MAY 2002

 

WEEK ENDING MAY 4

 

PRODUCT a) Hill-Rom bassinet with dropleaf work surface & chart rack; model 248;

b) Hill-Rom Clinical bassinet with dropleaf work surface & chart rack; model 1251.

CODE All lot numbers for model 248 and model 1251 bassinets.

RECALLING FIRM/MANUFACTURER Hill-Rom, Inc., Batesville, IN

REASON Drop leaf work surface may fall down; won't support infant.

VOLUME OF PRODUCT IN COMMERCE 6,321 bassinets.

DISTRIBUTION Nationwide and Canada, China, England, France, Germany, Honduras, Israel, Japan, Kuwait, Mexico, New Guinea, Panama, Taiwan, Turkey, United Arab Emirates and Uruguay.

 

PRODUCT The products are the femoral head implant from the Foundation Hip System. The products are labeled in part: "FOUNDATION***HIP SYSTEM ZIRCONIA FEMORAL HEAD***encore orthopedics". Each femoral head is packaged individually and labeled sterile.

CODE The Encore lot codes that corresponded to the TH lots from St. Gobain are:

Product Number 410-28-000, lot numbers: 427521, 427531, 461661, 462571, 464081, 468051, 468071, 476471, 476481, 510411, 511241, 515071, 518841, 518851, 527891, 527901, 527901A, 540411, 545001, 590221, 590231, 590241, and 590251

Product Number 410-28-035, lot numbers: 516821, 516831, 518841, 518851, 548771, 593021, 627691, 627701, 644001, and 679601

Product Number 410-28-035S, lot numbers: 548631 and 548121

Product Number 410-28-350, lot numbers: 425891, 461681, 468071, 476481, 510431, 515081, 516841, 545011, 548781, 593031, 627711, and 644011

Product Number 410-28-700, lot numbers: 421021, 421031, 425901, 510291, 514991, 518151, 545021, 593041, 597331, and 627721.

RECALLING FIRM/MANUFACTURER Encore Orthopedics, Inc., Austin, TX

REASON Femoral head component may fail.

VOLUME OF PRODUCT IN COMMERCE 459.

DISTRIBUTION Nationwide.

 

PRODUCT Covrsite Brand Wound Dressing, Part Numbers 59714100, 59714000 and 59714400.

CODE Covrsite (wound dressing):

Product Number Lot Number

59714100 0110055

0210055

0310055

0210080

0310080

0410080

01112805

02112805

59714000 0110080

59714400 0110059

0210059.

RECALLING FIRM/MANUFACTURER Smith & Nephew, Inc., Largo, FL

REASON Product was a wound dressing not adhering correctly.

VOLUME OF PRODUCT IN COMMERCE 215,160 dressings.

DISTRIBUTION Nationwide.

 

PRODUCT Optetrak Finned Cemented Tibial Tray (Total Knee Joint Replacement-tibial tray component). The device is intended

to be implanted during a knee joint replacement surgery.

CODE Catalog Number 200-04-32, Size 3F/2T, Serial Number Range of 0276096 through 0276125.

Catalog Number 200-04-33, Size 3F/3T, Serial Number Range of 0276012 through 0276095.

RECALLING FIRM/MANUFACTURER Exactech, Inc., Gainesville, FL

REASON Device packaging may be mislabeled with the wrong size parts.

VOLUME OF PRODUCT IN COMMERCE 114.

DISTRIBUTION Nationwide and Columbia, Germany, Lebanon, Mexico and Brazil.

 

PRODUCT Raptor Rail PTCA Balloon Dilitation Catheter Catalog Numbers RR115, RR215 and RR315.

CODE All lot numbers for the following product codes:

RR115(1.5mm X 15)

RR215(1.5mm X 20)

RR315(1.5mm X 30).

RECALLING FIRM/MANUFACTURER Cordis Corp., Miami Lakes, FL

REASON Some of these catheters had a slower than desired deflation or no deflation.

VOLUME OF PRODUCT IN COMMERCE 391 units.

DISTRIBUTION Nationwide.

 

PRODUCT Exactech Brand Bipolar Hip Prosthesis, intended for use as an endoprosthesis in hemi-hip arthroplasty procedures.

a) Catalog # BP-2843, 43 mm OD Bipolar, 28mm ID;

b) Catalog # BP-2844, 44 mm OD Bipolar, 28mm ID

CODE a) S/N 0176015 thru 0176020, S/N 0179203 thru 0179218, S/N 0205170 thru 0205174;

b) S/N 0168723 thru 0168735, and S/N 0168822 thru 0168830.

