FDA

Enforcement Report

October 16, 2002
02-41

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

_____________________________
PRODUCT
White Corn Tortilla Chips. The product is labeled as:
a) Hannaford Brand White Corn Tortilla Chips;
b) Stop & Shop Brand White Corn Tortilla Chips.
The product is sold in 20 ounce plastic packages.
Recall # F-001-3.
CODE
a) UPC Code 041268 12334,
Product Code SEP02X2B;
b) UPC Code 2112018199,
Product Code SEP02X2B.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wise Foods, Division of Borden Inc., Kennesaw, GA, by press release on August 6, 2002.
Manufacturer: Wise Foods Inc., Berwick, PA. FDA initiated recall is complete.
REASON
The product contained undeclared milk ingredients.
VOLUME OF PRODUCT IN COMMERCE
6024 units.
DISTRIBUTION
ME, MA, NH, NY, VT, NJ and RI.

_____________________________
PRODUCT
Packages labeled as French Dinner Rolls, which actually contained French Baguette Bread. Recall # F-002-3.
CODE
M421610000.
RECALLING FIRM/MANUFACTURER
Baker Boy Bake Shop, Inc., Dickinson, ND, by letter on July 11, 2002. The sub-accounts were notified by letter on July 12, 2002, followed by visit. Firm initiated recall is complete.
REASON
The French Baguette Bread was formulated to contain egg whites, and the label of the French Dinner Rolls did not list any egg ingredient.
VOLUME OF PRODUCT IN COMMERCE
Approximately 3,420 French Dinner Rolls packages (an estimated 1,000 of them contained baguettes).
DISTRIBUTION
Nationwide.

_____________________________
PRODUCT
American Spice brand, 2 oz. bottles. Recall # F-003-3.
CODE
Product is coded "AS-EXP: 0316/05 Lot # 03162002";
"AS-EXP: 0816/03 Lot # 08162001".
RECALLING FIRM/MANUFACTURER
American Spice Co., Inc., Miami, FL, by telephone, letter, visit and press release on August 27, 2002. FDA initiated recall is complete.
REASON
The product was contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
320 cases, 12/2 oz per case.
DISTRIBUTION
FL and Belize.

_____________________________
PRODUCT
You Chiun brand Soft Candy packed in clear plastic packages, net wt. 10.5 oz. (300 g). Imported from Taiwan.
Recall # F-004-3.
CODE
All codes on the market at the time of the recall including 08062002, 08252002 and 08192002. Barcode # 714248 800532.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blooming Import Inc., Brooklyn, NY, by allergen alert on February 22, 2002 and recall letter on February 23, 2002.
Manufacturer: Honda International Co. Ltd., Wu Chi City, Taichung. State initiated recall is complete.
REASON
The product contained undeclared peanuts.
VOLUME OF PRODUCT IN COMMERCE
27 cases (24 - 10.5 oz. bags per case).
DISTRIBUTION
NY.

_____________________________
PRODUCT
Melissa's Fresh Bay Leaves, net wt. 3/4 oz. (21 g).
Recall # F-005-3.
CODE
Lot numbers 19344903 and 19301503.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Melissa's World Variety Produce, Vernon, CA, by letter on August 5, 2002 and by press release on August 6, 2002.
Manufacturer: Herb Thyme Farms, Inc. Compton, CA.
State initiated recall complete.
REASON
The product was found to be contaminated with Listeria monocytogenes by the Georgia Department of Agriculture on July 29, 2002.
VOLUME OF PRODUCT IN COMMERCE
14 cartons (6 clam shells each).
DISTRIBUTION
AL, GA and FL.

_____________________________
PRODUCT
Scandinavian Smoke House brand Cold Smoked Norwegian Salmon (applewood) pieces (trimmings) packed in clear plastic vacuum packages. Recall # F-006-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Scandinavian Smoke House, Inc., San Francisco, CA, by telephone and letter on April 15, 2002. FDA initiated recall is complete.
REASON
The product was contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
3,300 lbs.
DISTRIBUTION
CA.

_____________________________
PRODUCT
CAF brand ROUND WHITE SESAME CRACKER, KEO ME TRANG, Net Weight: 100 g. PRODUCT OF VIETNAM. INGREDIENTS: White Sesame, Sugar, Tapioca Starch, Maltose. Recall # F-007-3.
CODE
All products on the market at the time the recall was initiated. Barcode # 52228 70025.
RECALLING FIRM/MANUFACTURER
Recalling Firm: CA First (NY) Trading, Inc., Brooklyn, NY, by telephone on May 1, 2002.
Manufacturer: Hua Heong Food Ind. Vietnam Co., Ltd., Ho Chi Minh City, Vietnam. State initiated recall is complete.
REASON
The product contained undeclared peanuts.
VOLUME OF PRODUCT IN COMMERCE
6 cases (60 packages per case).
DISTRIBUTION
NY.

_____________________________
PRODUCT
Horseradish Sauce sold under two brands:
a) Raskin brand Horseradish Sauce, net wt.: 8 oz.,
refrigerated.
b) Brede brand Deli Dressing Horseradish Sauce,
net wt. 8.5 oz., refrigerated. Recall # F-008-3.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Brede, Inc., Detroit, MI, by press release on August 1, 2002. FDA initiated recall is complete.
REASON
The product contained undeclared eggs.
VOLUME OF PRODUCT IN COMMERCE
75 cases (12 bottles/case).
DISTRIBUTION
MI.

