PRODUCT VITEK GPS-107Gram Positive Susceptibility Card, Catalog # V4368, for
in-vitro diagnostic use, 20
cards per package.
CODE Lot #M83X, Exp. 4/15/05.
RECALLING FIRM/MANUFACTURER BioMerieux, Inc., Hazelwood, MO.
REASON Some of the cards were stamped with an incorrect card
code causing the system to read and report the cards incorrectly.
VOLUME OF PRODUCT IN COMMERCE 1,988/20-card boxes.
DISTRIBUTION Nationwide, Colombia, Costa Rica, and China.
PRODUCT VITEK GPS-106 Gram Positive Susceptibility Card,
Catalog #V4335, for in-vitro diagnostic use, 20 cards per package.
CODE Lot P61X, Exp. 5/12/05.
RECALLING FIRM/MANUFACTURER BioMerieux, Inc, Hazelwood, MO.
REASON The cards were stamped with an incorrect card code that
causes the system to read and analyze the cards incorrectly.
VOLUME OF PRODUCT IN COMMERCE 1,955/20-card boxes.
DISTRIBUTION Nationwide.
PRODUCT Hill Rom brand Advanta bed; model P1600.
CODE All units distributed between January 1, 2004 and
February ll, 2004.
RECALLING FIRM/MANUFACTURER Hill-Rom, Inc., Batesville, IN.
REASON A potential pinch/shear point exists between the
restraint strap hook located underneath the knee section and the foot rail
mounting of the bed.
VOLUME OF PRODUCT IN COMMERCE 294 units.
DISTRIBUTION Nationwide and Canada.
PRODUCT PatientNet Monitoring System - PatientNet Central
Stations utilizing software Versions 1.03.14, 1.04xx, 2.00xx.
CODE All PatientNet Central Stations.
RECALLING FIRM/MANUFACTURER General Electric Medical Systems
Information Technology, Milwaukee, WI.
REASON Non-invasive blood pressure readings on central station
may not match bedside monitor due to software anomaly.
VOLUME OF PRODUCT IN COMMERCE 574 software units.
DISTRIBUTION Nationwide.
PRODUCT Impulse Single 5F 145 Multipack Catheters, Catalog
Number H749163913011.
CODE Lot Number 400934.
RECALLING FIRM/MANUFACTURER Boston Scientific Scimed, Maple
Grove, MN.
REASON Some of the catheters may have yellow foreign material
in their pigtail tips. The foreign material in the device could cause a stroke
or significant damage to organs other than the brain.
VOLUME OF PRODUCT IN COMMERCE 11 catheters.
DISTRIBUTION FL.
PRODUCT Vision Hollow Fiber Oxygenator with GBS Coating.
CODE Various codes. Lot numbers specified in each customer’s
letter.
RECALLING FIRM/MANUFACTURER Gish Biomedical, Inc., Rancho
Santa Margarita, CA.
REASON Customers reported leakage.
VOLUME OF PRODUCT IN COMMERCE 950.
DISTRIBUTION Nationwide.
PRODUCT
a) Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, Mini Titanium port,
Implantable Port System, Model #
M001452150, Catalog #45-215.
b) Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, STD Titanium Port,
Implantable Port System, Model #
M001453620, Catalog #45-362.
c) Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, Low Profile PS
port, Implantable Port System,
Model
# M001452380, Catalog #45-238.
d) Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, STD PS port,
Implantable Port System, Model
#
M001453660, Catalog #45-366.
CODE
a) 866561, 876068, 885270, 885444, 886041, 886398, 887738, 888993, 889702,
890163, 903721;
b) 866762, 885272, 887739, 889302, 889704, 892898, 896675, 903724, 904485.
c) 791484, 791485;
d) 866764, 879997, 885445, 886400, 887133, 888995, 903726.
RECALLING FIRM/MANUFACTURER Boston Scientific Corporation,
Natick, MA.
REASON Reports of catheter separation/fracture after
implantation resulting in distal migration of the catheter.
VOLUME OF PRODUCT IN COMMERCE 1,656 units.
DISTRIBUTION Nationwide.
PRODUCT NucliSensâ Easy Q Incubator, Product Number 285204
(this number can be found at the back of the instrument.
CODE Serial Numbers: 36061, 36065 and 36068.
RECALLING FIRM/MANUFACTURER Biomerieux, Inc, Durham, NC.
REASON Instrument malfunction. Electrical short circuit may
occur resulting in damage or a fire hazard.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION CT, MD, and MT.
PRODUCT
a) ACL Futura Instrument Analyzer.
b) ACL Advance Instrument Analyzer..
CODE
a) Software prior to Version V3-5;
b) Software version prior to V2-1.
RECALLING FIRM/MANUFACTURE Instrumentation Laboratory Co, Lexington, MA.
REASON Software may cause instrument to omit step causing
reagent carryover which may effect patient test result.
VOLUME OF PRODUCT IN COMMERCE 462 units.
DISTRIBUTION FL, and Canada.
PRODUCT
a) CryoValve, Aortic Valve and Conduit.
b) CryoValve, Pulmonary Valve and Conduit.
CODE
a) Donor #68607, Serial #8044081, Model #AV00;
b) Donor #68607, Serial #8044091, Model #PV00.
RECALLING FIRM/MANUFACTURER Cryolife Inc, Kennesaw, GA.
REASON CryoLife received additional information after release
of tissue indicating the donor had repeatedly reactive test results for
antibody to HCV (EIA) in 1995.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION DC, and TX.
PRODUCT TDx/TDxFLx Cortisol Reagent Pack, list 9116-65.
CODE List 9116-65, Lots 04111M200, 10239M200, 10060M200,
10060M201.