RECALLING FIRM/MANUFACTURER Exactech, Inc., Gainesville, FL

REASON The locking ring on the components is potentially assembled backwards.

VOLUME OF PRODUCT IN COMMERCE 49.

DISTRIBUTION Nationwide.

 

PRODUCT Icelock ratchet UX 721, Model L-721000. Designed for use with ICEROSS silicone upper extremity liners for upper extremity amputees.

CODE Lots 001,012,021.

RECALLING FIRM/MANUFACTURER Recalling Firm: OSSUR North America, Aliso Viejo, CA

Manufacturer: Ossur hf., Iceland.

REASON Pin does not stay engaged in lock mechanism.

VOLUME OF PRODUCT IN COMMERCE 136.

DISTRIBUTION Nationwide.

 

PRODUCT Misys Laboratory Microbiology Module

CODE Versions 5.2, 5.23 and 5.3.

RECALLING FIRM/MANUFACTURER Sunquest Information systems, aka Misys Healthcare, Tucson, AZ.

REASON Software does not allow comments to be shown in some reports.

VOLUME OF PRODUCT IN COMMERCE 735.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Roche Modular Analytics immunoassay based clinical chemistry analyzer, model E170, catalog number 7656961.

CODE All units with software version 01-03.

RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN

Manufacturer: Hitachi Ltd., Kbaraki-ken, Japan.

REASON Possibility of false negative and false positive results being reported.

VOLUME OF PRODUCT IN COMMERCE 76.

DISTRIBUTION Nationwide.

 

PRODUCT Condyle Screw Nut 1 x 05mm.

CODE K728316, K766233, K855148, K847887, K957599.

RECALLING FIRM/MANUFACTURER Recalling Firm: Howmedica Osteonics Corp., Allendale, NJ

Manufacturer: Stryker Trauma GmbH D24232 Schoenkirchen, Germany.

REASON Torque on the condyle nut onto the condyle screw may be high. As a result the required compression of condyle fragments is not possible.

VOLUME OF PRODUCT IN COMMERCE 181.

DISTRIBUTION Nationwide and Canada.

 

PRODUCT Gamma Nail System Common Name: Gamma Locking Nail-Cross Locking Screws.

CODE Catalog Number: 3370-5-030 Lot: K694036

Catalog Number: 3370-5-035 Lot: K694130.

RECALLING FIRM/MANUFACTURER Recalling Firm: Howmedica Osteonics Corp., Rutherford, NJ

Stryker Trauma GmbH D24232 Schoenkirchen, Germany.

REASON Mislabeling of the screw length on the outer package.

VOLUME OF PRODUCT IN COMMERCE 125.

DISTRIBUTION Nationwide.

 

PRODUCT Total Knee Augnentation Block Implants.

CODE All serial numbers with the range of AAAAA-ZZZZZ for the following Part Descriptions and Catalog numbers:

