PRODUCT
Becton
Dickinson's ProbeTec( ET Instrument.
CODE Instrument serial numbers 1001-2056.
RECALLING FIRM/MANUFACTURER Becton Dickinson & Co., Sparks, MD.
REASON Component of in vitro diagnostic device was incorrectly installed
causing incorrect reporting of patient results.
VOLUME OF PRODUCT IN COMMERCE 1,015 units.
DISTRIBUTION Nationwide and Internationally.
PRODUCT Sarns MP4 Cardioplegia Sets; catalog number 15501.
CODE Lot 322125.
RECALLING FIRM/MANUFACTURER Terumo Cardiovascular Systems Corp., Ann
Arbor, MI.
REASON There is a potential for delivery of a lower than intended amount
of cardioplegia solution to the heart during surgery.
VOLUME OF PRODUCT IN COMMERCE 208.
DISTRIBUTION Nationwide.
PRODUCT Papsure, Speculite, Disposable light for vaginal illumination.
10 packets per box.
CODE Lot numbers 24C06B, 24C06D, 24C06E, 24D04S.
RECALLING FIRM/MANUFACTURER Watson Diagnostics, Inc., Corona, CA.
REASON
Lights split,
spilling contents when bent to activate.
VOLUME OF PRODUCT IN COMMERCE 662.
DISTRIBUTION Nationwide.
PRODUCT Femoral Resection Guide, Scorpio L.R.S. Instrumentation.
CODE Catalog No: 8050-5103; 8050-5105; 8050-5107; 8050-5109; 8050-5111;
8050-5113.
RECALLING FIRM/MANUFACTURER Stryker Howmedica Osteonics, Mahwah, NJ.
REASON Scorpio Femoral Resection Guides have the potential to remove
more bone than necessary.
VOLUME OF PRODUCT IN COMMERCE 102.
DISTRIBUTION Canada, and Ireland.
PRODUCT Integris Monitor Arm; model P997-04.
CODE All units manufactured prior to June 20, 2003.
RECALLING FIRM/MANUFACTURER Hill-Rom Co, Inc., Batesville, IN.
REASON The monitor may separate from the monitor arm, allowing the
monitor to fall from the arm.
VOLUME OF PRODUCT IN COMMERCE 2,778.
DISTRIBUTION Nationwide, and Internationally.
PRODUCT Exactech Tibial Offset Bushing (sizes 1, 2, 3, 4, & 5).
CODE Catalog # 209-04-71, Lot # 10315011, Catalog # 209-04-72, Lot #
10315012; Catalog # 209-04-73, Lot # 10315013; Catalog # 209-04-74, Lot #
10315014 and Catalog # 209-04-75, Lot # 10315015.
RECALLING FIRM/MANUFACTURER Exactech, Inc., Gainesville, FL.
REASON The alpha and beta markings on the offset tibial bushings are in
a location that would lead to the improper selection of an offset tibial tray.
VOLUME OF PRODUCT IN COMMERCE 137.
DISTRIBUTION OH, ME, HI, and NY.
PRODUCT
a) Baxter Solution Set, 10 drops/mL, 101", Male LuerLock Adapter, catalog
1C8109; Baxter Healthcare Corporation, Deerfield, IL, USA.
b) Interlink System Solution Set with Microbore Tubing, 60 Drops/mL, 123",
2 injection sites, Male Luer Lock Adapter, catalog 2C6426; Baxter Healthcare
Corporation, Deerfield, IL, USA.
c) Interlink System Continu-Flo Solution Set with Microbore Tubing, 60
drops/mL, 128", 3 injection sites, Male Luer Lock Adapter, catalog 2C6521;
Baxter Healthcare Corporation, Deerfield, IL, USA.
d) Continu-Flo Solution Set, 10 drops/mL, 104", 0.22 Micron Downstream
High Pressure Extended Life Filter, 3 Injection Sites, Male Luer Lock Adapter,
catalog 2C6593; Baxter Healthcare Corporation, Deerfield, IL, USA.
e) Interlink System Vented Nitroglycerin Set, 104", PVC Tubing Segment,
Injection Site, Male Luer Lock Adapter, catalog 2C7551; Baxter Healthcare
Corporation, Deerfield, IL, USA.
f) Baxter Vented Nitroglycerin Set, 105", PVC Tubing Segment, Injeciton
Site, Male Luer Lock Adapter, catalog 2C7552; Baxter Healthcare Corporation,
Deerfield, IL, USA.
g) Clearlink System Continu-Flo Solution Set, 10 drops/mL, 113", 2 Luer
Activated Valves, Male Luer Lock Adapter, catalog 2C8519; Baxter Healthcare
Corporation, Deerfield, IL, USA.
h) Clearlink System Nitroglycerin Set with DUO-VENT Spike, 60 drops/mL,
105", PVC Tubing Segment, Luer Activated Valve, Male Luer Lock Adapter,
catalog 2C8851; Baxter Healthcare Corporation, Deerfield, IL, USA.
