FDA

Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

December 18, 2002
02-50

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III

_____________________________
PRODUCT
Health Ade Solutomic Bio-Available Vitamins in 1 quart bottles. Recall # F-102-3.
CODE
9315501 exp 12/01.
RECALLING FIRM/MANUFACTURER
Eniva Corporation, Blaine, MN, by telephone beginning on July 20, 2001. Firm initiated recall is complete.
REASON
The product appeared to be spoiled (product was clumpy and bottles swollen).
VOLUME OF PRODUCT IN COMMERCE
1100 - 32 fluid ounce bottles.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

****CORRECTION****

A product in Enforcement Report 02-48 was incorrect. The product was listed as YNTEST H.S. It should be SYNTEST H.S.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

_____________________________
PRODUCT
Hemacare Blood Bank Data Management System,
Recall # B-0301-3.
CODE
Version 5.2b(b).
RECALLING FIRM/MANUFACTURER
Mediware Information Systems, Inc., Melville, NY, by letter dated June 25, 2002. Firm initiated recall is ongoing.
REASON
Blood bank computer software, which had a defect that could cause antigen test results to be associated with the wrong unit or sample, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 version.
DISTRIBUTION
Nationwide, Singapore and Canada.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

_____________________________
PRODUCT
Alumina V40 Head
Femoral Bearing Head
Hip Joint, Metal/Ceramic/Polymer, Semi-Constrained Cemented or Nonporous Uncemented prosthesis. Recall # Z-0327-3.
CODE
Product number: 6260-7-036
Lot Numbers:
3269301
3515401
3515402
3516201
Product number: 6260-7-032
Lot Numbers:
2743801
2743802
2802001
2963601
2963602
2967901
2967902
3487001
3487101
3547901
3547902

***NEW***
Product Number: 6260-7-028
Lot Numbers:
2729301
2729302
2729303
2729304
2729305
2735901
2735902
2735903
3015901
3015902
3015903
3015904
3015905
3050901
3052401
3052402
3052403
3052404
3225601
3225603
3225604
3225605
3323801
3323802
3486701
3577001
3577002
3631501.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Howmedica Osteonics Corp., Rutherford, NJ, by letters on June 26, 2002.
Manufacturer: Stryker Howmedica Osteonics Corp. Co., Cork, Ireland. Firm initiated recall is ongoing.
REASON
V40 Alumina Heads may not assemble properly onto V40 hip stems.
VOLUME OF PRODUCT IN COMMERCE
190 (+676 28mm heads).
DISTRIBUTION
Nationwide and United Kingdom, Australia, France, and Italy.

_____________________________
PRODUCT
Epidural Catheterization Kit, model number AK-05503L. The kit is labeled as containing a 19 gauge catheter. The catheter permits access to the epidural space.
Recall # Z-0328-3.
CODE
Lot number RF2088943.
RECALLING FIRM/MANUFACTURER
Arrow Intl., Inc., Reading, PA, by letters dated October 14, 2002. Firm initiated recall is ongoing.
REASON
Mislabeled - package may contain incorrect gauge catheter.
VOLUME OF PRODUCT IN COMMERCE
720 kits.
DISTRIBUTION
IL, CA, IN, KY, and OH.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

_____________________________
PRODUCT
Qwikwash Tubing (Air, Waste, Water), list 6208-23; an accessory for use with the Abbott Commander Parallel Processing Center (PPC) and Qwikwash Instruments; each package contains 3 pieces of tubing. Recall # Z-0326-3.
CODE
All lots shipped between 4/26/2002 and 6/28/2002. There are no lot numbers on the tubing packages.
The affected tubing sets can be identifed by the lack of the TYGON logo imprinted on both the Water Tubing (tubing with black connectors) and the Air Tubing (tubing with white connectors).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Inc., Abbott Park, IL, by telephone on October 10, 2002 and by letters sent on October 11, 2002.
Manufacturer: Abbott Laboratories, Inc., Irving, TX. Firm initiated recall is ongoing.
REASON
Visual discoloration of water tubing assembly.
VOLUME OF PRODUCT IN COMMERCE
1343.
DISTRIBUTION
Nationwide, Canada, Germany and Singapore.

_____________________________
PRODUCT
Trade Name: ABC Fixation Pin.
System Name: ABC Cervical Plating System.
Common Name: Plate Fixation Pin. The device product number is FJ833R and sold 2 per box. Recall # Z-0329-3.
CODE
Lot number 51133750.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aesculap, Inc., Center Valley, PA, by letters dated September 11, 2002.
Manufacturer: Aesculap Ag & Co., Kg. Tuttlingen, Donau. Firm initiated recall is complete.
REASON
Pin manufactured with sharp tip and not hardened, pin may be susceptible to bending.
VOLUME OF PRODUCT IN COMMERCE
216 kits.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE--CLASS III

_____________________________
PRODUCT
Oxyglobin Hemoglobin glutamer-200 (Bovine) 125 mL NADA 141-067. Recall # V-008-3.
CODE
Lot numbers/Exp. Date:
V00C10A (08/2003)
V01C03B (04/2004)
V01C06B (04/2004)
V01C18B (08/2004)
V00C10B (08/2003)
V01C04A (04/2004)
V01C07A (05/2004)
V01C19A (09/2004)
V00C13A (09/2003)
V01C04B (04/2004)
V01C07B (05/2004)
V01C19B (09/2004)
V01C03A (04/2004)
V01C06A (04/2004)
V01C16B (08/2004)
RECALLING FIRM/MANUFACTURER
Biopure Corporation, Cambridge, MA, by letter dated November 4, 2002.
Firm initiated recall is ongoing.
REASON
Unapproved new drug.
VOLUME OF PRODUCT IN COMMERCE
11,296 units.
DISTRIBUTION
Nationwide.