Part Description Catalog Number

5mm Tibial Augmentation 1/3 Block Sz.1 204-41-05

8mm Tibial Augmentation 1/3 Block Sz.1 204-41-08

11mm RL,LM Tibial Augmentation 1/3 Block Sz.1 204-41-88

11mm RM, LL Tibial Augmentation 1/3 Block Sz.1 204-41-89

5mm Tibial Augmentation 1/3 Block Sz.2 204-42-05

8mm Tibial Augmentation 1/3 Block Sz.2 204-42-08

11mm RL, LM Tibial Augmentation 1/3 Block Sz.2 204-42-88

11mm LL, RM Tibial Augmentation 1/3 Block Sz.2 204-42-89

5mm Tibial Augmentation 1/3 Block Sz.3 204-43-05

8mm Tibial Augmentation 1/3 Block Sz.3 204-43-08

11mm RL, LM Tibial Augmentation 1/3 Block Sz.3 204-43-88

11mm LL, RM Tibial Augmentation 1/3 Block Sz.3 204-43-89

5mm Tibial Augmentation 1/3 Block Sz.4 204-44-05

8mm Tibial Augmentation 1/3 Block Sz.4 204-44-08

11mm RL, LM Tibial Augmentation 1/3 Block Sz.4 204-44-88

11mm RM, LL Tibial Augmentation 1/3 Block Sz.4 204-44-89

5mm Tibial Augmentation 1/3 Block Sz.5 204-45-05

8mm Tibial Augmentation 1/3 Block Sz.5 204-45-08

11mm RL, LM Tibial Augmentation 1/3 Block Sz.5 204-45-88

11mm RM, LL Tibial Augmentation 1/3 Block Sz.5 204-45-89

1/2 Tibial Augmentation Block, Sz 0 X 5 mm 204-60-05

1/2 Tibial Augmentation Block, Sz 0 X 8 mm 204-60-08

5mm Tibial Augmentation 1/2 Block Sz.1 204-61-05

8mm Tibial Augmentation 1/2 Block Sz.1 204-61-08

11mm RL, LM Tibial Augmentation 1/2 Block Sz.1 204-61-88

11mm RM, LL Tibial Augmentation 1/2 Block Sz.1 204-61-89

5mm Tibial Augmentation 1/2 Block Sz.2 204-62-05

8mm Tibial Augmentation 1/2 Block Sz.2 204-62-08

11mm RL, LM Tibial Augmentation 1/2 Block Sz.2 204-62-88

11mm RM, LL Tibial Augmentation 1/2 Block Sz.2 204-62-89

5mm Tibial Augmentation 1/2 Block Sz 3 204-63-05

8mm Tibial Augmentation 1/2 Block Sz 3 204-63-08

11mm RL, LM Tibial Augmentation 1/2 Block Sz 3 204-63-88

11mm RM, LL Tibial Augmentation 1/2 Block Sz 3 204-63-89

5mm Tibial Augmentation 1/2 Block Sz 4 204-64-05

8mm Tibial Augmentation 1/2 Block Sz 4 204-64-08

11mm RL, LM Tibial Augmentation 1/2 Block Sz 4 204-64-88

11mm RM, LL Tibial Augmentation 1/2 Block Sz 4 204-64-89

5mm Tibial Augmentation 1/2 Block Sz 5 204-65-05

8mm Tibial Augmentation 1/2 Block Sz 5 204-65-08

11mm RL, LM Tibial Augmentation 1/2 Block Sz 5 204-65-88

11mm RM, LL Tibial Augmentation 1/2 Block Sz 5 204-65-89

Full Wedge Tibial Augmentation, Size 1 X 07 deg 204-81-07

Full Wedge Tibial Augmentation, Size 2 X 07 deg 204-82-07

Full Wedge Tibial Augmentation, Size 3 X 20 204-82-13

Full Wedge Tibial Augmentation, Size 2 X 20 deg 204-82-20

Full Wedge Tibial Augmentation, Size 3 X 07 deg 204-83-07

Full Wedge Tibial Augmentation, Size 3 X 13 deg 204-83-13

Full Wedge Tibial Augmentation, Size 3 X 20 deg 204-83-20

Full Wedge Tibial Augmentation, Size 4 X 07 deg 204-84-07

Distal 5mm Femoral Aug, Sz. 1 208-05-01

Distal 5mm Femoral Aug, Sz. 2 208-05-02

Distal 5mm Femoral Aug, Sz. 3 208-05-03

Distal 5mm Femoral Aug, Sz. 4 208-05-04

Distal 5mm Femoral Aug, Sz. 5 208-05-05

Distal 10mm Femoral Aug. Sz. 1 208-06-01

Distal 10mm Femoral Aug, Sz. 2 208-06-02

Distal 10mm Femoral Aug, Sz. 3 208-06-03

Distal 10mm Femoral Aug, Sz. 4 208-06-04

Distal 10mm Femoral Aug, Sz. 5 208-06-05

Posterior 5mm Femoral Aug, Sz. 1 208-07-01

Posterior 5mm Femoral Aug, Sz. 2 208-07-02

Posterior 5mm Femoral Aug, Sz. 3 208-07-03

Posterior 5mm Femoral Aug, Sz. 4 208-07-04

Posterior 5mm Femoral Aug, Sz. 5 208-07-05

Posterior 10mm Femoral Aug, Sz. 1 208-08-01

Posterior 10mm Femoral Aug, Sz. 2 208-08-02

Posterior 10mm Femoral Aug, Sz. 3 208-08-03

Posterior 10mm Femoral Aug, Sz. 4 208-08-04

Posterior 10mm Femoral Aug, Sz. 5 208-08-05