i) Clearlink System Vented Paclitaxel Set, 10 drops/mL, 111", Polyethylene
Lined Tubing, Non-DEHP Pump Segment, 0.22 Micron Extended Life Filter, Luer
Activated Valve, Male Luer Lock Adapter, catalog 2C8857; Baxter Healthcare
Corporation, Deerfield, IL.
j) Continu-Flo Solution Set, 60 drops/mL, 106", 3 Luer Activated Valves,
Male Luer Lock Adapter, catalog 2C9906; Baxter Healthcare Corporation,
Deerfield, IL.
k) Baxter Y-Type Blood/Solution Set, 10 drops/mL, 112", Standard Blood
Filter, 170 to 260 Micron Filter, Injection Site, Male Luer Lock Adapter,
catalog 2C6750; Baxter Healthcare Corporation, Deerfield, IL, USA.
l) Clearlink System Y-Type Blood/Solution Set, 10 drops/mL, 112", Standard
Blood Filter, 170 to 260 Micron Filter, Luer Activated Valve, Male Luer Lock
Adapter, catalog 2C8750; Baxter Healthcare Corporation, Deerfield, IL.
m) Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter and
Pressure Pump, 15 drops/mL, 99", 170 to 260 Micro Filter, Large Standard
Blood Filter, 2 Injection Sites, Male Luer Lock Adapter, catalog 4C6723; Baxter
Healthcare Corporation, Deerfield, IL.
n) Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter, 15
drops/mL, 89", 170 to 260 Micron Filter, Large Bore Tubing, Male Luer Lock
Adapter, catalog 4C7776A; Baxter Healthcare Corp., Deerfield, IL.
o) Colleague Pump Syringe Adapter Set, 92", Injection Site, Non-DEHP
Tubing, Luer Lock Adapters, catalog 2C0169; Baxter Healthcare Corp, Deerfield,
IL.
p) Baxter Y-Type Blood/Solution Set with Pressure Pump, 10 drops/mL, 99",
170 to 260 Micron Filter,Large Standard Blood Filter, 2 Injection Sites, Male
Luer Lock Adapter, catalog 2C6723; Baxter Healthcare Corp., Deerfield, IL.
q) Baxter Solution Set, 10 drops/mL, 76", Luer Activated Valve, Male Luer
Lock Adapter, catalog 2C9901; Baxter Healthcare Corp., Deerfield, IL. r) Baxter
Solution Set, 60 drops/mL, 76", Luer Activated Valve, Male Luer Lock
Adapter, catalog 2C9902; Baxter Healthcare Corp., Deerfield, IL. s)Vented
Solution Set, 10 drops/mL, 92", Luer Activated Valve, Male Luer Lock
Adapter, catalog 2C9903; Baxter Healthcare Corp., Deerfield, IL.
t) Continu-Flo Solution Set, 10 drops/mL, 110", 3 Luer Activated Valves,
Male Luer Lock Adapter, catalog 2C9905; Baxter Healthcare Corporation,
Deerfield, IL.
u) Continu-Flo Solution Set, 10 drops/mL, 113", 2 Luer Activated Valves,
Male Luer Lock Adapter, catalog 2C9907; Baxter Healthcare Corporation,
Deerfield, IL.
v) Baxter Y-Type Blood/Solution Set, 10 drops/mL, 115", 80 Micron Filter,
Injection Site, Male Luer Lock Adapter, catalog 2C7617; Baxter Healthcare
Corporation, Deerfield, IL.
w) Baxter Y-Type Blood/Solution Set with Pressure Pump, 10 drops/mL, 99",
Large Standard Blood Filter, 170 to 260 Micron Filter, 2 Injection Sites, Male
Luer Lock Adapter, catalog 2C7623; Baxter Healthcare Corporation, Deerfield,
IL.
x) Fenwal Blood Component Recipient Set with Standard Blood Filter, 10
drops/mL, 55", 170 to 260 Micron Filter, catalog 4C2100; Baxter Healthcare
Corporation, Deerfield, IL.
y) Fenwal Y-Type Blood Component Recipient Set with Standard Blood Filter, 10
drops/mL, 65'', 170 to 260 Micron Filter, catalog 4C2196; Baxter Healthcare
Corporation, Deerfield, IL.
z) Fenwal Straight Type Blood Set with Large Standard Blood filter, 15
drops/mL, 80'', 170 to 260 Micron Filter, Injection Site, Male Luer Lock
Adapter, catalog 4C6766; Baxter Healthcare Corporation, Deerfield, IL.
aa) Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter, 15
drops/mL, 107", 2 Injection Sites, Male Luer Lock Adapter, catalog 4C7774;
Baxter Healthcare Corporation, Deerfield, IL.
bb) Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter, 10
drops/mL, 82", 170 to 260 Micron Filter, Large Bore Tubing, Male Luer Lock
Adapter, catalog 4C7776; Baxter Healthcare Corporation, Deerfield, IL.
