JUNE 2006

WEEK ENDING JUNE 3

PRODUCT Sterile packaged wound dressing with white and green inner pouch and outer carton labels, labeled in part:''***V.A.C.*** ABDOMINAL DRESSING WITH NON ADHERENT LAYER***Re-Order No. M6275080/5**, 
CODE Lot Codes: 05.13.05.01; 05.24.05.16; 06.09.05.24; 06.15.05.13; 07.06.05.08; 07.13.05.05.03; 07.14.05.06; 07.19.05.10; 07.28.05.15; 08.03.05.15; 08.10.05.15; 08.17.05.18; 08.17.05.30; 08.17.05.31; 09.07.05.23; 09.21.05.16; 09.28.05.16; 10.05.05.29; 10.19.05.22; 12.28.05.06; 01.11.06.16; 02.01.06.15; 02.01.06.16; 02.15.06.23; 02.15.06.24
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kinetic Concepts, Inc, San Antonio, TX, 
Manufacturer: Pacific Device De Mexico S A De C V, Tijuana B C Mex, Mexico,
REASON Complaints received regarding difficulty opening the nonadherent layer of the device prior to application to open abdominal wounds.
VOLUME OF PRODUCT IN COMMERCE 6,453 cases (5 dressings per case)
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Stratus CS STAT Fluorometric Analyzer BHCG TestPak (CBHCG) in vitro diagnostic,
b) Stratus CS STAT Fluorometric Analyzer CKMB TestPak (CCKMB) in vitro diagnostic,
c) Stratus CS STAT Fluorometric Analyzer Acute Care c TnI TestPak (CCTNI) in vitro
diagnostic, 
d) Stratus CS STAT Fluorometric Analyzer DDMR TestPak (CDDMR) in vitro diagnostic,
e) Stratus CS STAT Fluorometric Analyzer MYO TestPak (CMYO) in vitro diagnostic,
f) Stratus CS STAT Fluorometric Analyzer Acute Care pBNP TestPak (CpBNP) in vitro
diagnostic, 
g) Stratus CS STAT Fluorometric Analyzer BHCG DilPak (CBHCG-D) in vitro diagnostic,
h) Stratus CS STAT Fluorometric Analyzer CKMB DilPak (CCKMB-D) in vitro diagnostic,
i) Stratus CS STAT Fluorometric Analyzer cTnI DilPak (CCTNI-D) in vitro diagnostic,
j) Stratus CS STAT Fluorometric Analyzer DDMR DilPak (CDDMR-D) in vitro diagnostic,
k) Stratus CS STAT Fluorometric Analyzer MYO DilPak (CMYO-D) in vitro diagnostic,
l) Stratus CS STAT Fluorometric Analyzer Acute Care pBNP DilPak (CpBNP-D) in vitro
diagnostic, 
CODE
a) Lot #446003002 and 446058002;
b) Lot #245276002; 245289002; 245304002; 245318002; 245332002; 245361002;
246023002; 246037002; 246051002; 246065002; and 246079002;
c) Lot # 235276002; 235283002; 235290002; 235297002; 235304002; 235311002,
235318002; 235325002; 235338002; 235339002; 235346002; 235353002;
235361002; 236009002; 236016002; 236023002; 236030002; 236037002;
236044002; 236051002; 236058002; 236065002; 236072002; and 236079002;
d) Lot # 405297002; 405346002; 405030002; 406003002; and 406079002;
e) Lot # 515283002; 515311002; 515332002; 515339002; 516003002; 516016002;
516044002; 516058002; and 516072002;
f) Lot # 215276002; 215311002; 215332002; 216030002; 216065002;
g) Lot # 945297002; 945332002; 946011002; 946044002;
h) Lot # 845304002 and 846058002;
i) Lot # 835332002 and 836044002;
j) Lot # 805283002; 805346002; 806044002;
k) Lot # 816023002;
l) Lot # 916065002
RECALLING FIRM/MANUFACTURER Dade Behring, Inc, Newark, DE
REASON Foil sealing of theTestPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the magnitude of the inaccuracy may vary based on the degree of occlusion.
VOLUME OF PRODUCT IN COMMERCE 20,927 cartons
DISTRIBUTION Nationwide and Internationally

PRODUCT Extended Brilliance Workspace Imaging Workstation. An independent diagnostic viewing and processing workstation, for CT images. Software version 1.0 or 1.0.1, 
CODE All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems (Cleveland) Inc, Cleveland, OH, 
REASON Due to a software deficiency that occurs in the combine mode, a patients image can be filmed over a different patients image.
VOLUME OF PRODUCT IN COMMERCE 397 devices
DISTRIBUTION Nationwide and Internationally

PRODUCT Life Pulse High Frequency Ventilator (HFV), 
CODE Serial numbers 2585 and below
RECALLING FIRM/MANUFACTURER Bunnell, Inc, Salt Lake City, UT
REASON Potential loss of air flow or change in cycling of the ventilator. Valve Drive Regulator Board may not function properly at elevated temperatures. The increase in temperature could cause a reduction of power, causing the solenoid in the valve to function sporadically.
VOLUME OF PRODUCT IN COMMERCE 297 units
DISTRIBUTION Nationwide, Canada, and Czech Republic

PRODUCT Boston Scientific brand Pivot Steerable Microcatheter, 1.9F/2.4F, Catalog #: 1721, Universal Product Number: M00317210, 
CODE All codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Target, Fremont, CA,
Manufacturer: Boston Scientific, West Valley City, UT,
REASON During forward advancement, the user may experience increased resistance and may exhibit jump-effect, and this could result in increase in procedure time, or vessel injury, including perforation.
VOLUME OF PRODUCT IN COMMERCE 444 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) GE Medical Systems Innova 2000 and Innova 2000S, and Innova 2000 and
Innova 200S mobile version. Cardiovascular Imaging System, Recall # Z-0896-06;
b) GE Healthcare Innova 3100 and Innova 3100 with Bolus Chasing offered as an
option, Cardiovascular Imaging System, 
c) GE Healthcare Innova 4100 and Innova 4100 with Bolus Chasing offered as an
option. Digital Fluoroscopic Imaging System, 
CODE All serial numbers, all devices manufactured before November 2005
RECALLING FIRM/MANUFACTURER
Recalling Firm: General Electric Medical Systems LLC, Waukesha, WI
Manufacturer: General Electric Medical Systems, SCS, Bue Cedex, France, 
REASON Incorrect screws were used for mounting the detector, which may lead to a possible part falling onto a patient.
VOLUME OF PRODUCT IN COMMERCE 1,447 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Roche/Hitachi Glucose Hexokinase Reagent for use on the Hitachi Modular System; Catalog # 1929542 (11929542216). In vitro diagnostic, 
CODE Lot 672652; exp. 6/30/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corporation, Indianapolis, IN, 
Manufacturer: Roche Diagnostics GmbH, d-68305 Mannheim, Germany. 
REASON A contaminant will change the pH of the R2 bottle, causing deterioration of the enzyme, and resulting in incorrect or no results being reported.
VOLUME OF PRODUCT IN COMMERCE 269 kits
DISTRIBUTION Nationwide

PRODUCT Hoyer Hydraulic Patient Lifters model C-CB-L2, C-HLA, C-HLA-2, HML-400, C-HLA-2T and C-HLA-1, 
CODE
Devices manufactured between July 1, 2001 and December 31, 2004.
Serial Number (S/N) Range: C-CB-L2 (S/N's 0301L0905;
S/N's: 0110L001 to 0412L0176, 0110J194 to 0204J0795, 0205H0043 to 412H0080;
S/N's 0206L1296 to 0409L2483, 0206H0945 to 0409H2570;
S/N's 0107L0030 to 0412L0524, 0110J0195 to 0201J1338, 0202H0586 to 412H0082;
S/N's 0110L061 to 0412L0127, 0110J098 to 0208J0162, 0112H555 to 0409H2418
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sunrise Medical CCG, Inc. Stevens Point, WI
Manufacturer: Apex Health Care Manufacturer, Inc, Chia Yi Hsien, Taiwan. 
REASON A field correction is being conducted on select models of Hoyer Patient Lifts because of hydraulic jack problems that have resulted in patient injury. The possibility exists that the mounting stud located in the bottom of the hydraulic jack could become loose allowing the jack to disengage from the mast of the lift.
VOLUME OF PRODUCT IN COMMERCE 32,109 devices
DISTRIBUTION Nationwide, Canada, Asia, South America

PRODUCT Gri-bag: A single use, non pyrogenic flexible empty container with an incorporated 0.2 micron filter. It is supplied sterile in sealed peel-pack pouches. It is used to remove particulates in the Gri-fill pharmacy compounding system and as a container in the preparation of drug solutions. Gri-bag 500 ml, 
CODE FPB NEP, batch # X-003, code 722842
RECALLING FIRM/MANUFACTURER
Recalling Firm: Grifols Biologicals Inc. Los Angeles, CA
Manufacturer: Laboratorios Grifols, S.A.-Spain, Barcelona, Spain. 
REASON When the bags are filled with solution, they leak. The labeling process caused a hole to be formed in the bag.
VOLUME OF PRODUCT IN COMMERCE 218 units, each unit contains 5 bags
DISTRIBUTION CA, GA, and OR

PRODUCT Low-Boy Bed, AC-powered adjustable hospital bed with a low position of 7" to a high position of 30", 
CODE 156 Wheelchairs of Kansas and SIZEWise serial numbers. The serial numbers will be listed in the following format: SIZEWise number/Wheelchairs of Kansas number 22639/212666; 23243/212849; 22493/212646; 23245/212851; 21244/212428; 21254/212438; 22132/212502; 22140/212510; 22141/212511; 22142/212512; 22139/212509; 24403/213406; 22640/212667; 21251/212435; 23227/212860; 23228/212868; 23229/212869; 23257/212878/ 24384/213086; 24385/213087; 24398/213282; 24409/213412; 21252/212436; 22128/212498; 22636/212644; 23256/212879; 22502/212655; 22630/212658; 22642/212669; 21245/212429; 22129/212499; 23262/213073; 24401/213285; 22126/212496; 22496/212649; 23232/212863; 23239/212858; 23240/212846; 24402/213286; 23226/212871; 22135/212505; 22137/212507; 23246/212852; 23247/212853; 23248/212854; 23241/212847; 23260/213071; 23274/213084; 24387/213089; 23271/213081; 24396/213080; 22635/212663; 24411/213414; 24413/213416; 24414/213417; 24415/213418; 24416/213419; 24417/213420; 24418/213421; 24419/213425; 24420/213426; 24421/213427; 24422/213428; 25360/213429; 25361/213430; 25362/213431; 25363/213432; 25364/213433; 25365/213434; 25366/213435; 25367/213436; 25368/213437; 22136/212506; 22492/212631; 22638/212665; 22643/212670; 21240/212423; 21241/212424; 21246/212430; 22631/212659; 22632/212660; 22644/212874; 22646/212872; 23261/213072; 23263/213074; 23264/213075; 23265/212875; 23267/213077; 24391/213275; 24397/213281; 24399/213283; 21242/212425; 22498/212651; 23266/213076; 24400/213284; 24407/213410; 24408/213411; 21247/212431; 22495/212648; 23231/212866; 23234/212865; 24390/213123; 24389/213122; 24388/213121; 21253/212437; 23242/212848; 22134/212504; 22138/212508; 23249/212855; 23250/212856; 23251/212857; 23258/212877; 23259/212876; 22499/212652; 22500/212653; 22501/212654; 22628/212656; 22629/212657; 23233/212864; 23236/212861; 23237/212860; 24394/213278; 24395/213279; 21240/212423; 22497/212650; 24393/213277; 24405/213408; 24406/213409; 22127/212497; 22494/212647; 23230/212867; 23238/212859; 23255/212880; 24392/213276; 21249/212433; 21255/212439; 22131/212501; 22637/212671; 23252/212969; 23254/213070; 23270/213080; 24383/213085; 24386/213088; 23235/212862; 23244/212850; 22133/212503; 23253/212970; 23269/213079; 22130/212500; 22634/212662; 22645/212873; 24404/213407; 24410/213413; 22633/212661; 23272/213082; 23273/213083
RECALLING FIRM/MANUFACTURER Rayes, Inc, dba Wheelchairs of Kansas, Ellis, KS, 
REASON The bed may drop due to a malfunction of the actuator exceeding its stop.
VOLUME OF PRODUCT IN COMMERCE 161 beds
DISTRIBUTION Nationwide

PRODUCT Powder Free Latex, Non-sterile Medical Exam Gloves, Catalog #'4 22401, 22402, 22403, and 22404, 
CODE Lot/unit numbers: 04000130161, 04000130162, 04000160163, 04000130164
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gulf South Medical Supply Inc, Jacksonville, FL, 
Manufacturer: TG Medical Sdn Bhd, Selangor, Malaysia. 
REASON FDA's laboratory analysis found holes in the gloves that exceeded the allowable limit. Gloves with holes compromise the integrity of the latex barrier and have the potential to allow hazardous substances to come into contact with the user's skin.
VOLUME OF PRODUCT IN COMMERCE 815 cases, 100 each per box, 10 boxes per case
DISTRIBUTION Nationwide

