FDA

Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, U.S. Public Health Service, Department of Health and Human Services. It contains information on actions taken in connection with agency regulatory activities.
July 29, 1998 98-30

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

PRODUCT
Lite Smoked Salmon Spread, in pre-printed 6.5 ounce plastic containers. Recall #F-547-8.

CODE
AUG 13 1998.

MANUFACTURER
Indian River Quality Products, Plant City, Florida.

RECALLED BY
Manufacturer, by telephone and visit beginning on June 24, 1998, and by press release on June 26, 1998. Firm-initiated recall complete.

DISTRIBUTION
Florida.

QUANTITY
25 cases were distributed.

REASON
Product is contaminated with Listeria monocytogenes.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

PRODUCT
Gae Pi Dduk and Jeol Pyun Rice Cakes, in 1 pound packages. Recall #F-544/545-8.

CODE
All product.

MANUFACTURER
Kim Milling Company, Newport News, Virginia.

RECALLED BY
Manufacturer, by telephone on June 15, 1998. Firm-initiated recall complete.

DISTRIBUTION
Virginia.

QUANTITY
Firm estimates none remains on the market.

REASON
Product contains the following undeclared colors: FD&C Yellow No. 5 and FD&C Blue No. 1.

PRODUCT
Frozen Yellowfin Tuna Steaks, Archepelago brand, vacuum packed in plastic, net weight 10 pounds. Recall #F-550-8.

CODE
All dates up to the date of importation 6/11/97.

MANUFACTURER
Pt. Tirta Raya Mina (Persero), Jakarta, Indonesia.

RECALLED BY
Linden Trading Company, Inc., Compton, California, by fax on May 28, 1998. Firm-initiated recall complete.

DISTRIBUTION
Massachusetts, Pennsylvania, Florida.

QUANTITY
3,575 10-pound cartons were distributed.

REASON
High histamine levels in the product caused people to become ill.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III

PRODUCT
Metompkin brand Pasteurized Claw Crab Meat in 16 ounce cans. Recall #F-546-8.

CODE
All cans distributed between June 7, 1998 and June 11, 1998.

MANUFACTURER
Metompkin Bay Oyster Co., Crisfield, Maryland.

RECALLED BY
Inland Seafood, Atlanta, Georgia, by letter on June 11, 1998. Firm-initiated recall complete.

DISTRIBUTION
Georgia, North Carolina, South Carolina, Tennessee.

QUANTITY
249 1-pound cans were distributed.

REASON
Product is unfit for food due to cans having a bad smell and excess gas.

PRODUCT
Orangina and Orangina Light Sparkling Citrus Beverages, in 1 liter glass bottles: a) Orangina; b) Orangina Light. Recall #F-548/549-8.

CODE
Lot numbers: a) 7246, 7247, 7248, 7314, 7318, 7319, 7328, 7330, 7332, 8064, 8065 and 8068; b) 7245, 7317 and 7329.

MANUFACTURER
Canada Dry Bottling Company of New York, College Point, New York.

RECALLED BY
Austin, Nichols & Company, Inc., New York, New York, by press release faxed on April 2, 1998, followed by telephone, and by letter dated April 8, 1998. Firm-initiated recall complete.

DISTRIBUTION
a) Nationwide, Dominican Republic; b) Massachusetts, New Hampshire, Pennsylvania, Georgia, Colorado, Florida, California, Dominican Republic, Canada.

QUANTITY
a) 102,609 cases; b) 2,365 cases (12 bottles per case) were distributed.

REASON
Product is unfit for food due to being fermented.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I

PRODUCT
Kentron Alcohol Free Mouthwash and Gargle (Cetyl Pyridinium Chloride), in 4 fluid ounce plastic bottles. Recall #D-191-8.

CODE
No lot or production code appears on the bottle or on the 96 ounce shipping cases or on the admissions kit boxes. #711-04 is the product number for the cases of 96 bottles and #201112M is the product number for the Deluxe Mauve Kit Admissions Kit.

MANUFACTURER
Phoenix Cosmetics Laboratories, Holbrook, New York.

RECALLED BY
Kentron Healthcare, Inc., Springfield, Tennessee, by telephone on Friday, June 12 and 15, 1998, followed by letter on June 16, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Georgia, California, Louisiana, Tennessee, Florida, Arizona, Wisconsin, Texas, Pennsylvania, Mississippi.

