MANUFACTURER Stryker Howmedica Osteonics, Corp., Mahwah, NJ,
REASON The Xcelerate Patella Reamer Shaft Assembly and the Reamer Adapter do not mate properly. This could result in the removal of excessive bone from the patella leading to a thinner patella; a patella that does not have enough bone for adequate engagement with pegs or patella fracture.
VOLUME OF PRODUCT IN COMMERCE 24 units
DISTRIBUTION Nationwide, Canada, and UK

PRODUCT Corometrics® Model 250 Series Maternal/ Fetal Monitor, Models 256 and 259, part number 2024489-002. Intended for monitoring fetal and maternal vital signs: fetal heart rate; optional fetal movement detection, FHR and UA alarms; maternal uterine activity; heart/pulse rate, blood pressure and %SP02, 
CODE
Serial Numbers: SBE07014189PA SBE07014184PA SBE07014167PA SBE06524133PA SBE07014196PA SBE07024243PA SBE07034259PA SBE07024238PA SBE07034256PA SBE07024218PA SBE07034268PA SBE07024212PA SBE07054323PA SBE07064333PA SBE07064354PA SBE07034248PA SBE07024229PA SBE07024211PA SBE07024239PA SBE07024237PA SBE07024203PA SBE07064387PA SBE07064335PA SBE07064395PA SBE07014187PA SBE07024225PA SBE07024227PA SBE07014181PA SBE07024204PA SBE07024206PA SBE07034313PA SBE07044317PA SBE07034261PA SBE07024231PA SBE07034276PA SBE07064357PA SBE07024219PA SBE07014194PA SBE07044315PA SBE07024201PA SBE07024215PA SBE07034302PA SBE07034252PA SBE07014179PA SBE07034247PA SBE07034246PA SBE07014152PA SBE07024244PA SBE07014191PA SBE07034298PA SBE07034299PA SBE07024241PA SBE07044322PA SBE07024216PA SBE07044318PA SBE07024213PA SBE07044316PA SBE07034260PA SBE07064375PA SBE07064398PA SBE07064368PA SBE07064377PA SBE07064373PA SBE07064341PA SBE07064384PA SBE07034255PA SBE07064347PA SBE07014185PA SBE07024208PA SBE07024214PA SBE07024205PA SBE07024207PA SBE07064389PA SBE07064330PA SBE07064352PA SBE07034250PA SBE07034257PA SBE07034254PA SBE07044321PA SBE07024242PA SBE07024235PA SBE07034270PA SBE07034264PA SBE07024220PA SBE07024236PA SBE06514069PA SBE06514079PA SBE06514078PA SBE06514081PA SBE06514092PA SBE06514084PA SBE06514090PA SBE07014199PA SBE07064385PA SBE07064390PA SBE07064393PA SBE07064331PA SBE07014200PA SBE07064369PA SBE07024232PA SBE07034296PA SBE07064340PA SBE07034307PA SBE07034309PA SBE07064353PA SBE07034301PA SBE07034310PA SBE07034300PA SBE07034306PA SBE07034308PA SBE07044319PA SBE07034312PA SBE07034304PA SBE07014166PA SBE07034272PA SBE07034281PA SBE07034290PA SBE07034291PA SBE07054324PA SBE07064329PA SBE07034280PA SBE07064334PA SBE07064336PA SBE07024240PA SBE07034251PA SBE07034267PA SBE07034293PA SBE07034279PA SBE07034274PA SBE07034258PA SBE07064345PA SBE07034286PA SBE07034295PA
RECALLING FIRM/MANUFACTURER Datex Ohmeda, Inc., dba GE Healthcare, Laurel, MD
REASON Communication connector within monitor is defective and may cause potential loss of telemetry.
VOLUME OF PRODUCT IN COMMERCE 133 units
DISTRIBUTION Nationwide

PRODUCT 3.5mm X 32.5mm Cortical Screw used with the Polarus Humeral Fixation System,. Product labeled in part, "Polarus Humeral Fixation System& SIZE: 3.5mm X 32.5mm Cortical Screw... REF HCO3325-S... ". Polarus Humeral Fixation System, 3.5mm X 32.5mm Cortical Screw are packaged in a sterile inner package which are placed into an outer box. The cortical screws are used with the Polarus Locking Humeral Rod (Polarus Huemral Fixation System) for the multi-planar fixation. The screws are sold individually to support the Polarus Locking Humeral Rod systems in the field, CODE Lot: W24552; Expiration date: 2010-05
RECALLING FIRM/MANUFACTURER Acumed LLC, Hillsboro, OR,
REASON Package of 3.5mm X 32.5mm cortical screw may contain 3.5mm X 5mm cortical screw.
VOLUME OF PRODUCT IN COMMERCE 112 screws
DISTRIBUTION Nationwide and Internationally

PRODUCT Medtronic Midas Rex Legend tapered dissecting tool, Model F2/8TA23; Intended for use in Spinal, Cranial, Orthopedic, General Surgical and Plastic Surgery applications for transection, osteotomy, graft harvesting, bone shaping, laminectomy, entry hole, suture hole, and midface advancement, 
CODE
Lot numbers: 0000710253, 0000710254, 0000710256, 0000710257, 0000710258, 0000710266, 0000710267, 0000710271, 0000710272, 0000710274, 0000710275, 0000710276, 0000710277, 0000710278, 0000710279, 0000710280, 0000710281, and 0000710288
RECALLING FIRM/MANUFACTURER Medtronic Powered Surgical Solutions, Fort Worth, TX
REASON Cutting flute geometry of surgical dissecting tools may be outside of established tolerance. This may lead to reduced cutting performance, inability to perform desired dissection, increased risk of overheating, and potential need for revision surgery.
VOLUME OF PRODUCT IN COMMERCE 1,306 units
DISTRIBUTION Nationwide

PRODUCT
a) Stem Trial, Triathlon Revision Instruments; Non-Sterile; 100 mm length Catalog numbers: 5565-T-009, 5565-T-010, 5565-T-011, 5565-T-012, 5565-T-013, 5565-T-014 5565-T-015, 5565-T-016, 5565-T-017, 5565-T-018, 5565-T-019, 5565-T-020 5565-T-021, 5565-T-022, 5565-T-023, 5565-T-024, 5565-T-025; Used in Revision TKA, 
b) Stem Trial, Triathlon Revision Instruments; Non-Sterile; 150 mm length Catalog Numbers: 5566-T-009, 5566-T-010, 5566-T-011, 5566-T-012, 5566-T-013, 5566-T-014 5566-T-015, 5566-T-016, 5566-T-017, 5566-T-018, 5566-T-019, 5566-T-020 5566-T-021, 5566-T-022, 5566-T-023, 5566-T-024, 5566-T-025; Used in Revision TKA, 
CODE All lot codes
RECALLING FIRM/MANUFACTURER Stryker Howmedica Osteonics, Corp., Mahwah, NJ,
REASON Triathlon TS Stems Trails may crack, potentially causing fragments of the plastic handle to fragment and break off completely.
VOLUME OF PRODUCT IN COMMERCE 5,731 Instruments
DISTRIBUTION Nationwide and Internationally

PRODUCT 10% Buffered Formalin Phosphate; Certified For laboratory and manufacturing use only, not for drug, food or household use. Do not Transfer to an unmarked container. Catalog numbers: SF100-4, SF100-20, 
CODE Lot: 075923
RECALLING FIRM/MANUFACTURER ThermoFisher Scientific Co., LLC, Fair Lawn, NJ
REASON Assay tests on retention sample of 10% Buffered Formalin Phosphate showed it to be 3.417%, which is below the specification of 4-5%.
VOLUME OF PRODUCT IN COMMERCE 1,052 x 4 liters; 564 x 20 liters
DISTRIBUTION Nationwide and Internationally

PRODUCTGeneral X-Ray System types with Digital Spot Imaging (DSI) software. Software version: rel 6, 
CODE
Serial numbers: 8, 18, 31, 40, 41, 45, 51, 52, 62, 63, 67, 71, 78, 79, 83, 84, 87, 88, 99, 100, 102, 104, 105, 106, 112, 116, 117, 118, 119, 127, 131, 132, 134, 136, 143, 146, 149, 153, 157, 163, and 164
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA,
Manufacturer: Philips Medical System, The Netherlands. REASON X-ray images may be stored in the wrong patient file or corrupted; images from two different patients may be combined in one patient's folder or may be combined on one image (corrupted).
VOLUME OF PRODUCT IN COMMERCE 41 units
DISTRIBUTION Nationwide

PRODUCT
a) ENDOPATH®ETS-Flex Endoscopic Linear Cutter, ATW35 Utilized during general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses, 
b) ENDOPATH®ETS Endoscopic Linear Cutter, TSW35. Utilized during general,  gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses, 
c) ENDOPATH®ETS and ETS-Flex Endoscopic Linear Cutter Reload; TR35W. Utilized during general, gynecologic, urologic, and thoracic surgery for transection,  resection, and/or creation of anastomoses, 
d) FlexTray"Procedure Delivery System ENDOPATH®; FBW67XL, FD064, FDB15, TGL45XL, XBB02B, XBB58S, XBB59S, XLB01B, XLB50S, XPD51S. Utilized
during general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses, 
CODE
a) Batch #’s: D4G751, D4G753, D4G80W, D4G84U, D4G85N, D4G983, D4GA5T,  D4GA5U, D4GD6D, D4GE7U, D4GE7V, D4GH0X, D4GH8E, D4GK3M,
  D4GL0U, D4GN0F, D4GN0G, D4GN1C, D4GN85, D4GN86, D4GP7U,  D4GP7V, D4GT3X, D4GT3Y, D4GW1U, D4GW1V, D4GW2H, D4GW3G,
D4GW8H, D4H037, D4H038, D4H07L, D4H07M, D4H213, D4H214, D4H546, D4H55J, D4H61E, D4H61F, D4H66D, D4H66E, D4H804, D4H806, D4H80W,
D4H80X, D4H82E, D4H86F, D4H91Z, D4H97U, D4H98J, D4H98K, D4HA2X, D4HA54, D4HC1X, D4HC1Y, D4HC93, D4HC94, D4HD95, D4HD96, D4HE2D,
  D4HE2E, D4HF2F, D4HF2G, D4HG65, D4HG66, D4HJ0A, D4HJ8R, D4HJ9K,  D4HK2G, D4HK4G, D4HL5M, D4HL6K, D4HM2L, D4HM2N, D4HM7W,
D4HN1Y, D4HN1Z, D4HN5E, D4HR1L, D4HR1M, D4HT53, D4HT5K, D4HU3W, D4HU3X, D4HU79, D4HV1P, D4HV3C, D4HV3D, D4HW0G, D4HW1A, D4HY9R, D4HZ86, D4J14K, D4J198, D4J199, D4J91, D4JC0, and  D4JC9P;
b) Batch #s: D4G80V, D4G97P, D4G97R, D4GA09, D4GC96, D4GC97, D4GF6G, D4GH13, D4GH5J, D4GJ58, D4GK8C, D4GL2R, D4GN4E, D4GN99, D4GR13,
D4GT54, D4GT6V, D4GT93, D4GT9Z, D4GV02, D4GV03, D4H03D, D4H03F, D4H042, D4H052, D4H053, D4H090, D4H091, D4H092, D4H441, D4H442,
D4H50M, D4H58Z, D4H68R, D4H68T, D4H69Z, D4H99F, D4H99G, D4HC0R, D4HC1C, D4HE3E, D4HF3M, D4HG1D, D4HG1E, D4HH26, D4HJ3W, D4HJ3X,
  D4HK4P, D4HL73, D4HM13, D4HM15, D4HP2L, D4HP2M, D4HP6G, D4HP6J, D4HR98, D4HR9A, D4HV3A, D4HW7Y, D4HX1D, D4HY6J, D4HY98,
  D4HZ1M, D4HZ1N, D4J09J, D4J17L;
c) Batch #s: D4G80E, D4G85W, D4G903, D4G94L, D4GA32, D4GD36, D4GE66,  D4GH0T, D4GJ2K, D4GK3Y, D4GK9L, D4GM52, D4GM7U, D4GN6E,
  D4GP0J, D4GP4R, D4GP72, D4GR0X, D4GT2T, D4GV6T, D4GV87, D4GW38, D4GW9W, D4H070, D4H18C, D4H22G, D4H44D, D4H46J,  D4H48L, D4H49L, D4H51F, D4H60R, D4H70P, D4H72W, D4H77M,
D4H86J, D4H903, D4H930, D4HA5E, D4HC0M, D4HC72, D4HE2N, D4HG0T, D4HG35, D4HG6F, D4HG9G, D4HH5V, D4HH9D, D4HJ8K,  D4HL4G, D4HM5L, D4HN53, D4HP27, D4HP58, D4HP9X, D4HR68,  D4HT58, D4HU52, D4HW1L, D4HW24, D4HW7N, D4HX45, D4HX8P,  D4HY1D, D4HY6U, D4HZ5K, D4J03R, D4J08F, D4J13C, D4J187, D4G51J,
  D4G56F, D4G69L, D4G725;
d) Batch #: D4GR6F, D4GR6P, D4GT7G, D4H14H; Product Code: FD064,   Batch # D4G520; Product Code: FDB15, Batch # D4GD04;  Product Code: TGL45XL, Batch # D4J493; Product Code: XBB02B,  Batch # D4GK74, D4GU1T, D4HL3X, D4HL7C, D4HM4P, D4HM9D,
  D4JE0R; Product Code: XBB58S, Batch # D4G94G, D4GK69, D4GP93,  D4GW31, D4HG6V, D4J204; Product Code: XBB59S, Batch # D4GA1K,  D4GC1G, D4GD9U, D4GD7C, D4GX8R, D4HD17, D4HD6X, D4HE54,
  D4HM6G; Product Code: XLB01B, Batch # D4GD0R, D4GF8J, D4H593,  D4HR87; Product Code: XLB50S, Batch # D4GK4X, D4GP94, D4GT3K, D4HF0V, D4J47E, D4JE8P; Product Code: XPD51S, Batch # D4GT7T,
  D4HF7M , D4J32T
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ethicon Endo-Surgery Inc., Cincinnati, OH, Manufacturer: Ethicon Inc., Chihuahua, Mexico. 
REASON The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.
VOLUME OF PRODUCT IN COMMERCE 42,434 pieces
DISTRIBUTION Nationwide and Internationally

PRODUCT Boston Scientific Scimed Maverick 2 Monorail" PTCA Catheter, 3.0 mm 15 mm REF 38928-1530 Lot 9565194, Use before 2010-04 Indicated for balloon dilation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, CODE Lot 9565194, Exp April 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Natick, MA, 
Manufacturer: Boston Scientific Ireland, Ltd., Galway, Ireland. 
REASON The units within this lot may not meet thickness specifications surrounding the wire exit port wall, which may result in an air embolization if the Port Septum Wall burts.
VOLUME OF PRODUCT IN COMMERCE24 units
DISTRIBUTION Internationally

PRODUCT Boston Scientific Scimed Maverick 2 Monorail 12mm Balloon Catheter, 2.5 mm x 12 mm; REF 38928-1225 Use before 2007-01 UPN H7493892812250 Sterilized with ethylene oxide gas Boston Scientific Scimed Maverick 2 Monorail 20mm Balloon Catheter, 3.5 mm x 20mm Made in Ireland, REF 38928-2035; Use before 2007-01 UPN H7493892820350 Sterilized with ethylene oxide gas Indicated for dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, 
CODE Lots: 6240888, Exp January 2007; 6240363, Exp January 2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Natick, MA, 
Manufacturer: Boston Scientific Ireland, Ltd., Galway, Ireland. 
REASON Two lots may not be correctly labeled. Specifically, a 2.5 mm x 12 mm unit was incorrectly labeled as a 3.5 x 20 mm unit on the box and tyvek label.
VOLUME OF PRODUCT IN COMMERCE 67 units
DISTRIBUTION Internationally

PRODUCT Ev3 Protege GPS Biliary Stent Systems 6 mm, 60 mm, 120cm, .35, 6Fr, OTW Ev3 4600,  Ref SERB65-06-60-120; Use before 2009-01-01, Sterile EO Intended as a palliative treatment of malignant neoplasms in the biliary tree, 
CODE Lot: 2675311
RECALLING FIRM/MANUFACTURER Ev3, Inc., Plymouth, MN, 
REASON A Protege PS Biliary Stent System was mislabeled. The mislabeling resulted in a 9 mm diameter, 60 mm length stent being labeled as a 6 mm x 60 mm stent.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Nationwide

PRODUCT Ev3 Primus GPS Biliary Stent Systems 8 mm, 37 mm, B7, 40 mm, 5Fr, REF BXB35-08-37-75; Use before 2009-02, Sterile EO Intended as a palliative treatment of malignant neoplasms in the biliary tree, 
CODE Lot: 2092998
RECALLING FIRM/MANUFACTURER Ev3, Inc., Plymouth, MN,
REASON A Primus GPS Biliary Stent System was mislabeled. The mislabeling resulted in a 8 mm diameter, 27 mm length stent being labeled as a 8 mm x 37 mm stent.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Nationwide

PRODUCT
a) Medtronic 8578 Sutureless Pump Connector Revision Kit. A part of the Synchro Med II Infusion system, which is designed to restore and provide intrathecal administration of drug therapy, 
b) Model 8596SC Intrathecal Catheter Pump Segment Revision Kit. A part of the  SynchroMed II Infusion system, which is designed to restore and provide intrathecal administration of drug therapy, 
c) Model 8709SC Indura 1P One-Piece Intrathecal Catheter. A part of the SynchroMed II Infusion system, which is designed to restore and provide intrathecal administration of drug therapy., 
d) Model 8731SC Intrathecal Catheter. A part of the SynchroMed II Infusion system, which is designed to restore and provide intrathecal administration of drug therapy, 
CODE All lots numbers
RECALLING FIRM/MANUFACTURER Medtronic Neuromodulation, Minneapolis, MN,
REASON The SC catheters cannot completely engage with the Model 700-04M portal connector. The result of this condition is a possible leakage or disconnect of the SC catheter from the portal during the continuous therapy trial period.
VOLUME OF PRODUCT IN COMMERCE 232 pumps
DISTRIBUTION Belgium

PRODUCT HOUVA III Phototherapy System with DermaSense Technology comes on one skid within 10 cardboard boxes. A therapeutic product designed for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders, 
CODE
Serial #'s: 10134, 10145, 10147, 10148, 10105, 10151, 10112, 10113, 10114, 10101, 10150, 10140, 10103, 10123, 10135, 10135, 10138, 10137, 10122
RECALLING FIRM/MANUFACTURER National Biological Corp., Beachwood, OH, 
REASON Software allows operator to override “low line voltage” error warning and store light intensity value.
VOLUME OF PRODUCT IN COMMERCE 48 units
DISTRIBUTION Nationwide and Canada

PRODUCT Acu-Loc Distal Radius Plate, Standard, Left. Product labeled in part, “Acu-Loc Distal Radius Plate, Standard, Left… PL-DR50L W48003, 
CODE Lot: W4800; Expiration date: 2012-02
RECALLING FIRM/MANUFACTURER
Recalling Firm: Acumed LLC, Hillsboro, OR, 
Manufacturer: Specialized Medical Devices, Lancaster, PA. REASON Plates are incorrectly laser marked. The PL-DR50L plates are incorrectly laser marked with PL-DR70L.
VOLUME OF PRODUCT IN COMMERCE 51 plates
DISTRIBUTION Nationwide and Internationally

PRODUCT Radiation Protective Eyewear (only involving multifocals. FTC 28 Progress X-Ray Protective Eyewear Protective Eyewear is not sent with any package inserts or labeling. It is sent in plain envelope, bag or box. FT28 product numbers: PX-PROG, PX-FT28, FB-103-RXB, FB-500-RXB, FB-100-SRXB, FB-100-BRXB, FB-100-CRXB, FB-108-SRXB, FB-108-BRXB, RGS-97RX-BI, SFFT X-RAY, RGS-53-BI, LT-53-RXP, RG-500-SRG1.5, RG-500-SRG2.0,
CODE All radiation protective bifocals
RECALLING FIRM/MANUFACTURER Phillips Safety Products, Middlesex, NJ, 
REASON Radiation Protective Eyewear does not meet the radiation protection levels stated on the labeling.
VOLUME OF PRODUCT IN COMMERCE 845 pairs
DISTRIBUTION Nationwide and Internationally

WEEK ENDING SEPTEMBER 13

PRODUCT GE Precision 500D Classical Radiographic-Fluoroscopic X-ray System. Model #2289299-2, with console computer and touch screen fully integrated. The GE Precision 500D Classical Radiographic-Fluoroscopic X-ray System is used to perform radiographic and fluoroscopic x-ray examinations, 
CODE
2023567F53 203576P500 205783PRF4 208227ROOM6 208678500D 210916BRF1 218741P500 252847PR7 256880CR4 260463PRE 269657P500D 281401T500D 303450RM3DIG 303825P500 303837P50010 305325RM10 305325RM7 352401RF1 352402RM1 352596RF1 386HPORF 402481BP500 404785P500D1 406863P500 414649ENDOP1 419291FL1 503513RM4 504897RF 505627RF1 509525VP500 510267VARF 510797RM3 512943GTP500 570574PREC1 570574PREC2 580548P500B 601445PRF1 601853RF1 601853RF2 605333RM8 606759P500 606789PRE 606878P500 608756P500 609597P500 610378RF3 610378RF4 615446NRF 617414ENDO1 617789RFE 618964MPRF1 631427P500D 631444P500D 651220P500 662751RF1 671GMHAP5D 678454P500D1 678454P500D2 703558ROOM3 706335RF1 706774UB8 707443STJ2 712472P500 713441MMRF1 716878WCRF2 732840P5D 757314SRM1 757398RM1 773962PR1 801292PR5 801465RM1 801479RM5 805546P500 812825PRE500 814938RM1 815741P500 817545P500 818409RF1 828213AIRF2 843374P500 845561P500D 850431RM9 850934P500A 863902RF 864366ARF2 870864P500 908647500D 910452CFR3 918274500D 937440RM2 972981P500 973661500D 973676500D 979282P500D MONT500D USFREEDOM500 KW1013RX15 KW1085RX01 00490FLU01 C5123628 FP970407 00824FLU02 00471FLU03 00090FLU02 05229FLU02 705356PR500
RECALLING FIRM/MANUFACTURER GE Healthcare, Waukesha, WI, 
REASON It was reported that when the GE Precision 500D foot pedal is repeatedly activated, a defect in the fluoro-timer will cause the dose measurement to report a higher value than was actually received by the patient. Patient will receive a lower dosage irradiation time which will result in indication of cumulative air kerma higher than that to which the patient was actually exposed.
VOLUME OF PRODUCT IN COMMERCE 106 systems
DISTRIBUTION Nationwide, Italy, Kuwait, Great Britain, Spain and Canada

PRODUCT
a) GE Healthcare Definium 5000 Digital Radiographic Imaging System. Model numbers 5220493. The Definium 5000 System is designed to handle radiographic applications using the digital system. The system configuration  includes a choice of elevating or non-elevating or no table, a floor column stand with rotating U-arm, and GE's patented Digital detector that captures  radiographic images in digital form, as well as an X-ray generator/power unit,    
b) GE Healthcare Definium 5000 Digital Radiographic Imaging System. Model number:  5220493-2. The Definium 5000 System is designed to handle radiographic applications using the digital system. The system configuration includes a choice of elevating or non- elevating or no table, a floor column stand with rotating U-arm, and GE's patented Digital detector that captures radiographic images in digital form, as well as an X-ray generator/ power unit, 
CODE
a) PC0127XR06, M1973721;
b) 0002695030, 904321DEF5, 480543XR1, 254965D5000, 601855D5K, 914864D5000, 614293D5KX, 239482D5000, 239432D5000, 0002697145, RADNETDEF1, and 239596D5000
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Waukesha, WI, 
Manufacturer: Sedecal S.A., Algete, Spain. 
REASON GE Definium 5000 Collimator failed compliance testing due to a blade sizing issue.
VOLUME OF PRODUCT IN COMMERCE 14 units
DISTRIBUTION MD, FL, AZ, TX, MS, NY, OH, CA, Germany, France

PRODUCT Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test system, Product Number: 1760, 
CODE Lot Number: 97266, Exp. March 12, 2008
RECALLING FIRM/MANUFACTURER Siemens Medical Solution Diagnostics, Norwood, MA.
REASON False positive hCG results.
VOLUME OF PRODUCT IN COMMERCE 3,065 kits
DISTRIBUTION Nationwide, Canada, France, Korea, Netherlands, UK

PRODUCT
a) CryoValve, Aortic Valve & Conduit. Donor number 87732, b) CryoValve, Pulmonary Valve & Conduit. Donor number 87732, 
CODE
a) Serial number 8895131;
b) Serial number 8895391
RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, GA,
REASON Tissues taken from a donor whose blood culture was found positive for Serratia marcescens, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 tissues
DISTRIBUTION DE, TN

PRODUCT 

a) Deltec Cozmo® Insulin Pump, model 21-1700. A syringe infusion pump designed for Continuous Subcutaneous Insulin Infusion for the control of diabetes. Reorder Numbers: 21-1701-02/32/33/36/44/49/51/54/62/63/66/81 21-1702-02//49/51 21-
    1703-02/32/33/36/44/49/51/54/62/63/66/81 21-1704-
    02/32/33/36/44/49/51/54/62/63/66/81 21-1705-79 21-1706-79 21-1707-79 21-1711- 01/02/03/06/14/50 21-1712-01/02 21-1713-01/02/03/06/14/50 21-1714-
    01/02/03/06/14/50 21-1715-19 21-1716-19 21-1717-19, b) Deltec Cozmo® Insulin Pump, model 21-1800. This is similar to the currently distributed Deltec Cozmo® Insulin Pump Model 1700, with the exception of updated software that enhanced certain features and added a food data base to allow users to better manage dietary requirements in conjunction with the use of their insulin pump. Reorder Numbers: 21-1801-81 21-1803-81 21-1804-81 21-1805-
  49/51/81 21-1806-49/51/81 21-1807-49/51/81 21-1815-01/50 21-1816-01/50 21- 1817-01/50, 
CODE All serial numbers
RECALLING FIRM/MANUFACTURER Medical MD, Inc., Saint Paul, MN, 
REASON Smith Medical has received reports of Deltec Cozmo® Insulin Pumps powering down without an alarm. Investigation concluded that if the battery cap is not fully tightened, the Pump may power down and a brief "chirp" will sound. This may occur if the user has not sufficiently tightened the battery cap or if the battery cap is damaged. If a patient is asleep or does not regularly check their blood glucose, as trained, there is a potential risk of harm to the patient if the Pump's powering down goes unnoticed. When the Pump is powered down, delivery of insulin is interrupted.
VOLUME OF PRODUCT IN COMMERCE 39,646 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) InCompass® Spinal Fixation System T-Handle Driver; Part #2151-4 (9.5" shaft)  and 2151-5 (13" shaft); Non-sterile, Reusable Instrument; 
b) PathFinder® Spinal Fixation System T-Handle Driver; Part 2151-7 (13" shaft); Non-sterile, Reusable Instrument; 
CODE All lots
RECALLING FIRM/MANUFACTURER Abbott Spine, Austin, TX, 
REASON Reports received regarding disassembly of T-Handle Driver components during surgery dropping the closure top into the surgical site.
VOLUME OF PRODUCT IN COMMERCE 502 units
DISTRIBUTION Nationwide

PRODUCT
a) Boston Scientific SteeroCath-T Ablation Catheter. This catheter is indicated for general indications, treatment of supraventricular tachycardia (svt) and ventricular tachycardia (vt). This product in not indicated for use as an ablation catheters indicated for treatment of atrial flutter or for atrial fibrillation; Model Numbers:  M004EPT63030; M004EPT6303N40 and M004EPT6304K20, 
b) Boston Scientific SteeroCath-Dx Diagnostic Catheter, Model Numbers M0042027BL0 and M0042028BL0, 
CODE
a) Lot #’s: 0011058480, 0011118994; Lot# 0011106106; Lot# 0011058482;
b) Lot #’s: 0011092878, 0011092882, 0011107097;
    Lot #’s: 0011036506, 0011036507, 0011036585, 0011036586, 0011043535, 0011043537, 0011046910, 0011046913, 0011049772, 0011049773, 0011054879,
0011055000, 0011059409, 0011059410, 0011061991, 0011061992, 0011065023, 0011065024, 0011069509, 0011069510, 0011073729, 0011073730, 0011078604,  0011078605, 0011081318, 0011081445, 0011083742, 0011083743, 0011087354, 0011087355, 0011088108, 0011088109, 0011096360
RECALLING FIRM/MANUFACTURER Boston Scientific Corp., San Jose, CA,
REASON Package sterile barrier may be breached, compromising sterility.
VOLUME OF PRODUCT IN COMMERCE 827 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) OEC9800 Image Intensified fluoroscopic x-ray system (includes OEC 9800, OEC  FluoroTrak 9800 Plus, OEC 9800 Plus, and OEC 9800MD Motorized C-arm System), 
b) OEC 9900 Elite Image-intensified fluoroscopic x-ray system (includes OEC 9900 Elite Fluoroscopy System and 9900 EliteMD Motorized C-arm System),
CODE
a) Serial numbers: 82-0886, 82-1387, 82-1471, 82-1827, 82-1837, 82-2088, 82-2091-C, 82-2219, 82-2265, 82-2298, 82-2308, 82-2330, 82-2342, 82-2418, 82-2633, 82-2764,  82-2902, 82-2919, 82-2982, 82-3012-N, 82-3033, 82-3062, 82-3147, 82-3185,  82-3311, 82-3313, 82-3314, 82-3411, 82-3428-E, 82-3509, 82-3510, 82-3576, 82-3739, 82-3763, 82-3765, 82-3830, 82-3880, 82-7106, 82-7179-MH, 89-0014, 89-0017, 89-0938, 89-1128, 89-1451, 89-2212, 89-2402, 89-2773, 89-2989,
89-3078, 89-3083, 89-3164, 89-3301, 89-3356, 89-3487, 8S-0271, 8S-0488, 8S-0974, 8S-1460, 8S-1487, 8S-1508-N, 8S-1582, 8S-1932-N, 8S-2425, 8S-2507, 8S-3054, 8S-3236, 8S-3242, 8S-7141-MH, 8S-7199-MH;
b) Serial numbers: E2-0034, E2-0088, E2-0109, E2-0258, E2-0270, E2-7019-MH, E2-7020-MH, E2-7034-CMH, E2-7037-MH, E2-7043-MH, E9-0029, E9-0047,
E9-0169, E9-0171, E9-0172, E9-0173, E9-0177, ES-0113, ES-7015-MH
RECALLING FIRM/MANUFACTURER OEC Medical Systems, Inc., Salt Lake City, UT, 
REASON Use of existing four-pedal footswitch on a different machine may cause various operational errors.
VOLUME OF PRODUCT IN COMMERCE 112 units
DISTRIBUTION Nationwide

PRODUCT In vitro Diagnostic-Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test system Product Number: 1760 The Clinitest hCG Pregnancy Test is for in vitro diagnostic use as a qualitative method in the rapid detection of human chorionic gonadotropin (hCG) in urine specimens, 
CODE Lot 97552 Exp 05/16/08; Lot 97574 Exp 05/17/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solution Diagnostics, Norwood, MA, 
Manufacturer: Wampole Laboratories, Princeton, NY. 
REASON False negative hCG results due to decreased sensitivity.
VOLUME OF PRODUCT IN COMMERCE 8,180 kits
DISTRIBUTION Nationwide

PRODUCT
1) Zimmer Spine Cyclone anterior cervical plate, 1 Level, 14MM (Ti-6Al-4V); REF 600-01-114,
2) Zimmer Spine Cyclone anterior cervical plate, 1 Level, 16MM (Ti-6Al-4V); REF 600-01-116, 
3) Zimmer Spine Cyclone anterior cervical plate, 1 Level, 18MM (Ti-6Al-4V); REF 600-01-118, 
4) Zimmer Spine Cyclone anterior cervical plate, 1 Level, 20MM (Ti-6Al-4V); REF 600-01-120, 
5) Zimmer Spine Cyclone anterior cervical plate, 1 Level, 22MM (Ti-6Al-4V); REF 600-01-122, 
6) Zimmer Spine Cyclone anterior cervical plate, 1 Level, 24MM (Ti-6Al-4V);
    REF 600-01-124, Recall # Z-1722-2008;
7) Zimmer Spine Cyclone anterior cervical plate, 1 Level, 26MM (Ti-6Al-4V); REF 600-01-126, 
8) Zimmer Spine Cyclone anterior cervical plate, 1 Level, 28MM (Ti-6Al-4V); REF 600-01-128, 
9) Zimmer Spine Cyclone anterior cervical plate, 2 Level, 30MM (Ti-6Al-4V); REF 600-02-130, 
10) Zimmer Spine Cyclone anterior cervical plate, 2 Level, 32MM (Ti-6Al-4V);  REF 600-02-132, 11) Zimmer Spine Cyclone anterior cervical plate, 2 Level, 34MM (Ti-6Al-4V);
REF 600-02-134, 
12) Zimmer Spine Cyclone anterior cervical plate, 2 Level, 36MM (Ti-6Al-4V); REF 600-02-136, 
13) Zimmer Spine Cyclone anterior cervical plate, 2 Level, 38MM (Ti-6Al-4V); REF 600-02-138, 
14) Zimmer Spine Cyclone anterior cervical plate, 2 Level, 40MM (Ti-6Al-4V);  REF 600-02-140, 
15) Zimmer Spine Cyclone anterior cervical plate, 2 Level, 42MM (Ti-6Al-4V);  REF 600-02-142,
16) Zimmer Spine Cyclone anterior cervical plate, 2 Level, 44MM (Ti-6Al-4V); REF 600-02-144, 
17) Zimmer Spine Cyclone anterior cervical plate, 3 Level, 45MM (Ti-6Al-4V);  REF 600-03-145, 
18) Zimmer Spine Cyclone anterior cervical plate, 3 Level, 48MM (Ti-6Al-4V); REF 600-03-148, 
19) Zimmer Spine Cyclone anterior cervical plate, 3 Level, 51MM (Ti-6Al-4V); REF 600-03-151; 
20) Zimmer Spine Cyclone anterior cervical plate, 3 Level, 54MM (Ti-6Al-4V); REF 600-03-154, 
21) Zimmer Spine Cyclone anterior cervical plate, 3 Level, 57MM (Ti-6Al-4V); REF 600-03-157, 
22) Zimmer Spine Cyclone anterior cervical plate, 3 Level, 60MM (Ti-6Al-4V); REF 600-03-160, 
23) Zimmer Spine Cyclone anterior cervical plate, 3 Level, 63MM (Ti-6Al-4V); REF 600-03-163, 
24) Zimmer Spine Cyclone anterior cervical plate, 3 Level, 66MM (Ti-6Al-4V); REF 600-03-166, 
25) Zimmer Spine Cyclone anterior cervical plate, 4 Level, 60MM (Ti-6Al-4V); REF 600-04-160, 
26) Zimmer Spine Cyclone anterior cervical plate, 4 Level, 64MM (Ti-6Al-4V); REF 600-04-164, 
27) Zimmer Spine Cyclone anterior cervical plate, 4 Level, 68MM (Ti-6Al-4V); REF 600-04-168, 
28) Zimmer Spine Cyclone anterior cervical plate, 4 Level, 72MM (Ti-6Al-4V); REF 600-04-172, 
29) Zimmer Spine Cyclone anterior cervical plate, 4 Level, 72MM (Ti-6Al-4V); REF 600-04-176, 
30) Zimmer Spine Cyclone anterior cervical plate, 4 Level, 80MM (Ti-6Al-4V);  REF 600-04-18, 
31) Zimmer Spine Cyclone anterior cervical plate, 4 Level, 84MM (Ti-6Al-4V); REF 600-04-184, 
32) Zimmer Spine Cyclone anterior cervical plate, 4 Level, 88MM (Ti-6Al-4V); REF 600-04-188, 
CODE All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer, Inc., Warsaw, IN, 
Manufacturer: Zimmer Spine, Inc., Minneapolis, MN. 
REASON The screw locking cap may fracture when the surgeon rotates it into the locked position.
VOLUME OF PRODUCT IN COMMERCE 1,185 units
DISTRIBUTION AZ, CA, FL, GA, LA, MI, MN, MT, NH, NC, OK, PA, TN, TX, UT, WA, WI

PRODUCT UBiT®-IR300 Infrared Spectrophotometer, Software Versions 7.0, 7.01 and 7.11
CODE
300292 300427 300129 300159 300502 300055 300378 300586 300262 300326 300219 300239 300356 300339 300318 300439 300511 300547 300294 300672 300697 300699 300460 300633 300004 300519 300531 300344 300525 300596 300597 300644 300303 300662 300208 300606 300389 300381 300281 300594 300247 300061 300534 300627 300438 300501 300599 300602 300616 300646 300566 300443 300541 300176 300283 300409 300050 300065 300072 300105 300099 300086 300182 300375 300342 300423 300428 300429 300454 300456 300479 300503 300543 300601 300588 300071 300276 300031 300217 300178 300703 300175 300025 300563 300059 300168 300437 300017 300641 300416 300570 300348 300268 300467 300325 300202 300684 300266 300497 300114 300398 300155 300560 300637 300676 300073 300704 300705 300698 300204 300696 300316 300604 300665 300367 300695 300211 300232 300581 300611 300457 300308 300229 300490 300227 300162 300180 300286 300371 300504 300651 300515 300079 300317 300512 300170 300104 300106 300571 300465 300625 300666 300068 300088 300293 300003 300327 300430 300028 300070 300022 300011 300592 300530 300090 300132 300681 300372 300257 300148 300164 300192 300273 300297 300359 300481 300518 300285 300678 300223 300447 300385 300100 300545 300265 300365 300319 300382 300558 300289 300081 300638 300579 300120 300506 300655 300027 300468 300037 300002 300542 300131 300514 300436 300500 300110 300084 300145 300141 300307 300230 300331 300082 300115 300540 300632 300476 300631 300380 300048 300045 300167 300284 300374 300393 300421 300441 300451 300006 300173 300305 300144 300657 300420 300445 300634 300483 300347 300111 300238 300156 300653 300161 300498 300546 300459 300603 300058 300677 300101 300242 300691 300660 300431 300220 300433 300237 300405 300522 300189 300379 300109 300188 300218 300251 300391 300508 300656 300264 300639 300707 300685 300716 300158 300412 300138 300089 300121 300244 300551 300046 300263 300693 300370 300153 300493 300345 300619 300116 300195 300163 300418 300146 300562 300181 300198 300174 300240 300333 300613 300313 300051 300557 300669 300670 300295 300673 300113 300614 300246 300635 300568 300190 300710 300302 300213 300322 300361 300595 300309 300186 300026 300408 300667 300572 300555 300536 300054 300341 300362 300593 300455 300569 300346 300394 300260 300640 300659 300464 300582 300446 300112 300624 300323 300205 300160 300658 300005 300179 300528 300654 300462 300224 300349 300415 300626 300014 300469 300486 300553 300565 300016 300314 300452 300407 300123 300396 300152 300623 300494 300527 300664 300561 300142 300717 300706 300709 300564 300649 300585 300269 300127 300133 300009 300234 300321 300255 300397 300406 300417 300400 300529 300267 300587 300366 300600 300335 300612 300067 300643 300008 300136 300605 300711 300499 300384 300475 300584 300256 300607 300216 300085 300183 300134 300143 300474 300392 300310 300278 300130 300628 300093 300575 300097 300609 300424 300444 300702 300701 300708 300117 300047 300215 300470 300690 300556 300466 300567 300387 300154 300007 300682 300687 300353 300184 300434 300689 300012 300686 300035 300700 300013 300191 300029 300549 300340 300091 300448 300487 300226 300139 300636 300610 300271 300228 300312 300249 300137 300092 300080 300185 300020 300668
RECALLING FIRM/MANUFACTURER
Recalling Firm: Otsuka America Pharmaceutical, Inc., Rockville, MD, 
Manufacturer: Otsuka Electronics Co., Ltd., Shiga, Japan. REASON Medical device power supply may overheat and cause smoke to be emitted from the device.
VOLUME OF PRODUCT IN COMMERCE 463 units
DISTRIBUTION Nationwide and Mexico