_____________________________
PRODUCT
Chopped romaine lettuce and salad mixes containing chopped romaine packaged in bulk containers as follows:
a) 5 lb. plastic, heat-sealed bags labeled in part:
"Fresh Pre-Cut Vegetables Perishable-Refrigerate***NET WT. 5 LBS. 2.26 kgs. 100% Preservative Free".
b) 3 lb. plastic, heat-sealed bags labeled in part:
"Fresh Pre-Cut Vegetables Perishable-Refrigerate***NET
WT.3 LBS".
c) 2 lb. plastic, heat-sealed bags labeled in part:
"Fresh Pre-Cut Vegetables Perishable-Refrigerate***
NET WT.2 LBS".
(NOTE: the 5lb bags are used to package the 2 lb and 3 lb product; the firm reportedly crosses out the "5" and hand writes in a "2". Recall # F-009-3.
CODE
The affected product is all cut romaine lettuce/salad mixes produced July 7, 9, and 11, 2002.
RECALLING FIRM/MANUFACTURER
Spokane Produce Inc., Spokane, WA, by fax on August 11, 2002 and by telephone on August 12, 2002. FDA initiated recall is complete.
REASON
The product was associated with an outbreak of E. coli illness.
VOLUME OF PRODUCT IN COMMERCE
Approximately 3207 - 5lb bags.
DISTRIBUTION
WA, ID and MT.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I

_____________________________
PRODUCT
a) Methylprednisolone Acetate for Injection,
40 mg/mL,1 ml, single dose vial. Recall # D-004-3;
b) Methylprednisolone Acetate for Injection,
80 mg/mL,1 ml, single dose vial. Recall # D-005-3;
c) Baclofen for Injection, Preservative-Free,
2 mg/mL,10 mL vial. Recall # D-006-3;
d) Baclofen for Injection, Preservative-Free,
50 mcg/mL, 1 mL vial. Recall # D-007-3;
e) Baclofen for Injection, Preservative-Free,
500 mcg/mL,20 mL vial. Recall # D-008-3.
CODE
All lot codes are under recall.
RECALLING FIRM/MANUFACTURER
Portage Pharmacy (aka Innovative Professional Services), Portage, MI, by fax on June 17, 2002. Firm initiated recall is complete.
REASON
Microbial contamination; Penicillium mold, Methylobacterium, and/or Mycobacterium chelonae.
VOLUME OF PRODUCT IN COMMERCE
Approx. 791 vials.
DISTRIBUTION
MI.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

_____________________________
PRODUCT
Nardil Tablets (Phenelzine Sulfate Tablets, USP) 15 mg, 100 count bottles, Rx only. Recall # D-009-3.
CODE
Lot 354O1L exp. 9/30/02.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer, Inc., New York, NY, by letters on September 10, 2002.
Manufacturer: Pfizer, Inc., Lititz, PA. Firm initiated recall is ongoing.
REASON
Subpotent; (9 month stability).
VOLUME OF PRODUCT IN COMMERCE
19013 bottles.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

_____________________________
PRODUCT
Source Plasma, Recall # B-0001-3.
CODE
Unit 7196K098.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Greenville, SC, by letter dated March 3, 2002. Firm initiated recall is complete.
REASON
Blood product, which was not tested for syphilis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.

_____________________________
PRODUCT
Source Plasma, Recall # B-0002-3.
CODE
Units 71FPCGCY, 71FPCFXZ, 71FPCFQN.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Greenville, SC, by letter dated March 3, 2002. Firm initiated recall is complete.
REASON
Blood products, which were not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
Germany.

_____________________________
PRODUCT
BD Vacutainer_ Safety-Lok_ Blood Collection Sets (Catalogue # 367285, 367286, 367287, 367292, 367294, 367281, 367282, 367283, 367284). Recall # B-0003-3.
CODE
Lot Numbers / Expiration Dates:

RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Co., Franklin Lakes, NJ, by letter dated March 29, 2002.
Manufacturer: Becton Dickinson Vacutainer Systems, Sumter, SC. Firm initiated recall is ongoing.
REASON
Vacutainer_ Brand Safety-Lok_ Blood Collection Sets that have caused blood leakage during phlebotomy, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units.
DISTRIBUTION
Nationwide.

_____________________________
PRODUCT
Red Blood Cells, Leukoreduced, Irradiated.
Recall # B-0004-3.
CODE
Unit 10727-9256.
RECALLING FIRM/MANUFACTURER
United Blood Services, Scottsdale, AZ, by letter dated June 25, 2002. Firm initiated recall is complete.
REASON
Blood product, for which documentation of irradiation was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AZ.

_____________________________
PRODUCT
a) Red Blood Cells, Recall # B-0005-3;
b) Fresh Frozen Plasma, Recall # B-0006-3.
CODE
a) and b) Unit LL12679.
RECALLING FIRM/MANUFACTURER
San Diego Blood Bank, San Diego, CA, by telephone on April 15, 2002 and by letter dated June 5, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

_____________________________
PRODUCT
Source Plasma, Recall # B-0007-3.
CODE
Unit 71FPCBQP.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Greenville, SC, by letter dated February 14, 2002. Firm initiated recall is complete.
REASON
Blood product, that lacked assurance of sterility, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Germany.

_____________________________
PRODUCT
Source Plasma, Recall # B-0008-3.
CODE
Units 71 FPCGQB, 71 FPCGJR, 71 FPCGDT.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Greenville, SC, by letter dated March 21, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had not completed the CJD/nvCJD increased risk questions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
Germany.

