FDA

Enforcement Report

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

CODE
6-30-99.

MANUFACTURER
China Guangdong Zhanjiang Huahe Biscuits Industry Co. Ltd., Zhanjiang City, Guangdong Province, China.

RECALLED BY
Blooming Imports, Inc., Brooklyn, New York, by letter dated August 18, 1998. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets.

DISTRIBUTION
New York.

QUANTITY 100 cases (12 cans per case) were distributed.

REASON Product contained the unapproved color additive Ponceau 4R and contains undeclared Yellow No. 5.

________
PRODUCT
Health Delights Organic Rye with Caraway Seed Bread, in 28 ounce flexible plastic bags. Recall #F-074-9.

CODE
None.

MANUFACTURER
The Red Barn Bread Company, Corporation, Brooklyn, New York.

RECALLED BY
Manufacturer, by visit on June 5, 1998. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets.

DISTRIBUTION
New York.

QUANTITY
19 loaves were distributed.

REASON
Product contained undeclared wheat flour.

________
PRODUCT
Cheddar Style Tofu Rella, in 8 ounce individually packages. Recall #F-075-9.

CODE
Expiration dates (pull dates): 5/5/99 or 5/26/99.

MANUFACTURER
Whitehall Specialities, Inc., Whitehall, Wisconsin.

RECALLED BY
Rella Good Cheese Company, Santa Rosa, California, by letters on October 8, 1998, and November 4, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Arizona, Arkansas, California, Colorado, Connecticut, Florida, Hawaii, Iowa, Illinois, Indiana, New Hampshire, New Jersey, Oregon, Pennsylvania, Texas, Vermont, Washington state, Wisconsin.

QUANTITY
1,500 cases were distributed.

REASON
Product contains undeclared caseinate (milk protein).

________
PRODUCT
a) Hot Damn Old Kentucky brand Beer Cheese; b) Hot Dang Old Kentucky brand Beer Cheese, in 9 ounce jars. Recall #F-076/077-9.

CODE
None.

MANUFACTURER
Moore Things, Inc., doing business as Best of the Bluegrass, Lexington, Kentucky.

RECALLED BY
Manufacturer, by telephone on July 31, 1998, and August 1, 1998. Completed recall resulted from investigation by the Kentucky State Department of Public Health.

DISTRIBUTION
Kentucky, North Carolina, California.

QUANTITY
1,897 jars (1,067 pounds) of cheese food was distributed.

REASON
The products were hermetically sealed low-acid foods that were manufactured without registration, scheduled process filing, and adherence to federal canned food regulations.

________
PRODUCT
Asti brand Ready-to-Eat Jumbo Lupini Beans, in 8 ounce and 20 ounce jars. Recall #F-078-9.

CODE
All lots and codes manufactured prior to 6/4/98 (code 040806).

MANUFACTURER
Salvati Foods, Inc., Hicksville, New York.

RECALLED BY
Manufacturer, by letter on June 4, 1998. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets.

DISTRIBUTION
New York, New Jersey, Florida, California, Pennsylvania, Connecticut.

QUANTITY
830 cases were distributed.

REASON
Product was an acidified low-acid food that was manufactured without adherence to federal acidified food regulations.

________
PRODUCT
Banana Cream Pie, cut in 6 ounce slices, packaged in individually flexible plastic containers. Recall #F-081-9.

CODE
None - All slices of Banana Cream Pie manufactured and distributed prior to 11/10/98.

MANUFACTURER
L. Dennison, doing business as Specialty Pie Bakers, Mt. Vernon, Ohio.

RECALLED BY
Manufacturer, by telephone on November 10, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio and Michigan.

QUANTITY
Approximately 500 slices were distributed; firm estimated that less than 200 slices remained on market at time of recall initiation.

REASON
Product contains undeclared FD&C Yellow No. 5.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III

CODE
Lot numbers: a) 0508 through 2408; b) 0488 through 2408.

MANUFACTURER
Idaho Fresh Pack Inc., Lewisville, Idaho.

RECALLED BY
Manufacturer, by relabeling product beginning on or about August 28, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
Idaho, California, Texas, Illinois, Kentucky, Georgia, Pennsylvania.

QUANTITY
188,068 cases were distributed.

REASON
Products contained undeclared sulfites.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

CODE
The product is labeled under lot number "8202" and transfilled into cylinders that have the following bar codes: 009501, 011796, 012021, 012436, 012711, 014450, 018366, 020073, 020169, 020235, 024281, 024776, 024943, 038376, 038863, 038876, 039018, 039398, 041374, 043517, 044114, 047659, 047848, 047853, 047915, 048325, 050083, 050090, 051270 and 051754.