PRODUCT
a) CONTAK RENEWAL 3 CRT-D (model no. H170, H175, H177, H179). Cardiac
Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide.
CONTAK RENEWAL 3 devices provide ventricular tachyarrhythmia and cardiac
resynchronization therapies, 
b) CONTAK RENEWAL 4 CRT-D (model no. H190, H195, H199). Cardiac
Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide.
CONTAK RENEWAL 4 devices provide ventricular tachyarrhythmia and cardiac
resynchronization therapies, 
c) VITALITY DS (model T125) and VITALITY 2 (models T165, 175) ICD (implantable
cardiac defibrillator), 
CODE
a) Model H170, serial numbers: 360449, 360632, 360655, 360657, 360661, 360666,
360714, 360719, 360721, 360738, 360741, 360742, 360743, 360745, 360746,
360749, 360756, 360758, 360763, 360766, 360790, 360791, 360792, 360796,
360800, 360802, 360844, 360847, 360848, 360861, 360863, 360904, 360907,
360908, 360910, 360986, 360987, 360988, 360989, 360991.
Model H175 serial numbers: 310338, 310434, 310523, 310532, 310533, 310537,
310544, 310545, 310706, 310707, 310709, 310713, 310719, 310721, 310734,
310735, 310737, 310746, 310753, 310796, 310798, 310813, 310907, 310908,
310909, 310913, 310916, 310976, 310990, 310996, 311007, 311010, 311011,
311013, 311015, 311016, 311092, 311096, 311152, 311154, 311181, 311185,
311386, 311389.
Model H177, serial numbers: 280992, 281011, 281012, 281017, 281020, 281021,
281022, 281024, 281045, 281056, 281066, 28107, 281077, 281119, 281121,
281123, 281124, 281126, 281127, 281143, 281175, 281213, 281233, 281247,
281320, 281356, 281364, 281368, 281371, 281376, 281385, 281401, 281403,
281413, 281476, 281480, 281484, 281485, 281491, 281533, 281539, 281542,
281544, 281559, 281562, 281580.
Model H179, serial numbers: 110905, 110907, 110908, 110950, 110952, 110954,
110955, 110958, 110980, 110983, 110987, 110988, 111000, 111001, 111003,
111004, 111007, 111012, 111024, 111041, 111042, 111128, 111173, 111180,
111198, 111201, 111248, 111250, 111254, 111263, 111294, 111299, 111308,
111313, 111334, 111335, 111336, 111338, 111340, 111341, 111342, 111346,
111350, 111352, 111390, 111391, 111392, 111393, 111397, 111422;
b) Model H190, serial numbers: 310258, 310260, 310293, 310312, 310317, 310319,
310320, 310321, 310322, 310343, 310353, 310355, 310381, 310383, 310386,
310387, 310388, 310389, 310390.
Model H195, serial numbers: 350236, 350239, 350245, 350247, 350248, 350250,
350252, 350255, 350261, 350264, 350276, 350279, 350280, 350282, 350284,
350319, 350330, 350331, 350332, 350333, 350334, 350336, 350342, 350344,
350350, 350351, 350353, 350354, 350355, 350360, 350362, 350363, 350364,
350365, 350403, 350407, 350442, 350451, 350480, 350484, 350503, 350570,
350649.
Model H199, serial numbers: 320330, 320331, 320361, 320366, 320370, 320415,
320417, 320445;
c) Model T125, serial numbers: 115233, 115234, 115237, 115239, 115240, 115241,
115335, 115370, 115399, 115400, 115479.
Model T165, serial numbers: 110803, 110806, 110830, 110833, 110835, 110836,
111081, 111270, 111271, 111273, 111274, 111299, 111329, 111332, 111333,
111337, 111339, 111442, 111493, 111611, 111687, 111842, 111844, 111886,
111979, 112029, 112174, 112175.
Model T175, serial number 109787
RECALLING FIRM/MANUFACTURER
Recalling Firm: Guidant Corporation, Saint Paul, MN,
Manufacturer: Guidant-Ireland, Clomel, Ireland. 
REASON Devices manufactured with batteries built on April 26 or 27, 2005, by a single operator, may have battery welds that may have been performed at settings outside of typical manufacturing specifications at the supplier.
VOLUME OF PRODUCT IN COMMERCE 290 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) SYNCHRON LX 20, SYNCHRON LX 20 PROClinical Systems; Operating Software
Version 4.5; Part Number: A23724 In vitro diagnostic, 
b) SYNCHRON LX i 725 Clinical Systems; Operating Software Version 4.5; Part
Number: A23724, 
c) Unicel DxC 600/800 SYNCHRON Clinical Systems; Operating Software Version 1.0
and 1.2; Part Number: A20463 and A27331, 
CODE
a) Operating Software Version 4.5;
b) Software Version 4.5;
c) Software Version 1.0 and 1.2
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc, Fullerton, CA, 
Manufacturer: Beckman Coulter, Inc., Brea, CA. 
REASON It was confirmed that the ORDAC (Over Range Detection And Correction) feature (auto & manual) does not perform correctly for the glucose cup chemistry (GLUCm) when sample type of 'Other' is selected w/operating software version 4.5. Results for these samples could be elevated as much as twice the actual value. The ORDAC feature does function properly w/serum, plasma, urine & CSF.
VOLUME OF PRODUCT IN COMMERCE 2,800 systems total
DISTRIBUTION Nationwide and Internationally

PRODUCT Medtronic Model 37711 Restore Neurostimulator. The Restore Neurostimulator is an implanted, rechargeable neurostimulator which provides pain management therapy, 
CODE
NJH701951H thru NJH801963H, NJH701965H, NJH701967H thru NJH701969H, NJH701971H thru NJH701975H, NJH701978H thru NJH701986H, NJH702007H, NJH702008H, NJH702028H, NJH702029H, NJH702032H, NJH702033H, NJH702035H, NJH702036H, NJH702038H, NJH702039H, NJH702044H, NJH702045H, NJH702144H, NJH702145H, NJH702146H, NJH702150H, NJH702152H, NJH702153H, NJH702157H, NJH702158H, NJH702159H, NJH702160H, NJH702162H, NJH702163H, NJH702164H, NJH702166H, NJH702168H, NJH702169H, NJH702171H thru NJH702175H, NJH702183H, NJH702184H, NJH702213H, NJH702215H, NJH702216H, NJH702263H, NJH702324H, NJH702425H, NJH702427H, NJH702428H, NJH702429H, NJH702434H, NJH702436H, NJH702438H, NJH702439H, NJH702441H, NJH702443H, NJH702447H, NJH702451H, NJH702452H, NJH702455H, NJH702458H, NJH702487H, NJH702765H, NJH702772H, NJH702809H, NJH702834H, NJH702852, NJH702862H, NJH702863H, NJH702919H, NJH702980, NJH702982H, NJH702990H, NJH702993H, NJH702999H, NJH703001H
RECALLING FIRM/MANUFACTURER Medtronic Inc, Neurological & Spinal Division, Columbia Heights, MN
REASON A limited number of Model 37711 Restore Neurostimulators have an incorrect internal memory parameter that causes the device to indicate it is fully recharged when it may only be 80% to 90% recharged. This anomaly does not affect patient safety. This anomaly can be corrected by reprogramming the Restore Neurostimulator using specific software.
VOLUME OF PRODUCT IN COMMERCE 101 devices
DISTRIBUTION Nationwide

WEEK ENDING JUNE 10

PRODUCT
a) Talon Straight, 25 cm--Electrosurgical Device--RITA * Medical Systems, Inc. *
StarBurst™ Talon * * REF: 700-102846 * 4 cm Diameter * 25 cm Length * Sterile/R *
Catalog # 700-102846-RITA® *, 
b) XLie with Tubing, 12 cm, Electrosurgical Device-RITA * Medical Systems, Inc. *
StarBurst™ Xli enhanced with tubing set * * REF/Catalog: 700-103027 * 4-7 cm
Diameter * 12cm Length * Sterile/R * RITA® * , 
CODE
a) Lot number: 25969;
b) Lot number: 25952
RECALLING FIRM/MANUFACTURER Rita Medical Systems, Inc., One Horizon Way, Manchester, GA.
REASON Misbranding: Product may have the wrong device handle which incorrectly identifies the product and also has incorrect deployment depth marker.
VOLUME OF PRODUCT IN COMMERCE 40 units
DISTRIBUTION Nationwide and Italy