_____________________________
PRODUCT
Source Plasma, Recall # B-0009-3.
CODE
Units 71 FPCGNJ and 71 FPCGHR.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Greenville, SC, by letter dated March 21, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had not completed the CJD/nvCJD increased risk questions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
Germany.

_____________________________
PRODUCT
Recovered Plasma, Recall # B-0011-3.
CODE
Unit 03GN40759.
RECALLING FIRM/MANUFACTURER
American Red Cross, Atlanta, GA, by fax dated June 12, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had lived in Western Europe for greater than 6 months, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_____________________________
PRODUCT
Recovered Plasma, Recall # B-0012-3.
CODE
Unit 03K18869.
RECALLING FIRM/MANUFACTURER
American Red Cross, Southern Region, Atlanta, GA, by fax on May 6, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had lived in Western Europe for greater than 6 months, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0013-3.
CODE
Unit 03GK70297.
RECALLING FIRM/MANUFACTURER
American Red Cross, Atlanta, GA, by telephone on June 20, 2002 and by letter dated June 25, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had lived in Western Europe for greater than 6 months, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
GA.

_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0015-3;
b) Platelets, Leukocytes Reduced, Recall # B-0016-3;
c) Fresh Frozen Plasma, Recall # B-0017-3.
CODE
a); b) and c) Unit 16LH54794.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Central Ohio Region, Columbus, OH, by telephone on March 28, 2002 and by letter dated March 29, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to high risk behavior found to increase the risk of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
OH.

_____________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced, Recall # B-0018-3;
b) Platelets Pheresis, Leukocytes Reduced, Recall # B-0019-3.
CODE
a) Units 03LV06498 (parts 1 and 2), 03LV06503 - part 2,
03LV06512-part 2, 03LV06516-part 1, 03LV06520-part 1,
03LV06524-part 1, 03LV06527-part 1, 03LV06529-part 1,
03LV06535-parts 1 and 2, 03LV06537-parts 1 and 2.
b) Units 03LV06503 - part 1, 03LV06508, 03LV06510,
03LV06518 - parts 1 and 2, 03LV06524 - part 2,
03LV06530, 03LV06541, 03LV06543.
RECALLING FIRM/MANUFACTURER
American Red Cross, Southern Region, Atlanta, GA, by letter dated June 7, 2002. Firm initiated recall is complete.
REASON
Blood products, labeled as Leukocytes Reduced, but did not meet the requirements for a leukoreduced product, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 13 units;
b) 9 units.
DISTRIBUTION
GA.

_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0021-3;
b) Recovered Plasma, Recall # B-0022-3.
CODE
a) and b) Unit 07FL04787.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Arizona Region, Tucson, AZ, by letter dated March 13, 2002 and by fax dated March 20, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose eligibility to donate was not adequately verified, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AZ.

_____________________________
PRODUCT
Platelets, Recall # B-0026-3.
CODE
Unit 1890459.
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Lexington, KY, by letter dated July 12, 2002. Firm initiated recall is complete.
REASON
Platelets, collected from a donor that had ingested aspirin in the previous 36 hours, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.

_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0027-3;
b) Platelets, Leukocytes Reduced, Recall # B-1128-3.
CODE
a) and b) Unit 42FY32369.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Northern Ohio Region, Cleveland, OH, by letter dated May 15, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH.

_____________________________
PRODUCT
Source Plasma, Recall # B-0029-3;
CODE
Unit FDGKPM.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aventis-Bio Services, Inc., Knoxville, TN, by fax dated September 12, 2002.
Manufacturer: Aventis Bio-Services, Inc., Canton, OH.
Firm initiated recall is complete.
REASON
Source Plasma, collected in a manner that lacked assurance of sterility, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.

_____________________________
PRODUCT
Source Plasma, Recall # B-0030-3.
CODE
Unit 73115878.
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services, L.P., Deerfield, IL, by fax dated May 22, 2002.
Manufacturer: BioLife Plasma Services, L.P., Newport, KY.
Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor who did not answer a medical history question concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0031-3.
CODE
Units 40GK35778, 40GF41090, 40GR56470, 40GR57799, 40GC65117, 40GS63295, 40GC68591.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Heart of America Region, Peoria, IL, by letter dated August 7, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was using Tazorac for psoriasis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION
IL and CA, AK and AL.

_____________________________
PRODUCT
Source Plasma, Recall # B-0032-3.
CODE
G-49190-178, G-48945-178, G-47790-178, G-47485-178,
G-47258-178, G-46994-178, G-46416-178, G-46320-178,
G-45821-178, G-45467-148, G-45188-178, G-44777-178,
N-08747-178, N-08714-178, G-16389-178, G-16227-178,
N-06132-178, N-06120-178, G-15307-178, G-15234-178,
G-14876-178, G-14731-178, G-14416-178, G-14240-178,
G-13916-178, G-13744-178, G-13304-178, G-13000-178,
G-12833-178, G-12518-178, G-12360-178, G-12047-178,
G-11896-178, G-11540-178, G-11431-178, G-11081-178,
G-10837-178, G-10578-178, G-10185-178, G-09361-178,
G-09215-178, G-08854-178, G-08687-178, G-08352-178,
G-08189-178, G-07816-178, G-07636-178, G-07260-178,
G-07109-178, G-06780-178, G-06603-178, G-06215-178,
G-06042-178, G-05684-178, G-05537-178, G-05191-178,
G-05005-178, FT90022327, FT90022144, FT90020708, FT90020511, FT90019498, FT90019374, FT90019005, FT90016806, FT90015282, FT90007542, G-49467-178,
G-49695-178, G-61585-178, G-62340-178, G-63025-178,
G-63189-178, DDBBHW, DDBBKV, DDBBQR, DDBBWH, DDBBYZ, DDBCFD, DDBCHH, DDBCMW, DDBCQP, DDBCWC, DDBDCM, DDBPGY.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Melrose Park, IL, by fax dated May 22 and June 5, 2002. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor who tested positive for syphilis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
85 units.
DISTRIBUTION
IL, CA and GA.

