AUGUST 2000

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 20ƒ 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 20ƒ 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

H823H RAM015

843H RAM061

853H RAM021

N863H RAM016, RAM250

913H QPM169, RAM040

914H QPM060

923H QPM138, RAM002, RAM023

924H RAM080, RAM216

1627G QPM112, QPM154, QPM179

1627H QPM111, RAM073

1635G QPM116

1636G RAM150

1637G RAM093, RAM156

1638G QPM151, RAM030, RAM069

1638H RAM031

1640H RAM028

1642G QPM306

1643G QPM307

1653G QPM134

1654G RAM011, RAM029

1824H RAM219

1828H QPM308, RAM089

1915G QPM135, QPM216, QPM298, RAM025, RAM067

1916G QPM148.

RECALLING FIRM/MANUFACTURER Recalling Firm: Ethicon, Inc., Somerville, NJ

Manufacturer: Ethicon, Inc., Juarez, Mexico.

REASON Secondary packaging has overwrap seal anomaly.

VOLUME OF PRODUCT IN COMMERCE 15,409 dozen.

DISTRIBUTION Nationwide.

PRODUCT a) AxSYM Digoxin II; b) TDx/TDxFLx Digoxin II; c) IMx Digoxin.

CODE a) List no. 5B73-20; b) List no. 2213-20; c) List no. 9511-60.

RECALLING FIRM/MANUFACTURER Recalling Firm: Abbott Health PRODUCTs, Inc., Barceloneta, Puerto Rico,

Manufacturer: Abbot Health PRODUCTs, Inc., Diagnostic Plant Barceloneta, Puerto Rico.

REASON Assay may exhibit negative interference from aldosterone inhibitors.

VOLUME OF PRODUCT IN COMMERCE N/A because Device correction is independent of lot numbers.

DISTRIBUTION Not applicable (N/A) becuase the Device Correction is independent of lot numbers.

PRODUCT Medex Three-Way Anesthesia Style Stopcock with 20 inch, 33 inch, and 40 inch Extensions with Male Luer Locks and Male Luer Slips.

CODE

Catalog # Lot #

MX252L 31F070145

MX252L 31G170028

MX252L 31H090118

MX252L 31H090134

MX252L 31I210027

MX252S 31F070155

MX252S 31G170033

MX252S 31H090129

MX252S 31H290116

MX252S 31I210034

MX253L 31F070149

MX253L 31F270128

MX253L 31H090116

MX253L 31H090127

MX253L 31H270040

MX253L 31H290099

MX253L 31I210026

MX253L 31I210030

MX253L 31J110109

MX253S 31F070153

MX253S 31G170035

MX253S 31H090120

MX253S 31H270058

MX253S 31H290124

MX253S 31I210023

MX254 31F070150

MX254 31H090115

MX254 31H290134

The recalled units do not have expiration dates.

RECALLING FIRM/MANUFACTURER Medex, Inc., Dublin, OH

REASON The tubing may separate from the stopcock during patient use.

VOLUME OF PRODUCT IN COMMERCE 6,880 cases (344,008 units).

DISTRIBUTION Nationwide, Canada and New Zealand.

PRODUCT Sigma 8000 Volumetric Infusion Pumps with software version 3.50.01.

CODE The following serial numbers. 49105, 49111R, 49188R, 49288R, 49289R, 49402R, 49436R, 49448R, 49454R, 49466R, 49507R, 49525R, 49527R, 49532R, 49536R, 50927R, 50931R, 50935R, 50973R, 51288R, 51496R, 51533R, 51658R, 51663R, 51666R, 51674R, 51679R, 51684R, 51690R, 51691R, 51692R, 51694R, 51700R, 51705R, 51751R, 51753R, 51754R, 51758R, 51761R, 51763R, 51766R, 51768R, 51769R, 51781R, 51783R, 51892R, 51893R, 51895R, 51896R, 51899R, 51901R, 51903R, 51910R, 51912R, 51913R, 51916R, 51917R, 51918R, 51919R, 51921R, 51922R, 51925R, 51926R, 51931R, 51932R, 51934R, 51935R, 51939R, 51940R, 51941R, 51944R, 51945R, 51949R, 51950R, 51951R, 51957R, 51958R, 51961R, 51962R, 51963R,

