DECEMBER 2005

WEEK ENDING DECEMBER 3

PRODUCT cardioPAT Cardiovascular Perioperative Autotransfusion System, Model: LN 2050-110-E and Disposables: cardioPAT Replacement RBC Bags, LN 00270 cardioPAT Replacement Waste Bags, LN 00271 cardioPAT Replacement Intraoperative Suction Set, LN 00272 cardioPAT Replacement Postoperative Suction Set, LN 00273 cardioPAT cardiovascular Perioperative Autotransfusion System Disposable Set, LN 00274 cardioPAT Replacement One-Way Valve Assembly LN 00275
CODE All lot numbers
RECALLING FIRM/MANUFACTURER Haemonetics Corporation, Braintree, MA
REASON Blood clotting of patient post operative while on the cardioPAT Cardiovascular Perioperative Autotransfusion System.
VOLUME OF PRODUCT IN COMMERCE 4 systems and 486 disposables
DISTRIBUTION CA, MN, NE, and TX

PRODUCT Lysus® Infusion System - PT-3 Control. The Lysus Infusion System employs high frequency, low power ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature. (This system is also called the UltraFlo and EKOS Peripheral Infusion System in internal documents.) The Lysus® Infusion System consists of three main components, a single use Lysus® Infusion Catheter System which is comprised of a Drug Delivery Catheter (DDC) and removable Ultrasound Core (USC), and a reusable EKOS PT-3 Control System. During use, fluids are delivered through the side-holes of the DDC. The USC is placed through the central lumen of the DDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS PT-3 Control Unit provides power to the system and the user interface for operator control. A reusable, non-sterile Catheter Interface Cable with Pod connects the EKOS PT-3 Control Unit to the Lysus® Infusion Catheter System
CODE Serial numbers: PT3-002, PT3-006, PT3-007, PT3-009, PT3-012, PT3-013, PT3-014
RECALLING FIRM/MANUFACTURER Ekos Corporation, Bothell, WA
REASON Potential for a faulty thermal channel offset to be reported to the software causing faulty lower temperature values to be reported which allow a power increase.
VOLUME OF PRODUCT IN COMMERCE 7 units
DISTRIBUTION AZ, OH, WA, FL, IL, CA, and Germany

PRODUCT Bard RespiShield™ * Closed Suction System with InnoValve™ * Endotracheal Start Kit * QTY 1 Unit * 14F/4.7mm * Sterile * Rx Only
CODE Catalog Number: 220059, Lot Numbers: NGPD0713, NGPD0714, NGPE11, Catalog Number: 220067, Lot Number: NGPD2781, Catalog Number: 220068, Lot Number: NGPD0855, Catalog Number: 220069, Lot Numbers: NGPD0939, NGPD1735, NGPD2015, NGPE0403, NGPE0404, Catalog Number: 220141, Lot Number: NGPE1200, Catalog Number: 220145, Lot Number: NGPD0934, Catalog Number: 220155, Lot Number: NGPD2697, Catalog Number: 220211, Lot Number: NGPE1170
RECALLING FIRM/MANUFACTURER
Recalling Firm: C.R. Bard, Inc., Covington, GA
Manufacturer: Bard Sdn Bhd, Nogales, Mexico. 
REASON Varying degrees of difficulty were encountered when opening and closing the InnoValve.
VOLUME OF PRODUCT IN COMMERCE 10,169 units
DISTRIBUTION Nationwide

PRODUCT
a) FHC microTargeting Power Assist System used with the micro Targeting Drive System, models: 66-DA-ME; 66EL-MC; 66EL-MS; 66EL-MS-02; 66-EL-MS-03; 66-EL-RM; MT-DS-AM; MT-DS-MD. 
b) Medtronic microTargeting Drive Motor Option used with the micro Targeting Drive System with models: 9033G0711; 9033G0712; 9033G0713; 9033G0811 and FHC 1008-66,
CODE N/A
RECALLING FIRM/MANUFACTURER FHC, Inc, Bowdoinham, ME
REASON Power Assist microTargeting System may advance beyond intended target
VOLUME OF PRODUCT IN COMMERCE 300 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Terumo Sarns brand Soft-Flow Aortic Cannula with flange, angled, wire-reinforced, with Luer, 6 mm (18 Fr) OD with 3/8 inch connector, 14 inches (35 cm) long; catalog number 7080. 
CODE All lots (0332197, 0349597, 0360492, 0369078, 0373045, 0382401, 0391806 and 0399838)
RECALLING FIRM/MANUFACTURER Terumo Cardiovascular Systems, Corp., Ann Arbor, MI
REASON The product is labeled as sterile, but the firm has determined that the suture flange may tear through the front of the package.
VOLUME OF PRODUCT IN COMMERCE 48 units
DISTRIBUTION CA, IN, MO, Brazil and Germany

PRODUCT AQuify™ Drops, Long Lasting Comfort Drops * Relieves Dryness * For Soft and RGP Contact Lenses * 1/3 fl. Oz. (10mL) * Sterile
CODE Lot number: 52246
RECALLING FIRM/MANUFACTURER
Recalling Firm: CIBA Vision Corporation, Duluth, GA
Manufacturer: Ciba Vision Sterile Manufacturing, Ontario, Canada. 
REASON Lack of assurance of sterility at the time of manufacture.
VOLUME OF PRODUCT IN COMMERCE 29592 cases (24 units per case)
DISTRIBUTION Nationwide, Canada, Germany, Benelux, and the UK

PRODUCT Torque Limiting Handle, model # 10-40-0122, a component of the Lumbar Coral System (Pedicle Screw System).
CODE The Torque handles contain serial #1 through serial #76 and are part number 10-40-0122 contained in the Coral Lumbar System, Lot W1902 and W1558.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Theken Spine LLC, Akron, OH
Manufacturer: Holmed Corporation, South Easton, MA. 
REASON The torque value of the device may increase over time. The increase could exceed the tolerance specification.
VOLUME OF PRODUCT IN COMMERCE 71 or 75 units
DISTRIBUTION Nationwide