PRODUCT
a) Hall Easy-Fit® Prosthetic Heart Valve - Aortic A7700. The device uses a single pyrolytic carbon disc occluder pivoting within a titanium housing. The housing is machined into final configuration from a single piece of solid titanium and has no
welds or introduced bends. It is an open-membered design in which all members project centrally without distal attachment. A rotatable fabric sewing ring is affixed to the valve. The valve is provided on a holder (collect) to facilitate insertion and to provide protection during shipping and handling. The valve is
sterile and non-pyrogenic if seal and package are not opened, damaged, or broken,
b) Hall Easy-Fit® Prosthetic Heart Valve - Mitral M7700. The device uses a single pyrolytic carbon disc occluder pivoting within a titanium housing. The housing is machined into final configuration from a single piece of solid titanium and has no welds or introduced bends. It is an open-membered design in which all members project centrally without distal attachment. A rotatable fabric sewing ring is affixed to the valve. The valve is provided on a holder (collect) to facilitate insertion and to provide protection during shipping and handling. The valve is sterile and non- pyrogenic if seal and package are not opened, damaged, or broken,
CODE
a) USA 19A554013J 19A554110J 19A554192J 19A554193J 19A554196J 19A554287J 19A554292J 19A554298J 21A553685J 21A553921J 21A553982J 21A553985J 21A554133J 21A554959J 21A555003J 21A555206J 21A555473J 21A555711J 21A555821J 21A555906J 21A555914J 23A553480J 23A553533J 23A553611J 23A553837J 23A553987J 23A554034J 23A554663J 23A555403J 23A555772J 23A556211J 23A556271J 25A554669J 25A555417J 25A556058J 25A556107J 27A549092J 27A549340J 27A553554J 27A554155J 27A554159J 27A554224J 27A554225J 27A554232J 27A554236J 27A554436J 27A554507J 27A555286J 27A555289J 27A556046J 27A559810J 27A559811J 27A559812J 27A559918J 29A549102J 29A549192J 29A549193J 29A549242J 29A551836J 29A551988J 29A554151J 29A554156J 29A554158J 29A554226J 29A554231J 29A554435J 29A554438J 29A554439J, and 29A554440J EUROPE 19A554058J 19A554109J 19A554126J 19A554201J 19A554289J 19A554290J 19A554604J 19A554654J 19A554749J 19A554754J 19A560318J 19A560981J 19A560992J 19A561161J 19A561162J 19A561172J 19A561230J 19A561233J 19A561237J 19A561246J 21A553907J 21A554016J 21A555382J 21A555395J 21A555637J 21A555719J 21A555723J 23A553121J 23A553122J 23A553200J 23A553412J 23A553478J 23A553531J 23A553539J 23A553605J 23A553616J 23A553838J 23A554137J 23A554331J 23A554493J 23A554658J 23A554709J 23A554716J 23A554720J 23A554843J 23A554965J 23A554968J 23A555025J 23A555251J 23A555263J 23A555516J 23A555519J 23A555523J 23A555524J 23A555527J 23A555531J 23A555532J 23A555613J 23A555622J 23A555623J 23A555675J 23A555681J 23A555735J 23A555773J 23A555775J 23A555915J 23A555917J 23A555922J 23A555924J 23A555926J 23A555927J 23A555928J 23A555929J 23A556008J 23A556011J 25A554042J 25A554044J 25A554047J 25A554139J 25A554144J 25A554217J 25A554220J 25A554221J 25A554425J 25A554426J 25A554428J 25A554429J 25A554431J 25A554432J 25A554503J 25A554554J 25A554556J 25A554557J 25A554558J 25A554561J 25A554562J 25A556030J 25A556035J 25A556038J 25A556101J 25A556116J 27A549104J 27A549189J 27A549194J 27A549245J 27A549339J 27A549341J 27A551835J 27A551989J 27A553552J 27A553553J 27A554157J 27A554223J 27A554230J 27A554237J 27A554976J 27A555291J, and CANADA 21A554071J 23A555518J 25A554143J 27A551991J, and 27A555283J OTHER 19A553455J 19A553748J 19A553881J 19A553901J
19A553998J 19A554000J 19A554001J 19A554010J 19A554059J 19A554063J 19A554064J 19A554108J 19A554113J 19A554122J 19A554194J 19A554202J 21A553173J 21A553181J 21A553405J 21A553466J 21A553525J 21A553598J 21A553687J 21A553790J 21A553825J 21A553828J 21A553832J 21A553905J 21A553910J 21A553913J 21A553920J 21A553977J 21A553981J 21A553983J 21A553984J 21A554089J 21A554131J 21A554308J 21A554309J 21A554311J 21A554312J 21A554313J 21A554314J 21A554320J 21A554607J 21A554702J 21A554703J 21A554706J 21A554758J 21A554793J 21A554794J 21A554797J 21A554800J 21A554837J 21A554839J 21A554840J 21A554841J 21A554887J 21A554889J 21A554893J 21A554895J 21A554896J 21A554899J 21A554954J 21A554962J 21A555002J 21A555004J 21A555005J 21A555006J 21A555007J 21A555014J 21A555203J 21A555205J 21A555375J 21A555378J 21A555385J 21A555386J 21A555388J 21A555397J 21A555477J 21A555478J 21A555483J 21A555494J 21A555496J 21A555499J 21A555500J 21A555504J 21A555507J 21A555580J 21A555581J 21A555583J 21A555584J 21A555626J 21A555627J 21A555630J 21A555633J 21A555634J 21A555673J 21A555674J 21A555706J 21A555708J 21A555709J 21A555716J 21A555717J 21A555726J 21A555806J 21A555909J 21A555913J 21A555992J 21A555993J 21A555994J 21A555995J 21A555997J 21A556053J 21A556085J 21A556151J 23A553484J 23A554024J 23A554027J 23A554028J 23A554031J 23A554136J 23A554206J 23A554208J 23A554213J 23A554329J 23A554334J 23A554339J 23A554340J 23A554344J 23A554383J 23A554384J 23A554386J 23A554488J 23A554489J 23A554612J 23A554657J 23A554661J 23A554664J 23A554711J 23A554717J 23A555027J 23A555529J 23A555680J 23A555732J 23A555738J 23A555916J 23A555918J 23A555923J 23A555925J 23A556005J 23A556006J 23A556009J 23A556013J 23A556015J 23A556019J 23A556021J 23A556023J 23A556024J 23A556096J 23A556206J 23A556208J 23A556210J 25A554563J 25A554666J 25A555279J 25A555280J 25A555282J 25A555419J 25A555428J 25A555826J 25A555939J 25A555940J 25A556039J 25A556112J 27A549240J 27A554506J 27A554977J, and 29A554434J;

b) USA 23M546512J 23M547083J 23M547084J 23M547626J 23M547629J 23M547631J 23M547896J 23M547905J 25M553329J 25M553855J 25M554621J 27M555072J 27M555079J 27M555083J 27M555646J 27M555654J 27M555789J 27M555842J 29M554274J 29M560938J 29M561157J 29M561320J 29M561328J 29M561456J 31M552397J 31M553444J 31M553650J 31M553713J 31M553762J, and 31M555548J EUROPE 23M546513J 23M547076J 23M547088J 23M547195J 25M553559J 25M553640J 25M553854J 25M553931J 25M553946J 25M554246J 25M554629J 25M554858J 25M554910J 25M555060J 25M553850J 27M553375J 27M553383J 27M553562J 27M553570J 27M553572J 27M554161J 27M554172J 27M554173J 27M554176J 27M554181J 27M554182J 27M554185J 27M554187J 27M554189J 27M554260J 27M554262J 27M554263J 27M554264J 27M554265J 27M554267J 27M554269J 27M554271J 27M554351J 27M554354J 27M554358J 27M554450J 27M554454J 27M554458J 27M554511J 27M554518J 27M554642J 27M554643J 27M554645J 27M554646J 27M554810J 27M554863J 27M554870J 27M554923J 27M554992J 27M554993J 27M555069J 27M555315J 27M555330J 27M555333J 27M555341J 27M555342J 27M555347J 27M555350J 27M555353J 27M555439J 27M555440J 27M555441J 27M555442J 27M555443J 27M555444J 27M555538J 27M555540J 27M555541J 27M555543J 27M555545J 27M555546J 27M555641J 27M555642J 27M555644J 27M555647J 27M555652J 27M555691J 27M555743J 27M555744J 27M555745J 27M555746J 27M555754J 27M555755J 27M555763J 27M555787J 27M555791J 27M555852J 27M555858J 27M559405J 27M559440J 27M559448J 29M550088J 29M550209J 29M551061J 29M552565J 29M552612J 29M552648J 29M552649J 29M552717J 29M552722J 29M552922J 29M552927J 29M552937J 29M553239J 29M553240J 29M553289J 29M553295J 29M553353J 29M553355J 29M553442J 29M553763J 29M553857J 29M553858J 29M554079J 29M554080J 29M554369J 29M554400J 29M554578J 29M554679J 29M554680J 29M554683J 29M554684J 29M554734J 29M554736J 29M554737J 29M554744J 29M554783J 29M554871J 29M554872J 29M554874J 29M554875J 29M554877J 29M554879J 29M554929J 29M554930J 29M554931J 29M554932J 29M554933J 29M554935J 29M554936J 29M554937J 29M554939J 29M554940J 29M554941J 29M555095J 29M555099J 29M555101J 29M555107J 29M555110J 29M555153J 29M555154J 29M555158J 29M555556J 29M555560J 29M555561J 29M555656J 29M555657J 29M555665J 29M555984J 29M553354J 31M550204J 31M550207J 31M551255J 31M551256J 31M552714J 31M553351J 31M553443J 31M553446J 31M553576J 31M553657J 31M553711J 31M554466J 31M554471J 31M554577J 31M554876J 31M554880J 31M554934J 31M555371J 31M555372J 31M555549J 31M555980J, and 31M556181J CANADA 27M555436J 31M553577J, and 31M555160J OTHER 25M553700J 25M553796J 25M553798J 25M553799J 25M553841J 25M553933J 25M553943J 25M553948J 25M554348J 25M554565J 25M554619J 25M554626J 25M554633J 25M554721J 25M554729J 25M554731J 25M554733J 25M554775J 25M554803J 25M554804J 25M554805J 25M554806J 25M554856J 27M553374J 27M554676J 27M554922J 27M554926J 27M554989J 27M555001J 27M555084J 27M555313J 27M555314J 27M555316J 27M555317J 27M555331J 27M555332J 27M555337J 27M555338J 27M555339J 27M555340J 27M555343J 27M555345J 27M555348J 27M555349J 27M555430J 27M555433J 27M555437J 27M555542J 27M555643J 27M555645J 27M555649J 27M555687J 27M555689J 27M555690J 27M555741J 27M555748J 27M555749J 27M555751J 27M555752J 27M555759J 27M555786J 27M555790J 27M555843J 27M555846J 27M555851J 27M555854J 27M555945J 27M559304J 29M553712J 29M554078J 29M554085J 29M554086J 29M554087J 29M554784J 29M554928J 29M555098J 29M555108J 29M555159J 31M553761J 31M554280J 31M554465J 31M554468J 31M554685J 31M554735J 31M555370J 31M555373J 31M555547J 21A555222J 23A555240J 23A555676J 25A554043J 27M555544J 29A554153J 31M549988J, and 31M550134J
RECALLING FIRM/MANUFACTURER Medtronic Heart Valve Division, Spring Lake Park, MN,
REASON Medtronic has identified an issue with 685 Hall Easy-Fit® valves Models A7700 and M7700 in which the holder of the valve was incorrectly secured to the valve. This could potentially make it difficult to easily disengage the holder from the valve.
VOLUME OF PRODUCT IN COMMERCE 685 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Impax® 6.x Clients including: 6.3 all versions below 6.3.1 SU5, 6.2 all versions below 6.2.1 SU14 and 6.0 all versions. The Impax Systems are Picture Archiving and Communications system (PACs). PAC systems are used in the acceptance, transfer, display, storage and digital processing of medical images. Catalog Numbers for Impax 6.x Client Software: Radiologist Viewer - R6.0 Concurrent User, Package Code: 60+000250353, Product Code: L8DTC; Breast Imaging Radiologist Viewer - R6.0 Concurrent User, Package Code: 60+00025055, Product Code: L8DGM; Orthopeadic Viewer - R6 Concurrent User, Package Code: 60+00025056, Product Code: L8DEH, L4NVL; Radiologist w/QC Viewer - Concurrent User: Product Code: EW43C; Breast Imaging Radiologist w/QC Viewer - Concurrent User, Product Code: EW44E; Enterprise Viewer - Concurrent License, Product Code: L8DP3; Impax® 6 Orthopeadic Center Client Site License, Product Code: EW21Y; Impax® 6 Site License (includes client site license above - L8FEQ), Package Code: 60+00025123, and Product Code: L8FEQ.
CODE 6.3 all versions below 6.3.1 SU5, 6.2 all versions below 6.2.1 SU14 and 6.0 all versions.
RECALLING FIRM/MANUFACTURER AGFA Corp., Greenville, SC,
REASON The IMPAX client failed to “refresh” the image area upon receiving a study retrieved from archive. The system also erroneously displays this study retrieved from archive as the “active” study.
VOLUME OF PRODUCT IN COMMERCE 371 units
DISTRIBUTION Nationwide and Internationally

WEEK ENDING SEPTEMBER 20

PRODUCT LIFEPAK CR Plus Automated External Defibrillator. Device is primarily deployed in Public Access Defibrillator (PAD). It is a small lightweight device intended for use by minimally trained responders to treat victims of sudden cardiac arrest. Product is capable of 30 full discharges. Labeling on the device states LIFEPAK CR Plus LIFEPAK EXPRESS Defibrillators with ADAPTIV Biphasic Technology; Part number: 3200731-003, 3200731-027, and A3200731-003, 
CODE
Serial No’s: 30975799, 30975800, 30976004, 30976005, 30976011, 30976016, 30976020, 30976021, 30976024, 30976025, 30976027, 30976028, 30976030, 30976031, 30976035, 30976042, 30976050, 30976051, 30976052, 30976053, 30976059, 30976060, 30976062, 30976064, 30976066, 30976067, 30976068, 30976071, 30976075, 30976080, 30976081, 30976083, 30976084, 30976087, 30976089, 30976092, 30976093, 30976094, 30976096, 30976105, 30976106, 30976107, 30976110, 30976112, 30976114, 30976122, 30976126, 30976127, 30976129, 30976132, 30976136, 30976139, 30976141, 30976142, 30976143, 30976145, 30976147, 30976148, 30976151, 30976155, 30976157, 30976160, 30976162, 30976163, 30976166, 30976169, 30976171, 30976172, 30976173, 30976177, 30976180, 30976181, 30976182, 30976194, 30976195, 30976197, 30976200, 30976205, 30976207, 30976210, 30976211, 30976216, 30976217, 30976220, 30976224, 30976232, 30976240, 30990985, 31029332, 31029333, 31029334, 31029335, 31029336, 31029337, 31029338, 31029339, 31029340, 31029341, 31029342, 31029344, 31029346, 31029347, 31029348, 31029349, 31029350, 31029351, 31029355, 31029356, 31029357, 31029358, 31029359, 31029360, 31029361, 31029362, 31029363, 31029364, 31029365, 31029367, 31029368, 31029369, 31029371, 31029373, 31029375, 31029377, 31029381, 31029387, 31029390, 31029392, 31029401, 31469750, 34574276, 34634407, 34636114, 34637837, 34637879, 34638012, 34640657, 34641247, 34645809, 34701718, 34705207, 34705216, 34709423, 34709424, 34709425, 34709428, 34709429, 34709435, 34709436, 34709437, 34709442, 34709444, 34709454, 34709459, 34709462, 34709464, 34709475, 34709495, 34709496, 34709503, 34709507, 34709510, 34709513, 34709514, 34709515, 34709525, 34709527, 34709528, 34709531, 34709532, 34709536, 34709537, 34709538, 34709540, 34709542, 34710243, 34710249, 34710256, 34710258, 34710263, 34710265, 34710268, 34710276, 34710278, 34710284, 34710304, 34710307, 34710308, 34710310, 34710311, 34710312, 34710313, 34710318, 34712073, 34712074, 34738595, 34738601, 34738606, 34738610, 34738611, 34738616, 34739021, 34739031, 34739035, 34739040, 34739050, 34739068, 34740405, 34740464, 34740555, 34740565, 34740597, 34741052, 34741073, 34741088, 34741105, 34741106, 34741301, 34741313, 34741318, 34741319, 34741332, 34741341, 34741359, 34741369, 34741373, 34741382, 34741389, 34741392, 34741393, 34741394, 34742520, 34742530, 34742531, 34742538, 34742539, 34742540, 34742542, 34742552, 34742558, 34742609, 34742612, 34742613, 34742614, 34742640, 34742649, 34742652, 34742654, and 34743762
RECALLING FIRM/MANUFACTURER Physio Control, Inc., Redmond, WA, 
REASON The device is configured with the incorrect software for semi-automatic instead of fully automatic use. When the device is needed for a cardiac arrest emergency, the device will require that the user press the shock button instead of automatically delivering a shock as per the normal operation of the fully automatic device. Fully automatic defibrillators have a cover over the shock button making the button inaccessible by the user.
VOLUME OF PRODUCT IN COMMERCE 249 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) IMPAX® 4.1, Catalog Number: LHZQN007; IMPAX ® 4.5, Catalog Number: LZTJM; IMPAX ® 5.0, Catalog Number: L3CJE; IMPAX ® 5.1 Catalog Number:
  L4AW6; IMPAX ® 5.2, Catalog Number: L4EM2; IMPAX ® 6.0, Catalog Number: L73V4; IMPAX ® 6.2, Catalog Number: EWMDT; Picture Archiving and
Communications systems (PACs), used in the acceptance, transfer, display, storage and digital processing of medical images, 
b) WEB1000 Versions 3.1, Catalog Number: LD5GQ001; 4.1, Catalog Number: LZS5R, LZS9Z, LZTA4 and 5.1, Catalog Number: L7DOS, L7DLPU; Picture Archiving and Communications systems (PACs), used in the acceptance, transfer, display, storage and digital processing of medical images, 
CODE
a) IMPAX® 4.1, IMPAX ® 4.5, IMPAX ® 5.0, IMPAX ® 5.1 IMPAX ® 5.2, IMPAX ® 6.0, IMPAX ® 6.2;
b) WEB1000 version 3.1, WEB1000 version 4.1, and WEB1000 version 5.1
RECALLING FIRM/MANUFACTURER AGFA Corp., Greenville, SC, 
REASON Java version 1.6x (JAVA 6) is not compatible with AGFA IMPAX Administration/Service Tools. Due to a Software Mismatch data can be lost.
VOLUME OF PRODUCT IN COMMERCE 946 units
DISTRIBUTION  Nationwide and Canada

PRODUCT IMPAX® 6.2.1 System, Picture Archiving and Communications system (PAC), used in the acceptance, transfer, display, storage and digital processing of medical images, 
CODE Software version IMPAX 6.2.1
RECALLING FIRM/MANUFACTURER AGFA Corp., Greenville, SC, 
REASON Text and images may not be synchronized.
VOLUME OF PRODUCT IN COMMERCE 154 units
DISTRIBUTION Nationwide and Canada

PRODUCT Stryker Digital Capture System Ultra (SDC Ultra), Model Number 240-050-988, Stryker Endoscopy, image and video archiving system, 
CODE Serial numbers: 07H041654 - 08A069464, PP1.04
RECALLING FIRM/MANUFACTURER Stryker Endoscopy, San Jose, CA, 
REASON Patient Identification numbers and names may be applied to images from another patient due to a software issue. This failure mode can only occur when the pre-load function of the SDC ultra is used.
VOLUME OF PRODUCT IN COMMERCE 814 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Biomet Orthopedics Echo Hip Instrumentation Exact Slotted Stem Inserter, Part number: 31-555610, 
CODE Lots: 218606, 218614 and 217595
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biomet, Inc., Warsaw, IN, 
Manufacturer: Accellent Orthopedics, Brimfield, MA. 
REASON The instrument will not mate with its stem.
VOLUME OF PRODUCT IN COMMERCE 78 units
DISTRIBUTION Nationwide

PRODUCT
 1) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic  Stabilization Device, REF 7901000, 10mm, 5.5mm dia x 100mm, size: 10mm x  100mm, for spinal fixation, 
 2) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic  Stabilization Device, REF 7901010, 10mm, 5.5mm dia x 110mm, size: 10mm x 110mm, for spinal fixation, 
 3) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901020, 10mm, 5.5mm dia x 120mm, size: 10mm x 120mm, for spinal fixation,
 4) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901040, 10mm, 5.5mm dia x 40mm, size: 10mm x  40mm, for spinal fixation, 
 5) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901045, 10mm, 5.5mm dia x 45mm, size: 10mm x 45mm, for spinal fixation, 
 6) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901060, 10mm, 5.5mm dia x 60mm, size: 10mm x 60mm, for spinal fixation, 
 7) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901070, 10mm, 5.5mm dia x 70mm, size: 10mm x 70mm, for spinal fixation, 
 8) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901080, 10mm, 5.5mm dia x 80mm, size: 10mm x 80mm, for spinal fixation, 
 9) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901090, 10mm, 5.5mm dia x 90mm, size: 10mm x 90mm, for spinal fixation, 
10) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic  Stabilization Device, REF 7901500, 15mm, 5.5mm dia x 100mm, size: 15mm x 100mm, for spinal fixation, 
11) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic  Stabilization Device, REF 7901510, 15mm, 5.5mm dia x 110mm, size: 15mm x  110mm, for spinal fixation, 
12) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic  Stabilization Device, REF 7901520, 15mm, 5.5mm dia x 120mm, size: 15mm x  120mm, for spinal fixation, 
13) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic  Stabilization Device, REF 7901545, 15mm, 5.5mm dia x 45mm, size: 15mm x  45mm, for spinal fixation,
14) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901560, 15mm, 5.5mm dia x 60mm, size: 15mm x 60mm, for spinal fixation, 
15) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901570, 15mm, 5.5mm dia x 70mm, size: 15mm x 70mm, for spinal fixation, Recall # 
16) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901580, 15mm, 5.5mm dia x 80mm, size: 15mm x  80mm, for spinal fixation, 
17) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic  Stabilization Device, REF 7901590, 15mm, 5.5mm dia x 90mm, size: 15mm x  90mm, for spinal fixation, 
18) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic  Stabilization Device, REF 7881000, 10mm, 5.5mm dia x 100mm, size: 10mm x  100mm, for spinal fixation, not for distribution in the U.S.A. or its territories,
19) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic  Stabilization Device, REF 7881010, 10mm, 5.5mm dia x 110mm, size: 10mm x  110mm, for spinal fixation, not for distribution in the U.S.A. or its territories,
20) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic  Stabilization Device, REF 7881020, 10mm, 5.5mm dia x 120mm, size: 10mm x  120mm, for spinal fixation, not for distribution in the U.S.A. or its territories,
21) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7881040, 10mm, 5.5mm dia x 40mm, size: 10mm x  40mm, not for distribution in the U.S.A. or its territories, for spinal fixation,
22) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7881060, 10mm, 5.5mm dia x 60mm, size: 10mm x 60mm, not for distribution in the U.S.A. or its territories, for spinal fixation,
 23) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7881070, 10mm, 5.5mm dia x 70mm, size: 10mm x 70mm, not for distribution in the U.S.A. or its territories, for spinal fixation,
24) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7881080, 10mm, 5.5mm dia x 80mm, size: 10mm x 80mm, not for distribution in the U.S.A. or its territories, for spinal fixation,
25) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7881090, 10mm, 5.5mm dia x 90mm, size: 10mm x  90mm, not for distribution in the U.S.A. or its territories, for spinal fixation,
 26) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic  Stabilization Device, REF 7881500, 15mm, 5.5mm dia x 100mm, size: 15mm x  100mm, not for distribution in the U.S.A. or its territories, for spinal fixation,
 27) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7881510, 15mm, 5.5mm dia x 110mm, size: 15mm x 110mm, not for distribution in the U.S.A. or its territories, for spinal fixation,
 28) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7881520, 15mm, 5.5mm dia x 120mm, size: 15mm x 120mm, not for distribution in the U.S.A. or its territories, for spinal fixation,
29) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7881545, 15mm, 5.5mm dia x 45mm, size: 15mm x 45mm, not for distribution in the U.S.A. or its territories, for spinal fixation,
30) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic  Stabilization Device, REF 7881560, 15mm, 5.5mm dia x 60mm, size: 15mm x  60mm, not for distribution in the U.S.A. or its territories, for spinal fixation,
 31) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7881570, 15mm, 5.5mm dia x 70mm, size: 15mm x 70mm, not for distribution in the U.S.A. or its territories, for spinal fixation,
32) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7881580, 15mm, 5.5mm dia x 80mm, size: 15mm x 80mm, not for distribution in the U.S.A. or its territories, for spinal fixation,
33) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7881590, 15mm, 5.5mm dia x 90mm, size: 15mm x 90mm, not for distribution in the U.S.A. or its territories, for spinal fixation,
34) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic, Stabilization Device, REF 7881045, 10mm, 5.5mm dia x 45mm, size: 10mm x 45mm, not for distribution in the U.S.A. or its territories, for spinal fixation,
CODE All codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Sofamor Danek USA Inc., Memphis, TN, 
Manufacturer: Warsaw Orthopedic, Inc. dba Medtronic Sofamor Danek,Warsaw, IN. 
REASON Breaks: Shear failure of the cable component of the system.
VOLUME OF PRODUCT IN COMMERCE 7,970 units
DISTRIBUTION Nationwide and Internationally

PRODUCT GE Datex-Ohmeda Neonatal Enhancement for the Engstrom Carestation, Model # 1505-3272-00. Intended to provide mechanical ventilation for adults and pediatrics weighing 5kg and above having degrees of pulmonary impairment varying from minor to severe, 
CODE All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm; Datex - Ohmeda, Inc., Madison , WI, 
Manufacturer: Acutronic Medical Systems Ag, Hirzel, Switzerland. 
REASON Neonatal Flow Sensors supplied for use with the Neonatal Enhancement for the Engström Care station may result in the sensors providing invalid values and alarm messages when exposed to high flow rates.
VOLUME OF PRODUCT IN COMMERCE  394 (197 boxes and 2 Flow sensors/box)
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) VARIANT ß-thalassemia Short Program Hemoglobin Testing System, Model Number 270-0019 (250 tests), with ß-thalassemia ROM card lot PA 62600, PIN 2700104, 
b) VARIANT ß-thalassemia Short Program Hemoglobin Testing System, Model Number 270-0002 (500 tests), with ß-thalassemia ROM card lot PA 62600, PIN 2700104, CODE
a) Lot number 70080440;
b) Lot numbers: 70080140 and 70080276
RECALLING FIRM/MANUFACTURER Bio-Rad Laboratories Inc., Hercules, CA, 
REASON Some product ROM cards have an incorrect program loaded and are unable to be updated.
VOLUME OF PRODUCT IN COMMERCE 64 kits and 140 ROM cards
DISTRIBUTION Nationwide and Internationally

PRODUCT Hill-Rom 100 Low Bed; Model No. P3930, CODE All units
RECALLING FIRM/MANUFACTURER Hill-Rom, Inc., Batesville, IN, 
REASON The upper deck may collapse to its lowest position and the caster brakes may fracture if the bed is moved while the brakes are locked.
VOLUME OF PRODUCT IN COMMERCE 753 Beds
DISTRIBUTION Nationwide and Canada

PRODUCT
a) Gamma3 System Set Screwdriver, Flexible Shaft; 4mm. This product is non-sterile,  Orthopedic Device. The Gamma3 Locking Nail Systems are Intramedullary short and long fixation nails intended for control of rotation and shortening of fractured femurs. The screwdriver is used to place the set screw in the nail; Product number: 1320-0231, 
b) Gammas Set Screwdriver Instrument Set, Orthopedic Device. The Gamma3 Locking Nail Systems are Intramedullary short and long fixation nails intended for
control of rotation and shortening of fractured femurs. The screwdriver is used to place the set screw in the nail. Product number: 1320-6000, 
CODE
a) Lot Code on Package label K409181, Lot code engraved on Screwdriver: K968226;
    Lot code on package label: K610297, Lot code engraved on Screwdriver: K782153;
    Lot code on package label; K645667, Lot code engraved on screwdriver: K533686;
    Lot code on package label: K688034, Lot code engraved on screwdriver: K887079;
    Lot code on package label: K878962, Lot code engraved on screwdriver: K533686;
b) Lot code engraved on screwdrivers: K887079 and K782153
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics, Corp., Mahwah, NJ, 
Manufacturer: Stryker Gmbh, Kiel, Germany. 
REASON Stryker Trauma has become aware that five lots of the Gamma3 Set Screwdriver have hexagon tips that were not hardened to specification. If the screwdriver tip were to deform intra-operatively, the correct positioning of the set screw would not be possible, which could lead to lateral or medial migration of the lag-screw.
VOLUME OF PRODUCT IN COMMERCE 43 units
DISTRIBUTION Nationwide

PRODUCT AD 7 Patient table supplied with Allura Xper FD10 and Allura Xper FD10/10. Product is non-tilting but can be purchased with a tilt option; Part number 9896 002 04432, 
CODE All products
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, 
Manufacturer: Philips Medical Systems Ned Bv, Best, Netherlands.
REASON Potential for radiologic patient table to become immobile and unable to move again due to force sensor sensitivity to electromagnetic radiation.
VOLUME OF PRODUCT IN COMMERCE 39 units
DISTRIBUTION ND, FL, KY, MN, VA, ME, PA, NJ, CT, TX, CA, OH, TN, OR, GA, NY, SC, MO, WA, IL

PRODUCT
a) i-CAT Classic 3D Dental Imaging System; Part number 9140-0000-0000,
b) i-CAT 17-19 Cone Beam 3D Dental Imaging System. This product is also sold under a private label as KaVo 3D eXam; Part number 1-10-1-0. The KaVo part number is K1-10-3-0, 
CODE All devices; All manuals
RECALLING FIRM/MANUFACTURER Imaging Sciences, International, Inc., Hatfield, PA,
REASON Incorrect scatter information in the manual.
VOLUME OF PRODUCT IN COMMERCE 1,203 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Urethral Warming System-Galil Medical Warming Catheter. The product is contained within prostate kits. This product is used in cryosurgery to prevent freezing of tissue; Catalog number ASMCH0340 sold within kits with the following part numbers: FPRPR4570, FPRPR4508, FPRPR3008, FPRPR4070, FPRPR353, and FPRPR4003, CODE All units
RECALLING FIRM/MANUFACTURER
Recalling Firm: Galil Medical, Plymouth Meeting, PA,
Manufacturer: Galil Medical Ltd, Yokneam, Israel. 
REASON The warming catheter was manufactured with the inlet and outlet tubes switched.
VOLUME OF PRODUCT IN COMMERCE 541 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Custom Kit, Custom Angiographic Kit, REF: K05-YS1025, Sterile,
b) Custom Kit, Custom Angiographic Kit, REF: K05-YS1032, Revision A, Sterile,
c) Custom Kit, REF: K05-00843, Revision L, Sterile, 
CODE
a) Lot Number F594282;
b) Lot Number F603790;
c) Lot Number F580867
RECALLING FIRM/MANUFACTURER Merit Medical Systems, Inc., South Jordan, UT
REASON Convenience kits may be non-sterile due to inadequate package sealing.
VOLUME OF PRODUCT IN COMMERCE 139 kits
DISTRIBUTION MO, Japan

PRODUCT PT-3B Control Unit - component of the EndoWave Infusion Catheter System. EndoWave Infusion System consists of three main components, a single use EndoWave Infusion Catheter System which is comprised of a Drug Delivery Catheter (CD) and removable Ultrasound Core (USC) and a reusable EKOS PT-3B Control System. Box is labeled EndoWave Infusion System Drug Delivery Catheter with Ultrasound Core; Model PT3B; Catalog Number 600-10301, 
CODE
Serial Number: PT3B-001, PT3B-002, PT3B-004, PT3B-006, PT3B-007, PT3B-008, PT3B-009, PT3B-010, PT3B-011, PT3B-012, PT3B-013, PT3B-014, PT3B-017, PT3B-018, PT3B-020, PT3B-021, PT3B-022, PT3B-024, PT3B-025, PT3B-027, PT3B-029, PT3B-030, PT3B-031, PT3B-032, PT3B-033, PT3B-034, PT3B-035, PT3B-037, PT3B-038, PT3B-040, PT3B-041, PT3B-042, PT3B-043, PT3B-044, PT3B-045, PT3B-046, PT3B-047, PT3B-049, PT3B-050, PT3B-051, PT3B-052, PT3B-057, PT3B-058, PT3B-059, PT3B-060, PT3B-062, PT3B-063, PT3B-064, PT3B-065, PT3B-066, PT3B-067, PT3B-068, PT3B-070, PT3B-071, PT3B-072, PT3B-073, PT3B-074, PT3B-075, PT3B-076, PT3B-078, PT3B-079, PT3B-080, PT3B-082, PT3B-084, PT3B-085, PT3B-087, PT3B-088, PT3B-089, PT3B-090, PT3B-091, PT3B-093, PT3B-094, PT3B-095, PT3B-096, PT3B-097, PT3B-098, PT3B-099, PT3B-100, PT3B-102, PT3B-103, PT3B-104, PT3B-108, PT3B-109, PT3B-110, PT3B-111, PT3B-112, PT3B-113, PT3B-114, PT3B-115, PT3B-118, PT3B-119, PT3B-121, PT3B-123, PT3B-124, PT3B-127, PT3B-128, PT3B-130, PT3B-131, PT3B-132, PT3B-133, PT3B-135, PT3B-137, PT3B-138, PT3B-139, PT3B-140, PT3B-141, PT3B-143, PT3B-145, PT3B-146, PT3B-147, PT3B-148, PT3B-150, PT3B-151, PT3B-152, PT3B-153, PT3B-154, PT3B-155, PT3B-156, PT3B-157, PT3B-158, PT3B-159, PT3B-163, PT3B-164, PT3B-165, PT3B-168, PT3B-169, PT3B-172, PT3B-173, PT3B-174, PT3B-175, PT3B-176, PT3B-177, PT3B-178, PT3B-180, PT3B-181, PT3B-183, PT3B-186, PT3B-188, PT3B-192, PT3B-193, PT3B-195, PT3B-196, PT3B-197, PT3B-199, PT3B-201, PT3B-202, PT3B-204, PT3B-205, PT3B-206, PT3B-207, PT3B-208, PT3B-210, PT3B-211, PT3B-212, PT3B-214, PT3B-215, PT3B-217, PT3B-218, PT3B-219, PT3B-221, PT3B-253, PT3B-254, PT3B-255, PT3B-256, PT3B-257, PT3B-258, PT3B-259, PT3B-260, PT3B-261, PT3B-262, PT3B-263, PT3B-264, PT3B-265, PT3B-266, PT3B-267, PT3B-268, PT3B-269, PT3B-270, PT3B-271, PT3B-273, PT3B-274, PT3B-275, PT3B-276, PT3B-280, PT3B-285, PT3B-286, PT3B-287, PT3B-288, PT3B-289, PT3B-291, PT3B-292, PT3B-294, PT3B-295, PT3B-297, PT3B-298, PT3B-308, PT3B-310, PT3B-311, PT3B-312, PT3B-313, PT3B-314, PT3B-315, PT3B-316, PT3B-319, PT3B-320, PT3B-321, PT3B-323, PT3B-326, PT3B-328, PT3B-329, PT3B-332, PT3B-333, PT3B-334, PT3B-335, PT3B-337, PT3B-338, PT3B-339, PT3B-344
RECALLING FIRM/MANUFACTURER EKOS Corporation, Bothell, WA, 
REASON Potential for unit to burn patient.
VOLUME OF PRODUCT IN COMMERCE 218 units
DISTRIBUTION Nationwide

PRODUCT Siemens Linear Medical Accelerators equipped with COHERENCE Therapist R2.1 and Primeview 3 i R 2.1. Part Numbers: COHERENCE AG Therapist, 5863506 COHERENCE Therapist System, 7339125 COHERENCE Impression Therapist, 7341410 Primeview 3i, 7341428 AG Therapist 3rd Party V&R, 7345411 Impression Therapist 3rd Party V&R, 7345429 syngo based WS for 3rd Party V&R, 7345437 Coherence Therapist 2.0, 8139839 Primveview 3i 2.0, 8139847 Coherence Therapist 2.1, 8147667 and Primeview 3i 2.1, 8147675, 
CODE All Siemens Linear Medical Accelerators equipped with COHERENCE Therapist R2.1 and PrimeView 3i R2.1. System.
RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Concord, CA,.
REASON Images may potentially shift, causing an incorrect alignment of the patient, which may result in a dose to the wrong location. It was discovered through the complaint handling process that a potential image shift issue can occur after using the interactive shift tool and filtering tool due to incorrect consideration of the flat panel alignment.
VOLUME OF PRODUCT IN COMMERCE 143 units
DISTRIBUTION Nationwide and Internationally

PRODUCT BIOMET EZLoc 7-8mm TM Femoral Fixation, Catalog Number 904780. The Ezloc Is indicated for use for fixation of tendons & ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction, 
CODE Lot Number 305240
RECALLING FIRM/MANUFACTURER Biomet Sports Medicine, Ontario, CA,
REASON EZLoc Femoral Fixation devices, from two finished good lots were distributed with the incorrect component size inside the package. As supplied, label indicates product size as EZLoc 7-8mm 904780 L305240. Actual product enclosed may be EZLoc 9-10mm. Alternatively, as supplied, label indicates product size as EZLoc 9-10mm 904781 L305250. Actual product enclosed may be EZLoc 7-8mm.
VOLUME OF PRODUCT IN COMMERCE 160 units
DISTRIBUTION Nationwide, Internationally

PRODUCT PathFinder Cannulated T-Handle Bone Awl, Part Number 1155-2, 
CODE All lots
RECALLING FIRM/MANUFACTURER Abbott Spine, Austin, TX, 
REASON Breakage - Tips on the Pathfinder Bone Awl may bend or break prematurely.
VOLUME OF PRODUCT IN COMMERCE 180 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Keramos Replacement Polyethylene Liner, 48mm; Cat. #496-28-048; Sterile, Single Use, 
CODE Lot/Serial # 209392, 209402, 235162, 276612, 510931 and 964111
RECALLING FIRM/MANUFACTURER Encore Medical, Lp, Austin, TX
REASON Keramos Replacement Polyethylene Liner used as a replacement for the Keramos ceramic liner in revision hip replacement surgeries marketed without 510(k) approval.
VOLUME OF PRODUCT IN COMMERCE 180 units
DISTRIBUTION Nationwide

PRODUCT
a) Psi-Tec Tubing, 12'; 10/box; Part Number PT-5558, 

b) Autofuse Tubing, DIS SI; Part Number AFTU-DS; 
c) i-Vac Tubing, 8'; 10/box; Part Number B-5558; 

d) Lamis Tubing Set, 9'; 10/box; Part Number LAM-TUBING; 
e) Y Tubing Set, 9'; 10/box; Part Number LAM-Y; 
f) Irrigation Tubing, 25'; Part Number 5120-25;
g) Psi-Tec Syringe Pump Infiltration Tubing, 10'; 10/box; Part Number PT-INF-T; 
h) Contour Genesis Infiltration Tubing, 13'; Part Number CG-INF-T;
i) Contour Genesis Inf/IR Tubing; Part Number CG-UT; 

j) Contour Genesis Aspiration Tubing, 12'; Part Number CG-PT-5558;
CODE
a) Lot #: PT4900, PT4904, PT5906, PT5908, PT5912, PT5916, PT5920, PT5922,  PT5924, PT5928, PT5930, PT5932, PT5934, PT5938, PT5940, PT5942, PT5944,
PT5950, PT5952, PT5956, PT5958, PT5968, PT5970, PT5974, PT5976, PT5984, PT6986, PT6988, PT6990, PT6994, PT6996, PT6998, PT6102, PT6108, PT6110,
PT6114, PT6116, PT6118, PT6122, PT6124, PT6130, PT6134, PT6140, PT6142, PT6148, PT6150, PT6152, PT6158, PT6164, PT6168, PT7174, PT7176, PT7178,
PT7180, PT7182, PT7184, PT7186, PT7188, PT7190, PT7196, PT7198, PT7200, PT7206, PT7210, PT7212, PT7216, PT7218, PT7222, PT7220, PT7226, PT7228,
PT7230, PT7232, PT7234, PT7238, PT7240, PT7244, PT7246, PT7250, PT7252, PT7254, PT7266, PT7270, PT7272, PT7274, PT7276, PT7278, PT7280, PT7286,
PT8288, PT8296, PT8298, PT8300, PT8306, PT8308, PT8310, and PT8312;
b) Lot # AF4900, AF4904, AF5906, AF5908, AF5912, AF5916, AF5920, AF5922, AF5924, AF5928, AF5932, AF5934, AF5938, AF5942, AF5944, AF5950, AF5952,
AF5956, AF5958, AF5970, AF5974, AF5976, AF5984, AF6986, AF6988, AF6990, AF6994, AF6996, AF6998, AF6102, AF6108, AF6110, AF6114, AF6116, AF6122,
AF6126, AF6130, AF6134, AF6140, AF6148, AF6152, AF6158, AF6164, AF6170, AF7176, AF7182, AF7190, AF7196, AF7198, AF7200, AF7206, AF7210, AF7216,
AF7218, AF7222, AF7226, AF7230, AF7234, AF7238, AF7240, AF7246, AF7250, AF7258, AF7264, AF7270, AF7272, AF7278, AF7286, AF8288, AF8292, AF8298,
AF8300, AF8308 and AF8310;
c) Lot #: HI4900, HI4904, HI5906, HI5908, HI5912, HI5916, HI5920, HI5922, HI5924, HI5928, HI5930, HI5932, HI5934, HI5938, HI5940, HI5942, HI5944, HI5952, HI5956, HI5958, HI5974, HI5976, HI5984, HI6986, HI6988, HI6990, HI6994, HI6996, HI6998, HI6102, HI6108, HI6110, HI6114, HI6116, HI6122, HI6126, HI6130, HI6138, HI6144, HI6148, HI6154, HI6158, HI6164, HI7176, HI7178, HI7180, HI7182, HI7188, HI7202, HI7212, HI7204, HI7222, HI7226, HI7230, HI7240, HI7248, HI7254, HI7270, HI7272, HI7280, HI8292, HI8296, HI8304 and HI8316;
d) Lot #: LA4900, LA4904, LA5906, LA5908, LA5912, LA5916, LA5920, LA5922, LA5924, LA5928, LA5930, LA5932, LA5934, LA5938, LA5940, LA5942, LA5944, LA5952, LA5956, LA5958, LA5970, LA5974, LA5976, LA5984, LA6986, LA6988, LA6990, LA6994, LA6998, LA6102, LA6108, LA6110, LA6114, LA6116, LA6124, LA6130, LA6132, LA6140, LA6148, LA6152, LA6160, LA6168, LA7174, LA7178, LA7182, LA7184, LA7188, LA7190, LA7194, LA7198, LA7200, LA7206, LA7218, LA7226, LA7238, LA7240, LA7244, LA7248, LA7266, LA7272, LA7274, LA7276, LA8288, LA8292, LA8296, LA8298 and LA8312;
e) Lot #: LY4900, LY5906, LY5912, LY5920, LY5924, LY5928, LY5932, LY5938, LY5944, LY5952, LY5974, LY5984, LY6988, LY6994, LY6996, LY6102, LY6108, LY6110, LY6116, LY6130, LY6150, LY6164, LY7174,
LY7180, LY7190, LY7200, LY7212, LY7222, LY7238, LY7248, LY7268, LY7282, LY8298, LY8300 and LY8310;
f) Lot #: LS4904, LS4904, LS5908, LS5916, LS5922, LS5928, LS5934, LS5942, LS5956, LS5970, LS5974, LS5976, LS6988, LS6994, LS6998, LS6108, LS6114,
LS6124, LS6138, LS6148, LS6154, LS6168, LS7176, LS7178, LS7180, LS7184, LS7190, LS7202, LS7218, LS7232, LS7244, LS7258, LS7280 and LS8304;
g) Lot #: IN4900, IN5906, IN5916, IN5922, IN5928, IN5934, IN5942, IN5950, IN5956, IN5970, IN5974, IN5984, IN6986, IN6990, IN6996, IN6998, IN6108,
IN6114, IN6126, IN6142, IN6158, IN6168, IN7176, IN7196, IN7202, IN7240, IN7268 and IN8292;
h) Lot #: CI4900, CI5906, CI5912, CI5920, CI5929, CI5924, CI5930, CI5932, CI5938, CI5940, CI5942, CI5944, CI5948, CI5950, CI5952, CI5958, CI5970,
CI5976, CI6986, CI6996, CI6998, CI6108, CI6114, CI6124, CI6126, CI6134, CI6140, CI6172, CI7178, CI7182, CI7192, CI7200, CI7202, CI7204, CI7216,
CI7218, CI7228, CI7246, CI7248, CI7268, CI7280, CI8292, CI8298, CI8308 and CI8312;
i)  Lot #: CY5906, CY5912, CY5920, CY5924, CY5932, CY5938, CY5944, CY5952, CY5958, CY5974, CY5976, CY6986, CY6990, CY6996, CY6102, CY6110, CY6114, CY6126, CY6148, CY6154, CY6170, CY7184, CY7188,
CY7190, CY7206, CY7218, CY7226, CY7240, CY7252, CY7264, CY7278, CY8288 and CY8316;
j) All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mentor Texas, Inc., Irving, TX, 
Manufacturer: Byron Medical, Tucson, AZ.
REASON During packaging integrity validation, it was found that various product packages could fail, compromising the sterility of the devices.
VOLUME OF PRODUCT IN COMMERCE Approximately 70,000 boxes
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Fluid Administration Set, Custom Kit, REF: K09-05336DP, Caution: For manufacturing, processing or repacking. Product is used to transfer contrast media
and saline from a container to a patient's vascular system, 
b) Fluid Administration Set, Custom Kit, REF: K09-05785FP, Caution: For manufacturing, processing or repacking. Product is used to transfer contrast media
and saline from a container to a patient's vascular system, 
c) Fluid Administration Set, Custom Kit, REF: K09-05971AP, Caution: For manufacturing, processing or repacking. Product is used to transfer contrast media
and saline from a container to a patient's vascular system, 
d) Fluid Administration Set, Custom Kit, REF: K09-02842CP, Caution: For manufacturing, processing or repacking. Product is used to transfer contrast media
and saline from a container to a patient's vascular system, 
e) Fluid Administration Set, Custom Kit, REF: K09-09938P, Caution: For manufacturing, processing or repacking. Product is used to transfer contrast media and saline from a container to a patient's vascular system;
f) Fluid Administration Set, Custom Kit, REF: K09-09051P, Caution: For manufacturing, processing or repacking. Product is used to transfer contrast media and saline from a container to a patient's vascular system; 
g) Fluid Administration Set, Custom Kit, REF: K09-01280JP, Caution: For manufacturing, processing or repacking. Product is used to transfer contrast media
and saline from a container to a patient's vascular system; 

h) Fluid Administration Set, Custom Kit, REF: K10-01795DP, Caution: For manufacturing, processing or repacking. Product is used to transfer contrast media
and saline from a container to a patient's vascular system; 
CODE
a) Lot Number F605813;
b) Lot Number F604048;
c) Lot Number F607413;
d) Lot Number F605310;
e) Lot Number F604890;
f) Lot Number F607531;
g) Lot Number F604893;
h) Lot Number F604759
RECALLING FIRM/MANUFACTURER Merit Medical Systems, Inc., South Jordan, UT
REASON Convenience kits may contain non-filtered drip chambers.
VOLUME OF PRODUCT IN COMMERCE 865 kits
DISTRIBUTION Nationwide

