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