SEPTEMBER 2002

 

WEEK ENDING SEPTEMBER 7

 

PRODUCT Sterile Laceration Tray, product code 50-10890, packaged in sterile tray, 30 trays\case.
CODE Lot number 324580.
RECALLING FIRM/MANUFACTURER Recalling Firm: Deroyal Industries, Inc., Powell, TN.

Manufacturer: Deroyal Wound Care, Rose Hill, VA.
REASON Defective seals on surgical trays compromise device sterility.
VOLUME OF PRODUCT IN COMMERCE 90 trays.
DISTRIBUTION GA.

 

PRODUCT Buffered Iontophoretic Delivery Electrode System, non-sterile, single-use only, packaged in a metalized mylar bag, 12 per box.
IO-Drive Iontophoresis Electrode System. The product consists of 1 active drug delivery electrode, 1 return electrode, 1 or 2 alcohol swabs, and an instruction manual. The device is sold as a kit that is non-sterile and intended for single-use only.
The kits contain one of three sizes of the active electrode (small, medium, or large).
The medical device is sold under the 'Selective Med Components' label and several private labels as follows:
1) Buffered Iontophoretic Delivery Electrode System; North Coast Medical, Inc.
2) Buffered Iontophoretic Delivery Electrode System, EMSI, Tampa, Florida.
3) Buffered Iontophoretic Delivery Electrode System; MedPend, Inc., Lake Mary, FL.
4) Buffered Iontophoretic Delivery Electrode System; Rudolph Medical.
5) Buffered Iontophoretic Delivery Electrode System; Physio Tech.
6) Buffered Iontophoretic Delivery Electrode System; Spectramed.
7) IoDOSE Buffered Iontophoretic Delivery Electrode System; MagMed, Inc.
8) SUPER-TRODES Buffered Iontophoretic Delivery Electrode System; SME, Inc.
9) Buffered Iontophoretic Delivery Electrode System; Selective Med Components.
10) IONTO-Clone Buffered Iontophoretic Delivery Electrode System; New England Surgical, Inc.
CODE Lot Numbers: 5129-1, 5130-1, 5131-1, 5291-1, 5292-1, 5293-1, 5368-1, 5369-1, 5370-1, 5573-1, 5574-1, 5575-1, 5684-1, 5685-1, 5686-1, 5946-1, 5947-1, 5948-1, 6483-1, 6484-1, 6487-1, 6711-1, 6712-1, 6713-1, 7030-1, 7031-1, 7032-1, 7427-1, 7428-1, 7429-1, 7513-1, 7514-1, and 7515-1.
RECALLING FIRM/MANUFACTURER Selective Med Components, Inc., Mt. Vernon, OH.
REASON The device may cause skin burns.
VOLUME OF PRODUCT IN COMMERCE 70,000 kits.
DISTRIBUTION FL, MS, OH, MA, CA, VA, and NC.

 

PRODUCT Storz brand Concentrix Phacoemulsification Pack, Labeled as Sterile. Product or reference number CX4310.
CODE Lot Number: S7825.
RECALLING FIRM/MANUFACTURER Bausch & Lomb Surgical, Inc., Clearwater, FL.
REASON Irrigation line tubing may not properly adhere to the casette and leak or detach.
VOLUME OF PRODUCT IN COMMERCE 600 (100 boxes/6 units each).
DISTRIBUTION Nationwide and Australia, Canada and The Netherlands.

 

WEEK ENDING SEPTEMBER 21

 

PRODUCT SSCOR Suction Unit Model 2314; SSCOR Suction Unit Model 2314B; SSCOR Suction Unit Model 2315.
CODE All Codes.
RECALLING FIRM/MANUFACTURER Sscor, Sun Valley, CA.
REASON Overheats and fails to suck.
VOLUME OF PRODUCT IN COMMERCE 4105.
DISTRIBUTION Nationwide and Saudi Arabia.