PRODUCT
a) Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-1000. The LTV1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The LTV-1000 is a prescription medical device suitable for use in institutional, home and transport settings. 
b) Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-950. The LTV-950 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The LTV-950 is a prescription medical device suitable for use in institutional, home and transport settings.
c) Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-900. The LTV-900 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require
mechanical ventilation. The LTV-900 is a prescription medical device suitable for use in institutional,
home and transport settings. 
CODE
a) A01916, A01961, A02196, A02656, A02985, A03667, A03696, A03741, A03774, A03809, A04262, A05454, A06194, A06585-A06598, A06600-A06613, A06615, A06616, A06618-A06620, A06622-A06624, A06626-A06630, A06633, A06635-A06637, A06639-A06654, A06656-A06659,
A06661-A06670, A06672-A06684, A06686-A06696, A06698-A06700, A06702-A06707, A06709, A06710, A06712-A06716, A06734, A06746-A06748, A06750, A06755-A06758, A06760-A06763, A06765-A06766, A06769, A06771, A06779-A06780, A06783-A06785 and A07226;
b) C01063, C01112, C01605, C02231, C02247, C02488, C03055, C03096, C03123, C03137, C03437, C03492, C03828, C03861, C03884, C04056, C04580, C05336, C06640, C07105-C07107, C07109-C07113, C07115, C07116, C07118, C07122-C07126, C07130, C07141, C07145, C07152, C07154, C07157-C07160, C07162, C07168, C07170, C07173, C07188, C07194 and C07195;
c) B01117, B01236, B01483, B01637, B01640, B01655, B01802, B01816, B01954, B01974, B01997,
B03500-B03524, B03526-B03536
RECALLING FIRM/MANUFACTURER Pulmonetic Systems, Inc., Minneapolis, MN
REASON Pulmonetic Systems has identified the potential of a printed circuit board malfunction, which can result in a ventilator malfunctio (e.g. Vent INOP, HW Fault, Xducer Fault) and possibly resulting in failure of the ventilator to breathe for the patient. This malfunction may occur without an accompanying audible alarm.
VOLUME OF PRODUCT IN COMMERCE 249 devices and 20 printed circuit boards
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Guidant INSIGNIA I Entra family of pacemakers includes the following: SSI (model numbers 0484 and 0485); DDD (models 0985, 0986); SR (models 1195, 1198); and DR (models1294, 1295, 1296). Intermedics NEXUS Entra family of pacemakers includes the following: SSI (model 1326); DDD (model 1426); SR (model 1398) and DR (model 1494). The INSIGNIA I Entra pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Entra pacemakers are multiprogrammable
pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering
adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. The INSIGNIA and NEXUS I Entra adaptive-rate models have an accelerometer, which is a motion sensor that
responds to patient activity. Sterilized with gaseous ethylene oxide.
b) Guidant INSIGNIA I Ultra family of pacemakers includes the following: SR (models1190); and DR (models1290, 1291). Intermedics NEXUS I Ultra family of pacemakers includes the following: SR (model 1390) and DR (model 1490, 1491). The INSIGNIA I Ultra pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Ultra pacemakers are multiprogrammable pacemakers from
Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate
therapy and providing various levels of therapeutic and diagnostic functionality. These pacemakers include
ventricular Automatic Capture which automatically measures the ventricular pacing threshold and adjusts
the pacing output to 0.5 V above the measured threshold. Two sensors are available: these adapt the pacing rate to the patient’s changing metabolic demand. Minute ventilation responds to changes in respiration, and
the accelerometer responds to patient activity (motion). INSIGNIA and NEXUS I Ultra models can use
either the accelerometer or minute ventilation sensor, or a blend of both accelerometer and minute ventilation.
Sterilized with gaseous ethylene oxide
c) Guidant INSIGNIA I Plus family of pacemakers includes the following: SR (models1194); and DR (models 1297, 1298). Intermedics NEXUS I Plus family of pacemakers includes the following: SR (model 1394) and DR (model 1467, 1468). The INSIGNIA I Plus pacemakers are multiprogrammable
pacemakers from Guidant. The NEXUS I Plus pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. Two sensors are available:
these adapt the pacing rate to the patient’s changing metabolic demand. Minute ventilation responds
to changes in respiration, and the accelerometer responds to patient activity (motion). INSIGNIA and
NEXUS I Plus models can use either the accelerometer or Minute ventilation sensor, or a blend of both
Accelerometer and minute ventilation. Sterilized with gaseous ethylene oxide. 
d) Guidant INSIGNIA I AVT family of pacemakers includes the following: SSI (model 482), VDD (model 882), DDD (model 982), SR (model 1192 and DR (model 1292). Intermedics NEXUS I AVT family of pacemakers includes the following: SR (model 1392). The INSIGNIA I AVT pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I AVT pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. These pacemakers include ventricular Automatic Capture which automatically measures the ventricular pacing threshold and adjusts the pacing output to 0.5 V above the measured threshold. The INSIGNIA and NEXUS I Plus adaptive-rate models have an accelerometer, which is a motion sensor that responds
to patient activity. Sterilized with gaseous ethylene oxide. 
CODE
a) Affected devices may be found in the following serial number ranges. INSIGNIA Entra SSI (model 0484)
serial no. 100879 - 115237; (model 0485) serial no. 100088 - 100104; NEXUS Entra SSI (model 1326)
serial no. 100122 - 100175. INSIGNIA Entra DDD (model 0985) serial no. 100059 - 100089; (model 0986) serial no. 100600 - 104439; NEXUS Entra DDD (model 1426) serial no. 100032 - 100091. INSIGNIA Entra SR (model 1195) serial no. 100739 - 101623; (model 1198) serial no. 102498 - 117468;
NEXUS Entra SR (model 1398) serial no. 100067 - 100120. INSIGNIA Entra DR (model 1294) serial no. 101132 --107445 & 292190; (model 1295) serial no. 100503 - 102668; (model 1296)
serial no. 101519 - 153064; NEXUS Entra DR (model 1494) serial no. 100028 & 100029;
b) INSIGNIA Ultra SR (model 1190) serial no. 889963 --891468; NEXUS Ultra SR (model 1390) serial no. 100007 --100034. INSIGNIA Ultra DR (model 1290) serial no. 105229; (model 1291) serial no. 100279 - 100913; NEXUS Ultra DR (model 1490) serial no. 100007, 100008, 100009, 100013, 100014, 100015, 100016, 100017, 100018; (model 1491) serial no. 100007, 100008, 100009, 100010, 100013, 100015, 100016, 100017, 100018;
c) INSIGNIA Plus SR (model 1194) serial no. 107477 --123441; NEXUS Plus SR (model 1394) serial no. 100072 -- 100130. INSIGNIA Plus DR (model 1297) serial no. 282034 - 294735; (model 1298)
serial no. 128040 - 889944; NEXUS Plus DR (model 1467) serial no. 100011 - 100060; (model 1468)
serial no. 100090 - 100276.
d) INSIGNIA AVT SSI (model 482) serial no. 100005 - 100324; INSIGNIA AVT VDD (model 882) serial no. 100006 - 100410; INSIGNIA DDD (model 982) serial no. 100007 - 100473;
INSIGNIA AVT SR (model 1192) serial no. 100008 --100473; NEXUS AVT SR (model 1392) serial no.
100016 and 100020; INSIGNIA AVT DR (model 1292) serial no. 100007 - 100798
RECALLING FIRM/MANUFACTURER
Recalling Firm: Guidant Corporation, St. Paul, MN
Manufacturer: Guidant-Ireland, Clomel, Ireland. 
REASON A failure mode occurring at a low rate, has been identified within the INSIGNIA and NEXUS families of implantable pacemakers. Device behaviors which may be observed include: Intermittent or permanent loss of pacing output without warning, intermittent or permanent loss of telemetry and appearance of a reset warning message upon interrogation.
VOLUME OF PRODUCT IN COMMERCE 52,079 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Guidant INSIGNIA I Entra family of pacemakers includes the following: SSI (model numbers 0484 and 0485); DDD (models 0985, 0986); SR (models 1195, 1198); and DR (models1294, 1295, 1296). Intermedics NEXUS Entra family of pacemakers includes the following: SSI (model 1326); DDD (model 1426); SR (model 1398) and DR (model 1494). The INSIGNIA I Entra pacemakers are
multiprogrammable pacemakers from Guidant. The NEXUS I Entra pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. The INSIGNIA and NEXUS I Entra adaptive-rate models have an accelerometer, which is a motion sensor that responds to patient activity. Sterilized with gaseous ethylene oxide,
b) Guidant INSIGNIA I Ultra family of pacemakers includes the following: SR (models1190); and DR (models 1290, 1291). Intermedics NEXUS I Ultra family of pacemakers includes the following: SR (model 1390) and DR (model 1490, 1491). The INSIGNIA I Ultra pacemakers are multiprogrammable pacemakers from Guidant.The NEXUS I Ultra pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. These pacemakers include ventricular Automatic Capture which automatically measures the ventricular pacing threshold and adjusts the pacing output to 0.5 V above the measured threshold. Two sensors are available: these adapt the pacing rate to the patient’s changing metabolic demand. Minute ventilation responds to changes in respiration,
and the accelerometer responds to patient activity (motion). INSIGNIA and NEXUS I Ultra models can use
either the accelerometer or minute ventilation sensor, or a blend of both accelerometer and minute ventilation.
Sterilized with gaseous ethylene oxide.
c) Guidant INSIGNIA I Plus family of pacemakers includes the following: SR (model 1194); and DR (models 1297, 1298). Intermedics NEXUS I Plus family of pacemakers includes the following: SR (model 1394) and DR (model 1467, 1468). The INSIGNIA I Plus pacemakers are multiprogrammable
pacemakers from Guidant. The NEXUS I Plus pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. Two sensors are available: these adapt the pacing rate to the patient's changing metabolic demand. Minute ventilation responds to changes in respiration, and the accelerometer responds to patient activity (motion). INSIGNIA and NEXUS I Plus models can use either the accelerometer or minute ventilation sensor, or a blend of both accelerometer and minute ventilation. Sterilized with gaseous ethylene oxide,
d) Guidant INSIGNIA I AVT family of pacemakers includes the following: SSI (model 482), VDD (model 882), DDD (model 982), SR (model 1192 and DR (model 1292). Intermedics NEXUS I AVT family of pacemakers includes the following: SR (model 1392). The INSIGNIA I AVT pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I AVT pacemakers are multiprogrammable
pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering
adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. These
pacemakers include ventricular Automatic Capture which automatically measures the ventricular pacing
threshold and adjusts the pacing output to 0.5 V above the measured threshold. The INSIGNIA and NEXUS I Plus adaptive-rate models have an accelerometer, which is a motion sensor that responds to patient activity. Sterilized with gaseous ethylene oxide,
CODE All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Guidant Corporation, St. Paul, MN
Manufacturer: Guidant-Ireland, Clomel, Ireland. 
REASON Another failure mode, which occurs at a low rate, has been identified with the INSIGNIA and NEXUS families of implantable pacemakers. Device behaviors which may be observed include; intermittent or permanent loss of pacing output without warning, intermittent or permanent loss of telemetry and appearance of a reset warning message upon interrogation.
VOLUME OF PRODUCT IN COMMERCE 341,00 (an estimated 145,000 active in the US)
DISTRIBUTION Nationwide and Internationally

PRODUCT LifeShield Latex-Free HEMA Blood PlumSet, Nonvented, 110 Inch with 210 Micron Filter, Prepierced Injection Site and OPTION-LOK, Dual Channel, Capped Secondary Port; a sterile Rx blood administration set for use with the Plum Series Infuser; list number 11235-03,
CODE Lot 25-086-5H
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira, Inc., Lake Forest, IL
Manufacturer: Abbott Laboratories de Costa Rica S.A., La Aurora de Heredia, Costa Rica. 
REASON Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.
VOLUME OF PRODUCT IN COMMERCE 17,184 units
DISTRIBUTION Nationwide, PR, Mexico and Australia

PRODUCT Analogic SyneRad Multi Digital Radiology System, Model AN6150,
CODE Serial Numbers: 3604-M0120; 5004-M0125; 3204-M0118; 5004-M0126; 4404-M0124; 3204-M0119; 3005-M0131; 2404-M0115; 2404-M0117; 0205-M0130; 3604-M0121; 3904-M0122; 5004-M0127; 3805-M0132; 2705-M0128; 3904-M0123; 0205-M0129
RECALLING FIRM/MANUFACTURER Analogic Corporation, Peabody, MA
REASON Potential weld defect in the Overhead Tube Support assembly which connects to the telescoping arm. This could cause the tube assembly to fall, leading to possible injury of the user or patient.
VOLUME OF PRODUCT IN COMMERCE 17 units
DISTRIBUTION AZ, CA, FL, MA, OH, PA, TN, and TX

PRODUCT
a) Damon 3 Bracket Upper Right lateral .022 slot This device is a fixed attachment on a tooth which
Holds an archwire during orthodontic treatment. Part Number 491-4210
b) Damon 3 Bracket Upper Right lateral .022 slot Part Number 491-4211,
CODE
a) Lot Number100512025 and 100512020;
b) Lot Number 100514071 and 100512012
RECALLING FIRM/MANUFACTURER Ormco Corporation, Glendora, CA
REASON Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance.
VOLUME OF PRODUCT IN COMMERCE 2980 units
DISTRIBUTION Nationwide

PRODUCT Self Contained Biological Indicator, product code SCRE-06
CODE Lot codes 643, exp. date 4/05 and lot 674, exp. 10/05
RECALLING FIRM/MANUFACTURER
Recalling Firm: Namsa, Northwood, OH
Manufacturer: Raven Biological Labs, Inc., Ralston, NB. 
REASON The certified Ethylene Oxide D-values of the lots cannot be confirmed to be within specification.
VOLUME OF PRODUCT IN COMMERCE Lot 643: 10/50 kit boxes; lot 674: 39 boxes
DISTRIBUTIONCA, OH, NH, WA, NJ, and Internationally

PRODUCT
a) Spectrum Patient Monitor, Physiological, Patient with arrhythmia detection or alarms. Monitor can
monitor, display, trend and print a patient’s physiological parameters. The device has a 12.1 inch
color display and has a standard configuration of a 3 or 5 lead ECG, Masimo SET SpO2, non-invasive blood pressure, respiration, continuous temperature and IV Drug Calculations. Optional digital displays are
provided for invasive blood pressure (up to four) anesthetic agents, O2 and NO2, ST, and CO2,
b) Passport 2 with View 12 ECG Analysis Module. It is a transportable, multi-parameter physiological
monitor designed to monitor and display the following physiological parameters: ECG, Heart Rate derived from selected sources (Sp)2, ECG, IBP and NIBP), SpO2 level, ST Segment, Arrhythmia, Blood pressure (both invasive and non-invasive), Respiration rate (dirived from ECG or CO2), inspired or expired CO2, temperature, and gases (i.e. five anesthetsia gases, O2, N2O, and CO2),
CODE
a) All Spectrum Monitors that have the following Software Versions: A.19, A.20, B.23, B.24, B.25, B.27, C.18, D.07, E.07, F.09, F.16, F.17, F.26;
b) Passport 2 Monitors with software versions: S.10, T.15, T.31, V.07, W.09, W.13, W.14
RECALLING FIRM/MANUFACTURER Datascope Corp, Mahwah, NJ
REASON Software anomalies which include shut down while printing, invalid diastolic blood pressure display, and incomplete and inaccurate interpretation reports of 12-Lead ECG data.
VOLUME OF PRODUCT IN COMMERCE 1507 monitors
DISTRIBUTION Nationwide and Internationally

Boston Scientific Announces Worldwide Recall of Stainless Steel Greenfield® Vena Cava Filters 

  Boston Scientific Corporation (NYSE: BSX)  announced that it is voluntarily recalling all Stainless Steel Greenfield® Vena Cava Filters with 12Fr Femoral Introducer Systems manufactured before March 10, 2004. 