PRODUCT Abbott Free Style Blood Glucose Monitoring System Test Strips for use with FreeStyle Blood Glucose Monitoring Meter, 
CODE
Part numbers/Serial numbers/Exp. Date: CAT12050-01/0618625/Jul08; M70449-03/0703325/Feb09; CAT12450-01 (70345-02)/0618129/Jun08; CAT70450-01/0700815/Jan09; CAT70447-02/0628646/Oct08; CAT12450-01 (70345-02)/0627030/Sep08; CAT70450-02/0703019/Jan09; CAT12050-02/0703118/Jan09; CAT12050-03/0715129/May09
RECALLING FIRM/MANUFACTURER Abbott Diabetes Care, Inc., Alameda, CA,
REASON Flaws in strip voltage continuity may result in frequency of an Error 3 (“Er3”) message display and unreadable strips. This issue has the potential for creating a delay in generating blood glucose results and to delay diabetes management, potentially leading to either hypo or hyperglycemia and their associated complications.
VOLUME OF PRODUCT IN COMMERCE 2,954,900 strips
DISTRIBUTION Nationwide and Internationally

PRODUCT Scorpio Total Knee Posteriorly Stabilized Femoral Component, #7R, Catalog No.: 71-4107R; Scorpio Total Knee Posteriorly Stabilized Femoral Component, #7L, Catalog No. 71-4506L; 
CODE Lot Code: K05L310; Lot Code K05L224
RECALLING FIRM/MANUFACTURER Stryker Howmedica Osteonics Corp., Mahwah, NJ
REASON Mislabeled boxes -- Scorpio PS Right Femoral Component No Posts contained a Scorpio PS Left Femoral Component with Posts and vice versa.
VOLUME OF PRODUCT IN COMMERCE 8 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) ClearView Uterine Manipulator, Long tip version with disposable Sound-Dilator  (DSD-1000), REF CV2000, 9 cm, Sterile; 
b) ClearView Uterine Manipulator with disposable Sound-Dilator (DSD-1000), REF UM210, 7 cm, Sterile; CODE
a) Lot Number: 080154;
b) Lot Number: 080205
RECALLING FIRM/MANUFACTURER Clinical Innovations, LLC, Murray, UT, 
REASON Inadequate package seal could compromise sterility.
VOLUME OF PRODUCT IN COMMERCE 760 units
DISTRIBUTION CA, CO, FL, MO, OR, VA, Mexico, UK

PRODUCT
a) Allez Spine Laguna Pedicle Screw System: IT-FN1001, Laguna Sterilization Tray # 1 (Part Number: 54003); IT-FN1002, Laguna Sterilization Tray # 2  (Part Number: 54004); 
b) Allez Spine Del Mar Pedicle Screw System: IT-FN 1007, Del Mar Sterilization Tray (Part Number: 30013); 
CODE
a) Serial /System Numbers: 002, 003, 004, 005, 006, 007, 008, 009, 010, 012, 013, 014, 015, 017, 019, 020, 021, 023, 024, 025, 029, 030, 031, 032, 034, 035, 036, 038, 039, 040, 041, 042, 043, 044, 045, 048, 049, 050, 051, 053, 054, 055, 056, 057, 059, 060, 061, 062, 063, 064, 065, 066, 067, 068, 069, 070, 071, 072, 073, 074, 076, 077, 079, 080;
b) Serial /System Numbers: DM0001, DM0002
RECALLING FIRM/MANUFACTURER Allez Spine, LLC, Irvine, CA, 
REASON This field action was initiated because the cleaning, decontamination and sterilization procedures specified in the "Instructions for Use" for the impacted systems are incorrect. The use of these parameters in performing cleaning, decontamination and sterilization procedures may not result in clean and sterile product.
VOLUME OF PRODUCT IN COMMERCE 66 systems
DISTRIBUTION Nationwide to AZ, CA, CO, GA, IL, NV, TN, TX, UT

PRODUCT Psi Bands acupressure/acustimulation wrist bands in the following colors: Racer Black (UPC 859570001036), Daisy Chain (UPC 859570001029), Color Play (UPC 859570001043) and Cherry Blossom (UPC 859570001012), 
CODE All codes and devices manufactured between June 22 to December 20, 2006.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Psi Health Solutions, Pacific Grove, CA, 
Manufacturer: Asia Expo Consultants, Limited, Wanchai, Hong Kong SAR. 
REASON Product was marketed before its 510(k) application cleared.
VOLUME OF PRODUCT IN COMMERCE 21,000 units
DISTRIBUTION Nationwide

PRODUCT
a) Headset Model Number RTC-2K for use with the Serene Sound Digital MRI Compatible High Fidelity Stereo Sound System. Model Number: RTC-2K;  
b) Headset Model Number RTC-551-070 for use with the Serene Sound Digital MRI Compatible High Fidelity Stereo Sound System. Model Number RTC-551-070;
CODE
a) Serial No: a) 124-09606 b) 064-10057 c) 064-09863 d) 064-10066 e) 064-09801  f) 064-10055 g) 064-10268 h) 064-09932 i) 124-09624 j) 064-09768 k) 064-09988
  l) 064-10226 m) 064-09971 n) 064-09793 o) 064-09837 p) 104-09763 q) 064-10050  r) 124-10193 s) 064-10059 t) 064-10034;
b) Serial No: a) 064-10288 b) 064-10279 c) 114-09556 d) 124-09898 e) 104-09995  f) 064-10220 g) 064-10286 h) 124-09491 i) 104-09828 j) 064-10229 k) 064-10211
  l) 064-10241 m) 064-10214 n)064-09983 o) 064-10243 p) 064-10289 q) 064-10207 r) 064-10132 s) 104-09872 t) 064-10221 u) 064-10127 v) 064-10215 w) 104-09966
  x) 064-10263 y) 124-10116 z) 124-09983 aa) 124-09600 bb) 114-09613 cc) 064-09479
RECALLING FIRM/MANUFACTURER Resonance Technology, Inc., Northridge, CA, 
REASON Potential safety concerns - Use of this product with a MRI may result in the headset's cord overheating and patients experiencing burns to the skin.
VOLUME OF PRODUCT IN COMMERCE 49 units
DISTRIBUTION Nationwide and Internationally

PRODUCT GE Centricity AW Suite 2.0 Software running on the Centricity RA 1000 or RA600/CA1000 Workstation; for diagnostic image analysis; 
CODE Software version 2.0
RECALLING FIRM/MANUFACTURER GE Healthcare Integrated IT Solutions, Barrington, IL
REASON Incorrect measurement of the aortic length in certain cases of aneurysm during the use of the aorta protocol or customized protocol of the Centricity AW Suite 2.0 running on the Centricity RA 1000 or RA600/CA1000 workstations.
VOLUME OF PRODUCT IN COMMERCE 207 units
DISTRIBUTION Nationwide and Internationally

PRODUCT GE Centricity PACS RA1000 Workstation; for diagnostic image analysis; 
CODE Software version: 3.0.0.X, 3.0.1.X, 3.0.2.X, and 3.0.3.X
RECALLING FIRM/MANUFACTURER GE Healthcare Integrated IT Solutions, Barrington, IL
REASON A software anomaly results in incorrect study date and time information being displayed in the report screen and title, which may result in a potential patient misdiagnosis.
VOLUME OF PRODUCT IN COMMERCE 177 units
DISTRIBUTION Nationwide and Internationally

PRODUCT MIM 4.0 and MIM 4.1 is a software package designed for use in diagnostic imaging. It is a stand alone software package which operates on Windows 2000/XP; CODE Software versions 4.0.2-4.0.5 & 4.1.0-4.1.2
RECALLING FIRM/MANUFACTURER MIMvista Corp, Cleveland, OH,
REASON In MIM (4.0.2-4.0.5) and MIM (4.1.0-4.1.2) versions, there is an error that may occur during the calculation of statistics using the SUV Tool or Contour Statistics. It will occur only under the following specific circumstance: A fusion of a primary volume which has a Z-Axis slice separation larger than that of the secondary volume and statistics are reported on the secondary volume.
VOLUME OF PRODUCT IN COMMERCE 221 units
DISTRIBUTION Nationwide

PRODUCT Covidien/ Mallinckrodt CT9000 /CT9000 ADV (J-Bow component 241300). Model Number:  241300 injector suspension system, is an accessory to a device. The device is catalog numbers 9021M, 9023M, ADV9021, ADV9021M, ADV9024M, ADVEL9021, ADVEL9O21M, ADVEL9123, ADV9124M, ADVEL19021M, ADW9021, ADVI9021M, ADVI9023, ADVI9023M, ADW9024, ADWC9021, ADWC9021MOB, ADWC9023, ADWC9024, ADVUCI9021, ADWCI90210B, contrast media delivery system for diagnostic imaging, and contains the main injector; CODE PN'S: 800001, 800003, 800005, 800006, 800007, 820003, 820004, 820005, 820006, 820007, 820014, 820016, 820035, 820036
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mallinckrodt, Inc, Cincinnati, OH, 
Manufacturer: McMahon Medical, Inc., San Diego, CA. REASON The tubing metal begins to crack and thin. When this occurs it causes the tubing material to crack around the screws. This can cause the tubing to fall from the mounting plug.
VOLUME OF PRODUCT IN COMMERCE 2,546 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Bard Recovery Cone Removal System, Catalog Numbers: RC-15. The device is intended for use for percutaneously remove the recovery filter or facilitate the retrieval of foreign objects from the peripheral vascular system;
b) Bard Recovery Cone Removal System, Catalog Numbers: FBRC. The device is intended for use for percutaneously remove the recovery filter or facilitate the retrieval of foreign objects from the peripheral vascular system;
CODE
a) All lots with expiry dates between May 2008 and February 2011.
    Serial Numbers: GFPD1574 GFPD2170 GFPD1576 GFPD4227 GFPD1575  GFPD2171 GFPD4228 GFPD4229 GFPD4230 GFPD4723 GFPD4724 GFPD4725  GFPD4727 GFPD4728 GFPD4729 GFPD2172 GFPD4726 GFPE3233 GFPE3234
GFPE3236 GFPE3235 GFPE3238 GFPE3237 GFPE3239 GFPE3240 GFPE3241 GFPE3242 GFPE3243 GFPE3244 GFPE3245 GFPF2336 GFPF4114 GFPF4115
GFPF4116 GFPF4117 GFPF4118 GFPF4119 GFPF4121 GFPF4122 GFPF4123 GFPF4120 GFPF4124 GFPF4125 GFPF4126 GFPF4127 GFPF4108 GFPF4109
GFPF4110 GFPF4111 GFPF4112 GFPF4113 GFPH0443 GFPH0444 GFPH0445 GFPH0446 GFPH0449 GFPH0447 GFPH0448 GFPH0450 GFPH0451 GFPH0452 GFPH0453 GFPH0454 GFPH0455 GFPH0457 GFPH0456 GFPH0458 GFPK2806
GFPK2807 GFPK2808 GFPK2809 GFPK2810 GFPK2811 GFPK2812 GFPK2813
GFPK2814 GFPK2815 GFPK4721 GFPK4722 GFPL4248 GFPL4249 GFPL4250  GFPL4251 GFPL4252 GFPL4253 GFPL4254 GFPL4255 GFPL4256 GFPL4257
GFPL4258 GFPL4259 GFPL4261 GFPL4260 GFQA3500 GFQA3501 GFQA3502 GFQA3503 GFQA3504 GFQA3505 GFQA3512 GFQA3514 GFQA3516
GFQB1627 GFQB1628 GFQA3518 GFQB1629 GFQB1630 GFQB1631 GFQB3492  GFQB3493 GFQB3494 GFQB3495 GFQB3496 GFQB3497 GFQB3499 GFQB3498 GFQB3500 GFQB3501 GFQB3502 GFQB3503 GFQB3504 GFQB3505 GFQB3506  GFQC4378 GFQC4379 GFQC4382 GFQC4380 GFQC4381 GFQD0077 GFQD0078
GFQD0079 GFQD0080 GFQD0081 GFQD0082 GFQD2039 GFQD2038 GFQD2040 GFQD3742 GFQD3744 GFQD3745 GFQD3739 GFQD3740
  GFQD3741 GFQD3746 GFQD3747 GFQD3749 GFQE4409 GFQE4410 GFQE4724 GFQE4725 GFQF0388 GFQF0389 GFQF0392 GFQF4296 GFQF4297 GFQF4288 GFQF4289 GFQG2518 GFQG2841 GFQG3368 GFQG3369 GFQG3370
GFQG3371 GFQG3367 GFQG3372 GFQH2309 GFQH3845 GFQH3846 GFQI0229 GFQI0230 GFQI0231 GFQI0232 GFQI3507 GFQI3508 GFQJ0020 GFQJ0442 GFQJ0443 GFQJ0444 GFQJ0445 GFQJ0446 GFQJ0432 GFQI3994 GFQI3995 GFQJ4114 GFQJ4115 GFQJ4637 GFQJ4638 GFQJ4641 GFQJ4642 GFQJ4646
  GFQJ4644 GFQJ4645 GFQK3057 GFQK3788 GFQL0324 GFQL0249 GFQL0250 GFQL0322 GFQL0323 GFQL0711 GFQL2631 GFQL2632 GFQL0731 GFQL2633 GFQL4073 GFQL4074 GFQL4075 GFQL4076 GFQL4077 GFQL4078 GFRA3887 GFRA3888 GFRA5030 GFRA5031 GFRA5032 GFRB0123 GFRB0124 GFRC0529
GFRC0530 GFRC0531 GFRC0532 GFRC0533 GFRC0534 GFRC0535 GFRC2639 GFRC2628 GFRC2629 GFRC2631 GFRC2632 GFRC2633 GFRC2634 GFRC2635 GFRC2630 GFRC2636 GFRC2637 GFRC2638 GFRD3500 GFRD3501 GFRD3502 GFRE1347 GFRE1349 GFRE1350 GFRE1351 GFRE1422 GFRE1423 GFRE1424
GFRE4483 GFRE4484 GFRE4485 GFRE4486 GFRE4487 GFRE4488 GFRE4489 GFRE4490 GFRE4491 GFRE4492 GFRE4493 GFRE4494 GFRE4495 GFRE4496
GFRE4497 GFRE4498 GFRF3639 GFRF3640 GFRF3641 GFRF3642 GFRF3643 GFRF3644 GFRF3645 GFRF3646 GFRF3647 GFRF3648 GFRF3649 GFRG2502
GFRG2503 GFRG2505 GFRG2504 GFRG2506 GFRG2507 GFRG2508 GFRH4779
GFRH4781 GFRH4780 GFRH4783 GFRH4782 GFRH4784 GFRH4785 GFRH4786 GFRI0045 GFRI3372 GFRI3373 GFRJ4044 GFRI3380 GFRI3381
GFRJ4045 GFRI3379 GFRI3382 GFRI3383 GFRJ4046 GFRJ4047 GFRJ4048  GFRJ4049 GFRK3903 GFRK3904 GFRK3905 GFRL0039 GFSA2453 GFSA2452 GFSB0182;
b) All lots with expiry dates between May 2008 and February 2011. Serial Numbers:
GFRL3426 GFRL3425 GFRL3438 GFRL3439 GFRL3443 GFRL3445 GFRL3448 GFRL3424 GFRL3436 GFRL3437 GFSA0555 GFSA0027 GFSA0556 GFSA0557
GFSA0560 GFSA0610 GFSA0611 GFSA0612 GFSA0613 GFSA0614 GFSA0615 GFSA0644
RECALLING FIRM/MANUFACTURER Bard Peripheral Vascular, Inc., Tempe, AZ
REASON This action is being taken because the product has a potential for the handle to detach. The handle detachment may result in the device unable to retrieve the filter or foreign body.
VOLUME OF PRODUCT IN COMMERCE 12,679 units
DISTRIBUTION Nationwide

PRODUCT
a) Weck, DuraHook", Catalog #382800, 1/4" (6mm) Neuro Elastic Retractors, Sterile, Rx only,
b) Weck, DermaHook", Catalog #382805, 1/2" (12mm) Neuro Elastic Retractors, Sterile, Rx only,
CODE All manufacturing dates from 4/1/2006 through 3/19/2008;
    Lot numbers: 01A0800425, 01L0700008, 01L0700339, 01M0700052, 1996009, 2217638, T1206007, T1207101, T1207481, T1209127, T1209524, T1212329, T1212657, T1224116, T1224887, T1226599, T1228526, T1230381, T1232347, T1238489, T1240283, T1242666, T1244664, T1245240,T1238489, T1248506, T1249506, T1253534,T1255173, T1259102, T1278101, T1279049;
b) All manufacturing dates from 4/1/2006 through 3/19/2008;
    Lot numbers: 01A0800086, 01A0800168, 01A0822216, 01A0800323,  01L0700096, 01L0700257, 1996021, 2230335, 2614566, T1206008, T1206537, T1209084, T1209085, T1209525, T1211001, T1211685, T1212658, T1223079, T1226004, T1227679, T1229934, T1231416, T1233264, T1234305, T1236177, T1239174, T1242796,T1243832, T1243833, T1243834, T1247442, T1250478, T1251531, T1252452, T1254316, T1255368, T1256381, T1257718, T1258301, T1266798, T1267798, T1268854, T1269783, T1270679, T1271622, T1277206,
T1277284, T1279907
RECALLING FIRM/MANUFACTURER
Recalling Firm: Telefeix Medical, Durham, NC, 
Manufacturer: Hudson RCI Tecate S.de R.L. de C.V., Teleflex Medical, Tecate, B.C., Mexico. 
REASON The bands are breaking within the sealed packaging or in use prior to the expiration dates.
VOLUME OF PRODUCT IN COMMERCE 14,255 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Physio-Control LIFEPAK® 12 defibrillator/monitor. The LIFEPAK12 defibrillator/monitor series is a battery operated portable external defibrillator with monitor used by healthcare providers in EMS, hospital and clinic settings. The LIFEPAK 12 has both manual and semi-automatic defibrillation operations. When clinically indicated, the LIFEPAK 12 defibrillator/monitor allows the operator to deliver a brief, high-energy shock to the heart of the patient. Operators may pre-configure the device to reduce complexity during normal operation. Part Number 3010178-010, DVLP12-02-000102, UVLP12-02-000022, VLP12-02-000021, VLP12-02-000022, VLP12-02-000023, VLP12-02-000057, VLP12-02-000058, VLP12-02-000059, VLP12-02-000099, VLP12-02-000100, VLP12-02-000107, VLP12-02-000110, VLP12-02-000242, VLP12-02-000287, VLP12-02-000296, VLP12-02-000317, VLP12-02-000338, VLP12-02-000411, VLP12-02-000449, VLP12-02-000577, VLP12-02-000800, VLP12-02-000801, VLP12-02-000876, VLP12-02-000983, VLP12-02-000985, VLP12-02-001029, VLP12-02-001038, VLP12-02-001168, VLP12-02-001253, VLP12-02-001366, VLP12-02-001387, VLP12-02-001430, VLP12-02-001449, VLP12-02-001460, VLP12-02-002163, VLP12-02-002175, VLP12-02-002222, VLP12-02-002250, VLP12-02-002860, VLP12-02-003223, VLP12-02-003585, VLP12-02-003809, VLP12-02-003979, VLP12-02-004055, VLP12-02-004221, VLP12-02-004354, VLP12-02-006000, VLP12-02-006011, VLP12-02-006012, VLP12-02-006013, VLP12-02-006018, VLP12-02-006020, VLP12-02-006021, VLP12-02-006030, VLP12-02-006033, VLP12-02-006036, VLP12-02-006037, VLP12-02-006042, VLP12-02-006044, VLP12-02-006057, VLP12-02-006060, VLP12-02-006064, VLP12-02-006067, VLP12-02-006076, VLP12-02-006077, VLP12-02-006081, VLP12-02-006086, VLP12-02-006087, VLP12-02-006088, VLP12-02-006097, VLP12-02-006101, VLP12-02-006103, VLP12-02-006107, VLP12-02-006110, VLP12-02-006114, VLP12-02-006119, VLP12-02-006159, VLP12-02-006176, VLP12-02-006179, VLP12-02-006181, VLP12-02-006196, VLP12-02-006199, VLP12-02-006202, VLP12-02-006210, VLP12-02-006223, VLP12-02-006226, VLP12-02-006234, VLP12-02-006238, VLP12-02-006256, VLP12-02-006263, VLP12-02-006266, VLP12-02-006267, VLP12-02-006268, VLP12-02-006269, VLP12-02-006275, VLP12-02-006290, VLP12-02-006304, VLP12-02-006306, VLP12-02-006312, VLP12-02-006315, VLP12-02-006322, VLP12-02-006329, VLP12-02-006333, VLP12-02-006343, VLP12-02-006349, VLP12-02-006359, VLP12-02-006365, VLP12-02-006366, VLP12-02-006367, VLP12-02-006373, VLP12-02-006393, VLP12-02-006396, VLP12-02-006398, VLP12-02-006414, VLP12-02-006423, VLP12-02-006437, VLP12-02-006455, VLP12-02-006457, VLP12-02-006475, VLP12-02-006478, VLP12-02-006483, VLP12-02-006487, VLP12-02-006500, VLP12-02-006531, VLP12-02-006542, VLP12-02-006555, VLP12-02-006565, VLP12-02-006576, VLP12-02-006577, VLP12-02-006578, VLP12-02-006593, VLP12-02-006600, VLP12-02-006615, VLP12-02-006623, VLP12-02-006624, VLP12-02-006644, VLP12-02-006647, VLP12-02-006686, VLP12-02-006687, VLP12-02-006723, VLP12-02-006747, VLP12-02-006748, VLP12-02-006757, VLP12-02-006780, VLP12-02-006789, VLP12-02-006823, VLP12-02-006836, VLP12-02-006845, VLP12-02-006863, VLP12-02-006911, VLP12-02-006922, VLP12-02-006941, VLP12-02-006945, VLP12-02-006965, VLP12-02-007013, VLP12-02-007028, VLP12-02-007029, VLP12-02-007066, VLP12-02-007098, VLP12-02-007133, VLP12-02-007143, VLP12-02-007170, VLP12-02-007174, VLP12-02-007189, VLP12-02-007209, VLP12-02-007211, VLP12-02-007212, VLP12-02-007213, VLP12-02-007214, VLP12-02-007215, VLP12-02-007217, VLP12-02-007218, VLP12-02-007220, VLP12-02-007222, VLP12-02-007228, VLP12-02-007231, VLP12-02-007241, VLP12-02-007270, VLP12-02-007280, VLP12-02-007312, VLP12-02-007330, VLP12-02-007340, VLP12-02-007351, VLP12-02-007355, VLP12-02-007357, VLP12-02-007359, VLP12-02-007364, VLP12-02-007368, VLP12-02-007369, VLP12-02-007370, VLP12-02-007373, VLP12-02-007374, VLP12-02-007375, VLP12-02-007379, VLP12-02-007384, VLP12-02-007387, VLP12-02-007394, VLP12-02-007399, VLP12-02-007408, 
CODE
SN: 36285363, 36285396, 36285399, 36255174, 36255175, 36255176, 36255177, 36255178, 36176270, 36176271, 36176272, 36176273, 36176274, 36185900, 36150660, 36183667, 36183668, 36183669, 36183670, 36183671, 36183672, 36183673, 36217503, 36217504, 36175110, 36175111, 36175112, 36175113, 36175114, 36175115, 36175116, 36175117, 36175118, 36175119, 36175120, 36175121, 36175122, 36175123, 36175124, 36175125, 36175126, 36175127, 36175211, 36175212, 36175213, 36176278, 36183819, 36183820, 36183821, 36186386, 36186387, 36186389, 36186390, 36213282, 36213283, 36201095, 36201096, 36266477, 36266478, 36278215, 36278216, 36262903, 36262904, 36262905, 36255134, 36255135, 36255136, 36255139, 36255141, 36265918, 36255061, 36271596, 36271597, 36271598, 36271599, 36262898, 36262899, 36174623, 36174624, 36174625, 36174626, 36174627, 36174628, 36174629, 36174630, 36174631, 36174632, 36174633, 36174634, 36174635, 36174636, 36174637, 36174638, 36174639, 36174640, 36183216, 36183217, 36262662, 36262664, 36262665, 36262666, 36262667, 36262668, 36262669, 36262670, 36262671, 36266244, 36260617, 36260618, 36150802, 36213255, 36213256, 36213257, 36213258, 36213259, 36213260, 36213261, 36213262, 36255990, 36271561, 36271562, 36271563, 36271564, 36271565, 36271566, 36271567, 36271568, 36271569, 36271570, 36271571, 36271572, 36271573, 36271574, 36271575, 36271576, 36271577, 36271578, 36271579, 36271580, 36233648, 36233649, 36278171, 36285371, 36285372, 36285373, 36285374, 36285375, 36285376, 36285377, 36285378, 36285379, 36285380, 36285381, 36285382, 36285383, 36285384, 36285385, 36285386, 36285387, 36285388, 36285389, 36175216, 36175217, 36175218, 36175219, 36175220, 36175221, 36175222, 36175223, 36175224, 36175225, 36175226, 36175227, 36175228, 36175229, 36175230, 36175231, 36175232, 36175233, 36186049, 36186050, 36186051, 36186052, 36186053, 36186054, 36186055, 36186056, 36186057, 36186058, 36186059, 36186060, 36186061, 36186062, 36186063, 36186064, 36186065, 36186066, 36186067, 36186068, 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RECALLING FIRM/MANUFACTURER Physio Control, Inc., Redmond, WA, 
REASON The LIFEPAK12 defibrillator/monitor series (LP12) contain a Biphasic PCBA that may have a solder defect on the H Bridge component that could prevent the device from providing a defibrillation shock.
VOLUME OF PRODUCT IN COMMERCE 1,710 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Model 35A Series Mobile Transporters is an ambulance stretcher for patient transport. The following Models within the 35A series were subject to recall: (35-A, 35-AST, 35-A+, 35ITA, 35-ITDS, 35-ANM, 35-A+ST, 35-SL, 35-ITIB, 35-L);  
CODE
Serial Numbers: 07047767 07047768 07047769 07047770 07047771 07048489 07049108 07049109 07049111 07049112 07049113 07049114 07049115 07049116 07049118 07049119 07049120 07049122 07049123 07049124 07049166 07049167 07049168 07049169 07049170 07049171 07049172 07049173 07049174 07049175 07049176 07049177 07049178 07049179 07049180 07049181 07049182 07049183 07049723 07049724 07049726 07049727 07049728 07049729 07049730 07049731 07049732 07049733 07049734 07049735 07049736 07049737 07049775 07049776 07049777 07049778 07049779 07049780 07049781 07049782 07049783 07049784 07050473 07050474 07050475 07050476 07050477 07050478 07050479 07050480 07050481 07050482 07050483 07050484 07050485 07050486 07050487 07050488 07050489 07050490 07050491 07050492 07050493 07050494 07050495 07050496 07050497 07050564 07050565 07050566 07051124 07051144 07051145 07051146 07051147 07051148 07051149 07051150 07051151 07051152 07051153 07051154 07051155 07051156 07051157 07051158 07051159 07051160 07051161 07051162 07051163 07051878 07051879 07051880 07051881 07051882 07051883 07051884 07051885 07051886 07051887 07051928 07051929 07051930 07051931 07051932 07051933 07051935 07051936 07051937 07051938 07051939 07051940 07051941 07051942 07051943 07051944 07051945 07051946 07051947 07052491 07052492 07052493 07052494 07052495 07052496 07052497 07052498 07052499 07052500 07052501 07052502 07052503 07052504 07052543 07052544 07052545 07052546 07052547 07052548 07052549 07052550 07052551 07052552 07052553 07052554 07052555 07052556 07052557 07052639 07052693 07053218 07053219 07053220 07053221 07053222 07053223 07053258 07053259 07053260 07053261 07053262 07053263 07053264 07053265 07053266 07053267 07053268 07053269 07053270 07053271 07053272 07053273 07053274 07053275 07053276 07053277 07053278 07054057 07054059 07054060 07054071 07054074 07055360 07055361 07055364 07055365 07055366 07055367 07055368 07055953 07055958 07055960 07055964 07055965 07055966 07055967 07056805 07056807 07056808 07056809 07056810 07056811 07056812 07056813 07056814 07056815 07056816 07056817 07056818 07056819 07056820 07056821 07056822 07056823 07056824 07056825 07056826 07056827 07057297 07057298 07057301 07057302 07057303 07057304 07057305 07057306 07057308 07057309 07057310 07057311 07057314 07057317 07057321 07057322 07057323 07057966 07058028 07058617 07058620 07058626 07058673 07058676 07059925 07059928 07059929 07059931 07059932 07059933 07059934 07059935 07059938 07059939 07060434 07060435 07060437 07060438 07060439 07060440 07060441 07060442 07060449 07060457 07060459 07060460 07060461 07060462 07060463 07060464 07060465 07060466 07060467 07061019 07061020 07061029 07061030 07061031 07061039 07061040 07061041 07061042 07061043 07061046 07061047 07061049 07061050 07061051 07061052 07061059 07061060 07061067 07061068 07061069 07061070 07061072 07061073 07061074 07061075 07061076 07061077 07061078 07061086 07061087 07061089 07061090 07061091 07061092 07061093 07061094 07061097 07061098 07061101 07061103 07061104 07061105 07061106 07061107 07061114 07061115 07061116 07061118 07061173 07061712 07061713 07061714 07061715 07061716 07061717 07061718 07061720 07061721 07061722 07061723 07061724 07061725 07061726 07061727 07061728 07061729 07061730 07061733 07061735 07061736 07061737 07061738 07061739 07061740 07061742 07061745 07061747 07061748 07061749 07061750 07061751 07061752 07061753 07061759 07061760 07061761 07061762 07061763 07061764 07061767 07061768 07061769 07061771 07062345 07062346 07062347 07062348 07062349 07062350 07062351 07062352 07062353 07062354 07062355 07062356 07062357 07062358 07062359 07062360 07062361 07062362 07062363 07062364 07062365 07062368 07062369 07062370 07062371 07062372 07062373 07062374 07062381 07062382 07062383 07062384 07062564 07062565 07062577 07063284 07063285 07065704 07065705 07065706 07066543 07066544 07066545 07066546 07066547 07066548 07066549 07067804 07067805 08069464 08069465 08071534 08071535 08071536 08071537 08071553 08071554 08071555 08073210 08073211 08073212 08073213 08073214 08073215 08073216 08073217 08073218 08073219 08074231 08074232 08074233 08074234 08074235 08074236 888113814 888113815 888113816 888113817 888113818 888113819 888113820 888113821 888113822 888113823 888113824 888113825 888113826 888113827 888113828 888113829 888113830 888113831 888113832 BBB113833 BBB113834 BBB113835 8BB113836 BBB113837 BBB113838 BBB113839 BBB113840 BBB113841 BBB113842 BBB113843 BBB113844 BBB113845 BBB113846 BBB113847 BBB113848 BBB113849 BBB113850 BBB113851 BBB113852 BBB113853 BBB113854 BB8113855, and 8BB113856
RECALLING FIRM/MANUFACTURER Femo-Washington, Inc., Wilmington, OH, 
REASON A component defect was found in corner castings of the firm's wheeled ambulance stretchers. Some corner castings on the stretchers were found to be over-sized. Using an over-sized cone-shaped hole corner casting with an improperly seated shank pin could put undue stress on the top screw, possibly causing the screw securing a wheel to become loose or break and the wheel to detach from the stretcher.
VOLUME OF PRODUCT IN COMMERCE 783 units
DISTRIBUTION Nationwide

PRODUCT Stella Interdental Osteotome, 4 mm, 6 mm and 8 mm. Model numbers: 01-0575, 01-0576 and 01-0578. Product is intended to be used during the interdental osteotomy (bone cutting); 
CODE Lot numbers: 381250, 381251, 439970, 381240, 356510, 513250 and 354320
RECALLING FIRM/MANUFACTURER Biomet Microfixation, Inc., Jacksonville, Fl,
REASON The working tips of the Stella Osteotomes are thicker than specification.
VOLUME OF PRODUCT IN COMMERCE 36 units
DISTRIBUTION MO, NM, TX, Canada, Germany

PRODUCT
a) Edwards Lifesciences LLC, Fem-Flex II Femoral Venous Cannula, 12 Fr. x 11.5 cm,  REF FEMII012V, 
b) Edwards Lifesciences LLC, Fem-Flex II Duraflo Treated Femoral Venous Catheter, 8 Fr. x 11.5 cm, REF DIIFEMII008V; 
CODE
a) Lot 58458668;
b) Lot 58458813
RECALLING FIRM/MANUFACTURER Edwards Lifesciences Research Medical, Inc., Midvale, UT,
REASON Femoral Venous Cannula was color coded as an arterial cannula. This problem could result in a minor delay in the procedure. In the worst case, this product could be connected incorrectly during bypass, which would result in a more significant delay and has the potential to result in a permanent injury.
VOLUME OF PRODUCT IN COMMERCE 25 units
DISTRIBUTION Nationwide

PRODUCT
a) Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/15 cm, sterile; REF 26-226, UPN M001262260. The product is used with a radiofrequency  generator for the thermal coagulation necrosis of soft tissues, including partial or  complete ablation of nonresectable liver lesions; 
b) Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/25 cm, sterile;  REF 26-227, UPN M001262270. The product is used with radiofrequency  generator for the thermal coagulation necrosis of soft tissues, including partial or  complete ablation of nonresectable liver lesions; 
c) Boston Scientific LeVeen SuperSlim Needle Electrode, 3.0 cm/15 cm, sterile;  REF 26-228, UPN M001262280. The product is used with radiofrequency  generator for the thermal coagulation necrosis of soft tissues, Including partial or  complete ablation of nonresectable liver lesions; 

d) Boston Scientific LeVeen SuperSlim Needle Electrode, 3.0 cm/25 cm, sterile, REF 26-229, UPN M001262290. The product is used with radiofrequency  generator for the thermal coagulation necrosis of soft tissues, including partial or  complete ablation of nonresectable liver lesions; 
CODE
a) All lots. Lots: 0007754221, 0007756536, 0007760602, 0007773373, 0007773795, 0007795354, 0007795671, 0007829946, 0007860541, 0007924564, 0007929069, 0007935435, 0007935641, 0007935927, 0007967967, 0007973448, 0007973449, 0007983095, 0007999035, 0008029591, 0008029965, 0008047351, 0008055911, 0008100038, 0008100039, 0008119923, 0008119924, 0008138446, 0008142890, 0008142891, 0008147540, 0008165769, 0008165770, 0008165771, 0008181500, 0008198428, 0008198430, 0008202143, 0008229896, 0008246451, 0008246452, 0008247161, 0008250918, 0008250919, 0008262976, 0008262977, 0008279250, 0008287295, 0008632162, 0008633030, 0008678724, 0008715160, 0008745079, 0008745080, 0008745081, 0008745084, 0008745085, 0008757525, 0008764755, 0008815843, 0008815844, 0008840208, 0008842737, 0008843687, 0008855834, 0008865948, 0008870965, 0008885317, 0008922049, 0008922050, 0008922051, 0008962320, 0008971482, 0008976593, 0008993095, 0009012204, 0009012205, 0009012206, 0009034730, 0009059144, 0009070216, 0009081512, 0009092663, 0009103629, 0009103630, 0009103631, 0009104111, 0009275204, 0009277201, 0009277202, 0009288930, 0009292225, 0009294911, 0009295272, 0009295273, 0009330954, 0009344590, 0009352769, 0009386363, 0009409068, 0009429873, 0009449403, 0009457082, 0009464931, 0009488649, 0009501969, 0009520948, 0009538053, 0009554399, 0009568323, 0009595705, 0009595853, 0009609675, 0009622354, 0009645946, 0009662038, 0009679969, 0009696743, 0009711986, 0009726408, 0009726409, 0009731711, 0009747000, 0009749812, 0009776800, 0009784043, 0009800139, 0011001910, 0011007735, 0011017381, 0011027710, 0011036114, 0011042782, 0011083691, 0011111662, 0011300194, 0011303965, 0011312752 and 0011442784;
b) All lots. Lots: 0007754222, 0007757352, 0007774377, 0007778866, 0007787319, 0007802363, 0007819373, 0008025066, 0008033462, 0008119925, 0008126720, 0008139108, 0008167709, 0008187490, 0008189883, 0008191619, 0008272777, 0008274731, 0008301843, 0008900347, 0009106193, 0009261704, 0009261705, 0009261706, 0009275205, 0009292249, 0009344591, 0009382115, 0009422549, 0009437649, 0009446512, 0009464930, 0009505685, 0009532051, 0009569176, 0009595712, 0009647788, 0009663657, 0009749621, 0009783669, 0009799393, 0009993406 0011311216 and 0011517938;
c) Lots 0007685394, 0007688596, 0007690044, 0007693080, 0007710763, 0007717197, 0007718494, 0007757593, 0007769794, 0007778476, 0007798277, 0007799684, 0007815133, 0007819730, 0007820171, 0007820172, 0007830174, 0007873593, 0007874184, 0007874890, 0007877715, 0007936157, 0007836928, 0007961474, 0007998646, 0007999036, 0008014012, 0008047352, 0008047353, 0008051302, 0008051303, 0008053104, 0008056115, 0008119926, 0008122051, 0008123318, 0008126721, 0008139109, 0008144855, 0008144856, 0008160440, 0008162356, 0008167710, 0008170365, 0008170367, 0008181522, 0008195334, 0008195335, 0008198429, 0008221414, 0008222839, 0008222840, 0008235405, 0008237665, 0008237666, 0008237667, 0008247423, 0008257786, 0008258696, 0008258699, 0008283450, 0008309810, 0008309811, 0008611256, 0008611257, 0008640930, 0008645586, 0008645587, 0008874668, 0008764670, 0008764671, 0008764752, 0008837286, 0008845099, 0008851900, 0008852673, 0008860247, 0008865949, 0008874114, 0008886780, 0008898275, 0008927405, 0008962637, 0008966750, 0009066657, 0009067960, 0009080979, 0009102282, 0009106194, 0009124609, 0009129138, 0009136775, 0009154345, 0009159632, 0009190228, 0009281907, 0009282082, 0009290027, 0009292248, 0009292259, 0009331890, 0009335084, 0009382659, 0009405438, 0009423826, 0009456695, 0009460988, 0009466719, 0009479846, 0009498167, 0009505686, 0009520950, 0009538556, 0009555435, 0009564540, 0009573301, 0009591819, 0009609676, 0009639173, 0009658206, 0009677181, 0009690998, 0009711580, 0009716581, 0009730011, 0009730774, 0009746025, 0009763711, 0009779996, 0009795358, 0009802808, 0009806552, 0009806775, 0011004782, 0011020014, 0011035229, 0011035231, 0011042783, 0011083692, 0011135307, 0011135308, 0011165361, 0011165362, 0011165363, 0011249434, 0011249435, 0011286830, 0011300195, 0011303966, 0011312232, 0011312233, 0011312234, 0011314618, 0011378176, 0011405138, 0011428065, 0011428066, 0011428067 and 0011446252;
d) Lots: 8382, 0007772112, 0007799189, 0007810726, 0007873053, 0007916555, 0008034686, 0008123319, 0008135736, 0008135737, 0008144857, 0008147541, 0008185484, 0008189884, 0008206704, 0008271342, 0008396414, 0008428150, 0008470440, 0008546755, 0008625282, 0008815837, 0008839480, 0008845098, 0008865219, 0008870962, 0008891504, 0008971484, 0009070215, 0009080832, 0009107193, 0009125675, 0009137173, 0009154346, 0009160546, 0009299951, 0009303596, 0009333564, 0009385351, 0009429552, 0009446553, 0009457083, 0009488650, 0009498166, 0009564539, 0009569175, 0009606078, 0009623181, 0009647789, 0009663658, 0009711987, 0009734050, 0009750637, 0009783670, 0009800137, 0009802809, 0011038755, 0011299942 and 0011311215
RECALLING FIRM/MANUFACTURER Boston Scientific Corp., Spencer, IN, 
REASON The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines.
VOLUME OF PRODUCT IN COMMERCE 20,966 units
DISTRIBUTION Nationwide and Internationally