PRODUCT Panacryl Synthetic Absorbable Suture. Poly(L-lactide/glycolide) Suture. Undyed (white), braided, this suture is a synthetic absorbable sterile surgical suture composed of a copolymer of 95% lactide and 5% glycolide. The suture is coated with a copolymer composed of 90% caprolactone and 10% glycolide, 
CODE All codes. MH2548, MH2549, MH2550, MH2744, MH2745, MH7477, MH7478, MH7479, MH7481, MH7482, MH7495, MH7636, MH7637, MH7638, MH7703R, MH7708, MH7709, MH7710, MJ2180, MJ2181, MJ2182, MJ2213, MJ2214, MJ2739, MJ2740, MJ2741R, MJ2742R, MJ2743R, MJ2789, MJ7119, MJ7120, MJ7121R, MJ7330, MJ7331, MJ7332, MJ7363, MJ7364, MJ7365, MJ7706, MJ7707, MJ7826, MJ7827, MJ7886, MJ7900R, MJ7901R, MJ7902R, MJ7969, MJ7970, MJ7971, MJ7975, MJ7976, MJ7978, MJ7979, MJ7980, MJ7981, MJ7982, MJ7983, MJ7984, MJ7985, MJ7986, MJ7990, MJ7991, MJ7993, MJ7994, MJ8013, MJ8018, MJ8019, MJ8020R, MJ8021, MJ8022R, MJ8023R, MK2185, MK7186, MK7269, MK7343, MK7344, MK7376, MK7468, MK7469, MK7471, MK7472, MK7473, MK7474, MK7477, MK7478, MK7479, MK7480R, MK7481, MK7482, MK7483, MK7484, MK7486, MK7487, MK7501, MK7502, MK7503, MK7504, MK7505, MK7506, MK7507, MK7564, MK7565, MK7566, MK7567, MK7634, MK7822, MK7824, MK8014, MK8015, MK8016, MK8017, MK8023, MK8024, ML2020, ML2191, ML2941, ML7175R, ML7250, ML7424, ML7430, ML9750, ML9767, MM2056, MM2080, MM2581, MM2797, MM2798, MM2799, MM2800, MM2803, MM2804, MM2807, MM2810, MM7207, MM7589, MM7677, MM9729, MM9740, MM9750, MM9755, MM9891, MM9896, MM9897, MP2094, MP2403, MP2426, MP2474, MP2551, MP2601, MP2602, MP2603, MP2817, MP2840, MP2841, MP7251, MP7252, MP7351, MP7367, MP7644, MP7704, MP7761, MP7828, MP7829, MP7849, MP9702, MP9734, MP9759, MP9762, MP9772, MP9876, MP9916, PA2258, PA2259, PA2260, PA7254, PA7255, PA7256, PA7381, PA7400, PA7700, PA7702, PA7703, PA7742, PA7806, PA7807, PA7924, PA9717, PA9719, PA9729, PA9730, PA9749, PA9771, PA9776, PA9872, PA9873, PA9897, PB2421, PB2473, PB2474, PB2483, PB2545, PB2548, PB2555, PB2672, PB2673, PB2718, PB2755, PB2774, PB2795, PB2838, PB2861, PB2862, PB2874, PB7150, PB7345, PB7346, PB7633, PB7634, PB7637, PB7638, PB7639, PB7640, PB7641, PB7772, PB7773, PB7909, PB7910, PB9711, PB9712, PB9729, PB9739, PB9741, PB9743, PB9887, PB9926, PB9944, PB9951, PB9984, PC2042, PC2043, PC2057, PC2066, PC2104, PC2408, PC2459, PC2471, PC2481, PC2508, PC2509, PC2537, PC2598, PC2805, PC2814, PC2815, PC2829, PC2866, PC2924, PC2925, PC7126, PC7149, PC7323, PC7324, PC7325, PC7326, PC7327, PC7329, PC7392, PC7393, PC7394, PC7395, PC7770, PC7864, PC7904, PC7905, PC9700, PC9717, PC9756, PC9757, PC9776, PC9790, PC9792, PC9793, PC9803, PC9963, PC9966, PC9967, PD2091, PD2092, PD2183, PD2418, PD2420, PD2446, PD2463, PD2480, PD2481, PD2482, PD2494, PD2721, PD2723, PD2772, PD2774, PD2796, PD7290, PD7291, PD7331, PD7428, PD7544, PD7697, PD7698, PD7699, PD7732, PD7745, PD7746, PD7747, PD7767, PD7799, PD7899, PD9711, PD9719, PD9724, PD9725, PD9732, PD9743, PD9754, PD9755, PD9763, PD9766, PD9767, PD9889, PD9899, PD9913, PD9914, PD9933, PE2073, PE2185, PE2435, PE2552, PE2553, PE2558, PE2559, PE2586, PE2587, PE2603, PE2607, PE2612, PE2619, PE2896, PE2896S, PE2980, PE7565, PE7566, PE7567, PE7600, PE7627, PE7685, PE7686, PE7830, PE7879, PE7879S, PE9712, PE9730, PE9742, PE9754, PE9766, PE9817, PE9818, PE9825, PE9830, PG2011S, PG2132, PG2133, PG2159, PG2160, PG2161, PG2413, PG2451, PG2454, PG2456, PG2554, PG2624, PG2625, PG2629, PG2635, PG2636, PG2661, PG2662, PG2663, PG2694, PG2695, PG2702, PG2703, PG2780, PG2977, PG7131, PG7132, PG7383, PG7384, PG7474, PG7475, PG7488, PG7595, PG7620, PG7621, PG7717, PG7754, PG7755, PG7851, PG7852, PG7998, PG9708, PG9710, PG9730, PG9744, PG9748, PG9749, PG9750, PG9753, PG9757, PG9758, PG9849, PG9850, PG9884, PH2015, PH2410, PH2414, PH2423, PH2424, PH2427, PH2428, PH2429, PH2430, PH2431, PH2442, PH2446, PH2447, PH2449, PH2451, PH2477, PH2481, PH2742, PH2747, PH2774, PH2981, PH7180, PH7389, PH7390, PH7407, PH7408, PH9734, PH9735, PH9751, PH9756, PH9886R, PH9903, PJ2036, PJ2036D, PJ2037, PJ2037D, PJ2078, PJ2078D, PJ2220, PJ2221, PJ2413, PJ2418, PJ2419, PJ2420, PJ2422, PJ2430, PJ2478, PJ2479, PJ2484, PJ2485, PJ2500, PJ2505, PJ2508, PJ2631, PJ2650, PJ2650D, PJ2655, PJ2679, PJ2680, PJ2681, PJ2681D, PJ2682, PJ2682D, PJ2749, PJ2749D, PJ2750, PJ7245, PJ7246, PJ7247, PJ7255, PJ7255D, PJ7259, PJ7259D, PJ7440, PJ7549, PJ7577, PJ7578, PJ7584, PJ7584D, PJ7588, PJ7589, PJ7590, PJ7599D, PJ7599S, PJ7600, PJ7600D, PJ7601, PJ7606, PJ7606D, PJ7695, PJ7710, PJ9703, PJ9704D, PJ9704S, PJ9705, PJ9711, PJ9720, PJ9740, PJ9855, PJ9856, PJ9857, PJ9860, PJ9861, PJ9861D, PJ9866, PJ9866D, PJ9867, PJ9901, PJ9902, PK2198, PK2199, PK2244, PK2292, PK2405, PK2407, PK2409, PK2414, PK2441, PK2501, PK2522, PK2578, PK2583, PK2590, PK2644, PK2650, PK2654, PK2672, PK2689, PK2704, PK2705, PK2707, PK2734, PK2746, PK2748, PK2790, PK2803, PK2804, PK2806, PK2807, PK2837, PK7354, PK7381, PK7383, PK7384, PK9715, PK9715D, PK9717, PK9718, PK9720, PK9721, PK9733, PK9744, PK9746, PK9746D, PK9747, PK9748, PK9763, PK9782, PK9783, PK9784, PK9850, PK9851, PK9867, PK9885, PL2099, PL2196, PL2196D, PL2197, PL2197D, PL2198, PL2199, PL2199D, PL2200, PL2200D, PL2407, PL2412, PL2417, PL2417D, PL2418, PL2424, PL2424D, PL2448, PL2449, PL2505, PL2534, PL2538, PL2539, PL2572, PL2583, PL2597, PL2597D, PL2598, PL7126, PL7510, PL7594, PL7595, PL7705, PL7706, PL7799, PL7799D, PL9702, PL9709, PL9710, PL9713, PL9741, PL9741D, PL9745, PL9746, PL9756, PL9820, PL9837, PL9861, PM2071, PM2072, PM2140, PM2142, PM2423, PM2424, PM2465, PM2515, PM2762, PM2763, PM2764, PM7259, PM7448, PM7449, PM7450, PM7533, PM7534, PM7763, PM7763D, PM7764, PM7764D, PM9702, PM9704, PM9715, PM9717, PM9732, PM9734, PM9747, PM9748, PP2048, PP2410, PP2491, PP2536, PP2576, PP2578, PP2715, PP7163, PP7183, PP7184, PP7408S, PP7453, PP7454, PP9707, PP9708, PP9722, PP9723, PP9724, PP9735, PP9750, PP9835, QA2074, QA2075, QA2174, QA2236, QA2311, QA2413, QA2455, QA2486, QA2486D, QA2487, QA2491, QA2576, QA2590, QA2598, QA2609, QA2613, QA2636, QA7249, QA7250, QA7251, QA7956, QA7997, QB2040, QB2041, QB2075D, QB2075S, QB2076S, QB2087, QB2088, QB2121, QB2393, QB7120, QB7120D, QB7121, QB7122, QB7122D, QB7257, QB7703, QB7704, QB7854, QB7973, QB7974, QB9005, QB9006, QB9008, QB9009, QB9033, QB9047, QB9109, QB9134, QB9140, QB9269, QB9272, QB9282, QB9282D, QB9294, QB9340, QB9341, QB9344, QB9345, QB9347, QB9348, QB9373, QB9373D, QB9395, QB9405, QB9406, QB9415, QC2008, QC2015, QC2093, QC2121, QC2267, QC2294S, QC2468, QC2469, QC7139, QC7140, QC7141, QC7142, QC7161, QC7240, QC7241, QC7242, QC7324, QC8025, QC8026, QC9002, QC9004, QC9012, QC9089, QC9095, QC9102, QC9135, QC9252, QC9253, QC9256, QC9257, QC9264, QD2063S, QD2211, QD7624, QD7630, QD7752, QD9002, QD9021, QD9026, QD9029, QD9081, QD9093, QD9093D, QD9095, QD9111, QD9119, QD9120, QD9214, QD9251, QE2132, QE2402, QE2403, QE2404, QE7324, QE7655, QE7828, QE7829, QE9014, QE9016, QE9028, QE9029, QE9043, QE9136, QE9204, QE9233, QE9272, QG2412, QG2424, QG2439, QG2567, QG2568, QG7919, QG8133, QG9067, QG9096, QG9108, QG9130, QG9382, QG9393, QG9425, QG9428, QG9510, QH2040, QH2252, QH7484, QH7899, QH7900, QH7916, QH7918, QH7919, QH7920, QH7921, QH9006, QH9015, QH9017, QH9019, QH9021, QH9022, QH9039, QH9040, QH9041, QH9054, QH9055, QH9056, QH9066, QH9067, QH9073, QH9089, QH9093, QH9105, QH9107, QH9123, QH9141, QH9147, QH9184, QH9217, QH9437, QH9441, QH9446, QJ2017, QJ2263, QJ7337, QJ7504, QJ7614, QJ7938, QJ7976, QJ7977, QJ7978, QJ8014, QJ8015, QJ8033, QJ9004, QJ9019, QJ9033, QJ9058, QJ9059, QJ9075, QJ9081, QJ9082, QJ9135, QJ9136, QJ9161, QJ9162, QJ9195, QJ9208, QJ9252, QJ9275, QJ9357, QJ9366, QK2087, QK2234, QK2235, QK2258, QK2447, QK2456, QK2469, QK2475, QK7504, QK7571, QK7581, QK7592, QK7643, QK7644, QK8012, QK8209, QK8236, QK8257, QK8258, QK9016, QK9066, QK9067, QK9077, QK9088, QK9089, QK9115, QK9119, QK9120, QK9141, QK9152, QK9154, QK9169, QK9213, QK9215, QK9216, QK9248, QK9256, QK9257, QK9258, QK9259, QK9263, QK9280, QK9281, QK9315, QK9371, QK9399, QK9411, QK9427, QL2459, QL2462, QL2489, QL7504, QL7505, QL7703, QL7960, QL7961, QL8056, QL9026, QL9061, QL9062, QL9081, QL9139, QL9157, QL9238, QL9273, QL9306, QL9309, QL9313, QL9324, QL9347, QL9348, QL9356, QL9364, QL9365, QL9373, QL9374, QL9375, QL9384, QL9385, QL9394, QL9397, QL9408S, QL9424, QM2021, QM2056, QM2057, QM2084, QM2085, QM7357, QM7448, QM7794, QM7983, QM9020, QM9073, QM9083, QM9092, QM9161, QM9162, QM9163, QM9177, QM9199, QM9204, QM9205, QM9230, QM9249, QM9251, QM9269, QM9312, QM9317, QM9352, QP2050, QP2056, QP2070, QP2072, QP2083, QP2110, QP2111, QP2126, QP2127, QP2157, QP2167, QP2169, QP2182, QP2185, QP2227, QP2228, QP2406, QP7568, QP7579, QP7775, QP7960, QP8017, QP8018S, QP9364, QP9392, QP9452, RA2026, RA2038, RA2414, RA2560, RA7572, RA8206, RA9010, RA9034, RA9035, RA9039, RA9040, RA9059, RA9063, RA9102, RA9141, RA9163, RA9164, RA9172, RA9223, RA9363, RA9390, RA9393, RA9426, RB2214, RB2215, RB2258, RB7053, RB7489, RB7687, RB7912, RB9015, RB9016, RB9063, RB9083, RB9087, RB9092, RB9094, RB9095, RB9096, RB9128, RB9150, RB9161, RB9175, RB9201, RB9206, RB9240, RB9251, RB9274, RB9283, RB9290, RC2163, RC2419, RC2420, RC7331R, RC7477, RC7498, RC7499, RC7644, RC8146, RC9009, RC9014, RC9015, RC9055, RC9073, RC9098, RC9123, RC9136, RC9137, RC9138, RC9144, RC9158, RC9173, RC9174, RC9189, RC9202, RC9226, RC9227, RC9233, RC9234, RC9246, RC9248, RC9258, RC9295, RC9299, RC9307, RC9324, RC9371, RC9373, RC9384, RC9385, RC9386, RD2090, RD2164, RD2173, RD2268, RD2304, RD2338, RD7914, RD7978, RD9045, RD9046, RD9047, RD9061, RD9117, RD9144, RD9156, RD9166, RD9196, RD9218, RD9230, RD9285, RD9286, RD9440, RD9443, RE2051, RE2084, RE2106, RE2107, RE2144, RE7827, RE8006, RE8108, RE8127, RE8303, RE8352, RE9010, RE9055
RECALLING FIRM/MANUFACTURER Ethicon, Inc., Somerville, NJ
REASON The unique absorption profile of Panacryl in the suture could act as a foreign body so that surgeons should consider its use in specific situations.
VOLUME OF PRODUCT IN COMMERCE 1,061,712 sutures
DISTRIBUTION Nationwide and Internationally

PRODUCT Magnetic Resonance Imaging Device, 
CODE L001-L223 C002-C765 Hoo2-H733
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hitachi Medical Systems America, Inc., Twinsburg, OH,
Manufacturer: Hitachi Medical Corporation, Chiyoda-Ku, Tokyo, Japan. 
REASON The device has a software anomaly which causes the operating system to lock up and data to become corrupted during service procedures.
VOLUME OF PRODUCT IN COMMERCE 1,054 units
DISTRIBUTION Nationwide

PRODUCT ev3 Primus GPS Biliary Stent System. Balloon Expandable Stent and Delivery System. The stent is made from a 316L stainless steel tube cut into an open lattice design. It is mounted onto a non-compliant balloon catheter. It is deployed and expanded by inflating the balloon. Model number BXB35-05-17-120 and Model number BXB35-06-17-120, 
CODE Lot 1049856; Lot 1049864
RECALLING FIRM/MANUFACTURER Ev3, Inc., Plymouth, MN
REASON A Primus device labeled (pouch and box) as a BXB35-05-17-120 contained a 6mm x 20mm catheter instead of the intended 5mm x 20mm catheter.
VOLUME OF PRODUCT IN COMMERCE 29 systems
DISTRIBUTION Nationwide

PRODUCT Bard TruGuide Coxail Biopsy Needle with Depth Stop and additional Blunt Tip Stylet, Catalog Number C1816B, Device Listing Number E148687. The Bard TruGuide Coaxial Biopsy Needle is a three-part device consisting of an outer cannula with an attached female luer lock hub, and inner stylet with an attached male luer lock hub, and a flexible slip rink depth stop, CODE Lot number: REP JO196
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bard Peripheral Vascular, Inc., Tempe, AZ, .
Manufacturer: Bard Reynosa S.A. De C.V., Reynosa, Mexico. 
REASON Manufacturing change that has introduced variability in the length of the inner stylet. When the inner stylet length is inserted into the cannula component, the exposed stylet length may be up to 8mm longer than expected.
VOLUME OF PRODUCT IN COMMERCE 225 units
DISTRIBUTION CA, FL, NJ, MO, and TX