This recall includes only the Stainless Steel Greenfield® Vena Cava Filter with 12Fr Femoral Introducer Systems manufactured prior to March 10, 2004. All unused devices with a “use before date” prior to March 2007 are to be returned to Boston Scientific. The product code for these devices under recall is M001505010. The product code and the use before date of the device are located on the box and pouch label. The total number of devices involved in this recall is estimated at 18,000.

The products affected by this recall were distributed to hospitals worldwide. Boston Scientific is notifying affected hospitals through detailed recall notification letters, including instructions on how to return recalled product.

Inquires may be directed to Boston Scientific at 888-272-1001.

WEEK ENDING DECEMBER 10

PRODUCT Fleixiflo Quantum Enteral Pump
CODE Serial numbers: 1003276, 1022603, 1025074, 1027378, 1028541, 1049161, 1056343, 1056908, 1057323, 1057967, 1058939, 1059103, 1059366, 1059614, 1059641, 1059857, 1059892, 1059945, 1060026, 1060188, 1061131, 1061355, 1061492.
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Columbus, OH
REASON Pumps have the potential to malfunction and result in a significant over-under delivery of enteral formula.
VOLUME OF PRODUCT IN COMMERCE 24 devices
DISTRIBUTION Nationwide

PRODUCT Vaporizer Plate Consumable accessory used with the STERRAD 100 and the STERRAD 100S,
CODE 20220 STERRAO 100 Accessory Kit 1.8 20221 STERRAO 100 Accessory Kit 2.0 20222 STERRAO 100 Accessory Kit 2.0 Same as 20221 except single ply paper 20223 STERRAO 1 DOS Accessory Kit A (For use with Block 1.8 STERRAO 100S) 20224 STERRAO 1 DOS Accessory Kit B (For use with Block 2.0 STERRAO 1 DOS) 20225 STERRAO 100S Accessory Kit C (For use with Block 2.0 STERRAO System & Block 1.8 STERRAO with Printer Up Qrade kit install 03-53045- 1- 001 Vaporizer Plate, Shelf Pac 03-05660- 0- 001
RECALLING FIRM/MANUFACTURER Advanced Sterilization Products, Irvine, CA
REASON The STERRAD 100 and the STERRAD 100S vaporizer plates are prone to displacement allowing micro-droplets of H2O2 to contact the load. If the vaporizer plate is dislodged, there is an increased chance for operators to have contact with H2O2 resulting in transient burns during the removal of the load.
VOLUME OF PRODUCT IN COMMERCE 5,365 kits
DISTRIBUTION Nationwide and Internationally

PRODUCT High voltage generator XTP-8100G and XTPG-8100G for the Infinx-I series interventional angiography system.
CODE All
RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Med Systems, Inc., Tustin, CA
REASON Arcing might occur in the transformer of the high voltage generator, XTP-8100G and XTBP-8100G displaying an error message and interrupting fluoroscopy.
VOLUME OF PRODUCT IN COMMERCE 30 units
DISTRIBUTION Nationwide

PRODUCT Baxter and Baxter Interlink Buretrol Solution Sets, a sterile fluid pathway of various lengths, 60 drops/mL, with 150 mL Burette Ball Valve, 2 injection sites and male luer lock adapter
CODE All lots of product codes 2C7546(S) and 2C7566(S), as well as A2C7572, A2C9568 and A2C9584 for the Australian market, JC7566 for the Canadian market, and VMC9602P for the European market.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corporation, Round Lake, IL
Manufacturer: Baxter Healthcare Corporation of Puerto Rico, Aibonito, PR. 
REASON The Buretrol solution sets are currently labeled as acceptable for use with the Colleague Volumertric Pump, but there is a potential for a non-detection of an upstream occlusion under certain conditions.
VOLUME OF PRODUCT IN COMMERCE 7,507,494 sets
DISTRIBUTION Nationwide and Internationally

PRODUCT Terumo Sarns brand Flexible arterial cannula, 7.5 mm (22 Fr) OD with 3/8 inch connector, suture ring, 9.5 inches (24 cm) long, catalog number 13020, sterile, single use only
CODE Lot numbers: 0385384 and 0386969
RECALLING FIRM/MANUFACTURER Terumo Cardiovascular Systems Corp, Ann Arbor, MI
REASON There may be a solvent bond failure at the tubing/connector site of the cannula, resulting in the disconnection of the cannula parts.
VOLUME OF PRODUCT IN COMMERCE 2,520
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) PROFlex Transporter, Model numbers 35PST. Catalog number is PT3565
b) PROFlex Transporter, Model numbes 35P. Catalog number is PT3550,
CODE All serial numbers beginning with the letter “L” and followed by a sequence of six numbers
RECALLING FIRM/MANUFACTURER Ferno-Washington Inc., Wilmington, OH
REASON The firm received complaints of the stretchers folding. A fold is when the stretchers lowers on its own to either the next position, or any of the other seven positions of the stretcher.
VOLUME OF PRODUCT IN COMMERCE 2,188 stretchers
DISTRIBUTION Nationwide