PRODUCT DST-XL Model 1002375 is a multi-head, whole body gamma camera with infrared body contouring and anti-collision computed tomography system; 
CODE
211 0000000DSTX002 0000000DSTX003 0000000DSTX004 178 174 156 119 000000000A/255 000000000B/171 183 138 0000000DSTX008 000000000B/175 246 000000000D/207 00A108/168/331 0000000DSTX020 0000000DSTX010 000000000D/127 126 0000000000A252 0000000DSTX019 UNK10023750070 0000000DSTX016 204 000000000A/217 1461 000000000A/213 167 209 000000000A/241 000000000A/242 9833 154 9759 00000000097/63 00000000097/04 128 000000000A/166 112 0000271/119/28 000000000A/249 0000000136/300 0000000000A117 0000000#258097 9745 000226/116/273 149 00000000098/32 208 9747 000000000A/223 9723 9806 135 106 210 0000000000B186 132 0000000000A162 9737 142 159 000131/288/295 229 000000000A/190 000000000A/219 9756 158 000000000A/238 000000000A/195 9549 000000000A/191 9758 0000000DSTX014 0000000DSTX017 195 000000XL129601 0000000DSTX015 150 165 000000XL069502 134 225 A/229 222 000000DSTXL001 237 111 SMSA100801 122 194 000282/123/284 000304/144/308 000A104/A157/3 98410147 00000000A/1035 000250/109/257 180 UNKNOWN 000000000A/189 212 0000000000A226 223 000A202/A193/C 000113/259/275 113 181 164 A/245 A/249 000A102/161/32 000160/A101/32 000285/130/290 000293/135/297 000J2/229/A463 000182/124/357 000A205/200/C3 151 99370248 240 215 000000000A/195 152 168
RECALLING FIRM/MANUFACTURER 

Recalling Firm: GE Healthcare, Waukesha, WI, 
Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. 
REASON A cable failure associated with the arm or gantry rotation of the DST-XL Camera that may impact patient safety.
VOLUME OF PRODUCT IN COMMERCE 127 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Physio-Control LIFEPAK® 20 defibrillator/monitor. This product is an external defibrillator sold internationally and domestically; Device Part Number: 3202459-061, 3202487-015, 3202487-073, 3202487-075, 3202487-078,  3202487-079, 3202487-100, 3202488-036, 3202488-038 and 3202488-040;
 b) Physio-Control LIFEPAK® 20e defibrillator/monitor. This product is an external  defibrillator sold internationally only; Device Part Number: 3202488-053;
c) Keypad replacement for LIFEPAK20 or LIFEPAK20e. This product is an external defibrillator; 
CODE
a) Keypad lot codes (Lot codes appear on the original product packaging, but are not stamped onto the keypads): 10-07, 11-07, 12-07-P093, 12-07-P094, 01-08-N116, 01-08-N126, 01-08-P091, 01-08-P093; Device SN number: 31013593, 31018361, 31521701, 32358182, 33035378, 35506844, 35506880, 35506886, 35506887, 35512605, 35514416, 35719026, 35719588, 35719590, 35719593, 35740798, 35740799, 35742042, 35742271, 35742274, 35744129, 35744131, 35744132, 35744133, 35744201, 35744905, 35744912, 35744913, 35744914, 35744917, 35744919, 35744921, 35744931, 35744933, 35744934, 35744935, 35744939, 35744940, 35744941, 35746673, 35746683, 35746685, 36090252, 36090256, 36090257, 36090258, 36090259, 36090262, 36090264, 36090265, 36090266, 36090268, 36090269, 36090270, 36090272, 36090273, 36090274, 36090275, 36090278, 36090279, 36090280, 36090281, 36090285, 36090286, 36090287, 36090289, 36090290, 36093885, 36101738, 36101739, 36101740, 36101742, 36101743, 36101745, 36101746, 36133741, 36133760, 36137373, 36139003, 36139004, 36139008, 36139015, 36139016, 36139017, 36139018, 36139019, 36139022, 36139027, 36139028, 36139029, 36139030, 36139032, 36141368, 36141385, 36141389, 36141390, 36141403, 36141404, 36141405, 36142719, 36142720, 36142721, 36142724, 36142727, 36142732, 36143803, 36143804, 36143816, 36143817, 36143818, 36143819, 36143820, 36143821, 36143822, 36143824, 36143827, 36143831, 36143832, 36143833, 36143834, 36143835, 36143836, 36143837, 36143838, 36143839, 36143840, 36143841, 36143842, 36143843, 36143844, 36143845, 36143846, 36143847, 36143850, 36143851, 36146450, 36146451, 36146452, 36146454, 36146455, 36146457, 36146458, 36146459, 36146460, 36146461, 36146463, 36146464, 36146465, 36146467, 36146469, 36146470, 36146471, 36146472, 36146473, 36146474, 36146475, 36146476, 36146477, 36146478, 36146479, 36146480, 36146482, 36146483, 36146484, 36153459, 36153460, 36153463, 36163333, 36163334, 36163335, 36163340, 36163341, 36163349, 36163351, 36163353, 36163354, 36163420, 36163423, 36164927, 36164928, 36164930, 36164931, 36164932, 36164934, 36164936, 36164937, 36164938, 36164942, 36164943, 36164949, 36164950, 36164951, 36164953, 36164956, 36164957, 36164961, 36164962, 36164963, 36164964, 36164966, 36164967, 36164968, 36164969, 36164970, 36164971, 36164972, 36164973, 36164974, 36164976, 36164977, 36164978, 36164979, 36164980, 36164981, 36164982, 36164983, 36168841, 36168842, 36168843, 36168844, 36168846, 36168847, 36168848, 36168849, 36168850, 36168851, 36168852, 36168853, 36168854, 36168855, 36168856, 36168857, 36168858, 36168859, 36168860, 36168861, 36168862, 36168863, 36168864, 36168865, 36168866, 36168867, 36168868, 36168869, 36168870, 36168871, 36168872, 36168873, 36168874, 36168875, 36168876, 36168877, 36168878, 36168880, 36168881, 36168882, 36168883, 36168884, 36168885, 36168886, 36168887, 36168888, 36168889, 36168890, 36168891, 36168892, 36168893, 36172860, 36172861, 36172862, 36172863, 36172864, 36172865, 36172866, 36172867, 36172868, 36172869, 36172870, 36172871, 36172872, 36172873, 36172874, 36172875, 36172876, 36172877, 36172878, 36172879, 36172880, 36172881, 36172882, 36172883, 36172884, 36172885, 36172886, 36172887, 36172888, 36172889, 36172890, 36172891, 36172892, 36172893, 36172894, 36172895, 36172896, 36172897, 36172898, 36172899, 36172900, 36172901, 36172902, 36172903, 36172904, 36172905, 36172906, 36172907, 36172908, 36172909, 36172910, 36172911, 36172912, 36172914, 36172915, 36172916, 36172918, 36172919, 36172920, 36172921, 36172922, 36172923, 36175050, 36175051, 36175052, 36175053, 36175054, 36175055, 36175056, 36175057, 36175058, 36175059, 36175060, 36175061, 36175062, 36175063, 36175064, 36175065, 36175066, 36175067, 36175068, 36175069, 36175070, 36175071, 36175072, 36175073, 36175074, 36175075, 36175077, 36175078, 36175079, 36175080, 36175081, 36175082, 36175083, 36175084, 36175085, 36175086, 36175087, 36175088, 36175089, 36175090, 36175091, 36175092, 36175093, 36175094, 36175095, 36175096, 36175097, 36175098, 36175099, 36175100, 36175101, 36175102, 36175103, 36178241, 36178242, 36178246, 36178247, 36178248, 36178249, 36178250, 36178251, 36178252, 36178254, 36178255, 36178256, 36178257, 36178258, 36178259, 36178261, 36178263, 36178278, 36178835, 36178836, 36178837, 36178838, 36178839, 36178840, 36178841, 36178842, 36178843, 36178844, 36178845, 36178847, 36178848, 36178849, 36178850, 36178851, 36178852, 36179224, 36179225, 36179227, 36179228, 36179229, 36179232, 36179233, 36179234, 36179235, 36179236, 36183644, 36183645, 36183646, 36186161, 36186162, 36186163, 36186165, 36186166, 36186168, 36186169, 36186170, 36186171, 36186173, 36186174, 36186175, 36186176, 36186177, 36186179, 36186180, 36186181, 36186184, 36186185, 36186187, 36186188, 36186191, 36186192, 36186195, 36186196, 36186197, 36186198, 36186199, 36186201, 36186204, 36186206, 36186207, 36186208, 36186209, 36186210, 36186219, 36188677, 36188678, 36188679, 36188680, 36188682, 36188683, 36188684, 36188687, 36188688, 36188689, 36188691, 36188692, 36188693, 36188694, 36188695, 36188696, 36188697, 36188698, 36188699, 36188702, 36188751, 36188753, 36188754, 36188755, 36188756, 36188757, 36188758, 36188759, 36188760, 36188761, 36188762, 36188763, 36188764, 36188765, 36188766, 36188767, 36188768, 36188769, 36188770, 36188771, 36188772, 36188773, 36188774, 36190699, 36190700, 36190701, 36190702, 36190703, 36190704, 36190705, 36190706, 36190707, 36190708, 36190709, 36190710, 36190711, 36190713, 36190714, 36190715, 36190716, 36190717, 36190718, 36200457, 36200459, 36200460, 36200461, 36200462, 36200463, 36200467, 36200468, 36200470, 36231195, 36231199, 36231204, 36231206, 36231895, 36231896, 36231902, 36231904, 36231944, 36231946, 36231948, 36231951, 36231952, 36232023, 36232024, 36232025, 36232026, 36232027, 36232028, 36232029, 36232030, 36232031, 36232257, 36232258, 36232259, 36232260, 36232261, 36232262, 36232474, 36232476, 36232477, 36232479, 36232480, 36232481, 36232482, 36232483, 36233781, 36233782, 36233783, 36233796, 36233797, 36233798, 36233799, 36233800, 36233801, 36233802, 36233803, 36233805, 36234054, 36234055, 36234056, 36234058, 36234060, 36234062, 36234063, 36234064, 36234343, 36234344, 36234345, 36234525, 36234526, 36234528, 36234529, 36234530, 36234531, 36234532, 36234636, 36234637, 36234639, 36234645, 36234647, 36236441, 36236442, 36244526, 36244527, 36244528, 36244529, 36244579, 36244581, 36244582, 36244583, 36244586, 36244588, 36244590, 36244591, 36244592, 36244593, 36244594, 36244595, 36244596, 36244598, 36244600, 36244601, 36245174, 36245176, 36245177, 36245178, 36245179, 36245181, 36245182, 36245183, 36245184, 36245185, 36245186, 36245188, 36245189, 36245190, 36245191, 36245192, 36245193, 36245194, 36245195, 36245196, 36245197, 36245198, 36245199, 36245201, 36245204, 36245205, 36245208, 36245209, 36245210, 36253898, 36253899, 36253900, 36253901, 36253902, 36253904, 36253905, 36253906, 36253907, 36253908, 36253909, 36253910, 36253911, 36253912, 36253914, 36253915, 36253916, 36253917, 36253918, 36253919, 36253920, 36253921, 36253922, 36253923, 36253924, 36253925, 36253926, 36253927, 36253928, 36253929, 36253930, 36253931, 36253932, 36253933, 36253934, 36253936, 36253937, 36253938, 36253939, 36253940, 36253941, 36253942, 36253943, 36253944, 36253945, 36253946, 36253947, 36253948, 36253949, 36253950, 36253951, 36253952, 36253953, 36253954, 36253955, 36253956, 36253957, 36253958, 36253959, 36257336, 36257338, 36257339, 36257341, 36257342, 36257361, 36257362, 36257363, 36257364, 36257365, 36257366, 36257368, 36257369, 36257370, 36257372, 36257373, 36257374, 36257375, 36257376, 36257378, 36257379, 36257380, 36257381, 36257383, 36257387, 36257388, 36257389, 36257390, 36257392, 36257393, 36257394, 36257395, 36257396, 36257397, 36257398, 36257399, 36257400, 36259179, 36260824, 36260825, 36260826, 36260827, 36260828, 36260829, 36260830, 36260831, 36260832, 36260833, 36260834, 36260835, 36260836, 36260837, 36260838, 36260839, 36260840, 36260841, 36260842, 36260843, 36260845, 36260846, 36260847, 36260848, 36260849, 36260850, 36260851, 36260852, 36260853, 36260854, 36260855, 36260856, 36260857, 36260858, 36260859, 36260860, 36260861, 36260862, 36260863, 36260864, 36260865, 36260866, 36260867, 36260868, 36260869, 36260870, 36260871, 36260872, 36260873, 36264639, 36264640, 36264641, 36264642, 36264643, 36264644, 36264645, 36264646, 36264647, 36264648, 36264649, 36264650, 36264653, 36264654, 36264655, 36264656, 36264657, 36264658, 36264660, 36264662, 36264663, 36264664, 36264666, 36264668, 36264669, 36264670, 36264671, 36264672, 36264674, 36264676, 36264678, 36264680, 36264681, 36264684, 36264686, 36264687, 36264689, 36264690, 36264692, 36264693, 36264695, 36267500, 36267501, 36267502, 36267503, 36267504, 36267505, 36267506, 36267507, 36267508, 36267510, 36267512, 36267513, 36267514, 36267515, 36267516, 36267517, 36267518, 36267519, 36267520, 36267521, 36267523, 36267524, 36267525, 36267526, 36267528, 36267529, 36267530, 36270152, 36270153, 36270155, 36270157, 36270158, 36270162, 36270163, 36270165, 36270166, 36270167, 36270168, 36270169, 36270170, 36270171, 36270175, 36270178, 36270180, 36273072, 36273077, 36273078, 36273079, 36273080, 36273081, 36273082, 36273085, 36273087, 36273090, 36273092, 36273093, 36273094, 36273095, 36273096, 36273934, 36273935, 36273937, 36273939, 36273979, 36273980, 36273981, 36273983, 36273984, 36273987, 36273988, 36273989, 36273990, 36273992, 36273993, 36273994, 36273995, 36273997, 36273998, 36273999, 36274000, 36274001, 36274002, 36274003, 36274006, 36274688, 36274689, 36274694, 36274695, 36274696, 36274698, 36274700, 36274702, 36274703, 36274705, 36274707, 36274708, 36274711, 36274713, 36274913, 36274914, 36274915, 36274916, 36274917, 36274920, 36274921, 36280952 and 36280953;

b) Keypad lot codes (Lot codes appear on the original product packaging, but are not stamped onto the keypads): 10-07, 11-07, 12-07-P093, 12-07-P094, 01-08-N116, 01-08-N126, 01-08-P091, 01-08-P093; Device SN: 36053634, 36053641, 36053642, 36053647, 36053651, 36053653, 36053654, 36082047, 36082048, 36082049, 36082050, 36082051, 36082054, 36102742, 36102743, 36102744, 36102745, 36102746, 36107743, 36107744, 36107746, 36107747, 36109647, and 36109667;

c) Keypad lot codes (Lot codes appear on the original product packaging, but are not stamped onto the keypads): 10-07, 11-07, 12-07-P093, 12-07-P094, 01-08-N116, 01-08-N126, 01-08-P091, 01-08-P093. Customers who received the effected keypad will not be able to identify the unit based on lot code unless they retained the original product labeling.
RECALLING FIRM/MANUFACTURER Physio Control, Inc. Redmond, WA, 
REASON A thicker keypad that may prevent the door from fully latching closed. If the door is not fully closed, there is a potential that the defibrillator will not automatically change from automatic external defibrillation (AED) mode to manual mode by pressing the "MANUAL" button located on the lower left corner of the door. This may lead to a delay in defibrillation therapy.
VOLUME OF PRODUCT IN COMMERCE 1,315 keypads in LifePak units and 78 independent keypads
DISTRIBUTION Nationwide, Germany, Netherlands, Canada, Australia, Hong Kong

PRODUCT Suction Jar Lid for Medela Vario 18 Vacuum Pump used with the Bravo pH Monitoring System Medtronic Part Number: 9043K2101. (9043K2111 is the OUS version) The Vacuum Pump is used to provide the vacuum pressure during Capsule attachment. Correct Overflow lid: Medela CH-6341 Baar Switzerland Art. No. 077.0440, Small lid with conical patient connection 6-10mm and overflow protection device.(Incorrect overflow lid is Medela P/N: 077.0450); 
CODE Serial #: 1163101 - 1163120
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Neuromodulation, Minneapolis, MN,
Manufacturer: Medela AG Medical Technology, Baai, Switzerland. 
REASON Some Medela Vario 18 Vacuum Pumps were provided with an incorrect suction Jar Lid that did not have the correct conical connection for the Vacuum Tube.
VOLUME OF PRODUCT IN COMMERCE 1,500 units (20 affected)
DISTRIBUTION Nationwide and Canada

PRODUCT
a)  Medtronic Synchromed II Programmable Pump, 20 ml Pumps Model 8637-20. The implantable Medtronic SynchroMed II Programmable Pump is part of the
SynchroMed II Infusion System designed to contain and administer prescribed drugs to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories;
b) Medtronic Synchromed II Programmable Pump, 40 ml Pumps Model 8637-40. The implantable Medtronic SynchroMed II Programmable Pump is part of the
SynchroMed II Infusion System designed to contain and administer prescribed drugs to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories;
CODE
a) NGP300011H- NGP307363H NGP307409H NGP307456H NGP307464H NGP307466H NGP307467H NGP307473H NGP307481H NGP307482H NGP307485H NGP307486H NGP307487H NGP307488H NGP307489H NGP307490H NGP307491H NGP307493H NGP307494H NGP307495H NGP307496H NGP307499H NGP307500H NGP307501H NGP307502H NGP307503H NGP307504H NGP307505H NGP307506H NGP307507H NGP307508H NGP307509H NGP307510H NGP307511H NGP307518H NGP307519H NGP307520H NGP307522H NGP307523H NGP307525H NGP307532H NGP307539H NGP307542H NGP307547H NGP307550H NGP307553H NGP307554H NGP307556H NGP307558H NGP307559H NGP307562H NGP307564H NGP307566H NGP307567H NGP307568H NGP307570H NGP307572H NGP307574H NGP307575H NGP307577H NGP307579H NGP307581H NGP307582H NGP307583H NGP307584H NGP307587H NGP307591H NGP307593H NGP307594H NGP307595H NGP307596H NGP307597H NGP307598H NGP307600H NGP307602H NGP307603H NGP307604H NGP307606H NGP307608H NGP307609H NGP307612H NGP307614H NGP307616H NGP307618H NGP307619H NGP307620H NGP307621H NGP307623H NGP307624H NGP307625H NGP307626H NGP307627H NGP307628H NGP307629H NGP307633H NGP307634H NGP307636H NGP307640H NGP307642H NGP307643H NGP307644H NGP307645H NGP307646H NGP307647H NGP307648H NGP307649H NGP307652H NGP307654H NGP307655H NGP307657H NGP307658H NGP307659H NGP307660H NGP307662H NGP307663H NGP307853H NGP309113H, and NGP309162H;

b) NGV300002H - NGV405839H NGV405840H NGV405842H NGV405843H NGV405844H NGV405848H NGV405849H NGV405850H NGV405853H NGV405854H NGV405856H NGV405858H NGV405859H NGV405860H NGV405861H NGV405862H NGV405870H NGV405871H NGV405873H NGV405874H NGV405875H NGV405877H NGV405879H NGV405880H NGV405883H NGV405884H NGV405888H NGV405890H NGV405896H NGV405897H NGV405898H NGV405899H NGV405900H NGV405901H NGV405902H NGV405903H NGV405904H NGV405905H NGV405906H NGV405907H NGV405908H NGV405909H NGV405911H NGV405913H NGV405915H NGV405916H NGV405917H NGV405919H NGV405920H NGV405922H NGV405928H NGV405929H NGV405930H NGV405931H NGV405932H NGV405934H NGV405935H NGV405936H NGV405937H NGV405939H NGV405942H NGV405943H NGV405944H NGV405946H NGV405947H NGV405949H NGV405951H NGV405952H NGV405957H NGV405959H NGV405961H NGV405963H NGV405964H NGV405965H NGV405967H NGV405968H NGV405969H NGV405970H NGV405971H NGV405972H NGV405973H NGV405974H NGV405975H NGV405976H NGV405978H NGV405979H NGV405980H NGV405981H NGV405982H NGV405983H NGV405985H NGV405990H NGV405992H NGV405994H NGV405995H NGV405996H NGV405997H NGV405999H NGV406001H NGV406002H NGV406006H NGV406008H NGV406010H NGV406011H NGV406012H NGV406013H NGV406014H NGV406015H NGV406016H NGV406017H NGV406018H NGV406021H NGV406022H NGV406023H NGV406024H NGV406025H NGV406028H NGV406029H NGV406030H NGV406031H NGV406032H NGV406033H NGV406034H NGV406037H NGV406038H NGV406039H NGV406040H NGV406041H NGV406044H NGV406046H NGV406047H NGV406048H NGV406049H NGV406050H NGV406051H NGV406052H NGV406053H NGV406054H NGV406055H NGV406056H NGV406058H NGV406059H NGV406060H NGV406061H NGV406062H NGV406063H NGV406064H NGV406066H NGV406067H NGV406068H NGV406069H NGV406071H NGV406072H NGV406073H NGV406075H NGV406076H NGV406078H NGV406080H NGV406082H NGV406083H NGV406084H NGV406085H NGV406086H NGV406087H NGV406089H NGV406090H NGV406091H NGV406092H NGV406094H NGV406095H NGV406096H NGV406097H NGV406099H NGV406100H NGV406101H NGV406104H NGV406105H NGV406106H NGV406107H NGV406108H NGV406109H NGV406110H NGV406112H NGV406113H NGV406114H NGV406117H NGV406118H NGV406119H NGV406122H NGV406123H NGV406125H NGV406126H NGV406127H NGV406128H NGV406129H NGV406131H NGV406132H NGV406133H NGV406134H NGV406135H NGV406137H NGV406164H NGV406169H NGV406174H NGV406187H NGV406227H NGV406627H NGV406747H NGV407899H NGV407906H, and NGV408059H
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Neuromodulation, Minneapolis, MN,
Manufacturer: Medtronic Puerto Rico Operations Company, Juncos, PR. 
REASON SynchroMed II pumps (non-implanted) may have been manufactured without propellant.
VOLUME OF PRODUCT IN COMMERCE 11,920 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) AGA Medical Corporation AMPLATZER Delivery System, 10 French, 45 Degree Angle Curve, 80 Usable Length (cm), REF 9-DEL-10F-45/80. Sterile EO.
Manufactured in U.S.A. The AMPLATZER Delivery System was designed to facilitate attachment, loading, delivery and deployment of the AMPLATZER Septal Occluder and comprised of a delivery sheath, dilator, loading device,
plastic vise and delivery cable; 
b) AMPLATZER Sizing Balloon II, REF 9-SB-24. Sterile EO. Manufactured in U.S.A. A triple lumen balloon catheter with 3 radiopaque marker bands located inside the balloon to allow for radiographic measurement. The center of the balloon contains a pair of marker bands 0.4 mm apart and one marker band 15 mm proximal of that pair. The AMPLATZER Sizing Balloon II is intended for use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device; 
CODE
a) Lot number M07K29-32;
b) Lot number M08B11-34
RECALLING FIRM/MANUFACTURER AGA Medical Corp, Golden Valley, MN, 
REASON AGA Medical Corporation has identified an issue with outer pouch seal integrity within one production lot of 10 French 45/80 delivery systems and one lot of 24 mm Sizing Balloon. We have not observed incomplete seals with the inner pouch. An intact inner pouch seal will maintain device sterility.
VOLUME OF PRODUCT IN COMMERCE 10 delivery systems, 131 Sizing Balloons
DISTRIBUTION Nationwide, Brazil, Greece, Netherlands, Portugal, Slovakia

PRODUCT Varis Aria Radiation Oncology Version 8.1. The device is designed to assist the operator in providing accurate treatment setups for each patient by monitoring parameters and preventing the device from commencing radiation treatment plan inappropriately;
CODE
Serial numbers: HIT0002, HIT0004M, HIT0005, HIT0028, HIT0043M, HIT0052, HIT0064, HIT0097M, HIT0467, HIT0468, HIT0480M, HIT0468, HIT0480M, HIT0486, HIT0487, HIT0490, HIT0492, HIT0507, HIT0860, HIT0863, HIT0864, HIT0870M, HIT0890, HIT0909, HIT0910, HIT0912, HIT1132, HIT1151, HIT1152, HIT1155, HIT1157, HIT1159, HIT1168, HIT1172, HIT1356, HIT1359, HIT1363, HIT1369, HIT1373, HIT1381, HIT1390, HIT1394, HIT1544, HIT1548, HIT1551, HIT1558, HIT1571, HIT1573, HIT1577, HIT0107, HIT0121, HIT0124, HIT0125, HIT0145, HIT0147, HIT0170, HIT0227, HIT0249, HIT0270, HIT0288, HIT0300, HIT0314, HIT0318, HIT0321, HIT0326, HIT0339, HIT0346, HIT0350, HIT0351, HIT0355M, HIT0368, HIT0378, HIT0381, HIT0396, HIT0401, HIT0402, HIT0414, HIT0416, HIT0419, HIT0426, HIT0436M, HIT0437, HIT0461, HIT0515, HIT0522, HIT0525M, HIT0547, HIT0565, HIT0587, HIT0588, HIT0624, HIT0633, HIT0650, HIT2651, HIT0660, HIT0671, HIT0681, HIT0682, HIT0689, HIT0711, HIT0712, HIT0739, HIT0750, HIT0754, HIT0771, HIT0782, HIT0787, HIT0797, HIT0804, HIT0810, HIT0812, HIT0840, HIT0843, HIT0844, HIT0848, HIT0856, HIT0858, HIT0925, HIT0944, HIT0949M, HIT0950, HIT0951, HIM, HIT0951R1, HIT2956, HIT0962, HIT0968, HIT0977, HIT0993, HIT1006, HIT1010, HIT1016, HIT1024, HIT1027, HIT1043, HIT1047, HIT1052, HIT1058, HIT1062, HIT1064, HIT1072, HIT1082, HIT1087, HIT1093, HIT1098, HIT1110M, HIT1115, HIT1116, HIT1121, HIT1122, HIT1128, HIT1190, HIT1200, HIT1208, HIT1215, HIT1216, HIT1225, HIT1231, HIT1235, HIT1243, HIT1245, HIT1247, HIT1250, HIT1252, HIT1260, HIT1264, HIT1267, HIT1269, HIT1273, HIT1275, HIT1277, HIT1278, HIT1284, HIT1288, HIT1296, HIT1298, HIT1303, HIT1306, HIT1315, HIT1317, HIT1321, HIT1323, HIT1329, HIT1343, HIT1353, HIT1398, HIT1399, HIT1402, HIT1404, HIT1410, HIT1413, HIT1415, HIT1421, HIT1423, HIT1426, HIT1432, HIT1433, HIT1435, HIT1438, HIT1443, HIT1444, HIT1451, HIT1458M, HIT1464, HIT1469, HIT1473, HIT1478, HIT1481, HIT1483, HIT1486 , HIT1493, HIT1496, HIT1505, HIT1506, HIT1518M, HIT1521, HIT1526, HIT1539, HIT1541, HIT1579, HIT1584, HIT1592, HIT1594, HIT1597, HIT1599, HIT1604, HIT1606, HIT1614, HIT1616, HIT1623, HIT1626, HIT1628, HIT1632, HIT1635, HIT1639, HIT1644, HIT1658, HIT1660, HIT1662, HIT1678, HIT1679, and HIT1712
RECALLING FIRM/MANUFACTURER Varian Medical Systems, Oncology Systems, Palo Alto, CA,
REASON Dose delivery may be altered after import from a third party planning system during radiation therapy.
VOLUME OF PRODUCT IN COMMERCE 241 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Update Instructions "TH003/08/S" applies to Siemens brand SIMIVIEW 3000, SIMVIEW NT, and MEV ASIM S systems; Part Number: 5488460; The product is indicated for use in Radiation therapy simulation; 
CODE All codes
RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Concord, CA
REASON The firm sent an Update Instruction, "TH003/08/S" for Motion Enable Switch/holder assembly. The switch holder allows the motion enable switch to be activated if inserted partially; thereby enabling inadvertent motion and serious injury may result.
VOLUME OF PRODUCT IN COMMERCE 300 units
DISTRIBUTION Nationwide and Internationally

PRODUCT GE 1.5T and 3.0T Signa HDX MR System Model Number(s): 2226300, 2377062-61, 2395001, 2395001-2, 5107849, and 5127452. This system is indicated for use as a diagnostic imaging device to produce axial sagittula, coronal and oblique images, spectroscopic images, and or spectra, dynamic images of the internal structure or organs of the entire body;
CODE
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00000284650MR9 00000278674MR7 00000282003MR3 00000278676MR2 00000285674MR8 00000284869MR5 00000276265MR6 00000280673MR5 00000275647MR6 00000278851MR1 00000284234MR2 00000280000MR1 00000279068MR1 00000276266MR4 00000275967MR8 00000275648MR4 00000282549MR5 00000280781MR6 00000283745MR8 00000274744MR2 00000275046MR1 00000275968MR6 00000278397MR5 00000281341MR8 00000276434MR8 00000284261MR5 00000280780MR8 00000285053MR5 00000275465MR3 00000268369MR6 00000260651MR5 000000HDMR2329 000000HDMR2927 00000HDMR22498 00000HDMR10281 00000HDMR10273 00000HDMR20270 00000HDMR10462 000000HDMR2471 000000HDMR3334 000000HDMR2613 000000HDMR3288 000000HDMR2438 00000HDMR20181 000000HDMR2441 00000HDMR20228 000000HDMR2872 00000HDMR20034 00000276073MR4 00000001568422 000000HDMR2901 000000HDMR2799 00000HDMR20056 000000HDMR3407 00000DDDM10670 00000HDMR20044 00000HDMR20171 000000HDMR2444 00000HDMR10788 00000HDMR10322 000000HDMR2936 00000HDMR20294 000000HDMR2531 00000HDMR20219 00000HDMR20235 000000HDMR2829 000000HDMR2893 00000HDMR20018 000000HDMR2528 00000HDMR20061 00000HDMR10743 00000HDMR11028 000000HDMR2686 00000HDMR20206 000000HDMR2508 00000HDMR20142 00000HDMR20050 00000HDMR20151 000000HDMR2515 00000HDMR10404 000000HDMR2641 000000HDMR2888 00000HDMR20158 000000HDMR2998 00000275160MR0 000000HDMR3089 00000HDMR20276 00000HDMR20065 00000HDMR20053 000000HDMR2451 000000HDMR2463 000000HDMR2553 000000HDMR2689 000000HDMR2335 00000001516299 000000HDMR2482 00000275157MR6 00000HDMR20070 00000273807MR8 000000HDMR3373 000000HDMR1111 000000HDMR3298 00000HDMR10291 000000HDMR1005 00000HDMR10846 000000HDMR3048 000000HDMR3262 000000HDMR2591 000000HDMR2651 000000HDMR2675 00000HDMR10831 00000HDMR10334 00000HDMR10548 00000275162MR6 0000HDMR127452 000000HDMR2522 000000HDMR2344 000000HDMR2803 000000HDMR2626 00000HDMR20236 00000HDMR10739 000000HDMR1130 000000HDMR2993 00000273127MR1 00000HDMR20128 000000HDMR3088 00000HDMR20043 00000HDMR10368 00000274350MR8 00000275283MR0 00000HDMR10489 00000HDMR20084 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000000HDMR2831 00000HDMR20272 000000HDMR3199 000000HDMR3130 00000HDMR10477 000000HDMR2958 000000HDMR3459 00000HDMR20178 00000HDMR10878 00000HDMR20089 00000HDMR10787 00000HDMR20099 000000HDMR2769 000000HDMR2917 00000HDMR20290 00000HDMR19996 000000HDMR2395 000000HDMR3003 000000HDMR2483 000000HDMR2696 00000274392MR0 00000HDMR10343 000000HDMR2747 00000HDMR20246 00000HDMR10417 00000273839MR1 00000275236MR8 000000HDMR3301 000000HDMR3542 00000276031MR2 000000HDMR2313 00000273119MR8 000000HDMR2882 000000HDMR2902 00000275237MR6 00000274385MR4 00000HDMR20012 00000273832MR6 00000276038MR7 00000274383MR9 00000275168MR3 00000276042MR9 00000276102MR1 000000HDMR2572 000000HDMR2600 000000HDMR3028 000000HDMR3077 000000HDMR2835 000000HDMR2544 00000275151MR9 00000273132MR1 000000HDMR3452 00000275113MR9 00000275120MR4 00000275107MR1 00000HDMR10623 000000HDMR2521 000000HDMR2808 000000HDMR2779 000000HDMR2695
RECALLING FIRM/MANUFACTURER GE Medical Systems LLC, Waukesha, WI,
REASON Possible misdiagnosis or inappropriate treatment based on the image. Signal homogeneity may be affected when BRAVO applications are set with IR Prep off. The concern is that signal inhomogeneity can result in an erroneous diagnosis.
VOLUME OF PRODUCT IN COMMERCE 720 units estimate
DISTRIBUTION Nationwide and Internationally

PRODUCT DIFCO Laboratories, FA Streptococcus Group A, 5mL, Catalog Number: 223181, in vitro diagnostic; CODE Lot number: 6122656, Exp: 20090705
RECALLING FIRM/MANUFACTURER
Recalling Firm: BD Diagnostic Systems / Lee Laboratories, Grayson, GA, 
Manufacturer: Difco Laboratories, Inc., Detroit, MI. 
REASON Incorrect result: The product exhibited decreased fluorescence when testing with the homologous control organism.
VOLUME OF PRODUCT IN COMMERCE 26 units
DISTRIBUTION Nationwide Distribution and Canada

PRODUCT
a) ACUSON Antares 5.0 ultrasound system at SW revision 200.0.054 or 200.0.059A, with one of the following options installed: 3-Scape Imaging, Factory, PN 05937011
or 3-Scape Real Time Imaging, UPG ACU, PN 10033688. Material number 10032746, 10037592, 10032746, 10037591 or 10038202; 
b) Sonoline Antares 5.0 ultrasound system at SW revision 200.0.054 or 200.0.059A, with one of the following options installed: 3-Scape Imaging, Factory, PN 05937011
or 3-Scape Imaging, Field Upgrade, PN 07472520. Material number 5936518, 8653771 or 10037593; 
CODE
a) Serial numbers 113452 113554 113555 113556 113645 113904 114264 114276 114415 114566 114651 114672 114673 114678 114723 114729 114730 114745 114756 114783 114788 114797 114798 114803 114812 114824 114826 114841 114865 114868 114869 114875 114892 114893 114896 114900 114904 114907 114913 114915 114922 114924 114925 114929 114933 114936 114970 114976 114990 114998 115001 115012 115017 115022 115034 115037 115053 115060 115085 115087 115090 115105 115120 115121 115127 115128 115139 115157 115160 115161 115168 115175 115180 115183 115188 115190 115201 115217 115221 115242 115246 115252 115260 115275 115276 115279 115286 115288 115290 115291 115292 115306 115308 115327 115330 115349 115396 115402 115420 115427 115428 115433 115436 115443 115446 115454 115455 115458 115459 115462 115464 115465 115473 115475 115479 115481 115486 115489 115493 115498 115501 115503 115512 115523 115540 115555 115561 115562 115574 115576 115579 115602 115618 113249001 113344001 113423001 113458001 113593001 113731001 113735001 113887001 114252001 10741001 112079001 112376001 112534001 113038001 5000 5001 112978 113029 113048 113051 113052 113053 113068 113075 113092 113101 113105 113124 113131 113145 113147 113148 113204 113257 113259 113288 113299 113371 113407 113411 113414 113462 113469 113483 113540 113557 113584 113627 113640 113664 113672 113674 113682 113684 113694 113708 113715 113722 113756 113759 113767 113769 113780 113785 113790 113808 113809 113831 113832 113846 113849 113850 113851 113852 113855 113863 113873 113917 113980 113981 114012 114043 114052 114059 114061 114164 114271 114274 114313 114356 114363 114364 114369 114373 114401 114406 114412 114423 114461 114474 114475 114481 114482 114500 114581 114590 114595 114597 114655 114669 114671 114699 114703 114721 114738 114743 114744 114753 114760 114764 114775 114777 114787 114790 114792 114793 114796 114799 114802 114807 114809 114818 114819 114820 114827 114828 114831 114833 114835 114838 114842 114843 114844 114845 114847 114848 114849 114850 114851 114860 114861 114863 114864 114874 114876 114878 114880 114881 114882 114883 114885 114886 114890 114891 114894 114895 114899 114901 114908 114918 114920 114921 114927 114935 114937 114941 114942 114943 114944 114945 114950 114951 114954 114955 114956 114957 114960 114961 114962 114965 114973 114975 114977 114981 114984 114986 114991 114993 114996 115002 115006 115008 115010 115013 115018 115019 115028 115029 115030 115032 115033 115038 115039 115040 115041 115042 115043 115044 115045 115047 115050 115052 115054 115061 115070 115074 115082 115094 115098 115102 115103 115106 115108 115111 115112 115144 115146 115147 115149 115150 115151 115156 115158 115164 115172 115174 115189 115191 115192 115196 115199 115202 115205 115207 115209 115210 115216 115219 115228 115235 115238 115240 115245 115247 115251 115253 115254 115257 115258 115262 115263 115264 115266 115270 115273 115282 115289 115293 115296 115299 115300 115301 115302 115309 115312 115315 115316 115317 115319 115321 115322 115324 115326 115329 115336 115337 115346 115348 115350 115353 115356 115357 115360 115366 115367 115369 115375 115376 115377 115385 115391 115394 115397 115398 115416 115422 115444 115472 115478 115488 115494 115499 115510 115513 115514 115519 115521 115527 115529 115530 115535 115541 115542 115544 115551 115552 115556 115557 115558 115559 115565 115567 115570 115580 115582 115591 115592 115601 115604 115607 115610 115612 115617 115628 115169001;
b) Serial numbers 10163 10524 11148 11149 11150 110920 111158 111270 111287     111377 111389 111514 111558 111584 111712 111871 112317 112322 112388     112809 10188001 10437001 10566001 10604001 10669001 11008001 11047001      111552001 111692001 112081001 112081002 112087001 112089001 112117001
112178001 112182001 112306001 112360001 112384001 112554001 112597001 112697001 112704001 112743001 112744001 112776001 112859001 10722
111456 112288 112608
RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Mountain View, CA,
REASON Software issues may result in distorted images and inaccurate measurements, which could lead to a misdiagnosis.
VOLUME OF PRODUCT IN COMMERCE 539 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Ev3 IntraCoil Self-Expanding Peripheral Stent, Sterile EO, Model REF VT-5-60-135, Use before 2010-07. The IntraCoil is indicated for use in peripheral arteries in the leg in which balloon angioplasty has been applied. The InraCoil stent is indicated for placement in flexing regions and a tortuous lesion; 
CODE Lot Number: 4401432
RECALLING FIRM/MANUFACTURER Ev3, Inc., Plymouth, MN, 
REASON Incorrect Label: An IntraCoil 5mm x 40 mm stent was labeled as a 5 mm x 60 mm stent (VT-5-40-135 was labeled as VT-5-60-135),
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION Nationwide

PRODUCT Boston Scientific Flexima Biliary Stent System, 200 cm long, .035” (0.89 mm), sterile, REF 3921, UNP M00539210. System is used for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone; 
CODE Lot: 11374425
RECALLING FIRM/MANUFACTURER Boston Scientific Corp., Spencer, IN, 
REASON Rapid Exchange Biliary Stent may be mislabeled as Flexima Biliary Stent, which has a different delivery system included in the package.
VOLUME OF PRODUCT IN COMMERCE 80 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Smooth or threaded metallic bone fixation fastener. 3.5mm x 14.0 mm Locking Cortical Screw. Product labeled in 3.5 mm x 14.0 mm Locking Cortical Screw. Product labeled in part, "Congruent Plate System... Size: 3.5 mm x 14.0 mm Locking Cortical Screw... REF COL-3140-S LOT W46772...Product is used as an orthopedic implant;
CODE Work order number/Lot: W46772 (W=work order, ###=sequential number); Expiration date: 2012-02 (Year/Month)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Acumed LLC, Hillsboro, OR,
Manufacturer Firm: Eagle Medical Inc., Paso Robles CA. REASON Product mislabeled. The inner sticky labels for the patient identified the product incorrectly as a Cortical screw (non-locking). The product package was labeled correctly.
VOLUME OF PRODUCT IN COMMERCE 400 screws
DISTRIBUTION Nationwide and Internationally

PRODUCT AxSYM Rubella IgG Reagent Pack; List 3B23-20 The AxSYM Rubella IgG assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative and qualitative measurement of IgG antibodies to rubella virus in human serum or plasma (EDTA, heparin or sodium citrate) to aid in the determination of immune status to rubella, 
CODE
Lots: 61151M101 (exp. 12/28/08), 61151M100 (exp. 12/28/08), 60943M101 (exp. 09/22/08), 60943M100 (exp. 09/22/08), 58296M101 (exp. 10/05/08), 58296M100 (exp. 10/05/08), 58295M101 (exp. 09/22/08), 58295M100 (exp. 09/22/08), 58294M101 (exp. 09/01/08), 58294M100 (exp. 09/01/08), 57577M201 (exp. 08/10/08), 57577M200 (exp. 08/10/08), 56659M201 (exp. 07/21/08), 56659M200 (exp. 07/21/08), 56323M101 (exp. 06/30/08), 56323M100 (exp. 06/30/08), 55922M100 (exp. 06/20/08), 55922M101 (exp. 06/20/08), 55921M101 (exp. 06/09/08), and 55921M100 (exp. 06/09/08)
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Abbott Park, IL,
REASON An increase in complaints was noted for AxSYM Rubella IgG assay calibration failures due to error codes related to elevated Calibrator A (or Master Calibrator 1) rates too high.
VOLUME OF PRODUCT IN COMMERCE 33,486 reagent kits
DISTRIBUTION Nationwide and Internationally