_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0034-3.
CODE
Unit numbers 10722-2754 and 10727-0732.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated July 2, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AZ.

_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0035-3.
CODE
Unit number 10728-2634.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on June 12, 2002 and by letter on July 18, 2002.
Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AZ.
____________________________
PRODUCT
Source Plasma, Recall # B-0036-3.
CODE
Unit numbers 9WX430, 9WX442, 9WX470, 9WX491, 9WX530, 9WX540, 9WX576, FLBVJT, FLBVKN, FLBWDF, FLBWHD, FLBWJY, FLCMMF, FLCMRR, and FLCNCX.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Waco, TX, by letter on July 11, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to illegal drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units.
DISTRIBUTION
IL.

_____________________________
PRODUCT
Red Blood Cells, Recall # B-0039-3.
CODE
Unit number 3852037.
RECALLING FIRM/MANUFACTURER
Department of the Army, Walter Reed Army Medical Center Blood Bank, Washington, D.C., by letter dated July 2, 2001.
Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NM.

_____________________________
PRODUCT
Red Blood Cells, Recall # B-0040-3
CODE
Unit number C07821.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter dated March 18, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

_____________________________
PRODUCT
a) Red Blood Cells, Recall # B-0041-3;
b) Platelets Irradiated, Recall # B-0042-3.
CODE
a) and b) Unit number M72291.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter dated April 26, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA.

_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0043-3.
CODE
Unit number 29FV52085.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by letter dated March 7, 2002.
Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0044-3.
CODE
Unit number 53FJ77232.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letter dated January 16, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Maryland.

_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0045-3;
b) Fresh Frozen Plasma, Recall # B-0046-3.
CODE
a) and b) Unit number 53GQ93875.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by telephone on March 8, 2002 and by letter dated March 13, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to medication with the drug Purinethol, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MD.

_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B0047-3.
CODE
Unit numbers 8719675 and 8744908.
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, by letter dated July 25, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for the antibody to hepatitis B core antigen (anti-HBc), but were collected from a donor that had been previously deferred for reactive testing for anti-HBc, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

_____________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0010-3.
CODE
Units 40FP10666, 40P76999, 40P76998, 40P76973, 40P76981.
RECALLING FIRM/MANUFACTURER
American Red Cross, Atlanta, GA, by letter dated June 20, 2002. Firm initiated recall is complete.
REASON
Blood products, that lacked assurance of proper temperatures during shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
GA.

_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0014-3.
CODE
Unit 11GK52088.
RECALLING FIRM/MANUFACTURER
American Red Cross, Southern Region, Atlanta, GA, by letter dated May 20, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking Propecia, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
GA.

_____________________________
PRODUCT
Whole Blood, Autologous, Recall # B-0020-3.
CODE
Units 03KL106500, 03KL10608, 03KL10616, 03KL10617.
RECALLING FIRM/MANUFACTURER
American Red Cross, Southern Region, Atlanta, GA, by letter dated June 20, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected in expired collection bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
GA and MD.

_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0023-3;
b )Recovered Plasma, Recall # B-0024-3.
CODE
a) and b) Unit 42FM34325.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Northern Ohio Region, Cleveland, OH, by telephone on May 15, 2002 and by letter dated May 17, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose arm inspection was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH and CA.

_____________________________
PRODUCT
Source Plasma, Recall # B-0025-3.
CODE
Unit 53-DDJBTY-0.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Melrose Park, IL, by fax dated June 28, 2002. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0033-3.
CODE
Unit numbers 10730-1553, 10730-1570, 10730-4427, 10730-4434, 10730-4437, 10730-4439, 10730-5852, 10730-6371, 10730-7753, and 10730-7761.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter on June 11, 2002. Firm initiated recall is complete.
REASON
Blood products possibly exposed to unacceptable shipping temperatures were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units.
DISTRIBUTION
AZ.

_____________________________
PRODUCT
Red Blood Cells, Recall # B-0037-3.
CODE
Unit number 4814468.
RECALLING FIRM/MANUFACTURER
Department of the Navy, National Naval Medical Center Blood Bank, Bethesda, MD, by e-mail on December 22, 2001.
Firm initiated recall is complete.
REASON
Blood product, that did not have the additive solution included, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Saudi Arabia.

_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated.
Recall # B-0038-3.
CODE
Unit numbers 35GY19459 and 35GC11150.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Appalachian Region, Roanoke, VA, by letter dated May 7, 2002. Firm initiated recall is complete.
REASON
Blood products that were possibly out of controlled storage for more than 30 minutes were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA.

_____________________________
PRODUCT
Platelets Pheresis, Recall # B-0048-3.
CODE
Unit number 35P35968 (distributed as two split products).
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Appalachian Region, Roanoke, VA, by letter dated January 10, 2002. Firm initiated recall is complete.
REASON
Blood products, possibly exposed to unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA.