5mm Tibial Augmentation 1/3 Block Sz.1 204-41-05

8mm Tibial Augmentation 1/3 Block Sz.1 204-41-08

11mm RL,LM Tibial Augmentation 1/3 Block Sz.1 204-41-88

11mm RM, LL Tibial Augmentation 1/3 Block Sz.1 204-41-89

5mm Tibial Augmentation 1/3 Block Sz.2 204-42-05

8mm Tibial Augmentation 1/3 Block Sz.2 204-42-08

11mm RL, LM Tibial Augmentation 1/3 Block Sz.2 204-42-88

11mm LL, RM Tibial Augmentation 1/3 Block Sz.2 204-42-89

5mm Tibial Augmentation 1/3 Block Sz.3 204-43-05

8mm Tibial Augmentation 1/3 Block Sz.3 204-43-08

11mm RL, LM Tibial Augmentation 1/3 Block Sz.3 204-43-88

11mm LL, RM Tibial Augmentation 1/3 Block Sz.3 204-43-89

5mm Tibial Augmentation 1/3 Block Sz.4 204-44-05

8mm Tibial Augmentation 1/3 Block Sz.4 204-44-08

11mm RL, LM Tibial Augmentation 1/3 Block Sz.4 204-44-88

11mm RM, LL Tibial Augmentation 1/3 Block Sz.4 204-44-89

5mm Tibial Augmentation 1/3 Block Sz.5 204-45-05

8mm Tibial Augmentation 1/3 Block Sz.5 204-45-08

11mm RL, LM Tibial Augmentation 1/3 Block Sz.5 204-45-88

11mm RM, LL Tibial Augmentation 1/3 Block Sz.5 204-45-89

1/2 Tibial Augmentation Block, Sz 0 X 5 mm 204-60-05

1/2 Tibial Augmentation Block, Sz 0 X 8 mm 204-60-08

5mm Tibial Augmentation 1/2 Block Sz.1 204-61-05

8mm Tibial Augmentation 1/2 Block Sz.1 204-61-08

11mm RL, LM Tibial Augmentation 1/2 Block Sz.1 204-61-88

11mm RM, LL Tibial Augmentation 1/2 Block Sz.1 204-61-89

5mm Tibial Augmentation 1/2 Block Sz.2 204-62-05

8mm Tibial Augmentation 1/2 Block Sz.2 204-62-08

11mm RL, LM Tibial Augmentation 1/2 Block Sz.2 204-62-88

11mm RM, LL Tibial Augmentation 1/2 Block Sz.2 204-62-89

5mm Tibial Augmentation 1/2 Block Sz 3 204-63-05

8mm Tibial Augmentation 1/2 Block Sz 3 204-63-08

11mm RL, LM Tibial Augmentation 1/2 Block Sz 3 204-63-88

11mm RM, LL Tibial Augmentation 1/2 Block Sz 3 204-63-89

5mm Tibial Augmentation 1/2 Block Sz 4 204-64-05

8mm Tibial Augmentation 1/2 Block Sz 4 204-64-08

11mm RL, LM Tibial Augmentation 1/2 Block Sz 4 204-64-88

11mm RM, LL Tibial Augmentation 1/2 Block Sz 4 204-64-89

5mm Tibial Augmentation 1/2 Block Sz 5 204-65-05

8mm Tibial Augmentation 1/2 Block Sz 5 204-65-08

11mm RL, LM Tibial Augmentation 1/2 Block Sz 5 204-65-88

11mm RM, LL Tibial Augmentation 1/2 Block Sz 5 204-65-89

Full Wedge Tibial Augmentation, Size 1 X 07 deg 204-81-07

Full Wedge Tibial Augmentation, Size 2 X 07 deg 204-82-07

Full Wedge Tibial Augmentation, Size 3 X 20 204-82-13

Full Wedge Tibial Augmentation, Size 2 X 20 deg 204-82-20

Full Wedge Tibial Augmentation, Size 3 X 07 deg 204-83-07

Full Wedge Tibial Augmentation, Size 3 X 13 deg 204-83-13

Full Wedge Tibial Augmentation, Size 3 X 20 deg 204-83-20

Full Wedge Tibial Augmentation, Size 4 X 07 deg 204-84-07

Distal 5mm Femoral Aug, Sz. 1 208-05-01

Distal 5mm Femoral Aug, Sz. 2 208-05-02

Distal 5mm Femoral Aug, Sz. 3 208-05-03

Distal 5mm Femoral Aug, Sz. 4 208-05-04

Distal 5mm Femoral Aug, Sz. 5 208-05-05

Distal 10mm Femoral Aug. Sz. 1 208-06-01

Distal 10mm Femoral Aug, Sz. 2 208-06-02

Distal 10mm Femoral Aug, Sz. 3 208-06-03

Distal 10mm Femoral Aug, Sz. 4 208-06-04

Distal 10mm Femoral Aug, Sz. 5 208-06-05

Posterior 5mm Femoral Aug, Sz. 1 208-07-01

Posterior 5mm Femoral Aug, Sz. 2 208-07-02

Posterior 5mm Femoral Aug, Sz. 3 208-07-03

Posterior 5mm Femoral Aug, Sz. 4 208-07-04

Posterior 5mm Femoral Aug, Sz. 5 208-07-05

Posterior 10mm Femoral Aug, Sz. 1 208-08-01

Posterior 10mm Femoral Aug, Sz. 2 208-08-02

Posterior 10mm Femoral Aug, Sz. 3 208-08-03

Posterior 10mm Femoral Aug, Sz. 4 208-08-04

Posterior 10mm Femoral Aug, Sz. 5 208-08-05.

