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:[email protected]for 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
a) Lot number: 0000037028;
b) Lot number:
210764;
c) Lot Numbers: 0000030082 0000044305 210763;
d) Lot Number:
0000027006 0000048626 208415;
e) Lot Numbers: 0000115257 207343 216125;
f)
Lot Numbers: 0000013715 0000019773 0000026008 0000027691
0000065807
0000107195 0000114884 0000142208 0000143695 207344
209792 214174 215929
216117 220685;
g) Lot Numbers: 0000106474 180319 180320;
h) Lot Numbers:
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188187 200447 200786 202877 203553 204960 211561 213101 214919
217583
219366 222386 222387;
i) Lot Numbers: 0000188518;
j) Lot Numbers:
0000038283;
k) Lot Numbers: 0000067485 0000072512;
l) Lot Numbers:
0000040827 0000053734 0000171573;
m) Lot Numbers: 0000012692 0000017476
0000052795;
n) Lot Numbers: 0000032526 0000171583;
o) Lot Numbers:
0000025149;
p) Lot Numbers: 0000179184 178473 209767;
q) Lot Number:
0000004678;
r) Lot Numbers: 0000055719 0000085923 178472 205603;
s) Lot
Numbers: 0000099411;
t) Lot Numbers: 0000025151;
u) Lot Numbers:
0000032873 0000067482 0000182743;
v) Lot Numbers: 0000064092 0000065235
0000068445 0000077285 0000108383
0000152174 208918 212420;
w) Lot
Numbers: 0000099374 0000175190 0000180266;
x) Lot Numbers: 213798
215373;
y) Lot Numbers: 0000079570;
z) Lot Numbers: 0000029246 0000041244
0000090303 0000116131 204579
213554 223848;
aa) Lot Numbers: 0000005088
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bb) Lot Numbers: 0000001696 0000005659 0000009476
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186865
201667 204626 205350 211785 213371 214942 220436;
cc) Lot Numbers:
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0000128585 204128 210659 214624 217180
221581;
dd) Lot Numbers:
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201589 204546 205579 206975 209482 209483 213369 214129 215438
218112
220078 221415 223122 223880;
ee) Lot Number: 0000050710;
ff) Lot Numbers:
0000009467 0000017356 0000018656 0000041210
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0000074794 0000077721
0000080996 0000082769 0000083088 0000085997 0000093521
0000096040
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218835;
gg) Lot Numbers: 0000025988 0000064093 0000067488 0000094788
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206494;
hh) Lot Numbers: 0000045233 0000049060 0000095236 213485
219799;
ii) Lot Numbers: 0000064051 0000070414 0000077756 0000151229
217661;
jj) Lot Numbers: 0000051701 0000057224 0000059774 206376;
kk) Lot
Numbers: 0000025483 0000041243 0000046316 0000059735
0000116132;
ll) Lot
Number: 0000072934;
mm) Lot Numbers: 0000006813 0000009012 0000009040
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181734
184271 185910 187134 188547 201685 203306 205597 207631
208906 211159 214999
216576 218842 219217 221352;
nn) Lot Numbers: 0000139499;
oo) Lot
Numbers: 0000139502 0000139540;
pp) Lot Numbers: 0000070357 0000077811 203438
217381;
qq) Lot Numbers: 201000;
rr) Lot Numbers: 0000021160 0000029786
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212415 219669
222953;
ss) Lot Numbers: 0000002638 0000003429 0000078989 0000088047
0000161204
211158 213868 218547;
tt) Lot Numbers: 0000009532 0000013672
0000019809 0000022777 0000044800
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178292 180185
181735 182416 182417 183000 188007 203620 206606 212408 213693
219667;
uu) Lot Numbers: 0000005212 0000043605 0000053798 0000056337
0000068436