 

PRODUCT Vanish Point Blood Collection Tube Holder, packaged 10 units per sleeve, 25 sleeves per case.
CODE 11 lots recalled: RTI Lot number/Abbott Lot number D152A/700126S; D158A/710166S; D166A/720076S; D167A/720086S; D169A/720146S; D170A/720196S; D171A/720206S; D172A/730046S; D173A/730056S; D174A/730126S; D181A/730286S.
RECALLING FIRM/MANUFACTURER Retractable Technologies, Inc., Little Elm, TX.
REASON Unexpected premature retraction is possible.
VOLUME OF PRODUCT IN COMMERCE 951,750 units.
DISTRIBUTION Nationwide and Canada and Africa.

 

PRODUCT Misys Laboratory.
CODE Versions 5.2, 5.23 and 5.3.
RECALLING FIRM/MANUFACTURER Misys Healthcare Systems Inc., Tuscon, AZ.
REASON Software anomaly regarding cell counts.
VOLUME OF PRODUCT IN COMMERCE 469.
DISTRIBUTION Nationwide, and Internationally.

 

PRODUCT LIFEPAK 12 defibrillator/monitor. The particular part is the therapy connector - this connector allows hard paddles, disposable electrode cables, or internal-paddle cables to be easily connected or disconnected to the device.
CODE Serial numbers are non-continuous and can be obtained from the SEA-DO Recall Coordinator.
RECALLING FIRM/MANUFACTURER Medtronic Physio-Control Corp., Redmond, WA.
REASON Potential for interrupted pacing or defibrillator functions.
VOLUME OF PRODUCT IN COMMERCE 5494.
DISTRIBUTION Nationwide.

 

PRODUCT Model 8870 Software Application Card for the Model 8840 N’Vision Handheld Clinician programmer.
CODE All units are involved.
RECALLING FIRM/MANUFACTURER Medtronic, Inc., Neurological Division, Minneapolis, MN.
REASON An incorrect drug administration rate can be programmed into SynchroMed or SynchroMed EL implantable infusion pumps due to defective software.
VOLUME OF PRODUCT IN COMMERCE 34 Model 8870 Application Cards.
DISTRIBUTION Europe and the Middle East.

 

PRODUCT Mysis Commercial Laboratory
CODE Versions 3.2.0; 3.2.2; 3.2.3, 3.3.0, 3.3.1a, 3.3.1, 3.4.0, 3.4.1b, and 3.4.1a.
RECALLING FIRM/MANUFACTURER Mysis Healthcare Systems, Inc., Plano, TX.
REASON Software anomaly: a result for an accesion number came across the interface as negative but should have been Do Not Result (DNR).
VOLUME OF PRODUCT IN COMMERCE 44
DISTRIBUTION Nationwide.

 

PRODUCT HP Deskjet 970Cxi Printer connected as an accessory to the Elan ATAC 8000 Random Chemistry

CODE HP Deskjet 970Cxi Printer connected as an accessory to the Elan ATAC 8000 Random Chemistry Analyzer.
RECALLING FIRM/MANUFACTURER Elan Diagnostic Smithfield, RI
REASON Printer power cord may crack and cause electric shock.
VOLUME OF PRODUCT IN COMMERCE 29
DISTRIBUTION Nationwide

 

PRODUCT VACUTAINER Brand Luer Adapters (Catalog #367290).
CODE Catalog #367290 Lot #'s 1242595 and 1284859.
RECALLING FIRM/MANUFACTURER Recalling Firm: Becton Dickinson & Co., Franklin Lakes, NJ.
Manufacturer: Becton Dickinson & Co., Sumter, SC
REASON Needle Separated from the Hub.
VOLUME OF PRODUCT IN COMMERCE 3,690,000 units estimated in commerce.
DISTRIBUTION Nationwide.