RECALLING FIRM/MANUFACTURER Exactech, Inc., Gainesville, FL

REASON Compromise of sterility barrier packaging.

VOLUME OF PRODUCT IN COMMERCE 1723.

DISTRIBUTION Nationwide.

 

PRODUCT Laser Guard Endotracheal Tube Protector

CODE Catalog 400446, lot number 22853900.

RECALLING FIRM/MANUFACTURER Medtronic Xomed Jacksonville, FL

REASON The Endotracheal Tube Silver Foil wrap may develop breaks when manipulated. Potential for overheating or fire.

VOLUME OF PRODUCT IN COMMERCE 20.

DISTRIBUTION AK, CO and LA and Italy.

 

PRODUCT Cida-Steryl 28 II 3% Glutaraldehyde

CODE Lots L062701, L063001, L052111, L052211 and L042311.

RECALLING FIRM/MANUFACTURER Ecolab Inc., Huntington, IN

REASON May not effectively sterilize devices.

VOLUME OF PRODUCT IN COMMERCE Approx 700 cases of 4 quarts or 4 gallons each.

DISTRIBUTION Nationwide.

 

PRODUCT BX Velocity Balloon Expandable Stent, (common name is Coronary Stent and Delivery System, 8mm X 2.75, Sterile

CODE Catalog Number VW08275, lot number 40401536.

RECALLING FIRM/MANUFACTURER Cordis Corp., Miami Lakes, FL

REASON Stents could migrate from their original crimped position on the the delivery system.

VOLUME OF PRODUCT IN COMMERCE 91.

DISTRIBUTION Nationwide.

 

PRODUCT BioZ.com Hemodynamic Monitor Impedance Plethysmograph.

CODE All codes.

RECALLING FIRM/MANUFACTURER Cardiodynamics International Corp., San Diego, CA

REASON Improper responses with pacemaker patients.

VOLUME OF PRODUCT IN COMMERCE 27.

DISTRIBUTION Nationwide.

 

PRODUCT a) Video Bronchoscope, Model EB-1530T3, Device Listing #A845585. Classification: EOQ, Bronchoscope, CFR 874.4680.

b) Video Gastroscope, Model #EG-1540, Device Listing #A845591. Classification: FDS, Gastroscope, CFR 876.1500.

c) Video Esophagoscope, Model #EE-1540, Device Listing #A845597. Classification: GCL, Esophagoscope, CFR 876.1500.

CODE a) (333 units): Serial Numbers: A01001, A01005, A01011, A01014, A01015, A01017, A01018, A01022, A01024, A01037, A01038, A01039,

A01040, A01043, A01047, A01048, A01049, A01050, A01051, A01053, A01054, A01055, A01056, A01057, A01058, A01059, A01061, A01063, A01069, A01070, A01071, A01072, A01073, A01074, A01075, A01076, A01077, A01078, A01079, A01080, A01081, A01084, A01087, A01099, A01102, A01103, A01104, A01109, A01111, A01112, A01115, A01116, A01117, A01121, A01122, A01123, A01124, A01125, A01126, A01128,

A01129, A01130, A01131, A01135, A01137, A01139, A01140, A01142, A01143, A01144, A01145, A01147, A01148, A01149, A01151, A01152, A01153, A01155, A01157, A01158, A01159, A01162, A01166, A01167, A01169, A01170, A01171, A01172, A01173, A01175, A01176, A01178, A01179, A01180, A01181, A01183, A01188, A01192, A01197, A01202, A01207, A01208, A01209, A01210, A01213, A01215, A01220, A01222,