PRODUCT EP-4 Computerized Stimulator -- 2 channel and 4 channel. The product consists of a touchscreen portable PC controlling a two channel dedicated EP stimulator. The stimulator is capable of single channel, simultaneous and sequential stimulation at programmed output settings using built-in protocols, and includes an emergency stimulation function, 
CODE Model number: EP-4-02 and EP-4-04. EP40312-001 through 010; EP40403-001 through 014; EP40406-001 through 042; EP40408-001 through 039; EP40410-001 through 040; EP40411-001 through 040; EP40504-001 through 040; EP40506-001 through 040; EP40508-001 through 020; EP40510-001 through 020; EP40511-001 through 040
RECALLING FIRM/MANUFACTURER EP Medsystems, West Berlin, NJ
REASON Under certain circumstances the device may exhibit the following behaviors: 1)-Initiation of a rapid stimulation train without command, when the device is in use in conjuction with an electrosurgical unit or RF ablation unit-2)-Presence of a DC offset voltage on an output channel-3)-Inability to synchronize with a non-EP MedSystems recording system.
VOLUME OF PRODUCT IN COMMERCE 187 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Endopath Probe Plus II, Hook Electrode, 5 mm Shaft, 34 cm length,
hollow tip electrdode, Product Code EPS01, 
b) Endopath Probe Plus II, Foot-Controlled PistolGrip Handle, Product Code EPH01,
c) Endopath Probe Plus II, Hand-Controlled PistolGrip Handle, Product Code EPH02,
d) Endopath Probe Plus II, Hand Controlled PencilGrip Handle, Product Code EPH04,
e) Endopath Probe Plus II, Spatula Electrode, 5mm shaft, 34 cm length, hollow tip
electrode, Product Code EPS02, 
f) Endopath Probe Plus II, Right Ange Electrode, 5 mm shaft, 34 cm length, hollow tip
electrode, Product Code EPS03, 
g) Endopath Probe Plus II, Curved Dissector Electrode, 5mm shaft, 34 cm length, hollow
tip electrode, Code EPS04, 
h) Endopath Probe Plus II, Spatula Electrode, 5mm shaft, 29cm length, hollow tip
electrode, Code EPS06, 
i) Endopath Probe Plus II, Curved Dissector Electrode, 5mm shaft, 29cm length,
hollow tip electrode, Code EPS08, 
j) Endopath Probe Plus II, Needle Electrode, 5mm shaft, 29cm length, hollow tip
electrode, Code EPS09, 
k) Endopath Probe Plus II, Open End Suction/Irrigation Canula, 10mm shaft, 34 cm
length, Code EPS11, 
l) Endopath Probe Plus II, Flexible Fiber Canula, 5mm shaft, 29cm length, Code EPS13,
CODE
a) Lot numbers: C4D111, C4DD09, C4DD0H, C4DE5L, C4DK67, C4DM01, C4DM03,
and C4DN03;
b) Lot numbers: C4DG34 and C4DN1J;
c) Lot numbers: C4DG7H and C4DL5W;
d) Lot numbers: C4DF27. C4DL5U;
e) Lot numbers: C4DK34 and C4DK9L;
f) Lot numbers: C4DD4K, C4DJ5E, C4DK9M, and C4DN5E;
g) Lot numbers: C4DK66 and C4DL7N;
h) Lot numbers: C4DK35, C4DL86, and C4DN7U;
i) Lot number: C4DN1K;
j) Lot number: C4DN7V;
k) Lot number: C4DL3J;
l) Lot number: C4DL5V
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ethicon Endo-Surgery Inc., Cincinnati, OH, 
Manufacturer: Ethicon Endo-Surgery, Inc., S.A. de C.V. Planta II, Ciudad Juarez, Mexico. 
REASON There is a possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device.
VOLUME OF PRODUCT IN COMMERCE 1,627 cases/6 devices per case
DISTRIBUTION Nationwide and Internationally

PRODUCT Zinnanti Injector -- 2.0; Size 2.0 mm, Length 23 cm, latex free, single-use, sterile. For in-office or hospital use when efficient sealing of the uterine cervix is required for the injection of liquid or gas such as hysterosalpingography, salpingoplasties, hydrotubation and Rubin’s test. REF TMI1153, 
CODE Lot number: M20772
RECALLING FIRM/MANUFACTURER Catheter Research, Inc., Indianapolis, IN,
REASON The uterine stop component was not included with the device.
VOLUME OF PRODUCT IN COMMERCE 660 units
DISTRIBUTION MN and Spain

PRODUCT Medtronic Kinetra 7428. Dual Program Neurostimulator for Deep Brain Stimulation. Rx only. Kinetra neurostimulator is a component of the Activa System. The Medtronic Activa System is an implantable, multiprogrammable system that delivers electrical stimulation to selected areas of the brain. The dual program Model 7428 Kinetra Neurostimulator generates electrical signals that are transmitted to the brain. The neurostimulator consists of electronic circuitry and a battery, which are hermetically sealed in a titanium case,
CODE NFD621879S, NFD621891S, NFD621901S, NFD621981S, NFD621976S, NFD622170S, NFD622185S, NFD622189S, NFD622201S, NFD622247S, NFD622279S, NFD623035S, NFD622345S, NFD622349S, NFD622372S, NFD622382S, NFD622387S, NFD622400S, NFD622414S, NFD622466S, NFD622542S, NFD622564S, NFD622629S, NFD622664S
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Neurological, Minneapolis, MN,
Manufacturer: Medtronic Puerto Rico Operations Co, MedRel, Juncos, PR. 
REASON A specific subset of model 7428 Kinetra implantable neurostimulators may fail due to lifted wirebonds between the hybrid circuit and battery. This failure mechanism may present clinically as loss of functionality and a return of the patient's underlying medical conditions.
VOLUME OF PRODUCT IN COMMERCE 24 devices
DISTRIBUTION CA, OR, PA, Belgium, France, Germany, Italy, Spain, Switzerland, and United Kingdom

PRODUCT Medtronic Paceart 2004 Second Edition & Paceart 2005 First Edition versions of the Paceart Gateway Software. The Medtronic Paceart System is a personal computer based pacemaker-testing system, a 12-lead electrocardiograph, and a transtelephonic receiving station. It provides data that can be used to analyze implanted pacemaker performance based on electrocardiographic measurements, either taken directly from the patient or programmer. The system can measure, store, and display any of the 12 standard leads. Reports and charts are available by means of a laser printer. The system also includes a database that collects and stores patient data. Optional software allows the device to function as an unattended transtelephonic receiving station, 
CODE Paceart 2004 second edition and Paceart 2005 first edition
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Inc., Cardiac Rhythm Management, Minneapolis, MN,
Manufacturer: Medtronic Paceart, Arden Hills, MN. 
REASON The Paceart System could inappropriately insert data from a patient’s Medtronic CareLink transmission into another patient’s Paceart record. An issue associated with the automated batch transfer of implanted cardiac device data from the Medtronic CareLink network to the Paceart System exists.
VOLUME OF PRODUCT IN COMMERCE 210 units
DISTRIBUTION Nationwide  

Hamilton Medical Issues a Medical Device Safety Alert on certain RAPHAEL Ventilators

Hamilton Medical, Inc. is recalling  forty seven (47) RAPHAEL ventilators with older generation software. Current RAPHAEL Color and RAPHAEL XTC ventilators are not affected by this action. Only four (4) customer facilities have been impacted by this action. Hamilton Medical, Inc. has already contacted these facilities regarding immediate field corrections.

The following RAPHAEL ventilators are affected:

RAPHAEL (Software version 2.2x)
RAPHAEL Silver (Software version 2.2xS)
RAPHAEL Color (Software version 2.2xC, 2.2xCU)

Customers who have product affected by this recall should (1) verify the proper function of their devices as described in Section 3 of the RAPHAEL Operator's Manual, (2) attach a caution sticker to the ventilator advising the clinician to check the LowMinVol alarm after oxygen cell calibration and (3) change their in-house test procedures for oxygen calibration as indicated in the corrective action package supplied to each affected user. Copies of this information are available from the Company although each customer affected has already been contacted and this information has been forwarded. The ventilators may continue to be used after these steps are complete.

Hamilton Medical, Inc. has also arranged for all customer units affected by this action to receive new current generation software at no charge, that will not only eliminate this problem but also provide our valuable customers with noninvasive ventilation (NIV) and with tubing resistance compliance (TRC) along with a bi-directional apnea back-up among other enhancements.

Customers outside of the United States and Canada are encouraged to contact Hamilton Medical AG, Technical Support at +41 81 6606010, mailto:techsupport@hamilton-medical.chfor specific information related to international devices.

Customers with questions may contact the Company at 800-426-6331 for a complete set of documentation relating to this action.

WEEK ENDING JUNE 17

PRODUCT Discovery ST PET/CT imaging system with gantry model number 5105797. Catalog Identifiers: S9114LA/LB/MA/MN, S9118LA/LB/MA/MN, S9116LA/MA. 

CODE 617243PETCT, 203688DST, ALLIANCEPETCT30, 203863DST, 973989DST, 908979DST, 212535DST, 412942DST, 814366CTPET, 202715PTCT, 443663DST, 850863FWPET, 863680DST, 251343DST, 832237EHDST, 0002584305, 574535PET, 763257DST, DMSIPCO7, EPHCPASRW1, 801408DST, 949417DST, 406255PET, 805546CT1, 415222CL1, 503692PETCT, 360SALPET, 425228DST, 402390DST1, 201996DST, AH4001PE01, 2558941, 082445040002, 082445160009, 082445160006, 082445160010, 514340DST, 423468PE01, 10495DST01, A4194408, 10094PTM70, 00060DST01, 00060DST02, A5138110, C5123618, A5215931, A99263302, A5111228, A5808512, A5279305, A5645908, YE0010, YE0009, 81DST2547033, ZWL0470, PER10934, 732292DST, ALLIANCEPCT41, DMSIPC15, 763463PC14, ALLIANCEPETCT28, ALLIANCEPETCT29, 972867DST, 082445040003, 2585577DISCPET, A5645911, YE0100, YE0113, YE0404, YE0403, 0834450002, 787269PETCT, 0002592878
RECALLING FIRM/MANUFACTURER General Electric Med Systems, LLC, Waukesha, WI, 
REASON The LightSpeed CT Technical Reference Manual was omitted from the document kit shipped with the PET/CT system.
VOLUME OF PRODUCT IN COMMERCE 74 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Optetrak Cemented Finned Tibial Tray Sz. 4F/5T. Knee prosthesis. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P53 mm M/L 83mm***STERILE, SINGLE USE ONLY FOR CEMENTED USE ONLY*** ***.'' Catalogue number 200-04-45, 
CODE Serial number range 0730621-07306351; Lot number 452500
RECALLING FIRM/MANUFACTURER Exactech, Inc., Gainesville, FL,
REASON An implant within a lot of finned tibial trays manufactured at Exactech was not made to specification. The locking cavity in the tibial tray was not fully machined thus preventing the tibial insert from locking in place.
VOLUME OF PRODUCT IN COMMERCE 14 implants
DISTRIBUTION AL, LA, Spain, Germany and Greece

PRODUCT Gliding Nail Radiolucent Guide instrument set, Model Number: GNRADIOLUCENTGUIDE, instrument set that contains one unit of each of the following instrument: 1130020-A: GNp Carbon Targeting Handle 1130021-A: GN Adapter Screw for Handle SW 10 1130022-A: GN Targeting Guide Carbon 125° 1130023-A: GN Targeting Guide Carbon 135° 1130060-A: GNp Drill Guide Locking No. 3 1133158-A: GN Centering Sleeve 
CODE Revision A Serial Number: None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Plus Orthopedics USA, San Diego, CA, 
Manufacturer: Plus Orthopedics AG, Rotkreuz, Switzerland.
REASON PLUS USA has been informed by PLUS AG that the accuracy of the instrument set may be affected in some cases. It is possible that in rare cases where patients have sclerotic (excessively hardened or firm) bone, that components may deform under application of force as the surgeon attempts to penetrate this bone with the instruments.
VOLUME OF PRODUCT IN COMMERCE 5 sets
DISTRIBUTION CA, ID and NY 

PRODUCT Anestar and Anestar Plus Anesthesia System. 
CODE Serial Numbers starting with 4600: A51083; C51104; C51116; C51117; C51120; C51121; C51125; E41025; G30143; L41062; L41063; L41064; L41065; L41071; L41075; 010001; 010002; 010008; 010010; A20024; A51076; A51077; A51078; A51081; A51084; B20027; B30076; B30077; B30078; B30081; B30082; B30083; B41005; B51087; B51088; B51089; B51092; B51096; C30087; C30092; C30093; C30094; C30095; C30096; C30097; C30098; C30099; C30102; C41014; C41015; C41017; C41020; C51114; C51118; D20035; D20036; D20037; D20038; D20042; D20043; D20044; D30100; D30101; D30103; D30104; D30105; D30106; D30107; D30108; D30109; E30112; E30113; E30115; E30116; E30117; E30118; E41029; F30120; F30128; F30129; F30131; F30132; F30133; F30134; F30135; G30136; G30137; G30138; G30139; G30140; G30142; H20045; H20047; H20051; H20052; I10010; I41031; I41035; I41036; I41038; I41041; I41042; I41043; I41044; I41045; I41046; I41047; I41048; I41049; I41050; J20055; J20056; J20057; J20059; J20060; J20061; J20063; J20064; K41057; L41066; L41073; A20018; A20023; A30069; A30070; B20026; B20028; B20030; B30084; B30086; C41031; C41018; D20014; I41034; I41037; K41060; L30162; L41068; C51101; C51103; C51111; C51113; D51131; F30122US; F30127; H30149; I41033; I41039; I41040; 010007; E30114; H30144; H30145; H30146; H30147; H30148; H30150; H30151; H30152; H30153; H30155; A30066; A30067; A30071; A51080; A51082; A51085; B41002; B51086; B51090; B51097; C41011; C41061; C41091; C51105; C51108; C51115; C51123; D51127; D51129; D51132; D51135; E41022; E41023; E41024; E41026; F30130; H20048; I41032; K41051; K41052; K41053; K41054; K41059; L41069; A51079; B41004; B41009; A30072; A30073; A30074; A30075; D20039; D20040; E30119; H30154; 010012; A20020; A20034; K41055; K41056; K41058; L30156; L30157; L30159; L30160; L30161; L41067; L41070; L41074; A30068; B51091; B51093; B51094; B51095; C30088; C30089; C30090; C30091; D10005; E41021; E41027; E41028; E41030; L30163; L30167; B51098; C51112; B20032; D51126; D51130; D51133; D51134; L30164; L30166; F30121; F30123; A20015; A20016; A20022; B10001; B20029; B20031; B20033; B30079; B30080; B41001; B41003; B41006; B41007; B41008; B41010; C51102; C51107; C51109; C51110; F30124; F30125; F30126; G30141; H20046; H20049; H20050; H20053; H20054; I10008; I10013; J20058; J20062; L30158; L40161; A20021; L41072. Serial Numbers starting with AF0: 1040-L5; 1045-A6; 1043-L5; 1029-K5; 1037-L5; 1005-I5; 1032-K5; 1036-L5; 1035-L5; 1034-L5; 1033-L5; 1032-L5; 1031-K5; 1030-K5; 1028-K5; 1027-K5; 1026-K5; 1025-K5; 1024-K5; 1023-K5; 1022-K5; 1021-K5; 1020-K5; 1019-K5; 1018-K5; 1017-K5; 1016-K5; 1015-K5; 1014-J5; 1013-J5; 1012-J5; 1011-J5; 1009-I5; 1008-I5; 1007-I5; 1004-I5; 1003-I5; 1001-I5; 1055-A6; 1051-A6; 1048-A6; 1046-A6; 1042-L5; 1010-I5; 1044-A6; 1041-L5; 1038-L5; 1006-I5; 1053-A6; 1052-A6; 1049-A6; 1047-A6; 1039-L5.
RECALLING FIRM/MANUFACTURER Datascope Corp, Mahwah, NJ, 
REASON The Anestar and Anestar Plus Anesthesia System may produce periods of high Positive End-Expiratory Pressure (PEEP), in both manual and mechanical ventilation mode due to an issue with the Applied Pressure Limit (APL) valve.
VOLUME OF PRODUCT IN COMMERCE 337 UNITS
DISTRIBUTION Nationwide and Australia, El Salvador, and Venezuela.