MANUFACTURER
Tech Air, A Division of Dempsey Enterprises Inc., White Plains, New York.

RECALLED BY
Manufacturer, by telephone on October 23, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
New York.

QUANTITY
30 cylinders were distributed; firm estimated that 7 cylinders remained in commerce at time of recall initiation.

REASON
Current good manufacturing practice deviations; including but not limited to failure to maintain production records documenting finished product testing for strength and purity and use of industrial grade oxygen for medical product transfilling.

________
PRODUCT
Oxygen, USP, Rx, compressed in various high pressure cylinders, for medical use. Recall #D-033-9.

CODE
Lot numbers 1320 through 1510.

MANUFACTURER
Helget Gas Products, Inc., North Kansas City, Missouri.

RECALLED BY
Helget Gas Products, Inc., Omaha, Nebraska, by telephone on November 10, 1998, followed by visit and letter on November 11 & 12, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Missouri and Kansas.

QUANTITY
Approximately 7,856 cylinders were distributed.

REASON
Possibility of oil/foreign substance(s) contamination.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

CODE
All product codes.

MANUFACTURER
Medical Research Products, Miami, Florida.

RECALLED BY
Manufacturer, by letter sent during the week of November 16, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
Undetermined. Promotional literature will be field destroyed not physical product.

REASON
Misbranding - Literature/dosage instructions make unapproved medical claims for product.

________
PRODUCT

Phenylpropanolamine Hydrochloride 75 mg/Chlorpheniramine Maleate
8 mg. extended release capsules packaged in bottles of 10, 20,
and 30 count capsules, OTC under the following brand names:
a) AMERICAN FARE brand Cold Capsules Made for Kmart Corporation,
Troy, Michigan 48084.  NDC 0113-0482-52;
b) AMERICAN FARE brand 12 Hour Cold Capsules Made for Kmart
Corporation, Troy, Michigan 48084.  NDC 49738-482-60;
c) ARBOR brand Cold Caps Distributed by Arbor Drugs, Inc., Troy,
Michigan 48084.  NDC 50165-482-60;
d) CVS cold capsules Distributed by CVS, Woonsocket, RI 02895. 
[Label bears no NDC#];
e)   equate brand cold capsules Distributed by Perrigo Co.,
Allegan, MI 49010  [Label bears no NDC#];
f) FOOD LION brand Cold Capsules Distributed by Food Lion Stores,
Inc., Salisbury, NC 28144 NDC 55316-008-51;
g) health PRIDE brand Cold Capsules Distributed by Compass Foods,
Montvale, NJ 07645.  [label bears no NDC#];
h) H-E-B PHARMACY brand Cold Caps Distributed by H-E-B, San
Antonio, TX 78204;
i) Marquee brand Maximum Strength Severe Cold & Flu Cold Caps
Distributed by Fleming Companies, Inc., Oklahoma City, OK 73216. 
NDC 11205-501-73;
j) The Medicine Shoppe brand Cold Capsules Distributed by
Medicine Shoppe International, Inc., St. Louis, Missouri 63132. 
NDC 49614-482-52;
k) Meijer brand Cold Caps Dist. by Meijer, Inc., Grand Rapids, MI
49544.  NDC 41250-482-52;
l) RITE AID brand Cold Caps Distributed by Rite Aid Corporation,
Harrisburg, PA 17105.  [label bears no NDC#];
m) SAFEWAY brand Cold Capsules Distributed by Safeway, Inc., P.O.
Box 99, Pleasanton, CA 94566-0009.  NDC #21130-482-52;
n) Shurfine brand Cold Caps Distributed by Shurfine
International, Inc., Northlake, IL 60164-1889.  [label bears no
NDC#];
o) ValueRite brand Cold Caps Distributed by McKesson Corp., One
Pst Street, San Francisco, CA 94104.  NDC #49348-027-47;
p) VONS brand Cold Capsules Distributed by Vons, P.O. Box 99,
Pleasanton, CA 94566-0009.  NDC # 58828-482-52;
q) Walgreens brand Cold Capsules Distributed by Walgreen Co.,
Deerfield, IL 60015-4681.  NDC # 0363-0482-65;
r) Wegmans brand Cold Capsules Distributed by Wegmans Food
Markets, Inc., Rochester, NY 14692.  [label bears no NDC#];
s) Woolworth brand Cold Capsules Marketed by Woolworth Co., New
York, NY 10279.  NDC # 12443-482-52.  Recall #D-034-9.