 

PRODUCT Power supply cord sold with and used with Spacelabs Medical Models 90342, 90344, 90346, 90348, and 90479 telemetry systems/receiver housings.
CODE All codes.
RECALLING FIRM/MANUFACTURER Recalling Firm: Spacelabs Medical, Inc., Redmond, WA.

Manufacturer: Winegard Company, Burlington, IA.
REASON Power supply cord not UL or CSA approved.
VOLUME OF PRODUCT IN COMMERCE 759 power supplies.
DISTRIBUTION Nationwide.

 

PRODUCT Misys Commercial Laboratory.
CODE Versions 3.3.0, 3.3.1, 3.4.0 and 3.4.1a.
RECALLING FIRM/MANUFACTURER Mysis Healthcare Systems, Inc., Plano, TX.
REASON Software anomaly. If the deformatter begins to process data prior to all patient result records or orders being extracted from the flat files, the remaining results or orders will not be extracted. This can result in data being processed out of sequence into the Mysis Commercial Laboratory System.
VOLUME OF PRODUCT IN COMMERCE  7.
DISTRIBUTION TX, FL, NY, MN, NC and PA.

 

PRODUCT a) MediSense ExacTech Blood Glucose Test Strips (50 Count); b) MediSense ExacTech Blood Glucose Test Strips (100 Count);

c) MediSense ExacTech RSG Blood Glucose Test Strips(50 Count)
CODE a) Lot Number: 45874; b) Lot Number: 45874; c) Lot Number: 45852.
RECALLING FIRM/MANUFACTURER Recalling Firm: Abbott Laboratories, Inc., Medisense Products, Bedford, MA.
Manufacturer: Medisense UK Limited Abingdon Oxon.
REASON Blood Glucose Test Strip May Give False High Readings.
VOLUME OF PRODUCT IN COMMERCE 6,241 Boxes (50 test strips/box).
DISTRIBUTION Nationwide.

 

PRODUCT Optetrak 1/2 Tibial Augmentation Block Implants, (Classification name: knee joint patellofemoral polymer/metal/polymer semi-constrained). Product is intended to be implanted during total knee joint replacement surgery where augmentation of the standard implant components is required.
CODE All serial numbers less than 0260014 for the following products:

Part Description

Catalog Number

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.


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

REASON Compromise of sterility barrier packaging.
VOLUME OF PRODUCT IN COMMERCE 1828.
DISTRIBUTION Nationwide.

 