WEEK ENDING SEPTEMBER 27

PRODUCT Philips OmniDiagnost Eleva X-Ray System is a diagnostic imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications. Product number: 9896 002 04432. Site ID #: 506241, 500046, 521648, 522220, 520020, 533112, 533314, 533471, 533530, 535257, 535118, 535924, 540860, 541490, 539106, 547017, 547142, 549798, 547348, 550258, 553676, 553235, 
CODE SN number: 43, 49, 52, 107, 123, 131, 152, 157, 171, 179, 185, 202, 266, 333, 337, 389, 408, 446, 485, 491, 514, 515
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, 
Manufacturer: Philips Medical Systems Ned Bv, Best, Netherlands. 
REASON Unexpected movement of the X-ray table may occur. These movements may lead to patient injury, e.g., an uncontrolled tilt may cause the patient to slip off.
VOLUME OF PRODUCT IN COMMERCE 22 units
DISTRIBUTION Nationwide

PRODUCT Altaire MRI System Emergency Rundown Switch Unit (ERDU) is intended to provide the physician with physiological and clinical information obtained non-invasive and without the use of ionizing radiation, 
CODE Serial # L001-L242 (not inclusive)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hitachi Medical Systems America, Inc., Twinsburg, OH, 
Manufacturer: Hitachi Medical Corporation, Chiyoda-Ku, Tokyo, Japan. 
REASON The firm’s Altaire MR Scanner’s Emergency Rundown Switch Unit (ERDU), that is used to shut down the device in an emergency, was found to be defective. An ERDU failure could delay or prevent patient access leading to possible patient death or serious injury.
VOLUME OF PRODUCT IN COMMERCE 235 units
DISTRIBUTION Nationwide

PRODUCT VNUS Medical U-CLIP Removal Tool, UREM1860, is intended for the removal of U-Clip anastomotic devices,
CODE Lot 0610315
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Cardiac Surgery Technologies, Minneapolis, MN, 
Manufacturer: Medtronic Mexico EG, Sonora, Mexico. REASON Medtronic has identified one lot #0610315 of U-Clip Removal Tools, Catalog UREM1860FW that was incorrectly assembled. The nose cone attachment, on the body of the removal tool, may not contain sufficient adhesive, which can allow the nose cone to separate from the body of the device.
VOLUME OF PRODUCT IN COMMERCE 80 units
DISTRIBUTION Nationwide

PRODUCT
a) ABL700 Series analyzer - Human Blood Analyzer (Laboratory Device),
b) ABL800 FLEX Series Analyzer - Human Blood Analyzer (Laboratory Device),
CODE
a) ABL700 Series (902-441);
b) ABL800 Flex (902-754)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America Inc., Westlake, OH, Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. 
REASON Reported calibration errors are not displayed on the analyzers parameter bar screen or on the patient results when the calibration number is between 32768 - 65535 and 98303 - 131070. This may cause the operator to perform measurements and obtain questionable results.
VOLUME OF PRODUCT IN COMMERCE 2,481 units
DISTRIBUTION Nationwide and Internationally

PRODUCT LIFEPAK 1000 defibrillator - portable battery powered semi-automated model that can be operated in either of three modes: Automated external defibrillator (AED), manual defibrillator and electrocardiographic (ECG) mode. The defibrillator is intended for indoor or outdoor use in a wide variety of hospital and pre-hospital settings including ground and air ambulances, physician's offices, aircraft, stadiums and specialty medical clinics. ECG monitoring is intended for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm recognition and heart rate monitoring. Affected part numbers: 320371500021 through 320371500038, 320371500043, 320371500044, 320371500046, 320371500048, 320371500050, 320371500056, 320371500058, 320371500063, and 320371500067, 
CODE
Domestic: 35223068, 35267516, 35267519, 35892406, 35895430, 35242436, 35892542, 35977949, 35267533, 35267553, 35910136, 35972647, 35972648, 35972649, 35972650, 35972651, 35972652, 35972653, 35942190, 35942193, 35938673, 35223075, 35969804, 35969805, 35926650, 35926651, 35926652, 35926653, 35926654, 35926655, 35926562, 35967657, 35967658, 35967659, 35967660, 35967661, 35967664, 35967665, 35967666, 35967667, 35969810, 35969811, 35969812, 35969813, 35972478, 35972479, 35972480, 35972481, 35972482, 35904997, 35973187, 35974263, 35974264, 35974265, 35974266, 35974267, 35974268, 35969073, 35969090, 35969091, 35969092, 35969093, 35969094, 35969095, 35969096, 35969097, 35969098, 35969099, 35969100, 35969101, 35969102, 35969103, 35969104, 35969105, 35972621, 35972622, 35972623, 35972624, 35972625, 35965677, 35965678, 35965679, 35965680, 35965682, 35965684, 35965685, 35965688, 35965689, 35965690, 35967568, 35988737, 35988738, 35988739, 35988740, 35223108, 35223112, 35223114, 35220224, 35894843, 35894847, 35895509, 36126318, 35960736, 35965709, 35967427, 35967428, 35967429, 35267501, 35267536, 35267540, 35220192, 35267515, 35267555, 35267564, 35267567, 35899706, 35940395, 35988726, 35988727, 35988728, 35988729, 35988730, 35988731, 35970273, 35970274, 35267539, 35941278, 35941279, 35941281, 35937926, 35941681, 35941682, 35941683, 35941684, 35969806, 35220228, 35237266, 35240666, 35937929, 35937930, 35937931, 35989256, 35989257, 35989258, 35989259, 35267499, 35267518, 35267535, 35267537, 35267544, 35267554, 36056305, 35989250, 35989251, 35240665, 35977960, 35977961, 35977962, 35977963, 35985351, 35985352, 35937080, 35969397, 35938191, 35925967, 35925969, 35925970, 35977943, 35969809, 35973251, 35973252, 35940914, 35940915, 35940916, 35940917, 35975854, 35975855, 35937412, 35936972, 35989254, 35989209, 35989210, 35989211, 35989212, 35989214, 35989216, 35989217, 35989218, 35989219, 35989220, 35989221, 35989222, 35989223, 35984629, 35984630, 35984631, 35242411, 35910064, 35910065, 35927618, 35927625, 35220222, 35941658, 35941659, 35941660, 35220058, 35220059, 35937407, 35937079, 35969142, 35969143, 35977658, 35977659, 35220234, 35237239, 35237250, 35237254, 35237258, 35237264, 35237268, 35371825, 35894840, 35895512, 35895515, 35976917, 35976918, 35977112, 35977113, 35938844, 35985323, 35949829, 35989230, 35989231, 35989232, 35989233, 35969372, 35969373, 35969374, 35940414, 35940415, 35940416, 35240661, 35220184, 35267505, 35267532, 35267542, 35892536, 35892538, 35892539, 35895417, 35895428, 35895429, 35895507, 35985335, 35985336, 35985337, 35985338, 35985339, 35985340, 35940923, 35940924, 35940925, 35940926, 35940927, 35940928, 35940929, 35940930, 35940931, 35940932, 35940933, 35940934, 35267534, 36066526, 35476349, 35976916, 36066043, 35936912, 35936913, 35936914, 35969843, 35988243, 35988244, 35988245, 35988246, 35988247, 35988248, 35988249, 35988250, 35988251, 35988252, 35988253, 35988254, 35988255, 35988256, 35988257, 35987853, 35987854, 35987855, 35987856, 35987857, 35987858, 35987859, 35987860, 35987861, 35239096, 35938488, 35938489, 35938490, 35938491, 35938492, 35938494, 35938495, 35938496, 35938497, 35938498, 35938499, 35938500, 35938501, 35938502, 35240659, 35240660, 35240658, 35243101, 35243102, 35243104, 35243105, 35973242, 35936907, 35936908, 35936909, 35936976, 35936977, 35936978, 35936979, 35936980, 35936981, 35936982, 35989247, 35220056, 35976645, 35976646, 35976647, 35937396, 35937397, 35937398, 35937399, 35969155, 35937405, 35969361, 35969368, 35223079, 35941213, 35941214, 35242430, 35267521, 36059851, 35220225, 35220226, 35938437, 35938438, 35973138, 35220229, 35977680, 35976802, 35976814, 35967591, 35967592, 35967593, 35967594, 35967596, 35215160, 35242418, 35223091, 35215179, 35977955, 35977956, 35977957, 35977119, 35242419, 35240663, 35267541, 35215123, 35215124, 35215099, 35542818, 35542819, 35985320, 35985321, 35985322, 35984620, 35984621, 35949854, 35949855, 35976611, 35976612, 35976613, 35976614, 35987845, 35987846, 35987847, 35949843, 35892381, 35892384, 35938843, 35938845, 35938846, 35938847, 35941665, 35907652, 35975856, 35267502, 35976902, 35976906, 35976908, 35976910, 35936807, 35931716, 35931717, 35931718, 35931719, 35931722, 35931724 INTERNATIONAL: 35239067, 35239068, 35239069, 35239070, 35239072, 35239084, 35239088, 35363261, 35526920, 35526921, 35526922, 35526923, 35526924, 35526925, 35526926, 35542908, 35542909, 35508807, 35508811, 35508824, 35508832, 35508843, 35508845, 35810714, 35810715, 35810716, 35810717, 35810718, 35810719, 35810720, 35810721, 35810722, 35810723, 35363231, 35369859, 35505854, 35505855, 35505856, 35505857, 35586318, 35586901, 35586903, 35587862, 35587863, 35734627, 35734629, 35734630, 35734631, 35734619, 35734620, 35734621, 35734622, 35734632, 35935143, 35935152, 35935153, 35935155, 35935156, 35937304, 35969554, 35969555, 35969556, 35969557, 35969558, 35969559, 35969560, 35969561, 35969562, 35969563, 35508830, 35891899, 35891907, 35891908, 35891910, 35216482, 35217295, 35242374, 35242375, 35242376, 35242377, 35242378, 35242379, 35242380, 35242381, 35242382, 35242383, 35242384, 35242385, 35242386, 35242387, 35242388, 35242389, 35242390, 35242391, 35242392, 35242393, 35242394, 35242395, 35242396, 35242397, 35242398, 35242399, 35242400, 35242401, 35242403, 35242404, 35242405, 35242406, 35242407, 35242408, 35242409, 35242410, 35242412, 35242413, 35242414, 35242415, 35242416, 35242417, 35242422, 35242424, 35242425, 35242426, 35242427, 35242428, 35242429, 35242431, 35242432, 35242434, 35242435, 35242437, 35242438, 35242439, 35303872, 35303874, 35303877, 35303886, 35303887, 35303888, 35303889, 35303890, 35303891, 35303892, 35303893, 35303897, 35324247, 35324248, 35324249, 35324251, 35324252, 35324254, 35324255, 35324256, 35324257, 35324258, 35324259, 35324260, 35324261, 35324270, 35324271, 35324272, 35324273, 35324601, 35325480, 35514565, 35514566, 35514567, 35514568, 35514569, 35514570, 35514573, 35514574, 35514575, 35514576, 35514577, 35514578, 35514579, 35514580, 35514581, 35514582, 35514583, 35514584, 35514585, 35514586, 35514587, 35514588, 35514589, 35514590, 35514591, 35514592, 35514593, 35514594, 35514595, 35514596, 35514597, 35514598, 35514599, 35514600, 35521728, 35521729, 35521730, 35521731, 35521732, 35521733, 35521736, 35521739, 35521740, 35521742, 35521743, 35521744, 35521745, 35521746, 35521747, 35521748, 35521749, 35521750, 35521751, 35521752, 35521753, 35521754, 35521756, 35521757, 35509591, 35521763, 35521764, 35521765, 35521766, 35521767, 35521768, 35521769, 35521770, 35521771, 35521772, 35521773, 35521774, 35521776, 35521778, 35521779, 35521781, 35521782, 35521783, 35521784, 35501101, 35521795, 35521796, 35521797, 35521798, 35521799, 35521800, 35476379, 35476380, 35476381, 35566509, 35566512, 35566514, 35573132, 35573133, 35573134, 35573136, 35573138, 35573139, 35573141, 35573142, 35573143, 35573144, 35573145, 35573146, 35573147, 35573148, 35573149, 35573150, 35573151, 35573154, 35574103, 35242402, 35242420, 35267514, 35476348, 35225555, 35226258, 35222373, 35222364, 35225006, 35225007, 35242233, 35242236, 35226336, 35242234, 35242310, 35242314, 35242315, 35242316, 35242317, 35242318, 35245558, 35245559, 35245560, 35245561, 35246717, 35246718, 35246720, 35246723, 35246724, 35246726, 35246731, 35246733, 35246735, 35246739, 35246740, 35246741, 35246742, 35246743, 35246744, 35246745, 35246746, 35246747, 35246748, 35246749, 35246751, 35246752, 35246753, 35246754, 35246758, 35248807, 35248808, 35271234, 35271235, 35271236, 35271237, 35271238, 35271244, 35271245, 35271246, 35271247, 35271248, 35271249, 35271253, 35271254, 35271549, 35271550, 35271551, 35271552, 35271554, 35271556, 35271559, 35271560, 35271563, 35271564, 35271568, 35271569, 35271570, 35271571, 35271572, 35271573, 35271574, 35270620, 35270621, 35270622, 35270623, 35270624, 35270625, 35270626, 35272368, 35272370, 35272371, 35272372, 35272373, 35272374, 35246685, 35246686, 35246687, 35246688, 35246689, 35246690, 35246691, 35246692, 35246693, 35246699, 35246706, 35246707, 35246708, 35246709, 35272476, 35272477, 35270660, 35245554, 35245565, 35245566, 35245567, 35245570, 35270665, 35274082, 35274104, 35276145, 35276146, 35248810, 35271562, 35273796, 35273811, 35273817, 35273820, 35273821, 35273824, 35273825, 35273826, 35273828, 35273837, 35272483, 35272485, 35273752, 35273774, 35246967, 35273964, 35273967, 35276151, 35276152, 35246755, 35248809, 35190671, 35273805, 35273932, 35273934, 35273777, 35273783, 35273957, 35273958, 35273959, 35273960, 35276209, 35276066, 35274086, 35274087, 35274088, 35274089, 35274090, 35274091, 35274092, 35274093, 35274094, 35274095, 35274096, 35274098, 35293110, 35293119, 35293123, 35293127, 35293130, 35293132, 35293133, 35293134, 35293135, 35293136, 35293137, 35293138, 35296110, 35296112, 35296114, 35296116, 35296117, 35296119, 35296120, 35296122, 35296124, 35296126, 35296127, 35296128, 35296129, 35296130, 35296131, 35296132, 35296133, 35296134, 35296135, 35296136, 35296137, 35296138, 35296139, 35296141, 35296989, 35297006, 35274259, 35274261, 35274262, 35274263, 35274264, 35274265, 35274266, 35274267, 35274268, 35274269, 35274270, 35293987, 35294006, 35294165, 35294167, 35295202, 35295204, 35295205, 35295254, 35295255, 35295256, 35295257, 35295258, 35296146, 35296147, 35296148, 35296149, 35296150, 35296151, 35296152, 35296153, 35296154, 35296155, 35296156, 35296157, 35296158, 35296159, 35296160, 35296161, 35296162, 35296164, 35293818, 35293912, 35293913, 35293914, 35293955, 35293970, 35293095, 35293096, 35303935, 35292839, 35293974, 35293984, 35293986, 35293790, 35293960, 35301228, 35276067, 35296078, 35272480, 35295135, 35304482, 35304485, 35304488, 35304489, 35304492, 35304493, 35304495, 35304499, 35304500, 35304502, 35304503, 35304504, 35304505, 35304506, 35304507, 35304508, 35304512, 35304514, 35304522, 35304525, 35304526, 35304528, 35304529, 35304536, 35304537, 35304538, 35304540, 35304541, 35304542, 35304543, 35304544, 35304545, 35304550, 35304552, 35304553, 35304556, 35304557, 35304559, 35301790, 35294172, 35296072, 35296076, 35296077, 35295235, 35295236, 35293789, 35293816, 35293820, 35296063, 35294196, 35293131, 35325539, 35325540, 35325541, 35325542, 35325543, 35325544, 35325550, 35325551, 35325552, 35325553, 35325554, 35325557, 35325560, 35325561, 35325563, 35325564, 35325566, 35325571, 35325573, 35325574, 35325575, 35325576, 35325577, 35325578, 35325579, 35325580, 35325581, 35325582, 35325583, 35325584, 35325585, 35325586, 35325587, 35296030, 35327150, 35327156, 35327159, 35327160, 35327161, 35327162, 35327163, 35327170, 35327171, 35327174, 35327175, 35327177, 35327179, 35327180, 35327183, 35327185, 35327194, 35327200, 35327227, 35327228, 35327232, 35327234, 35363336, 35369584, 35369591, 35363269, 35363881, 35402318, 35402334, 35398577, 35402364, 35424290, 35424291, 35424292, 35424293, 35424294, 35424295, 35424296, 35424298, 35424300, 35424309, 35424311, 35424312, 35424313, 35412729, 35422363, 35424324, 35412744, 35428592, 35412732, 35412730, 35412731, 35412733, 35412734, 35453012, 35453032, 35453046, 35453049, 35453051, 35455626, 35372669, 35438439, 35455684, 35458604, 35469773, 35469774, 35469775, 35469776, 35469777, 35469778, 35469780, 35469782, 35469784, 35469797, 35492121, 35484768, 35494550, 35494551, 35494552, 35494554, 35494555, 35494557, 35494558, 35494561, 35494563, 35500311, 35499349, 35499351, 35499352, 35499353, 35499354, 35497109, 35499365, 35500472, 35497110, 35506699, 35508848, 35509447, 35506692, 35499357, 35499358, 35506682, 35506683, 35506684, 35506685, 35506686, 35506687, 35506688, 35506689, 35510516, 35509446, 35508847, 35515020, 35515685, 35516073, 35550674, 35550678, 35550679, 35550687, 35559432, 35559434, 35559435, 35559436, 35559438, 35560042, 35560609, 35561478, 35560140, 35560328, 35560329, 35560330, 35560331, 35560332, 35560385, 35563333, 35563658, 35560390, 35560770, 35560771, 35563607, 35563611, 35563615, 35563623, 35563640, 35563644, 35563679, 35564108, 35573044, 35573045, 35572999, 35573043, 35589210, 35501244, 35521735, 35590439, 35590441, 35239082, 35293976, 35273787, 35318768, 35274260, 35276150, 35609807, 35609808, 35609810, 35609818, 35609819, 35294182, 35611860, 35521762, 35632575, 35632576, 35632577, 35632579, 35632581, 35632585, 35633882, 35633922, 35633923, 35633924, 35633925, 35633926, 35633927, 35633928, 35633929, 35633930, 35633931, 35633932, 35633933, 35633934, 35633936, 35633939, 35633941, 35633951, 35633873, 35633875, 35633879, 35239079, 35324250, 35293981, 35294010, 35294158, 35294173, 35318765, 35637690, 35651589, 35651590, 35273785, 35328478, 35657802, 35669708, 35508837, 35664049, 35497108, 35508812, 35508817, 35508819, 35508836, 35708524, 35328467, 35521760, 35521761, 35239080, 35239085, 35267309, 35721120, 35273786, 35273788, 35326314, 35325520, 35740743, 35810724, 35810725, 35810726, 35810727, 35810728, 35810729, 35810730, 35810731, 35810732, 35810733, 35744811, 35813408, 35813404, 35905347, 35911976, 35911977, 35911978, 35911979, 35911980, 35911984, 35911985, 35911986, 35911987, 35911988, 35912165, 35912166, 35912167, 35912168, 35912169, 35912172, 35912176, 35912179, 35932609, 35932610, 35932611, 35932612, 35916546, 35916552, 35916554, 35934445, 35934446, 35934449, 35934451, 35934452, 35914662, 35914663, 35914675, 35914676, 35932592, 35932658, 35932659, 35931077, 35932394, 35934060, 35930689, 35931089, 35934182, 35934676, 35931886, 35940404, 35810738, 35293086, 35303936, 35273784, 35935159, 35951913, 35960678, 35969713, 35969716, 35969717, 35969718, 35971026, 35971028, 35971040, 35972420, 35972421, 35972422, 35972423, 35972424, 35972425, 35972426, 35972271, 35983150, 35983151, 35983153, 35983154, 35983155, 35983156, 35983157, 35983158, 35983469, 35983470, 35983471, 35983472, 35983473, 35983474, 35983475, 35983476, 35983477, 35983478, 35983479, 35983480, 35983481, 35983482, 35983483, 35983484, 35983485, 35983486, 35983488, 35983489, 35983490, 35983491, 35983492, 35983493, 35983494, 35983495, 35983496, 35983497, 35983498, 35983499, 35983500, 35983502, 35983503, 35983504, 35983505, 35983506, 35983507, 35983508, 35983509, 35983510, 35983201, 35983202, 35983203, 35934187, 35934188, 35934189, 35934190, 35934191, 35984510, 35292353, 35398593, 35508815, 35508831, 35926986, 35984533, 35223119, 35223120, 35223123, 35223131, 35242354, 35242355, 35242356, 35242358, 35242359, 35242360, 35242361, 35242326, 35242327, 35242328, 35242329, 35242340, 35242341, 35242342, 35242343, 35242344, 35242353, 35245748, 35223125, 35267304, 35267305, 35267306, 35267308, 35267289, 35267290, 35267291, 35267292, 35267293, 35267294, 35267295, 35267297, 35267298, 35267299, 35267300, 35267302, 35267303, 35301231, 35301234, 35301791, 35301792, 35301795, 35301798, 35301801, 35301804, 35303869, 35318736, 35318737, 35318730, 35318731, 35293988, 35308660, 35308663, 35308664, 35308665, 35318754, 35318758, 35318759, 35318761, 35318763, 35318739, 35318740, 35318742, 35318745, 35318748, 35318749, 35318750, 35318751, 35318767, 35372692, 35369648, 35390603, 35402294, 35427344, 35412742, 35438423, 35438424, 35484646, 35521780, 35521755, 35521758, 35521759, 35559406, 35559408, 35559409, 35559410, 35559411, 35559412, 35559413, 35559417, 35559418, 35560673, 35560674, 35550677, 35526932, 35526934, 35526937, 35563024, 35563025, 35563330, 35550681, 35550683, 35550685, 35560593, 35563620, 35567493, 35561508, 35561524, 35572910, 35563672, 35572996, 35572988, 35572989, 35318729, 35324244, 35324245, 35590362, 35294008, 35294009, 35586912, 35573451, 35628260, 35293783, 35293787, 35293812, 35318727, 35328473, 35328475, 35632962, 35632963, 35632964, 35632965, 35632966, 35611861, 35611862, 35611863, 35611864, 35611865, 35611866, 35611867, 35611868, 35611869, 35611870, 35664105, 35664111, 35667357, 35664406, 35664419, 35664899, 35665555, 35665558, 35665562, 35508827, 35508828, 35508833, 35508835, 35508840, 35508844, 35509589, 35685323, 35239086, 35326341, 35497107, 35508814, 35508818, 35508820, 35508821, 35508825, 35508829, 35508834, 35508838, 35508839, 35508841, 35508842, 35509590, 35239081, 35239083, 35239087, 35736269, 35736339, 35736340, 35814784, 35896890, 35735644, 35894004, 35926670, 35927324, 35940426, 35953462, 35976973, 35976974, 35976975, 35976976, 35976977, 35976978, 35976979, 35976980, 35976981, 35976982, 35976983, 35976984, 35976985, 35976986, 35976987, 35983205, 35983206, 35983207, 35983208, 35983209, 35983210, 35983211, 35983212, 35983191, 35983192, 35971160, 35977158, and 35971177
RECALLING FIRM/MANUFACTURER Physio Control, Inc., Redmond, WA, 
REASON Potential for the display screen to dim and eventually go blank. The risk to patient is a delay in defibrillation therapy if the defibrillator was needed in a cardiac arrest situation. Death or permanent impairment can occur if the user fails to deliver a defibrillation shock or defibrillation is delayed.
VOLUME OF PRODUCT IN COMMERCE 1,647 devices
DISTRIBUTION Nationwide and Internationally

PRODUCT ArthroCare brand Topaz XL ArthroWand with Integrated Cable Wand, Catalog Number: AC4045-01; Sterile Surgical Device. Product is indicated for ablation and debridement of tendons in orthopedic procedures, 
CODE
Lot Numbers: A603250-A, A609450-A, A610250-A, A615750-A, A616850-A, A627860-A, A627860-B, A604670-A, A615870-A, A620170-A, A623270-A, and A634670-A
RECALLING FIRM/MANUFACTURER ArthroCare Corporation, Sunnyvale, CA, 
REASON Devices for which sterility may be compromised as evidenced by punctures in the plastic tray during shipping. The risk to the patient is a potential infection subsequent to the surgical procedure.
VOLUME OF PRODUCT IN COMMERCE 2,129 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Biomet Hybrid Glenoid Boss Cutter; item 406150. - Surgical instrument used to prepare the natural shoulder glenoid surface for implanting a Hybrid Glenoid component. This instrument is intended to function by drilling a hole into the natural glenoid surface allowing the center boss of glenoid implant to sit within the hole, and the non-articulating surface of the glenoid implant to rest flush onto the natural glenoid surface, 
CODE Lots 44550, 110100, 171760, 211530, 211550, 767940, 820310, 820330, 827250, 853810, 866590, 919780, 919790, 919800, 968270, 980230 and 980250
RECALLING FIRM/MANUFACTURER Biomet, Inc., Warsaw, IN,
REASON The glenoid implant may not seat fully on the face of the natural glenoid due to inadequate measurement tolerances (tolerance stack-up) in the design of the cutter. Use of the instrument may lead to incomplete seating of the glenoid implant, elevating the theoretical risk of glenoid loosening, which may lead to early revision surgery. The problem may contribute to early device failure and patient injury because the stack-up tolerances could result in inadequate removal of bone from the natural glenoid surface. Long range health consequences may include: premature breakdown of cement mantle, excessive fatigue loading, the potential for early device failure and patient injury.
VOLUME OF PRODUCT IN COMMERCE 189 units
DISTRIBUTION Nationwide

PRODUCT
a) LS-232 Large 12 LeadWear Single Pack - Disposable ECG Monitoring component intended for use as a radiofrequency signal transmitter and receiver of    electrocardiograph physiological signals which are displayed on the ECG monitors of various manufacturers' systems that have been validated for compatibility,
b) LS-202 Large LeadWear Combo Pack - Disposable ECG Monitoring component intended for use as a radiofrequency signal transmitter and receiver of    electrocardiograph physiological signals which are displayed on the ECG monitors of various manufacturers' systems that have been validated for compatibility,
CODE All lots
RECALLING FIRM/MANUFACTURER GMP Companies/Lifesync Corp., Ft Lauderdale, FL.
REASON LifeSync Wireless ECG System - Intermittent failure when using LS-202 and LS-203 LeadWear in conjunction with LS-41245 and LS-41285 Adaptors. The out of box failure manifests as a V-Lead failure, leading to a possible delay in treatment based upon a delay in ECG monitoring.
VOLUME OF PRODUCT IN COMMERCE 1,344 units
DISTRIBUTION Nationwide

PRODUCT Is-anti-Gliadin IgG Enzyme Immunoassay Test Kit packaged in cardboard boxes with individual components secured within a foam insert. Catalog Number # 720-800. Laboratory In-Vitro Diagnostic Assay intended for the semi-quantitative detection of IgG antibodies to Gliadin in human serum by indirect enzyme immunoassay as an aid in the diagnosis of celiac disease, 
CODE Lot # S0207, Expiration Date: Nov. 30, 2008.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Diamedix Corporation, Miami, FL, 
Manufacturer: D-Tek Sa, Mons, Belgium.
REASON Standards and controls in the Is-anti-Gliadin IgG Test Kits are exhibiting low activity. A drop in the O.D.s the Positive Control could potentially recover low out of range (which would invalidate the test), or false positive test results could be obtained.
VOLUME OF PRODUCT IN COMMERCE 174 Test Kits
DISTRIBUTION Nationwide and Internationally

PRODUCT Electrode Adaptor Cable Quick-Combo System, Model 9055. The 9055 Electrode Adaptor is intended for use by trained personnel who use a Cardiac Science Automated External Defibrillator (AED) for defibrillation with Medtronic QUICK-COMBO Electrodes, CODE Lot numbers: 123004, 92804, 62305, 63005, 52504, 50405, 33105, 12605, 12505, 7715, 6952, 6838
RECALLING FIRM/MANUFACTURER Cardiac Science Corporation, Bothell, WA,
REASON Instructions For Use is not clear about how the AED voice and text prompts will differ when the adapter is used.
VOLUME OF PRODUCT IN COMMERCE 63 units
DISTRIBUTION Nationwide, Canada, Norway, Guam

PRODUCT Lupine BR Anchor w/Orthocord TCP/PLGA Absorbable Anchor, size 2 (5 metric) Braided Composite Suture, violet 36" (91cm) Size 2 (5metric) eyelet loop. Made in Switzerland; Sterile. The Lupine BR Anchor System is indicated for use in soft tissue bone fixation. Catalog Number 210711, 
CODE Lot Number 3069512
RECALLING FIRM/MANUFACTURER
Recalling Firm: DePuy Mitek, Inc., a Johnson & Johnson Co., Raynham, MA, 
Manufacturer: Ethicon SARL, Neuchatel, Switzerland. REASON Lupine BR Anchor w/Orthocord was assembled with an incorrect suture configuration. The suture loop was not assembled at the distal end of the anchor. It was only threaded through the suture hole in the anchor. Risk associated with incorrect suture configuration include premature breakage.
VOLUME OF PRODUCT IN COMMERCE 105 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Intuitive Surgical DA Vinci Surgical System, Mode; S Cardiac Probe Gasper Instrument, Model IS2000, Part Number 420215-02. The IS2000 CPG is used during cardiac ablation procedures, 
CODE Lot Number: 802011
RECALLING FIRM/MANUFACTURER Intuitive Surgical, Inc., Sunnyvale, CA
REASON The product has a software interface problem. When the product is connected to the da Vinci IS2000 System it will not allow the System to recognize the Instrument which makes the IS2000 CPG instrument nonfunctional at all sites. Risks associated are loss of operability of the instrument, delay in surgery, and loss of dexterity.
VOLUME OF PRODUCT IN COMMERCE 11 units
DISTRIBUTION Nationwide

PRODUCT Depuy LCS Knee - Orthopedic knee implant. Meniscal bearing insert, Sz: STD, mm thick 12 5, sterile; Depuy Orthopaedics, Inc., Warsaw, IN; REF 1178-21-025). Product is a prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing intended to to allow for motion between the plastic bearing and metal baseplate components of a knee prosthesis. It is intended to replace a knee joint in order to relieve pain and restore knee function, for indications such as osteoarthritis, inflammatory arthritis, traumatic arthritis, and revision of failed knee prostheses, 
CODE Lot: B2LE31000
RECALLING FIRM/MANUFACTURER Depuy Orthopedics, Inc., Warsaw, IN
REASON Labeling Discrepancy -- Mislabeled and mis-etched as to size. Inserts were labeled and packaged as size Standard, 12.5mm Inserts but were actually a 10mm Inserts. Risks include but not limited to: a delay in the procedure while the proper component is located, and tight joint with constricted movement as a result of implantation of the wrong thickness of insert.
VOLUME OF PRODUCT IN COMMERCE 6 units
DISTRIBUTION Nationwide

PRODUCT Accuracy Cyberknife Robotic Radiosurgery System, medical charged particle radiation therapy device. Model number 020700 (axum/standard treatment couch) and 021756 hand controller. The device is indicated for treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated, CODE All models
RECALLING FIRM/MANUFACTURER Accuray, Inc., Sunnyvale, CA, 
REASON Couch may move unexpectedly, which may result in patient impacting the linear accelerator.
VOLUME OF PRODUCT IN COMMERCE 105 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Zimmer NEXGEN Complete Knee Solution articular surface insertion instrument, non-sterile. This device is a surgical instrument used during knee arthroplasty procedures to snap or lock the polyethylene bearing surface into the retaining rail on a metal tibial plate, 
CODE Lots 60577285, 60582624, 60587308, 60603255 and 60610860
RECALLING FIRM/MANUFACTURER Zimmer, Inc., Warsaw, IN,
REASON The instrument is prone to fracture during use.
VOLUME OF PRODUCT IN COMMERCE 500 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Triathlon Femoral Sizer - The Femoral sizer was developed for use with the Triathlon Total Knee Instrumentation system. It interfaces with the Modular Handled and the Femoral Stylus to facilitate sizing for a femoral component, and preparing holes to accept the corresponding 4:1 Cutting Guide. The femoral sizer is designed to prepare the femoral cuts in 3 degrees of external rotation by referencing against the posterior condyles. The Femoral sizer is set by locking it into the left or right orientation based on the femur. Catalog Number: 6541-1-603, 
CODE All lots (except lot codes NMZC01, NMYV01, NMYW03)
RECALLING FIRM/MANUFACTURER Styker Howmedica Osteonics Corporation, Mahwah, NJ
REASON When attempting to position the Triathlon Femoral Sizer, the pre-setting may slip from L (left knee) to R (right knee) and vice verse intra-operatively.
VOLUME OF PRODUCT IN COMMERCE 560 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Short Barrel Sideplate, Omega + 140 degrees, 4 slots; The Omega Plus Compression Screw system consists of a series of lag screws, proximal hip side plates, supracondylar side plates, and compression screw designed to be used in the temporary stabilization of fractures of the proximal femur (intracapsular or intertrochanteric) and/or distal third of the femur (supracondylar area. These components are now made available in sterile packaging. Catalog Number: 3362-0-404,
CODE Lot code: E00985
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics Corp. Mahwah, NJ, 
Manufacturer: Stryker Trauma AG, Selzach, Switzerland. REASON The packaging labeled as catalog number 3362-0-040; lot code E00985, 140 x 4 slot may contain a 5 hole slot.
VOLUME OF PRODUCT IN COMMERCE 20 units
DISTRIBUTION Nationwide

PRODUCT
a) Stryker Ureteral Kit, Model number 220-180-516, The ureteral kit is a ureteral transillumination device with reusable illumination source and a fiberoptic light ureteral catheter kit which is provided sterile for single use disposable application.
The device is intended to be used to transilluminate the ureter during laparoscopic and open surgical procedures of the lower abdomen or pelvic areas to help the surgeon identify the ureter, 
b) Stryker Ureteral Universal Kit, Model number 220-180-517, The ureteral kit is a ureteral transillumination device with reusable illumination source and a fiberoptic
light ureteral catheter kit which is provided sterile for single use disposable application. The device is intended to be used to transilluminate the ureter during laparoscopic and open surgical procedures of the lower abdomen or pelvic areas to
help the surgeon identify the ureter, 
CODE
a) Lot numbers 4023, 4105, 4158, 4360, 4524, 4585, 4740, 4862, 4880, 5070, 5211, 5328;
b) Lot numbers: 4025, 4169, 4362, 4647, 4711, 5196, 5461
RECALLING FIRM/MANUFACTURER Stryker Endoscopy, San Jose, CA, .
REASON Kit fibers may not illuminate along entire length, which may result in inadequate visibility of the urethral structures during surgery.
VOLUME OF PRODUCT IN COMMERCE 322 kits
DISTRIBUTION Nationwide, Australia, Canada, Scandinavia, Italy, Switzerland

PRODUCT ON-Q PainBuster Infusion Pump (270 ml, 5 ml/hr), REF PS6504, Part No. 5001260. The pump is indicated for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, percutaneous and epidural. The ON-Q Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to or around surgical wound sites or close proximity to nerves when compared with narcotic only pain management. CODE Lot Number: 772166
RECALLING FIRM/MANUFACTURER I-Flow Corporation, Lake Forest, CA,
REASON The ON-Q PainBuster, REF PS6504 (lot number 772166), box may contain the wrong product, ON-Q PainBuster, REF PS6502. If the wrong product is used, patients would receive a 2 ml/hr infusion rather than a 5 ml/hr infusion, which could result in inadequate pain relief.
VOLUME OF PRODUCT IN COMMERCE 345 units
DISTRIBUTION Internationally

PRODUCT Medacta AMIS Universal Table for Leg Positioner, Model Number: 01.15.10.0172. The AMIS universal table for leg positioner and AMIS Leg Positioner are used during Anterior Minimally Invasive Surgery for hip arthroplasty. The system aids the surgical procedure by providing support and alignment of the limb,
CODE All product of Model Number 01.15.10.0172
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medacta Usa Inc., Camarillo, CA, 
Manufacturer: Medacta International SA, Strada Regina, Switzerland. 
REASON Medacta is issuing this Recall because improper connection of the table clamping mechanism may result in the AMIS table becoming separated from the surgical table resulting in injury to the patient.
VOLUME OF PRODUCT IN COMMERCE 20 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Lactosorb Trauma Plating System, part numbers: 915-2100, 915-2423, 915-2113, 915-2810, 915-2418, 915-2105, 915-2832 and CP-1323. The system is used in trauma and reconstructive surgical procedures in the mid face and craniofacial skeleton. Used to support non-load bearing tissues of cranial maxillofacial anatomy, including but not limited to brow fixation,
CODE Lot numbers: 898240, 898330, 898250, 898350, 898320, 951140, 868920, 978810
RECALLING FIRM/MANUFACTURER Biomet Microfixation, Inc., Jacksonville, FL,
REASON The outer foil pouch on the Lactosorb Plate system was not properly sealed. The product is labeled as sterile, but the lot was not sterilized. These devices are intended to be implanted into bone and are required to be sterile. A heavy bioburden would increase the potential for bone infection (osteomyelitis).
VOLUME OF PRODUCT IN COMMERCE 117 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) VisuaLine Single Dip Oxycodone; intended for in vitro immunoassay test completed  by visual color comparison used for the detection of drugs of abuse. Sun Biomedical
  Part Numbers: 15-2016; 
b) VisuaLine Propoxyphene; Propoxyphene test system, intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse. Sun Biomedical Part #: 15-2017,
c) VisuaLine Tricyclic Antidepressants: Six Dip (COC-THC-OPI-MET-BZD-OXD);
Six Dip (COC-THC-OPI-MET-PCP-OXD); Eight DIP (COC-THC-OPI-MET-AMP-BAR-BZD-OXD); Nine Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-TCA);
Ten Dip X (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-TCA); Ten Dip   (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-OXD); Ten Dip (COC-THC-  OPI-MET-PCP-AMP-BAR-BZD-TCA-OXD); Five Dip (COC-THC-OPI-BZD- OXD); and Six Dip (CPC-THC-OPI-MET-AMP-OXD). Sun Biomedical Part
15-2043; Part 15-2046; Part 15-2065; Part 15-2072; Part 15-2080; Part 15-2083; Part 15-2085; Part 15-2095; and Part 15-2101. Product is intended for in vitro  immunoassay test completed by visual color comparison used for the detection of drugs of abuse, 
CODE
a) Lot number Vis-OXD-dip 07-018-1-275 or Vis OXD-Dip 07-081-257;
b) lot number: Vis-PPX Dip 07-094-1-85;
c) Lot Vis-6SP-Dip 08-021-1; Lot Vis-6SP-Dip 07-270-1; Lot Vis-8SP-Dip-07-207-2;  Lot Vis-9SP-Dip-07-106-1; Lot Vis-10 Dip 06-204-2, Vis-10 Dip 07-002-2,
Vis-10-Dip-07-231-1; Part 15-2083, lot Vis-10SP-Dip-07-311-1; Vis-10SP-Dip 07-
324-1, VIS 10SP-Dip-08-045-3; Lot Vis 10SP Dip-07-201-1, Vis-10SP-Dip 07- 263-1; Lot Vis 5SP-Dip 07-284-2; Vis 5SP-Dip -8-008-01; Lot Vis-6SP Dip-07-326-1
RECALLING FIRM/MANUFACTURER Sun Biomedical Laboratories, Inc., Blackwood, NJ, 
REASON Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied.
VOLUME OF PRODUCT IN COMMERCE 1,137 units
DISTRIBUTION Nationwide

PRODUCT PANTA Nails, 10mm x 150 length. The Newdeal Ankle Nail is intended for use in tibiotalocalcaneal arthrodesis and the treatment of trauma to the hindfoot and distal tibia. The nail affords rigid, load sharing fixation that incorporates a simple nail-mounted, in-line method of compression across the arthrodesis site. Catalog number 500050ND, 
CODE Lot: E7XX
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integra LifeSciences Corp., Plainsboro, NJ, Manufacturer: NewDeal SA, Lyon, France
REASON Certain PANTA Nails from one lot were incorrectly manufactured. The internal thread for certain PANTA Nails may present an insufficient depth and may not allow the engagement of the threaded part of the compression device. The risks presented include: an increase in surgery time, or the implantation of a nail less ideally suited for the patient's anatomy if no other 10 mm nail is available.
VOLUME OF PRODUCT IN COMMERCE 45 nails
DISTRIBUTION Nationwide

PRODUCT
a) Biomet OSS Interlok IM Stem w/Screw, straight collar, 11 mm x 225 mm, TI6AL4V  alloy, sterile; REF 150490. Orthopedic implant intended as part of a replacement knee
joint,
b) Biomet OSS Interlok IM Stem w/Screw, straight collar, 13 mm x 225 mm, TI6AL4V alloy, sterile; REF 150491. Orthopedic implant intended as part of a replacement knee
joint, 
c) Biomet OSS Interlok IM Stem w/Screw, straight collar, 15 mm x 225 mm, TI6AL4V alloy, sterile; REF 150492. Orthopedic implant intended as part of a replacement knee
joint, 
CODE
a) Lots 564030 and 217680;
b) Lots 354050, 138040 and 067490;
c) Lots 354060 and 138050
RECALLING FIRM/MANUFACTURER Biomet, Inc., Warsaw, IN, 
REASON Mislabeled--The product is not collared, although the label states that it is collared. A non-collared component will provide a reduced contact with bone interface and/or a delay in the procedure may be incurred while clarifying package contents.
VOLUME OF PRODUCT IN COMMERCE 14 units
DISTRIBUTION Nationwide