51966R, 51967R, 51969R, 51970R, 51974R, 51975R, 51979R, 51980R, 51981R, 51982R, 51983R, 51984R, 51985R, 51988R, 51989R, 51991R, 51993R, 51996R, 51999R, 52001R, 52003R, 52005R, 52007R, 52011R, 52018R, 52020R, 52021R, 52026R, 52030R, 52032R, 52033R, 52040R, 52041R, 52044R, 52049R, 52050R, 52054R, 52055R, 52057R, 52058R, 52062R, 52065R, 52067R, 52069R, 52072R, 52073R, 52075R, 52077R, 52078R, 52081R, 52084R, 52085R, 52089R, 52090R, 52091R, 52093R, 52094R, 52095R, 52098R, 52100R, 52106R, 52108R, 52117R, 52125R, 52127R, 52133R, 52263, 52343R, 52413R, 52620, 52744R, 52771R, 53016, 53047, 53052, 53131, 53146, 53154, 53626, 53813, 53862, 54147, 54458, 54471, 54476, 54570, 54574, 54639, 54643, 54757, 54910, 54929, 55063, 55110, 55115, 55202, 55232, 55267, 55274, 55332R, 55398R, 55414, 55433, 55658, 55738, 55757, 55764, 55786, 55815, 55832, 55835, 56205, 56323, 56442, 56479, 56506, 56511, 56540, 56578, 56722, 56785, 56838, 56872, 56924R, 56927R, 56928R, 56940R, 56968, 57199, 57365, 57800, 58070, 58399, 58447, 58686, 58707, 58745, 59541, 59669, 59774, 59758, 60120, 60296, 60342,

60343, 60344, 60347, 60348, 60350, 60354, 60357, 60366, 60367, 60368, 60421, 60422, 60427, 60429, 60431, 60433, 60435, 60437, 60439, 60442, 60559, 61024, 61395, 61469, 61626, 62026, 62035, 62041, 62042, 62045, 62053, 62054, 62056, 62057, 62058, 62195, 62252, 62259; and 62279 THRU 62418; and 62420, 62421, 62425, 62428, 62429, 62433, 62434, 62435, 62436, 62437, 62440, 62443, 62448, 62449, 62450, 62452, 62453, 62454, 62456, 62457, 62465, 62468, 62469, 62470, 62481, 62485, 62486, 62488, 62492, 62506, 62516, 62519, 62522, 62525, 62528, 62529, 62532, 62533, 62538, 62540, 62542, 62543, 62544, 62545, 62546.

RECALLING FIRM/MANUFACTURER Sigma International Medina, NY

REASON Software error: Distal occlusions may not be detected (no alarm) at rates above 550 ml/hr.

VOLUME OF PRODUCT IN COMMERCE 447 infusion pumps and 604 chips v. 3.50.01.

DISTRIBUTION Nationwide and Canada.

PRODUCT AeroVent II Collapsible Holding Chamber (CHC) - for use in the administration of metered dose inhaler medications into a ventilator breathing circuit.

CODE The following Part Numbers/Lot Numbers represent all PRODUCT ever shipped.

Part Number: 85750

lot numbers: 2127-01; 127-02; 2142-01; 2142-02; 2142-03; 2179-01; 2179-02; 2225-01

Part Number: 85750A

lot numbers: 2147-01; 2147-02

Part Number: 58750

lot numbers: 2145-01; 2160-01; 2188-01.

RECALLING FIRM/MANUFACTURER Monaghan Medical Corp., Plattsburgh, NY

REASON Collapsable Holding Chamber inadvertently opening.

VOLUME OF PRODUCT IN COMMERCE 957 cases/50 per case.

DISTRIBUTION Nationwide.

PRODUCT Prolactin Calibrators, Prolactin Controls, AxSYM and IMx Prolactin Reagents.