RECALLING FIRM/MANUFACTURER Abbott Laboratories HPD/ADD/GPRD,
Abbott Park, IL.
REASON The package inserts contain incorrect control values
for the urinary free cortisol extraction procedure.
VOLUME OF PRODUCT IN COMMERCE 1,487 kits.
DISTRIBUTION Internationally.
PRODUCT IMMULITE 2000 Intact PTH kit.
CODE Kit lots L2KPP 117 (exp date Aug 31 2004) and 118 (exp
date Oct 31 2004).
RECALLING FIRM/MANUFACTURER Diagnostic Products Corp, Los
Angeles, CA.
REASON High bias noted in samples collected with EDTA.
Indication is to not run samples with EDTA.
VOLUME OF PRODUCT IN COMMERCE 2,416.
DISTRIBUTION MO, CO, VA, CT, DC, and Internationally.
PRODUCT
a) FreshLook ColorBlends®, Daily wear soft (hydrophilic) contact lens, BC:
Median, DIA: 14.5, Rx Only, Sterile,
SPH -5.25, LOT ***, 2006-08. Product is packed in 6 packs.
b)
FreshLook® Colors, Daily wear soft (hydrophilic) contact lens, BC: Median, DIA:
14.5, Rx Only, Sterile,
SPH
***, LOT ***, 2006-11, 6-pack, 2 pack and single trial. Product is packed in 6
packs, 2 packs and single trial
packs (Samples not for sale).
c) FreshLook® Enhancers, Daily wear soft (hydrophilic) contact lens, BC:
Median, DIA: 14.5, Sterile, SPH-0.75,
LOT ***, 2008-06, WJ®, Product is packed in 6 packs.
d) FreshLook® Toric, Daily wear soft (hydrophilic) contact lens, BC: Median,
DIA: 14.5, Sterile, SPH -1.50, CYL -
0.75, AXIS 020, LOT ***, 2006-04, Product is packed in 6 packs.
CODE
a) Lot #063302, Exp. Date: 2006-08, Lot #088472, Exp. Date:2008-07, Lot
#073059, Exp. Date 2008-02, Lot #074338,
Exp. Date: 2008-02;
b) Lot #067121, Exp. Date 2006-11, Lot #065047, Exp. Date 2006-11, Lot #065530,
Exp. Date 2006-11, Lot #079803,
Exp. Date 2003-08, Lot #065310, Exp. Date: 2006-11, Lot #0-65427, Exp. Date:
2006-11;
c) Lot #085612, Exp. Date: 2008-06, Lot #095007, Exp. Date: 2008-06, Lot
#098003, Exp. Date 2008-06;
d) Lot #072145, Exp. Date: 2006-04.
RECALLING FIRM/MANUFACTURER Ciba Vision Corporation, Duluth,
GA.
REASON The lens inside the package does not match the
prescription information labeled on the primary package.
VOLUME OF PRODUCT IN COMMERCE 7420 6pk, 1000 2pk, 1720 single
blister.
DISTRIBUTION Nationwide and Internationally.
PRODUCT Acuson Cypress Echocardiography System. Catalog number
8264604;
CODE Serial numbers 73480 through 73535, 71165, 71561, 72532,
73125, and 73292.
RECALLING FIRM/MANUFACTURER Siemans Medial Solutions USA, Inc,
Plymouth Meeting, PA.
REASON Software problem - mode does not appear on screen.
VOLUME OF PRODUCT IN COMMERCE 46 units.
DISTRIBUTION Nationwide and Internationally.
PRODUCT RAD SOURCE RS 3000 Blood Irradiator Three Bag Option.
CODE Serial numbers: 1002 through 1005, 1007 through 1009,
1011 through 1023.
RECALLING FIRM/MANUFACTURER Rad-Source Technologies, Inc.,
Boca Raton, FL.
REASON The firm completed a cooling system retrofit to
preclude overheating and failure.
VOLUME OF PRODUCT IN COMMERCE 20.
DISTRIBUTION Nationwide.
PRODUCT Weber SolarJet S CO2 Vector
Laser Coder System.
CODE Serial number 09333451.
RECALLING FIRM/MANUFACTURER Weber
Marking System, Inc., Arlington Heights, IL.
REASON The laser product failed to comply with the performance
standards, including certification, identification, warning logotype label,
aperture label and submission of a product report.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.
PRODUCT Carbomedics VT-200 Valve Tester.
CODE All lots.
RECALLING FIRM/MANUFACTURER Carbomedics, Inc., Austin, TX.
REASON Excessive cleaning and resterilization cause cracking and crazing
of device causing the device to malfunction during use.
VOLUME OF PRODUCT IN COMMERCE 4,606 instruments.
DISTRIBUTION Nationwide and Internationally.
PRODUCT Asahi APS Series Dialyzers, Model Nos. APS-100S, APS-550S,
APS-650S, APS-750S, APS-900S, APS-1050S. The dialyzers are intended for single
or initial use and under reprocessing and reuse conditions for up to 15 reuse
cycles.
CODE The recall is no lot specific.
RECALLING FIRM/MANUFACTURER Asahi Medical Co., Ltd, Chiyoda Ku, JP.
REASON Customer reprocessing methods for the reusable hollow fiber
dialyzers may damage the hollow fibers and result in blood leaks during
dialysis.
VOLUME OF PRODUCT IN COMMERCE 180,000 units estimated.
DISTRIBUTION NJ, OH, TX, CA, GA, PA, IL, and IN.