PRODUCT
a) CATHETER LA5IMAA 5F 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Model #: LA5IMAA, 

b) CATH.GUIDE 5F JL 4.0 110CM CATHETER LA5JL40A LA 5F 110CM JL40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Model # LA5JL40A, ;

c) CATH.GUIDE 5F JR 4.0 110CM CATHETER LA5JR40A LA 5F 110CM JR4.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Model #LA5JR40A, 

d) CATH GUIDE 5F SR3.0 LAUNCHER CATHETER LA5SR30 LA 5F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Model#LA5SR30,

e) CATH GUIDE 5F SR3.5 LAUNCHER CATHETER LA5SR35 LA 5F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA5SR35, 

f) CATH GUIDE 5F SR4.0 LAUNCHER CATHETER LA5SR40 LA 5F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA5SR40,;

g) CATH.GUIDE 5F SR 5.0 110CM CATHETER LA5SR50A LA 5F 110CM SR5 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA5SR50A, 

h) CATH. GUIDE 6F 3DRC LAUNCHER CATHETER LA63DRC LA 6F 100CM 3DRC Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number:LA63DRC,

i) CATH. GUIDE 6F AL 1.0 110CM LA CATHETER LA6AL10A LA 6F 110CM AL10 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6AL10A, 

j) CATH. GUIDE 6F AL 2.0 110CM LA CATHETER LA6AL20A LA 6F 110CM AL20 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6AL20A, 

k) CATH GUIDE 6F LAUNCHER AL 3.0 CATHETER LA6AL30A LA 6F 110CM AL30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6AL30A, ;

l) CATH. GUIDE 6F EBU3.5 110CM LA CATHETER LA6EBU35A LA 6F 110CM EB35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6EBU35A, ;

m) CATH. GUIDE 6F EBU4.0 110CM LA CATHETER LA6EBU40A LA 6F 110CM EB40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6EBU40A, 

n) CATH GUIDE 6F LAUNCHER EBU 4.5 CATHETER LA6EBU45A LA 6F 110CM EB45 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6EBU45A, 

o) CATHETER LA6HSIA 6F 110CM HSI Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number : LA6HSIA, 

p) CATH. GUIDE 6F JL3.5 110CM LAU CATHETER LA6JL35A LA 6F 110CM JL35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6JL35A,

q) CATH. GUIDE 6F JL4.0 5 PACK LA Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6JL405, 

r) CATH. GUIDE 6F JL4.0 110CM LAU CATHETER LA6JL40A LA 6F 110CM JL40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6JL40A, 

s) CATH.GUIDE 6F JL 4.0 SH 110CM CATHETER LA6JL40SHA LA 6F 110CM JL40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6JL40SHA, ;

t) CATHETER LA6JL45A 6F 110CM JL4 CATHETER LA6JL45A 6F 110CM JL45 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6JL45A, ;

u) CATH. GUIDE 6F JL5.0 110CM LAU CATHETER LA6JL50A LA 6F 110CM JL50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6JL50A, 

v) CATH. GUIDE 6F JR4.0 110CM LAU CATHETER LA6JR40A LA 6F 110CM JR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6JR40A, ;

w) CATH.GUIDE 6F JR 4.0 SH 110CM CATHETER LA6JR40SHA LA 6F 110CM JR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6JR40SHA, 

x) CATH. GUIDE 6F JR5.0 110CM LAU CATHETER LA6JR50A LA 6F 110CM JR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6JR50A, 

y) CATHETER LA6MB1A LA 6F 110CM M Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6MB1A, 

z) CATH. GUIDE 6F SR3.0 LAUNCHER CATHETER LA6SR30 LA 6F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6SR30, 

aa) CATH. GUIDE 6F SR3.0 W/SH LAUN CATHETER LA6SR30SH LA 6F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6SR30SH, ;

bb) CATH. GUIDE 6F SR3.5 LAUNCHER CATHETER LA6SR35 LA 6F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6SR35, ;

cc) CATH. GUIDE 6F SR3.5 W/SH LAUN CATHETER LA6SR35SH LA 6F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6SR35SH, 

dd) CATH. GUIDE 6F SR4.0 LAUNCHER CATHETER LA6SR40 LA 6F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA6SR40,

ee) CATHETER LA6SR40A 6F 110CM SR4 CATHETER LA6SR40A 6F 110CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code:
LA6SR40A, 

ff) CATH. GUIDE 6F SR4.0 W/SH LAUN CATHETER LA6SR40SH LA 6F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA6SR40SH, 

gg) CATH. GUIDE 6F SR4.5 LAUNCHER CATHETER LA6SR45 LA 6F 100CM SR45 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA6SR45, 

hh) CATH. GUIDE 6F SR4.5 W/SH LAUN CATHETER LA6SR45SH LA 6F 100CM SR45 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA6SR45SH, ;

ii) CATH. GUIDE 6F SR5.0 LAUNCHER CATHETER LA6SR50 LA 6F 100CM SR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA6SR50,

jj) CATH. GUIDE 6F SR5.0 W/SH LAUN CATHETER LA6SR50SH LA 6F 100CM SR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA6SR50SH, 

kk) CATH. GUIDE 6F SR6.0 LAUNCHER CATHETER LA6SR60 LA 6F 100CM SR60 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6SR60, 

ll) CATH. GUIDE 6F SR6.0 W/SH LAUN Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6SR60SH, 

mm) CATH. GUIDE 7F 3DRCC LAUNCHER CATHETER LA73DRC LA 7F 100CM 3DRC Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA73DRC, 

nn) CATHETER LA7IMAA LA 7F 110CM I CATHETER LA7IMAA LA 7F 110CM IMA Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA7IMAA, 

oo) CATHETER LA7MB1A LA 7F 110CM M CATHETER LA7MB1A LA 7F 110CM MB Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA7MB1A, 

pp) CATH. GUIDE 7F SR3.0 LAUNCHER CATHETER LA7SR30 LA 7F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA7SR30,

qq) CATH. GUIDE 7F SR3.0 W/SH LAUN CATHETER LA7SR30SH LA 7F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA7SR30SH, 

rr) CATH. GUIDE 7F SR3.5 LAUNCHER CATHETER LA7SR35 LA 7F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA7SR35 LA7SR35, 

ss) CATH. GUIDE 7F SR3.5 W/SH LAUN CATHETER LA7SR35SH LA 7F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA7SR35SH, 

tt) CATH. GUIDE 7F SR4.0 LAUNCHER CATHETER LA7SR40 LA 7F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA7SR40, 

uu) CATH. GUIDE 7F SR4.0 W/SH LAUN CATHETER LA7SR40SH LA 7F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA7SR40SH, 

vv) CATH. GUIDE 7F SR4.0 LAUNCHER CATHETER LA7SR40 LA 7F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA7SR40, 

ww) CATH. GUIDE 7F SR4.0 W/SH LAUN CATHETER LA7SR40SH LA 7F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA7SR40SH, 

xx) CATH. GUIDE 7F SR5.0 LAUNCHER CATHETER LA7SR50 LA 7F 100CM SR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA7SR50, 

yy) CATH. GUIDE 8F 3DRC LAUNCHER CATHETER LA83DRC LA 8F 100CM 3DRC Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA83DRC, ;

zz) CATH. GUIDE 8F 3DRC W/SH LAUNC Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA83DRCSH, 

aaa) CATH.GUIDE 8F EBU 4.0 110CM CATHETER LA8EBU40SHA LA 8F 110CM EB40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA8EBU40SHA, 

bbb) CATH.GUIDE 8F EBU 4.5 SH 110CM CATHETER LA8EBU45SHA LA 8F 110CM EB45 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA8EBU45SHA,;

ccc) CATH.GUIDE 8F EBU 5.0 SH 110CM CATHETER LA8EBU50SHA LA 8F 110CM EB50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA8EBU50SHA, ;

ddd) CATH. GUIDE 8F SR3.0 LAUNCHER Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA8SR30, 

eee) CATH. GUIDE 8F SR3.0 W/SH LAUN Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA8SR30SH, 

fff CATH. GUIDE 8F SR3.5 LAUNCHER CATHETER LA8SR35 LA 8F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA8SR35,

ggg) CATH. GUIDE 8F SR3.5 W/SH LAUN CATHETER LA8SR35SH LA 8F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA8SR35SH, 

hhh) CATH. GUIDE 8F SR4.0 LAUNCHER CATHETER LA8SR40 LA 8F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA8SR40, 

iii) CATH. GUIDE 8F SR4.0 W/SH LAUN CATHETER LA8SR40SH LA 8F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA8SR40SH, 

jjj) CATH. GUIDE 8F SR5.0 LAUNCHER Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA8SR50, 

kkk) CATH. GUIDE 8F SR5.0 W/SH LAUN Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA8SR50SH, 

lll) CATH. GUIDE 8F SR6.0 LAUNCHER Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA8SR60, 

mmm) CATH. GUIDE 8F SR6.0 W/SH LAUN Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA8SR60SH, 

nnn) CATHETER SA63DRC SA 6F 100CM 3 CATHETER SA63DRC SA 6F 100CM 3DRC Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: SA63DRC, 

ooo) CATHETER SA63DRCSH Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: SA63DRCSH, 

ppp) CATHETER SA6SR35 SA 6F 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: SA6SR35, 

qqq) CATHETER SA6SR40 SA 6F 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: SA6SR40, 

rrr) CATHETER SA6SR50 SA 6F 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: SA6SR50, 

sss) CATHETER SB63DRC SB 6F 100CM 3 CATHETER SB63DRC SB 6F 100CM 3DRC Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: SB63DRC, 

ttt) CATHETER SB63DRCSH SB 6F 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: SB63DRCSH, 

uuu) CATHETER SB6SR30 SB 6F 100CM S Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: SB6SR30, 

vvv) CATHETER SB6SR35 SB 6F 100CM S Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: SB6SR35, 

www) CATHETER SB6SR35SH SB 6F 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: SB6SR35SH, ;

xxx) CATHETER SB6SR40 SB 6F 100CM S CATHETER SB6SR40 SB 6F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: SB6SR40, 

yyy) CATHETER SB6SR40SH SB 6F 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: SB6SR40SH, 

zzz) CATHETER SB6SR50 SB 6F 100CM S Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: SB6SR50, 

aaaa) CATHETER SB73DRCSH SB 7F 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: SB73DRCSH, 

bbbb) CATHETER Z26AL10A Z2 6F 110CM AL10 Z26 AL10 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26AL10A

cccc) 6F Z2 AL 2.0 110CM CATHETER Z26AL20A Z2 6F 110CM AL20 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26AL20A

dddd) 6F Z2 AL 3.0 110CM CATHETER Z26AL30A Z2 6F 110CM AL30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26AL30A

eeee) 6F Z2 AR 2.0 110CM CATHETER Z26AR20A Z2 6F 110CM AR20 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26AR20A

ffff) CATHETER Z26EBU35A Z2 6F 110CM EB35 Z26 EBU35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26EBU35

gggg) CATHETER Z26EBU40A Z2 6F 110CM CATHETER Z26EBU40A Z2 6F 110CM EB40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: Z26EBU40A, 

hhhh) 6F Z2 FL 4.0 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product code: Z26FL40A

iiii) 6F Z2 JL 4.0 110CM CATHETER Z26JL40A Z2 6F 110CM JL40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26JL40A

jjjj) 6F Z2 JR 4.0 110CM CATHETER Z26JR40A Z2 6F 110CM JR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26JR40A