_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0056-3.
CODE
Unit 10728-8173.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ
Manufacturer: United Blood Services, Scottsdale, AZ, by telephone on April 8, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor who had recently had surgery, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AZ.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

_____________________________
PRODUCT
Roche brand Elecsys 2010 clinical chemistry analyzers. Recall # Z-0005-3.
CODE
Serial numbers 1058-11, 1164-70 and 0806-10.
(All analyzers with software version 06-01.)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by telephone on August 8, 2002.
Manufacturer: Hitachi Ltd., Instrument Division, Ibaraki-ken, Japan. Firm initiated recall ongoing.
REASON
Possibile incorrect breast cancer marker results.
VOLUME OF PRODUCT IN COMMERCE
3.
DISTRIBUTION
IL and WV.

_____________________________
PRODUCT
Access 2 Immunoassay System--Beta Human Chorionic Gonadotropin Reagent. Recall # Z-0006-3.
CODE
Lots 104702 and 104703.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by telephone or letter on or about July 31, 2002. Firm initiated recall is ongoing.
REASON
Stability.
VOLUME OF PRODUCT IN COMMERCE
1508 kits.
DISTRIBUTION
Nationwide and Canada.

_____________________________
PRODUCT
Medline Total Hip Pack Custom Sterile Kit.
Recall # Z-0009-2.
CODE
Catalog #DYNJ19079B, lot 02GD1484.
RECALLING FIRM/MANUFACTURER
Medline Industries, Inc., Waukegan, IL, by visit on September 6, 2002. Firm initiated recall is complete.
REASON
Questionable sterility.
VOLUME OF PRODUCT IN COMMERCE
8 kits.
DISTRIBUTION
KY.

_____________________________
PRODUCT
Toilet Seats, part number 50, used with several different models that do and do not lift patients to standing position. Recall # Z-0014-3.
CODE
All serial numbers of models listed.
RECALLING FIRM/MANUFACTURER
Mobility Inc., San Diego, CA, by letter dated February 5, 2002. Firm initiated recall is complete.
REASON
Patient assist toilet seat locks up and won't lift patient to standing again.
VOLUME OF PRODUCT IN COMMERCE
193 parts, toilet seats.
DISTRIBUTION
Nationwide and Internationally.

_____________________________
PRODUCT
Somatom Model #
7005502 --Sensation 4
4806118 --Volume Zoom
7114023 --Volume Access
3810152 --Balance
3810160 --Emotion
3810160 --Emotion Duo
3810079 --Esprit
3810137 --Esprit +
Recall # Z-0016-3.
CODE
300 Serial Numbers.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Systems, Inc., Iselin, NJ, by letter in June 2002.
Manufacturer: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing.
REASON
A false patient name will appear when MPPS function is used.
VOLUME OF PRODUCT IN COMMERCE
300.
DISTRIBUTION
CT.

_____________________________
PRODUCT
ICONOS R200 tilting X-Ray table. Recall # Z-0017-3.
CODE
Siemens part #: 70 30 518.
Serial Numbers: 01006, and 01008.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Systems, Inc., Iselin, NJ, by letter July 26, 2002.
Manufacturer: Siemens Medical Solutions Erlangen, Germany.
Firm initiated recall is ongoing.
REASON
Due to metal washers, the tilt drive is reduced.
VOLUME OF PRODUCT IN COMMERCE
2.
DISTRIBUTION
MA.

_____________________________
PRODUCT
Cordis DUCOR Angiographic Catheter, TS 6F .038 100CM JR4 MOD, Diagnostic Catheter. Recall # Z-0018-3.
CODE
Catalog Number MODC13312, lot number K1101455.
RECALLING FIRM/MANUFACTURER
Cordis Corp., Miami Lakes, FL, by visit on or about January 31, 2002. Firm initiated recall is complete.
REASON
Packages units seals may be opened compromising Sterility Barrier.
VOLUME OF PRODUCT IN COMMERCE
795.
DISTRIBUTION
OH, MN, MI and AR.

_____________________________
PRODUCT
The firm is Field correcting with a warning sticker their SRI Disposable Procedure Packs containing Kimberly Clark Corp. ORTHOARTS Lower Extremity Drapes, Non-Sterile, stock code 79278-10, ORTHOCARTS Lower Extremity Drapes, Stock Code 89278-10, ORTHOCARTS Hip Drape, Non-Sterile, Stock Code 79346-10 and ORTHOCARTS Hip Drape, Stock Code 89346-10, ORTHOARTS drapes Stock number 79267-10 and also ORTHOARTS drapes Stock Number 89267-10, various lot numbers. Kimberly Clark notified them initially on 12/19/01 and again on 1-31-02 (additional products and codes) of the recall (ATL monitored recall classified under Z-784/796-2) and the component was repacked into one of their Surgical Kits that had to be field corrected in the field with a warning sticker.The surgical kits under correction are labeled as: (1) "SADDLEBACK MEMORIAL ARTHROSCOPY PACK, REORDER # ORO433A LOT # 20077 EXP DATE 10/01/04; (2) GARDEN CITY HOSPITAL ORTHO KNEE PACK RECORDER # ORO665B, LOT # 20490, EXP. DATE 4/01/03; (3) GARDEN CITY HOSPITAL KNEE ARTHROSCOPY PACK, RECORDER # ORO667, LOT # 20491, EXP. DATE 04/01/06; (4) E OKLAHOMA OUTPATIENT STERILE EXTREMITY REORDER # ORO375 LOT # 10174, EXP. DATE 03/01/04 SRI/STERILE RECOVERIES. Recall # Z-0020-3.
CODE
Product Code ORO433A Lot Numbers: 18427, 18588, 19294, 20077;
Product Code OR0665B Lot Numbers: 19910, 20490, 21171;
Product Code ORO0375 Lot Number: 10174;
Product Code ORO667 Lot Number: 21547.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sterile Recoveries, Inc./Surgical Express Inc., Plant City, FL, by letters on December 20, 2001.
Surgical Express, Plant City, FL. Firm initiated recall is complete.
REASON
Supplier is recalling because the product may compromise the sterile field.
VOLUME OF PRODUCT IN COMMERCE
268.
DISTRIBUTION
CA, MI and OK.