PRODUCT
a) NEONATE 1 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece
cuff for single patient use only. Sold under the Welch Allyn label with Part
#5082-101-1, and sold as part of a multi-pack (1 of each size) with Part
#5082-241-9; Allegiance "Tactics" label with Part #30502-110S; and
Arden label with Part #5084-101-1.
b) NEONATE 1 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece
cuff, for single patient use only. Sold under the Welch Allyn "Tycos"
label with Part #s 5082-101-2, 5082-101-2CL, and sold as part of a multi-pack
(1 of each size) with Part #5082-241-10; Allegiance "Tactics" label
with Part #s 30502-110 and 30502-210; and Arden label with Part #s 5084-101-2
and 633-5084-101-2.
c) NEONATE 2 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece
cuff for single patient use only. Sold under the Welch Allyn "Tycos"
label with Part # 5082-102-1 and sold as part of a multi-pack (1 of each size)
with Part #5082-241-9; Allegiance Healthcare "Tactics" label with
Part # 30502-111S; and Arden label with Part # 5084-102-1.
d) NEONATE 2 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece
cuff for single patient use only. Sold under the Welch Allyn "Tycos"
label with Part # 5082-102-2, 5082-102-2CL, 671-5082-102-2, and sold as part of
a multi-pack (1 of each size) with Part #5082-241-10; Allegiance Healthcare
"Tactics" label with Part # 30502-111 and 30502-211; and Arden label
with Part # 5084-102-2 and 634-5084-102-2.
e) NEONATE 3 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece
cuff for single patient use only. Sold under the Welch Allyn "Tycos"
label with Part # 5082-103-1 and sold as part of a multi-pack (1 of each size)
with Part #5082-241-9; Allegiance Healthcare "Tactics" label with
Part # 30502-112S; and Arden label with Part # 5084-103-1.
f) NEONATE 3 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece
cuff for single patient use only. Sold under the Welch Allyn "Tycos"
label with Part # 5082-103-2, 5082-102-2CL , and sold as part of a multi-pack
(1 of each size) with Part #5082-241-10; Allegiance Healthcare "Tactics"
label with Part # 30502-112 and 30502-212; and Arden label with Part #
5084-103-2, and 635-5084-103-2.
g) NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece
cuff for single patient use only. Sold under the Welch Allyn "Tycos"
label with Part # 5082-104-1 and sold as part of a multi-pack (1 of each size)
with Part #5082-241-9; Allegiance Healthcare "Tactics" label with
Part # 30502-113S; and Arden label with Part # 5084-104-1.
h) NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece
cuff for single patient use only. Sold under the Welch Allyn "Tycos"
label with Part # 5082-104-2, 5082-104-2CL, and sold as part of a multi-pack (1
of each size) with Part #5082-241-10; Allegiance Healthcare "Tactics"
label with Part # 30502-113 and 30502-213; and Arden label with Part #
5084-104-2 and 636-5084-104-2.
i) NEONATE 5 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece
cuff for single patient use only. Sold under the Welch Allyn "Tycos"
label with Part # 5082-105-1 and sold as part of a multi-pack (1 of each size)
with Part #5082-241-9; Allegiance Healthcare "Tactics" label with
Part # 30502-114S; and Arden label with Part # 5084-105-1.
j) NEONATE 5 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece
cuff for single patient use only. Sold under the Welch Allyn "Tycos"
label with Part # 5082-105-2, 5082-105-2CL, and sold as part of a multi- pack
(1 of each size) with Part #5082-241-10; Allegiance Healthcare
"Tactics" label with Part # 30502-114 and 30502-214; and Arden label
with Part # 5084-105-2 and 637-5084-105-2.
CODE Code dates between May 13, 2003 and January 23, 2004. (Codes found
on outer carton only).
RECALLING FIRM/MANUFACTURER Welch Allyn, Inc, Skaneateles Falls, NY.
REASON GMP deficiencies.
VOLUME OF PRODUCT IN COMMERCE 221,200 units.
DISTRIBUTION Nationwide and worldwide.
PRODUCT Baxter Meridian Hemodialysis Instrument, product codes 5M5576
and 5M5576R.
CODE All serial numbers.
RECALLING FIRM/MANUFACTURER Baxter Healthcare Renal Div., Mc Gaw Park,
IL.
REASON Microbubbles of air in the extracorporeal blood circuit during
hemodialysis therapy on the Meridian.
VOLUME OF PRODUCT IN COMMERCE 2,949 units.
DISTRIBUTION Nationwide, Mexico, China and Korea.
PRODUCT Hill-Rom brand TotalCare bed system; model P1900 -
remanufactured only.
CODE All remanufactured beds distributed between August 2003 and
February 2004.
RECALLING FIRM/MANUFACTURER Hill-Rom, Inc., Batesville, IN.
REASON A warning label, advising users not to use oxygen tents with this
equipment because of the potential for a fire, was not placed on these
remanufactured beds.
VOLUME OF PRODUCT IN COMMERCE 52.
DISTRIBUTION AZ, FL, GA, NV, PR, TX, VA, and Canada.
PRODUCT
a) VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains a radiopaque
Coaxial Dilator (4 Fr), a 21 Ga. echogenic entry needle, and a .018 in. / 0,46
mm guidewire with a floppy lip. Cat. #45-988.
b) VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains a radiopaque
Coaxial Dilator (5 Fr), a 21 Ga. Echogenic entry needle, and a .018 in. / 0,46
mm guidewire with a floppy lip. Cat. #45-994.
CODE
a) 912502, Exp. 10/31/05;
b) 910482, Exp. 10/31/05.
RECALLING FIRM/MANUFACTURER Boston Scientific Corporation, Natick, MA.
REASON Kits containing 5 Fr dilators may be labeled as 4 Fr. Kits
containing 4 Fr dilators may be labeled as 5 Fr.