QUANTITY
346 cases, 96 4-ounce bottles each, and 346 cases, 12 admissions kits each were distributed.

REASON
Microbial contamination: Burkholderia cepacia, Pseudomonas aeruginosa, and Klebsiella oxytoca.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

PRODUCT
Nitroglycerin Capsules, Rx drug used in the prevention and
treatment of angina pectoris associated with coronary artery
disease in bottles of 60 and 100, under the following labels: 
Time-Cap, URL, Ethex, Goldline, Kenwood, Qualitest, and Rugby:
a) Nitroglycerin Capsules, Extended Release, 2.5 mg
NDC numbers: 49483-221-10 (Time-Cap Labs 100 capsules),
             0482-1025-01 (Kenwood 100 capsules)
             0603-4782-21 (Qualitest 100 capsules)
             58177-004-03 (Ethex 60 capsules)
             58177-004-04 (Ethex 100 capsules)
             0536-4083-01 (Rugby 100 capsules)
             0677-0485-01 (URL 100 capsules)
b) Nitroglycerin Capsules, Extended Release, 6.5 mg
NDC numbers: 49483-222-06 (Time-Cap Labs 60 capsules)
             0482-1065-01 (Kenwood 100 capsules)
             0603-4783-21 (Qualitest 100 capsules)
             0182-0703-01 (Goldline 100 capsules)
             0536-4084-01 (Rugby 100 capsules)
             0677-0486-01 (URL 100 capsules)
c) Nitroglycerin Capsules, Extended Release, 9.0 mg
NDC numbers: 49483-223-06 (Time-Cap Labs  60 capsules)
             49483-223-10 (Time-Cap Labs 100 capsules)
             0482-1090-01 (Kenwood 100 capsules)
             0603-4784-20 (Qualitest  60 capsules)
             0182-1670-26 (Goldline 60 capsules)
             58177-006-03 (Ethex 60 capsules)
             58177-006-04 (Ethex 100 capsules)
             0536-4090-08 (Rugby 60 capsules)
             0677-0967-06 (URL 60 capsules).
Recall #D-201/203-8.

CODE
Lot numbers: a) F056H EXP 6/2000, G024H EXP 7/2000, J062H EXP 9/2000; b) C046H EXP 3/2000, D036H EXP 4/2000, F044H EXP 6/2000; c) D005H EXP 4/2000.

MANUFACTURER
Time-Cap Labs, Inc., Farmingdale, New York.

RECALLED BY
Manufacturer, by letter dated June 8, 1998, followed by telephone. Firm-initiated recall ongoing.

DISTRIBUTION
Alabama, Arkansas, Connecticut, Florida, Illinois, Kentucky, Louisiana, Michigan, Missouri, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Puerto Rico, Canada.

QUANTITY
a) 3,615 60-count bottles; 53,943 100-count bottles, and 281,204 bulk capsules; b) 9,809 60-capsules bottles, 33,381 100-capsule bottles and 652,268 bulk capsules; c) 11,280 60-capsule bottles and 2,688 100-capsule bottles were distributed.

REASON
Unapproved ingredient used in manufacturing.

UPDATE
Recall #D-100/103-8, Propranolol HCL (Inwood Laboratories), which appeared in the March 25, 1998, April 1 and 15, 1998 Enforcement Reports has been extended as follows: Propranolol HCL, 60 mg, Extended Release (ER) Capsules, 60 mg, Lot numbers: 7H001, 7H002, 7H004 & 7H005; Propranolol HCL 80 mg, Extended Release (ER) Capsules, Lot number 7F050; Propranolol HCL, 120 mg, Extended Release (ER) Capsules, Lot number 7J041; Propranolol HCL, 160 mg, Extended Release (ER) Capsules, Lot numbers: 7F061, 7F063.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

PRODUCT
Guaifenesin Syrup with Codeine, (Guaifenesin 100 mg/Codeine Phosphate 10 mg), in 5 mL and 10 mL unit dose and 4 and 16 fluid ounce bottles. NDC numbers: 0121-0422-05 (5 mL unit dose), 0121-0422-10 (10 mL unit dose), 0121-0422-04 (4 oz. bottles), 0121-0422-16 (16 oz. bottles). Recall #D-200-8.