_____________________________
PRODUCT
Apligraf (Graftskin). Recall # Z-0021-3
CODE
Lot Number: GS0206.20.01.

RECALLING FIRM/MANUFACTURER
Organogenesis Inc., Canton, MA, by telephone and fax on September 6, 2002. Firm initiated recall is complete.
REASON
Product may be contaminated with mycoplasma.
VOLUME OF PRODUCT IN COMMERCE
117.
DISTRIBUTION
Nationwide.

_____________________________
PRODUCT
Bicor Hi-P and Neuorostar Hi-P Angiographic systems. Recall # Z-0022-3.
CODE

  Part No.      Serial Nos.
  62 58 383     01001-01173
  63 79 767     02001-02099
  62 58 425     01001-01030
  63 79 668     01101-01209.

_____________________________
PRODUCT
AVA3X Advanced Venous Access Device (introducer valve)

Model numbers:
IAVA3XI
M3L85FHS
M3L85FHSI
M3L85FHK
M3L85FHKI
M3L85FHK12
M3L85FHKIN
M3L85FKI.
Recall # Z-0023-3.
CODE

  942C0182 942D0480
  942C0183 942D0481
  942C0184 942D0497
  942CC185 942DC479
  942CC186 942E0662
  942CC187 942E0663
  942CC188 942E0666
  942CC189 942EC664
  942CC190 942EC665
  942C0191 942EC741
  942D0474 942G0157
  942D0475 942GC162
  942D0477 952CC326
  952DC602

_____________________________
PRODUCT
Encore Brand, linear array, phased array, curved array, and microconvex probes:
Model No. LK5.38EX, Encore L5, 5.5 MHz Linear probe
Model No. LK7.38EX, Encore L7, 7.0 MHz linear probe
Model NO. PK4.28EX, Encore V4, 3.5 MHz phased array probe
Model No. CK4.60EX, Encore C3, 3.5 MHz curved probe
Model No. CK6.10IX, Encore EC7, 6.5 MHz microconvex probe
Each probe is serialized. Individual probes are packaged in a cardboard carrying case with inner foam padding. Each shipper would contain 3 case units. There is no physical labeling on the product that identifies the product brand names as indicated above. Each probe unit is tagged with only the following information: a serial number and the model number or patrial brand name such as "C3" or "V4". Recall # Z-0024-3.
CODE
Serial Number
1930 (36 pcs)
CK460EX-R:
00001
00002
00J100
00J101
00K102
00K103
00K104
00K105
00K106
00K107
00K108
01C131
00N110
00N112
00N111
01A113
01A114
01A115
01A116
01B117
01B118
01B119-1
01B120
01C121
01C122
01C123
01C124
01C125
01C126
01D136
01E137
01E138
01E139**
01E140**
01E141
01F151

1931 (31 PCS)
PK428EX-R
00001
00002
00J100
00K101**
00K102*
00K103**
00K104*
00M105**
00M106**
00N107**
00N108-1**
00N109**
00N110*
01A111
01A112
01A113
01A114
01A115*
01A116*
01A117
01B118**
01N119
01E124**
01E125*
01E126*
01E127*
01E128*
01E129*
01E130*
01E131
01E132

1995 (84 PCS)
CK460EX
01C127
01C128**
01C129**
01C130**
01C132**
01C133**
01C134**
01C135**
01F142**
01F143**
01F144**
01F145**
01F146**
01F147
01F148
01F149
01F150
01G152**
01G153
01G154**
01G155**
01G156**
01G157**
01G158**
01G159**
01G160**
01G161
01G162**
01G163**
01G164**
01G165**
01G166**
01G167
01H168
01H169**
01H170**
01H171
01H172**
01H173**
01J175**
01J176**
01J177**
01J178**
01J179**
01J180**
01J181**
01J183**
01J184**
01K185
01K186**
01K187**
01K188**
01K189**
01K190**
01K191**
01K192**
01K193**
01K194**
01K195**
01J182**
01M196**
01M197**
01M198**
01M199**
01N200
01N201**
01N202
01N203**
01N204
01N205**
01N206**
01N207**
01N208**
01N209**
01N210**
01N211
01N212
01N213
01N214**
01N215**
01N216**
01N217
01N218**
01N219**

1995 (4PCS)
PK428EX
01C120*
01C121*
01C122*
01C123*

1996 (10 PCS)
LK738EX
PP01-1
PP02**
PP03
PP04
PP05
PP06
PP07
PP08**
PP09
PP10

1999 (34 PCS)
EC7
01H001
01H002**
01K003
01K004
01K005
01K006
01M007**
01M008**
01M009
01M010
01M011**
01M012**
01M013**
01M014
01M015
01M106
01M107**
01N018
01N019**
01N020**
01N021**
01N022**
01N023**
01N024**
02A025**
02A026**
02A027**
02A028**
02A029**
02A030**
02A31**
02A32**
02A33**
02A34**

2076 (20 PCS)
LK738EX
PP1
PP12-3**
PP13**
01M001
01M002**
01M003**
01M004
01M005**
01M006**
01M007-1**
01M008-1**
01M009-2**
01M010-2**
01M011-1**
01N012**
01N013**
01N014
01N015
02A016
02A017**

2077 (17 PCS)
LK538EX
PP01
PP02
PP03-4**
PP04
PP05-4**
PP06
PP07
PP08-3**
PP09**
PP10-4**
PP11-4**
PP12-5**
PP13-4**
PP14-3**
PP15-3**
PP16**
PP17**
RECALLING FIRM/MANUFACTURER
Recalling Firm: Thales Components Corporation, Totowa, NJ, by fax and letter dated June 7, 2002.
Manufacturer: Thales Microsonics, Sophia Antipolis Cedex, France. Firm initiated recall is ongoing.
REASON
Excessive heat generated from probes.
VOLUME OF PRODUCT IN COMMERCE
236.
DISTRIBUTION
MA.