VOLUME OF PRODUCT IN COMMERCE 175 boxes.
DISTRIBUTION Nationwide and Canada.
PRODUCT
a) BD Test Strips. The US market BD Test Strips are identified by Catalog Numbers
322027 (50 count BD Test
Strips Durable medical Equipment consignees), 322053 (50 Count BD Test Strips
Trade consignees), and 322060 (10 Count BD Test Strips packaged within BGM
kits). The Canadian market BD Test Strips are identified by Catalog Numbers 322002 (50 count BD Test Strips),
322003 (100 count BD Test strips), and 322009 (10 count BD Test strips). Health
Hazard Evaluation: There is negligible medical risk to patients with diabetes
using the BD
blood glucose systems due to the increase of E-3 error messages.
b)
The BD Blood Glucose Monitoring Systems identified as the BD Latitude, and BD
Logic. Becton Dickinson also distributes the Paradigm Link Blood glucose
Monitor which is sold exclusively for Medtronic Mini Med. US
Market BD Blood Glucose Monitoring System kit catalog Numbers: 322025 (BD Logic
Blood Glucose Monitor Durable Medical Equipment consignees); 322050 (BD
Latitude Diabetes Management System); 322051 (BD Logic Blood Glucose Monitor);
32205175 ( BD Logic Blood Glucose Monitor); 322200 (Paradigm Link Blood Glucose
Monitor - clear); 322201 ( Paradigm Link Blood Glucose Monitor - smoke); 322202
(Paradigm Link Blood Glucose Monitor - blue); 322203 (Paradigm Link Blood
Glucose Monitor - purple). Canadian market BD Blood Glucose Monitoring System
kit catalog numbers: 322000 (BD Latitude Diabetes Management System); 322001
(BD Logic Blood Glucose Monitor).
CODE
a) US Market Lot Numbers: 2064322; 2064333; 2071311; 2078294; 2099353; 2120336;
3057009; 3064013; 3064016;
3064018; 3064030; 3064037; 3064069; 3064076; 3064079; 3064083; 3064090;
3064104; 3064107; 3064112; 3064118;
3064121; 3064125; 3064132; 3064156; 3064167; 3064170; 3064174; 3064182;
3064188; 3064237; 3064245; 3064279;
3071009; 3071153; 3078041; 3078128; 3092028; 3106007.
Canadian
Market Lot Numbers: 3064125; 3071153; 3064279; 3071009; 3071153; 3064156;
3064182; 3064188.
b) US Market BD Logic Lot Numbers: 2057320; 2057325; 2507327; 2057361; 2064338;
2064339; 2064341; 2071322;
2071351; 2078324; 2078326; 2078351; 2085324; 2085339; 2085351; 2085360;
2092322; 2092341; 2099322; 2099360;
2106325; 2113325; 3057022; 3057136; 3057147; 3064143; 3064147; 3064148;
3071015; 3071122; 3071125; 3071127;
3071170; 3078023; 3078037; 3078126; 3078135; 3078136; 3078141; 3078142;
3078174; 3085127; 3085139; 3085142;
3085149; 3085161; 3085174; 3092021; 3092122; 3092147; 3092174; 3092176;
3092177; 3099020; 3099147; 3099153;
3099171; 3099174; 3099176; 3099178; 3106147; 3106162; 3113141; 3120176;
3127176.
US Market BD Latitude Lot Numbers: 2057360; 2064360; 2071352; 2078352; 2078353;
2085353; 2092354; 2092360; 2099354; 2099357; 2106357; 2113357; 3057020;
3057021; 3057052; 3064021; 3064055; 3064056; 3064064; 3071021;
3071064; 3085090; 3092106; 3106022.
US Market Paradigm Link Blood Glucose Monitors Lot Numbers (co-Branded BD
Logic): 3057049; 3057051;
3057055; 3057056; 3057058; 3057063; 3057064; 3057070; 3057071; 3057073;
3057098; 3057115; 3057120; 3064045;
3064058; 3064059; 3064077; 3064091; 3064097; 3071049; 3071056; 3071072;
3071076; 3071078; 3071080; 3071090;
3071104; 3071112; 3071120; 3078044; 3078045; 3078051;3078064; 3078069; 3078077;
3078090; 3078101; 3078106;
3085055; 3085056; 3085079; 3085092; 3085093; 3085105; 3085106; 3085108;
3092044; 3092069; 3092085; 3092101;
3092104; 3099055; 3099083; 3099101; 3099108; 3099125; 3106072; 3106078;
3106097; 3106100; 3106118; 3113042;
3113069; 3113107; 3120104; 3127055; 3127056; 3127059; 3127076; 3134090;
3134107; 3141069; 3141112; 3155100.
US Market Paradigm Link (clear) Lot Numbers: 3057199; 3064189; 3064246;
3071178; 3085198; 3085281; 3085282;
3092188; 3120177.
US Market Paradigm Link (smoke) Lot Numbers: 3057183; 3057184; 3057197;
3057198; 3057227; 3057241; 3064204;
3064255; 3064267; 3071196; 3071199; 3071203; 3071245; 3071255; 3078202; 3085184;
3085287; 3092287.
US Market Paradigm Link (Blue) Lot Numbers: 3057189; 3057195; 3057233; 3064196;
3064197; 3064262; 3071232;
3071289; 3078196; 3078294; 3085181; 3085188; 3085261; 3085293; 3113178;
3113182.
US Market Paradigm Link (purple) Lot Numbers: 3057188; 3057196; 3057280;
3064192; 3064195; 3071205; 3071279;
3078184; 3078204; 3078232.