PRODUCT
a) AD5 table for use with Integris and Integris Allura x-ray systems,
b) AD6 table for use with Integris and Integris Allura x-ray systems. The AD6 is the tilt version
c) AD5 table, modified, used with the XPER x-ray systems. The modification on the table is the
cables used for connecting to the XPER systems.
d) AD6 table, modified, used with the XPER systems.The modification on the table is the cables used
for connecting to the XPER systems.
CODE Site numbers for all tables/units: 68168, X0941, 17508, 76380, 519874, 67597, 37872, 100641, 101610, 41222, 84827, 520582, 13093, 76463, 52479, 52480, 52482, X1036, 44969, X1620, 38936, 44808, X1135, 10105, 6820, 6833, 44976, 44975, 44977, 62834, 80330, X0915, X1237, 44821, 44825, 83663, 83664, 83665, 41128, 250073, 41117, 83019, 17334, 17488, 76378, 537466, 100328, X1438, 62377, 62459, 17470, 17547, 76595, 59675, 73426, 73962, 85633, 85635, 505356, 59418, 62653, 62968, 62968, 86456, 85058, 105961, 531926, 62921, X0103, 103763, X1527, 13891, 13980, 13732, 38186, 533857, 38728, 62770, 41109, 535775, 59390, 506008, 85090, 74011, 38592, 537175, X1222, X1732, X1733, X0187, X1313, X1566, X0408, X1646, 26108, 104565, 534565, 82609, 82612, 85096, 26063, 505453, 59610, 59611, 520949, 86068, 26137, 103957, 17651, 76257, 76323, 10439, 10440, 13117, 44848, 10495, 86289, 10325, 17502, 530658, 101609, 37894, 37937, 100704, 87024, 17633, 103420, X0975, X1496, 101135, 504871, 101040, 25979, 38385, 82635, 82636, 82637, 82638, 82639, 37908, 82640, 25908, 62765, 83840, 13294, X0409, X1067, 35593, 82528, 10329, 76411, 84791, 67580, 41330, 83323, 37880, 37964, 73987, 38949, 41423, 41461, 41221, 3580, 44877, 86427, 50312, 38862, 85678, 67486, 45026, 85126, 85131, 47185, 38932, 85415, 73903, 44714, 62376, 86580, 505380, 50419, 83949, 62977, 87324, 13118, 13539, 13644, 100485, 62544, 62668, X1474, 83016, 82665, 74061, 82692, 87055, 86087, 103282, 103283, 103380, 86322, 76198, 504468, 6738, 6814, 530660, 101589, 86135, 17313, 84715, 84716, 35500, 52470, 522136, 102715, 104382, 102870, 103002, X0377, 62306, 83823, 103214, X0886, X1324, X0078, X1695, 87339, 26095, X1557, 86598, 10464, 76327, 76328, 76343, 76445, 86936, 102746, 104403, 86429, 100685, 86431, X0042, 40917, 538194, X1547, 6777, X1724, 83311, 83327, 86196, 44752, 104383, 104384, 17382, 62530, 40929, 10482, 102348, 38373, 17492, 17599, 534155, 76465, 46879, 76360, 76360, 76511, 76512, 68211, 87012, 35473, 38356, 76872, 13631, 102179, 13631, 13035, 82706, 50129, 102664, 103445, 104416, X1358, 13289, 41425, 102650, 59423, 38681, 506509, 38181, 38182, 62891, 84467, 13731, 38925, 38926, 83833, 47127, 13577, 17625, 84790, X1158, X1159, 44774, 50152, 73917, 82526, 62787, 83605, 101938, 13719, 100823, 86367, 45060, 532241, 505886, 82633, 82642, 86585, 86599, 17497, 82915, 38352, 83040, 44766, 83313, 100841, 68044, 68159, 531939, 38879, 38882, 38903, 38904, 38905, 38906, 38907, 41458, 87317, 87318, 38935, 67428, 68231, 82576, 38788, 38795, 59377, 41478, 41480, 102676, X1643, X1687, 506060, 250581, 505520, 50197, 504636, 504638, 13702, 13511, 13512, 85498, 86603, 14026, 14029, 26179, 82615, 59302, 38642, 59380, 59421, 59422, 59710, 520701, 86450, 85120, 38358, 38359, 47138, 76335, 68254, 68255, 40905, 500041, 50184, 31023, 35303, 35617, 41288, 52465, 52472, 86061, 530656, 102855, 85042, 76217, 17596, 76459, 6783, 6784, 6785, 86253, 537181, 100701, 86144, 536639, 10478, 533541, 82950, 37959, 85501, 59548, 38637, 85676, 101239, 62798, 101238, 519673, 10390, 38919, 85020, 102863, 86914, 86934, 534879, 41293, 41294, 86398, 103212, 103213, 6660, 67433, 76999, 87023, 102629, X0626, X1738, X1736, 505611, 86935, 6739, 76830, 100262, 101606, 101607, 86066, 100261, 85488, 41154, 41155, 86022, 100657, 37924, 62792, 86434, 83015, 17380, 35356, 17500, 76486, 535173, 83996, 85179, 534252, 41153, 47187, 17519, 13109, 76575, 76594, 85095, 86981, 17458, 17457, 17327, 83855, 38933, 76962, 83607, 86572, 26286, 45051, 100811, 76931, 76932, 76933, 82691, 35319, 35434, 83310, 59659, 104201, 86149, 41019, 47042, 17578, 82643, X1327, 250334, 102707, 38386, 38387, 13617, 13670, 14101, 519212, 76831, 519767, 534268, 534270, 86577, X0969, X0973, X0974, 44779, 50222, 50223, 50224, 83807, 86126, 50335, 100432, 13997, 13107, 102908, X0434, X0902, 100612, 83399, 83399, 505270, 76546, 76545, 59709, X0036, 13065, 83659, X0939, 102808, 102810, X1186, X0384, X0043, X1064, X1065, 519676, 101612, 59552, 38868, 38934, 38941, 68157, 74016, 41163, 41164, 84436, 47190, 10391, 35308, 101873, 26295, 59296, 41328, 41329, 84843, 521918, 62669, 87070, 76813, 13452, 76986, 86136, 76558, 76559, 76560, 102809, 85692, 47139, 62435, 62436, 62804, 101583, 62299, 62524, 83632, 101952, 82664, 102193, 100658, 83821, 86575, 506541, 50142, 82676, 530396, 44857, 82814, 83054, 50389, 50392, 38290, 86319, 40224, 45045, 40406, 41026, 105073, 101036, 101434, 38329, 85195, 505077, X0913, 102868, X0146, 41018, 84443, 82823, 504646, 82645, 10104, 82917, 101465, X1558, 532152, 10277, 62390, 62519, 62892, 100948, 38017, 505064, 13688, 14010, 83841, 85092, 87603, 85689, 74046, 82543, 100949, 100950, 500052, 534159, 87530, X1066, X1339, 82522, 50083, 25993, 85106, 35447, 100839, 59551, 59698, 59699, 38339, 47141, 47188, 86321, 38297, 38297, 35281, 100606, 100607, 83667, 86989, 17474, 17475, 76528, 13044, 83994, 537644, 86057, 62940, 45077, 532383, 37910, 35463, 86129, 86992, 13615, 100881, 62976, 13863, 14021, 102161, 505135, 100945, 82711, 38416, 38109, 38110, 84378, 73885, 83882, 44712, 85055, 10454, 10463, 10465, 85098, 6837, 41269, 85416, 38986, 519199, 80325, 45058, 45059, 103022, 506026, 17453, 76557, 85497, 26060, 101566, 67430, 38948, 102612, 76500, 62636, 62638, 62639, 86502, 86502, 13462, 531649, 38554, 59360, 534756, X1223, 68151, 13441, X1483, 102677, 250338, X0436, X1546, 102871, X1511, X0351, 13461, 535202, 13937, 13634, 52485, 38928, 505803, 505807, 44767, 44768, 50202, 82591, 13883, 100840, 41455, 41475, 13589, 13590, 13716, 13743, 13982, 85129, 26117, 85634, 86145, 62833, 13664, 13502, 13683, 40217, 102949, 103327, 6643, 76917, 86063, 84789, X0041, X0202, X0338, X1168, 102673, 532653, 13629, 13756, 6995, 6996, 6818, 50147, 534874, 25952, 17472, 17472, 41139, 504664, 6867, 86290, 41017, 86189, 17504, 17505, 76514, 519536, 535387, 533290, X0134, X0151, 6602, 83926, 38261, 85015, 100316, 6951, X0179, 521525, 76148, 100611, X1227, 86424, 74044, 17598, 13710, 62335, 85016, 86341, 6652, 6654, 38146, X1232, 103144, 86494, 83670, 86488, 13530, 84826, 25999, 84447, 25965, 25973, 26064, 100865, 68002, 82575, 26268, 101567, 59490, 73927, 101949, 101216, 76992, 38937, 38937, 68154, 68156, 76992, 506009, X0079, 250300, 250674, 17628, 26159, 26160, 26161, 52466, 82822, 41145, 101615, 101928, 74080, 41207, 52488, 521313, 84852, 62557, 41355, 533397, 44820, 504655, 38918, 84734, 85008, 536471, 535250, X0063, X0066, 25992, 25935, 25948, 25989, 25992, 38376, 38377, 38378, 38406, 86169, 86170, 86171, 26204, 101110, 25895, 26218, 102243, 83309, 522224, 82539, 50180, 505252, 62483, 59434, 85639, 10313, 85010, 85011, 6946, 85018, 534786, 62528, 100496, 87315, 519136, 13259, 38757, 26048, 520623, X0104, X1389, 87334, 102096, 38916, 76987, X1341, 13043, 62559, 62871, 87300, 520688, 86576, 35441, 521562, 86420, 86420, 85107, 38789, X0683, 13046, 13699, 13992, 13993, 76214, 76460, 76462, 83924, 86495, 76489, 76490, 62648, 102032, 59364, 14147, 76527, 62955, 82709, X1584, 522456, 62320, 13482, 102158, 59557, 82517, 82592, 82523, 73912, X1269, X0712, 62238, 44791, 44966, 17291, 86295, 62975, 86537, 87316, 532148, 82699, 84752, X0978, X1164, 59501, 59383, 83842, 83875, 45066, 83024, 76365, 76324, 84489, 41460, 67628, 82572, 534380, X1699, 76520, 505250, 44854, 50125, 50388, 534108, 68214, 35410, 35411, 62920, 83081, 47269, 83013, 83028, 62649, 62651, 62967, 82909, 38964, 68171, 85409, 520964, 50203, 102523, 44327, 38355, 101617, 101618, 86982, 85197, 100812, 83993, 41079, 84821, 50310, 82593, 52464, 101564, 62340, 85499, 62835, 86540, 44946, 101160, 6849, 101205, 76497, 67587, 76955, 82537, 82577, 105908, 37923, 38028, 38062, 38204, 38205, 82661, 506121, 86433, 13990, 13106, 13108, 17529, 76454, 76547, 76574, 76576, 76577, 85087, 101945, 35489, 100470, X0044, 26006, 26007, 26094, 533848, 104325, X1484, X1498, 87528, 41116, X1185, 6571, 62424, 86435, 13734, X1494, 506655, 85137, 85190, X0051, 59396, 83863, 520189, 101037, 41114, 41115, 83023, 101619, 10441, 38733, 100645, 87081, 82824, 85640, X1637, X1315, X1316, X1688, 86505, 101575, 86422, 41406, 52451, 41374, 31001, 41191, 532218, 86088, 505804, 41103, 41104, X1335, X1499, 519678, 41150, 41242, 100783, 52476, 52477, 59275, 83861, 83862, 38573, X0069, X1665, 83322, 83324, 44689, 50371, 50373, 50405, 102572, X1146, 102098, 13113, 84714, 50231, 87004, 101430, 86994, 52463, X0040, 104480, 14068, 103034, 25998, 26076, 62999, 59703, 87337, X1486, X1491, X1493, 38754, 102714, 102790, 505680, 59520, 505008, 13570, 14168, 100585, 102418, 82945, 100869, 76525, X0374, X1684, 47089, 531758, 102094, 76953, 105866, X1528, 83822, 82696, 84445, 38276, 102180, X1794, 101077, X1228, 100475, 14044, 84721, 26062, 38425, 38426, 102817, 85128, 38718, 38719, 536173, 85641, 13114, 13685, 84487, 26069, 26073, 84481, 100486, 100487, X0017, 103447, 38702, 38703, 38704, 38705, 62998, 17369, 37883, 37884, X1476, 59311, 83834, 86421, 26217, 62942, 62948, 85004, 13628, 13720, 85013, 100630, 13240, 13595, 13596, 103005, 76521, 76522, 44697, 50433, 62625, 62806, 86419, 14145, 102842, 101078, 105422, 13484, 76397, 76398, 530464, 530668, 505650, 10166, 13242, 13485, 13914, 13915, 41027, 13463, 13878, 10431, 13627, 13689, 13633, 13639, 102160, 102162, 13890, X1235, 103255, 38336, 520840, X0893, 82916, 76133, 40344, 520526, 38531, 38532, 38533, 59391, 82542, 76832, 76873, 6778, 6949, 532240, 100521, 44860, 25964, 26072, 519730, 84823, 84845, 504908, 38203, 38206, 37988, 38201, 40389, 40390, 10430, 13296, 13599, 80310, 80315, 100656, 76442, 86971, 86972, 62627, 62628, 44791, 13292, 102166, 84998, 87084, X1717, X1718, X0016, X0767, X1246, 13483, 13941, 13592, 85057, 50030, 86360, 6917, 6547, 6770, 6875, 6876, 6911, 76870, 44896, 50187, 85150, 85169, 25835, 13562, 13954, 13994, 50305, 50306, 40938, X1716, 10442, 76443, 76342, 102001, 85041, 91650, 6733, 86975, 76325, 100696, 102000, 506693, 76918, 519868, 10288, 100862, 100861, 100864, X1492, X0093, 37970, 26061, 38389, 87319, 17612, 76505, 50438, 82520, 82521, 82719, 82514, 84713, 38199, 44973, 76572, 506069, 76580, 44971, 44972, 59300, 62773, 25950, 59400, 26293, 101073, 85135, 45104, 41129, 47006, 86332, 62460, 62969, 44763, 73988, 85643, 44719, 40132, 41028, 101620, 82825, 10100, 47110, 532234, 103182, 100610, 82589, 62339, 104410, X1035, 38080, 59366, 86991, 86993, 102869, 85638, 45072, 100961, 86252, 519118, 38437, 505706, 6821, 35427, 35485, 80305, 44978, 50145, 50339, 83904, 500004, 13519, 13557, 86536, 86542, 6753, 84828, 84829, 102823, 10414, 76867, 44844, 44842, 44845, 44850, 505068, 82812, 25849, 41224, 76883, 76884, 76885, 76886, 102083, 102995, X0731, 80320, 80322, 80323, X1685, X1686, 102037, 6607, 6869, 6962, 102038, 59527, 73950, 74012, 74013, 50185, 50186, 534545, 13534, 87366, X1224, 100719, 103015, 40307, 50332, 17626, 17627, 76084, 38755, 62637, 62786, 62803, 59271, 59310, 59373, 62655, 87068, 87069, 41141, 530466, 76395, 76471, 521154, 13230, 104341, 102632, 13290, 76941, 76503, 76504, 62805, 62606, 102874, 104345, 41479, 62493, 62531, 45047, 45048, 41176, 41268, 100683, 47106, 100327, 100875, 105684, 44740, 50374, 50375, 101208, 86506, 59379, 44698, 44886, 44809, 26158, 59368, 6957, 76510, 17514, 76455, 10403, 13503, 62521, 6967, 50311, 50345, 102558, 86065, 76387, 250333, X1342, 41050, 38790, 38792, 531799, 103211, 85196, 62521, 506369, 519196, 521310, 47168, 47169, 47046, 47140, 87013, X1596, 86581, 62386, 101966, 13910, 26109, 6803, 6839, 85070, 76389, 35488, 519981, 41020, 41021, 85130, 40131, 100788, 76555, 41430, 76995, 102778, 520756, 506469, 85133, 35450, 41405, 41409, 41411, 35318, 41151, 41266, 80327, 100613, 35354, 35448, 41178, 41267, 41336, 41340, 41341, 41385, 103147, 86539, 86538, 83026, 38298, 6944, 76880, 76882, 6788, 86953, 41272, 59346, 535777, 10455, 10462, 13575, 13605, 504868, 6671, 59301, 82815, 86578, 86583, 86584, 83927, 73908, 26288, 26289, 62772, 44784, 83838, X1525, X0889, 76346, 17528, 62508, 62774, 62775, 62776, 62779, 62671, 86437, 87364, 506048, 62670, 62941, 86415, 100714, 35436, 35505, 41335, 76184, 74053, 73963, 82608, 41424, 86172, 533394, 534131, 86272, 87179, 101973, 505363, X0609, X0610, X1268, 83326, 25974, 26144, 26264, 504344, 101309, 83375
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co, Phillips, Bothell, WA,
Manufacturer: Philips Medical Systems, Netherlands. 
REASON Potential for high voltage exposure involving the injector interface connector of patient support tables.
VOLUME OF PRODUCT IN COMMERCE 1,793 devices
DISTRIBUTION Nationwide