CODE
: 5 mL unit dose - Lot # 6K29, 7C17, 7E37; 10 mL unit dose - Lot # 6L30, 7A36, 7B34, 7C16, 7D30, 7E38; 4 fl. oz. bottles - Lot # 6E16, 6I13, 6K28, 6L29, 7A34, 7B33, 7C15, 7D24, 7E36; 16 fl. oz. bottles - Lot # 6I14.

MANUFACTURER
Pharmaceutical Associates, Inc., Greenville, South Carolina.

RECALLED BY
Manufacturer, by letter on April 23, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
5 mL - 228,440 units; 10 mL - 97,450 units 4 oz. - 143,803 units; 16 oz. - 720 units were distributed.

REASON
Subpotent for codeine phosphate (12 month stability).

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

PRODUCT
Fresh Frozen Plasma. Recall #B-633-8.

CODE
Unit numbers: 18R87577, 18R87581, 18R87612.

MANUFACTURER
American Red Cross Great Lakes Region, Lansing, Michigan.

RECALLED BY
Manufacturer, by letter dated December 24, 1997. Firm-initiated recall complete.

DISTRIBUTION
Michigan.

QUANTITY
3 units were distributed.

REASON
Blood products were collected from donors whose arm had not been scrubbed for a minimum of thirty seconds prior to venipuncture.

PRODUCT
Source Leukocytes. Recall #B-1243-8.

CODE
Unit #11K26077.

MANUFACTURER
American Red Cross Blood Services, St. Louis, Missouri.

RECALLED BY
Manufacturer, by telephone on April 30, 1997. Firm-initiated recall complete.

DISTRIBUTION
New Jersey.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who self-excluded and was not recalled prior to pooling due to a failure in record review.

PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-1292/1293-8.

CODE
Unit #53T55759.

MANUFACTURER
American Red Cross Blood Services, Baltimore, Maryland.

RECALLED BY
Manufacturer, by letter dated April 20, 1998. Firm-initiated recall complete.

DISTRIBUTION
Maryland.

QUANTITY
1 unit was distributed.

REASON
Blood products were collected from a donor taking the drug Methotrexate.

PRODUCT
Red Blood Cells. Recall #B-1314-8.

CODE
Unit #50LH03.

MANUFACTURER
American Red Cross Blood Services, Toledo, Ohio.

RECALLED BY
Manufacturer, by telephone on February 6, 1998, and by letter dated February 19, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who had no hemoglobin check recorded during screening.

PRODUCT
a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-1316/1318-8.

CODE
Unit numbers: a) 2540953, 2486751, 2479467; b) 2486751; c) 2540953, 2486751, 2479467.

MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, Indiana.

RECALLED BY
Manufacturer, by letter dated March 31, 1998. Firm-initiated recall complete.

DISTRIBUTION
Indiana, Pennsylvania, Switzerland.

QUANTITY
a) 3 units; b) 1 unit; c) 3 units were distributed.

REASON
Blood products were collected from a donor taking an experimental drug, Raloxifene.

PRODUCT
Red Blood Cells. Recall #B-1319-8.

CODE
Unit #12004246.

MANUFACTURER
W.E. & Lela I. Stewart Blood Center, Inc., Stewart Regional Blood Center, Tyler, Texas.

RECALLED BY
Manufacturer, by telephone on December 8, 1997. Firm-initiated recall complete.

DISTRIBUTION
Texas.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor with an elevated ALT.

PRODUCT
Red Blood Cells. Recall #B-1323-8.

CODE
Unit numbers: 11317-2290 and 11317-8818.

MANUFACTURER
United Blood Services, El Paso, Texas.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated April 15, 1998. Firm-initiated recall complete.

DISTRIBUTION
New Mexico and Texas.

QUANTITY
2 units were distributed.

REASON
Blood products were collected from a donor who traveled to an area considered endemic for malaria.

PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-1324/ 1325-8.

CODE
Unit #11317-4124.

MANUFACTURER
United Blood Services, El Paso, Texas.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated April 7, 1998. Firm-initiated recall complete.

DISTRIBUTION
New Mexico and Switzerland.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor whose screening for high risk behavior was incomplete.

PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma; c) Recovered Plasma. Recall #B-1328/1330-8.