A01225, A01227, A01228, A01230, A01231, A01232, A01242, E01243, E01244, E01245, E01246, E01247, E01248, E01251, E01253, E01254, E01255, E01259, E01260, E01261, E01262, E01263, E01264, E01265, E01268, E01270, E01271, E01273, E01275, E01279, E01280, E01282, E01283, E01285, E01286, E01288, E01296, E01298, E01305, E01306, E01308, E01309, E01312, E01314, E01315, E01316, E01318, E01321, E01322, E01323, E01327, E01329, E01332, E01334, E01335, E01336, E01337, E01338, E01339, E01340, E01341, E01343, E01344, E110465, E110466, E110467, E110468, E110469, E110470, E110471, E110472, E110473, E110474, E110476, E110477, E110478, E110481, E110482, E110483, E110484, E110485, E110490, E110491, E110492, E110493, E110494, E110496, E110500, E110501, E110502, E110503, E110504, E110505, E110506, E110508, E110510, E110512, E110519, E110520, E110521, E110522, E110523, E110524, E110525, E110528, E110534, E110535, E110539, E110540, E110541, E110544, E110545, E110546, E110548, E110549, E110552, E110553, E110557, E110559, E110560, E110561, E110565, E110566, E110567, E110568, E110569, E110571, E110572, E110573, E110574, E110575, E110576, E110577, E110578, E110579, E110580, E110581, E110582, E110590, E110591, E110592, E110593, E110594, E110595, E110596, E110597, E110599, E110600, E110603, E110604, E110606, E110608, E110609, E110610, E110611, E110613, E110617, E110619, E110620, E110626, E110633, E11346, E11347, E11348, E11349, E11350, E11352, E11353, E11354, E11356, E11357, E11361, E11364, E11374, E11380, E11382, E11383, E11387, E11388, E11389, E11390, E11391, E11392, E11394, E11396, E11397, E11398, E11399, E11401, E11403, E11404, E11405, E11406, E11407, E11408, E11409, E11410, E11411, E11412, E11413, E11429, E11430, E11431, E11432, E11433, E11434, E11435, E11439, E11442, E11443, E11448, E11450, E11451, E11452, E11453, E11454, E11456, E11457, E11458, E11459, E11460, E11461, E11462, E11463, E11464.

b) (24 units): Serial Numbers: A01003, E010013, E010014, E010015, E010016, E010017, E010019, E010020, E010022, E010026, E010027, E010029,

E010031, E010034, E010037, E010038, E010039, E010041, E010042, E010047, E010048, E010049, E010051, E010056.

c) (24 units): Serial Numbers: A01001, A01006, E010011, E010012, E010014, E010015, E010016, E010019, E010020, E010021, E010022, E010023,

E010027, E010028, E010029, E010030, E010031, E010033, E010034, E010037, E010038, E010039, E010040, E010041.

RECALLING FIRM/MANUFACTURER Recalling Firm: Pentax Precision Instrument Corp., Orangeburg, NY

REASON Lubricant leaking from bronchoscope caused by puncture at the point where the instrument channel is secured to the distal end.

VOLUME OF PRODUCT IN COMMERCE a) 333 units; b) 24 units; c) 24 units.

DISTRIBUTION Nationwide and Canada, Chile, Brazil and Guam.

 

PRODUCT

a) Hill-Rom brand TranStar Electric Stretcher;

b) Hill-Rom brand TranStar OB/GYN Stretcher;

c) Hill-Rom brand TranStar Procedural Stretcher;

d) Hill-Rom brand TranStar Surgical Stretcher;

e) Hill-Rom brand TranStar Trauma Stretcher;

f) Hill-Rom brand Durastar Hydraulic Stretcher.

CODE All units distributed prior to March 1, 2002.

RECALLING FIRM/MANUFACTURER Hill-Rom, Inc., Batesville, IN

REASON May leak hydraulic fluid.

VOLUME OF PRODUCT IN COMMERCE 38,770 units.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Hill-Rom Exam Plus lights, catalog numbers P965-00 and P965-01.

CODE All units

RECALLING FIRM/MANUFACTURER Hill-Rom Co. Inc., Batesville, IN

REASON Incorrectly labeled for use during surgical procedures.

VOLUME OF PRODUCT IN COMMERCE 9451 units.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Double Port Flow Adapter, STERIS Part Number 200388.

1) Sold as a component of STERIS Quick Connect Kit #C1460; 2) Also sold individually as a replacement component.

CODE Part Number 200388.

RECALLING FIRM/MANUFACTURER Steris Corp., Mentor, OH

REASON Adapter ports may be obstructed with glue, and affect the sterilization process.

VOLUME OF PRODUCT IN COMMERCE 83.

DISTRIBUTION Nationwide and Canada, New Zealand, Great Britain and Italy.

 

PRODUCT Omni-Diagnost X-Ray System, fluoroscopic x-ray system: multifunctional, universal, overtable x-ray system offering

fluroscopic, radiographic, angiographic and interventional techniques in a wide variety of applications.

CODE p/n 9896 000 59551 shipped before 11/01.

RECALLING FIRM/MANUFACTURER Recalling Firm: Philips Medical Systems North America, Inc., Bothell, WA

REASON The scan carriage may collide with the patient's knees.