CODE Prolactin Calibrators List 9C07-1

Lot No. Exp. Date

75255Q100 1/12/02

78013Q100 2/19/02

79026Q100 4/9/02

80697Q100 5/28/02

Prolactin Controls List 9C07-10

Lot No. Exp. Date

77575Q100 3/19/02

78753Q100 4/25/02

80284Q100 4/24/02

81124Q100 5/16/02

AxSYM Prolactin Master Calibrators List 7A62-32

Lot No. Exp. Date

75256Q100 1/12/02

78020Q100 2/21/02

79027Q100 4/9/02

80584Q100 5/26/02

83668Q100 7/12/02

IMx Prolactin List No. 2244-22

Lot No. Exp. Date

78752Q100 5/7/02

80548Q100 9/27/02

84329Q100 11/02/02.

RECALLING FIRM/MANUFACTURER Recalling Firm: Abbott Health PRODUCTs, Inc., Barceloneta, Puerto Rico

Manufacturer: Abbott Health PRODUCT, Inc., Diagnostic Plant Barceloneta, Puerto Rico.

REASON The concentration of Prolactin may have decreased by approx. 20%.

VOLUME OF PRODUCT IN COMMERCE 14,055 units.

DISTRIBUTION Nationwide.

PRODUCT Inrad brand 2 part CHIBA type needle with accumark sheath, 15 cm., sterile.

CODE Catalog # 45018. Lot 6990-9004.

RECALLING FIRM/MANUFACTURER Inrad, Inc., Kentwood, MI

REASON 20 cm needle labeled as 15 cm needle.

VOLUME OF PRODUCT IN COMMERCE 100.

DISTRIBUTION NM.

WEEK ENDING MAY 18

PRODUCT AeroVent II Collapsible Holding Chamber (CHC) - for use in the administration of metered dose inhaler medications into a

ventilator breathing circuit.

CODE The following Part Numbers/Lot Numbers represent all products ever shipped.

Part Number 85750:

Lot numbers:

2127-01

2127-02

2142-01

2142-02

2142-03

2179-01

2179-02

2225-01

Part #85750A;

Lot numbers:

2147-01

2147-02

Part Number 58750;

Lot numbers:

2145-01

2160-01

2188-01.

RECALLING FIRM/MANUFACTURER Monaghan Medical Corp., Plattsburgh, NY

REASON Collapsable Holding Chamber inadvertently opening.

VOLUME OF PRODUCT IN COMMERCE 957 cases/50 per case.

DISTRIBUTION Nationwide.

PRODUCT Amira AtLast brand Blood Glucose Test System.

CODE All units/lots.

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

Manufacturer: Amira Medical, Scotts Valley, CA.

REASON Alternate site results not reliable when patient blood glucose level is low.

VOLUME OF PRODUCT IN COMMERCE 250,000 meters.

DISTRIBUTION Nationwide and Japan.

PRODUCT Baxter Interlink Solution Sets and Baxter Interlink Secondary Medication Sets which contain the BD Interlink Lever Lock Cannula; these sterile fluid paths are used for the administration of fluids from a container to a patient's vascular system through a needle or catheter

inserted into a vein. 48 units per case.

CODE a) Product code 1C8476, lot GR169524; b) Product code 1C8591, lots GR169987, GR169979, GR169961; c) Product code 2C6401, lot range SI366112R through SI376533R; d) Product code 2C6402, lot range SI366484R through SI377192R; e) Product code 2H6490, R01K28305, R01K28313, R01K28321; f) Product code 2C7451, lot ranges R215186 through R221010, R01H17212 through R01K30087, and SI365791R through SI376699R; g) Product code 2C7452, lot ranges R215087 through R222604 and R01H14284 through R01K30111; h) Product code 2H7451, lot ranges R217364 through R223099 and R01H22170 through R01K12176.

RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Healthcare Corp., Round Lake, IL

Manufacturer: Baxter Healthcare Corp., Cleveland, MS.

REASON Fluid leaks associated with BD Lever Lock cannulas.

VOLUME OF PRODUCT IN COMMERCE 14,295,103 sets.