PRODUCT Hill-Rom brand Affinity Three birthing bed.
CODE All beds with a serial number of D196AA4617 or lower.
RECALLING FIRM/MANUFACTURER Hill-Rom, Inc., Batesville, IN.
REASON Calf support mounting screws may loosen and back out, allowing the calf support to become unstable/fall off.
VOLUME OF PRODUCT IN COMMERCE 4,473 beds.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Stryker Howmedica Osteonics V40TM Femoral Head, 26mm Diameter, (5o40’ Taper).
CODE Device : V40TM Femoral Head, 26mm Diameter, (5o40’ Taper) Catalog #: 6260-5-226  Lot #’s: BZDJPR, BZEHYR, CABHVR, CABHWR, CABPZR, CABRCR, CABRDR, CABRER, CACNGR, CAFFKR, CAFFLR, CAFFNR, CAFFPR, CAFFRR, CAFFSR, CAFFUR, CAGBMR, CAGBNR, CAGBOR, CAGBRR, CAGBSR, CAGBVR, CAGBWR, CAGSJR, CAGSKR, CAGSNR, CAHMER, CAHMFR, CAHUWR, CAHUYR, CAJEPR, CAJERR, CAJESR, CAJETR, CASUBR, CATJKR, CATJLR, CAVFMR, CAVFNR, CAVGBR, CAVGDR, CAVGDR, CAVMSR, CAVMTR, CAVMUR, CAWKOR  Expiration Dates: 12/2006 (Lot #’s: CABHWR, CAGBWR, CAHMFR, CAJEPR, CAJERR, CAJESR, CAJETR)
1/2007 (Lot #’s BZDJPR, BZEHYR, CABHVR, CABPZR, CABRCR, CABRDR, CABRER, CACNGR, CAFFKR, CAFFLR, CAFFNR, CAFFPR, CAFFRR, CAFFSR, CAFFUR, CAGBMR, CAGBNR, CAGBOR, CAGBRR, CAGBSR, CAGBVR, CAGSJR, CAGSKR, CAGSNR, CAHMER, CAHUWR, CAHUYR) 2/2007 (Lot #’s CASUBR, CATJKR, CATJLR, CAVFMR, CAVFNR, CAVGBR, CAVGDR, CAVGDR, CAVMSR, CAVMTR, CAVMUR, CAWKOR) Device: 2o52’ Taper Femoral Head, 26mm Diameter +0mm
Catalog #: 6280-0-126 Lot #’s: 6089722R, 6314756R, 6877383R, 6902451R, 6902452R, 6978671R, 6978672R, CADULR, CADUMR, CAJDER, CAJDHR, CAJHIR Expiration Dates: 1/2007 (Lot #’s 6089722R, 6877383R, 6902451R, 6902452R, 6978671R, 6978672R, CADULR, CADUMR, CAJDER, CAJDHR, CAJHIR) 3/2007 (Lot # 6314756R)
RECALLING FIRM/MANUFACTURER Howmedica Osteonics Corp., Rutherford, NJ.
REASON Product mix up. Skirted heads in Non-skirted packaging.
VOLUME OF PRODUCT IN COMMERCE 125.
DISTRIBUTION NJ.

 

PRODUCT a) Stryker Howmedica Osteonics Unitrax® C-Taper Neck Adjustment Sleeve (Adapter for Unipolar Head). b) Stryker Howmedica Osteonics Unitrax® V40TM Std. Sleeve 5o 40’ Modular Adapter (Neck Adjustment Sleeve.

CODE a) Unitrax® C-Taper Neck Adjustment Sleeve 6942-7-065 Lot 7153061
b) Unitrax® V40TM Std. Sleeve 5o 40’ Modular Adapter 6942-6-065 Lot 7153072
RECALLING FIRM/MANUFACTURER Howmedica Osteonics Corp., Rutherford, NJ.
REASON Product package mixup. Incorrect taper.
VOLUME OF PRODUCT IN COMMERCE 38.
DISTRIBUTION NJ and Canada.

 

PRODUCT Flexima Ureteral Stent System Kit as follows: See Code Section.
CODE Boston Scientific/Medi-Tech Flexima RegularUreteral Stent System Kit as follows:

Catalog #

Product
Gauge/length

Lots Affected

27-410

USK/6/20/Reg

3309365
3654511
3871346

27-411

USK/6/22/Reg

3007121
3127119
3323329
3477054
3532532
3550119
3644298
3661611
3687166
3821902
3933757

27-412

USK/6/24/Reg

3073644
3323330
3480623
3533784
3548206
3821903
3766772

27-413

USK/6/26/Reg

3089476
3153194
3238115
3323338
3394293
3538046
3673635
3821904
3852712

27-414

USK/6/28/Reg

3480624
3544701
3683352
3871347

27-415

USK/8/20/Reg

3075354

27-416

USK/8/22/Reg

2984060
3149041
3685263
3935558

27-417

USK/8/24/Reg

3136719
3323596
3484096
3533785
3558400
3685287
3751452
3821906
3888130
3908810

27-418

USK/8/26/Reg

3251321
3276534
3534002
3690325
3881927

27-419

USK/8/28/Reg

3142848
3359543
3552848
3591057
3888131


RECALLING FIRM/MANUFACTURER Recalling Firm: Boston Scientific Corp./Medi-Tech, Watertown, MA.
Manufacturer: Medi-Tech, a division of Boston Scientific Corp., Spencer, IN.
REASON Outer carton multi language label incorrectly identifies the device as Biliary instead of Ureteral Stent.
VOLUME OF PRODUCT IN COMMERCE 946.
DISTRIBUTION The Netherlands.