CODE
Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled.

MANUFACTURER
American Red Cross Blood Services, Tucson, Arizona.

RECALLED BY
Manufacturer, by letters dated December 5, 23, or 26, 1997, January 2, 23, 26, 1998, February 2 or 5, 1998. Firm-initiated recall complete.

DISTRIBUTION
Arizona, Pennsylvania, Utah, California, Massachusetts.

QUANTITY
a) 73 units; b) 5 units; c) 67 units were distributed.

REASON
Blood products were incorrectly tested for syphilis.

PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma; c) Recovered Plasma. Recall #B-1331/1333-8.

CODE
Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled.

MANUFACTURER
American Red Cross Blood Services, Tucson, Arizona.

RECALLED BY
Manufacturer, by letters dated January 5 and 6, 1998, February 6, 1998, or by fax on January 5, 1998. Firm-initiated recall complete.

DISTRIBUTION
Arizona, Michigan, Utah, California.

QUANTITY
a) 66 units; b) 9 units; c) 58 units were distributed.

REASON
Blood products were incorrectly tested for syphilis.

PRODUCT
Platelet, Pheresis. Recall #B-1334-8.

CODE
Unit #40P60520.

MANUFACTURER
American Red Cross, Peoria, Illinois.

RECALLED BY
Manufacturer, by telephone on May 5, 1998, and by letter dated May 27, 1998. Firm-initiated recall complete.

DISTRIBUTION
Illinois.

QUANTITY
1 unit was distributed.

REASON
Blood product was inappropriately prepared with an unacceptable volume for the platelet yield.

PRODUCT
Fresh Frozen Plasma. Recall #B-1335-8.

CODE
Unit #13GM18226.

MANUFACTURER
American Red Cross, Detroit, Michigan.

RECALLED BY
Manufacturer, by letter dated March 2, 1998. Firm-initiated recall complete.

DISTRIBUTION
New York.

QUANTITY
1 unit was distributed.

REASON
Blood product corresponded to red blood cells which were returned because of confirmed clots.

PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-1336/ 1337-8.

CODE
Unit #14004-1468.

MANUFACTURER
United Blood Services, Baton Rouge, Louisiana.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letters dated February 17, 1998, March 3, 1998, and April 14, 1998. Firm-initiated recall complete.

DISTRIBUTION
Louisiana and Florida.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were drawn from an unsuitable donor.

PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-1338/ 1339-8.

CODE
Unit #36042-9697.

MANUFACTURER
United Blood Services, Ventura, California.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated February 17, 1998, and by fax on March 3, 1998, and April 14, 1998. Firm-initiated recall complete.

DISTRIBUTION
California and Switzerland.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were drawn from an unsuitable donor.

PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma; c) Recovered Plasma. Recall #B-1340/1342-8.

CODE
Unit numbers: a) 19024-6275, 19026-5184, 19019-1845; b) 19024-6275; c) 19026-5184.

MANUFACTURER
United Blood Services, Reno, Nevada.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letters dated March 3, 1998, and April 14, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nevada and North Carolina.

QUANTITY
a) 3 units; b) 1 unit; c) 1 unit was distributed.

REASON
Blood products were drawn from an unsuitable donor.

PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Recovered Plasma. Recall #B-1343/1346-8.

CODE
Unit numbers: a) 16050-9641, 16055-3362; b) 16050-9641, 16055-3362; c) 16055-3362; d) 16050-9641.

MANUFACTURER
United Blood Services, Meridian, Mississippi.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letters dated February 17, 1998, April 14, 1998, and March 3, 1998. Firm-initiated recall complete.

DISTRIBUTION
Mississippi, Montana, Switzerland.

QUANTITY
a) 2 units; b) 2 units; c) 1 unit; d) 1 unit.

REASON
Blood products were drawn from an unsuitable donor.

PRODUCT
a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-1350/1352-8.

CODE
Unit numbers: 13FJ23430 and 13FL70798.

MANUFACTURER
American Red Cross Blood Services, Detroit, Michigan.

RECALLED BY
Manufacturer, by telephone and letter dated November 14, 1997. Firm-initiated recall complete.

DISTRIBUTION
Michigan, California, New York.

QUANTITY
2 units of each component were distributed.