PRODUCT
a) CryoValve, Alt Aortic Valve & Conduit, Donor #30436, Model #AV05, Donor #30676, Model #AV05
b) CryoValve, Alt Pulmonary Valve, Donor #29892, Model #PV15
c) CryoValve, Alt Pulmonary Valve & Conduit, Donor #28776, Model #PV05, Donor #29275,
Model #PV05, Donor #30815, Model #PV05,
d) CryoValve, Aortic Valve, Donor #28956, Model #AV10
e) CryoValve, Aortic Valve & Conduit, Donor #29051, Model #AV00, Donor #67609, Model #AV00,
Donor #68422, Model #AV00, Donor #69368, Model #AV00, Donor #69826, Model #AV00,
Donor #69934, Model #AV00, Donor #30373, Model #AV00
f) CryoValve, Aortic Valve & Conduit SG, Donor #66126, Model #SGAV00, Donor #66858,
Model #SGAV00, Donor #67001, Model #SGAV00, Donor #67404, Model #SGAV00,
g) CryoValve, Pulmonary Valve, Donor #29558, Model #PV10, Recall # Z-0216-06;
h) CryoValve, Pulmonary Valve & Conduit, Donor #68206, Model #PV00, Donor #68241,
Model #PV00, Donor #68422, Model #PV00, Donor #69368, Model #PV00, Donor #69826,
Model #PV00, Donor #69934, Model #PV00, Donor #67086, Model #PV00, Donor #30309,
Model #PV00
i) CryoValve, Pulmonary Valve & Conduit SG, Donor #65569, Model #SGPV00, Donor #66126,
Model #SGPV00, Donor #67001, Model #SGPV00, Donor #67404, Model #SGPV00, Donor #61482,
Model #SGPV00, Donor #66320, Model #SGPV00, Donor #66035, Model #SGPV00
CODE
a) Serial #6230415, Serial #6231586;
b) Serial #6202748,
c) Serial #6162886, Serial #6180566, Serial #6235387;
d) Serial #6169392;
e) Serial #6170536, Serial #7966771, Serial #8047328, Serial #8022381, Serial #8071460, Serial #8059698, Serial #6216684;
f) Serial #8111039, Serial #7988012, Serial #7996690, Serial #7972081;
g) Serial #6190065;
h) Serial #7960244, Serial #7971710, Serial #8047344, Serial #8022398, Serial #8047344, Serial #8022398, Serial #8071361, Serial #8059703, Serial #7993957, Serial #6218156;
i) Serial #7949899, Serial #8111048, Serial #7996682, Serial #7972091, Serial #7692521, Serial #8099887, Serial #8103460
RECALLING FIRM/MANUFACTURER Cryolife Inc, Kennesaw, GA
REASON Previously released tissues no longer meet CryoLife’s enhanced suitability release criteria because donors possessed a positive post processing microbiological culture of “potentially pathogenic” organisms.
VOLUME OF PRODUCT IN COMMERCE 34 units
DISTRIBUTION Nationwide

PRODUCT Product is a Pruitt Aortic Occlusion Catheter contained in a molded tray. The product is labeled in part: "***LeMaitre VASCULAR** FL 33713***Pruitt Aortic Occlusion Catheter***REF 2101-12***STERILE***"
CODE Lot No: 1010505-07, 1010505-08, 1030404-09, 104104-05, 1041404-06, 1042204-12, 1042704-01, 1042704-03, 1052204-01, 1061404-04, 1061404-05, 1070204-03, 1080204-08, 1082304-06, l100604-01, l100704-01, l120104-02, l121604-04
RECALLING FIRM/MANUFACTURER LaMaitre Vascular, Inc., St Petersburg, FL
REASON LeMaitre Vascular is recalling certain lots of its Pruitt Aortic Occlusion Catheters due to a packaging defect which could compromise product sterility.
VOLUME OF PRODUCT IN COMMERCE 1,919 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Advisor Vital Signs Monitor (model 9200), catalog number 920634235, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1)with 3-lead 60 Hz ECG, standard SPO2 option, printer and battery;
b) Advisor Vital Signs Monitor (model 9200), catalog number 920654230, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) with 3-lead 60 Hz ECG, standard SPO2 option, and printer;
c) Advisor Vital Signs Monitor (model 9200), Catalog number 920654235, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) with 3-lead 60 Hz ECG, standard SPO2 option, printer and battery
d) Advisor Vital Signs Monitor (model 9200), catalog number 920654335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1)3-lead 60 Hz ECG, standarn SPO2, Invasive pressure/temperature option, printer and battery,
e) Advisor Vital Signs Monitor (model 9200), catalog number 920655235, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) 3-lead 60 Hz ECG, Nellcor SPO2 option, printer and battery
f) Advisor Vital Signs Monitor (model 9200), catalog number 920754235, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) 5-lead 60 Hz ECG, standard SPO2 option, printer and battery
g) Advisor Vital Signs Monitor (model 9200), catalog number 925454220, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) CE/MDD marking, 3-lead 50 Hz ECG and standard SPO2 option
h) Advisor Vital Signs Monitor (model 9200), catalog number 925454225, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) CE/MDD marking, 3-lead 50 Hz ECG, Standard SPO2 option and battery
i) Advisor Vital Signs Monitor (model 9200), catalog number 925454325, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) CE/MMD marking, 3-lead 50 Hz ECG, standard SPO2 option, Invasive Pressure/Temp option and battery,
j) Advisor Vital Signs Monitor (model 9200), catalog number 925454335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) EC/MDD marking, 3-lead 50Hz ECG, standard SPO2 option, Invasive Pressure/Temperature
option, printer and battery
k) Advisor Vital Signs Monitor (model 9200), catalog number 925474335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) CE/MDD marking, 3-lead 50 Hz ECG, standard SPO2 option, Invasive Pressure/Temperature
option, printer and battery,
l) Advisor Vital Signs Monitor (model 9200), catalog number 925534325, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) CE/MDD marking, 5-lead 50 Hz ECG, standard SPO2 option, Invasive Pressure/Temperature and battery
m) Advisor Vital Signs Monitor (model 9200), catalog number 925654320, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) CE/MDD marking, 3-lead 60 Hz ECG, standard SPO2 option and Invasive Pressure/Temperature option
n) Advisor Vital Signs Monitor (model 9200), catalog number 925654335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) CE/MDD marking, 3-lead 60 Hz ECG, standard SPO2 option, Invasive Pressure/Temperature
option, printer and battery,
o) Advisor Vital Signs Monitor (model 9200), catalog number 925674325, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) CE/MDD marking, 3-lead 60 Hz ECG, standard SPO3 option, Invasive Pressure/Temperature and battery
p) Advisor Vital Signs Monitor (model 9200), catalog number 925754220, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) CE/MDD marking, 5-lead 60 Hz ECG and standard SPO2 option;
q) Advisor Vital Signs Monitor (model 9200), catalog number 925754225, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) CE/MDD marking, 5-lead 60 Hz ECG, standard SPO2 and battery
r) Advisor Vital Signs Monitor (model 9200), catalog number 925754325, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) CE/MDD marking, 5-lead 60 Hz ECG, standard SPO2 option, Invasive Pressure/Temperture option, printer and battery
s) Advisor Vital Signs Monitor (model 9200), catalog number 92D654335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) 3-lead 60 Hz ECG, standard SPO2 option, Invasive Pressure/Temperature, printer and battery,
t) Advisor Vital Signs Monitor (model 9200), catalog number 92D754335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) 5-lead 60 Hz ECG, standard SPO2 option, invasive Pressure/Temperature, printer and battery,
u) Advisor Vital Signs Monitor (model 9200), catalog number 92E654335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) 3-lead 60 Hz ECG, standard SPO2 option, invasive Pressure/Temperature option, printer and
battery
CODE
a) AM05070149, AM05070150, AM05070151;
b) Serial number: AM05070100, AM05070101, AM05070102, AM05070103, AM05070104, AM05070105, AM05070106, AM05070107, AM05070108, AM05070109, AM05070110, AM05070111 and AM05070112;
c) Serial number: AM05070166;
d) Serial number: AM05070144;
e) Serial numbers: AM05070146; AM05070147, AM05070148; AM0580001, AM0580002, AM0580003, AM0580004, AM0580005, AM0580006 and AM0580007;
f) Serial numbers AM05070167 and AM05070168;
g) Serial number: AM05070061;
h) Serial number: AM05070145;
i) Serial numbers: AM05070083, AM05070084, AM05070085, AM05070086, AM05070087 and AM05070089;
j) Serial numbers: AM05080012 and AM05080013;
k) Serial numbers: AM05080008, AM05080009, AM05080010 and AM05080011;
l) Serial numbers: AM05070039, AM05070043, AM05070044, AM05070045, AM05070046, AM05070047, AM05070048, AM05070049, AM05070050, AM05070051 and AM05070052;
m) Serial numbers: AM05070196, AM05070197, AM05070198, AM05070199, AM05070200, AM05070201, AM05070202, AM05070203, AM05070204, AM05070205 and AM05080023;
n) Serial numbers: AM05070171, AM05070172, AM05070173, AM05070174 and AM05070175;
o) Serial numbers: AM05070113, AM05070114, AM05070115, AM05070116, AM05070117, AM05070118, AM05070119, AM05070120, AM05070121 and AM05070122;
p) Serial number: AM05070123;
q) Serial number: AM05070169 and AM05070170;
r) Serial numbers: AM05070124, AM05070125, AM05070126, AM05070127, AM05070130, AM05070131, AM05070132, AM05070133, AM05070134, AM05070135, AM05070221, AM05070222, AM05070224, AM05070225, AM05070226, AM05070227, AM05070228, AM05070229, AM05070230 and AM05070231;
s) Serial number: AM05070136;
t) Serial number: AM05070143;
u) Serial number: AM05080016
RECALLING FIRM/MANUFACTURER Smiths Medical PM, Inc., Waukesha, WI
REASON Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace detect function is turned on and the primary lead is set to Lead II, III or any of the augmented leads, AVL, AVR or AVF on the Advisor monitor.
VOLUME OF PRODUCT IN COMMERCE 107 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Gamma3 Long Nail Kit, 120 degree, 11 x 320mm Right, Catalog 3220-0320S and 125 degree catalog number 3225-0360S
CODE Lot code K949396, Lot code K949408
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ.
Manufacturer: Stryker Trauma, Kiel, Germany. 
REASON The Gamma Nail manufactured with an incorrect lag screw hole angulation. Catalog number 3220-0320S, Lot code K949396 was manufactured with a lag screw hole angulation of 120 degrees instead of 125 degrees. Catalog number 3225-0360S, Lot code K949408 was manufactured with a lag screw hole angulation of 125 degrees instead of 120 degrees.
VOLUME OF PRODUCT IN COMMERCE 19 kits
DISTRIBUTION Nationwide