Canadian BD Latitude Lot Numbers: 3057041; 3057042; 3057043.
Canadian BD Logic Lot Numbers: 3057203; 3057205; 3057224; 3057234; 3064199;
3064203; 3064205; 3064224;
3071202; 3071204; 3071237; 3078198; 3078199; 3078205; 3085202; 3099204;
3120198.
RECALLING FIRM/MANUFACTURER Becton Dickinson & Company, Franklin
Lakes, NJ.
REASON 39 lots of BD Test strip may produce an increased frequency of
E-3 messages when used during blood glucose testing.
VOLUME OF PRODUCT IN COMMERCE
a)
15,011,221;
b) 207,092.
DISTRIBUTION Nationwide and Canada.
PRODUCT QPC1680 Quick Connect, for Pentax 30/40/K Series Two-Channel GI
Endoscopes, in the Steris System 1 Sterile Processing System with the C1160
Universal Flexible Processing Tray, Cat. No. QPT1680.
CODE
Lots
#2925196, #2911782, #2925238.
RECALLING FIRM/MANUFACTURER Steris Corp., Mentor, OH.
REASON A defective port adapter may affect the sterilization process of
the attached endoscope.
VOLUME OF PRODUCT IN COMMERCE 40 units.
DISTRIBUTION Nationwide, Canada, Italy, and Germany.
PRODUCT
a) Zimmer brand Coonrad/Morrey total elbow interchangeable ulnar assembly,
small, left, 3 in. length, tivanium
TI-6AL-4V alloy/UHMWPE, sterile, for use with bone cement. Cat. No.
32-8105-53-01.
b) Zimmer brand Coonrad/Morrey total elbow interchangeable Ulnar assembly,
small, right, 3 in. length, tivanium
TI-6AL-4V alloy/UHMWPE, sterile, for use with bone cement. Cat. No.
32-8105-53-02.
CODE
a) Lot 60039452;
b) Lots 60039453, 60039454, 60040852 and 60041552.
RECALLING FIRM/MANUFACTURER Zimmer, Inc., Warsaw, IN.
REASON Right ulna implants were etched and labeled as left ulna
implants. Left ulna implants may have been etched and labeled as right ulna implants.
VOLUME OF PRODUCT IN COMMERCE 49 units.
DISTRIBUTION Nationwide and Internationally.
PRODUCT Clinical Chemistry Uric Acid; LN 7D76-20.
CODE Lot number: 95015HW00.
RECALLING FIRM/MANUFACTURER Abbott Laboratories Diagnostic, Div., South
Pasadena, CA.
REASON Unacceptable upward drift of results in control runs within 24
hour period.
VOLUME OF PRODUCT IN COMMERCE 796 kits.
DISTRIBUTION Nationwide and Internationally.
PRODUCT Giardia/Cryptosporidium Rapid In-vitro diagnostic Test Kits.
These are sold under two names as follows: Meridian ImmunoCard Stat
Cryptosporidium/Giardia Rapid Assay; Becton Dickenson (BD) ColorPac
Giardia/Cryptosporidium Rapid Assay.
CODE Lots 081077, 081093, 081138, 071093, 071138.
RECALLING FIRM/MANUFACTURER Genzyme Diagnostics, San Diego, CA.
REASON False Positive results.
VOLUME OF PRODUCT IN COMMERCE 2,671 kits.
DISTRIBUTION OH, and MD.
PRODUCT Codman Holter Salmon Rickham Reservoir with Ventricular
Catheter, Catalog Number: 82-1671.
CODE
Lot Number:
1106525.
RECALLING FIRM/MANUFACTURER Codman & Shurtleff, Inc., Raynham, MA.
REASON Drainage tips absent from catheter tip.
VOLUME OF PRODUCT IN COMMERCE 39 units.
DISTRIBUTION CA, GA, MI, NC, SC, TN, TX, Italy and Germany.
PRODUCT Cryo Valve, Aortic Valve & Conduit. Donor #69588, Model
#AVOO.
CODE Serial #8069423.
RECALLING FIRM/MANUFACTURER Cryolife, Inc, Kennesaw, GA.
REASON Microorganisms were detected in donor tissue associated with this
allograft, specifically Aeormonas hydrophila.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT Biomet brand Absolute Bi-Polar Shoulder Shell 48 mm w/locking
ring; part 113156.
CODE Lot 551440.
RECALLING FIRM/MANUFACTURER Biomet, Inc., Warsaw, IN
REASON The locking ring was not included and the shoulder implanted
without the locking ring.
VOLUME OF PRODUCT IN COMMERCE 6.
DISTRIBUTION CA, FL, WA, Germany and Venezuela.
PRODUCT
a) NOW RSV Test. Item Number 430-430, Kit Number 430-00R.
b) NOW Filariasis Rapid test for W. bancrofti antigen. (Export use only) Item
Number 620-430, Kit Number 620-
000.
c) NOW Malaria (Export use only) Item Number 660-430, Kit Number 66005, Kit
Number 660-000.
CODE
a) Lot Numbers 015168 and 015172;
b) Lot Number 015187;
c) Lot Numbers 015001 and 015002.
RECALLING FIRM/MANUFACTURER Binax, Inc, Portland, OR.
REASON Pouch integrity compromised.
VOLUME OF PRODUCT IN COMMERCE 1575 kits.
DISTRIBUTION KS and Internationally.
PRODUCT Architect Ca 19-9 Reagent Kit, list 6C04-20 (1 x 100 tests) and
6C04-25 (4 x 100 tests).
CODE Lot numbers 07747M100 and 07747M101.
RECALLING FIRM/MANUFACTURER Abbott Laboratories HPD/ADD/GPRD, Abbott
Park, IL.