_____________________________
PRODUCT
CMI Velvet Touch Vacuum Extractor Cup Reusable Soft Silicone Cup for Vacuum Assisted Childbirth, Ref 202VT. Individually packaged. Non-Sterile. Latex free. Metal handle is stamped with the number 120301.
Recall # Z-0025-3.
CODE
Part Number: 202 VT, CMI Velvet Touch Cup, Lot 112179,
Reusable Silicon Vacuum Cup, Lot 120748.
RECALLING FIRM/MANUFACTURER
Utah Medical Products, Inc., Midvale, UT, by letter on September 13, 2002. Firm initiated recall is ongoing.
REASON
Chrome plating reported flaking from the device handle.
VOLUME OF PRODUCT IN COMMERCE
67.
DISTRIBUTION
Nationwide, Canada and Israel.

_____________________________
PRODUCT
Baxter Swivel Wye Anesthesia Breathing Circuits:
a) Baxter Isoflex Adult Anesthesia Breathing Circuit with
Swivel Wye, Gas Sampling Elbow with Luer Lock Port, and
2 Liter Roughcoat Bag. Recall # Z-0026-3;
b) Baxter Isoflex Adult Anesthesia Breathing Circuit with
Swivel Wye, Gas Sampling Elbow with Luer Lock Port, and
3 Liter Bag. Recall # Z-0027-3;
c) Baxter Isoflex Adult Anesthesia Breathing Circuit with
Swivel Wye, Gas Sampling Elbow with Luer Lock Port,
Two-Way Filter (Bacterial/Viral Retentive) and 3 Liter
Bag. Recall # Z-0028-3;
d) Baxter Isoflex Adult Anesthesia Breathing Circuit with
Swivel Wye with Luer Lock Gas Sampling Port, Two-Way
Filter (Bacterial/Viral Retentive) and 3 Liter Roughcoat
Bag. Recall # Z-0029-3;
e) Baxter Adult Anesthesia Breathing Circuit with Swivel
Wye, Gas Sampling Elbow with Luer Lock Port, Two-Way
Filter (Bacterial/Viral Retentive) and 3 Liter Bag.
Recall # Z-0030-3;
f) Baxter Adult Anesthesia Breathing Circuit with Swivel
Wye, Gas Sampling Elbow with Luer Lock Port, and 3
Liter Bag. Recall # Z-0031-3;
g) Baxter Thick-Cuff Adult Anesthesia Breathing Circuit
with Swivel Wye, Gas Sampling Elbow with Luer Lock
Port,and 3 Liter Bag. Recall # Z-0032-3;
h) Baxter Thick-Cuff Adult Anesthesia Breathing Circuit
with Swivel Wye, Gas Sampling Elbow with Luer Lock Port,
Two-Way Filter (Bacterial/Viral Retentive) and 3 Liter
Bag. Recall # Z-0033-3;
i) Baxter Adult Anesthesia Breathing Circuit with Swivel
Wye with Luer Lock Gas Sampling Port, Two-Way Filter
(Bacterial/Viral Retentive) and 3 Liter Roughcoat Bag.
Recall # Z-0034-3;
j) Baxter Adult Anesthesia Breathing Circuit with Swivel
Wye with Luer Lock Gas Sampling Port, and 3 Liter
Roughcoat Bag. Recall # Z-0035-3;
k) Baxter Adult Anesthesia Breathing Circuit with Swivel
Wye with Luer Lock Gas Sampling Port, Gas Sampling Elbow
with Luer Lock Port, and Two-Way Filters
(Bacterial/Viral Retentive). Recall # Z-0036-3.
CODE
a) catalog 2L3844, lots R01K12986, R01K13018;
b) catalog 2L3919, lots R01K15070, R01K15211;
c) catalog 2L3920, lots R01L09014, R01K12218, R01K13091,
R01L19112, R02F12315, R02G17130, R02G30125, R02G30232,
R02H06016;
d) catalog 2L3926, lot R02G10150;
e) catalog 2L3952, lots R02F05012, R02F06317, R02F16019,
R02G16017, R02G16082, R02G16165;
f) catalog 2L3953, lots R02G08105, R02G30281, R02H12147;
g) catalog 2L3963, lots R02F06259, R02F25143;
h) catalog 2L3965, lot R02F06242;
i) catalog 2L3967, lots R02G21017, R02H08061;
j) catalog 2L3968, lot R02H12139;
k) catalog 2L4333, lot R02G29028.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letter dated September 5, 2002.
Manufacturer: Baxter Healthcare Corp., Cartago, Costa Rica.
Firm initiated recall is ongoing.
REASON
Cracks in anesthesia breathing circuits may cause inadequate ventilation.
VOLUME OF PRODUCT IN COMMERCE
54,509 units.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

_____________________________
PRODUCT
Contact Lenses. Recall # Z-0007-3.
CODE
Lot number 0001707, expiration 2007/04.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ciba Vision Corp., Duluth, GA, by letter on September 20, 2002.
Manufacturer: CIBA Vision Corp., DesPlaines, IL.
Firm initiated recall is ongoing.
REASON
Mislabeling on packages of multipak lenses.
VOLUME OF PRODUCT IN COMMERCE
50 six-pack cartons.
DISTRIBUTION
Nationwide.