kkkk) CATH, GUIDE 6F JR4.0 SH 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26JR40SHA

llll) CATH GUIDE 6F MB2 110CM Z2 CATHETER Z26MB2A Z2 6F 110CM MB2 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26MB2A

mmmm) 6F Z2 MP1 110CM CATHETER Z26MP1A Z2 6F 110CM MP1 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26MP1A

nnnn) 6F Z2 GUIDING CATHETER SR3.0 CATHETER Z26SR30 Z2 6F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26SR30

oooo) 6F Z2 GUIDING CATH SR3.0 SH CATHETER Z26SR30SH Z2 6F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26SR30SH

pppp) 6F Z2 GUIDING CATHETER SR3.5 CATHETER Z26SR35 Z2 6F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26SR35

qqqq) 6F Z2 GUIDING CATH SR3.5 SH CATHETER Z26SR35SH Z2 6F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26SR35SH

rrrr) 6F Z2 GUIDING CATHETER SR4.0 CATHETER Z26SR40 Z2 6F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26SR40

ssss) 6F Z2 GUIDING CATH SR4.0 SH CATHETER Z26SR40SH Z2 6F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: Z26SR40SH

tttt) 6F Z2 GUIDING CATHETER SR5.0 CATHETER Z26SR50 Z2 6F 100CM SR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: Z26SR50

uuuu) 6F Z2 GUIDING CATH SR5.0 SH CATHETER Z26SR50SH Z2 6F 100CM SR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: Z26SR50SH

vvvv) 7F Z2 FR 4.0 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: Z27FR40A

wwww) 7F Z2 JL 4.0 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: Z27JL40A

xxxx) 7F ZUMA 2 JR 4.0 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z27JR40A

yyyy) 7F Z2 MB2 110CM CATHETER Z27MB2A Z2 7F 110CM MB2 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code:Z27MB2A

zzzz) 7F Z2 MP1 110CM CATHETER Z27MP1A Z2 7F 110CM MP1 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z27MP1A

aaaaa) 7F ZUMA 2 SR3.0 100CM CATHETER Z27SR30 Z2 7F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z27SR30

bbbbb) 7F ZUMA 2 SR3.5 100CM CATHETER Z27SR35 Z2 7F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z27SR35

ccccc) 7F ZUMA 2 SR3.5 SH 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z27SR35SH

ddddd) 7F ZUMA 2 SR4.0 100CM CATHETER Z27SR40 Z2 7F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: Z27SR40

eeeee) 7F ZUMA 2 SR4.0 SH 100CM CATHETER Z27SR40SH Z2 7F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: Z27SR40SH

fffff) 7F ZUMA 2 SR5.0 100CM CATHETER Z27SR50 Z2 7F 100CM SR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z27SR50

ggggg) CATH. GUIDE 8F AR1.0 W/SH 110C Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28AR10SHA

hhhhh) CATH. GUIDE 8F EBU3.5 W/SH 110 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28EBU35SHA

iiiii) CATH. GUIDE 8F EBU4.0 W/SH 110 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product code: Z28EBU40SHA

jjjjj) CATH. GUIDE 8F EBU5.0 W/SH 110 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28EBU50SHA

kkkkk) CATH. GUIDE 8F FR4.0 W/SH 110C Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28FR40SHA

lllll) CATH. GUIDE 8F MB1 W/SH 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28MB1SHA

mmmmm) 8F ZUMA 2 SR 3.0 100CM CATHETER Z28SR30 Z2 8F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR30

nnnnn) 8F ZUMA 2 SR 3.5 100CM CATHETER Z28SR35 Z2 8F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR35

ooooo) 8F ZUMA 2 SR 3.5 SH 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR35SH

ppppp) 8F ZUMA 2 SR 4.0 100CM CATHETER Z28SR40 Z2 8F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR40

qqqqq) 8F ZUMA 2 SR 4.0 SH 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR40SH

rrrrr) 8F ZUMA 2 SR 5.0 100CM CATHETER Z28SR50 Z2 8F 100CM SR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR50

sssss) 8F ZUMA 2 SR 5.0 SH 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR50SH

ttttt) 5F ZUMA SR3.0 CATHETER ZM5SR30 Z2 5F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM5SR30

uuuuu) ZM5SR35 5F ZUMA SR3.5 CATHETER ZM5SR35 Z2 5F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM5SR35

vvvvv) 5F ZUMA SR4.0 CATHETER ZM5SR40 Z2 5F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM5SR40

wwwww) 5F ZUMA SR5.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM5SR50

xxxxx) 6F ZUMA AL1.0 W/110CM LENGTH CATHETER ZM6AL10A ZM 6F 110CM AL1.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6AL10A, 

yyyyy) 6F ZUMA AL1.0 W/110CM LENGTH CATHETER ZM6AL10A ZM 6F 110CM AL1.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6AL10A, 

zzzzz) 6F ZUMA AR2.0 CATHETER ZM6AR20A ZM 6F 110CM AR2.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6AR20A

aaaaaa) 6F ZUMA DC3.5 W/110CM LENGTH GUID CATH 6F ZUMA DC 3.5 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Codes: ZM6DC35A , ZM6DC35A00

bbbbbb) 6F ZUMA DC4.0 W/110CM LENGTH GUID CATH 6F ZUMA DC 4.0 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Codes: ZM6DC40A ,ZM6DC40A00

cccccc) 6F ZUMA EBU3.5 W/110CM LENGTH CATHETER ZM6EBU35A ZM 6F 110CM EB35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6EBU35A, 

dddddd) 6F ZUMA EBU4.0 W/110CM LENGTH GUID CATH 6F ZUMA EBU4.0 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6EBU40A, ZM6EBU40A00

eeeeee) ZM6JL40A 6F ZUMA JL40 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6JL40A

ffffff) 6F ZUMA JL40 110CM CATHETER ZM6JL40A ZM 6F 110CM JL4.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6JL40A

gggggg) CATH, GUIDE 6F JL6.0 110CM ZUM CATHETER ZM6JL60A ZM 6F 110CM JL60 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6JL60A, 

hhhhhh) ZM6JR40A 6F ZUMA JR4.0 110CM CATHETER ZM6JR40A ZM 6F 110CM JR4.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6JR40A

iiiiii) 6F ZUMA JR5.0 110CM CATHETER ZM61JR50A ZM 6F 110CM JR5.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6JR50A

jjjjjj) 6F ZUMA MAC 3.5 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6MAC35A

kkkkkk) 6F ZUMA MAC 4.0 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6MAC40A

llllll) 6F ZUMA SL5.0 CATHETER ZM6SL50 ZM 6F 100CM SL5.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6SL50

mmmmmm) 6F ZUMA SR3.0 CATHETER ZM6SR30 ZM 6F 100CM SR3.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6SR30

nnnnnn) 6F ZUMA SR3.5 CATHETER ZM6SR35 ZM 6F 100CM SR3.5 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6SR35

oooooo) 6F ZUMA SR4.0 CATHETER ZM6SR40 ZM 6F 100CM SR4.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6SR40

pppppp) 6F ZUMA SR5.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6SR50
CODE
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b) Lot number: 210764;
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219232 221749 223371;
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aaa) Lot Numbers: 182211;
bbb) Lot Numbers: 182212;
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0000063123;
uuu) Lot Number: 0000045678;
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0000080591 0000106158 0000125305 0000134506 177556 203498
207021 209062 209425 215419 221286;
qqqq) Lot Numbers: 0000032871 0000058520 0000138126 0000149130 177525
224420;
rrrrr) Lot Numbers: 0000002433 0000006514 0000012046 0000027687
0000028673 0000033680 0000033718 0000043780 0000046956 0000067140
0000072965 0000076643 0000080168 0000081106 0000085973 0000095150
0000106493 0000134505 0000172339 178512 182950 186089 202512 205561
208500 211542 214599 215763 221279 222892;
ssss) Lot Numbers: 0000011190 0000011209 0000046897 0000050822
0000058465 0000059945 0000076641 0000091580 0000104403
0000120202 0000134918 0000156721 179670 208478 214319;
tttt) Lot Numbers: 0000060403 0000065850 0000140267 179669
209039 211282;
uuuu) Lot Numbers: 0000047798 206499;
vvvv) Lot Numbers: 0000072581 0000077802 0000174555;
wwww) Lot Number: 0000035239;
xxxx) Lot Numbers: 0000120798;
yyyy) Lot Numbers: 0000087257 0000090981;
zzzz) Lot Numbers: 0000076629 0000087109 0000087254;
aaaaa) Lot Numbers: 0000050020 0000054722;
bbbbb) Lot Numbers: 0000026381 208835;
ccccc) Lot Numbers: 0000033365 0000076630;
ddddd) Lot Numbers: 0000002247 0000008188 0000015219 0000015885
0000057268 0000075237 0000103319 0000151685 0000176359
212367 221319;
eeeee) Lot Numbers: 0000027588 0000027596 0000028599 0000183448;
fffff) Lot Numbers: 213488 215327;
ggggg) Lot Number: 206715;
hhhhh) Lot Numbers: 215377;
iiiii) Lot Number: 206732;
jjjjj) Lot Number: 0000083439;
kkkkk) Lot Number: 0000083434;
llll) Lot Number: 206745;
mmmmm) Lot Numbers: 0000050014 0000102672;
nnnnn) Lot Numbers: 0000011215 0000032531 0000040323 0000064232
184861 209079 213092;
ooooo) Lot Numbers: 0000044125 0000050795 209041;
ppppp) Lot Numbers: 0000010657 0000021552 0000075807 215424;
qqqqq) Lot numbers: 0000002224 208965 213818;
rrrrr) Lot Numbers: 0000170203 220956;
sssss) Lot Number: 216303;
ttttt) Lot Number: 0000097904;
uuuuu) Lot Numbers: 0000004321 0000016470;
vvvvv) Lot Numbers: 0000031314 0000120842 0000171203 0000176191
0000183404 212571 214571;
wwwww) Lot Numbers: 0000033244 0000049489 0000143877 215963;
xxxxx) Lot Numbers: 0000096756;
yyyyy) Lot Numbers: 0000162767 144574 155445;
zzzzz) Lot Numbers: 0000111382 0000162772 203444;
aaaaaa) Lot Numbes: 128977 130210;
bbbbbb) Lot Numbers: 128977 130210;
cccccc) Lot Number: 128977;
dddddd) Lot Numbers: 188392 209053 212288;
eeeeee) Lot Numbers: 0000109164 128977 130210;
ffffff) Lot Numbers: 0000109164 128977 130210;
gggggg) Lot Number: 0000129379;
hhhhhh) Lot Number: 0000162769;
iiiiii) Lot Number: 136251;
jjjjjj: Lot Number: 0000080611;
kkkkkk) Lot Number: 0000080610;
llllll) Lot Number: 128283;
mmmmmm) Lot Number: 0000080967;
nnnnnn) Lot Numbers: 0000005115 0000012614 0000014791 0000021492
0000049651 0000052460 0000102704 0000203280 129920 136399 138569;
oooooo: Lot Numbers: 0000000770 0000002134 0000028207 0000043814
0000090410 0000103759 0000125699 0000137834 0000151268
0000164481 127482 128283 128616 128988 130040 130595 132042 134208
135297 136396 138223 139414 141461 145170 223496;
pppppp) Lot Number: 0000178091
RECALLING FIRM/MANUFACTURER Medtronic, Inc., Danvers, MA.
REASON Potential for non-sterility due to loss of package integrity.
VOLUME OF PRODUCT IN COMMERCE 10,493 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Hitachi CXR-4 CT Computed Tomography X-ray System (including SceptreP3 PET/CT)
CODE Serial Number: CXR46201-46213 PC 46002-36011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hitachi Medical Systems America Inc., Twinsburg, OH.
Manufacturer: Hitachi Medical Corporation, Chiyoda-Ku, Tokyo, Japan.
REASON The device has a software anomaly which affects the system's ability to create Multiplanar Reconstructions (MPR). Some images from the resulting series do not display correctly, or display at all, when MPR was run on them.
VOLUME OF PRODUCT IN COMMERCE 15 devices
DISTRIBUTION Nationwide

PRODUCT Hitachi Emission Computed Tomography System Hitachi CX-4 CT (including SceptreP3 PET-CT). 
CODE CXR46201-46214 PC46002-46011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hitachi Medical Systems America Inc., Twinsburg, OH.
Manufacturer: Hitachi Medical Corporation, Chiyoda-Ku, Tokyo, Japan.
REASON The device has a software anomaly which causes blank images to be created during Multiplanar Reconstruction processing or results in an inherent filming error in which a reference scale is improperly sized.
VOLUME OF PRODUCT IN COMMERCE 16 devices
DISTRIBUTION Nationwide