CODE
a) Lot numbers UR139824 through UR168476. Please note: Baxter lot numbers are
represented by an internal reference code "UR" followed by a six
digit sequential number, or by the letter "U" followed by a six digit
sequential number with and "R" suffix. Any lot number appearing
within the identified six digit sequential number range is subject to the
recall;
b) Lot number UR146407;
c) Lot numbers UR117432 through UR167015;
d) Lot numbers UR161117 through UR167718;
e) Lot numbers UR133769 through UR165696;
f) Lot numbers UR142943 through UR167627;
g) Lot numbers UR129585 through UR168716;
h) Lot numbers UR141788 through UR167684;
i) Lot numbers UR134353 through UR157545;
j) Lot numbers U573428R through UR168989;
k) Lot numbers UR151456 through UR158261;
l) Lot numbers UR128876 through UR168104;
m) Lot numbers UR150458 through UR166892;
n) Lot numbers UR160143 through UR166538;
o) Lot numbers UR152843 through UR164376;
p) Lot numbers UR144147 through UR158808;
q) Lot numbers U563262R through UR102517;
r) Lot numbers U565523R through U573899R;
s) Lot numbers U568576R through UR135046;
t) Lot numbers U556902R through UR126946;
u) Lot numbers U569160R through UR131276;
v) Lot numbers UR147777 through UR157008;
w) Lot numbers UR124917 through UR158857;
x) Lot numbers UR110346 through UR123513;
y) Lot numbers UR117606 through UR122614;
z) Lot numbers UR140772 through UR166058;
aa)Lot numbers UR144543 through UR156901;
bb)Lot numbers UR153460 through UR153494.
RECALLING FIRM/MANUFACTURER Baxter Healthcare, Corp., Round Lake, IL.
REASON There are possible pinholes or perforations in the set tubing,
caused by damage that occurred during the packaging process.
VOLUME OF PRODUCT IN COMMERCE 4,534,365 units.
DISTRIBUTION Nationwide and Internationally.
PRODUCT
a) Spiral Z Expandable Metal Biliary Stent.
b) Za-Stent Expandable Metal Biliary Stent.
c) Zilver Expandable Metal Biliary Stent.
CODE
a) Reorder #SZBS-10-7.5-C, Amended 8/8/2003 to include SZBS-10-5.7-C;
b) Reorder #ZABS-10-8-C, Amended 8/8/2003 to include: ZABS-10-4-C, ZABS-10-6-C;
c) Reorder #ZILBS-6-6, , ZILBS-10-8, ZILBS10-6, Amended 8/8/2003 to include:
ZILBS-10-4, ZILBS-8-4, ZILBS-8-6, ZILBS-8-8, ZILBS6-4,
ZILBS-6-8.
RECALLING FIRM/MANUFACTURER Wilson-Cook Medical Inc., Winston-Salem, NC.
REASON The inner catheter of the introducer system may break after stent
deployment.
VOLUME OF PRODUCT IN COMMERCE 12,144 units.
DISTRIBUTION Nationwide, and Internationally.
PRODUCT
a) Optima Poly Screw Driver, Part OP20002 Revision C.
b) Optima Large Poly Screw Driver, Part OP20012 Revision B.
CODE
a) Lot No. 03030301 and 05120308;
b) Lot No. 04240301 and 04140302.
RECALLING FIRM/MANUFACTURER U & I America, Murray, UT.
REASON Reports of pieces chipping off the tip of screwdriver during use.
VOLUME OF PRODUCT IN COMMERCE 310 units.
DISTRIBUTION MN.
PRODUCT
a) 1680 Invisatrace series ECG Electrodes, radiotranslucent clear tape ECG electrode
with wet gel. This is a single use, disposable device. Electrodes are packaged
and sold as:
1) Cat No 1680-001 (1 unit per pouch/30 per
box);
2)
Cat No 1680-003 (3 units per pouch/30 per box);
3)
Cat No 1680-005 (5 units per pouch/50 per box); and
4) Cat No 1680-030 (30 units per pouch/no
box). The electrodes are packaged 600 units/case.
b) 1690 Ultratrace Series ECG Electrodes, clear tape ECG electrode with wet
gel. This is a single use, disposable device. Electrodes are packaged and sold
as:
1)
Cat No 1690-001 (1 unit per pouch/30 per box);
2)
Cat No 1690-003 (3 units per pouch/30 per box);
3)
Cat No 1690-005 (5 units per pouch/50 per box);
4)
Cat No 1690-010 (50 units per pouch/no box/ 1000 per case);
5)
Cat No 1690-030 (30 units per pouch/no box). The above are sold in boxes
of 600 with the exception of 1690-010 (sold 1000 per case) as noted above.
CODE
a) 1) 0305301, 0306091, 0306092; 2) 0306241; 3) 0306042; 4) 0306021, 0306051.
b) 1) 0306092, 0306201, 0306202; 2)
0305231, 0305232, 0306201; 3) 0305162, 0305221, 0305301, 0306031, 0306042,
0306051,
0306191, 0306252, 0306301;
4) 0305231, 0306171;
5) 0305281, 0306031, 0306051, 0306101, 0306131, 0306161, 0306231, 0306232,
0306261.