PRODUCT Philips Gallileo Automatic Collimator, Part Numbers: 9896 010 00612, 9896 010 00614, 9896 010 00615. The device is a diagnostic x-ray beam-limiting device intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam, 
CODE
Site numbers: 6544, 10029, 10033, 10417, 10419, 10434, 10461, 10481, 10498, 10499, 13012, 13028, 13032, 13034, 13122, 13125, 13131, 13146, 13198, 13216, 13224, 13225, 13243, 13244, 13246, 13247, 13248, 13249, 13250, 13251, 13252, 13254, 13256, 13278, 13279, 13285, 13295, 13295, 13912, 14078, 14081, 14176, 26155, 38193, 38194, 38197, 38281, 38299, 38319, 38350, 38354, 38367, 38446, 38609, 38633, 38667, 38684, 38747, 38875, 38959, 38960, 38989, 40934, 40934, 41237, 41353, 41408, 41464, 41469, 41471, 41472, 41473, 45034, 50386, 50448, 52452, 52453, 52454, 52457, 52458, 52458, 52474, 76579, 76586, 76829, 76891, 76894, 76905, 76906, 76907, 76907, 76908, 76909, 76920, 76921, 76922, 76926, 76943, 76949, 76969, 76970, 76976, 76981, 76991, 76998, 80316, 80333, 82557, 82560, 82568, 82569, 82614, 82632, 82647, 82648, 82654, 82681, 82686, 82705, 82718, 82724, 82725, 82806, 82808, 82828, 82832, 82833, 82833, 82835, 82919, 82919, 82938, 82941, 82944, 83008, 83009, 83010, 83011, 83012, 83029, 83043, 83072, 83331, 83332, 83338, 83341, 83390, 83391, 83603, 83604, 83619, 83652, 83653, 83800, 83801, 83866, 83900, 83908, 83942, 83948, 83960, 83998, 84419, 84439, 84440, 84453, 84454, 84455, 84457, 84458, 84488, 84497, 84701, 84705, 84723, 84731, 84817, 84818, 84846, 84847, 84848, 84849, 84862, 84863, 84891, 84929, 84932, 84937, 84943, 84972, 85009, 85036, 85053, 85063, 85066, 85069, 85103, 85115, 85118, 85151, 85152, 85162, 85181, 85439, 85461, 85463, 85465, 85466, 85468, 85495, 85627, 85628, 85696, 85697, 85698, 85699, 85860, 86014, 86072, 86073, 86075, 86117, 86119, 86120, 86123, 86210, 86211, 86212, 86219, 86220, 86222, 86225, 86227, 86230, 86266, 86267, 86268, 86270, 86279, 86300, 86301, 86302, 86304, 86306, 86307, 86308, 86310, 86311, 86314, 86325, 86336, 86337, 86338, 86357, 86382, 86383, 86385, 86388, 86402, 86451, 86455, 86472, 86493, 86493, 86507, 86550, 86602, 86605, 86614, 86621, 86622, 86625, 86902, 86904, 86919, 86920, 86921, 86943, 86951, 86963, 86973, 86974, 87003, 87014, 87027, 87028, 87032, 87039, 87048, 87049, 87057, 87071, 87082, 87141, 87144, 87301, 87303, 87321, 87338, 87602, 87606, 87608, 100039, 100094, 100203, 100244, 100245, 100428, 100433, 100437, 100439, 100441, 100454, 100455, 100490, 100544, 100547, 100569, 100571, 100572, 100573, 100584, 100591, 100602, 100616, 100617, 100619, 100642, 100659, 100678, 100772, 100773, 100782, 100807, 100824, 100827, 100868, 100885, 100891, 101081, 101213, 101218, 101308, 101405, 102496, 104373, 250090, 250100, 250439, 250677, 250678, 557777, 557784, 557786, 557787, 557803, 557833, 557876, 557880, 557885, 557938, 557943, 557990, 558001, 558008, 558014, 558040, 558052, 558060, 558154, 558155, 558156, 558157, 558160, 558163, 558181, 558186, 558207, 558208, 558210, 558284, 558289, 558290, 558291, 558292, 558294, 558295, 558304, 558311, 558312, 558361, X1727, 6983, 10000, 10002, 10006, 10178, 10392, 10393, 10410, 10418, 10435, 10493, 13173, 13178, 13178, 13245, 13257, 13283, 13284, 13293, 13970, 14070, 14169, 14177, 26294, 38195, 38196, 38207, 38268, 38314, 38342, 38361, 38423, 38608, 38610, 38625, 38626, 38634, 38656, 38679, 38689, 38693, 38695, 38712, 38743, 38745, 38963, 40936, 41120, 41121, 41420, 41463, 41468, 50230, 50322, 50427, 50446, 50447, 52450, 59652, 62868, 62950, 62997, 76391, 76578, 76829, 76837, 76925, 76940, 76957, 76958, 76959, 76960, 76967, 76973, 80318, 80339, 82503, 82515, 82516, 82561, 82571, 82613, 82630, 82646, 82656, 82674, 82675, 82712, 82720, 82722, 82726, 82728, 82805, 82809, 82831, 82834, 82920, 82942, 82949, 82954, 83001, 83007, 83031, 83074, 83083, 83308, 83319, 83369, 83370, 83648, 83651, 83698, 83909, 83936, 83943, 83944, 83947, 84420, 84434, 84461, 84703, 84851, 84857, 84858, 84893, 84931, 84938, 84939, 84963, 84964, 85029, 85030, 85037, 85109, 85117, 85147, 85148, 85149, 85166, 85167, 85168, 85184, 85402, 85403, 85405, 85437, 85438, 85462, 85467, 85484, 85486, 85492, 85493, 85494, 85683, 86015, 86070, 86071, 86078, 86213, 86216, 86221, 86221, 86226, 86228, 86232, 86309, 86344, 86358, 86359, 86384, 86386, 86389, 86394, 86395, 86397, 86400, 86543, 86579, 86601, 86606, 86607, 86611, 86613, 86618, 86619, 86623, 86901, 86938, 86939, 86942, 86964, 86976, 86979, 86980, 86990, 87005, 87016, 87017, 87031, 87045, 87050, 87051, 87079, 87136, 87137, 87138, 87142, 87169, 87175, 87178, 87196, 87320, 87333, 87363, 87609, 100426, 100438, 100443, 100457, 100481, 100489, 100494, 100549, 100555, 100556, 100557, 100604, 100605, 100614, 100615, 100618, 100770, 100780, 100825, 100834, 100835, 100848, 100855, 100867, 101076, 101079, 101080, 101132, 101240, 101563, 102081, 102335, 102337, 102338, 102339, 102340, 102341, 102342, 102344, 102376, 102385, 102388, 102609, 250043, 250092, 250313, 250679, 505640, 557789, 557792, 557794, 557812, 557883, 557935, 557940, 557988, 557991, 558009, 558010, 558013, 558017, 558018, 558019, 558024, 558025, 558026, 558030, 558063, 558064, 558158, 558174, 558184, 558190, 558195, 558205, 558224, 558226, 558285, 558293, 558302, 558308, 558310, 558366, 558370, 20278751, 82730, 83073, 10405, 13253, 38975, 76831, 82617, 82657, 83956, 84712, 86223, 86451, 100322, 100633, 100633, 104199
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems, North America Co. Phillips, Bothell, WA, 
Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. 
REASON The collimator could fall from the x-ray stand, due to loosening screws, and strike a patient or operator underneath.
VOLUME OF PRODUCT IN COMMERCE 709 devices
DISTRIBUTION Nationwide

PRODUCT
a) M-Style® Mushroom Cup® Vacuum Assisted Delivery System used with hand pump (Ref: 10007LP). Product is intended to assist a clinician in the delivery of an infant during childbirth. Indicated for use during vaginal delivery and Cesarean sections. 
b) M-Style® Cup with Universal Vacuum Release (UVR) used with wall suction, Vacuum Assisted Delivery System (Ref: 10015LP). Product is intended to assist a clinician in the delivery of an infant during childbirth. Indicated for use during  vaginal delivery and Cesarean sections. 
c) Mystic® II M-Style® Mushroom Cup Vacuum Assisted Delivery System (Ref: 10057). Product is intended to assist a clinician in the delivery of an infant during childbirth. Indicated for use during vaginal delivery and Cesarean sections.
CODE
a) 57860, 57861, 57864, 57866, 57868, 57870, 57872, 57873, 57874, 58113, 60728,  60729, 60730, and 60742;
b) 57816, 57817, 57852, 57853, 57854, 57855, 57856 57857, 57858, 57859, 58114,  60756, and 60757;
c) 57735, 57760, 57761, 57768, 57908, 57909, 57910, 57911, 57912, 57913, 57918, 57919, 57922, 57924, 57925, 58299, and 60815
RECALLING FIRM/MANUFACTURER Cooper Surgical, Inc., Trumbull, CT,
REASON Vacuum Assisted Delivery System may have a loss of vacuum, or the cup will not release from the baby's head. A loss of vacuum may delay delivery and require the use of forceps and/or c-section for delivery. An inability to remove the cup from the head may delay delivery and/or prevent the user from applying forceps if necessary. This may result in serious injury or death to the baby.
VOLUME OF PRODUCT IN COMMERCE 35,527 devices
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) GE 1.5T and 3.0T Signa HDx MR System. The product is used as a diagnostic  imaging device to produce axial sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the body; 1) Model 5127452; 2) Model 2377062-61; 3) Model 2395001-2,    
b) GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System. The product is used as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the body. 1) Model: 5107849; 2) Model: 5107849-2; 3) Model: M3000PT; 4) Model: M3000PW, 
CODE
a) 1) 00000HDMR20228 00000276057MR7 00000275160MR0 000000HDMR2544 00000HDMR10417 00000HDMR10094 00000274383MR9 00000273832MR6 00000274385MR4 00000276073MR4 00000274359MR9 00000HDMR10273 00000273119MR8 00000DDDM10670 00000HDMR20073 00000HDMR10739 000000HDMR2451 000000HDMR2335 00000HDMR20189 000000HDMR1004 00000HDMR10489 00000HDMR10291 00000HDMR20151 00000HDMR20061 00000HDMR10743 000000HDMR2528 000000HDMR2976 00000HDMR20044 000000HDMR2773 00000HDMR20294 00000HDMR20059 00000HDMR10418 00000HDMR10831 00000HDMR20036 and 00000HDMR20056;
2) 00000008376YR6 00000007126YR6 00000007551YR5 00000007555YR6 00000006690YR2 00000007518YR4 00000008525YR8 00000005222YR5 00000007134YR0 00000008354YR3 00000005989YR9 00000007107YR6 00000008100YR0 00000007594YR5 00000006710YR8 00000008103YR4 00000007092YR0 00000007503YR6 00000007574YR7 00000006754YR6 00000007542YR4 00000008116YR6 00000008522YR5 00000006685YR2 00000007105YR0 00000008564YR7 00000005974YR1 00000005545YR9 00000006705YR8 00000006600YR1 00000007585YR3 00000005532YR7 00000008549YR8 00000007533YR3 00000007498YR9 00000005231YR6 00000006583YR9 00000005216YR7 00000007554YR9 00000009031YR6 00000006708YR2 00000007117YR5 00000007864YR2 00000007866YR7 00000007514YR3 00000008342YR8 00000005546YR7 00000007892YR3 00000007865YR9 00000006556YR5 00000006660YR5 00000007862YR6 00000009421YR9 00000007556YR4 00000008378YR2 00000008539YR9 00000006656YR3 00000005536YR8 00000008115YR8 00000008335YR2 00000052299YR0 00000006727YR2 00000006726YR4 and 00000007572YR1;
3) 00000280673MR5 00000278397MR5 00000277211MR9 00000276434MR8 00000275968MR6 00000278549MR1 00000280781MR6 00000276265MR6 00000275046MR1 00000283745MR8 00000284233MR4 00000275648MR4 00000280000MR1 00000279068MR1 00000275967MR8 00000274744MR2 00000276266MR4 00000280001MR9 00000278851MR1 00000275647MR6 00000281340MR0 00000275465MR3 and 00000282549MR5;

b) 1) 00000262460MR9 00000270245MR4 00000260692MR9 00000269581MR5 00000268123MR7 00000277574MR0 00000267973MR6 00000280302MR1 00000262803MR0 00000270974MR9 00000273229MR5 00000277190MR5 00000277189MR7 00000279752MR0 00000261198MR6 00000272433MR4 00000269437MR0 00000265177MR6 00000264407MR8 00000265173MR5 00000274998MR4 00000268011MR4 00000270383MR3 00000262459MR1 00000269326MR5 00000261064MR0 00000271248MR7 00000263970MR6 00000276409MR0 00000274835MR8 00000278722MR4 00000271120MR8 00000262456MR7 00000273459MR8 00000266821MR8 00000266071MR0 00000276491MR8 00000266066MR0 00000265061MR2 00000266754MR1 00000271234MR7 00000266343MR3 00000273365MR7 00000262299MR1 00000263879MR9 00000262793MR3 00000273341MR8 00000266822MR6 00000269340MR6 00000273230MR3 00000262800MR6 00000261678MR7 00000271246MR1 00000280388MR0 00000261205MR9 00000262666MR1 00000262673MR7 00000260480MR9 00000276591MR5 00000279460MR0 00000272533MR1 00000263974MR8 00000262667MR9 00000261066MR5 00000271124MR0 00000277955MR1 2333 00000272072MR0 00000261069MR9 00000264087MR6 00000267322MR6 00000274839MR0 00000265005MR9 00000275642MR7 00000270466MR6 00000275086MR7 00000261061MR6 00000275845MR6 00000272076MR1 00000269435MR4 00000270387MR4 00000268518MR8 00000268477MR7 00000268515MR4 00000269575MR7 00000272968MR9 00000270026MR8 00000272969MR7 00000272070MR4 00000268692MR1 00000271662MR9 00000268417MR3 00000270467MR4 00000272536MR4 00000273529MR8 00000279146MR5 00000275668MR2 and 00000260651MR5;
2) 00000279077MR2 00000282686MR5 00000283386MR1 00000283076MR8 00000279423MR8 00000278623MR4 00000278626MR7 00000279921MR1 00000276633MR5 00000273541MR3 00000274170MR0 00000274930MR7 00000281703MR9 00000281443MR2 00000281019MR0 00000275936MR3 00000279713MR2 00000273267MR5 and 00000273266MR7;
3) 00000266842MR4 00000266160MR1 00000271322MR0 00000275009MR9 00000268302MR7 00000263655MR3 00000264783MR2 00000266194MR0 00000267528MR8 00000026005MR8 00000266156MR9 00000265852MR4 00000267533MR8 000267533MR8ZZ 00000265968MR8 00000267529MR6 00000267527MR0 00000266690MR7 00000264643MR8 00000267618MR7 00000268837MR2 00000270528MR3 00000270097MR9 00000268301MR9 00000269332MR3 and 00000267860MR5;
4) 00000266270MR8 00000250462MR9 and 00000263921MR9
RECALLING FIRM/MANUFACTURER GE Healthcare, Waukesha, WI, 
REASON GE healthcare has become aware of an artifact which could affect the diagnostic capability associated with the 3.0T Propeller T2 Flair application of the 3.0T Signa HDx scanner.
VOLUME OF PRODUCT IN COMMERCE 269 units
DISTRIBUTION Nationwide and Internationally

PRODUCT EKOS EndoWave Infusion System consisting of a Drug Delivery Catheter and an Ultrasound Core. Labeled as Sterile, Single Use Only. The device is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature, CODE
071126006-001, 071126006-002, 071126006-003, 071126006-005, 071204008-001, 071128015-001, 071128015-002, 071128015-003, 071128015-004, 071128015-005, Item number 500-52106, expiration date 2009-10
RECALLING FIRM/MANUFACTURER EKOS Corp., Bothell, WA, 
REASON Product mislabeled - 6 cm treatment zone catheter had been built using 50 cm treatment zone drilled tubing. Consequently, drug was delivered outside of the treatment zone.
VOLUME OF PRODUCT IN COMMERCE 10 units
DISTRIBUTION WA, NC, IL, OH, NY, MI, KY

PRODUCT
a) Arrow Balloon Temporary Pacing Catheter Kits, Part number AI-07155-KS, (Distributed in the U.S.). 5 Fr. (110 cm) Pacing Catheter, 6 Fr. Introducer Sheath, .035 inch diameter spring-wire guide, Single use. The device is indicated for use in sampling blood for oxygen levels and measuring pressure in the right heart,
b) Arrow Balloon Temporary Pacing Catheter Kits, Part number AI-07155-IK, (Distributed in Canada, Croatia, Dominican Republic, Honduras, New Zealand, Russia, South Africa and Venezuela). For Export Only, 5 Fr. (110 cm) Pacing Catheter, 6 Fr. Introducer Sheath, .035 inch diameter spring-wire guide, Single use,  Sterilized. The device is indicated for use in sampling blood for oxygen levels and
measuring pressure in the right heart,
CODE
a) Lot # RF8015919;
b) Lot # RF8015920
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arrow International Inc., Asheboro, NC, Manufacturer: Arrow International Inc, Reading, PA. 
REASON The 5 Fr. (110cm) Temporary Pacing Catheter/ 6 Fr. Introducer Kits do not contain a complete 6 Fr. Introducer Assembly.
VOLUME OF PRODUCT IN COMMERCE 686 kits
DISTRIBUTION Nationwide, South Africa, Venezuela

PRODUCT
a) CMS-MST572 5F insertion kit with 5 cm tear away. The product is shipped 10 kits per box and is intended for use in percutaneous procedures to introduce and position   catheters, pacing leads and other interventional devices within the coronary and peripheral vasculature,
b) USCT5D, Pro-PICC CT 5F x 55 cm Dual Lumen. infusion catheter insertion kit. The product is shipped 5 units per box and is indicated for short and long term access    to the central venous system, 
CODE
a) Lot #: MAPA870;
b) Lot #: MAPA880
RECALLING FIRM/MANUFACTURER Medical Components, Inc. dba MedComp, Harleysville, PA,ng.
REASON Kit contains incorrect component.
VOLUME OF PRODUCT IN COMMERCE 350 units
DISTRIBUTION PA, TX

PRODUCT Phillips Medical Systems, SureSigns VS3 Vital Signs Monitor model numbers 863071, 863072, 863073, 863074. All four model numbers have the same user manual. The device is intended for monitoring, recording and alarming of multiple physiological parameters, 
CODE Model #’s only
RECALLING FIRM/MANUFACTURER Philips Medical Systems, Andover, MA,
REASON Some users of SureSigns VS3 Signs Monitor may have assumed that the SpO2 Non-Pulsatile and SpO2 No Sensor technical alarms were enabled when the SureSigns VS3 Vital Signs Monitor was not in Interval non-invasive blood pressure (NBP) mode. These alarms are only enabled when interval NBP mode is selected. If when monitoring SpO2, the clinician does not notice when the sensor is no longer attached, the patient is not being monitored through Spo2.This could result in delay or lack of needed therapy. The labeling provided with the monitor did not fully describe this feature.
VOLUME OF PRODUCT IN COMMERCE 7,529 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Medtronic 1x8 3777-xx, Low Impedance Lead Kit for Spinal Cord Stimulation (SCS), Contents of the inner package are STERILE. Method of sterilization: Ethylene Oxide, Rx Only, Model 3777-75, 
CODE Lot number V030733, Serial numbers V030733017, V030733018, V030733026.
RECALLING FIRM/MANUFACTURER
Medtronic Neuromodulation, Minneapolis, MN, 
Manufacturer: Medtronic Puerto Rico Inc., Villalba Pr, PR. .
REASON Product contains accessory stylets that are not the correct length.
VOLUME OF PRODUCT IN COMMERCE 39 distributed (3 subject to recall, 36 already used or returned)
DISTRIBUTION NC, FL

PRODUCT AneuRx AAAdvantage stent graft and the Xcelerant Delivery System with Hydro. Product number lLXCH161685. The product is designed to treat infrarenal abdominal aortic or aorto-ilac aneurysms during an endovascular approach, 
CODE Serial numbers: V00092566, V00092567, V00092568, and V00092569
RECALLING FIRM/MANUFACTURER Medtronic CardioVascular, Santa Rosa, CA, 
REASON Products may contain elevated Endotoxin (pyrogen) levels above the firm’s specifications, and the product is labeled as containing no pyrogen.
VOLUME OF PRODUCT IN COMMERCE 4 devices
DISTRIBUTION NC, VA

PRODUCT
a) Esprit Ventilator, Model V1000 manufactured with Power Supply PN 1015852. The Esprit Ventilator is a microprocessor controlled, electrically powered,    mechanical ventilator. PN 701-01000, R
b) Esprit Power Supply Snubber Board Assembly FRU, PN 1036236 The Esprit Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. PN 1036236, 
c) Esprit Power Supply Field Replacement Unit (FRU), PN 101 8246 The Esprit Ventilator is a microprocessor controlled, electrically powered, mechanical Ventilator. PN 1018246, 
CODE
a) Serial Numbers: VS3007041 VS3007181 VS3007263 VS3007672 VS3007895 VS3009980 VS3007527 VS3006533 VS3006642 VS3007000 VS3007167 VS3007175 VS3007477 VS3007485 VS3007486 VS3007540 VS3007546 VS3007564 VS3007611 VS3007613 VS3007773 VS3007851 VS3008688 VS3008878 VS3007806 VS3008988 VS3009084 VS3009074 VS3009124 VS3009545 VS3009605 VS3009665 VS3009872 VS3009895 VS3009897 VS3009918 VS3009922 VS3009940 VS3010330 VS3010325 VS3010361 VS3010379 VS3010601 VS3010612 VS3010652 VS3010656 VS3010662 VS3010668 VS3010678 VS3010684 VS3010696 VS3010688 VS3010744 VS3010800 VS3010815 VS3010826 VS3010832 VS3010867 VS3010872 VS3010873 VS3010895 VS3010942 VS3005888 VS3006538 VS3006545 VS3006556 VS3006560 VS3006525 VS3006581 VS3006585 VS3006654 VS3006668 VS3006694 VS3007057 VS3007005 VS3007126 VS3007127 VS3007134 VS3007132 VS3007151 VS3007152 VS3007010 VS3001228 VS3001229 VS3001311 VS3001324 VS3001344 VS3001348 VS3001406 VS3001411 VS3001690 VS3000577 VS3000585 VS3001227 VS3001274 VS3001280 VS3001297 VS3001304 VS3001321 VS3001234 VS3001375 VS3001744 VS3001861 VS3001164 VS3001277 VS3001327 VS3001400 VS3001854 VS3000910 VS3001218 VS3001399 VS3001385 VS3009867 VS3009019 VS3009706 VS3011031 VS3011076 VS3007814 VS3010170 VS3010426 VS3010509 VS3010916 VS3010919 VS3010928 VS3010682 VS3010869 VS3010874 VS3010885 VS3005886 VS3010693 VS3010824 VS3007757 VS3008853 VS3008945 VS3008989 VS3004976 VS3005856 VS3006199 VS3006203 VS3007530 VS3000955 VS3000998 VS3001015 VS3001283 VS3001674 VS3002006 VS3002033 VS3002034 VS3002082 VS3006562 VS3007049 VS3007639 VS3007659 VS3010402 VS3010405 VS3010407 VS3010466 VS3010486 VS3010523 VS3010544 VS3010568 VS3010554 VS3010590 VS3000563 VS3007066 VS3010617 VS3008584 VS3002008 VS3001633 VS3001880 VS3001900 VS3001993 VS3001998 VS3002021 VS3002023 VS3002063 VS3002077 VS3002083 VS3002130 VS3002136 VS3002792 VS3003177 VS3007383 VS3007541 VS3007904 VS3008640 VS3008660 VS3008665 VS3008786 VS3008802 VS3008845 VS3008846 VS3008852 VS3009589 VS3009737 VS3009874 VS3009877 VS3009971 VS3010108 VS3010115 VS3010123 VS3010121 VS3010127 VS3010139 VS3010142 VS3010169 VS3010381 VS3010368 VS3010712 VS3010731 VS3010775 VS3010806 VS3010829 VS3010847 VS3010854 VS3010904 VS3010922 VS3010934 VS3010935 VS3010940 VS3010941 VS3010946 VS3010959 VS3011026 VS3011029 VS3011039 VS3011042 VS3011048 VS3011055 VS3011057 VS3011059 VS3011067 VS3008846 VS3002199 VS3002205 VS3002207 VS3000911 VS3004618 VS3004668 VS3004986 VS3005762 VS3005817 VS3005816 VS3005804 VS3005822 VS3005908 VS3006190 VS3006215 VS3006529 VS3006552 VS3006666 VS3007014 VS3007012 VS3007145 VS3007168 VS3007221 VS3007274 VS3007299 VS3007413 VS3007439 VS3007507 VS3007582 VS3007753 VS3007880 VS3007866 VS3007893 VS3007898 VS3008528 VS3009644 VS3009647 VS3009649 VS3009650 VS3010760 VS3010757 VS3010792 VS3001068 VS3004467 VS3004468 VS3004476 VS3004493 VS3004515 VS3004526 VS3004581 VS3004583 VS3004585 VS3004590 VS3004593 VS3004597 VS3004599 VS3004608 VS3004620 VS3004645 VS3004658 VS3004670 VS3004675 VS3004677 VS3004690 VS3004756 VS3004943 VS3004965 VS3004979 VS3000567 VS3000575 VS3000602 VS3000617 VS3000635 VS3000907 VS3000909 VS3000943 VS3000946 VS3000952 VS3000960 VS3000970 VS3000973 VS3001666 VS3001677 VS3001681 VS3001683 VS3001686 VS3001692 VS3001695 VS3001710 VS3001725 VS3001743 VS3002752 VS3003168 VS3003239 VS3003277 VS3003671 VS3003677 VS3003678 VS3003694 VS3003735 VS3003808 VS3004022 VS3004055 VS3004068 VS3004070 VS3004071 VS3004075 VS3004084 VS3004085 VS3004086 VS3004110 VS3004214 VS3001032 VS3001048 VS3001059 VS3001060 VS3001061 VS3001065 VS3001066 VS3001067 VS3001074 VS3001075 VS3001076 VS3001078 VS3001087 VS3001113 VS3001117 VS3001632 VS3001094 VS3001630 VS3001644 VS3001651 VS3004243 VS3004247 VS3004281 VS3004282 VS3004318 VS3004371 VS3000560 VS3000607 VS3000906 VS3000957 VS3000964 VS3001019 VS3001035 VS3001036 VS3001070 VS3001084 VS3001111 VS3001103 VS3001109 VS3001637 VS3001685 VS3001673 VS3001707 VS3001705 VS3001702 VS3001689 VS3001672 VS3001675 VS3001659 VS3001642 VS3001711 VS3001650 VS3001701 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VS3000574 VS3000631 VS3000637 VS3000641 VS3000644 VS3000918 VS3000921 VS3000922 VS3000923 VS3000924 VS3000934 VS3000986 VS3000995 VS3001010 VS3001014 VS3001016 VS3001018 VS3001041 VS3001052 VS3001053 VS3001054 VS3001055 VS3001232 VS3001240 VS3001259 VS3001268 VS3001272 VS3001301 VS3001331 VS3001360 VS3001741 VS3001794 VS3002134 VS3002632 VS3002667 VS3002668 VS3002708 VS3002721 VS3002760 VS3002926 VS3003726 VS3003747 VS3003811 VS3004178 VS3004464 VS3004538 VS3004561 VS3004577 VS3004601 VS3004629 VS3004674 VS3004811 VS3004837 VS3004851 VS3004980 VS3004987 VS3001012 VS3009014 VS3009567 VS3009576 VS3007501 VS3007717 VS3006550 VS3006566 VS3006643 VS3006650 VS3006652 VS3006657 VS3007024 VS3007204 VS3007206 VS3007272 VS3007305 VS3007508 VS3007600 VS3007683 VS3008639 VS3008776 VS3008872 VS3008932 VS3008936 VS3009066 VS3009110 VS3009121 VS3009136 VS3009145 VS3009157 VS3009173 VS3009179 VS3009182 VS3009148 VS3009547 VS3009549 VS3009555 VS3009566 VS3009610 VS3009643 VS3009666 VS3009692 VS3009698 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VS3003013 VS3004638 VS3005013 VS3004925 VS3007190 VS3007193 VS3009646 VS3010820 VS3000584 VS3001023 VS3001046 VS3001122 VS3001123 VS3001643 VS3001814 VS3002027 VS3006424 VS3007284 VS3009623 VS3007684 VS3010937 VS3010467 VS3010418 VS3010448 VS3010514 VS3010410 VS3010413 VS3010423 VS3010438 VS3010499 VS3010510 VS3010529 VS3010535 VS3010539 VS3010543 VS3010506 VS3010585 VS3008702 VS3008781 VS3002806 VS3003105 VS3003172 VS3003191 VS3003196 VS3003633 VS3006555 VS3006559 VS3007301 VS3007630 VS3007638 VS3007670 VS3008942 VS3008986 VS3009601 VS3009655 VS3009662 VS3009879 VS3010730 VS3010776 VS3010860 VS3010908 VS3010918 VS3010965 VS3011013 VS3011037 VS3011066 VS3011069 VS3011077 VS3010674 VS3005659 VS3011773 VS3011780 VS3011783 VS3011785 VS3011788 VS3011792 VS3011795 VS3011796 VS3011800 VS3011801 VS3011804 VS3011810 VS3004565 VS3004648 VS3004689 VS3004729 VS3004830 VS3004942 VS3004983 VS3005041 VS3004974 VS3005627 VS3005681 VS3005656 VS3005719 VS3005689 VS3005690 VS3005702 VS3005789 VS3005801 VS3005778 VS3005811 VS3005813 VS3005814 VS3005815 VS3005752 VS3004956 VS3005806 VS3005665 VS3005802 VS3005800 VS3005731 VS3005823 VS3005819 VS3005824 VS3005828 VS3005834 VS3010503 VS3010924 VS3007617 VS3010415 VS3010808 VS3010879 VS3010900 VS3010927 VS3011045 VS3010192 VS3010939 VS3011040 VS3011058 VS3011086 VS3007280 VS3009882 VS3009907 VS3010131 VS3011073 VS3011078 VS3011081 VS3011082 VS3011084 VS3010441 VS3010492 VS3010039 VS3010056 VS3010813 VS3010859 VS3010917 VS3010926 VS3011041 VS3010799 VS3010856 VS3010903 VS3009993 VS3010100 VS3010753 VS3011047 VS3009035 VS3010075 VS3010724 VS3010786 VS3010805 VS3010858 VS3010875 VS3010890 VS3010914 VS3010915 VS3010929 VS3010930 VS3010981 VS3010989 VS3010994 VS3011004 VS3011024 VS3011052 VS3011054 VS3011063 VS3011064 VS3011074 VS3007297 VS3007321 VS3011070 VS3011009 VS3011071 VS3011053 VS3011065 VS3010602 VS3010801 VS3010790 VS3010952 VS3010957 VS3010987 VS3011010 VS3011016 VS3005820 VS3005893 VS3005894 VS3005899 VS3005905 VS3005925 VS3005942 VS3007016 VS3007029 VS3007047 VS3007059 VS3007054 VS3007070 VS3007082 VS3007102 VS3007006 VS3007112 VS3007125 VS3007161 VS3007173 VS3007192 VS3007240 VS3007236 VS3007241 VS3007257 VS3007316 VS3007317 VS3007325 VS3007328 VS3007351 VS3007361 VS3007367 VS3007390 VS3007406 VS3007419 VS3007424 VS3007431 VS3007440 VS3007444 VS3007465 VS3007466 VS3007468 VS3007482 VS3007500 VS3007511 VS3007521 VS3007522 VS3007528 VS3007539 VS3007547 VS3007548 VS3007557 VS3007561 VS3007558 VS3007573 VS3007584 VS3007585 VS3007495 VS3007592 VS3007602 VS3007616 VS3007632 VS3007621 VS3007648 VS3007653 VS3007656 VS3007655 VS3007667 VS3007676 VS3007678 VS3007695 VS3007735 VS3007737 VS3007873 VS3007877 VS3007884 VS3007595 VS3007862 VS3007910 VS3007922 VS3008523 VS3007899 VS3008537 VS3008539 VS3008545 VS3008556 VS3008587 VS3008597 VS3008602 VS3007803 VS3008649 VS3008653 VS3008710 VS3008794 VS3008833 VS3008877 VS3008885 VS3008897 VS3008901 VS3008920 VS3008972 VS3008975 VS3009128 VS3009570 VS3009626 VS3009645 VS3009651 VS3009652 VS3009653 VS3009654 VS3009656 VS3009657 VS3009659 VS3009661 VS3009664 VS3009669 VS3009670 VS3009684 VS3009690 VS3009694 VS3009697 VS3009699 VS3009701 VS3009702 VS3009704 VS3009707 VS3009796 VS3009854 VS3009898 VS3009910 VS3009911 VS3009931 VS3009951 VS3009955 VS3009965 VS3009973 VS3009990 VS3009994 VS3010007 VS3010019 VS3010024 VS3010043 VS3010066 VS3010068 VS3010069 VS3010082 VS3010128 VS3010196 VS3010185 VS3010388 VS3010409 VS3010417 VS3010442 VS3010433 VS3010453 VS3010461 VS3010468 VS3010475 VS3010462 VS3010483 VS3010496 VS3010500 VS3010504 VS3010517 VS3010472 VS3010567 VS3010571 VS3010583 VS3010587 VS3010591 VS3010596 VS3010600 VS3010607 VS3010624 VS3010633 VS3010636 VS3010641 VS3010643 VS3010645 VS3010629 VS3010666 VS3010667 VS3010704 VS3010707 VS3010718 VS3010717 VS3010720 VS3010727 VS3010728 VS3010747 VS3010742 VS3010738 VS3010743 VS3010846 VS3010861 VS3010862 VS3010841 VS3010884 VS3010839 VS3003627 VS3003337 VS3003707 VS3003160 VS3001154 VS3002791 VS3002952 VS3001139 VS3001166 VS3001661 VS3001676 VS3001736 VS3001757 VS3001819 VS3001833 VS3001842 VS3001844 VS3001858 VS3001911 VS3001912 VS3001923 VS3001972 VS3002026 VS3002096 VS3002116 VS3002185 VS3002731 VS3002748 VS3002757 VS3002769 VS3002771 VS3002785 VS3002797 VS3002817 VS3002837 VS3002850 VS3002858 VS3002872 VS3002909 VS3002911 VS3002934 VS3002939 VS3002947 VS3002955 VS3002961 VS3002963 VS3002965 VS3002972 VS3002974 VS3002980 VS3003100 VS3003108 VS3003109 VS3003123 VS3003126 VS3003133 VS3003150 VS3003156 VS3003159 VS3003176 VS3003184 VS3003192 VS3003200 VS3003202 VS3003209 VS3003235 VS3003255 VS3003258 VS3003260 VS3003265 VS3003267 VS3003270 VS3003273 VS3003276 VS3003282 VS3003287 VS3003293 VS3003294 VS3003296 VS3003298 VS3003300 VS3003310 VS3003317 VS3003321 VS3003323 VS3003336 VS3003339 VS3003351 VS3003359 VS3003361 VS3003364 VS3003376 VS3003378 VS3003404 VS3003412 VS3003417 VS3003421 VS3003426 VS3003439 VS3003623 VS3003626 VS3003628 VS3003629 VS3003631 VS3003634 VS3003635 VS3003638 VS3003640 VS3003643 VS3003644 VS3003649 VS3003650 VS3003651 VS3003652 VS3003654 VS3003655 VS3003656 VS3003657 VS3003658 VS3003659 VS3003661 VS3003663 VS3003664 VS3003666 VS3003670 VS3003686 VS3003702 VS3003704 VS3003728 VS3003729 VS3003730 VS3003731 VS3003737 VS3003741 VS3003743 VS3003750 VS3003752 VS3003754 VS3003757 VS3003763 VS3003766 VS3003770 VS3003772 VS3003774 VS3003785 VS3003793 VS3003803 VS3003807 VS3003813 VS3003814 VS3003831 VS3003836 VS3003841 VS3003844 VS3003846 VS3003848 VS3003849 VS3003851 VS3003852 VS3003854 VS3003855 VS3003858 VS3003887 VS3003890 VS3003928 VS3002846 VS3002973 VS3003102 VS3003117 VS3003143 VS3003164 VS3003254 VS3003291 VS3003292 VS3003391 VS3003625 VS3003630 VS3003637 VS3003668 VS3007026 VS3004635 VS3004813 VS3005642 VS3005696 VS3005810 VS3005897 VS3005945 VS3006191 VS3006213 VS3006220 VS3006385 VS3006546 VS3006549 VS3006578 VS3006587 VS3006584 VS3007199 VS3007215 VS3007296 VS3007304 VS3007397 VS3007512 VS3007712 VS3007715 VS3007771 VS3007777 VS3007823 VS3007834 VS3007908 VS3007896 VS3008567 VS3008558 VS3008646 VS3009154 VS3009155 VS3009809 VS3009828 VS3009848 VS3010394 VS3010532 VS3010533 VS3005695 VS3005784 VS3005909 VS3006679 VS3007563 VS3008622 VS3009834 VS3010079 VS3010089 VS3010099 VS3010104 VS3010609 VS3010605 VS3010611 VS3010713 VS3010749 VS3010750 VS3010825 VS3011038 VS3011068 VS3011072 VS3007106 VS3009975 VS3010124 VS3010354 VS3007324 VS3007556 VS3008912 VS3010200 VS3010333 VS3010335 VS3010561 VS3010748 VS3011083 VS3005668 VS3005691 VS3007208 VS3008541 VS3008696 VS3010469 VS3010508 VS3010566 VS3010588 VS3010721 VS3003197 VS3005661 VS3008643 VS3008863 VS3008976 VS3009625 and VS3010733;

b) Serial Numbers: VS6500009 VS6500013 VS6500019 VS6500024 VS6500096 VS6500112 VS6500116 VS6500117 VS6500640 VS6500644 VS6500645 VS6500350 VS6500204 VS6500210 VS6500221 VS6500227 VS6500427 VS6500438 VS6500446 VS6500313 VS6500332 VS6500967 VS6500308 VS6500357 VS6500362 VS6500367 VS6500213 VS6500038 VS6500103 VS6500106 VS6500108 VS6500123 VS6500144 VS6500165 VS6500300 VS6500307 VS6500310 VS6500323 VS6500343 VS6500355 VS6500358 VS6500354 F21380F023872 F21380F023873 F21380F023874 F21380F023877 F21380F023878 F21380F023981 F21380F024067 VS6500183 VS6500043 VS6500100 VS6500145 VS6500435 VS6500451 VS6500455 VS6500457 VS6500466 VS6500467 VS6500471 VS6500483 VS6500503 VS6500508 VS6500510 VS6500512 VS6500519 VS6500528 VS6500533 VS6500541 VS6500548 VS6500037 VS6500092 VS6500111 VS6500122 VS6500129 VS6500447 VS6500535 VS6500522 VS6500551 VS6500074 F21380F023825 F21380F023836 F21380F023840 F21380F023844 F21380F023895 F21380F023896 F21380F023905 F21380F023906 F21380F023908 F21380F023912 F21380F023918 F21380F023923 F21380F023924 F21380F023927 F21380F023979 F21380F023987 F21380F024020 VS6500136 VS6500296 VS6500301 VS6500315 VS6500331 VS6500335 VS6500345 VS6500314 VS6500318 VS6500328 VS6500336 VS6500344 VS6500218 VS6500217 VS6500386 VS6500424 VS6500449 VS6500453 VS6500454 VS6500456 VS6500093 VS6500151 VS6500086 VS6500207 VS6500079 VS6500237 VS6500239 VS6500283 VS6500284 VS6500285 VS6500286 VS6500287 VS6500288 VS6500290 VS6500292 VS6500293 VS6500295 VS6500351 VS6500353 VS6500356 VS6500363 VS6500368 VS6500378 VS6500413 VS6500423 VS6500641 VS6500672 VS6500683 VS6500703 VS6500723 VS6500734 VS6500738 VS6500773 VS6500785 VS6500787 VS6500790 VS6500810 VS6500826 VS6500833 VS6500837 VS6500846 VS6500847 VS6500852 VS6500857 VS6500858 VS6500864 VS6500875 VS6500880 VS6500881 VS6500882 VS6500883 VS6500885 VS6500888 VS6500889 VS6500891 VS6500893 VS6500896 VS6500897 VS6500898 VS6500899 VS6500900 VS6500902 VS6500903 VS6500904 VS6500907 VS6500908 VS6500909 VS6500910 VS6500911 VS6500912 VS6500913 VS6500914 VS6500915 VS6500918 VS6500919 VS6500920 VS6500921 VS6500924 VS6500927 VS6500931 VS6500935 VS6500936 VS6500937 VS6500573 VS6500765 VS6500922 VS6500379 VS6500387 VS6500390 VS6500392 VS6500394 VS6500395 VS6500396 VS6500399 VS6500441 VS6500445 VS6500448 VS6500035 VS6500063 VS6500068 VS6500078 VS6500107 VS6500604 VS6500610 VS6500611 VS6500618 VS6500623 VS6500624 VS6500654 VS6500598 VS6500600 VS6500608 VS6500609 VS6500025 VS6500156 VS6500164 VS6500203 VS6500208 VS6500209 VS6500219 VS6500222 VS6500186 VS6500977 VS6500205 VS6500001 VS6500071 VS6500152 VS6500197 VS6500161 VS6500173 and VS6500184;

c) Serial Numbers: VSF5200298 VSF5200306 VSF5200312 VSF5200337 VSF5200398 VSF5200466 VSF5200628 VSF5200571 VSF5200608 VSF5200615 VSF5200329 VSF5200470 VSF5200474 VSF5200524 VSF5201550 VSF5201552 VSF5202104 VSF5202115 VSF5202826 VSF5202829 VSF5201193 VSF5201199 VSF5201202 VSF5201203 VSF5201204 VSF5202791 VSF5202793 VSF5200224 VSF5200292 VSF5200350 VSF5200351 VSF5203007 VSF5203118 VSF5203226 VSF5203704 VSF5203732 VSF5204192 VSF5204201 VSF5204209 VSF5204212 VSF5200297 VSF5200406 VSF5200340 VSF5200065 VSF5200067 VSF5200080 VSF5201108 VSF5204331 VSF5204335 VSF5204359 VSF5201082 VSF5201094 VSF5200089 VSF5200310 VSF5203769 VSF5203847 VSF5200326 VSF5201746 VSF5200303 VSF5200809 VSF5201557 VSF5200407 VSF5200551 VSF5200555 VSF5200567 VSF5200631 VSF5200638 VSF5200645 VSF5200793 VSF5200802 VSF5200824 VSF5200827 VSF5200846 VSF5203473 VSF5203622 VSF5203846 VSF5204323 VSF5203470 VSF5202787 VSF5203216 VSF5203227 VSF5203229 VSF5203232 VSF5203110 VSF5204060 VSF5204061 VSF5204068 VSF5204175 VSF5204154 VSF5200348 VSF5200359 VSF5200364 VSF5200400 VSF5200404 VSF5202388 VSF5203708 VSF5204156 VSF5203678 VSF5200357 VSF5200360 VSF5200374 VSF5200378 VSF5200388 VSF5200412 VSF5200476 VSF5200481 VSF5200508 VSF5200527 VSF5200531 VSF5200532 VSF5200533 VSF5204180 VSF5204262 VSF5204365 VSF5204367 VSF5204439 VSF5204444 VSF5204447 VSF5204451 VSF5204461 VSF5204465 VSF5204466 VSF5204467 VSF5204468 VSF5204512 VSF5204516 VSF5204517 VSF5204520 VSF5204529 VSF5201595 VSF5201710 VSF5201974 VSF5202819 VSF5202830 VSF5204437 VSF5204492 VSF5203161 VSF5203420 VSF5203810 VSF5203848 VSF5203174 VSF5203411 VSF5203677 VSF5203439 VSF5200096 VSF5200098 VSF5200100 VSF5200101 VSF5200102 VSF5200103 VSF5200104 VSF5200105 VSF5200106 VSF5200107 VSF5200108 VSF5200110 VSF5200111 VSF5200112 VSF5200114 VSF5200115 VSF5200116 VSF5200118 VSF5200119 VSF5200121 VSF5200122 VSF5200347 VSF5200855 VSF5201026 VSF5201163 VSF5201175 VSF5201505 VSF5201522 VSF5201523 VSF5201545 VSF5201547 VSF5201750 VSF5201758 VSF5202057 VSF5202116 VSF5202125 VSF5202395 VSF5203027 VSF5203426 VSF5203725 VSF5203772 VSF5203849 VSF5204063 VSF5204093 VSF5204128 VSF5204138 VSF5204141 VSF5204145 VSF5204194 VSF5204200 VSF5204307 VSF5204315 VSF5204452 VSF5204477 VSF5204482 VSF5204486 VSF5204489 VSF5204490 VSF5204519 VSF5200097 VSF5200259 VSF5200284 VSF5200377 VSF5200550 VSF5200862 VSF5200886 VSF5201002 VSF5201013 VSF5201024 VSF5201043 VSF5201044 VSF5201059 VSF5201062 VSF5201078 VSF5201153 VSF5201167 VSF5203855 VSF5204050 VSF5204178 VSF5204254 VSF5200113 VSF5200099 VSF5200109 VSF5200281 VSF5200386 VSF5200462 VSF5200480 VSF5200528 VSF5200573 VSF5200586 VSF5200831 VSF5200843 VSF5200844 VSF5200895 VSF5201011 VSF5201020 VSF5201050 VSF5201029 VSF5201063 VSF5201067 VSF5201138 VSF5201161 VSF5201168 VSF5201169 VSF5201178 VSF5201192 VSF5201158 VSF5201181 VSF5201182 VSF5201751 VSF5201997 VSF5202238 VSF5202252 VSF5202248 VSF5202255 VSF5203024 VSF5203025 VSF5203028 VSF5203179 VSF5203753 VSF5203858 VSF5204028 VSF5204179 VSF5204142 VSF5204150 VSF5204041 VSF5204252 VSF5204313 VSF5204326 VSF5203105 VSF5203422 VSF5201244 VSF5201569 VSF5202394 VSF5201240 VSF5201257 VSF5201504 VSF5202096 VSF5203047 VSF5203173 VSF5203233 VSF5203475 VSF5201510 VSF5202798 VSF5203006 VSF5203053 VSF5203183 VSF5203432 VSF5204158 VSF5204266 VSF5204357 VSF5204387 VSF5204392 VSF5204337 VSF5201260 VSF5201268 VSF5202055 VSF5203184 VSF5202124 VSF5202005 VSF5204364 VSF5204370 VSF5203987 VSF5204518 and VSF5200343
RECALLING FIRM/MANUFACTURER Respironics California Inc., Carlsbad, CA,
REASON This action is being taken to address power supply failures on the Esprit Ventilator which have occurred in some units. These failures, which were discovered through routine product monitoring, have been reported in countries that utilize an input voltage of greater than 200 volts AC. Some customers have reported a burning smell coming from the ventilator.
VOLUME OF PRODUCT IN COMMERCE 2,019 units
DISTRIBUTION Internationally