PRODUCT
a) Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part F#1010563
b) Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010564
c) Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010565
d) Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010566
e) ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter)- Base Part #FG1010567
f) ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010568
CODE
a) All part numbers and all lot numbers of the 135 cm length delivery catheter are affected: 1) Base Part # FG1010563; Suffix (Stent Length, mm) = -20, -30, -40, -60, -80, -100.
b) All part numbers and all lot numbers of the 135 cm length delivery catheter are affected: 1) Base Part # FG1010564; Suffix (Stent Length, mm) = -20, -30, -40, -60, -80, -100.
c) All part numbers and all lot numbers of the 135 cm length delivery catheter are affected: 1) Base Part # FG1010565; Suffix (Stent Length, mm) = -20, -30, -40, -60, -80, -100.
d) All part numbers and all lot numbers of the 135 cm length delivery catheter are affected: 1) Base Part # FG1010566; Suffix (Stent Length, mm) = -20, -30, -40, -60, -80, -100.
e) All part numbers and all lot numbers of the 135 cm length delivery catheter are affected: 1) Base Part # FG1010567; Suffix (Stent Length, mm) = -20, -30, -40, -60, -80, -100
f) All part numbers and all lot numbers of the 135 cm length delivery catheter are affected: 1) Base Part # FG1010568; Suffix (Stent Length, mm) = -20, -30, -40, -60, -80, -100.
RECALLING FIRM/MANUFACTURER Guidant Endovascular Solutions, Inc., Temecula, CA, by letter dated April 3, 2006.
REASON Design: increasing number of customer complaints with a trend of stent deployment difficulties. The difficulties are reported during acute deployment of the stent, therefore patients in whom a stent has successfully been implanted are not affected by this action.
VOLUME OF PRODUCT IN COMMERCE Approximately 38,203 units
DISTRIBUTION Nationwide

PRODUCT St. Jude AGILIS Steerable Introducer, Reorder number 408304 and 408308, Agilis Steerable Catheter Introducer Set consists of a dilator, guidewire, and steerable sheath, which is designed to provide flexible catheter positioning in the cardiac anatomy. EXPANDED RECALL The Reorder number affected by the recall expansion is 408304. 
CODE Lot number range: 1169725 to 1181488 EXPANDED RECALL additional lot numbers are: 1182741, 1182742, 1182743, 1182744, 1182745, 1184211, 1185314, 1186554, 1186557.
RECALLING FIRM/MANUFACTURER St. Jude Medical / Daig Division, Minnetonka, MN
REASON St Jude Medical has determined that a limited number of Agilis Steerable Introducers manufactured in late 2005 are susceptible to the hemostasis hub leaking or separating from the handle. The risks that exist are related to the loss of hemostasis through the Agilis introducer and/or the possibility of air or foreign body being introduced into the patient with resultant embolism.
VOLUME OF PRODUCT IN COMMERCE 2,489 devices
DISTRIBUTION Nationwide and Internationally

PRODUCT Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic absorbable sterile surgical suture comprised of a copolymer made from 90% gycolide and 10%L-lactide. 
CODE Product Codes/Product Lot Numbers-Expiration Dates: J774D/SB2371-01/2008; JB725/SB2416-01/2008; J864D/SB2426-01/2008.
RECALLING FIRM/MANUFACTURER Ethicon, Inc., Somerville, NJ
REASON Misalignment of packaging sealing platform created open seals and/or open channels in the packaging seal causing degradation of the sutures
VOLUME OF PRODUCT IN COMMERCE 1,157 dozen sutures
DISTRIBUTION Nationwide, Japan, Canada, and Taiwan

PRODUCT Amplatz Goose Neck Microsnare Kit, Model SK400 (175 cm length x 4mm loop snare x .018'',0.46mm) and SK701 (200 cm length x 7mm loop snare x 0.18'' x 0.46mm) ev3, 4600 Nathan Lane North, Plymouth, Minnesota, 55442-2920 USA. For one time use only. Sterilization with Ethylene Oxide gas. Do not resterilize.------The Amplatz Goose Neck Microsnare Kit contains one Amplatz Goose Neck Microsnare, one Microcatheter, one Microsnare Introducer and one torque device. 

CODE Lot number 277755; Lot number 575327
RECALLING FIRM/MANUFACTURER Ev3, Inc., Plymouth, MA
REASON ev3 has determined that one test unit from each of two lots did not meet minimum tensile strength requirements and therefore the entire lots are being recalled.
VOLUME OF PRODUCT IN COMMERCE 58
DISTRIBUTION Nationwide and Canada, Germany and Japan

 

WEEK ENDING JUNE 24

MRL, Inc. a Welch Allyn Company, Issues a Voluntary Worldwide Recall of Selected AED20 Automatic External Defibrillators

MRL, Inc., a Welch Allyn Company, announced it is initiating a worldwide  recall of 580 AED20 Automatic External Defibrillators manufactured in Buffalo Grove, IL between April and October of 2003, with serial numbers 205199 through 205786. These 580 AED20's may experience failure or unacceptable delay in analyzing the patient's ECG and may fail to deliver appropriate therapy, which possibly could result in failure to resuscitate the patient This will occur in combination with an error message on the device display reading "DEFIB COMM FAIL SELF TEST FAILED." This problem occurs because of an intermittent electrical connection within the device.

Customers with questions may contact the company at 1.800.462.0777 or 1.847.520.0300 for more information.

PRODUCT
a) PlusRite Power Strike Metal Halide Lamps, 
b) PlusRite Low Watt Metal Halide Lamps, 
c) PlusRite Universal Metal Halide Lamps, 
d) PlusRite Protected Metal Halide Lamps,
e) PlusRite Mercury Vapor Lamps, 
CODE N/A
RECALLING FIRM/MANUFACTURER Fanlight Corporation Inc., City of Industry, CA, 
REASON The non-self-extinguishing mercury vapor and metal halide lamps failed to comply with the performance requirements of 21 CFR 1040.30 and the certification and identification requirements of 21 CFR 1010.2 and 1010.3.
VOLUME OF PRODUCT IN COMMERCE 100,000 devices
DISTRIBUTION Nationwide

 PRODUCT
a) Aortic Perfusion Cannula with plastic tip, 22 Fr. X 28 cm Edwards Lifesciences, REF: A3221190A,
b) Duraflow Treated Aortic Perfusion Cannula with plastic tip, 22 Fr. X 28 cm Edwards Lifesciences, REF: DARH221190TA,
c) Aortic Perfusion Cannula with plastic tip, 22 Fr. X 28 cm Edwards Lifesciences, REF: ARH221190TA,
d) Duraflow Treated Aortic Perfusion Cannula with plastic tip, 22 Fr. X 28 cm Edwards Lifesciences, REF: DARH221190A,
e) Aortic Perfusion Cannula with plastic tip, 22 Fr. X 23 cm Edwards Lifesciences, REF: AH221190A,
f) Aortic Perfusion Cannula with metal tip, 22 Fr. X 23 cm Edwards Lifesciences, REF: MT022A, 
g) Aortic Perfusion Cannula with metal tip, 22 Fr. X 23 cm Edwards Lifesciences, REF: MT022TA, 
CODE
a) Lot number: 58194673;
b) Lot number: 58194842;
c) Lot numbers: 58196967, 58199178;
d) Lot number: 58198731;
e) Lot number: 58200588;
f) Lot numbers: 58209961, 58193894, 58203989, 58213564;
g) Lot numbers: 58208130, 58216517
RECALLING FIRM/MANUFACTURER Edwards Lifesciences Research Medical, Inc., Midvale, UT
REASON Due to potential embrittlement of the plastic tip which may crack or separate during use.
VOLUME OF PRODUCT IN COMMERCE 616 units (Domestic), 1540 units (Foreign)
DISTRIBUTION CA, CT, FL, IN, KS, MA, MI, TN, TX, Australia, Chile, EU, India, Singapore, and Taiwan

PRODUCT
a) Weck Hem-o-lok ML Polymer Ligating Clips; Rx, sterile, medium large size, non-absorbable polymer ligation clips; 6 clips per cartridge,
14 cartridges per sales unit, 12 sales units per case, catalog number 544230, 
b) Weck Hem-o-lok L Polymer Ligating Clips; Rx, sterile, large size, non-absorbable polymer ligation clips; 6 clips per cartridge,
14 cartridges per sales unit, 12 sales units per case, catalog number 544240, 
c) Weck Hem-o-lok XL Polymer Ligating Clips; Rx, sterile, extra large size, non-absorbable polymer ligation clips; 6 clips per cartridge,
14 cartridges per sales unit, 12 sales units per case, catalog number 544250,
d) Weck Hem-o-lok Endo 5 Automatic Clip Applier with Medium Polymer Ligating Clips; Rx, sterile, single use, disposable clip applier with
medium size, non-absorbable polymer ligation clips; 15 clips per applier, 3 appliers per sales unit, 6 units per case, catalog number 543965,
CODE All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teleflex Corporation, Limmerick, PA, .
Manufacturer: Teleflex Medical, Research Triangle Park, NC.
REASON The Hem-o-lok ligating clips may become dislodged following ligation of the renal artery after laparoscopic donor nephrectomy. Hem-o-lok ligating clips are now contraindicated for use in ligating the renal artery during laparascopic nephrectomies in living donor patients.
VOLUME OF PRODUCT IN COMMERCE 10,458,708 clips
DISTRIBUTION Nationwide

PRODUCT Signify hCG Serum Urine 30 Test Kit, Abbott List No. 07K09-30, ABI List No. 6026KSI, 
CODE Lot number: 84936, Exp. 02/10/2007
RECALLING FIRM/MANUFACTURER Applied Biotech, Inc., San Diego, CA, 
REASON Certain kits from the product lot may contain test devices which contain incorrect reaction strips. Use of such devices may produce false negative results with patient samples at and above the limit of detection of the product.
VOLUME OF PRODUCT IN COMMERCE 1,198 Kits (35,940 tests)
DISTRIBUTION IL

PRODUCT Heartport Direct Flow Arterial Cannula, product code DFK24. The device is sold separately and also in the following Kit Model Numbers: EDNN241, EDNN242, EDNN243, and EDNN244, 
CODE Lot Numbers: MS0206031; MS0206032; MS0505014; MS0505020; MS0605009; MS0605038; MS0605039; MS0705034; MS0705035; MS0705044; MS0905040; MS0905066; MS1105041; MS1105061; MS1205043
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ethicon, Inc., Somerville, NJ, 
Manufacturer: Accellent, Inc., Laconia, NH. 
REASON During cardiopulmonary bypass (CPB) the distal tip of the arterial cannula can become disconnected from the body of the cannula.
VOLUME OF PRODUCT IN COMMERCE 368 devices
DISTRIBUTION Nationwide, UK and Italy

PRODUCT Boston Scientific Wiseguide Guide Catheter 7F, .076', Femoral Approach. Catalog number: 19500-448, Catalog number: 19500-498, Catalog number: 19500-08, Catalog number: 19500-09, Catalog number: 19500-132, Catalog number: 19500-27, 
CODE Lot # 655713, L0t # 655721, L0t # 657310, L0t # 657311, L0t # 655680, L0t # 655695,
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific, Maple Grove, MN, .
Manufacturer: Avenida Norske Edificio G1 Local B, Tijuana, Mexico. 
REASON Gaps were identified between polymer segments on the 7F Wiseguide Guide Catheter in which the PTFE was not properly laminated to the braid of the catheter. This delamination of the PTFE from the braid could compromise the device delivery.
VOLUME OF PRODUCT IN COMMERCE 75 devices
DISTRIBUTION Nationwide

PRODUCT Hitachi Altaire Magnetic Resonance Imaging System,
CODE L001 thru L223
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hitachi Medical Systems America, Inc., Twinsburg, OH, 
Manufacturer: Hitachi Medical Corporation, Chiyoda-Ku, Tokyo, Japan.
REASON Circuit Failure -- There is the potential risk of the Phase Loss Detector Safety Device (PHSEN PCB) malfunctioning in the event of a power loss. The circuit may fail to turn off the systems main breaker when 2 of the 3 power phases are lost.
VOLUME OF PRODUCT IN COMMERCE 213 devices
DISTRIBUTION Nationwide

PRODUCT Altaire Nuclear Magnetic Resonance Imaging Device Systems, 
CODE Serial Numbers: Altaire -- L217, L219, L221, L224 and L225
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hitachi Medical Systems America, Inc., Twinsburg, OH, 
Manufacturer: Hitachi Medical Corporation, Chiyoda-Ku, Tokyo, Japan..
REASON Software anomaly -- A software defect can cause the slice line indicator to become mis-positioned during Multi-Planar Reconstructions (MPR) with the potential for patient mis-diagnosis.
VOLUME OF PRODUCT IN COMMERCE 5 devices
DISTRIBUTION CO, OH, NB, and TX

PRODUCT MRP-7000, AIRIS Magnetic Resonance Imaging Systems, 

CODE Asset Tag Numbers: 7001-7154; A007-A901; AG004-AG039
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hitachi Medical Systems America, Inc., Twinsburg, OH, 
Manufacturer: Hitachi Medical Corporation, Chiyoda-Ku, Tokyo, Japan. 
REASON Software anomaly. A software defect in the referenced systems can cause a slice indicator (reference line) to be mis-positioned on the cross-reference image when it is magnified. This image error could result in a possible patient mis-diagnosis.
VOLUME OF PRODUCT IN COMMERCE 283 devices
DISTRIBUTION Nationwide

PRODUCT Hitachi AIRIS II MRI Nuclear Magnetic Resonance Imaging System, 
CODE Serial Numbers: C322 to C546; and C746 to C772
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hitachi Medical Systems America, Inc., Twinsburg, OH, 
Manufacturer: Hitachi Medical Corporation, Chiyoda-Ku, Tokyo, Japan.
REASON Improper Assembly-The AIRIS/AIRIS II MRI system has the potential for the input wiring of a power transformer to overheat due to damaged wiring or possible loose connections.
VOLUME OF PRODUCT IN COMMERCE 248 devices
DISTRIBUTION Nationwide