RECALLING FIRM/MANUFACTURER Conmed Corporation, Utica, NY.
REASON Separation of the sensing element from the body of the electrode.
VOLUME OF PRODUCT IN COMMERCE 1,003,072.
DISTRIBUTION Nationwide and Internationally.
PRODUCT Abbott Aeroset System list number 9D05-01.
CODE All units.
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX.
REASON ICT assays run using a manual dilution will not be calculated
correctly by the software.
VOLUME OF PRODUCT IN COMMERCE 143.
DISTRIBUTION Nationwide, and Internationally.
PRODUCT Bardex(r) Foley Catheter, 22 Fr 40cc- 20cc Ribbed Balloons,
Coleman Model Red Latex, 3 Way Radiopaque, Lubricath Coated, Sterile, Single
Use Device. The catheter is an open whistle tip with two eyes on the same side.
It is made of red latex for added catheter stiffness and radiopacity, with a
Lubricath hydrophilic coating. This product has 3 lumens; a lumen for drainage,
a lumen for inflation of the bladder balloon, and a lumen for inflation of the
prostatic balloon. Catalog Number 6016L22.
CODE All units packaged from January 1999 and shipped prior to September
2002.
RECALLING FIRM/MANUFACTURER C. R. Bard, Inc., Urological Division,
Covington, GA.
REASON On some units the inflation valve labeling is reversed on the
Prostate and Bladder balloon inflation ports.
VOLUME OF PRODUCT IN COMMERCE 1,461 units.
DISTRIBUTION Nationwide, Canada, Belgium and Germany.
PRODUCT Anti-Cardiolipin IgA ELISA test kit. Product is manufactured for
Sigma Diagnostics, Inc., Saint Louis, MO.
CODE Sigma Product number 552-B; Lot Number 060K6464 Expiration Date:
12-05-2001.
RECALLING FIRM/MANUFACTURER Zeus Scientific, Inc., Branchburg, NJ.
REASON Bacterial contamination of the high positive control.
VOLUME OF PRODUCT IN COMMERCE 130.
DISTRIBUTION MO.
PRODUCT Access Immunoassay System Technical Update 03.1, Part number
387851.
CODE Software version 3.29.
RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA.
REASON Defective software media distributed with upgrade software may
cause installation failure and systems lock.
VOLUME OF PRODUCT IN COMMERCE 1,615.
DISTRIBUTION Nationwide.
PRODUCT ABX Diagnostices Pentra 60C+ Hematology Analyzer.
CODE Software versions of up to 1.7.
RECALLING FIRM/MANUFACTURER ABX Diagnostics, Inc., Irvine, CA.
REASON Instrument fails to obtain correct patient information/results
due to malfunction of the equipment's sample door.
VOLUME OF PRODUCT IN COMMERCE 159.
DISTRIBUTION Nationwide.
WEEK ENDING SEPTEMBER 20
PRODUCT
Easy Access
PACS System with software.
CODE Software Release 5, 6.2, or 7.2.
RECALLING FIRM/MANUFACTURER Philips Medical Systems, Bothell, WA.
REASON Potential display of an incorrect body part description on
patient images.
VOLUME OF PRODUCT IN COMMERCE 46 units.
DISTRIBUTION Nationwide.
PRODUCT
Datex-Ohmeda
S/5 Anesthesia Delivery Units.
CODE Serial numbers: 40022312, 40022313, 40027688, 40032184, 40032233,
4002321, 40032330, 40032546, 40036365, 40043483, 40043493 through 40043495,
40043497, 40054495, 40065046, 40065073, 40065818, 40067311, 40067345, 40080026,
40080031, 40080032, 40080035 through 40080037, 40080039, 40080041, 40080042,
40080056, 40080063, 40080064, 40080070, 40080073, 40082935, 40082937 through
40082941, 40082975, 40082979, 40082980, 40082981, 40082986 through 40082989,
40083005, 40083008 through 40083028, 40084505, 40084508, 40084509, 40084512,
40084523, 40084524, 40084535 through 40084538, 40085637, 40085638, 40085642
through 40085644, 40085656, 40085666, 40085681, 40085683 through 40085698,
40085700, 40085702 through 40085707, 40085710 through 40085712, 40085723,
40085734 through 40085736, 40086464, 40088538, 40088544 through 40088548,
40088550 through 40088553, 40088574, 40088585, 40088586, 40089324 through
40089328, 40089333 through 40089340, 40089342 through 40089350, 40089359
through 40089363, 40089398, 40089402, 40089420, 40089421, 40092286, 40092287,
40092290, 40092291, 40092368 through 40092372, 40094139, 40094140, 40094142
through 40094149, 40095400 through 40095433, 40097292 through 40097298,
40097314 through 40097319, 40097321, 40098708, 40098711, 40098714, 40098716
through 40098719, 40098725 through 40098738, 40098751 through 40098754,
40100505 through 40100510, 40102542, 40102543, 40103791, 40103792, 40103796,
40103809, 40103810, 40103817, 40103820, 40103821, 40104726, 40104728, 40104733
through 40104747, 40105932, 40105933, 40105944 through 40105946, 40105952
through 40105954, 40106542 through 40106547, 40106549, 40106551, 40106552,
40106568 through 40106585, 40107959, 40107963, 40107964, 40107976 through
40107985, 40107990 through 40107996, 40107998, 40108817, 40108821, 40108832
through 40108846, 40108848 through 40108850, 40108853, 40109523 through
40109525, 40109531, 40109532, 40109534 through 40109544, 40109546, 40109550,
40110654 through 40110673, 40110684 through 40110688, 40110700, 40110702,
40110703, 40111775 through 40111783, 40111791 through 40111795, 40111804,
40111807 through 40111809, 40112657, 40112659 through 40112661, 40113737,
40113747 through 40113749, 40113755, 40113761, 40113762, 40113767, 40113768,
40113770 through 40113774, 40114922 through 40114928, 40114931 through
40114933, 40115990 through 40116023, 40117237 through 40117244, 40118114
through 40118116, 40118125, 40119844, 40119864, 40119867 through 40119873,
40120169 through 40120178, 40120182, 40120183, 40120908 through 40120917,
40120920, 40120924, 40120929, 40120930, 40120932, 40122181, 40122187, 40122189,
40122627, and 40132124
RECALLING FIRM/MANUFACTURER Datex-Ohmeda, Inc., Madison, WI.