PRODUCT iReview" Software (Accessory To) iLab Ultrasound Imaging System, Model Number: H74900018010, Catalog Number: 1801; Product is manufactured and distributed by Boston Scientific Corporation, Fremont, CA The iReview" Software is provided on CD and is a computer application designed for reviewing cases recorded with firm's iLab "System, and for exporting stills or videos of those runs,
CODE Lot Number: 74791
RECALLING FIRM/MANUFACTURER Boston Scientific Corporation, Fremont, CA,
REASON The firm initiated a recall of a specific iReview" Software, Ver 1.0 Kit, which was released for distribution in a non-validated format.
VOLUME OF PRODUCT IN COMMERCE 10 kits
DISTRIBUTION FL, MI, CA, AZ, SC

PRODUCT Trauma Fixation Systems - The Slotted Mallet is an auxiliary optional instrument available with the Phoenix Tibia Nail System. If desired, it may be used to seat the nail into the medullary canal. The Phoenix Tibial Nail System is indicated for alignment, stabilization, fixation of fractures caused by trauma or disease and the fixation of long bones that have been surgically prepared for correction of deformity and arthrodesis. Catalog number: 14-442053-00,
CODE Lot numbers: 502398, 503684
RECALLING FIRM/MANUFACTURER EBI, L.P., Parsippany, NJ,
REASON Customer complaint received regarding the separation of the mallet handle during a medical procedure.
VOLUME OF PRODUCT IN COMMERCE 38 mallets
DISTRIBUTION Nationwide

PRODUCT
a) Biopsy Guide Starter Kits C5-2 used with the Philips HD3 Ultrasound System intended for diagnostic ultrasound imaging or fluid analysis of the human body. C5-2 Part No. 989605353731, 
b) Biopsy Guide Starter Kits C7-3 used with the Philips HD3 Ultrasound System intended for diagnostic ultrasound imaging or fluid analysis of the human body. The C7-3 kits were not serialized. Any kits that shipped after April 3, 2008 are not affected by this issue. 
c) Biopsy Guide Starter Kits L9-5, used with the Philips HD3 Ultrasound System intended for diagnostic ultrasound imaging or fluid analysis of the human body; Part No. 989605353761, 
CODE
a) Lot #'s: 6503, 6536, 6536, 6693, 6801, 6978, 7175, 7861, 7861, 7982, 7861, 8053, 8286 and 9155. SN # ranges: 123-152, 153-167, 178-187, 168-177, 188-197,
198-207, 208-222, 223-224, 233-247, 248-251, 225-232, 252-254, 255-264 and 265-269;
b) No batch or lot numbers available. The affected C7-3 kits were distributed between November 29, 2005 and April 3, 2008;
c) Lot #'s: 6446, 6546, 6546, 6627, 6627, 6627, 6987, 6987, 7154, 7366, 7850 and 7983. SN # ranges: 133-162, 304-318, 319-323, 163-167, 168-177, 178-187, 188-193, 194- 197, 198-212, 213-217, 218-249 and 250-264
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems, Andover, MA, Manufacturer: Medison Company, Gangwon-Do Nam-Myeon. 
REASON HD3 Biopsy Guide Kits do not contain adequate labeling instructions for safe and effective use.
VOLUME OF PRODUCT IN COMMERCE 173 units
DISTRIBUTION Nationwide and

PRODUCT
a) Physio-Control Internal Defibrillator Handles, 1) PN: 3010901-002 for use with LIFEPAK 12 and 20. 2) PN: 805249-014 thru 019 for use with LIFEPAK 9 and 9P,
b) Internal Defibrillation Electrodes: PN: 805355-10 thru 14 and 805355-020 thru -024,
CODE
a) 1) Lot Numbers: 0003, 0004, 0005, 0006, 0007, 0008, 0009, 0012, 0101, 0102, 0103, 0104, 0106, 0107, 0108, 0109, 0110, 0111, 0112, 0201, 0202, 0204, 0205, 0206, 0207, 0208, 0209, 0210, 0211, 0212, 0301, 0302, 0303, 0304, 0305, 0306, 0307, 0308, 0310, 0312, 0401, 0402, 0403, 0404, 0405, 0406, 0407, 0411, 0412, 0501, 0502, 0503, 0504, 0505, 0509, 0510, 0511, 0512, 0602, 0603, 0604, 0605, 0606, 0608, 0610, 0611, 0612, 0701, 0702, 0704, 0705, 0710, 0711, 9808, 9809, 9811, 9812, 9902, 9904, 9905, 9907, 9909, 9910, 9911, 9912;
2) Lot Numbers: 0002, 0003, 0004, 0006, 0007, 0008, 0009, 0011, 0101, 0102, 0103, 0104, 0105, 0110, 0112, 0201, 0202, 0203, 0205, 0206, 0208, 0209, 0211, 0304, 0305, 0306, 0307, 0308, 0401, 0402, 0404, 0405, 0412, 0502, 0503, 0506, 0507, 0509, 0603, 0604, 9508, 9509, 9608, 9609, 9610, 9702, 9706, 9708, 9709, 9807, 9809, 9811, 9812, 9902, 9906, 9907, 9908, 9909, 9912;

b) Lot Numbers: 0001, 0060, 0080, 0090, 0100, 0102, 0104, 0106, 0107, 0123, 0197, 0200, 0203, 0204, 0205, 0206, 0207, 0300, 0301, 0304, 0305, 0306, 0307, 0398, 0399, 0404, 0405, 0407, 0499, 0500, 0501, 0502, 0503, 0504, 0505, 0507, 0600, 0601, 0604, 0605, 0606, 0607, 0698, 0700, 0703, 0704, 0705, 0706, 0707, 0800, 0802, 0803, 0804, 0805, 0806, 0807, 0895, 0899, 0900, 0901, 0903, 0904, 0905, 0906, 0907, 1000, 1001, 1002, 1004, 1005, 1006, 1007, 1023, 1097, 1099, 1101, 1103, 1104, 1105, 1106, 1107, 1201, 1202, 1204, 1205, 1206, 1207, 1298, 1300, 1302, 1304, 1305, 1306, 1307, 1398, 1400, 1402, 1403, 1404, 1405, 1406, 1407, 1498, 1499, 1501, 1502, 1505, 1506, 1601, 1602, 1603, 1604, 1605, 1606, 1607, 1700, 1701, 1702, 1703, 1704, 1705, 1706, 1707, 1797, 1799, 1801, 1802, 1804, 1805, 1806, 1807, 1898, 1899, 1903, 1905, 1906, 1907, 1999, 2000, 2001, 2002, 2003, 2004, 2005, 2006, 2101, 2103, 2104, 2105, 2106, 2107, 2202, 2203, 2205, 2206, 2207, 2298, 2299, 2300, 2301, 2302, 2304, 2305, 2306, 2399, 2402, 2403, 2405, 2406, 2407, 2499, 2500, 2501, 2502, 2503, 2505, 2506, 2507, 2599, 2600, 2601, 2602, 2603, 2605, 2606, 2607, 2698, 2699, 2702, 2800, 2802, 2806, 2807, 2899, 2900, 2901, 2903, 2904, 2905, 2906, 2907, 2999, 3000, 3001, 3002, 3005, 3006, 3007, 3098, 3099, 3100, 3101, 3102, 3104, 3105, 3106, 3107, 3197, 3198, 3203, 3204, 3205, 3206, 03294, 3299, 3302, 3303, 3305, 3306, 3398, 3399, 3400, 3401, 3403, 3404, 3405, 3406, 3407, 3498, 3499, 3500, 3501, 3503, 3505, 3507, 3597, 3599, 3602, 3603, 3605, 3606, 3607, 3697, 3698, 3699, 3700, 3701, 3702, 3705, 3706, 3707, 3798, 3799, 3805, 3806, 3807, 3899, 3900, 3901, 3905, 3906, 3907, 3998, 4000, 4003, 4005, 4006, 4007, 4099, 4100, 4101, 4102, 4103, 4105, 4106, 4107, 4197, 4199, 4200, 4201, 4203, 4204, 4206, 4207, 4298, 4299, 4300, 4302, 4304, 4305, 4306, 4307, 4399, 4401, 4405, 4406, 4498, 4499, 4500, 4502, 4503, 4506, 4507, 4600, 4601, 4603, 4605, 4606, 4607, 4699, 4701, 4702, 4704, 4705, 4706, 4797, 4799, 4803, 4805, 4806, 4900, 4904, 4906, 4907, 4998, 5000, 5001, 5002, 5003, 5005, 5006, 5103, 5105, 5106, 5199, 5200, 5203, 5204, 5205, 5206, 5299, 5301
RECALLING FIRM/MANUFACTURER Physio Control, Inc., Redmond, WS,
REASON Based on testing, sterilization methods described in labeling may be ineffective and may cause damage or corrosion to the paddles or handles. If handles and/or paddles are not sterilized adequately and are used on a patient, there is a risk of infection. If handle discharge button is damaged during sterilization, defibrillation therapy may be prevented.
VOLUME OF PRODUCT IN COMMERCE 47,274 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Advantx-E is an angiographic X-Ray system, 
b) Innova 2100IQ is a Digital Fluoroscopic Imaging System that consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector, 
c) Innova 3100/3100IQ is a cardiovascular Imaging System. The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector,
d) Innova 4100/4100IQ is a X-Ray system that consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector, 
e) Innova 2000's principle system components include a C-arm, image acquisition, processing and archiving capabilities, 
f) Innova 2121-1Q/3131-1Q is a Biplane Cardiovascular Imaging System. The Innova Biplane systems are the first and only digital flat panel biplane system with a full sized lateral plane to cover lateral anatomy without requiring multiple contrast injections and radiation exposures,
CODE
a) 206598LCBI 215955LCLP 304843LCA 309655FSP4 312942EP1 318377MC1XX 405840SOIC 409772VAS5 505887CL1 507225CC101 516663EP2 574294LCA 602532LCA 609653LCA 609757CCL5 609757EP1 609757LCEP 610988EP 615443LCA 650369SV2 702731LCPLUS 706774UEP1 714670LCA 717544EP8 717763EP1 717782EP1 757398EP 760241LCV 772468LCA 773564LCA 781769NCL 818884LCA 864560SPLCA 936266LCA 954MWLCA 956994BICATH BPANGIO ECXV1407CLCV ECXV1407ELCV ECXV1407ILC OLC-ADVE VASCSOUTH 309655FSP2A 501978LAB2 918307CDLC 810326LCA 918307SHLC1 410614CV6 314525ACL1A 904739EP 843797LCA2 603669ELCV 703689LCA2 301896ANGIO2 361788LCPLUS 915670LCA 612273LCLP 617636EP BPEP 770844NFLCA 281420LAB2 918744JB5 215750LCLP 410543CATH3 904202EPA 504785LCA 303839CL4 856342LCLP 717544EP7 213977LCLP1 314768SMOL1 215823LCLP BG4549VA01 4406 2584562 1165109 082406030007T 82406030011 82406040023 82406040024 82406050008 82406050009 82406060002 82406070009 82406070011 82406090011 82406090012 82406090014 82406090015 82406090017 82406090021 82406100012 82406100013 82406100015 82406100017 82406110001 82406110003 82406120015 82406130015 82406130016 82406130017 82406140018 82406160036 82406160037 82406160038 82406160041 82406180003 82406190009 82406190011 82406190012 82406190013 82406200003 82406230009 82406230011 82406230012 82406270006 82406290001 82406300001 82406310002 82406532603 082406ATCLCV1 82406030012 82406120017 82406100014 82406020003 82406100016 82406140019 82406310004 82406090018 82406090020 82406090016 82406090019 82406040026 82406140021 82406010012 82406130018 82406060003 82406270007 519663LCP 519685LCNP 416369LCLP 514398BIPLAN CS1118VA02 UC1923XR23 EG1235VA01 EG1703VA01 FP721A02 DPN85900 YE162A29 NE185034 YE645824 YP158312 A1105902 A4160425 A9793301 M2002604 M2528706 M4212427 X2881402 A1064503 A1105901 M1076843 B1607012 M4488827 A9793306 00440VAS01 GE1006VA01 GP1046VA01 2546301ADLCV 835060023 8.30066E+13 8.3016E+12 8.30166E+12 8.30166E+13 8.30168E+13  8.30166E+13 8.3006E+13 A5375115 A5719806 A5114287 A5267808 A5687002 B5381808 A5719814 A5129811 A5332104 C5821416 YX1512 YX1513 YX1525 YX1675 YX1678 YX1681 YX1700 YX1516 YX1530 YX2222 KW1001VA02 KA1048VA01 LB1018VA01 LB1188VA01 MA1274VA01 MA1361VA01 MA1276VA01 MA1272VA01 MA1205VA01 MA1288VA01 MA1312VA01 MA1174VA01 MT1014VA01 2504649LC+ 33XVLCN544793 6622LCDLX 9926LCPLUS NG1018VA01 RTD1205 RO4165VA01 RU1047VA01 RU1086VA03 RU1175VA01 RU1379VA01 RU2076VA01 RU2400VA01 RU2580VA01 RU1205VA01 SY2035VA01 SY2026RX01 06092VAS01 34004VAS01 34107VAS01 65005VAS01 78001VAS01 01002VAS02 853060178 853060181 853060182 853060183 853060184 853060185 853060186 853060190 853060180 853060188 853060189 853060192 5982LCV 388555220VASMET YU4060VA01;

b) 2100 Q _ 505848CATH1 505848EP 318448INNOVA3 305682IN2 4105502100 410554INNOVA2 208367INNOVA 2035762100 214947MINNOVA 214947MINNOVA2 303839CL2 252384CATH1 303788CL1 4436432100 8184092100 219932DCL2 305364P2100 713794LAB1 727869CATH3 727869CCL2 727869EP5 208227CATH1 8157412100 816861KCVAI2 308865GIN1 865693CCL 865693CCL2 516562INNOVA6 516562INNOVA7 865977CCL 217383CCL2A 541732CV2 251435ICV3 239436CATH4 732776CATH4 212305CATH1 65049321 304424INNOVA 215453INNOVA21 229228INNOV21C RPINNOVA2100 303425CL3 317355INNOVA3 330363LAB3 330375LAB2 336538ARCL1 360456XCL4 405604D2100 408559INV1 410554INNOVA1 414291CL2 414649INNOVA2 417269SCLA 417347FCV4 501257VALAB1 508856IN21 516562INNOVA2A 518243LAB2 561548ET2 570476INNOVA21 573761SMC2 573815BCR2 573815BCR3 573815BCR4 574535IN21 602239CLAB2 607737CL1 610250INNOVA1 610250INNOVA3 612273INNOVA2 615284CV3 615342CV3 615446CV1 617636CL1 630856H2100 650369SV4 651582IN3 661327INNOVA1 661327INNOVA2 713375U2100 717217INN21 717544GECATH2 717544GECATH3 718470EP 727942CATH2 732324INN1 732923INN 770HMCCL1 781340IN1 781340IN3 785354HRTEP 803256PCL5 808547QCV1A 808547QCV3A 812238UN21 813615CL1 813615CL8 813615CL9 813615EP3 814452EP 815759CARDIAC1 817329BG2100 843724CL1 843724CL2 843724CL3 843724EP1 845368LAB1 845368LAB2 856853IN2100 858554INNOVA2 864255SFCL1 904597CATH 910343EP1 910671INOV21 916781INNOVA2 937208INNOVA2 954735CL2 954987CCL7 954987CCL8 973579LAB1 985898INNOVAA 985898INNOVAB CM2100 ECXV1406F FHOMEP 508335INNOVA 828213IN21 901765EP 262255INNOVA2 410337INNOVA6 573256MHC 804764CATH2 845365V13 847316INNOVA1 847316INNOVA2 910162009 910162010 910162011 910162012 910163011 910163014 010120RX44 82416100014 82416150002 82416100011 82416130026 82416010007 82416030005 82416040011 82416040012 82416040014 82416050003 82416060001 82416100009 82416100012 82416100017 82416120008 82416130016 82416130019 82416130023 82416130024 82416160007 82416180003 82416200004 82416210007 82416220010 82416120009 82416030004 82416100007 604875AINNOVA1 416480INNOVA 604682INNOVA1 604682INNOVA2 604875AINNOVA2 26814ANGI2 2664023INNOVA 2641225INNOVA CS1118VA03 HC4348XR02 PC0052XR07 PC0052XR08 507902XR01 HC0222XR35 HC4355XR06 HC4480XR05 HC1995XR03 DK1066VA02 DZ1006VA01 FEB52055 ME612436 CEE15663 C99999164 FI1017VA02 FI1017VA03 A4166952 B1650215 B5483438 M1334109 M2068110 M2569315 M2844529 M4176519 M4183841 M4200108 M4211066 M4496941 M4198195 M181374801 00060VAS02 00159VAS04 00192VAS04 00192VAS05 00234VAS01 00282VAS02 00371VAS01 00440VAS02 00440VAS03 00463VAS06 00888VAS02 01065VAS01 05208VAS02 05217VAS02 10507VAS01 H2077VAS27 H17654VAS8 828160007 600010VA01 HU1094VA01 HU1116VA01 HU1205VA01 HU1231VA10 835160017 835160018 IE1100VA02 IE1077VA01 IE1053VA01 8.3016E+12 8.3016E+13 8.30161E+13 8.30162E+13 8.30163E+13 8.30166E+13 8.30168E+13 8.30169E+13 8.30168E+13 IQ1126VA01 A5333036 A5333037 A147111802 A5125125 A5131858 A5155141 A5164510 A5219606 A5220710 A5286803 A5400910 A5605743 A5624112 A5800506 A5807919 A58080104 B5120723 C5123625 C5123626 C5323515 B5603933 A5111034 YV0054 YV0057 YV0058 YV0059 YV0060 YV0061 YV0062 YV0063 YV0064 YV0065 YV0066 YV0067 YV0068 YV0069 YV0070 YV0071 YV0072 YV0073 YV0074 YV0077 YV0080 YV0055 YV0056 850060723 KW1018VA01 KW1018VA02 KW1018VA03 LV4000VA02 LV4000VA03 LV4001VA02 MA1004VA02 644INNOVA21 83INNOVA2588441 NO1009VA03 NO1064VA03 920169006 600151VA01 600042VA03 PL1677VA01 787844INNOVACL1 787844INNOVACL2 787844INNOVACL3 PER00218 RO1108XR01 SA1011VA01 SA1054VA02 A004RX01 A020RX13 847160003 SY1001VA02 SY2005VA01 06052VAS01 20001VAS02 34009VAS06 34134VAS02 35049VAS01 58010VAS01 80002VAS01 35021VAS02 853060191;

c) 215576INNOVA1 760242CATH1 281420LAB23100 541382CV3 205783BCL5 2035763100 843797TCL2 361980INNOVA2 214590PH3100 303629CL4 303629EP 3027443100 303788CL2 239939CLA 8184093100 919731WMINOV 305364P3100 281440CL3 208227CATH2 7028533100 865693CCL1 6619483100 219326IN31 7022333100 209334LINNOVA1 502587LAB1 219877IN31 9734293100 215335INNOVA1 239436CATH3 239513CRLAB1 812858GWLAB1 812858GWLAB2 8014793100 270688INN 65049331 8508573100 850469BCV1 207662CL4 207879CL131 541677MINNOVA1 5033703100 253968INNOVA 412437INNOVA 303425CL4 2595303 228818VASC 316651INNOVA31 316962WCVC1 316962WCVC2 325428CATH1 336832MCPV 360456XCL3 361857CATH1 405272SCL2 405604D3100 405840OIC3100 406447VAIN3 406543IN3 413582C3100 414447CL1 414647CL1 414649CL3 414649CL4 414805INNOVA1 415925INV1 423495MCL6 423844CCL1 478274CTH1 502852INNOVA 510797INV8 512901NI3100 516562INNOVA8 516562INNOVA9 530244XC106 561548CL4 570476INNOVA31 573458CL1 573632CRC2 6012883100CV2 603421PCL 610595CL1 610770INNOVA31 610983INNOVA1 616392INNOVA 617732IN9 618241GSI3100 631968INNOVA2 631968INNOVA3 671GMHAINVA 708WESTSUB3100 713359INC 713948INA 717782INNOVA31A 718245UNITY 718470INNOVA2 718780CATH2 732776CATH6 770991CL1 772LWCL1 775982CATH2 781340IN2 803255CL1 804285CATH1 814676C1 815344CARDIAC3 816478MC1 816861KCVAI1 816943STJIC1 816985NKCI 847362CONCATH4 856596IN3100 864255SFCL3 901516R3 903UT3100 904276CTH1 909464IN3 909825VAINNOVA 910343NHIN4 913345MI1 940626DCH3100 954987CCL9 956698INN31 970350CL1 970945CL1 973877LAB4 ECXV1406B FHORLCL7 480728LAB2 865481CCL2 8157413100 251633PROV 907562CATH1 201996LAB1 207351YCL1 281420LAB1 412623LAB2 480821IN2 508856IN2 541MWHINNOVA 573882UMC1 610447CL1 610891CL1 617789IN1 706774CCL4 706774CCL5 713776M3100 717782INNOVA31 803256PCL1 812450CATH1 815226INN2 918494IN31A 952993INNOVA5 BPINNOVA1 845365V19 918333JPIN1 909788INNOVA1 516663INNOVA2 312STMNAZ3100 518525LAB1 540953INNOVA 717217INN31 573815BCR1 313593IC2 561266IN31 812450EP1 808547QCV2A 765453INNOVA1 413447CATH 770991CL3 417269SCLD 619340VA8 928779INNOVA1 713794LAB9 313593IC1 713794LAB7 956389INN31 316268INNOVAA 732294INOV 318448INNOVA2 318449INNOVA2 602239LAB4 7028803100A 310423INNOVA1 602239LAB6 812482INNOVA 702616INNOVA 724773C1 502587LAB4 973971LAB3 4103323100 214324INNOVA2 619482INNOVA1 BPINNOVA2 602266LAB2 956994INN1 773792CL3100 314768SMCL3 812238LIB1 812283IN31 FHORLCL1 409899LAB3 936266CL1 8613100 563421CATHLAB8 309691P3100 956994INN2 817433HSW3100 803329CL31 413540IN1 601553CL3 608524NOVA 850678IN3100 714966INNOVA 7083333100 619541INNOVA31 904202CATH3 615769SKYCV2 201541LAB2 615338CV2 718283INNOVA3 773NORWG3100 5034353100 4103623100 8019643100 7278253100 505662NOVA 378INV31 AH4300XR03 910064009 910163012 910163013 910163015 910064007 910064008 910162006 910162008 910163006 910163007 910163009 BA4080VA01 140024RX09 2573329 BE5003VA02 82416040018 82416290001 82416140003 82416130018 82416080001 82416010006 82416020004 82416030006 82416040015 82416040019 82416100013 82416110003 82416120010 82416140002 82416150001 82416160008 82416160009 82416190004 82416190001 82416190002 82416190003 82416210006 82416210008 82416220008 82416270002 82416300001 82416310003 82416310006 82416170002 82416030003 82416100006 82416100010 82416120007 82416130015 82416160006 82416210003 82416210004 82416220009 82416130017 82416040016 82416070004 82416070003 82416040010 82416100008 82416120006 82416120005 82416050002 82416040017 2625365INNOVA 2645993INNOVA CS1006VA03 HC4348XR01 HC1536XR04 DK1066VA01 FPG86403 FPG93008 DPM32143 DPN88402 FI1064VA01 M2030709 M4163030 M4166988 M5480755 M6083613 M2848425 M2970614 M4016034 M40480151 A9190149 M40480167 GE1005VA01 GE1004VA01 H1420VAS04 24516572980IN HU1099VA04 IQ1083VA01 IR1747VA01 A5127281 A5112597 A5162256 A5333035 A5812244 B5274834 B5332001 B5810907 A5125119 A5108239 A5203215 JO1000VA01 YV0048 YV0033 YV0034 YV0035 YV0038 YV0039 YV0040 YV0042 YV0043 YV0044 YV0045 YV0046 YV0047 YV0023 YV0024 YV0025 YV0027 YV0028 YV0029 YV0030 YV0031 YV0032 YV0037 YV0036 YV0026 YV0022 850060719 850060724 850060726 850060727 850060728 LB1160XR07 LV4012VA01 52XVINN2565367 477XVIN2553211 834160003 NO1005VA05 920169007 2048000INNOVA PL1082VA01 PL1622VA01 600050VA02 PL1681VA01 PL1688VA01 600098VA01 RU1482VA02 RU1142VA01 RU2581VA01 RU2457VA01 RU1550VA01 RU1156VA01 RU1449VA01 RU1457VA01 RU3092VA01 RU1692VA01 RU2741VA01 RU1001VA02 600130VA01 SA1010VA02 TN1016VA01 01012VAS01 41018VAS01 58002VAS01 60001VAS01 06074VAS01 853060194 388567772VASMET 3882569347VAMET;

d) 3184734100 706774USP3 6309784100 6616324100 304256INNOVA 2035764100 352596SPEC 5135844100 719560INN41 303320OR41 303436ANGIO 3027444100 574294IN41 239939INNOVA 864255SF4100 3016094100 414649CL2 812858GWSP 212639ACT1 8014794100 4134474100 5033704100 509474SH41 201541SP1 281401T4100 918744JR4100 22925941V2 SHOWCASE4100 317887INNOVAPV 330489SPEC9 352333INVOR 386254HS1 386254HS2 386HPOS1 404GHSIR1 412647OR10 414649DVI 419696LAB1 505848V4100 508650IN41 509482HFI 512901NI4100 530888ANG206 541686SPR1 570321LAB2 610988INNOVA4 617636IN1 619229INNOVA1 623848SP 630275G41 630275G41B 650493ANGIOCT 662244GTSP 678EJCIR1 706291RINN2 706651SP1 706733SP1 708783SP4100 713375U4100 718630LIBERTY 727791INNOVA 770535N4100 803256SP 804594ANGIO 812238UN41 812825INNOVA1 813615CL10 817465AR4100 817922BA4100 843577CL2 845368RM10 850747IN4100 863687INV24 864573LAB2 865373SP 865481SUR 908522SP1 915577SP1 918682IN41 954MW4100 COR359867 DR4100 PEMBROKE4100 RADNETXV1 RHD4100 423495M4100E 423493I4100 8593134100 708WESTSUB4100 80140841 80180741 2194654100 4082594100 4105434100 4137484100 5094744100 5417684100 5703214100 5705224100 6082634100 7028804100 219326IN41 229228INNOV41C 22925941V 252816INNOVA 269226IN1 269226IN2 269983IN41 303839CL1 308534ANG 313876SP41 316651INNOVA41 317338PV3 360754INNOVA 401274IN41 412623LAB1 412623LAB3 414328INN4100 419251LAB1 508383IN4100 603650ANG1 608263ACT 608263XMR 617726RF2Y6 626359INNOVA 706291RINN 718206LIBERTY1 760633IR1 773878SWGANGIO1 801268INNOVA 804285CATH2 804764CATH3 810342A41 813558INTV 816943SP1 817433HSW4100 828298VASC 847842GS4100 856365ANGIO 903GS4100 904202SP1 904BSSP 952993INNOVA2 972335LIB 972566INNOVA3 985867INNOVA2 MIRAMAR41 WCATHLAB41 334286BSP 706278INNOVA1 561747IN4 252847PRS2 918744JC4100 850494WSP1 252816INNOVA 804594CATH 574535IN41 813745INTV 813972INTV 229228INNOV41V 508856OR41 717763INNOVA41 865541CCL5 SLIN4100 717763OR4100 239436CATH1 609652CATH3 80158241 216844INNOVA 77573841 727819SPSC ECXVINNOVARST3 404GHSIR2 989466INNOVA 404616INNOVA 352333VASC 812279INNOVA1 901726SP2 817255NH4100 828696IN41 304347INNOVA 918307SHIN4 724656ANG 757736INNOVA 315448RM4 941483INNOVA41 515263IL4100 4103374100 5138534100 8595724100 352401CATH 6029234100 5134754100 816276SP1 903CSM4100 319338VA4100 715369INN4100 407518SP3 956632INN4100 407518SP2 414961INN4100 904276SP 614293LIBERTY1 325670CATH 251435ICV5 315448RM5 573761SMA 3018774100 865693CCL3 614293LIBERTY2 229434INNOV 757398INNOVA 574647IN41 205759CL2 304255INNOVA 352401VASC 407SPECIALS 6012884100SP1 4438494100 740592INNOVA 804320CATH2B 478633INOV 8159374100 910063039 190020RX09 BG4037XR01 BE5005VA01 82406070010 82406310005 82416100016 82416130020 82416130021 82416130025 82416220006 82406120016 82416130010 82416130011 82416130013 82416160005 82406010011 82416130012 514842AINNOVA 613548INNOVA3 4163694100 250370INNOVA 306766INNOVA 416756INNOVA 519685INNOVA CS1054VA01 HC0220XR07 487692XR01 FI1015VA02 FI1015VA01 M1230007 00490VAS02 01278VAS01 10091VAS01 00137VAS01 00171VAS01 HU1039VA02 IE1100VA01 IL1043VA01 8.30062E+13 A5102671 A5163317 A5605732 C5603903 B5801711 XF0150 XF0151 XF0152 XF0153 XF0154 XF0155 XF0200 YV0007 XF0022 XF0149 YV0004 YV0003 YV0005 850060718 850060720 850060721 850060722 850060725 850060707 0850BOSNIA1 KW1001VA03 KW1018VA04 KW1013VA01 LB1037VA01 MA1020VA01 BRD0411 NO1015VA04 600042VA02 600050VA01 787620IN4100 787653INNOVA 600152VA01 RU1018VA03 RU1106VA02 SA1005VA06 SA1188VA03 06004VAS02 853060187;

e)  2000- ECXV1406C 812450CATH2 256880IN1 508856IN4 615316INOV2 610988INNOVA1 310540INNOVA 210297NECATH1 314966DCL2A 213977INNOVA1 650696INV1 865541CCL2 415206CATH 609653INNOVA 732776CATH5 985867INNOVA1 615327CV2 FHORLCL6 315448RM3 573472CATH 315448RM1 315448RM2 865541CCL1 318448INNOVA 636916SPCL1 410543CATH6 606439INNOVA 801373EP 423495CHIRM1 316268INNOVAEP 973971LAB1 440835INNOVA 801373CATH1 718780CATH1 801373CATH2 AL9INNOVAVAN 865481CCL1 518525LAB2 708425INNOVA1 408259INV 610270INNOVA 207795CL2 619260INNOVA 516663INNOVA1 860210CV 610954INNOVA2 717270INNOVA1 803329CL20 920288CATH2 865693CCL5 702731INNOVA2 601553CL2 831624INV1 936266CL2 775982CATH3 832355SMIN 713897CIN 636947JCL3 861EP2 717544CATH4 407518OPCL 330375LAB1 801429INNOVA 701234GE2 701234GE3 610988INNOVA3 918494IN2A 920015947 219947EP 336832MCCL1 DR2000 ECXV1401A 773878WCL 217258CATH MCTHSC2 717763INNOVA2 713776MINNOVA 508798INC2 626915INNOVA 920288CATH1 615222STCL3 540932INNOVA 541282CV1 361788NOVA 727825CATH 262243INNOVA1 352344CATH1 414291CL3 FHVIN2000 817255NH2000 410614CV7 719560HCL2 603668CLCB 352INVCATH 512341RI 219465CL1 612467INNOVA1 602239LAB1 918307SHIN1 619739INNOVA 918307SHIN2 805497INNOVA1 513559INNOVA 414219INNOVA 707546INNOVA 940384INNOVA2 573632CRC1 904202CATH1 206598INNOVA1 972540INN 972335INN 405272SCL4 615284CV2 312792RINOV2 480512IN1 423844CCL2 516562INNOVA5 309691HCL1 502587LAB3 229259INOV2 718226INNOVA1 904202CATH2 219465EP 619457INNOVA3 843692INNO 843674INNOVA 401274IN3 419227CL3 619691INNOVA 940764INOV1 940764INOV3 563421CATHLAB7 513861INNOVA 614293INNOVA3 561798CL1 208381INNOVA 212746J412 816932HRT2 803256PEP1 940764INOV2 623848LAB1 415750SCL2 WCATHLAB2000 KMCINNOVA 817922INNOVA 205783BCL4 330837INNOVA 570969CATH 615327CV1 727521CATH3 773STJINNOVA200 619340VA7 601268INNOVA1 512447SI2 256386IN1 407321INCL1 773878SWGCATH1 615222STCL5 503215INNOVA 281351TINNOVA 920926CATH1 903798WINN 209526ICATH1 805497INNOVA2 717270INNOVA2 717544CATH1 215728INNOVA 773878SWGCATH2 732776CATH1 573761SMC1 760633INNOVA 239436CATH2 973971EP2 412647LABA 859233INNOVA2 610988INNOVA2 412647LABB 812283IN20 908668INNOVA 724773C2 718918CATH1 443849INNOVA 610447CL2 708202VA2K 856342INNOVA 952993INNOVA4 952993INNOVA3 859233INNOVA1 814534C1 719776EP1 281893INNOVA 502587LAB5 317621EP2 478765CTH2 718963INNOVA1 718226INNOVA2 708597EP 478765CTH1 910162005 910163008 0910162004A 910163010 910163004 1157760 BE5006VA01 82416100005 82416120002 82416130009 82416220005 82416220004 82416220007 82406140020 82416210002 82416040008 82416030002 82416010004 82416160004 82416040013 82416210005 82416200006 82416040007 82416120003 82416120004 82416050001 82416310005 82416310004 613548INNOVA2 905895INNOVA1 514843AINNOVA 819563CINNOVA2 514376CARDIO 604682INNOVA 905895INNOVA2 905895INNOVA3 266150XR14 2575962INNOVA HC1536XR02 HC5533XR08 HC1627XR20 HC5546XR09 UC3287XR05 HC3285XR06 HC3121XR01 DZ1027VA01 EG1003VA01 EG1524VA01 ME256638 DE203229 FE421134 FEE08424 FEE12418 M2030707 E4167627 M4163751 M2147243 M2569312 M2002611 A9793302 X100378801 M2208714 S4160056 X76305701 B4498640 B4498642 M4046541 M4159626 M1327506 01224VAS02 00577VAS04 00159VAS03 00577VAS03 10238VAS01 00391VAS01 10044VAS01 00463VAS05 01245VAS01 10100VAS05 00162VAS03 10100VAS04 01224VAS03 00171VAS02 00285VAS03 00285VAS02 00490VAS01 00327VAS01 00506VAS01 10086VAS03 00424VAS01 00285VAS01 10501VAS01 00529VAS01 H2015VAS15 H2009VAS17 828060057 HU1044VA01 835160015 835160019 IE1018VA02 IE1029VA01 IE1031VA04 IE1006VA01 IL1098XR02 8.30168E+13 8.30162E+13 8.3016E+13 8.30162E+13 8.30168E+13 8.30161E+13 8.30168E+13 8.30162E+13 8.30168E+13 8.30166E+13 8.30162E+13 8.30168E+13 8.30166E+13 8.30168E+13 8.30166E+13 8.3016E+13 8.30168E+13 IR1632VA03 IR1667VA01 A5113511 A5189713 A5807006 A5203209 A5108714 A51152101 A5130609 A5108235 A5129951 A5129954 A5359404 A5129022 C5343110 A5129953 B5418905 A5730901 YX1487 YX1486 YX1492 YXZ471 YX1493 YX1494 YX1491 850060711 850060715 850060709 850060708 850060710 850060712 850060713 850060714 850060717 LB1050VA02 LWD0302 NO1064VA01 PK1251VA01 PL1101VA02 PL1008VA01 PL1529VA01 809840INNOVA 809852INNOVA RU1070VA01 600107VA01 RU1016VA01 RU1463VA01 RU1717VA01 RU2167VA01 SA1054VA01 SA2045VA01 SY1007VA01 SY2011VA01 856160001 856160003 856160004 856160005 TN1194VA01 TN1012VA01 TN1059VA01 07010VAS01 06070VAS01 16016VAS01 853060179 388558268VASAND 388256938VASMET 3882591464VAMET;

f) ECXV1402B 4146492121 COR373252 N4192939
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Waukesha, WI, 
Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. 
REASON Risk of sudden table drop.
VOLUME OF PRODUCT IN COMMERCE 1,684 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Bausch & Lomb Millennium Phacoemulsification Needles, Needle Tapered Hub 15 Degree, REF DP8115, 6 needles per pouch, nonsterile,
b) Bausch & Lomb Millenium Phacoemulsification Needles, Needle Tapered Hub 30 Degree, REF DP8130, 6 needles per pouch, nonsterile,
c) Bausch & Lomb Millenium Phacoemulsification Needles, Needle Tapered Hub 45 Degree, REF DP8145, 6 needles per pouch, nonsterile,
d) Bausch & Lomb Millenium Phacoemulsification Needles, Needle Thin Tip 15 Degree, REF DP8415, 6 needles per pouch, nonsterile, 
e) Bausch & Lomb Millenium Phacoemulsification Needles, Needle Thin Tip 30 Degree, REF DP8430, 6 needles per pouch, nonsterile, 
f) Bausch & Lomb Millenium Phacoemulsification Needles, Needle Thin Tip Angled 30 Degree, REF DP8430A, 6 needles per pouch, nonsterile,
g) Bausch & Lomb Millenium Phacoemulsification Needles, Needle Microflow 2.2 30 Degree, REF DP8730, 6 needles per pouch, nonsterile, 
h) Bausch & Lomb Millenium Phacoemulsification Needles, Needle Frag 15 Degree, REF MVS 1600A, 6 needles per pouch, nonsterile, 
i) Bausch & Lomb Millenium Phacoemulsification Needles, Needle Frag 60 Degree, REF MVS1601A, 6 needles per pouch, nonsterile, 8;
CODE
a) Lot number 3168901;
b) Lot numbers 3168943, 3169532, 3169835, 3170331, 3170923, 3171342, 3171562, 3171566, 3172013, 3172110, 3172318, 3172319;
c) Lot numbers 3169597, 3170626, 3171091, 3171345, 3171567, 3171819, 3172014, 3172111, 3172320, 3172619;
d) Lot numbers 3168902, 3171340, 3172112, 3172321, 3172885;
e) Lot numbers 3169293, 3169294, 3170628, 3171200, 3171343, 3171344, 3171560, 3171561, 3171817, 3172015, 3172113, 3172114, 3172322, 3172527, 3172529;
f) Lot numbers 3169954, 3169955, 3169977, 3171339, 3171565, 3171820, 3172323, 3172525, 3172886;
g) Lot numbers 3167767, 3169291, 3170562, 3171088, 3171199, 3171346, 3171564;
h) Lot number 3171341;
i) Lot number 3168937
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bausch & Lomb, Inc., Rochester, NY,
Manufacturer: Accellent, Inc., Orchard Park, NY. 
REASON The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and non-reusable.
VOLUME OF PRODUCT IN COMMERCE 4,055/6-needle packages
DISTRIBUTION Nationwide and Internationally