VOLUME OF PRODUCT IN COMMERCE 25.

DISTRIBUTION Nationwide.

 

PRODUCT All DataCare Systems Software, as follows:

a) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog GD9200;

b) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog GD9201;

c) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog BP9251;

d) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog BP9252;

e) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment

Catalog GD9200;

f) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment;

Catalog GD9201;

g) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment;

Catalog GD9206;

h) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment;

Catalog GD9207;

i) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment;

Catalog GD9208;

j) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment;

Catalog BP9251;

k) DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment;

Catalog BP9252;

l) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9202;

m) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9209;

n) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9010;

o) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9211;

p) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9212

q) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog BP9215;

r) DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog BP9216.

CODE All units.

RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN

REASON Potential patient/sample mismatch.

VOLUME OF PRODUCT IN COMMERCE Approx. 512 installations.

DISTRIBUTION Nationwide, the United Kingdom and Canada.

 

PRODUCT CryoValve Allograft

CODE Serial No. 6083099, Model No. PV00.

RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA

REASON Serodilution of plasma.

VOLUME OF PRODUCT IN COMMERCE One.

DISTRIBUTION OK.

 

PRODUCT Steel Oxygen Wrench. The device is a Class I steel oxygen wrench. a) Catalog number 169 has a security wire attached to the wrench. b) Catalog number 169W does not have the wire.

CODE a) Lot number P0110502; b) Lot numbers P1101701 and P0100602.

RECALLING FIRM/MANUFACTURER Recalling Firm: Instrumentation Industries, Inc., Bethel Park, PA

Manufacturer: MK Manufacturing Forestville, CT.

REASON Slots may not be big enough to fit on E tanks.

VOLUME OF PRODUCT IN COMMERCE 265.

DISTRIBUTION CA, LA, MT, NC, NM, PA, WI and Canada

 

PRODUCT CryoValve Allograft - Heart Valve

CODE Serial No. 3887073, Model Number PV00.

RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA

REASON Serodilution of Plasma.

VOLUME OF PRODUCT IN COMMERCE One.

DISTRIBUTION OH.

 

PRODUCT Brand Name: Walgreens Sterile Insulin syringes, single use, disposable, 0.3cc and 1.0cc 29 Gauge.

CODE Description: Corrugated case: 3/10cc 29G Walgreens brand syringes Catalog No. 677257 Lot Code: 7688

Description: Boxes, identified 1cc 29G Walgreens brand syringes Catalog No: 677259 Lot Code: 7688.

RECALLING FIRM/MANUFACTURER Recalling Firm: Becton Dickinson & Co. Franklin Lakes, NJ

Manufacturer: Boin Medica Co., Inc, Kumi City, Kyungbuk, Korea.

REASON Mispackaged syringes; 3/30cc syringes into 1.0cc syringe boxes.

VOLUME OF PRODUCT IN COMMERCE 2,460 boxes.

DISTRIBUTION PA, FL, WI, IL and TX.

 

PRODUCT Gyroscan NT System, MRI.

CODE p/n: 9896 030 0660, 9896 030 0645, 9896 030 0527, 9896 030 0511, 9896 030 0461.

RECALLING FIRM/MANUFACTURER Recalling Firm: Philips Medical Systems North America Company, Bothell, WA

Manufacturer: Philips Medical Systems Nederland, B.V. Netherlands.

REASON Potential for misdiagnosis. When two images were subtracted, one with contrast and the other without contrast, irregular vessels could be the result on the final image.

VOLUME OF PRODUCT IN COMMERCE 220.

DISTRIBUTION Nationwide.

 

PRODUCT Integris H5000, Angiographic X-ray system

CODE Units with SYSCO software version 11.1.2.

RECALLING FIRM/MANUFACTURER Recalling Firm: Philips Medical Systems North America, Inc., Bothell, WA

Manufacturer: Philips Medical Systems Nederland, b.v 5680 Da Best, Netherlands.

REASON System may occasionally re-boot during a patient examination.

VOLUME OF PRODUCT IN COMMERCE 171.

DISTRIBUTION Nationwide.

 

PRODUCT LightCycler v1.0; catalog # 2011468; LightCycler v1.1; catalog # 2043912. The device is a medium-sized polymerase chain reaction analyzer for use in industrial, laboratory and domestic setting.

CODE All units.

RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN

Manufacturer: Roche Diagnostics Corp., Mannheim, Germany.

REASON Glass capillary breakage.

VOLUME OF PRODUCT IN COMMERCE 190.

DISTRIBUTION Nationwide.

 

PRODUCT Hydroview brand Intraocular Lens, Posterior chamber lenses, various diopters.