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176812 208561 212698 213441 217363;
vv) Lot Numbers: 0000009532
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181735 182416 182417 183000 188007 203620 206606 212408
213693 219667;
ww) Lot Numbers: 0000005212 0000043605 0000053798 0000056337
0000068436
0000068560 0000071683 0000076651 0000108452 0000137727 0000164243
176812 208561 212698 213441 217363;
xx) Lot Numbers: 0000046310
0000174582 200307 217387 200307 217387;
yy) Lot Numbers: 0000004701
0000014620 0000021416 0000025411 0000029777
0000045286 0000055307 0000064166
0000068034 0000069020 0000073860
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0000098637 0000105371
0000120165 0000124169 0000140820 0000158119 200877
208238 214166
219232 221749 223371;
zz) Lot Numbers: 0000010532
0000010592 0000025412 0000042510
0000042512 0000064172 0000076113 0000081546
0000083017 0000094114
0000097316 0000098646 0000108373 0000132346 175818
186369 201732
201960 204235;
aaa) Lot Numbers: 182211;
bbb) Lot
Numbers: 182212;
ccc) Lot Numbers: 182213;
ddd) Lot Number: 0000028228
0000106504 0000187129;
eee) Lot Numbers: 0000028244 0000126527;
fff) Lot
Numbers: 0000008114 0000056825 0000065756 0000068482
0000099448 0000149030
216757 218174;
ggg) Lot Numbers: 0000052427 0000063888 0000099509 220162
222827 224805;
hhh) Lot Numbers: 0000005106 0000019230 0000020662 0000021409
0000022601 0000022850 0000023102 0000024790 0000050764 0000064169
0000082447 0000084632 0000104324 0000126514 0000173027 207120
211660
214574;
iii) Lot Numbers: 0000022920 0000060990 0000099507 0000124687
0000172308 203668 211659 215934 216087;
jjj) Lot Numbers: 0000117602
0000150334 220682;
kkk) Lot Numbers: 0000059849 0000126533;
lll) Lot
Numbers: 0000028261 0000126532;
mmm) Lot Numbers: 0000059850
0000118491;
nnn) Lot Numbers: 0000040400 0000047046 0000054305 0000054306
0000063145 0000063184 0000071797 0000075774 0000082018
0000094143
0000098747 0000100009 0000106139 0000116560;
ooo) Lot Numbers: 0000047113
0000055826 0000055827 0000063161
0000063162 0000063163 0000063187;
ppp)
Lot Numbers: 0000155875;
qqq) Lot Numbers: 0000155328;
rrr) Lot Number:
0000038960;
sss) Lot Numbers: 0000055758 0000055759 0000055760 0000070849
0000071307 0000071309 0000073024 0000073025 0000075756
0000080599
0000082939 0000093035 0000096718 0000097929
0000100993 0000103729 0000110816
0000113625 0000114979
0000126421 0000130789 0000134456 0000141335 0000148442
0000149211 0000154614 0000173136 0000173875 0000175333;
ttt) Lot Numbers:
0000055801 0000055802 0000063121 0000063122
0000063123;
uuu) Lot Number:
0000045678;
vvv) Lot Numbers: 0000045369 0000071809;
www) Lot Numbers:
0000045084 0000167550;
xxx) Lot Numbers: 0000045356 0000055781 0000063100
0000098654
0000159338;
yyy) Lot Numbers: 0000063472;
zzz) Lot Numbers:
0000045684;
aaaa) Lot Numbers: 0000136356;
bbbb) Lot Numbers:
0000021993;
cccc) Lot Numbers: 0000024748;
dddd) Lot Numbers:
0000080580;
eeee) Lot Numbers: 0000114946 217167;
ffff) Lot Numbers:
0000013651 224840;
gggg) Lot Numbers: 0000013652;
hhhh) Lot Number:
0000050786;
iiii Lot Numbers: 0000036905 0000038771 0000040866 0000088875
0000146906 217168;
jjjj) Lot Numbers: 0000043735 208961 218172;
kkkk)
Lot Number: 224554;
llll) Lot Numbers: 0000087118 0000087255;
mmmm) Lot
Numbers: 0000007859 0000087103 0000087253 0000091588
0000092982 0000103702
0000142221 0000148507 0000182815;
nnnn) Lot Numbers: 0000026950 0000033974
0000156729 180318 211049 214903;
oooo) Lot Numbers: 0000048764;
pppp) Lot
Numbers: 0000021424 0000044133 0000059944 0000061632
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