_____________________________
PRODUCT
Remel Chocolate Agar, Product #01301, for use in the culturing of pathogenic Neisseria and Haemophilus, packaged 15 plates/pkg. Recall # Z-0008-3.
CODE
Lot 231162, Exp. 9/26/02.
RECALLING FIRM/MANUFACTURER
Remel Inc., Lenexa, KS, by telephone and letter on August 29, 2002. Firm initiated recall is ongoing.
REASON
Doesn't exhibit growth of Haemophilus influenzae ATCC10211.
VOLUME OF PRODUCT IN COMMERCE
5,580 plates.
DISTRIBUTION
KS, MO, MN, IA, FL, CA, IL, WI and RI.

_____________________________
PRODUCT
Medtronic Bo-ject DHF 37 Disposable Hypodermic Needle Electrode, 37 mm x 0.41 mm, Product Catalog Number 9013S0441. Recall # Z-0015-3.
CODE
Lot 2773196.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Gastroenterology and Urology Shoreview, MN, by letter on August 15, 2002.
Manufacturer: Medtronic A/S 2740 Skovlunde. Firm initiated recall ongoing.
REASON
Some of the recalled hypodermic needle electrodes have blocked or partially blocked needle cannulas, leading to no or insufficient flow.
VOLUME OF PRODUCT IN COMMERCE
264 Disposable Hypodermic Needle Electrodes.
DISTRIBUTION
CA, MN, NC and Denmark, Finland, Greece and Switzerland.

_____________________________
PRODUCT
Bausch & Lomb CX5710 Viscous Fluid Injector Accessory Pack. Recall # Z-0019-3.
CODE
Lot Numbers 0104251244 and 0200211245.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bausch & Lomb Surgical, Inc., St. Louis, MO, by letter on August 7, 2002.
Manufacturer: Escalon Trek Medical, New Berlin, WI.
Firm initiated recall is ongoing.
REASON
The flange of the syringe included within the CX5710 Viscous Fluid Injection Accessory Pack is too large to properly fit into the syringe coupler.
VOLUME OF PRODUCT IN COMMERCE
351 boxes (6 accessory packs per box, 2,106 units in total).
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II

_____________________________
PRODUCT
Land O'Lakes Farmland Feed 32% Grow Big Floater, For Catfish Grown In Ponds or Artificial Culture Systems, packaged in 50-lb. bags, product #1960014, contains animal protein products. Recall # V-003-3.
CODE
None.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Land O'Lakes Farmland Feed LLC, Arden Hills, MN, by fax on August 21, 2002.
Manufacturer: Land O'Lakes Farmland Feed LLC, Kansas City, KS. FDA initiated recall is complete.
REASON
Label lacks BSE warning statement.
VOLUME OF PRODUCT IN COMMERCE
Approx. 18,872/50-lb. bags.
DISTRIBUTION
KS, TX, CO, NE, IL, MO, IA, OK and SD

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS III

_____________________________
PRODUCT
Fort Dodge Arquel, Meclofenamic Acid 500 mg., 10/10-gram packets per carton, ea. packet contains 500 mg. meclofenamic acid as a 5% granulation, RX, NADA 95-641, product of Canada, indicated for the oral treatment of acute or chronic inflammatory diseases involving the musculoskeletal system of the horse. Recall # V-002-3.
CODE
Lot #16994, Exp. Jun 02
Lot #22422, Exp. Apr 03.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fort Dodge Animal Health Fort Dodge, IA, by telephone on December 14, 2001.
Manufacturer: Trillium Health Care Manufacturing Inc., Brockville, Ontario, Canada. Firm initiated recall is complete.
REASON
Dissolution failure.
VOLUME OF PRODUCT IN COMMERCE
4,679/10-packet boxes.
DISTRIBUTION
Nationwide.

_____________________________
PRODUCT
Fort Dodge Panolog Ointment, Nystatin-Neomycin Sulfate-
Thiostrepton-Triamcinolone Acetonide Ointment USP, for use in dogs and cats only, packaged in 7.5- and 15-ml. tubes, each ml contains 100,000 units nystatin, 2.5 mg. neomycin sulfate equivalent to neomycin base, 2,500 units thiostrepton, and 1-mg. triamcinolone acetonide in Plastibase (plasticized hydrocarbon gel), RX, NADA #012-258, used in the treatment of acute and chronic otitis, interdigital cysts, in anal gland infections in dogs, and for dermatologic disorders. Recall # V-004-3.
CODE
Lot 1284207, Exp. Feb 02 (15 ml.)
Lot 1284206, Exp. Jun 02 (7.5 ml).
RECALLING FIRM/MANUFACTURER
Fort Dodge Animal Health Fort Dodge, IA, by telephone on December 14, 2001 and April 2, 2002. Firm initiated recall is complete.
REASON
Out of specification for nystatin at 20-month stability test point.
VOLUME OF PRODUCT IN COMMERCE
60,900/15-ml. tubes and 195,995/7.5-ml. Tubes.
DISTRIBUTION
Nationwide.

END OF ENFORCEMENT REPORT FOR OCTOBER 16, 2002

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