REASON
Blood products were collected from a donor who reported a history of jaundice.

PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma; c) Recovered Plasma. Recall #B-1353/1355-8.

CODE
Unit numbers: a) KE97719, KT86995, KT81739, KE85452; b) KE97719; c) KT86995, KT81739, KE85452.

MANUFACTURER
The Blood Center of Central Iowa, Des Moines, Iowa.

RECALLED BY
Manufacturer, by letter dated April 8, 1998, and June 27, 1998. Firm-initiated recall complete.

DISTRIBUTION
Iowa, New York, California, Switzerland.

QUANTITY
a) 4 units; b) 1 unit; c) 3 units.

REASON
Blood products were collected from a donor with a history of cancer.

PRODUCT
Platelets, Pheresis. Recall #B-1356-8.

CODE
Unit #2500289.

MANUFACTURER
Central Texas Regional Blood & Tissue Center, Austin, Texas.

RECALLED BY
Manufacturer, by telephone on March 10, 1998, followed by letter. Firm-initiated recall complete.

DISTRIBUTION
Texas.

QUANTITY
1 unit was distributed.

REASON
Platelets, Pheresis was collected from a donor who had taken a nonsteroidal anti-inflammatory drug within 72 hours of donation.

PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma. Recall #B-1358/1360-8.

CODE
Unit #1395275.

MANUFACTURER
LifeSource, Glenview, Illinois.

RECALLED BY
Manufacturer, by telephone on February 25, 1998, and July 7, 1998. Firm-initiated recall complete.

DISTRIBUTION
Illinois.

QUANTITY
1 unit of each component.

REASON
Blood products were collected from a donor who was taking the drug Tegison.

PRODUCT
Platelets. Recall #B-1361-8

CODE
Unit #2132432.

MANUFACTURER
LifeSource, Glenview, Illinois.

RECALLED BY
Manufacturer, by telephone on February 1, 1998. Firm-initiated recall complete.

DISTRIBUTION
Illinois.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor whose suitability was not adequately determined.

PRODUCT
Red Blood Cells. Recall #B-1362-8.

CODE
Unit #KE78278.

MANUFACTURER
Virginia Blood Services, Richmond, Virginia.

RECALLED BY
Manufacturer, by telephone on June 11, 1998, and by letter dated June 24, 1998. Firm-initiated recall complete.

DISTRIBUTION
Virginia.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who had identified the donation for confidential self exclusion.

PRODUCT
Red Blood Cells. Recall #B-1363-8.

CODE
Unit KP49240.

MANUFACTURER
Virginia Blood Services, Richmond, Virginia.

RECALLED BY
Manufacturer, by telephone on June 24, 1998. Firm-initiated recall complete.

DISTRIBUTION
Virginia.

QUANTITY
1 unit was distributed.

REASON
Autologous blood product, which tested repeat repeatedly reactive for the antibody to the Hepatitis B core antigen (anti-HBc), was distributed without a "Biohazard" label.

PRODUCT
Platelets, Pheresis. Recall #B-1364-8.

CODE
Unit #KZ50973.

MANUFACTURER
Virginia Blood Services, Richmond, Virginia.

RECALLED BY
Manufacturer, by letter dated July 1, 1998. Firm-initiated recall complete.

DISTRIBUTION
Virginia.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who had dental sutures removed on the day of donation.

PRODUCT
Platelets, Pheresis. Recall #B-1365-8.

CODE
Unit #40P60893.

MANUFACTURER
American Red Cross Blood Services, Peoria, Illinois.

RECALLED BY
Manufacturer, by letter dated June 2, 1998. Firm-initiated recall complete.

DISTRIBUTION
Illinois.

QUANTITY
1 unit was distributed.

REASON
Blood product was distributed with an unacceptable platelet yield.

PRODUCT
a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-1367/1369-8.

CODE
Unit #53G77058.

MANUFACTURER
American Red Cross Blood Services, Baltimore, Maryland.

RECALLED BY
Manufacturer, by letter dated April 22, 1998, and by "Questionable Plasma Inquiry" sent on May 15, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Maryland, Pennsylvania, California.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor who was taking the drug Tegison.

PRODUCT
Allergenic Extracts: AS Trees 1 Mix. Recall #B-1376-8.

CODE
Lot #A7010201.