PRODUCT
a) Portex 4902 Glass L.O.R. Syringe,
b) Portex 4903 Glass L.O.R. Syringe,
c) Portex 4904 Glass L.O.R. Syringe,
d) 4950-16 Portex Epidural Mini-pack,
e) 4950-17 Portex Epidural Mini-pack,
f) 4950-18 Portex Epidural Mini-pack,
g) 4954-16 Portex Epidural Mini-pack,
h) 4954-17 Portex Epidural Mini-pack,
i) A1272-17 Portex Epidural Mini-pack,
j) A1378-18 Portex Epidural Mini-pack,
k) A1967-18 Portex Epidural Mini-pack,
l) A1991-18 Portex Epidural Mini-pack,
m) A2549-22 Spinal Needle
n) A3176-18 Portex Epidural Mini-pack,
CODE
a) Lot Numbers; 102151, 103108, 103218, K132627, K148054, K156266, K163449, K176543, K197127, K211492, K535999, K555552, K586403, K626840, K667012, K678478, K705482;
b) Lot Numbers: 102517, K154089, K211495, K222113, K512485, K522220, K538711, K559480, K573554, K618300, K643592, K669735, K686834, K700785;
c) Lot Numbers: 102518, K163468, K176555, K510385, K520203, K529939, K532723, K533729, K586882, K633942, K675421, K676747, K681955, K682698;
d) Lot Numbers: 101219, 103102, 105025, 106337, 109045, 110699, 111198, K110057, K110924, K124484, K128817, K132629, K141382, K144904, K147200, K148053, K157883, K160686, K163440, K189808, K211510, K221874, K511628 4950-17;
e) Lot Numbers: 101146, 101452, 105024, 107076, 109224, 111199, K110058, K121072, K124485, K128818, K132630, K141613, K143220, K147085, K151519, K163451, K180107, K189821, K211507, K223552, K527934, K541698, K558498, K598204, K632932, K638749, K642968, K656458, K699000;
f) Lot Numbers: 101609, 102516, 103474, 104171, 107437, K128819, K148055, K156254, K542470;
g) Lot Numbers: K171983, K189454, K204089, K221871, K504917, K508494, K515834,
K519834, K522275, K525643, K529958, K547910, K549185, K629253, K632933,
K636834, K643593, K645615, K655989, K656463;
h) Lot Numbers: K167341, K184428, K197145, K209523, K222123, K502514, K512986, K517133, K523565, K525700, K529957, K554390, K558495, K573614, K630925, K633623, K656459, K673351, K688226, K704809;
i) Lot Numbers: 104084, 106642, 109225, 110490, 111564, K114323, K122390, K139141, K140940, K144881, K149138, K153136, K159840, K165909, K169546, K177950, K189450, K195968, K209079, K216388, K223346, K501076, K504897, K507099, K510126, K513437, K521324, K523542, K525641, K535225, K537099, K544240, K554384, K582148, K620716, K631306, K632931, K634625, K646389, K646391, K656284, K674392, K683683,
K696769, K699269, K704805;
j) Lot Numbers: 012383, 101306, 106641, 111202, K128822, K141918, K147447, K171974, K207397, K511073, K558479, K658947;
k) Lot Numbers: K143207, K620710, K696763;
l) Lot Numbers: 101610, 103217, K510133;
m) Lot Number: 109345;
n) Lot Numbers: K534360, K547115, K671715, K687779;
RECALLING FIRM/MANUFACTURER Smiths Medical ASD, Inc., Keene, NH
REASON Tray may contain holes compromising the sterility of the device.
VOLUME OF PRODUCT IN COMMERCE 84,651 units
DISTRIBUTION Nationwide

PRODUCT Long Length Dyax Nail, Catalog No. 1594-4430S
CODE Lot number: K559623
RECALLING FIRM/MANUFACTURER
Recalling Firm: Styker Howmedica Osteonics Corp, Mahwah, NJ.
Manufacturer: Stryker Trauma, Kiel, Germany..
REASON Device was manufactured with a lag screw hole angulation of 135 degrees rather than 130 degrees.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION Nationwide

PRODUCT
a) TLC Self -Retaining Retractor System-Single Product Code: 820-175
b) TLC Self -Retaining Retractor System-5/box Product Number:820-176
c) TLC Retractor and Single Step Pelvic Drape (contains 1 Product Code 820-175) Product Code: 820-177
d) Precision Twist Transvaginal Sling Kit with Non-Absorbable, Polybutester Monofilament Suture (contains 1 Product Code 820-175) Product Code: 820-172
e) Precision Tack Transvaginal Sling Kit with Non-Absorbable, Braided Polyester Suture (contains 1 Product Code 820-175) Product Code: 820-171
f) Capio CL Kit Transvaginal Suture Capturing Device (1TLC Retractor box) Product Code:831-130
g) Precision Tack Transvaginal Sling Kit with Non-Absorbable, Polybustester Monofilament Suture (contains 1 Product Code 820-175) Product Code: 820-124,
h) Precision Tack Transvaginal Sling Kit with Non-Absorbable, Braided Polyester Suture (contains 1 Product Code 820-175) Product Code: 820-123
CODE All lots codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corporation, Natick, MA
Manufacturer: Applied Medical Technology, Inc., Cleveland, OH. 
REASON Sterility of device compromised due to breach in packaging.
VOLUME OF PRODUCT IN COMMERCE 13,499 singles
DISTRIBUTION Nationwide

WEEK ENDING DECEMBER 17

PRODUCT Product labeled in part: "**Banicide ADVANCED, A Reusable Sterilizing & Disinfecting Solution***Active Ingredient: Glutaraldehyde (1,5 Pentanedial) 3.5%***NET CONTENTS: 3.8l (ONE U.S. GALLON)*** 
CODE The following 3 codes were recalled initially: (LOT EXP 110305, LOT EXP 110605, LOT EXP 110705) On October 3, 2005 the firm expanded the recall to include all product produced between October 2004 through August 2005. Following are all the recalled lot codes. 100105, 100205, 100305, 100405, 100505, 100605, 110105, 110205, 110305, 110405, 110505, 110605, 110705, 120105, 120205, 120305, 010106, 010206, 010306, 010406, 010506, 020106, 020206, 020306, 020406, 020506, 020606, 020706, 020806, 030106, 030206, 030306, 030406, 030506, 030606, 030706, 030806, 030906, 031006, 031106, 040106, 040206, 040306, 050106, 050206, 050306, 050406, 060106, 060206, 060306, 060406, 060506, 070106, 070206, 070306, 070406, 080106
RECALLING FIRM/MANUFACTURER Pascal Company, Inc., Bellevue, WA
REASON The product, Banicide Advanced, a reusable sterilizing and disinfecting solution, is likely to be ineffective for its intended use because testing found it failed testing for sporicidal use.
VOLUME OF PRODUCT IN COMMERCE 89,992 units (each unit is one gallon)
DISTRIBUTION Nationwide and Israel

PRODUCT Custom heart lung perfusion packs
CODE 210 unique catalog numbers with 779 unique lot numbers
RECALLING FIRM/MANUFACTURER Cobe Cardiovascular, Inc, Arvada, CO
REASON One way valve in the heart lung pack assembly may be missing.
VOLUME OF PRODUCT IN COMMERCE 21,512 units
DISTRIBUTION Nationwide

PRODUCT
a) Symphony DR model 2550 and ELA Rhapsody DR model 2510. A dual chamber rate-responsive pacemaker that uses both minute ventilation and accelerometer sensors. Sterilization with Ethylene Oxide Gas. Sorin Group, ELA medical, 98, rue Maurice Amoux, 92120 Montrouge --France. Made in France. b) ELA Rhapsody SR model 2210. A single chamber rate-responsive pacemaker that uses both minute
ventilation and accelerometer sensors. Sterilization with Ethylene Oxide Gas. Sorin Group, ELA medical, 98, rue Maurice Amoux, 92120 Montrouge - France. Made in France.
CODE
a) Symphony DR 2250 serial numbers: 238WG020, 243WG055, 246WG094, 246WG109, 250WG029, 303WG027, 303WG038, 303WG074, 303WG078, 306WG073, 309WG262, 314WG057, 315WG188 and 320WG220. Rhapsody DR 2510 Serial numbers: 318WJ010, 318WJ060 and 318WJ061;
b) Rhapsody SR 2210 Serial numbers: 244WE078, 249WE059, 309WE066, 309WE145, 316WE215, 316WE233 AND 321WE080
RECALLING FIRM/MANUFACTURER
Recalling Firm: ela Medical Llc, Plymouth, MN
Manufacturer: ELA Medical, S.A.S., Montrouge, France. 
REASON Through post-market surveillance, ELA Medical has observed that a no-output condition could occur in a limited number of Symphony or rhapsody pacemakers. The no-output condition could occur due to metal migration caused by a specific manufacturing process.
VOLUME OF PRODUCT IN COMMERCE 28
DISTRIBUTION Nationwide