REASON Possible disruption of mechanical ventilation or disruption of
anesthetic agent delivery.
VOLUME OF PRODUCT IN COMMERCE 544 units.
DISTRIBUTION Nationwide.
PRODUCT
BiodivYsio?
SV Over The Wire (OTW) Coronary Stent, 2.25 mm diameter;
a)
Catalog # B3225-10;
b)
Catalog # B3225-10;
c) Catalog # B3225-15;
d)
Catalog # B3225-18.
CODE a) Lot # 010586G; b) Lot # 030176G; c) Lot # 010626G; d) Lot #
020246G.
RECALLING FIRM/MANUFACTURER Abbott Vascular Devices, Redwood City, CA.
REASON The medical device is misbranded in that the compliance chart of
the Stent diameter may allow over expansion that may result in vessel damage.
VOLUME
OF PRODUCT IN COMMERCE 74 units.
DISTRIBUTION Nationwide.
PRODUCT
CryoValve
Heart-valve, allograft.
CODE Donor #60741, Model #SGAV10, Serial #783013.
RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA.
REASON Donor of aortic valve had procurement cultures that were positive
for E-coli.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT
CryoValve
Heart Valve.
CODE Donors processed prior to 1/26/1998.
RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA.
REASON CryoLife initiated a retrospective review per FDA request, to
insure that current regulatory guidelines for donor blood testing have been met
for certain donors.
VOLUME OF PRODUCT IN COMMERCE 325 units.
DISTRIBUTION Nationwide and Internationally.
PRODUCT
Boston
Scientific Medi-Tech Imager II 5F Selective Angiographic Catheter.
CODE Lot 24495.
RECALLING FIRM/MANUFACTURER Boston Scientific Scimed, Maple Grove, MN.
REASON Some of the recalled catheters may be in pouches with incomplete
seals.
VOLUME OF PRODUCT IN COMMERCE 160 catheters (32 boxes of 5 each).
DISTRIBUTION Nationwide.
PRODUCT
a) Sarns brand Retrograde Cardioplegia Cannula, 17 Fr, steerable stylet, ribbed
balloon, manual-inflate. Catalog # 4428.
b) Sarns brand Retrograde Cardioplegia Cannula, 17 Fr, malleable stylet, ribbed
balloon, manual-inflate. Catalog # 4430.
c) Sarns brand Retrograde Cardioplegia Cannula, 13 Fr, steerable stylet, ribbed
balloon, manual-inflate. Catalog # 5578.
d) Sarns brand Retrograde Cardioplegia Cannula, 13 Fr, malleable stylet, ribbed
balloon, manual-inflate. Catalog # 5579.
e) Sarns brand Retrograde Cardioplegia Cannula, 15 Fr, guidewire stylet, smooth
balloon, manual-inflate. Catalog # 7270.
f) Sarns brand Retrograde Cardioplegia Cannula, 15 Fr, guidewire stylet, ribbed
balloon, manual-inflate. Catalog # 7272.
CODE
a) Lots 1200590 and 1200600;
b) Lots 1200570, 1200580 and 1203920;
c) Lot 1197400;
d) Lots 1203930 and 1203940;
e) Lots 1200560, 1205410, 1205420 and 1209760;
f) Lot 1207930.
RECALLING FIRM/MANUFACTURER Terumo Cardiovascular Systems, Corp, Ann
Arbor, MI.
REASON Product is labeled as sterile, but inadequate package seal
results in lack of assurance of sterility.
VOLUME OF PRODUCT IN COMMERCE 1,441.
DISTRIBUTION Nationwide and Internationally.