 

PRODUCT a) Cryosurgery System-Welch Allyn; b) LM-900 Leisegang Cryosurgery System.
CODE a) Cryosurgery System-Welch Allyn Catalog No. 88372 Serial Numbers: 010201 to 050215; 110101 to 110103
b) LM-900 Leisegang Cryosurgery System  Catalog Number: 50501 and 50502 Serial Numbers: 12744 to 13500.
RECALLING FIRM/MANUFACTURER Coopersurgical, Inc., Trumbull, CT

REASON Tip may separate from Cryogun when pressure is released during operation.
VOLUME OF PRODUCT IN COMMERCE 767.
DISTRIBUTION Nationwide and Canada, Guatamala, Costa Rica, Mexico, Manila and Istanbul.

 

PRODUCT a) Microstream Smart CapnoLine Oral/Nasal O2/CO2 Cannula; b) Microstream Smart CapnoLine Nasal O2/CO2 Cannula;
 c) MAC-Line Smart Oral Nasal 02/CO2 Cannula; d) MAC-Line Smart Nasal O2/C02Cannula.
CODE

Description                                                           Oridion PN

O2/CO2 Nasal FilterLine Adult                           006912

O2/CO2 Nasal FilterLine Adult Long                007739

O2/CO2 Nasal FilterLine Pediatric                     006913

O2/CO2 Nasal FilterLine Pediatric Long           007740

Smart CapnoLine Adult                                      007264

Smart CapnoLine Intermediate                           007265

Smart CapnoLine Pediatric                                 007266

Smart CapnoLine O2 Adult                                007267

Smart CapnoLine O2 Adult Long                      007741

Smart CapnoLine O2 Intermediate                     007268

Smart CapnoLine O2 Intermediate Long          007742

Smart CapnoLine O2 Pediatric                           007269

Smart CapnoLine O2 Pediatric Long                 007743

Smart MacLine Adult                                          007601

Smart MacLine Intermediate                              007602

Smart MacLine Pediatric                                     007603

Smart MacLine O2 Adult                                    007604

Smart MacLine O2 Intermediate                        007605

Smart MacLine O2 Pediatric                               007606

Nasal MacLine O2 Adult                                    007609

Nasal MacLine O2 Pediatric                               007610

PRIVATE LABEL:

Nellcor Puritan Bennet US & Tyco Europe (OEM)

Description                                                           Oridion PN     NPB PN

O2/CO2 Nasal FilterLine Adult                          006899         063568

O2/CO2 Nasal FilterLine Pediatric                     006900         063569

Smart CapnoLine Adult                                      007341         064093

Smart CapnoLine Intermediate                           007342         064094

Smart Capnoline Pediatric                                   007343         064095

Smart CapnoLine O2 Adult                                007344         064842

Smart CapnoLine O2 Intermediate                     007345         064843

Smart CapnoLine O2 Pediatric                           007346         064844

PRIVATE LABEL:

MPC (Medtronic PhysioControl Corp) (OEM)

Description                                                           Oridion PN     MPC PN

O2/CO2 Nasal FilterLine Adult                          006903         006903

O2/CO2 Nasal FilterLine Pediatric                     006905         006905

Smart CapnoLine Adult                                        007354         007354

Smart CapnoLine Intermediate                           007355         007355

Smart Capnoline Pediatric                                   007356         007356

Smart CapnoLine O2 Adult                                007357         007357

Smart CapnoLine O2 Intermediate                     007358         007358

Smart CapnoLine O2 Pediatric                           007359         007359              

RECALLING FIRM/MANUFACTURERORIDION MEDICAL LTD., Jerusalem.
REASONOral Nasal Cannula missing holes for the delivery of supplemental oxygen.
VOLUME OF PRODUCT IN COMMERCE8668 cases (25 units/cs).
DISTRIBUTION Nationwide.