DISTRIBUTION Nationwide and Internationally.

PRODUCT Somatom Esprit, Esprit+, Balance, Emotion, Emotion Due, Volume Zoom, and Volume Access.

CODE Siemens part:

Somatom: Computed Tomography System, Diagnostic Imaging

Esprit: 3810079

Esprit+: 3810137

Balance: 3810152

Emotion: 3812160

Emotion Duo: 3812950

Volume Zoom: 4806118

Volume Access: 7114023.

All serial numbers under these models.

RECALLING FIRM/MANUFACTURER Recalling Firm: Siemens Medical Systems, Inc., Iselin, NJ

Manufacturer: Siemens Medical Solutions, Erlangan,Germany.

REASON Errors occurring while using graphics tools.

VOLUME OF PRODUCT IN COMMERCE 400.

DISTRIBUTION Nationwide.

PRODUCT Steri-Oss Replace Select TiUnite Implant.

CODE Catalog Number 62004; Lot number 338849.

RECALLING FIRM/MANUFACTURER Nobel Biocare USA, Inc., Yorba Linda, CA

REASON Labeling mix-up.

VOLUME OF PRODUCT IN COMMERCE 124.

DISTRIBUTION Nationwide.

PRODUCT Pressure Regulator Assembly (Cat. No. 85). This is a component part used in Infant and Child models of the Laerdal

Silicone Resuscitator (LSR). It is also distributed in replacement patient valve assemblies, and as individual spare parts.

CODE Identification of the recalled part: Molded-in number "4" on the top of the Regulator Cap identifies the affected parts. (Caps with numbers "2", "3", and "5" are NOT affected.)

RECALLING FIRM/MANUFACTURER Recalling Firm: Laerdal Medical Corp., Wappingers Falls, NY

Manufacturer: Laerdal Medical, Stavanger, Norway.

REASON Molding irregularity in Pressure Regulator Cap which could impede free movement of valve stem.

VOLUME OF PRODUCT IN COMMERCE 2,250 (approximately 25% of these are mold #4).

DISTRIBUTION Nationwide and Canada.

PRODUCT Hill-Rom brand Resident low bed, model 872.

CODE All beds distributed prior to May 4, 2001.

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

REASON Pinched cables may cause arcing/shock hazard.

VOLUME OF PRODUCT IN COMMERCE 3031 beds.

DISTRIBUTION Nationwide and Canada.

PRODUCT a) Model No. 105-5060 1.5 French FlowRider Micro Catheter

b ) Modelel No. 105-5063 1.8 French FlowRider Micro Catheter.

c) Model No. 105-5067 1.5 French FlowRider Plus Micro Catheter.

d) Model No. 105-5068 1.8 French FlowRider Plus Micro Catheter.

The difference between a FlowRider and FlowRider Plus is the presence of a silicone lubricant in the lumen of the FlowRider

which is absent in the Plus.

CODE All lots all codes.

RECALLING FIRM/MANUFACTURER Micro Therapeutics, Inc., Irvine, CA

REASON Catheter rupture.

VOLUME OF PRODUCT IN COMMERCE 8505.

DISTRIBUTION Nationwide and Internationally.

PRODUCT Misys Laboratory Information System, Versions 5.23 and 5.3.

CODE Versions 5.23 and 5.3.

RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tucson, AZ

REASON No QA Checking Performed on Differential Results.

VOLUME OF PRODUCT IN COMMERCE 450.

DISTRIBUTION Nationwide and Internationally.

PRODUCT HP InkJet Printers connected as an accessory to a Beckman Coulter.

CODE All printer power cords manufactured by Longwell.

RECALLING FIRM/MANUFACTURER Recalling Firm: Beckman Coulter, Inc., Brea, CA

Manufacturer: Longwell Electronics, Inc., Brea, CA.

REASON Printer Power Cord may cause shock to lab personnel.

VOLUME OF PRODUCT IN COMMERCE Unknown.

DISTRIBUTION Nationwide and Internationally.