PRODUCT
a) Angiotensin I (1251) Radioimmunoassay Kit, 250 Tube, Catalog Number: NEA104
For in-vitro diagnostic use.
b) Angiotensin I (1251) Radioimmunoassay Kit, 500 Tube, Catalog Number: NEA105,
For in-vitro diagnostic use.
CODE
a) Lot 181269, Expiration 8/27/03;
b) Lot 181611, Expiration 8/27/03.
RECALLING FIRM/MANUFACTURER Perkinelmer Life Sciences, Inc., Boston, MA.
REASON Incorrect calibration standard value may result in 25% higher
assay values for controls and patient samples.
VOLUME OF PRODUCT IN COMMERCE 77 kits.
DISTRIBUTION Nationwide and Internationally.
PRODUCT
Harvard 2,
Dual Infusion Pump (P/N 2002-001).
CODE Software versions V1.2R or earlier.
RECALLING FIRM/MANUFACTURER Harvard Clinical Technology, South Natick,
MA.
REASON Under specific sequence conditions, the unit may appear to be
infusing, but is not.
VOLUME OF PRODUCT IN COMMERCE 384 units.
DISTRIBUTION Nationwide.
PRODUCT
Triton T-700
Traction Unit. Model/Catalogue Nos: 7950 (120 Volt) and 7952 (220 Volt).
CODE Serial Numbers 6211-6230, 1907 and 1920.
RECALLING FIRM/MANUFACTURER Chattanooga, Corp, Hixson, TN.
REASON Product contains an improper bracket for the transducer.
VOLUME OF PRODUCT IN COMMERCE 18 units.
DISTRIBUTION IL, CA, TX, OH, FL, LA, WA, NC and DC.
PRODUCT
Misys
Laboratory System.
CODE Version 5.2 through 5.3.2 using LabAccess Results.
RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ.
REASON Software design deficiency. If the dilution factor is added to
the same result twice, incorrect specimen values are reported.
VOLUME OF PRODUCT IN COMMERCE 171.
DISTRIBUTION Nationwide and Internationally.
PRODUCT
AxSYM
Homocysteine Reagent Pack, list 5F51-20.
CODE Lots 01724M300, 03314HN00, 03533HN00.
RECALLING FIRM/MANUFACTURER Abbott Laboratories HPD/ADD/GPRD, Abbott
Park, IL.
REASON There is a kit-to-kit difference within the lots, with the
reagents generating different polarization values than those in others.
VOLUME OF PRODUCT IN COMMERCE 3,505 kits.
DISTRIBUTION Nationwide and Internationally.
PRODUCT
Calculator/Data
Processing Module for Clinical Use.
CODE Version 3.x.
RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ.
REASON Software Design Defect. Under certain conditions, results are
removed.
VOLUME OF PRODUCT IN COMMERCE 47.
DISTRIBUTION Nationwide.
bioMérieux, Inc. Recalls Two Lots of
VIDAS® Chlamydia Assay
bioMérieux,
Inc.
announced that it initiated a worldwide
voluntary product recall of two lots, 040212-0 and 040218-0, of its VIDAS®
Chlamydia (CHL) assay for the detection of Chlamydia
trachomatis. Two thousand two hundred and four kits, 60 tests per
kit, were distributed to clinical laboratories from June 4 to July 30, 2003.
bioMérieux,
Inc. learned, through routine internal Quality Control testing, that the
recalled lots contained a raw material that caused an accelerated degradation
of the product performance. As a result, a positive or equivocal test result
may be reported as negative. Based upon studies conducted at bioMérieux, the
assay was producing valid results up to July 24, 2003. Patients receiving a
negative test result with these test kits since July 24, 2003, should ask their
physicians if they should be re-tested.
Clinical
laboratories were notified by bioMérieux to discontinue use of the recalled
test kits and to destroy any remaining product. The company also recommended
re-testing of any negative test results obtained since July 24, 2003.
bioMérieux
has implemented corrective actions. The company has produced new lots of the
VIDAS Chlamydia Assay and has shipped them to our customers. bioMérieux has
notified the U.S. Food and Drug Administration (FDA) and is cooperating with
the FDA regarding recall activities.
Laboratories with questions should contact
bioMérieux, Inc. at 1- 800-682-2666. Physicians with questions on this recall
should contact their clinical diagnostic laboratories. Consumers with questions
about this recall should contact their physicians.
VIDAS
is a registered trademark of bioMérieux.
PRODUCT Alumina ceramic liner for acetabular shell. This is
part of the Transcend ceramic-on-ceramic total hip system.
CODE Part No. Lot Serial No. 73003258 070A122950 71002846
101A147607 72003252 101A147579 71002846 01214750 73003258 020A116075 73003258
101A147616 71002846 101A147609 71002846 01214749 72003252 01214581 72003252
01215268 73003258 101A147617 73003258 01214576 74003664 101A147618 72003252
101A147580 71002846 048A080430 72003252 0124580 71002846 01214751 74003664 061A136523
72003252 119A112057 73003258 01214575 71002846 031A139399 72003252 101A147577
72003252 01214582 72003252 101A147578 71002846 039A100609 72003252 081A145884.