CODE Model Number H60M, Lot Numbers 5YXP and 6R4B.

RECALLING FIRM/MANUFACTURER Bausch & Lomb Surgical, Inc., Clearwater, FL

REASON Lenses were labeled with incorrect dioptic powers.

VOLUME OF PRODUCT IN COMMERCE 17.

DISTRIBUTION Japan, France and Great Britain.

 

PRODUCT MacroPore NS CraniLoc Burr Hole Clamp. This is a part of the CraniLoc Cranial Flap Fixation System. Catalog Number: 6692599.

CODE Lots 51715, 51716, 51717, and 51782.

RECALLING FIRM/MANUFACTURER Macropore, Inc., San Diego, CA

REASON Loosening and breakage.

VOLUME OF PRODUCT IN COMMERCE 1400.

DISTRIBUTION Nationwide and the Netherlands.

 

PRODUCT GYROSCAN NT SYSTEM, MRI - Magnetic Resonance Systems.

CODE p/n 9896 030 00901, 9896 030 00902, 9896 030 00911, 9896 030 00912.

RECALLING FIRM/MANUFACTURER Recalling Firm: Philips Medical Systems North America Company, Bothell, WA

Manufacturer: Phillips Medical Systems Nederland, B.V. 5680 DA BEST, Netherlands.

REASON Potential for tabletop (bed) to slide.

VOLUME OF PRODUCT IN COMMERCE 17.

DISTRIBUTION Nationwide.

 

PRODUCT a) Polarus Humeral Rod, part #HRH-0824-S, 8mm x 240mm.

b) Polarus Humeral Rod, part #HRH-0826-S, 8mm x 260mm.

These implants belong to the Polarus Humeral Rod System product line which is a system of rods and screws for the fixation of

humeral fractures and their accompanying instrumentation.

CODE a) lot W04193; b) lot W04194.

RECALLING FIRM/MANUFACTURER Acumed, Inc., Hillsboro, OR

REASON Mislabeled - 240mm Polarus rod labeled as 260mm Polarus rod & vice versa.

VOLUME OF PRODUCT IN COMMERCE Two units of each size.

DISTRIBUTION Puerto Rico.

 

PRODUCT Precision UV (ultraviolet blocking) daily or extended wear soft (hydrophilic) contact lens.

CODE Lot Number 31648106, exp. date 2005/09; Lot Number 31682132, exp. date 2005/10.

RECALLING FIRM/MANUFACTURER Recalling Firm: Ciba Vision Corp., Duluth, GA

Manufacturer: Ciba Vision Batam Pulau Batam, Indonesia.

REASON Product was distributed without the proper labeling.

VOLUME OF PRODUCT IN COMMERCE 82 three-packs.

DISTRIBUTION Nationwide and Puerto Rico.

 

WEEK ENDING MAY 11

 

PRODUCT GIBCO *** AIM-V Medium, for ex vivo activation of lymphocytes

-with L-glutamine

-with streptomycin @50 mcg/mL

-with gentamicin sulfate, USP @ 10 mcg/mL

-without penicillin G sodium.

Label states: "Check for product appearance before use. The performance characteristics of this product have not been officially established. It has not been approved to date for any human or animal in vivo applications except for certain investigational studies. ***"

Sold in 1000 ml bottles and in 10L bags

CODE

1097192, exp. 3/30/03

1097193, exp. 2/28/03

1101041, exp. 4/30/03

1102964, exp. 5/30/03

1107910, exp. 6/30/03

1112578, exp. 8/30/03

1115447, exp. 9/30/03

1119526, exp. 11/30/03.

RECALLING FIRM/MANUFACTURER Invitrogen Corp., Grand Island, NY

REASON Media fill failures.

VOLUME OF PRODUCT IN COMMERCE 4,149 units.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Sterile Ethicon Gut Sutures.

Brand Label: Chromic Surgical Gut Suture; Plain Surgical Gut Suture; Plain Fast Absorbing Suture

CODE

Product Code Lot Number

Number

G12H RAM158

G122H RAM185, RAM186

G123H QPM297, RAM248

G127H RAM057

G152H QPM141

G172H QPM049, QPM142

U207H RAM154

U246H RAM063

634G RAM008

635H RAM051, RAM097

636G QPM187, RAM053

636H RAM079

687G RAM049

752G QPM107

770G QPM108, RAM027, RAM047

796G RAM182

802H QPM170

810H RAM017

H810H RAM014

811H RAM003, RAM024, RAM086

813H RAM144

H820G RAM007

H821G QPM186, RAM034

H822H RAM037

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