PRODUCT
EasyVision RAD - Radiological Image Processor, software versions: SW R4 2V2L2, SW R4 2V2L3, SW R4 2V2L4, SW R4 2V2L5, SW R4 2V2L6, and SW R4 2V2L7. The EasyVision RAD consists of a computer with digital interfaces, one or two (optional) monitors with keyboard and mouse, and software. The viewing, analysis, processing and printing functions are sent to the EasyVision by means of PMSNet (Philips Medical Systems communication protocol). The main image source for the PCR (Philips Computed Radiography) system is the CR-Reader. Remote database access and image transfer functions are implemented using the DICOM Query/Retrieve and Storage services. The EasyVision RAD provides the following features: receives images sent to it by remote applications (e.g. workstations or imaging modalities) and stores them in a local database; allows the operator to copy images from the local database to remote databases and vice versa; allows a remote system to query the EasyVision local database and to retrieve images from it; allows the operator to view, analyze, process and print the images stored in the local database. Operator may print images stored in the database on a DICOM printer, and is able to read and write DICOM CD-R disks. The device allows processing of and access to the stored raw data so that an image can be post-processed using different image processing algorithms. Part numbers and cooresponding software version in: 9896 050 03232 (SW R4 2V2L2), 9896 050 03233 (SW R4 2V2L3), 9896 050 03234 (SW R4 2V2L4), 9896 050 03235 (SW R4 2V2L5), 9896 050 03236 (SW R4 2V2L5, not delivered to the US), 9896 050 03237 (W R4 2V2L6), and 9896 050 03238 (W R4 2V2L7).,
CODE
Site ID: 540176, 540154, 534389, 534391, 521504, 521505, 521506, 521670, 521672, 521673, 521376, 534390, 521328, 521375, 521379, 104351, 104354, 104355, 104356, 104357, 521374, 521381, 534392, 534395, 104353, 534830, 534865, 535443, 535445, 535446, 546779, 540166, 521382, 540180, 540181, 540179, 504854, 102954, 102955, 102942, 105492, 505042, 505043, 534936, 86442, 520994, 520995, 521692, 521693, 521710, 521834, 522170, 104166, 519567, 533563, 102123, 532780, 103361, 531781, 533089, 533120, 533779, 533782, 533783, 533784, 533785, 533899, 534249, 506123, 506177, 506836, 506837, 505266, 541000, 541001, 105920, 105767, 505230, 104192, 104757, 104759, 104760, 104761, 104762, 105768, 505683, 531848, 531849, 531851, 531853, 537547, 102125, 102126, 102127, 506300, 506301, 506302, 506303, 506304, 531845, 531846, 536186, 102121, 105702, 533813, 105381, 105170, 105706, 105709, 506023, 506025, 506127, 519528, 104363, 105162, 105701, 250408, 519157, 520528, 520991, 520992, 530694, 105383, 105398, 105400, 105401, 105698, 505489, 519837, 87167, 105697, 105710, 105711, 105712, 105782, 105907, 505842, 505843, 505844, 534167, 536167, 539032, 105632, 521453, 535448, 521454, 521937, 521938, 105168, 105172, 536086, 536593, 536595, 102643, 105384, 104350, 105161, 105163, 105175, 250063, 250077, 250078, 519572, 520164, 520671, 522174, 522176, 534383, 542527, 506399, 506400, 506551, 506552, 519840, 522259, 105166, 522262, 105936, 535449, 103978, 103979, 104011, 105320, 520684, 521674, 532073, 532108, 532109, 534384, 104053, 104006, 504357, 103326, 103567, 104362, 505121, 505128, 505133, 506204, 519806, 519885, 520047, 521006, 522256, 531850, 83034, 83035, 83036, 86029, 86030, 86239, 86240, 87150, 87151, 87152, 87166, 100920, 100922, 100923, 100956, 101306, 101646, 101696, 101698, 101892, 102029, 102145, 102146, 102147, 102644, 102831, 102832, 102906, 103042, 103177, 103205, 103226, 103294, 103339, 103565, 103578, 103706, 103715, 103810, 103822, 103824, 103825, 103853, 103914, 103918, 103940, 103973, 103974, 104031, 104092, 104344, 104352, 104522, 104524, 104525, 104527, 104538, 104582, 104583, 104633, 104677, 104790, 104970, 105164, 105171, 105173, 105192, 105231, 105321, 105354, 105669, 105704, 105893, 105962, 504740, 504880, 504881, 505004, 505051, 505092, 505122, 505123, 505124, 505126, 505127, 505129, 505130, 505131, 505132, 505667, 505889, 506154, 506294, 506351, 506352, 506395, 506444, 506472, 506780, 506847, 506849, 519108, 519109, 519110, 519111, 519112, 519123, 519647, 519876, 519877, 519878, 519882, 519884, 520243, 520407, 520408, 520672, 520673, 520683, 520685, 520686, 520704, 520757, 520763, 520767, 520771, 520782, 520786, 520788, 520789, 520790, 520796, 520797, 520931, 520962, 520963, 520970, 520972, 521052, 521112, 521230, 521447, 521517, 521519, 521746, 521827, 521865, 521891, 521963, 522175, 522196, 522217, 522246, 522252, 522371, 522460, 522474, 530402, 530414, 530561, 530563, 530606, 530627, 530674, 530758, 531831, 532071, 532270, 532276, 532277, 532475, 532476, 532784, 533241, 533247, 533321, 533529, 533561, 534379, 534381, 534407, 534430, 534601, 534626, 535410, 535442, 535679, 536615, 537529, 539244, 539371, 539937, 541901, 542525, 543598, X1776
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America, Co. Phillips, Bothell, WA, 
Manufacturer: Philips Medical Systems Gmbh, DMC, Hamburg, Germany. 
REASON Inaccurate measurements when exporting radiography images to Picture Archiving and Communications System (PACS).
VOLUME OF PRODUCT IN COMMERCE 401 units
DISTRIBUTION Nationwide

PRODUCT
a) OmniFit HFx X-ray Templates, Literature No.: LTEM80 1-7; The device consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting,
b) OmniFit HFx Sell Sheets, Literature Number LHFX-SS rev 1. The device consists of a pattern or guide intended for medical purposes, such as selecting or positioning    orthopedic implants or guiding the marking of tissue before cutting,
CODE
a) Literature Number: LTEM80 1-7;
b) LHFX-SS rev 1; Literature Number: LCEA-B
RECALLING FIRM/MANUFACTURER Stryker Howmedica Osteonics Corp., Mahwah, NJ, 
REASON The OmniFit HFx Templates were produced without a warning statement indicating a potential function of fit issue when using -3mm and -5mm heads or sleeves on certain stems.
VOLUME OF PRODUCT IN COMMERCE Templates - 865 units; Sell Sheets - 1,919; Cutting Edge - 810
DISTRIBUTION Nationwide and Internationally

PRODUCT ABBOTT Clinical Chemistry Phenytoin, List Number: 1E07-20, is used for the quantization of phenytoin in human serum or plasma, 
CODE
Lot Numbers: 42036HW00, 44084HW00, 45051HW00, 47055HW00, 50039HW00, 52013HW00, 55015HW00, 59088HW00
RECALLING FIRM/MANUFACTURER Abbott Laboratories Inc., South Pasadena, CA, 
REASON An Abbott investigation has determined that the phenytoin reagent does not maintain an onboard stability of 28 days as stated in the phenytoin package insert. In addition, the 14 day calibration interval is also not being met. Further investigation is required to determine the root cause of this issue. Until the cause has been determined and a corrective action defined, specific instructions are provided.
VOLUME OF PRODUCT IN COMMERCE 3266 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/15 cm, sterile. The device is intended to be used in conjunction with a Radio Therapeutics Corporation
radiofrequency (RF) generator for thermal coagulation necrosis of soft tissue, including partial or complete ablation of nonresectable liver lesions, 
b) Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/25 cm, sterile. The device is intended to be used in conjunction with a Radio Therapeutics Corporation
radiofrequency (RF) generator for thermal coagulation necrosis of soft tissue, including partial or complete ablation of nonresectable liver lesions, 
c) Boston Scientific LeVeen SuperSlim Needle Electrode, 3.0 cm/15 cm, sterile. The device is intended to be used in conjunction with a Radio Therapeutics Corporation
radiofrequency (RF) generator for thermal coagulation necrosis of soft tissue, including partial or complete ablation of nonresectable liver lesions, 
d) Boston Scientific LeVeen SuperSlim Needle Electrode, 3.0 cm/25 cm, sterile. The device is intended to be used in conjunction with a Radio Therapeutics Corporation
radiofrequency (RF) generator for thermal coagulation necrosis of soft tissue, including partial or complete ablation of nonresectable liver lesions, 
CODE All lots
RECALLING FIRM/MANUFACTURER Boston Scientific, Corp., Spencer, IN, 
REASON The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines.
VOLUME OF PRODUCT IN COMMERCE 15,604 devices
DISTRIBUTION Japan

PRODUCT Artisan Control Catheter, model number 04454. Steerable guide catheter for human use intended to facilitate manipulation, positioning and control for collecting electrophysiological data within the heart atria, 
CODE
Lot numbers: 2182, 2185, 2186, 2199, 2200-2203, 2205, 2206, 2008, 2213-2218, 2220, 2223-2231, 2233, 2234, 2236-2245, 2247, 2249, 2251, 2261-2263, 2265, 2267-2271, 2273, 2274, 2276-2279, 2284, 2288-2297, 2301-2303, 2305, 2309, 2315, 2318, 2320-2322, 2324, 2327, 2328, 2330, 2332, 2334, 2342, 2344-2349, 2351, 2353, 2355-2357, 2359-2363, 2366-2367, 2370, 2370, 2374-2375, 2377-2378, 2381-2382, 2384, 2387-2389, 2391, 2392, 2394,2395, 2397, 2399, 2400, 2404, 2405, 2412, 2417, 2420, 2421, 2423-2426, 2429, 2430, 2432-2434, 2436, 2442, 2444, 2446-2448, 2450, 2453, 2457-2461, 2463-2467, 2469-2472, 2475-2483, 2485-2490, 2494, 2497, 2500, 2502-2504, 2508, 2510, 2512-2518, 2522, 2526, 2529, 2531-2532, 2534, 2536, 2538, 2539, 2547, 2549, 2551, 2553, 2556, 2558-2560, 2562-2565, 2568, 2569, 2571, 2574-2577, 2579, 2581-2582, 2586, 2588-2589, 2591-2596, 2601, 2604, 2609, 2610, 2612, 2617, 2619, 2626, 2627, 2636, 2637, 2639-2642, 2644, 2675, 2682, 2684, 2685, 2688, 2689, 2698-2699, 2701-2707, 2709, 2716, 2720, 2722-2723, 2726-2727, 2729, 2732-2735, 2738, 2741, 2743, 2745, 2746, 2752, 2754-2757, 2761, 2767, 2773-2774, 2776, 2779, 2782, 2783, 2785-2789, 2791, 2797-2798, 2801, 2803-2804, 2806, 2809, 2812, 2814-2815, 2817-2818, 2821, 2822, 2824, 2827, 2829-2831, 2833-2837, 2839, 2843, 2848, 2850, 2854, 2857, 2862, 2865, 2872, 2879, 2882, 2886, 2888, 2889, 2894, 2896, 2898, 2904, 2908-2909, 2913, 2915, 2920, 2922, 2924, 2925, 2930, 2932, and 2940
RECALLING FIRM/MANUFACTURER Hansen Medical, Inc., Mountain View, CA.
REASON The catheter's flexible bellows portion may develop a leak. This has the potential to cause loss of homeostasis, flush fluid leakage, and/or introduction of air into the catheter with a risk of subsequent embolism.
VOLUME OF PRODUCT IN COMMERCE 369 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Fountain Infusion System, 4F, REF IS4-90-50, Sterile. Continuous flush catheter intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient, 
CODE Lot numbers: F496042, and F587928
RECALLING FIRM/MANUFACTURER Merit Medical Systems, Inc., South Jordan, UT,
REASON Catheters were packaged with occluding wires that were too long for the catheter. Potential for wire to not occlude the catheter appropriately, allowing the wire to exit the tip of the catheter further than intended, posing a potential risk of physical damage to the patient.
VOLUME OF PRODUCT IN COMMERCE 15 units
DISTRIBUTION Nationwide

PRODUCT On-Q C-bloc 400 ml, 1-7 ml/hr Select-A-Flow + 5 ml/60 min ONDEMAND, REF CB005 indicated for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites, 
CODE Lot Numbers: 792457 and 7A2667
RECALLING FIRM/MANUFACTURER I-Flow Corporation, Lake Forest, CA
REASON Two lots of ON-Q C-bloc, Model Number CB005 may contain an incorrect fill port label.
VOLUME OF PRODUCT IN COMMERCE 220 units
DISTRIBUTION Nationwide

PRODUCT Vacuette, Plastic Cannula HOLDEX®, Ref 450216, Single packed, sterile, single use disposable tube holder with off center plastic cannula at the top and a stainless steel needle on the underside of the holder. It is intended for use in routine specimen withdrawal from collection bags or bottles through needless cannula ports, CODE Lot #A10074, A100745, A100746, A100747, A110749, and A110750
RECALLING FIRM/MANUFACTURER
Recalling Firm: Greiner Bio-One North America, Inc., Monroe, NC,   
Manufacturer: Greiner Bio-One Gmbh, Kremsmunster, Austria. 
REASON At removal of the tube from the holder the needle may dislodge and become stuck in the tube stopper with the blunt end of the needle facing out.
VOLUME OF PRODUCT IN COMMERCE 1,606,005 units
DISTRIBUTION Nationwide

PRODUCT Suction Jar Lid for Medela Vario 18 Vacuum Pump used with the Bravo pH Monitoring System Medtronic Part Number: 9043K2101. (9043K2111 is the OUS version) The Vacuum Pump is used to provide the vacuum pressure during Capsule attachment. Correct Overflow lid: Medela CH-6341 Baar Switzerland Art. No. 077.0440, Small lid with conical patient connection 6-10mm and overflow protection device.(Incorrect overflow lid is Medela P/N: 077.0450), 
CODE Serial #: 1163101 - 1163120
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Neuromodulation, Minneapolis, MN, 
Manufacturer: Medela AG Medical Technology, Baai. REASON Some Medela Vario 18 Vacuum Pumps were provided with an incorrect suction Jar Lid that did not have the correct conical connection for the Vacuum Tube.
VOLUME OF PRODUCT IN COMMERCE 1,500 units (20 affected)
DISTRIBUTION Nationwide and Canada

PRODUCT Flexipet Manipulation Pipette 300 micron. The product is boxed with 1 vial of 10 pipettes. This product is used for the intracytoplasmic single sperm injection of oocytes, 
CODE Lot #: 72169
RECALLING FIRM/MANUFACTURER Cook Vascular, Inc., Vandergrift, PA
REASON Mislabeled – 300 micron flexipets were labeled as 80 microns.
VOLUME OF PRODUCT IN COMMERCE 80 vials
DISTRIBUTION TN, NJ, MD, Indonesia, Australia, and Ireland

PRODUCT Zimmer 4.5 Compression plate-broad, 10 hole, 167 MM length, stainless steel, non sterile, Manufactured at Zimmer; REF 4945-10-01. The product is used for stabilization of fractures during the normal healing process, CODE Lot: 60985554
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer Inc., Warsaw, IN,
Manufacturer: Zimmer Manufacturing B.V. Mercedita, PR. REASON An impurity in the metal may affect the strength of the plate or biocompatibility of the material with the body.
VOLUME OF PRODUCT IN COMMERCE 7 units
DISTRIBUTION Internationally

PRODUCT Varian Medical Systems FastPlan, versions 5.5 and 5.5.1, model number HZ3. The product is a radiation treatment planning system
CODE
Serial numbers HZ30495 HZ30077 HZ39010 HZ30021 HZ30398 HZ30540 HZ30698 HZ32020 HZ32054 HZ38006 HZ30258 HZ30110 HZ39011 HZ30033 HZ30403 HZ30556 HZ30703 HZ32021 HZ32056 HZ38062 HZ30737 HZ30111 HZ39012 HZ30054 HZ30404 HZ30557 HZ30727 HZ32024 HZ32058 HZ39018 HZ30273 HZ30112 HZ39013 HZ30061 HZ30407 HZ30571 HZ30731 HZ32026 HZ32059 HZ39066 HZ32023 HZ30154 HZ39014 HZ30131 HZ30422 HZ30572 HZ30740 HZ32028 HZ32060 HZ39071 HZ39019 HZ30181 HZ39015 HZ30144 HZ30426 HZ30574 HZ30762 HZ32029 HZ32062 HZ39165 HZ30630 HZ30182 HZ39016 HZ30171 HZ30460 HZ30588 HZ32001 HZ32032 HZ32063 HZ39997 HZ32045 HZ30190 HZ30178 HZ30207 HZ30461 HZ30612 HZ32002 HZ32033 HZ32064 HZ39998 HZ32046 HZ30368 HZ30283 HZ30208 HZ30462 HZ30617 HZ32004 HZ32034 HZ32065 HZ30743 HZ30108 HZ30500 HZ30167 HZ30224 HZ30485 HZ30620 HZ32005 HZ32035 HZ32069 HZ32025 HZ30139 HZ30712 HZ32019 HZ30230 HZ30507 HZ30640 HZ32006 HZ32036 HZ32071 HZ32027 HZ30594 HZ32013 HZ30280 HZ30251 HZ30508 HZ30646 HZ32007 HZ32037 HZ32072 HZ30624 HZ32052 HZ30573 HZ30265 HZ30509 HZ30649 HZ32008 HZ32044 HZ32073 HZ30604 HZ39001 HZ32040 HZ30293 HZ30510 HZ30656 HZ32010 HZ32047 HZ32074 HZ32003 HZ39002 HZ32061 HZ30294 HZ30511 HZ30670 HZ32012 HZ32048 HZ32077 HZ30219 HZ39004 HZ30032 HZ30312 HZ30513 HZ30674 HZ32014 HZ32049 HZ35070 HZ30019 HZ39005 HZ30730 HZ30330 HZ30520 HZ30675 HZ32016 HZ32050 HZ36101 HZ30044 HZ39006 HZ32009 HZ30342 HZ30531 HZ30681 HZ32017 HZ32051 HZ36102 HZ30058 HZ39007 HZ30001 HZ30349 HZ30537 HZ30684 HZ32018 HZ32053 and HZ37015
RECALLING FIRM/MANUFACTURER Varian Medical Systems Oncology Systems, Palo Alto, CA,
REASON Due to issues with image orientation verification, a patient may receive all or some of prescribed high dose to healthy tissue instead of intended area.
VOLUME OF PRODUCT IN COMMERCE 182 units
DISTRIBUTION Nationwide and Internationally

PRODUCT CABG PACK, Surgical Convenience Kit, Sterile, Reorder #: K12T-02449B. A combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the products’ intended uses, 
CODE Lot Number: V583783
RECALLING FIRM/MANUFACTURER
Recalling Firm: Merit Medical Systems, Inc., South Jordan, UT, 
Manufacturer: Linvatec Corp., Largo, FL. 
REASON Component of convenience kit may not be sterile.
VOLUME OF PRODUCT IN COMMERCE 36 kits
DISTRIBUTION PA

PRODUCT Navigator System Surgical kit (SGKIT), handles inside of SGKIT Surgical Kit SGDPH1 through SGDPH5. The product is used for CT guided surgery,
CODE Lots# 790554, 790555, 807340, 799305, 807340, 790082, and 808640
RECALLING FIRM/MANUFACTURER Biomet 3i, Inc., Palm Beach Gardens, FL,
REASON The drill malfunctions while in use. The drill has been observed to become lodged in the handle.
VOLUME OF PRODUCT IN COMMERCE 182 units
DISTRIBUTION Nationwide and Internationally 

PRODUCT Intran Plus, Disposable Intrauterine Pressure Catheter System, Part numbers IUP-400, IUP-400S, IUP-450, IUP-450S, IUP-500, IUP-550, IUP-600, IUP-600S, IUP-650, IUP-650S, IUP-700, IUP-750, Sterile, Single Use, 
CODE
Lot numbers less than 1072755. Also 1080086, 1080087, 1080088, 1080089, 1080091, 1080093, 1080095, 1080245, 1080246, 1080247, 1080248, 1080249, 1080250, 1080266, 1080296, 1080297, 1080298, 1080299, 1080301, 1080302, 1080393, 1080394, 1080395, 1080432, 1080610, 1080669, and 1080721
RECALLING FIRM/MANUFACTURER Utah Medical Products, Inc., Midvale, UT, 
REASON Possibility of compromised package sterility prior to the expiration date.
VOLUME OF PRODUCT IN COMMERCE 300,000 units
DISTRIBUTION CA, KS, MO, NC, NV, TX, VA, WA and Japan

PRODUCT 740 Series Multiparameter Monitor Software Version 3.0 Model Numbers: 740-1, 740M-1, 740-2T, 740M-2T, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS, 740-3NL, 740M-3NL, 740-3NN, and 740M-3NN. Indicated for use for non-invasive monitoring of blood pressure, oxygen saturation, pulse and temperature of adults, pediatric and neonatal patients, in the care of health professionals
CODE Serial Numbers: 0809834-0823035
RECALLING FIRM/MANUFACTURER CAS Medical Systems, Inc., Branford, CT, 
REASON Software: Audible alarm may be silenced if changed from the factory setting.
VOLUME OF PRODUCT IN COMMERCE 820 units
DISTRIBUTION Nationwide, Canada, Jordan, UK, France and Taipei

PRODUCT da Vinci S Surgical System, Model number IS2000 Endoscopic Instrument Control System, 
CODE
Serial numbers SG099, SG145, SG162, SG205, SG294, SG295, SG298, SG299, SG300, SG301, SG302, SG303, SG304, SG305, SG306, SG307, SG308, SG309, SG310, SG311, SG312, SG313, SG314, SG315, SG316, SG317, SG318, SG319, SG320, SG321, SG322, SG323, SG324, SG325, SG326, SG327, SG328, SG329, SG330, SG331, SG332, SG333, SG334, SG35, SG336, SG337, SG39, SG340, SG341, SG342, SG323, SG344, SG345, SG346, SG347, SG348, SG349, SG350, SG351, SG352, SG353, SG355, SG356, SG357, SG358, SG359, SG360, SG361, SG362, SG363, SG364, SG365, SG367, SG368, SG369, SG370, SG371, SG373, SG374, SG375, SG376, SG379, SG380, SG381, SG382, SG383, SG384, SG385, SG386, SG387, SG388, SG390, SG393, SG394, SG395, SG396, SG397, SG399, SG400, SG401, SG402, SG403, SG404, SG405, SG406, SG407, SG408, SG409, SG410, SG411, SG412, and SG413
RECALLING FIRM/MANUFACTURER Intuitive Surgical, Inc., Sunnyvale, CA
REASON Defective software chip may cause the system to fail and lock up.
VOLUME OF PRODUCT IN COMMERCE 112 systems
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Hospira Intralock Lipid Compatible 3-Way Stopcock, Item Number 423830401 Indicated for fluid flow directional control and for providing access port(s) for administration of solutions, 
b) Hospira Monitoring Kit (PA Line) with 03ml Flush Device. Item Number: 460760451 Indicated for fluid flow directional control and for providing access port(s) for
administration of solutions, 
c) Hospira Left Heart Kit, Item Number: 46084053 Indicated for fluid flow directional control and for providing access port(s) for administration of solutions, 
d) ICU Medical, Inc. Cath Lab Kit W/3Port "ON" Manifold, Waste Bag, Syringe & TP4; Item Number: AG7843 Indicated for fluid flow directional control and for providing
    access port(s) for administration of solutions, 
CODE
a) Lot Numbers: 49-208-YJ, 49-209-YJ, 49-210-YJ, 49-211-YJ, 49-212-YJ, 50-052-SN, 51-451-K4, 53-306-YJ, 54-499-K4, 54-569-SN, 55-915-K4, 56-752-LA, 56-912-YJ, 58-191-LA, 58-331-LA, 60-465-2A, 61-821-LA, 61-855-LA, 62-717-R5, 63-222-SN;
b) Lot Number: 41-501-LA;
c) Lot Numbers: 48-807-K4 and 61-844-K4;
d) Lot Numbers: 44-504-R5, 558884, 570634, and 603566
RECALLING FIRM/MANUFACTURER
Recalling Firm: ICU Medical, Inc., San Clemente, CA, 
Manufacturer: ICU Medical de Mexico, S.A., Baja California, Mexico. 
REASON Improper orientation of the stopcock handle questions whether there is an adequate gas path to assure sterility, which presents a possible compromise of sterility.
VOLUME OF PRODUCT IN COMMERCE 490,998 units
DISTRIBUTION Nationwide

PRODUCT Gyrus ACMI 10 Fr. Dual Lumen Catheter Reference Number: 608 BX (Box of 5) and 608 (single unit) This product has multiple uses, including ureteral dilation, anesthetic injection, stone displacement, contrast injection, and safety wire / guidewire placement. The "ACMI" Dual Lumen Catheter is a radiopaque ureteral catheter. 
CODE
Lot Numbers: 7124026, 7131020, 7138014, 7152018, 7158015, 7169005, 7201018, 721 1016, 72I404l, 7227021, 7232046, 7253048,  7256034, 7263052, 7269089, 7276035, 7277024, 7284042, 7291034, 7296052, 7303068, 7306089, 7312076, 7324062, 7337052, 7 344047, 7347078, 7354102, 7361043, 8010043,  8017047, 8025006, 8031030, 8036057, 8045050, 8052064, 8059055, 8066067, and 8073030
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gyrus ACMI Corp., Southborough, MA, Manufacturer: Primrose Medical, Inc., Walpole, MA. 
REASON Particulate matter in the catheter.
VOLUME OF PRODUCT IN COMMERCE 6,820 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Panda® iRes and Giraffe® Infant Warmers, labeled in part: Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology, 
CODE
HDJL50229 HDJL50230 HDJL50231 HDJL50232 HDJM50087 HDJM50085 HDJL50290 HDJL50291 HDJL50292 HDJL50293 HDJL50512 HDJL50513 HDJL50514 HDJL50515 HDJL50516 HDJM50199 HDJM50200 HDJM50201 HDJL50279 HDJL50285 HDJL50496 HDJL50497 HDJL50498 HDJL50499 HDJL50500 HDJL50501 HDJL50502 HDJL50503 HDJL50504 HDJM50203 HDJL50256 HDJL50257 HDJL50327 HDJL50543 HDJL50539 HDJM50066 HDJM50067 HDJM50068 HDJM50008 HDJM50009 HDJM50010 HDJM50011 HDJL50489 HDJL50490 HDJL50492 HDJL50518 HDJL50519 HDJL50520 HDJM50088 HDJM50089 HDJM50090 HDJM50091 HDJL50233 HDJL50234 HDJL50235 HDJL50236 HDJL50190 HDJL50191 HDJL50192 HDJL50193 HDJL50194 HDJL50384 HDJL50385 HDJL50386 HDJL50387 HDJL50388 HDJL50389 HDJL50390 HDJL50391 HDJL50397 HDJL50398 HDJL50399 HDJL50400 HDJL50488 HDJL50491 HDJL50493 HDJL50494 HDJL50517 HDJL50521 HDJL50522 HDJL50523 HDJL50289 HDJM50069 HDJM50070 HDJL50457 HDJL50538 HDJL50472 HDJL50428 HDJL50429 HDJL50430 HDJL50432 HDJL50433 HDJL50434 HDJL50435 HDJL50364 HDJL50485 HDJL50318 HDJL50319 HDJL50320 HDJL50321 HDJL50322 HDJL50323 HDJL50324 HDJL50401 HDJL50402 HDJM50012 HDJL50311 HDJL50312 HDJL50313 HDJL50314 HDJL50478 HDJL50462 HDJL50463 HDJL50464 HDJL50380 HDJL50381 HDJL50524 HDJL50525 HDJL50526 HDJL50527 HDJL50270 HDJL50271 HDJM50016 HDJM50017 HDJM50018 HDJM50071 HDJL50540 HDJL50541 HDJM50053 HDJM50054 HDJM50098 HDJM50099 HDJM50101 HDJM50103 HDJM50105 HDJM50124 HDJL50166 HDJL50167 HDJL50168 HDJL50169 HDJL50170 HDJL50171 HDJL50172 HDJL50173 HDJL50174 HDJL50175 HDJL50176 HDJL50177 HDJL50303 HDJL50304 HDJL50305 HDJL50306 HDJL50307 HDJL50308 HDJL50309 HDJL50310 HDJL50466 HDJL50467 HDJL50470 HDJL50471 HDJL50365 HDJL50366 HDJL50367 HDJL50368 HDJL50369 HDJL50370 HDJL50371 HDJL50372 HDJL50373 HDJL50374 HDJL50379 HDJM50030 HDJM50031 HDJM50032 HDJM50033 HDJM50034 HDJM50035 HDJM50036 HDJM50037 HDJM50038 HDJM50039 HDJM50040 HDJM50041 HDJM50042 HDJM50106 HDJM50107 HDJM50126 HDJM50127 HDJM50128 HDJM50129 HDJM50130 HDJM50131 HDJM50132 HDJM50133 HDJM50134 HDJM50135 HDJM50136 HDJM50137 HDJL50254 HDJL50255 HDJM50073 HDJM50074 HDJM50075 HDJM50076 HDJM50077 HDJM50078 HDJM50079 HDJM50080 HDJM50081 HDJM50082 HDJL50461 HDJL50479 HDJL50246 HDJL50247 HDJL50248 HDJL50249 HDJL50250 HDJL50251 HDJL50252 HDJL50253 HDJL50315 HDJL50316 HDJL50300 HDJL50299 HDJL50301 HDJL50195 HDJL50196 HDJL50197 HDJL50198 HDJL50199 HDJL50200 HDJL50201 HDJL50202 HDJL50203 HDJL50204 HDJL50205 HDJL50206 HDJL50207 HDJL50208 HDJL50209 HDJL50210 HDJL50211 HDJL50212 HDJL50213 HDJL50287 HDJL50288 HDJL50473 HDJL50474 HDJL50475 HDJL50476 HDJL50477 HDJL50468 HDJL50469 HDJL50508 HDJL50509 HDJL50510 HDJL50511 HDJM50005 HDJM50006 HDJM50007 HDJL50448 HDJL50456 HDJL50458 HDJL50268 HDJL50269 HDJL50046 HDJL50047 HDJL50048 HDJL50049 HDJL50050 HDJL50051 HDJL50052 HDJL50053 HDJL50054 HDJL50055 HDJL50056 HDJL50057 HDJL50058 HDJL50059 HDJL50060 HDJL50067 HDJL50068 HDJL50069 HDJL50070 HDJL50071 HDJL50072 HDJL50073 HDJL50074 HDJL50075 HDJL50076 HDJL50077 HDJL50078 HDJL50079 HDJL50080 HDJL50081 HDJL50082 HDJL50083 HDJL50084 HDJL50085 HDJL50086 HDJL50087 HDJL50088 HDJL50089 HDJL50090 HDJL50091 HDJL50092 HDJL50093 HDJL50094 HDJL50095 HDJL50096 HDJL50097 HDJL50098 HDJL50099 HDJL50100 HDJL50101 HDJL50102 HDJL50103 HDJL50104 HDJL50105 HDJL50106 HDJL50107 HDJL50108 HDJL50109 HDJL50110 HDJL50111 HDJL50112 HDJL50113 HDJL50114 HDJL50115 HDJL50116 HDJL50117 HDJL50118 HDJL50119 HDJL50120 HDJL50121 HDJL50122 HDJL50123 HDJL50124 HDJL50125 HDJL50126 HDJL50127 HDJL50128 HDJL50129 HDJL50130 HDJL50131 HDJL50132 HDJL50133 HDJL50134 HDJL50135 HDJL50136 HDJL50137 HDJL50138 HDJL50139 HDJL50140 HDJL50141 HDJL50142 HDJL50143 HDJL50144 HDJL50145 HDJL50146 HDJL50147 HDJL50148 HDJL50149 HDJL50150 HDJL50151 HDJL50152 HDJL50153 HDJL50155 HDJL50156 HDJL50161 HDJL50162 HDJL50163 HDJL50164 HDJL50165 HDJL50237 HDJL50238 HDJL50239 HDJL50241 HDJL50242 HDJL50240 HDJL50243 HDJL50244 HDJL50245 HDJL50403 HDJL50404 HDJL50405 HDJL50406 HDJL50407 HDJL50408 HDJL50409 HDJL50410 HDJL50411 HDJL50412 HDJL50413 HDJL50414 HDJL50415 HDJL50416 HDJL50417 HDJL50418 HDJL50419 HDJL50420 HDJL50421 HDJL50294 HDJL50505 HDJM50083 HDJM50084 HDJL50273 HDJL50274 HDJL50506 HDJL50507 HDJL50295 HDJL50375 HDJL50376 HDJL50377 HDJL50378 HDJL50357 HDJL50358 HDJL50359 HDJL50360 HDJL50362 HDJL50383 HDJM50072 HDJL50317 HDJL50356 HDJL50459 HDJL50460 HDJL50422 HDJL50423 HDJL50226 HDJL50227 HDJL50228 HDJL50443 HDJL50444 HDJL50445 HDJL50446 HDJL50447 HDJM50202 HDJM50204 HDJL50481 HDJL50482 HDJL50483 HDJL50484 HDJM50019 HDJM50020 HDJM50021 HDJM50022 HDJM50023 HDJM50024 HDJM50025 HDJM50026 HDJM50027 HDJM50028 HDJL50363 HDJL50542 HDJL50465 HDJM50003 HDJM50004 HDJM50198 HDJM50092 HDJL50328 HDJL50452 HDJL50453 HDJL50454 HDJL50455 HDJM50206 HDJM50207 HDJL50280 HDJL50281 HDJL50449 HDJL50450 HDJL50451 HDJM50086 HDJL50261 HDJL50262 HDJL50263 HDJL50264 HDJL50265 HDJL50266 HDJL50267 HDJL50278 HDJL50528 HDJL50529 HDJL50530 HDJL50531 HDJL50532 HDJL50533 HDJL50534 HDJL50535 HDJL50536 HDJL50537 HDJL50275 HDJL50276 HDJL50277 HDJL50480 HDJL50258 HDJL50259 HDJL50260 HDJM50095 HDJM50064 HDJM50065 HDJL50214 HDJL50215 HDJL50216 HDJL50217 HDJL50218 HDJL50219 HDJL50220 HDJL50221 HDJL50222 HDJL50223 HDJL50224 HDJL50225 HDJL50296 HDJL50297 HDJL50298 HDJL50272 HDJL50392 HDJL50393 HDJL50394 HDJL50436 HDJL50437 HDJL50438 HDJL50439 HDJL50440 HDJM50013 HDJM50014 HDJM50000 HDJM50001 HDJM50002 HDJM50044 HDJM50043 HDJL50442 HDJL50441 HDJL50286 HDJL50287 HDJL50325 HDJL50326 HDJL50329 HDJL50330 HDJL50424 HDJM50148 HDJM50149 HDJM50150 HDJM50151 HDJM50152 HDJM50153 HDJM50154 HDJM50155 HDJM50156 HDJM50157 HDJM50158 HDJM50159 HDJM50160 HDJM50161 HDJM50162 HDJM50163 HDJM50164 HDJM50165 HDJM50166 HDJM50167 HDJM50168 HDJM50169 HDJM50170 HDJM50171 HDJM50172 HDJM50173 HDJM50174 HDJM50175 HDJM50176 HDJM50177 HDJL50487 HDJM50015 HDJL50018 HDJL50019 HDJL50020 HDJL50021 HDJL50022 HDJL50023 HDJL50024 HDJL50025 HDJL50026 HDJL50027 HDJL50028 HDJL50029 HDJL50030 HDJL50031 HDJL50032 HDJL50033 HDJL50034 HDJL50037 HDJL50038 HDJL50040 HDJL50043 HDJL50044 HDJL50045 HDJL50154 HDJL50178 HDJL50179 HDJL50180 HDJL50181 HDJL50182 HDJL50183 HDJL50184 HDJL50185 HDJL50186 HDJL50187 HDJL50188 HDJL50189 HDJL50431 HDJM50029 HDJM50045 HDJM50046 HDJM50047 HDJM50048 HDJM50049 HDJM50050 HDJM50051 HDJM50052 HDJM50055 HDJM50056 HDJM50057 HDJM50058 HDJM50059 HDJM50060 HDJM50061 HDJM50062 HDJM50093 HDJM50094 HDJM50096 HDJM50097 HDJM50100 HDJM50102 HDJM50104 HDJM50143 HDJM50178 HDJM50179 HDJM50180 HDJL50036 and HDJL50061
RECALLING FIRM/MANUFACTURER Datex, Ohmeda, Inc. dba GE Healthcare, Laurel, MD, 
REASON Medical device software may be subject to signal interference of the Hands Free Alarm Silence feature that could impact patient safety.
VOLUME OF PRODUCT IN COMMERCE 639 devices
DISTRIBUTION Nationwide

PRODUCT Hill-Rom Procedural Stretcher with auto-contour option; Model P8000F. Wheeled hospital stretcher consisting of a platform mounted on a wheeled frame, designed to transport patients and to allow for patient care before, during and after transport, 
CODE All units with serial numbers H352AN3566 through I222AN9588 and shipped prior to 8/13/07
RECALLING FIRM/MANUFACTURER Hill-Rom, Inc., Batesville, IN, 
REASON The auto contour function on/off handle may be inadvertently activated while the head of the stretcher is raised, increasing the possibility of the head section to become jammed and preventing it from lowering. This may result in a delay to the procedure.
VOLUME OF PRODUCT IN COMMERCE 564 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Straumann Handpiece Driver for RN Solid Abutment 6° L 26.0mm,Stainless Steel -- Reference Number: 80426. Product is intended as radiographic guides and surgical templates for the initial placement of the 2.2 mm pilot drill used in the site preparation for the placement of Straumann dental implants,
CODE Lot Number: C4724
RECALLING FIRM/MANUFACTURER
Recalling Firm: Straumann Manufacturing Inc., Andover, MS, 
Manufacturer: Instituit Strauman, Basel, Switzerland. 
REASON Handpiece driver is out of specification and will not function with the dental solid abutment. Possible risks involved include: inconvenience to patient and the need to reschedule surgery or proceed without the device.
VOLUME OF PRODUCT IN COMMERCE 129 units
DISTRIBUTION Nationwide

PRODUCT Essenta DR - digital multifunctional x-ray system (application SW release 1.0.2 and lower). The device is intended for routine exams, including specialist areas like trauma or pediatric work, excluding mammography. Equip No: 553491, 554498, 554944, 554358, 553270, 557203, 556089, 556080, 555457 and 556275, 
CODE
Serial Number: 368645, 372631, 375371/SN0800002, 375730/SN07000032, 375372/SN07000028, 383083/SN07000023, 378493/SN07000025, 379442/SN0800001, 379183/SN07000030 and 379050/SN0800005
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems, North America Co. Philips, Bothell, WA,
Manufacturer: Philips Medical Systems Gmbh, DMC, Hamburg, Germany. 
REASON Bright artifacts may appear on a patient image from a previous exposure, which might lead to a misdiagnosis.
VOLUME OF PRODUCT IN COMMERCE 10 units
DISTRIBUTION Nationwide

PRODUCT
a) Cook Hilal Embolization Microcoil, 3 mm, sterile. The device is an intravascular  implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral arteriovenous malformations, 
b) Cook Hilal Embolization Microcoil, 6 mm, sterile. The device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral arteriovenous malformations
CODE
a) Lots 1897765, 1902927, 1908780, 1910237, 1918237, 1921667, 1929329, 1934204, 1971324, 1971325, 1987735, 1991576, 1994124, 2000417, 2007745,
  2012753x, 2012753, 2021721, 2026715, 2031205, 2034254, 2039748, 2051785, 2063422, 2066776, 2072751 and 2080653;
b) Lots F2100451, F2102327, F2102038, F2102833, F2109137, F2112851, F21114679, F2122527, F2125284, F2126416, F2136920, F2141567, F2142403,
F2142578, F2143038, F2146823, F2146882, F2147969, F2150692, F2159335, F2159263, F2161387, F2172446, F2188499, F2189353, F2203609, F2204861, F2207480, F2213136, F2213468 and F2215748
RECALLING FIRM/MANUFACTURER Cook, Inc., Bloomington, IN, 
REASON The product length is declared incorrectly in mm when the unit of measurement should be cm.
VOLUME OF PRODUCT IN COMMERCE 1,338 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) EndoVive Safety PEG Kits 24 F Universal Product Number (UPN): MOO56648 1. The product provides nutrition directly into the stomach of adult and pediatric
patients who are unable to consume by conventional methods, 
b) EndoVive Safety PEG Kits 24 F Universal Product Number (UPN): MOO566460. The product provides nutrition directly into the stomach of adult and pediatric
patients who are unable to consume by conventional methods, 
CODE a) and b) Lot Number: 11712923
RECALLING FIRM/MANUFACTURER Boston Scientific Corporation, Natick, MA,
REASON Mislabeled: Inner box labeled 20 Fr PEG, outer and tray label correctly labeled 24 Fr PEG
VOLUME OF PRODUCT IN COMMERCE 16 kits
DISTRIBUTION NJ, SC, TN, VA, WI

PRODUCT Zimmer Metasul Head 32/-4”S”, taper 12/14, hip implant component; REF 19.32.05, 
CODE Lot: 2299218
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer, Inc., Warsaw, IN, 
Manufacturer: Zimmer Gmbh, Winterthur, Switzerland. REASON The wrong part may be in the package. Package may contain a 28 mm head.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION FL, PA, TX, VA

PRODUCT Zimmer M/G Unicompartmental Knee System headed screw, 48 mm length, sterile, Catalog No. 00-5791-041-00. Used during surgery for the cutting guide. This screw is not permanently implanted, 
CODE Lot: 60954069
RECALLING FIRM/MANUFACTURER
Zimmer, Inc., Warsaw, IN,
REASON An impurity in the metal may affect the strength of the screw, resulting in breakage and/or surgical delays.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION FL, China, India