 

WEEK ENDING SEPTEMBER 28

 

PRODUCT LCx Neisseria gonorrhoeae Assay, Amplification & Detection Kit, 96 tests. 

CODE All lots list 8A48-81: lots 84073M400, 84075M400, 84142M300, 84146M300, 85099M300, 85487M20085488M200, 85489M200

list 8A48-82: lots   86800M300, 87007M400, 87103M400, 87225M100, 87240M100, 87243M100, 87376M200, 87377M200, 87378M200, 87818M100,

87899M200, 87905M200, 88097M300, 88105M300, 88106M300, 88107M300, 88110M300, 88111M300, 88439M200, 88439M201, 88556M300, 88850M300, 89177M300, 89187M100.

RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Abbott Park, IL

REASON May not meet sensitivity specifications.

VOLUME OF PRODUCT IN COMMERCE 15,084.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Diagnost 88 with a monitor support arm 9804-404-10X03, 9804-404-40X03 [where X is any number 0-9].

CODE Diagnost 88 with a monitor support arm 9804-404-10X03, 9804-404-40X03 [where X is any number 0-9]

RECALLING FIRM/MANUFACTURER Philips Medical Systems North America, Inc., Shelton, CT

REASON Monitor may fall due to failure of support arm.

VOLUME OF PRODUCT IN COMMERCE 6.

DISTRIBUTION MS, NJ and NY.

 

PRODUCT Trade name: EmpowerCT Injector System, Model/Catalog #: 9800. Legally Marketed Name: PercuPump II with EDA CT Injector

CODE Injectors Affected by the "Service Advisory" with software version 1.02a or earlier have serial numbers P61012 – P61076. The system can be configured with various accessories which include the following catalog numbers: 9830, 9820, 9825, 9870, 9850, 9851, 9852, 9853, 9855, 9856, 9857, 9858, 9860, 9871, 9875, 9876, 9877, 9885S M & L, 9886S M & L, 9887, 9888, 9895, 9896, 6720, 7881.

RECALLING FIRM/MANUFACTURER E-Z-EM, Inc., Westbury, NY.

REASON Software anomaly can cause excess contrast agent to be injected during test injection.

VOLUME OF PRODUCT IN COMMERCE 61 units.

DISTRIBUTION Nationwide.

 

PRODUCT Opera & Tempo Patient Lifts, Non-AC Powered:

a) model KPB3500-21US - Opera Combi;

b) model KPB3002-21US - Opera Combi with Scale;

c) model KPB3100-22US - Opera PPP (Power Patient Positioning);

d) model KPB3160-22US - Opera PPP with Scale;

e) model KPB5100-23US - Tempo PPP (Power Patient Positioning);

f) model KPB5150-23US - Tempo PPP with Scale;

g) model KPB5000-23US - Tempo with 4 Point Hanger Bar;

h) model KPB5050-23US - Tempo with 4 Point Hanger and Scale.  

CODE Opera Patient Lifts with serial numbers prior to GB2002896045002; Tempo Patient Lifts with serial numbers prior to GB1902895367001.

RECALLING FIRM/MANUFACTURER Recalling Firm: Arjo, Inc., Roselle, IL.

Manufacturer: Arjo Ltd., Gloucester, United Kingdom.

REASON Hanger bar and jib may detach from the patient lift.

VOLUME OF PRODUCT IN COMMERCE 660 lifts.

DISTRIBUTION Nationwide.

 

PRODUCT Becton Dickinson's EpiCenter Data Management System software.

CODE EpiCenter Software, version 3.20B, Catalog #441007.

RECALLING FIRM/MANUFACTURER Becton Dickinson Microbiology Systems, Sparks, MD

REASON IVD software defect may cause incorrect patient results to be reported.