REASON The reagent lots may produce patient results that are lower than
expected when compared to other lots of in-date reagents.
VOLUME OF PRODUCT IN COMMERCE 1,987 kits.
DISTRIBUTION Canada, Australia, Germany and Japan.
PRODUCT AxSYM Troponin-I Reagent Kit, list 3C29-20, 100 test kit.
CODE Lot numbers 10264M300, 10264M301, 10265M300, and 10265M301.
RECALLING FIRM/MANUFACTURER Abbott Laboratories HPD/ADD/GPRD, Abbott
Park, IL
REASON An increase in complaints of higher than normal patient results,
some from the healthy population range to above the diagnostic cutoff for an
Acute Myocardial Infarction.
VOLUME OF PRODUCT IN COMMERCE 7,394 kits.
DISTRIBUTION Nationwide and Internationally.
PRODUCT MicroSTAAR Injector w/Foam Tip Plunger, Model MSI-PF.
CODE Lot 11853090. Sterility Date: 11/18/2003. Expiration Date:
10/31/2006.
RECALLING FIRM/MANUFACTURER Staar Surgical Co, Inc., Monrovia, CA.
REASON Injector mold design/manufacture and wear caused material flash
to develop preventing assembly of the device prior to use.
VOLUME OF PRODUCT IN COMMERCE 690 injectors.
DISTRIBUTION Nationwide.
PRODUCT Coag-A-Mate( MTX and MTX II Instrument Operator Manual.
CODE All Codes.
RECALLING FIRM/MANUFACTURER Biomerieux, Inc., Durham, NC.
REASON Typographical error in the Operator Manual. In Chapter 11 of the
MTX/MTX II Operator Manual, the numerical range for the Warning Flag is shown
as 00-99. The correct numerical range is 0-99. The "list of error and
warning" chart shows a numerical range representing the codes 00-9. The
correct numerical range for the first ten error/warning codes are 0-9.
VOLUME OF PRODUCT IN COMMERCE Unknown.
DISTRIBUTION Nationwide and Internationally.
PRODUCT Pathromtin SL. Partial Thromboplastin Time Tests. The product is
sold in kits containing 10 and 20 vials.
CODE Lot numbers 523785, 523785A, 523785B, and 523787.
RECALLING FIRM/MANUFACTURER Dade Behring, Inc., Newark, NJ.
REASON Cloudy appearance or precipitate.
VOLUME OF PRODUCT IN COMMERCE 77,886 vials.
DISTRIBUTION PA, and Internationally.
PRODUCT
a) Cryo Valve, Pulmonary Valve & Conduit. Donor # 69091, Model # PVOO.
b) Cryo Valve, Aortic Valve & Conduit. Donor # 69091, Model # AVOO.
CODE
a) Serial # 8009917;
b) Serial # 8009937.
RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA.
REASON The donor of the tissue had a viral syndrome at the time of
death.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CT, and PA.
PRODUCT
a) BD L-Cath NN (24ga x 30cm), L-Cath Catheter System.
b) BD L-Cath EX (20ga x 15cm), L-Cath Catheter System.
c) BD L-Cath EX (28ga x 20cm), L-Cath Catheter System.
CODE
a) REF 384522, Lot numbers 2226035, 3274339, 3240808, 3294199, 3365138,
3220423, 3192307, 3073801;
b) REF 384703, Lot Number 3007152;
c) REF 384510, Lot Numbers 2158054, 2158055.
RECALLING FIRM/MANUFACTURER Becton Dickinson Infusion Therapy, Sandy, UT.
REASON Catheters have stylets extending past the catheter tip, which, if
not noticed could cause injury upon insertion.
VOLUME OF PRODUCT IN COMMERCE 7,810 units.
DISTRIBUTION Nationwide, Australia, Canada and Japan.
PRODUCT
a) Philips MX8000 IDT CT Scanner System, 10 & 16 slice images.
b) Philips Brilliance CT Scanner System, 6, 10 & 16 slice images.
CODE
a) Serial Numbers: 2501 to 2554; 3006; 3008 to 3337;
b) Serial Numbers: 2555 to 2568; 3335 to 3392; 9701 to 9725.
RECALLING FIRM/MANUFACTURER Philips Medical Systems (Cleveland) Inc.,
Cleveland, OH.
REASON The CT couch may move downward to its lower limit without
command.
VOLUME OF PRODUCT IN COMMERCE 453 units.
DISTRIBUTION Nationwide and Internationally.
PRODUCT Transcranial Doppler Ultrasound System with 2 MHz Transducer:
TCD 100M Digital Transcranial Doppler Ultrasound System & PMD 100 Digital Transcranial
Doppler Ultrasound System (these systems are the same hardware and software -
the change from TCD 100M to PMD 100 is a marketing change). Software version
1.3.0 Model numbers 10119, 10863, 10919, 10968, 11016, 11052, 11090, 11091,
11235, 11236.
CODE Serial numbers 0001-0016, 0018-0035, 0037-0043, 0045-0048,
0050-0060, 0062-0064, 0066-0080, 0082-0157.
RECALLING FIRM/MANUFACTURER Spencer Technologies, Inc., Seattle, WA.
REASON
Potential
for saved blood flow velocity values to not agree with actual velocity values
as shown on the spectrogram axis.
VOLUME OF PRODUCT IN COMMERCE 147.
DISTRIBUTION Nationwide and Internationally.
PRODUCT Bemis Two-Gallon Sharps Container, Models #102 020, #102 030,
and #102 040. (The only difference between the models is in color. Model 102
040 is yellow, Model 102 020 is beige and Model 102 030 is red.).
CODE Lot #20040001 and Lot #20040004.