PRODUCT 8mm SATELLITE™ Sphere CoCr contained in a SATELLITE™ Spinal System (internal fixation device-vertebral stabilization/fusion), 

CODE Lot number: W05K0555
RECALLING FIRM/MANUFACTURER Medtronic Sofamor Danek Instrument Manufacturing, Bartlett, TN, .
REASON Device marketed without 510 (k) or PMA clearance.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION LA

PRODUCT
a) X-Sizer Thrombectomy Catheter System (ev3) Model number XD-CS1150-45 (for US distribution). Model number XR-CS1150-45
(for foreign distribution). 1.5mm. Sterilization with Ethylene Oxide Gas.
 b) X-Sizer Thrombectomy Catheter System (ev3) Model number
XD-CS1200-55 (for US distribution). Model number XR-CS1200-55 (for foreign distribution). 2.0mm. Sterilization with Ethylene Oxide Gas, 

CODE
a) Model number XD-CS1150-45 (for US distribution), lot numbers: 782344, 782345, 782366, 782379, 782386, 782389, 782403, 782404, 782406,
782407, 782412, 782421, 782428, 782429, 782430, 782436, 782438, 782439, 782441, 782445, 782526, 986604, 986604, 986604, 986605,
986609, 986620, 986626, 986640, 986641, 986642, 986645, 986656, 986659, 1174394, 1174395, 1212529, 1229730, 1231296, 1234273,
1240986, 1241067, 1271238, 1272506, 1280664, 1280952, 1281088, 1282693, 1289590, 1289978, 1293902, 1295372, 1300605, 1302005,
1303572, 1308536, 1310238, 1362165;
Model number XR-CS1150-45 (for OUS distribution), lot numbers: 782773, 782777, 782787, 782788, 782790, 782791, 782795, 782796, 782797,
782798, 782800, 782801, 782804, 782808, 782811, 782812, 782816, 782818, 782822, 782848, 987054, 987055, 987056, 987058, 987059,
987062, 987063, 987064, 987065, 987066, 987067, 987070, 987070, 987070, 987071, 987073, 987076, 987078, 1057871, 1077841, 1077842,
1077843, 1077844, 1077846, 1077847, 1077848, 1077854, 1077856, 1077859, 1077862, 1095087, 1095089, 1296437, 1296552, 1313297,
1313502, 1313543, 1313562, 1313611, 1313645, 1314989, 1314991, 1314994, 1315002, 1315042, 1315058, 1315113, 1315140, 1315183,
1315211, 1315245, 1315292, 1315294, 1315313, 1315328, 1315365, 1315378, 1315383, 1315623, 1315624, 1315625, 1315626, 1315632,
1315633, 1315636, 1315639, 1315640, 1315644, 1315646, 1317128, 1317133, 1317134, 1317135, 1317144, 1317301, 1326969, 1326969,
1326969, 1326970, 1326972, 1326973, 1326974, 1326977, 1326982, 1326983, 1326998, 1326999, 1327006, 1327008, 1327011, 1327546,
1342794, 1342852, 1342874, 1342882, 1342888, 1342957, 1342980, 1343007, 1343019, 1343036, 1343045, 1343094, 1343108, 1343125,
1343136, 1343266, 1343273, 1343292, 1343314, 1363701, 1363712, 1363725, 1363742, 1363791, 1363827, 1363850, 1363974, 1363976,
1364006, 1364034, 1364049;
b) Model number XD-CS1200-55 (for US distribution) lot numbers: 782706, 782707, 782708, 782708, 782708, 782718, 782724, 986901, 986902,
986904, 986908, 986909, 986910, 986911, 986912, 986915, 986916, 986918, 986919, 986921, 986922, 986922, 986922, 986922, 986922,
986925, 986932, 986934, 1130582, 1156888, 1156888, 1156888, 1212539, 1212540, 1212543, 1215499, 1215500, 1215506, 1215511,
1215511, 1215511, 1215514, 1242336, 1328479, 1328597, 1336891, 1337003.
Model number for XR-CS1200-55 (OUS distribution) lot numbers: 782873, 782875, 782876, 782877, 782878, 782879, 987127, 987128, 987129,
987130, 987131, 987132, 1302736, 1327016, 1344586, 1344591, 1344595, 1344614, 1344624, 1344626, 1344627, 1344633, 1346625, 1346626,
1346651, 1346676, 1346677, 1346678, 1364066, 1364075, 1364081, 1364082, 1364090, 1364099, 1364118, 1364170, 1364179, 1364186,
1364200, 1364226, 1364255, 1364283
RECALLING FIRM/MANUFACTURER Ev3, Inc, Plymouth, MN, 
REASON Loss of Operating Vacuum during use. It has been determined that a small percentage of X-Sizer Thrombectomy Catheter Systems from specific lots may lose operating vacuum prematurely due to a system leak within the Control Module. This failure can lead to the inability to complete the procedure of thrombus removal and the necessity to remove the device prior to achieving a satisfactory result.
VOLUME OF PRODUCT IN COMMERCE 1,463 devices
DISTRIBUTION Nationwide and Internationally

Sage Products Inc. Issues a Recall of Comfort Shield® Perineal Care Washcloths in the U.S. and Canada

Sage Products Inc., of Cary, Illinois, is initiating a recall of specific lots of Comfort Shield Perineal Care Washcloth product codes due to contamination with Burkholderia cepacia. See identified lots, below.  

Code #

Lot #

Dates shipped

7403

1301

02/10/06 - 02/13/06

7403

1312

02/13/06 - 03/02/06

7403

1312

02/13/06 - 03/02/06

7403

1457

02/24/06 - 03/01/06

7403

1677

05/02/06 - 05/03/06

7408

1848

04/18/06

7503

1999

05/03/06 - 05/16/06

7524

2070

05/01/06 - 05/15/06

7524

2086

05/11/06 - 05/15/06

7905

1766

03/22/06 - 06/12/06

7503-M

1702

04/13/06

7503-M

1995

04/13/06 - 05/19/06

No other lots of Comfort Shield Perineal Care Washcloths from Sage Products are known to be affected by this recall.

The product was distributed to hospitals, medical centers and long-term care facilities in the U.S. and Canada. There was no known distribution through retail sales. 

Customers who have the affected lots of these products should stop usage, sale and distribution, and should contact Sage Products to coordinate product return and replacement. Product is available for immediate replacement and no stock outage is anticipated. To arrange for product replacement, contact Customer Service at 1-800-323-2220. Return affected product only, to Sage Products Inc, 3909 Three Oaks Road, Cary, IL 60013, attention: Customer Service.

WEEK ENDING JUNE 30

PRODUCT Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Model AED20, part 972200, catalog # 972211, 972212, 972213, 972214, 972215 and 972216
CODE Serial numbers 205199 through 205786, except for 205213, 205236, 205237, 205238, 205239, 205240, 205242, 205243, 205247, 205307, 205308, 205309, 205465, 205653, 205654, 205656, 205664, 205665, 205667, 205669, 205677, 205678, 205684, 205703, 205708, 205719, 205732, 205736, 205754, 205756, 205760, 205762, 205763, 205764, 205767, 205774, 205775, 205777, 205781, 205782, 205784. Also included in the recall are serial numbers 201784, 202804, 205179, 205790, 205806, 205808, 205818, 205842, 205866, 206076, 206078, 206079, 206080, 206081, 206096, 206125, 206131, 206137, 206138, 206140, 206162, 206164, 206175, 206177, 206180, 206216, 207511, 207518, 207520, 207521, 207522
RECALLING FIRM/MANUFACTURER MRL, Inc., A Welch Allyn Company, Buffalo Grove, IL
REASON The Welch Allyn AED 20 Defibrillators may display a “Defib Comm” error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropriate therapy. 
VOLUME OF PRODUCT IN COMMERCE 580 units
DISTRIBUTION Nationwide and Internationally

PRODUCT LADARVision Excimer Laser System
CODE CustomCornea software only. System serial numbers with prefix L4N and L4U
RECALLING FIRM/MANUFACTURER Alcon Laboratories, Inc., Orlando, FL
REASON A software error associated with the use of the Measuring Mode (ruler tool) on the LADARVision4000 Excimer Laser Systems. Use of this feature after alignment of the horizontal reference line will negate compensation for cyclotorsion on Custom Cornea procedures, possibly adversely affecting clinical outcomes.
VOLUME OF PRODUCT IN COMMERCE 436 units
DISTRIBUTION Nationwide and Internationally

PRODUCT

a) Auto Suture-ChemoSite Low Profile -implantable low profile Venous Access System with printed polyurethane catheter and 9 French Introducer Kit Catalog Number: 120021 
b) Auto Suture ChemoSite Low Profile Venous Access System with 9FR Introducer Kit with Silicone Catheter Catalog Number: 120025. 
c) Auto Suture ChemoSite Catheter 9FR Introducer Kit with 9FR Peel-Away Sheath Catalog Number: 120039. 
d) Auto Suture ChemoSite Implantable Venous Kit Access System with 9FR Introducer Kit Catalog Number: 120045.
e) Auto Suture ChemoSite Catheter Introducer Kit with 9FR Peel-Away Sheath Catalog Number: 120049. 
f) Auto Suture ChemoSite Implantable Venous Access System with 9FR Introducer Kit with Silicone Catheter Catalog Number: 120066.
CODE
a) Lot Numbers: N5M40, N6B01;
b) Lot Numbers: N5M160, N6B268;
c) Lot Numbers: N5L380, N5M159, N6B02, N6B45;
d) Lot Numbers: N5M90, N6A546, N6B147, N6B351, N6C127, N6C331;
e) Lot Number: N5M255;
f) Lot Numbers: N5L338, N5M232, N6B266, N6C11
RECALLING FIRM/MANUFACTURER 

Recalling Firm: United States Surgical, North Haven, CT.

Manufacturer: B. Braun Medical, Inc., Allentown, PA
REASON The 9F device may contain a 10 F sheath instead of the 9F.
VOLUME OF PRODUCT IN COMMERCE 2,524 units
DISTRIBUTION Nationwide and Internationally

 

PRODUCT Stericover/ Sterile Disposable Polyethylene Drape ---Universal Video Camera/ Laser Arm Equipment Cover; 7'' x 96''
CODE Lots: 0796316, 0796319 and 0796320
RECALLING FIRM/MANUFACTURER 

Recalling Firm: Abbott Spine, Austin, TX, 

Manufacturer: Sterimed, Inc., Cartersville, GA
REASON Non-sterility-Distributor testing of outside manufacturer's product (Sterimed, Inc) revealed positive sterility test results.
VOLUME OF PRODUCT IN COMMERCE 326 drapes
DISTRIBUTION Nationwide

PRODUCT Stryker Trio Mobile Surgery Platform; Model 1033
CODE Serial numbers 0412060619, 0501073240, 0501073241, 0501073327, 0501073328, 0501073329, 0501073330, 0408062292, 0408062293, 0502069215, 0504072232, 0409062008, 0409062003, 0409062004, 0409062005, 0409062006, 0410065050, 0502069214, 0410058767, 0409062001, 0409062274, 0512070516, 0602079782, 0602079817, 0602079818, 0602079819, 0408062389, 0408062390, 0408062391, 0409062007, 0411060535, 0506071242, 0410065046, 0501073064, 0501073065, 0501073066, 0501073084, 0501073085, 0501073086, 0501073087, 0501073188, 0501073189, 0501073190, 0602079542, 0506071118, 0510071070, 0510071071, 0510071072, 0605087579, 0504072089, 0602079541, 0505069588, 0502069314, 0502069315, 0510071241, 0511071674, 0511071675, 0511071676, 0511071677, 0511071678, 0511071679, 0511071680, 0504072088, 0512070514, 0512070515, 0412060744, 0412060745, 0412060746, 0412060855, 0412060856, 0412060857, 0501073001, 0501073002, 0501073003, 0502069148, 0601084043, 0507070537, 0510071069, 0502069034, 0502069035, 0502069036, 0502069150, 0502069151, 0502069152, 0502069153, 0510071243, 0410058765, 0507070691, 0507070692, 0507070693, 0507070694, 0507070695, 0507070696, 0507070697, 0507070698, 0507070699, 0507070700, 0603084573, 0409062002, 0410058766, 0502069149, 0503068501, 0503068502, 0503068503, 0506071116, 0506071117, 0506071241, 0603084574, 0410065049, 0501073373, 0501073374, 0501073375, 0501073376, 0502069032, 0502069033, 0502069313, 0603084672, 0411060618, 0411060619, 0411060620, 0411060621, 0411060802, 0411060803, 0411060804, 0412060504, 0412060505, 0412060506, 0412060616, 0412060617, 0412060618, 0505069589, 0505069590, 0505069591, 0505069592, 0410065047, 0509069501, 0509069502, 0505069749, 0505069750, 0502069216, 0410065045, 0410065048, 0411060801, 0408062151, 0409062273, 0409062275, 0502069312, 0503068633, 0503068634, 0503068635, 0503068636, 0511071540, 0511071541, 0511071542, 0511071543 and 0503068637
RECALLING FIRM/MANUFACTURER Stryker Medical Div. of Stryker Corporation, Portage, MI
REASON An incorrect pin may have been used during assembly and therefore the device may give way during use.
VOLUME OF PRODUCT IN COMMERCE 156 units
DISTRIBUTION Nationwide and Internationally