PRODUCT Bard UroForce™ Balloon Dilation Catheter with Glissando™ Coating * BARD * Sterile/EO
CODE Catalog #887504, Lot #GFPG2394; Catalog #887510, Lot #GFPG2399; Catalog #887604, GFPG2401, GFPG2402, GFPG2403, GFPG2404, GFPG2405, GFPG2424; Catalog #887610, Lot #GFPF3439, GFPG2406; Catalog #888404, Lot #GFPG2409, Catalog #888604, Lot #GFPG2411, GFPH1415; Catalog #888510, Lot #GFPG2415, GFPH2024; Catalog #888604, Lot #GFPG2417, GFPG2418; Catalog #888610, Lot #GFPF3451
RECALLING FIRM/MANUFACTURER C.R. Bard, Urological Division, Covington, GA
REASON There is a potential for the lumen to collapse and prevent passage over a guidewire.
VOLUME OF PRODUCT IN COMMERCE 480 units
DISTRIBUTION Nationwide, Belgium, Canada

PRODUCT Abbott brand CELL-DYN 1800 DILUENT Packaged in 3.8L containers, List Numbers: 99226-01, 08H17-01,(on box), 99226-01, 08H17-02 (on bottle)
CODE (List Number On the Box---List Number On the bottle---Lot Number): 99226-01---99229-01---15632I2; 08H17-01---08H17-02---15631I2; 08H17-01---08H17-02---15661I2; 08H17-01---08H17-02---16823I2; 08H17-01---08H17-02---17906I2; 08H17-01---08H17-02---17907I2; 08H17-01---08H17-02---18089I2; 08H17-01---08H17-02---19184I2; 08H17-01---08H17-02---19296I2; 08H17-01---08H17-02---20413I2; 08H17-01---08H17-02---21540I2; 08H17-01---08H17-02---22739I2; 08H17-01---08H17-02---23889I2
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Santa Clara, CA
REASON The product failed 12-month stability testing that can lead to falsely reduced hemoglobin (Hgb) test results.
VOLUME OF PRODUCT IN COMMERCE 50,437 units
DISTRIBUTION Nationwide and Internationally

PRODUCT LifeScan OneTouch SureSoft Lancing Device, single use lancing device. 
CODE Part Number 021-139-01 OT SureSoft Hospital, Regular 200, Lot numbers, SW2764, SW3427, SW2779, SW2785, SW3339, SW3342, SW3394, SW3395. Part number 021-140-01, OT SureSoft Hospital, Gentle 200, Lot numbers, SW2846, SW2833, SW2774, SW2868, SW2834, SW2765, SW2869, SW2894, SW2896.
RECALLING FIRM/MANUFACTURER Lifescan Inc, Milpitas, CA
REASON In some cases, the needles in the single use lancing device may not retract, causing a potential for needle sticks.
VOLUME OF PRODUCT IN COMMERCE 1,301 boxes
DISTRIBUTION Nationwide and Canada

PRODUCT KODAK DirectView DR 7100 System, Catalog # 133-6049. This is a digital radiology system. The major components are: operator console; digital imaging capture device; tilting table with floating top; ceiling-mounted x-ray tube; x-ray generator timing and distribution unit. 
CODE s/n DR71000121 and DR71000123.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Eastman Kodak Co, Rochester, NY
Manufacturer: Analogic Corporation, Peabody, MA. 
REASON Potential weld defect in the Overhead Tube Support assembly which connects the tube assembly to the telescoping arm. This could cause the tube assembly to fall, injuring anyone near the unit.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION FL, KY, MI, NY, OH, PA, and SC and China

PRODUCT Fusion OMNI- GT * DOME TIP: ERCP Catheter: 6.0 FR./200 CM. 8 Minimum Accessory Channel: 4.2 MM * Disposable - Single Use Only * Compatible Wire Guide: .035” * Rx Only, 
CODE Lot number: W2073307, W2073308, W2074626, W2074627, W2074628, W2074629, W2074630, W2075126, W2075127, W2075128, W2075129, W2075130, W2076301, W2076302, W2076303, W2076304, W2076305, W2076306, W2076843, W2076844, W2076845, W2076846, W2076847, W2076848, W2076849, W2076850, W2076851, W2076852, W2076853, W2076854, W2076855, W2076856, W2076857, W2101351, W2103706, W2104274, W2104275, W2108267, W2108774, W2109312, W2109313, W2111333, W2114602, W2114603, W2116350, W2118471, W2121588, W2121589, W2122051, W2122052, W2122053, W2124537, W2125592, W2125593, W2125594, W2125595, W2129956, W2125597, W2129958
RECALLING FIRM/MANUFACTURER Wilson-Cook Medical Inc, Winston Salem, NC
REASON Misbranded; The catheter size listed on the product label is 6 French, which is inaccurate. The catheter size is 7 French.
VOLUME OF PRODUCT IN COMMERCE 1045 units
DISTRIBUTION Nationwide and Internationally

PRODUCT LifeScan OneTouch Ultra Primary Care Physician Demo Kits, Blood Glucose Meter, 
CODE Listing Number B026094, Code 90273 Kaban, all demo kits shipped between 04/08/2005 and 08/23/2005
RECALLING FIRM/MANUFACTURER Lifescan Inc, Milpitas, CA,
REASON Users may inadvertently change units of measurement on demonstration kits of the OneTouch Ultra Blood Glucose Meters.
VOLUME OF PRODUCT IN COMMERCE 2843 units
DISTRIBUTION Nationwide

PRODUCT LifeScan brand OneTouch Ultra Test strips, 25 strips per vial, part number 020-245-07, CODE Lot number 2591755
RECALLING FIRM/MANUFACTURER Lifescan Inc, Milpitas, CA
REASON Vials of OneTouch Ultra Test Strips marked with quantities of 25 per vial actually contain only 10 strips.
VOLUME OF PRODUCT IN COMMERCE 5799 vials
DISTRIBUTION NY, KY, MO, AL, TN, LA and IL

Endologix Announces Voluntary Recall of Powerlink System Delivery Catheter

 Endologix, Inc. announced that it is voluntarily conducting a product recall of selected Powerlink® System delivery catheters marketed in the U.S., which are used to deliver the Company's minimally invasive treatment for abdominal aortic aneurysms (AAA). This action does not include the Powerlink stent grafts that have been implanted in patients. In addition, it does not include the large diameter 34 mm Powerlink System being evaluated under an investigational device exemption or Powerlink Systems sold outside of the U.S., as both of these Systems utilize a different delivery catheter.

WEEK ENDING DECEMBER 24

PRODUCT Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R
CODE All Serial numbers beginning with 20000
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corporation, Renal Division, McGaw Park, IL
Manufacturer: Baxter Healthcare Corporation, Largo. FL. 
REASON Inadequate instructions for routing single tubing lines through the double-tubing clips on the front of the instrument to eliminate the risk of kinks in the tubing, which have been associated with a death and a serious injury.
VOLUME OF PRODUCT IN COMMERCE 2,838 units
DISTRIBUTION Nationwide, Mexico and Asia

PRODUCT
a) Guidant INSIGNIA I Entra family of pacemakers includes the following: SSI (model numbers 0484 and 0485); DDD (models 0985, 0986); SR (models 1195, 1198); and DR (models1294, 1295, 1296). Intermedics NEXUS Entra family of pacemakers includes the following: SSI (model 1326); DDD (model 1426); SR (model 1398) and DR (model 1494). The INSIGNIA I Entra pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Entra pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. The INSIGNIA and NEXUS I Entra adaptive-rate models have an accelerometer, which is a motion
sensor that responds to patient activity. Sterilized with gaseous ethylene oxide.
b) Guidant INSIGNIA I Ultra family of pacemakers includes the following: SR (models1190); and DR (models1290,1291). Intermedics NEXUS I Ultra family of pacemakers includes the following: SR (model 1390) and DR (model 1490, 1491). The INSIGNIA I Ultra pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Ultra pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. These pacemakers include ventricular Automatic Capture which automatically measures the ventricular pacing threshold and adjusts the pacing output to 0.5 V above the measured threshold. Two sensors are available: these adapt the pacing rate to the patient’s changing metabolic demand. Minute ventilation responds to changes in respiration, and the accelerometer responds to patient activity (motion). INSIGNIA and NEXUS I Ultra models can use either the accelerometer or minute ventilation sensor, or a blend of both accelerometer and minute ventilation. Sterilized with gaseous ethylene oxide.
c) Guidant INSIGNIA I Plus family of pacemakers includes the following: SR (model 1194); and DR (models1297, 1298). Intermedics NEXUS I Plus family of pacemakers includes the following: SR (model 1394) and DR (model 1467, 1468). The INSIGNIA I Plus pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Plus pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. Two sensors are available: these adapt the pacing rate to the patient's changing metabolic demand. Minute ventilation responds to changes in respiration, and the accelerometer responds to patient activity (motion). INSIGNIA and NEXUS I Plus models can use either the accelerometer or minute ventilation sensor, or a blend
of both accelerometer and minute ventilation. Sterilized with gaseous ethylene oxide. 
d) Guidant INSIGNIA I AVT family of pacemakers includes the following: SSI (model 482), VDD (model 882), DDD (model 982), SR (model 1192 and DR (model 1292). Intermedics NEXUS I AVT family of pacemakers includes the following: SR (model 1392). The INSIGNIA I AVT pacemakers are multiprogrammable pacemakers from Guidant.The NEXUS I AVT pacemakers are multiprogrammable
pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality.
These pacemakers include ventricular Automatic Capture which automatically measures the ventricular
pacing threshold and adjusts the pacing output to 0.5 V above the measured threshold. The INSIGNIA and NEXUS I Plus adaptive-rate models have an accelerometer, which is a motion sensor that responds to patient activity. Sterilized with gaseous ethylene oxide.
CODE All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Guidant Corporation, Saint Paul, MN
Manufacturer: Guidant-Ireland, Clomel, Ireland. .
REASON Another failure mode, which occurs at a low rate, has been identified with the INSIGNIA and NEXUS families of implantable pacemakers. Device behaviors which may be observed include; intermittent or permanent loss of pacing output without warning, intermittent or permanent loss of telemetry and appearance of a reset warning message upon interrogation.
VOLUME OF PRODUCT IN COMMERCE 341,000
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Liko UNO 100 Patient Lift
b) Liko UNO 102 Patient Lift
c) SABINA I and SABINA II Patient Lift
CODE
a) S/N Range: 7090602-7093161;
b) Serial Numbers: 33590-42291;
c) Serial Numbers: 401205-414442
RECALLING FIRM/MANUFACTURER
Recalling Firm: Liko, Inc, Franklin, MA
Manufacturer: Liko AB, Lulea, Sweden. 
REASON Incorrect length leg pin bolts may cause patient lift failures.
VOLUME OF PRODUCT IN COMMERCE 3,141 units
DISTRIBUTION Nationwide