RECALLING FIRM/MANUFACTURER Bemis Manufacturing Co., Sheboygan Falls, WI.
REASON The closure flap of the recalled sharps containers have two tabs
that fit into slots on the cover for final closure and locking but some of the
covers have one of the tabs that will not fit into the designated slot because
the slot is occluded with plastic.
VOLUME OF PRODUCT IN COMMERCE 1,290 containers (43 cases with 30 sharps
containers per case).
DISTRIBUTION Nationwide and Canada.
PRODUCT
a) Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087", 2.21
mm, Overall Length 54 cm, CS Wide
Tip Shape, CS-W, REF 6705.
b) Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087", 2.21
mm, Overall Length 44 cm, Coronary
Sinus - Multi-Purpose Tip Shape, CS-MP, REF 6716.
c) Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087", 2.21
mm, Overall Length 49 cm, Coronary
Sinus - Multi-Purpose Tip Shape, CS-MP, REF 6717.
d) Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087", 2.21
mm, Overall Length 49 cm, Coronary
Sinus - Multi-Purpose Hook Tip Shape, CS-MPH, REF 6752.
e) Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087", 2.21
mm, Overall Length 49 cm, Coronary
Sinus - Hook Tip Shape, CS-H, REF 6754.
f) Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087", 2.21
mm, Overall Length 49 cm, Coronary
Sinus - Multi-Purpose Long Tip Shape, CS-MPL, REF 6756.
g) Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087", 2.21
mm, Overall Length 49 cm, Coronary
Sinus - Amplatz 6.0 Tip Shape, CS-A6, REF 6758.
h) Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087", 2.21
mm, Overall Length 54 cm, Coronary Sinus - Extended Hook Tip Shape, CS-Extended
H, REF 6778.
i) Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087", 2.21
mm, Overall Length 54 cm, Coronary
Sinus - Multi-Purpose Tip Shape, CS-MP, REF 7300.
j) Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087", 2.21
mm, Overall Length 54 cm, Coronary
Sinus - Multi-Purpose Hook Tip Shape, CS-MPH, REF 7369.
k) Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087", 2.21
mm, Overall Length 54 cm, Coronary
Sinus - Hook Tip Shape, CS-H, REF 7438.
l) Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087", 2.21
mm, Overall Length 54 cm, Coronary
Sinus - Multi-Purpose Long Tip Shape, CS-MPL, REF 7507.
m) Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087", 2.21
mm, Overall Lenght 54 cm, Coronary
Sinus - Amplatz 6.0 Tip Shape, CS-A6, REF 7576.
n) Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087", 2.21
mm, Overall Length 54 cm, Coronary
Sinus - Amplatz 6.0 Tip Shape, CS-A6, REF 7576.
o) Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087", 2.21
mm, Overall Lenght 54 cm, Coronary Sinus - Extended Hook Right Tip Shape, CS-EH
R, REF 7592.
p) Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087", 2.21
mm, Overall Length 54 cm, Coronary Sinus - Extended Hook Right Tip Shape, CS-EH
R, REF 7592.
q) Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087", 2.21
mm, Overall Length 54 cm, Coronary Sinus - Extended Hook Straight Right Tip
Shape, CS-EH ST R, REF 7593.
CODE
a) Lots 4012251, 4012451, 4012851, 4012951, 4020451, 4021951, and 4022551;
b) Lot 4021651;
c) Lots 4011451, 4012451, 4012951, 4020451, 4021151, 4021751, 4021951, 4022351,
and 4022551;
d) Lots 4012451, 4020651, 4021651, and 4021951;
e) Lots 4012051, 4020551, 4020551, 4021151, 4022151, 4022151, and 4022551;
f) Lots 4012851, 4021151, 4021751, 4021951 and 4022351;
g) Lots 4012151, 4012251, 4021951, and 4022151;
h) Lots 4011251, 4012151, 4012451, 4012951, 4020551, 4021051, 4021851, and
4021851;
i) Lots 4011451, 4012151, 4012451, 4020451, 4020651, 4021251, 4021751, 4022351,
and 4022551;
j) Lots 4011251, 4012151, 4012851, 4020551, 4020651, 4022151, and 4022551;
k) Lots 4011251, 4012151, 4012851, 4020551, 4020651, 4021651, 4021851, 4021951,
and 4022551;
l) Lots 4020551, 4021151, 4021251, and 4022551;
m) Lots 4012151, 4012451, 4012451, 4020451, 4020651, 4021851, and 4022151;
n) Lots 4012151, 4012451, 4012451, 4020451, 4020651, 4021851, and 4022151;
o) Lots 4011451 and 4020551;
p) Lots 4011451 and 4020551;
q) Lots 4012051, 4012851, 4021651, 4022151, and 4022351.
RECALLING FIRM/MANUFACTURER Guidant Corp-Cpi Division, Saint Paul, MN.
REASON The terminal hub component in some of the catheters has an
unintended abrupt transition between the entry port and the catheter lumen
which can result in difficulty introducing or removing delivery system
components during lead placement.
VOLUME OF PRODUCT IN COMMERCE 2,090 catheters.
DISTRIBUTION Nationwide.
PRODUCT
a) One-level Ant-Cer Plates (Assembly Level). 1706-1024,1706-1026, 1706-1028,
1706-1030, 1706-1032, and product literature.
b) 1757-1: Compressor/Distractor Instrument (aka Plate Distractor Forceps), and
product literature.
CODE All lots on the market.
RECALLING FIRM/MANUFACTURER Spinal Concepts, Inc., Austin, TX.
REASON Design has insufficient articulating distance between the two
component plates to prevent disassociation in vivo.