VOLUME OF PRODUCT IN COMMERCE 336 units.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT SurgAssist Circular Stapler DLU, Digital Loading Unit. The device is a single use sterile device. The device has 24 implantable titanium staples with it. The device is individually packaged and sold/shipped 6 devices per box.

CODE SurgAssist CS29, Circular Stapler DLU, 29mm - lots:  DS000103; DS000105; DS000108 and DS000110.

SurgAssist CS33, Circular Stapler DLU, 33mm - lots: DS000009; DS000014; DS000020; DS000022; DS000025; DS000029; DS000031; DS000034; DS00003 5; DS000060; DS000066; DS000067; DS000074; DS000079; DS000080; DS000098; DS000101 and DS000109.

RECALLING FIRM/MANUFACTURER Power Medical Interventions, Inc., New Hope, PA

REASON Does not complete firing cycle.

VOLUME OF PRODUCT IN COMMERCE 1080 units.

DISTRIBUTION Nationwide and Germany, Italy and Ireland.

 

PRODUCT Tosoh brand AIA-PACK Progesterone Calibrator Set.

CODE Catalog # 020381, Lot # C332226, Expiration Date 3/2003.

RECALLING FIRM/MANUFACTURER Recalling Firm: Tosoh Medics, Inc., South, San Francisco, CA

REASON This product does not meet the stated claim for shelf life stability.

VOLUME OF PRODUCT IN COMMERCE 35.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT The Power Cord from the printer that may be sent as an accessory to the Architect i2000 System or Abbott Commander.

CODE Not specified.

RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX

REASON Power Cord recalled from Supplier.

VOLUME OF PRODUCT IN COMMERCE 337.

DISTRIBUTION Nationwide and Singapore, Hong Kong and Korea.

 

PRODUCT Exactech brand AcuDriver Carbide punch, long, Model Name Carbide punch, sterile, Catalog Number 400-40-25.

CODE Serial Numbers 0105608-0105621.

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

REASON Sterility barrier may be compromised in some packaging.

VOLUME OF PRODUCT IN COMMERCE 8.

DISTRIBUTION FL, LA, MN, ME, NY, NV AND WA.

 

PRODUCT Huber Plus Safety Infusion Set, product code MM 2034. The proprietary name is Huber Plus Safety Infusion Set and the common name is Huber Needle and Administration Set.

CODE Lot number 2D018MK.

RECALLING FIRM/MANUFACTURER Now Medical Distribution Inc., West Chester, PA

REASON Device labeled with incorrect gauge size.

VOLUME OF PRODUCT IN COMMERCE 4575 units.

DISTRIBUTION CA, KS, MN, NY, OH, PA and WA.

 

PRODUCT Premier HSV, an EIA diagnostic test kit, packaged under the Meridian Premier brand label.

CODE --- Premier HSV kits ---

Lot Numbers and Exp. Dates:

#550010.079, Exp. 02 Aug 02

#550010.080, Exp. 02 Aug 02

#550010.082, Exp. 26 Jul 02

The catalog number is #550010. --- OPD Substrate Tablets (kit component) --- Lot Number: 9677.043

RECALLING FIRM/MANUFACTURER Meridian Bioscience, Inc., Cincinnati, OH

REASON The OPD Substrate Tablets have deteriorated due to moisture, and may result in inaccurate test results.

VOLUME OF PRODUCT IN COMMERCE 594 kits (lot .07930; lot .080 2; lot .082 2).

DISTRIBUTION Nationwide.

 

PRODUCT Focus Night and Day extended wear contact lens

CODE Lot 2517083.

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

REASON A 2-Week Focus lens found inside carton of Focus Night and Day lens.

VOLUME OF PRODUCT IN COMMERCE 933/six-pack cartons.

DISTRIBUTION Nationwide and Internationally.