RECALLING FIRM/MANUFACTURER Wright Medical Technology, Inc.,
Arlington, TN.
REASON Wright Medical commercially distributed Transcend
alumina acetabular shell liners lacking the required process validation.
VOLUME OF PRODUCT IN COMMERCE 133
DISTRIBUTION Nationwide.
PRODUCT
a) Gyroscan ACS-NT system.
b) Gyroscan NT-Intera 1.5T.
c) Gyroscan 1.5T Intera.
CODE X1753, X1412, X1595, X1662, 102718, X1757, X1693, X1523,
X1740, X1742, 86293, 101206, 86292, X0717, X1602, X1563, X1670, X1648, X1582,
10009, 10353, 86280, 13057, 13056, 4139, 87605, 84700, 86968, 10082, 87604,
86082, 101111, 84899, 87183, 87161, 87146, 86020, 87135, 86121, 86080, 101608,
X0083, 87148, 87145, 83306, 83303, 86184, 86147, 84478, 87188, X1759, 86559,
85685, 102095, 83804, 100460, 85433, 83802, 82678, 85119, 83946, 84433, 86019,
83301, 84861, 84860, 87527, 84820, 100786, 84477, 100785, 86083, 101072, 100459,
83325, 84887, 86056, 87147, 83396, 86596, 85684, 62832, 85500, 85688, 86406,
86411, 100916, 85422, 100469, 85686, 86407, 87310, 87309, 86595, 85139, 85172,
63046, 101408, 85141, 86335, 86317, 87033, 85157, 101165, 38317, 86334,
47189,86287, 86288, 101429, 87053.
RECALLING FIRM/MANUFACTURER Philips Medical Systems, Bothell,
WA.
REASON Patient burns related to high SAR levels and the
combined use of Synergy Body Coil and synergy Flex-M coil.
VOLUME OF PRODUCT IN COMMERCE 112.
DISTRIBUTION Nationwide.
PRODUCT
a) Diagnost 94.
b)
Multidiagnost 96.
c) Multidiagnost 97.
CODE The firm utilizes
a site number specific to each unit:
a) 26018, 62634, 62635, 38507;
b) 17197, 17368, 17325, 76449, 17247, 17339, 17304, 13444, 6616, 6558, 6559,
6426, 6539, 6541, 6583, 35366, 37859, 31000, 67642, 62363, 62362, 62278, 62300,
25769, 25901, 25884, 25768, 25900, 25888, 25834, 25967, 25710, 25907, 62279,
62310, 62403, 62391, 62309, 62404, 73921, 50135, 44742, 44670, 44703, 44760,
44699, 46921, 52354;
c) X1207, X1069, X0668, 76345, 17605, 17436, 6852, 6853, 13709, 13971, 6935,
13608, 13951, 6981, 6993, 35481, 86113, 38023, 41372, 62666, 62667, 38897,
37995, 59497, 62936, 62504, 62885, 62988, 62937, 74057, 38657, 38530, 38500,
74056, 59633, 45014, 45013, 47166, 40940.
RECALLING FIRM/MANUFACTURER Philips Medical Systems, Bothell,
WA.
REASON Spontaneous movement of table without input from an
operator.
VOLUME OF PRODUCT IN COMMERCE 91 units.
DISTRIBUTION Nationwide.
PRODUCT BD Blood Glucose Test strips. BD Latitude, 100 Test Strips
100 Bandelettes Reactives, Manufactured for BD by Nova Biomedical Corp,
Waltham, MA, Distributed by Becton Dickinson Canada, Inc., Oakville, ON.
CODE Catalog # 322002 (fifty count packaging) Lot Number:
2064256; Catalog # 322003 (one hundred count packaging) Lot Numbers: 2064256,
2064273, 2071280.
RECALLING FIRM/MANUFACTURER Becton Dickinson & Company,
Franklin Lakes, NJ.
REASON Test strips may not be meeting specifications at the
lower range of glucose values.
VOLUME OF PRODUCT IN COMMERCE 754,800 strips.
DISTRIBUTION Canada.
PRODUCT BVS 5000t Bi-Ventricular Support System
Transport/Backup Console. Catalog Number 0050-000.
CODE Serial Numbers: 3042, 3045-3047, 3049-3080.
RECALLING FIRM/MANUFACTURER Abiomed, Inc., Danvers, MA.
REASON Bi-Ventricular support system may switch to battery
when primary voltage (AC) is available.
VOLUME OF PRODUCT IN COMMERCE 36 units.
DISTRIBUTION Nationwide.
PRODUCT HeartStart XL Defibrillator Monitor. Model M4735A.
CODE Units with software versions A.02.00 or greater.
RECALLING FIRM/MANUFACTURER Philips Medical Systems, Andover,
MA.
REASON Instructions for use include additional information on
configuration for selecting Power on Lead.
VOLUME OF PRODUCT IN COMMERCE 16,736 units.
DISTRIBUTION Nationwide and Internationally.