VOLUME OF PRODUCT IN COMMERCE 87
DISTRIBUTION Nationwide.
PRODUCT RETi-LOCK Cluster-Hole Acetabular Shells with Sealed
Screw-holes.
CODE Lot numbers: 1548942, 1548943, 1548944, 1548947, 1548948, 1548949,
1548950, 1553246, 1553248, 1553251, 1553252, 1553254, 1553259, 1553261,
1553262, 1553265, 1553266, 1553268, and 1553269.
RECALLING FIRM/MANUFACTURER Centerpulse Orthopedics, Inc., Austin, TX.
REASON Complaints of acetabular shell disassociating with the bone.
VOLUME OF PRODUCT IN COMMERCE 145 units.
DISTRIBUTION CA, DC, MD, LA, ID, and WA.
PRODUCT Magnum II Bariatric Patient Care System.
CODE Serial No. FTxxxxxx (where xxxxxx is a 6-digit number sequence).
RECALLING FIRM/MANUFACTURER Hill-Rom Manufacturing, Inc, Charleston, SC.
REASON
Bed may pose a health hazard due to:
a) Inability to articulate the frame during transport;
b) Exposed sharp edge of footplate;
c) Shear point between seat section and lymph panel and
d) Patient fall.
VOLUME OF PRODUCT IN COMMERCE 1,424 units.
DISTRIBUTION Nationwide and Canada.
PRODUCT CryoValve, Pulmonary Valve and Conduit. Model # PV00. Donor
#69347.
CODE Serial #8022177.
RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA.
REASON CryoLife was notified by the Tennessee Department of Health, that
a recipient had contracted a Group A Streptococcus infection from orthopedic
tissue originating from the same donor as CryoLife donor 69347.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IN.
PRODUCT
a) Bacchus brand Trellis(tm) Plus, Peripheral Infusion System, 6.0 Fr Catalog
Numbers: BAC TRR 006 140 10, BAC TRR 006 140 20.
b) Bacchus brand Trellis(tm) Reserve, Peripheral Infusion System, 6.0 Fr
Catalog Numbers: BAC TRE 06 100 10, BAC TRE 06 100 20, BAC TRE 06 140 10, BAC
TRE 06 140 20.
CODE
a) Lot Numbers: M02-50216, M02-50217, M02-50219, M02-50220, M02-50227, M02-50228,
P02-30014, P02-30013;
b) Lot Numbers: M02-50380, M02-50381, M02-50382, P03-30000, P03-30006,
P03-30007, P03-30010, P03-30011, P03-30012, P03-30014, P03-30019, P03-30030,
P03-30031, P03-30032, P03-30035, P03-30036, P03-30037, P03-30041, P03-30043, P03-30045,
P03-30051, P03-30052, P03-30053, P03-30055, P03-30056, P03-30059, P03-30061,
P03-30062, P03-30063, P03-30067, P03-30069, P03-30071, P03-30072, P03-30073,P03-30076,
P03-30077, P03-30078, P03-30079, P03-30080, P03-30081, P03-30085, P03-30086, P03-30087,
P03-30088, P03-30091, P03-30093, P03-30095, P03-30096, P03-30100, P03-30101,
M03-50338, M03-50339, P03-30107, P03-30108, P03-30113, P03-30114.
RECALLING FIRM/MANUFACTURER Bacchus Vascular, Inc., Santa Clara, CA.
REASON The device has the potential for fractures at the distal end
during use.
VOLUME OF PRODUCT IN COMMERCE 1,260 units.
DISTRIBUTION Nationwide and Internationally.
PRODUCT Medex 3000 Series Syringe Infusion Pumps.
CODE Model numbers: 3010 (General use pump for use with 3cc to 60cc
syringes, 3010a (Pump for use with 1 cc to 60cc syringes), 3010aE (Use with 1cc
to 60cc syringes in UK), 3010aVX (Evaluation pump for use with 1cc to 60cc
syringes), 3010aZE (Refurbished pump for use with 1cc to 60cc syringes), 3010E
(Pump for use with 3-60cc used in the UK), 3010SD (Model 3010 pump used for
demonstrations), 3010VX (Evaluation pump for use with 3-60cc syringes), 3010E,
3500 (Pump with software for rapid occlusion detection and upper and lower
programmable infusion dose limits), 3500BC (Not currently in distribution,
3500E (Pump with software for rapid occlusion detection and upper and lower
programmable infusion dose limits used I the UK), 3500G (Pump with face plates
and software for rapid occlusion detection and upper and lower programmable
infusion dose limits in the German language), 3500SD (Model 3500 pump used for
demonstrations, 3500VX (Evaluation pump with software for rapid occlusion
detection and upper and lower programmable infusion dose limits.
RECALLING FIRM/MANUFACTURER Medex, Inc., Duluth, GA.
REASON Inadequate warning label: It is possible for an Extracorporeal
Membrane Oxygenation (ECMO) circuit to generate high negative pressures on the
inlet side.
VOLUME OF PRODUCT IN COMMERCE 7,896 units.
DISTRIBUTION Nationwide, China, Hong Kong & UK.
PRODUCT
Medtronic
Trillium Affinity NT Integrated-CVR Membrance Oxygenator and Cardiotomy Venous
Reservoir with Trillium Biopassive Surface (on the oxygenator), Model 541T-R.
CODE Lot 0402000017.
RECALLING FIRM/MANUFACTURER Medtronic Perfusion Systems, Brooklyn Park,
MN.
REASON An incorrect date of manufacture and incorrect use-by date were
printed on the labels of the pouches used for the product.
VOLUME OF PRODUCT IN COMMERCE 132 units.
DISTRIBUTION FL, IA, LA, ME, MN, and NY.