PRODUCT Medtronic Intersept Custom Tubing Packs. The packs are custom assembled for hospitals and each is identified with

a product number. The product numbers and hospitals or distributors, for which the packs were assembled, are identified below:

Product number 0V67R10; Made for: MERCY HOSPITAL, Des Moines, IA

Product number 1H22R2; Made for: EXTRACORPOREAL ALLIANCE, Port Huron, MI

Product number 1H23R5; Made for: EXTRACORPOREAL ALLIANCE, Pontiac, MI

Product number 1P82R3; Made for: EXTRACORPOREAL ALLIANCE, Dearborn, MI

Product number 2D68R2; Made for: PROVIDENCE MEDICAL CENTER, Kansas City, KS

Product number 2D81R; Made for: COMPREHENSIVE PREFERRED CARE SVR, Buffalo, NY

Product number 5778R19.

Made for: HEALTH MIDWEST, Kansas City, MO

CODE

PRODUCT # LOT

0V67R10 0201000908

0V67R10 0202000147

0V67R10 0202000406

0V67R10 0202000408

0V67R10 0202004036

1H22R2 0202002131

1H23R5 0202004031

1P82R3 0202003516

1P82R3 0202003520

2D68R2 0203000095

2D68R2 0203001683

2D81R 0201002670

2D81R 0201002671

5778R19 0202000164

5778R19 0203001047

5778R19 0203001045

5778R19 0203001046.

RECALLING FIRM/MANUFACTURER Recalling Firm: Medtronic Perfusion Systems, Minneapolis, MN

Manufacturer: Medtronic Mexico, S. Del R.L. de C.V. Tijuana, BB.

REASON The vent valves in the recalled tubing packs may leak blood during cardiopulmonary bypass surgery, or the parts of the valves may separate, due to inadequate glue application.

VOLUME OF PRODUCT IN COMMERCE 856 tubing packs.

DISTRIBUTION IA, KS, MI, MO and NY.

PRODUCT Gambro Phoenix Hemodialysis System.

CODE Catalog Number: 6022933700 Serial Numbers in the range PH0165-PH1769.

RECALLING FIRM/MANUFACTURER Recalling Firm: Gambro Healthcare, Lakewood, CO

Manufacturer: Gambro Dasco S.p.A. 41036, Medolla, Italy.

REASON Incorrect measurement of dialysate conductivity due to electronic comp. failure.

VOLUME OF PRODUCT IN COMMERCE 827 units.

DISTRIBUTION Nationwide.

PRODUCT BD MST Accessory Kit

CODE Catalog 384820, Lot 106458.

RECALLING FIRM/MANUFACTURER Becton Dickinson Infusion Therapy Systems, Inc., Sandy, UT

REASON Kits labeled as containing 16 GA introducer actually contained 20 GA introducer.

VOLUME OF PRODUCT IN COMMERCE 410 units.

DISTRIBUTION Nationwide.

PRODUCT CryoValve Allograft

CODE Serial No. 6281362, Model Number MV 10.

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

REASON Donor did not meet current guidelines regarding behavioral/social history.

VOLUME OF PRODUCT IN COMMERCE One valve.

DISTRIBUTION UT.

PRODUCT CryoValve Allograft.

CODE Serial Number 6281354, Model Number AV40.

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

REASON Donor did not meet current guidelines regarding behavioral/social history.

VOLUME OF PRODUCT IN COMMERCE One valve.

DISTRIBUTION WA.

PRODUCT Vitros Immunodiagnostics CEA (carcinoembryonic antigen) Calibrators

CODE

Lot 210, Exp. 28 March 2002

Lot 220, Exp. 25 April 2002

Lot 230, Exp. 11 June 2002

Lot 240, Exp. 11 June 2002.

RECALLING FIRM/MANUFACTURER Recalling Firm: Ortho-Clinical Diagnostics, Inc., Rochester, NY

Manufacturer: Ortho-Clinical Diagnostics, Inc., Cardiff.

REASON Calibration failures/shift in QC results.

VOLUME OF PRODUCT IN COMMERCE 279 domestic / 495 international.

DISTRIBUTION Nationwide and Internationally.