MANUFACTURER
Allergy Laboratories of Ohio, Inc., Columbus, Ohio.

RECALLED BY
Manufacturer, by telephone on January 7, 1998, and by letter dated January 8, 1998. Firm-initiated recall complete.

DISTRIBUTION
Missouri.

QUANTITY
1 50-ml vial was distributed.

REASON
Allergenic extract product failed sterility testing.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

PRODUCT
Whole Blood. Recall #B-1257-8.

CODE
Unit #22KS29166.

MANUFACTURER
American Red Cross Blood Services, Philadelphia, Pennsylvania.

RECALLED BY
Manufacturer, by letter dated October 30, 1997. Firm-initiated recall complete.

DISTRIBUTION
Pennsylvania.

QUANTITY
1 unit was distributed.

REASON
Autologous blood product, tested repeat reactive for the antibody to the human T-lymphotropic virus 1 (anti-HTLV-1), was distributed contrary to the firms standard operating procedures.

PRODUCT
a) Platelets; b) Plasma, Frozen. Recall #B-1300/1301-8.

CODE
Unit numbers: a) 29FL49507, 29FS73501, 29KL08520; b) 29FS73501.

MANUFACTURER
American Red Cross Blood Services, Norfolk, Virginia.

RECALLED BY
Manufacturer, by letter dated April 2 and 24, 1998. Firm-initiated recall complete.

DISTRIBUTION
Virginia and North Carolina.

QUANTITY
a) 3 units; b) 1 unit was distributed.

REASON
Blood products were collected from three units of whole blood with extended collection times.

PRODUCT
Red Blood Cells. Recall #B-1320-8.

CODE
Unit #11008405.

MANUFACTURER
W.E. and Lela I. Stewart Blood Center, Inc., Stewart Regional Blood Center, Tyler, Texas.

RECALLED BY
Manufacturer, by telephone on January 14, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas.

QUANTITY
1 unit was distributed.

REASON
Blood product was labeled with an extended expiration date.

PRODUCT
Irradiated Red Blood Cells. Recall #B-1326-8.

CODE
Unit #3324022.

MANUFACTURER
Inland Northwest Blood Center, Spokane, Washington.

RECALLED BY
Manufacturer, by telephone on April 12, 1998. Firm-initiated recall complete.

DISTRIBUTION
Washington state.

QUANTITY
1 unit was distributed.

REASON
Blood product was labeled with an extended expiration date.

PRODUCT
Red Blood Cells. Recall #B-1327-8.

CODE
Unit #0310423.

MANUFACTURER
Inland Northwest Blood Center, Spokane, Washington.

RECALLED BY
Manufacturer, by letter dated January 16, 1998. Firm-initiated recall complete.

DISTRIBUTION
Washington state.

QUANTITY
1 unit was distributed.

REASON
Blood product was incorrectly tested for CMV.

PRODUCT
a) Fresh Frozen Plasma; b) Cryoprecipitated AHF. Recall #B-1347/1348-8.

CODE
Unit numbers: a) 50Y03750; b) 50LH00012, 50LH00305.

MANUFACTURER
American Red Cross Blood Services, Toledo, Ohio.

RECALLED BY
Manufacturer, by telephone on February 20, 1997, followed by letters dated May 12, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio and Michigan.

QUANTITY
a) 1 unit; b) 2 units were distributed.

REASON
Blood products were prepared from units of whole blood with extended collection times or no recorded phlebotomy completion time.

PRODUCT
Red Blood Cells. Recall #B-1349-8.

CODE
Unit #13FR05139.

MANUFACTURER
American Red Cross Blood Services, Detroit, Michigan.

RECALLED BY
Manufacturer, by letter dated April 14, 1998. Firm-initiated recall complete.

DISTRIBUTION
Michigan.

QUANTITY
1 unit was distributed.

REASON
Blood product was prepared from a unit of whole blood with no documented collection time was distributed without a visual inspection for clots.

PRODUCT
Autologous Red Blood Cells. Recall #B-1366-8.

CODE
Unit numbers: 10011305 and 10011514.

MANUFACTURER
W.E. & Lela I. Stewart Blood Center, Inc., Tyler, Texas.

RECALLED BY
Manufacturer, by letter dated May 8, 1998. Firm-initiated recall complete.