PRODUCT
a) Gyroscan ACS-NT with software versions R6x, R7x, R8x.
b) Gyroscan NT-Intera.
c) Gyroscan Intera 1.0T & 1.5T.
CODE a) 6808, 87145,
86595, 50426, 100214, 101131, 63045, 103171, 41391, 38189, 37996, 85119, 84433,
83876, 102571, 86121, X1577, 44876, 86368, 44793, 87011, 101572, 100916, 82507,
85500, 13606, 86147, 76475, 86235, X1663, 38380, 101111, 37929, X1412, 86280,
37941, 38134, 101608, 25924, 84418, 101138, 6947, 86292, 83044, 63046, 86293,
86406, 102095, 50309, 87355, X1348, 101976, 76919, 17533, 37911, X0038, 26178,
85443, 101946, 13056, 41377, 76320, 59428, 84861, 14134, 76480, 101780, 50430,
50430, 50378, 13275, 85139, 45016, 87183, 86559, 102614, 102616, X1374, 101206,
83041, X1664, X1373, X1730, X1084, X1085, X1270, X1582, X1670, X1352, X1083,
X1231, X1272, X1669, X1563, X1741, X0165, X1743, X1280, X1086, X0717, X1271,
X0942, X0940, X1740, X1081, 86184, 83303, 101056, 103142, 83631, 38415, 59528,
59357, 83616, 101346, 102018, 76477, 38652, 101313, 38508, 50226, 76848, X1759,
86555, 86082, 14117, 86925, 86020, 13894, 103126, 83080, 101874, 17648, 82506,
86410, 86570, 82610, 38731, 17573, 87365, 62659, 82668, 102889, 41346, 87038,
84887, 103207, 86556, X1043, 87311, 52408, X1593, X1753, 83071, 101423, 100679,
38797, 6841, 47029, 13967, 86248, 13754, 101347, 50390, 102548, 87019, 44994,
87605, 101934, 83325, 41392, 86596, 101425, X1594, 82583, X1353, 83306, 25958,
86335, 86317, 76352, 40904, 10009, 85172, 83395, 103258, 45036, 86597, 37938,
100459, 41441, 13748, 38749, 14128, X1756, 101551, 13058, 87135, X1080, 102110,
38143, 37986, 83946, 82955, 100462, 85436, X0034, 62658, 76807, 76469, 25966,
13932, 102724, 87527, 86408, 101188, 38111, 44833, 41362, 41345, 38966, 26219,
26074, 82627, 86411, 85688, 85686, 82626, 87604, 50336, 86019, 87309, 13020,
84860, 38984, X1668, X1602, 13334, 13338, 13948, 102004, 76847, 102003, 6840,
87188, 26149, 13947, 80335, 83802, 10367, 10409, 38345, 85684, 50412, 50411,
100463, 86409, 83804, 38257, 86056, 87033, 45071, X1163, 101162, 102194, 87161,
87146, 84899, 59707, 13413, 85141, 10432, 13977, 58023, 103064, 87018, 86558,
86236, X1693, 102137, 86148, 103143, 84820, 38441, 87062, X0054, 102718, 26150,
103116, 100460, X1757, 82580, 100469, 38661, 86334, 101429, 76321, 101584,
103351, 41250, 85157, 44813, 86560, 82678, 85685, 14065, X1281, 82547, X1595,
41459, 85442, X1662, 41440, X1710, 38650, 101431, 86281, 101432, 83940, 86381,
X0084, X1739, 47189, 87053, 38438, 86413, 100323, 10396, 76359, 76358, 17481,
17585, 17483, 17482, 82534, 100461, 86968, 83396, 10353, 86250, 86918, 100478,
83615, 101560, 41064, 13729, 101084, 47043, 17394, 13976, 14144, 84700, 87607,
X1216, X1215, 13730, 13864, 100826, 50407, X1648, 17683, 13057, 13966, 87147,
82546, 38651, 86407, 59427, 84478, 84484, 87148, 59384, 59475, 103135, 62953,
86313, 59338, 83394, 59712, 86151, 86083, 62832, 83708, 87310, 26133, 82619,
87168, 87526, 87067, 83051, 101348, X1635, 103041, 102671, 102561, 83916,
38317, 103101, X0162, 84477, 26119, 100785, X1179, X1523, 86080, 85433, 38303,
38304, 86316, 44810, 40975, 83941, 45063, 50432, 101412, 87036, 102907, 45006,
102157, 101165, 101878, 85158, 47058, 41342, 13965, 73974, 86379, 41147, 84859,
102617, 101408, 83995, 83301, 38420, X1649, 86404;
b) Serial numbers listed under Gyroscan ACS-NT with software versions R6x, R7x,
R8x;
c) Serial numbers listed under Gyroscan ACS-NT with software versions R6x, R7x,
R8x.
RECALLING FIRM/MANUFACTURER Philips Medical Systems, Bothell,
WA.
REASON Patient burns from cables near or in contact with the
patient during use.
VOLUME OF PRODUCT IN COMMERCE 435.
DISTRIBUTION Nationwide.