PRODUCT LAP Band Sterile, Lap-Band Adjustable Banding System, 9.75cm and 10.0cm sizes. PMA# P000008 dated 6/5/01.

The Lap-Band System is an inflatable silicone band that is laparoscopically placed around the upper part of the stomach to restrict how much food can be eaten at one time. It is indicated for use in weight reduction of severely obese patients.

CODE Catalog numbers B-20210 LAP-BAND System II (9.75cm) and B-20220 LAP-BAND System II (10.0cm) are located on the primary and the box labels. Serial numbers S01LB186-89, S01LB186-90, S01LB199-11, S01LB199-12, S01LB199-13, S01LB210-56, S01LB210-57, S01LB210-58,

S01LB210-59, S01LB210-60, S01LB196-151, S01LB196-152, S01LB196-153, S01LB195-154, S01LB201-153, and S01LB196-155 are located on the primary and the box labels.

Serial number code breakdown is as follows: S = Sterile 01= 2001 LB= Lap-Band Next three/four numbers are sequentially assigned.

RECALLING FIRM/MANUFACTURER Bioenterics Corp., Carpinteria, CA

REASON Does not conform to PMA re: labeling.

VOLUME OF PRODUCT IN COMMERCE 16.

DISTRIBUTION NY, OR, CA and NV.

PRODUCT 2-K AC-2409-D acid concentrate and bicarbonate dialysate, 55 Gallons, calcium 2.50 meq/l, etc.

CODE Lot Number G9D051.

RECALLING FIRM/MANUFACTURER Recalling Firm: Gambro Healthcare, Deland, FL

Manufacturer: Di-Chem Concentrates, Inc., Lewisberry, PA.

REASON Calcium Concentrate was higher than the specified range.

VOLUME OF PRODUCT IN COMMERCE 119/55 gallon.

DISTRIBUTION NJ, IL, PA, OH, MD, WASH DC, MI and NY.

PRODUCT Aeroset Cholesterol Reagent

CODE Lot 82099HW00 Firm's List No. 7D62-01.

RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., South Pasadena, CA

REASON Stability may be compromised over time, product currently OK.

VOLUME OF PRODUCT IN COMMERCE 715

DISTRIBUTION Nationwide and Internationally.

WEEK ENDING MAY 25

PRODUCT Invacare Reliant Scales, Models RSC600 and RSC600E.

CODE Serial Numbers 98A through 01L.

RECALLING FIRM/MANUFACTURER Invacare Corp., Elyria, OH

REASON The bolts that hold the scale to the lift may break and cause patient injury.

VOLUME OF PRODUCT IN COMMERCE 2,104.

DISTRIBUTION Nationwide, England and Isreal.

PRODUCT Hex-Lock Abutment, 2.5 mm Diameter. This medical device is designed for use in the firmís Sulzer Dental Implant Systems.

The catalog numbers affected are HLA3/4. The devices are labeled sterile. Product is packaged in a glass vial labeled in part, ìPARAGON

IMPLANT COMPANY***HLA3/4 [00280]**Hex-Lock Abutment for 3.5 mm D Neck flared to 4.5 mm Req.***LOT 012239**2006-07**STERILE***î. (Note: Sulzer Dental acquired Paragon Dental Company in 1/01 and some of the Paragon labels remained.)

Vial is packaged in a white chipboard box labeled in part, ìPARAGON***SULZER MEDICA***Sulzer Dental Inc.***Calabasas Hills, CA 91301 USA***REF HLA3/4***LOT 012239***Hex-Lock Abutment***STERILE***Use by: 2006-07***î.

Instructions for use labeled in part, ìHEX-LOCK ABUTMENT TOP***INDIRECT (CLOSED-TRAY) TRANSFER TECHNIQUE***î.

CODE Lot 012239, Exp Date 7/2006.

RECALLING FIRM/MANUFACTURER Sulzer Dental Inc., Carlsbad, CA

REASON Sterility compromised.

VOLUME OF PRODUCT IN COMMERCE 1.

DISTRIBUTION PA.