DISTRIBUTION
Tennessee.

QUANTITY
1 unit was distributed.

REASON
Unlicensed blood products were distributed interstate.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I

PRODUCT
Cobe Cartridge for Hemodialysis, the blood tubing set used on the COBE Centrysystem 3 dialysis machine for use in dialysis:

a) Catalog No. 003109-400; b) Catalog No. 003109-410;
c) Catalog No. 003110-500; d) Catalog No. 003111-500;
e) Catalog No. 003112-500; f) Catalog No. 003113-500;
g) Catalog No. 003114-500; h) Catalog No. 003210-500;
I) Catalog No. 003212-500; j) Catalog No. 003101-000;
k) Catalog No. 003212-515.  Recall #Z-609/619-8.

CODE
All lot numbers.

MANUFACTURER
COBE Renal Care de Mexico, Tijuana, BC, Mexico.

RECALLED BY
GAMBRO Healthcare, Lakewood, Colorado, by telephone beginning May 22, 1998, by press release on May 25, 1998, and by letter sent on May 26, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Colorado, Maryland, Massachusetts, Mississippi, Montana, Nebraska, New Jersey, New York, North Dakota, Pennsylvania, South Dakota, Texas, Utah, Virginia, and Wyoming.

QUANTITY
04D15308 - 225 cases (3375 units) 04D15309 - 411 cases (6165 units) 04D15310 - 102 cases (1530 units) were distributed. The firm estimates approximately 370 cases are available for return.

REASON
Products may have a partially occluded opening in the arterial side of the COBE Cartridge which delivers blood from the blood pump segment to the dialyzer. Blood flowing through this opening may cause mechanical damage to red blood cells and result in hemolysis during treatment.

UPDATE SureStep Blood Glucose Monitoring System (Meter), recalled by LifeScan, Inc., Milipitas, California, Recall #Z-631-8, which appeared in the July 1 and July 15, 1998 Enforcement Reports should read: RECALLED BY: Firm issued press release on June 4, 1998. Firm initiated recall ONGOING.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

PRODUCT
Manan Prostate Uni-Lock Needle Device, 18 ga x 20 cm, sterile, single use Rx two-part needle designed to prevent the prostate from rotating during prostate seeding procedures. Recall #Z-703-8.

CODE
Catalog # PLUS 1820, All lots.

MANUFACTURER
Manan Medical Products, Northbrook, Illinois (responsible firm).

RECALLED BY
Medical Device Technologies, Gainesville, Florida (repacker), by letter, on May 21, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Florida, North Carolina, Alabama, Georgia, Indiana, New York, Pennsylvania, Kentucky, Ohio, Missouri, Illinois, Oregon, Nebraska.

QUANTITY
111 cartons (10 sets per carton) were distributed.

REASON
The plastic body of the needle may come open at the weld line, increasing the risk of a malfunction.

PRODUCT
DePuy and Cerasiv brand Ceramic Femoral Heads, intended as permanent replacements for defective hip bones. Recall #Z-704-8.

CODE
All codes.

MANUFACTURER
Hospital for Special Surgery, Department of Biomechanics & Biomaterials (The Dana Center), New York, New York.

RECALLED BY
Hospital for Special Surgery (HSS), New York, New York, by letters sent on October 2, 1992, December 13, 1994, December 13, 1995, and December 31, 1996. Firm-initiated recall complete.

DISTRIBUTION
New York.

QUANTITY
184 units were implanted.

REASON
The ceramic heads are subject to fracture, apparently caused by the metallic stems (trunions) which were out of tolerance.

PRODUCT
VIEWPOINT Image Assisted Surgery Device, Model No. 6814 indicated for use in Intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous) and in spinal surgical procedures. Recall #Z-705-8.

CODE
Code 116 or greater.

MANUFACTURER
Picker International, Inc., Cleveland, Ohio.

RECALLED BY
Manufacturer, by letter on May 6, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio, Iowa, Tennessee, Colorado, Connecticut, Florida, Minnesota, New Mexico, Texas, Washington, Oklahoma, New York, Georgia, and Virginia.

QUANTITY
23 units were distributed.

REASON
The device was distributed without adequate sterilization validation data for optical probe component of the instrument.

END OF ENFORCEMENT REPORT FOR JULY 29, 1998.


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