PRODUCT StrykeFlow II Disposable Suction/Irrigator; AHTO Tube Set; Model Numbers: 250-070-500, 250-070-520, 250-070-540, 250-070-600, 250-070-620
CODE Lots 05258F through 05299FG2
RECALLING FIRM/MANUFACTURER Styker Endoscopy, San Jose, CA
REASON Devices sterility may be compromised as evidenced by a crack in the package.
VOLUME OF PRODUCT IN COMMERCE 12,766 boxes, 6 units per box
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) 16 G /5F Dual Lumen L-Cath catheter only.
b) 16 G / 5F Dual Lumen L-Cath Basic Kit with Insyte Autoguard,
c) 16 G / 5F Dual Lumen L-Cath Complete Kit with Introsyte Autoguard
d) 16 G / 5F Dual Lumen L-Cath Basic Kit with Introsyte,
e) 16 G / 5F Dual Lumen L-Cath Complete Kit with Introsyte,
f) 16 G / 5F Dual Lumen L-Cath Basic Kit with U-Wing,
g) 16 G / 5F Dual Lumen L-Cath complete kit with U-Wing,
CODE
a) REF 384468. All lots manufactured since 1999 to 3/7/2005;
b) REF 384584;
c) REF 384590;
d) REF 384426;
e) REF 384427;
f) REF 384424;
g) REF 384425
RECALLING FIRM/MANUFACTURER Becton Dickinson Infusion Therapy, Sandy, UT
REASON Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.
VOLUME OF PRODUCT IN COMMERCE 33,265 units
DISTRIBUTION Nationwide, Australia, Canada, and Japan

PRODUCT Toshiba Excelart VANTAGE Model MRT-1503, Magnetic Resonance Imaging Systems, Regulation Number 21 CPR § 892.1000, Regulatory Class II, Product Code 90-LNH and was cleared with K032490
CODE Serial Numbers: A4622037, A4612031, A4622017, A4532013, A4582010, A5532048, A4592013, A4532012, A5532022, A4602028, A3592003, A4522007, A5512041, A4612015, A4572020, A4602029, A4622039, A4612030, A4542015, A4602014, A4602026, A4622036, A5522045, A5532047, A4612033, A5512040, A4612032, A4562003, A4572004, A4592012, A4562018, A4622035, A4522009, A4602025, A3582001, A5512043, A45320 11, A4602024, A5512018, A4572006, A4572023, A5512019, A5532049, A3592002, A4602027, A4552002, A4512006, A4552017, A5522046, A4572005, A4562019, A4572021, A4522008, A4612034, A4582009, A3612004, A4622016, A4532010, A3622001, A5512044, A4552016, A4572007, A4592011, A4572008, & A5512042
RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Med Sys Inc, Tustin, CA
Manufacturer: Toshiba Medical Systems Company, Tochigi-Ken, Japan.
REASON There is a hardware problem of water leakage in the cooling system inside the ASGC, requiring the replacement of the gradient coil.
VOLUME OF PRODUCT IN COMMERCE 65 units
DISTRIBUTION Nationwide

PRODUCT Bio-Rad brand "TOX/See Drug Screen Test"; Catalog numbers: 1945182EX, 1945216, 194-5223
CODE 9450311-1, 9450319, 9450545, 9450547, 9450311, 9451356, 94532016CE
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bio-Rad Laboratories, Inc, Hercules, CA
Manufacturer: Applied Biotech Inc., San Diego, CA. 
REASON The device was producing false negative results for cocaine tests.
VOLUME OF PRODUCT IN COMMERCE 384 units
DISTRIBUTION Nationwide, Canada, France, UK, Germany and Italy

WEEK ENDING DECEMBER 31

PRODUCT Stainless Steel Greenfield Vena Cava Filter with 12 Fr / 4,0 mm FlexCarrier Capsule. For Femoral Vein Introduction Only. Catalog No. 50-501. Sterile EO. Single Use Only. Read Instructions for Use before using this device. The Stainless Steel Greenfield Vena Cava Filter with 12 Fr. / 4,0 mm introducer System is a permanently implanted stainless steel device designed to protect against pulmonary embolism while maintaining potency of the inferior vena cava. The Stainless Steel Greenfield Vena Cava Filter comes preloaded in a 12 Fr. / 4,0 mm jugular or femoral introducer catheter.
CODE All codes of product manufactured before March 10, 2004, with lot/batch # between 5145758 and 6387904
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corporation, Maple Grove, MN
Manufacturer: Boston Scientific Cork Ltd., Cork, Ireland. 
REASON There have been reports of detachment at the bond between the carrier capsule and the outer sheath of the Greenfield Vena Cava Filters with 12 Fr Femoral introducer Systems manufactured before March 10, 2004. If the capsule should detach during an implantation procedure, there is a risk of cardiac and pulmonary embolization.
VOLUME OF PRODUCT IN COMMERCE 18,000 units
DISTRIBUTION Nationwide (except ND) and Internationally

PRODUCT
a) Viceroy Inflation Syringe, 60mL, Sterile, Rx only. Catalog Number: V6010,
b) Viceroy Inflation Syringe, 60mL, without gauge. Catalog Number: V6001,
CODE
a) Lot Numbers: F395368;
b) Lot Numbers: F395371, F398796, F404213
RECALLING FIRM/MANUFACTURER Merit Medical Systems, Inc, South Jordan, UT
REASON Inflation device may not hold vacuum during angioplasty procedure.
VOLUME OF PRODUCT IN COMMERCE 305 units
DISTRIBUTION FL, UT, and Internationally

PRODUCT
a) SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix SlimLine, SlimLine Hybrid, Corpectomy, ThinLine and Ant-Cer Anterior Cervical Plating Systems
b) SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix SlimLine and SlimLine Hybrid Anterior Cervical Plating Systems
c) SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix Corpectomy Anterior Cervical Plating Systems,
d) SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix ThinLine Anterior Cervical Plating Systems,
e) SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix Ant-Cer Anterior Cervical Plating Systems,
CODE
a) Doc #499-0062-MKC, rev A;
b) Doc #499-0005-MKC, rev D;
c) Doc #499-0057-MKC, rev A;
d) Doc #499-0035-MKC, rev B;
e) Doc #499-0014-MKC, rev B
RECALLING FIRM/MANUFACTURER Abbott Spine, Austin, TX
REASON Modification to labeling for surgical implant.
VOLUME OF PRODUCT IN COMMERCE Approximately 9516
DISTRIBUTION Nationwide

PRODUCT Pentra 80 and Pentra 80XL Hematology Analyzers
CODE All Serial numbers
RECALLING FIRM/MANUFACTURER ABX Diagnostics Inc, Irvine, CA
REASON Software defect, instrument may erroneously give a result of “0” or “---”.
VOLUME OF PRODUCT IN COMMERCE 67 units
DISTRIBUTION Nationwide

PRODUCT
a) Stainless Steel Greenfield Vena Cava Filter with 12 Fr. / 4,0 mm FlexCarrier Capsule. Catalog no. M001505010. Sterile EO. Single Use Only. The devices are permanently implanted devices designed to protect against pulmonary embolism while maintaining patency of the inferior vena cava. It is
inserted through the internal jugular or femoral vein using a percutaneous puncture or surgical cutdown. The Stainless Steel Greeenfield Vena Cava Filter comes preloaded in a 12 Fr. / 4.0 mm jugular or femoral
introducer catheter. 
b) Titanium Greenfield Vena Cava Filter with 12 Fr./4,0 mm Introducer System. Catalog no.
M001503010. Sterile EO. Single Use Only. The devices are permanently implanted devices designed to protect against pulmonary embolism while maintaining patency of the inferior vena cava. It is inserted through the internal jugular or femoral vein using a percutaneous puncture or surgical cutdown.
The Titanium Greeenfield Vena Cava Filter comes preloaded in a jugular or a femoral introducer catheter. 
CODE
a) Lot numbers: 7132606, 7132607, 7132608, 7133116, 7136847, 7136848, 7142615,
7142616 and 7147508;
b) Lot numbers: 7129578 and 7124116
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corporation, Maple Grove, MN
Manufacturer: Boston Scientific Cork Ltd., Cork, Ireland. 
REASON Certain units within eleven lots of the 12 Fr Greenfield Vena Cava Filter may lack a taper on the braided sheath of the delivery system. The lack of a taper could lead to vessel damage as a result of the sheath catching on the edge of the vein and causing a tear.
VOLUME OF PRODUCT IN COMMERCE 268 units
DISTRIBUTION Nationwide, Chile, Japan, Netherlands and Taiwan

PRODUCT Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tubes, sterile, Product 67HA70. 
CODE Lot G667991
RECALLING FIRM/MANUFACTURER Smiths Medical ASD, Inc., Gary, IN
REASON Instructions for use included in the package are for a different tracheostomy tube.
VOLUME OF PRODUCT IN COMMERCE 91 units
DISTRIBUTION Nationwide

PRODUCT 3G Storm Series Power Wheelchair with Power Tilt Option. 
CODE Serial numbers: 05G066858, 05G066859, 05G071801, 05G071803, 05G077773, 05G079666, 05G089011, 05G089012, 05G092274, 05G105434, 05G106984, 05G111332, 05G117359, 05G121857, 05G125563, 05H144898
RECALLING FIRM/MANUFACTURER Invacare Corporation, Elyria, OH
REASON When the powered seating system is tilted completely in the rearward position, a potential pinch point is created between the seat and the seat frame.
VOLUME OF PRODUCT IN COMMERCE 16 devices
DISTRIBUTION AL, GA, CA, IL, KS, MN, NC, PA, TX, and VA

PRODUCT Dade Actin FS Activated PTT Reagent. Reagent and Control Partial Thromboplastin Time. Catalog number B4218-100
CODE Lot number 527263 exp 2/3/06
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dade Behring, Inc., Newark, DE
Manufacturer: Dade Behring GmbH, Marburg, Germany. 
REASON Prolonged aPTT results.
VOLUME OF PRODUCT IN COMMERCE 4,176 packs
DISTRIBUTION Nationwide

PRODUCT Product is a CALYSTO Series IV Physio-monitoring & Information System model # M-S0053,
CODE Serial numbers 970424D to 200501499
RECALLING FIRM/MANUFACTURER Witt Biomedical Corporation, Melbourne, FL
REASON Customer complained that a boom monitor came off the boom. No patient or user injury was associated with the incident.
VOLUME OF PRODUCT IN COMMERCE 1541 units
DISTRIBUTION Nationwide

PRODUCT Bard electrophysiology SSV H. Lee 9.5F split sheath with valve and sideport. The product is packaged in individual pouches and shipped 5 pouches per case. Catalog number 808950
CODE Lot number S16143
RECALLING FIRM/MANUFACTURER Thomas Medical Products Inc, Malvern, PA
REASON Mislabeled as 9.5F actually contains 10.5F.
VOLUME OF PRODUCT IN COMMERCE 445 kits
DISTRIBUTION Nationwide