CODE
Schwarz Lot 1460012. Finished product lots 7HA113, 7HA133, 7HA134, 7HA165 AND 7HA270. Expiration date of all lots is 10/98. Lot 7HA113 was packaged in bottles of 10's. Lots 7HA133, 7HA165 and 7HA270 were packaged in bottles of 20's. Lot 7HA134 was packaged in bottles of 30's.

MANUFACTURER
Schwarz.Pharma Manufacturing Inc., Seymour, Indiana, by telephone on June 16,1998 , and leter dated June 28, 1998.

RECALLED BY
Perrigo Company, Allegan, Michigan (repacker/distributor).

DISTRIBUTION
Nationwide.

QUANTITY
approximately 117, 276 Bottles were distributed.

REASON
Uniformity of dosage failure Chlorpheniramine Maleate-Superpotent.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

CODE
Unit numbers: a) 36251-5700, 36253-5120; b) 36251-5700; c) 36252-6738; d) 36251-5700.

MANUFACTURER
United Blood Services, Ventura, California.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on October 7, 1998, and by letter dated October 22, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
California and Switzerland.

QUANTITY
a) 2 units; b-c) 1 unit of each component was distributed.

REASON
Blood products were collected from donors whose donor history screening was incomplete.

________
PRODUCT
Platelets, Pheresis. Recall #B-210-9.

CODE
Unit numbers: 36252-5111, 36252-5135-02, 36252-5162, 36252-9114-01, 36253-3204-01.

MANUFACTURER
United Blood Services, Ventura, California.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated October 19, 1998. Firm-initiated recall complete.

DISTRIBUTION
California and Arizona.

QUANTITY
5 units were distributed.

REASON
Blood products had unacceptable platelet counts.

________
PRODUCT
Corneas. Recall #B-211-9.

CODE
Lot Numbers 1295-97 and 1296-97.

MANUFACTURER
The Eye Bank for Sight Restoration, Inc, New York, New York.

RECALLED BY
Manufacturer, by telephone on or about October 14, 1997, followed by letter. Firm-initiated recall complete.

DISTRIBUTION
New York.

QUANTITY
2 lots.

REASON
Corneas were from a donor who tested repeatedly reactive for the HIV-1 p24 antigen.

________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-233/234-9.

CODE
Unit #V93366.

MANUFACTURER
Aurora Area Blood Bank, Aurora, Illinois.

RECALLED BY
Manufacturer, by letter dated September 30, 1998. Firm-initiated recall complete.

DISTRIBUTION
Illinois and Switzerland.

QUANTITY
1 unit of each component was distributed.

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

________
PRODUCT
Red Blood Cells. Recall #B-238-9.

CODE
Unit #18GL08789.

MANUFACTURER
American Red Cross, Lansing, Michigan.

RECALLED BY
Manufacturer, by letter dated April 10, 1998. Firm-initiated recall complete.

DISTRIBUTION
Michigan.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor taking the drug Methotrexate.

________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced; b) Recovered Plasma. Recall #B-241/242-9.

CODE
Unit #4759252.

MANUFACTURER
BloodCare, Dallas, Texas.

RECALLED BY
BloodCare, doing business as Cater BloodCare, Bedford, Texas, by letter dated January 6, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas and Switzerland.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor who had previously been deferred for having engaged in high risk behavior.

________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Cryoprecipitated AHF; d) Recovered Plasma. Recall #B-243/247-9.

CODE
Unit numbers: a) 1144398, 2736632, 4528718, 4569718, 4723755, 4751117, 4822029, 5156305, 5329607, 6245941, 6359146, 6982911, 7226838, 7700488, 7794486, 8392317, 8587146, 9708414; b) 2736632, 5156305, 5329607, 6359146, 7226838, 7700488, 7794486, 8392317; c) 4569718, 4723755, 5156305, 6359146, 7794486, 8392317, 8587146, 9708414; d) 6245941; e) 1144398, 2736632, 4528718, 4632898, 4751117, 4822029, 5329607, 6245941, 6982911, 7226838, 7700488.

MANUFACTURER
BloodCare, Dallas, Texas.

RECALLED BY
BloodCare, doing business as Carter BloodCare, Bedford, Texas, by letter dated June 9, 1998, and August 4, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas, Florida, Switzerland.

QUANTITY
a) 18 units; b) 8 units; c) 8 units; d) 1 unit; e) 11 units were distributed.

REASON
Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (HIV-1), but were collected from a donor who previously tested repeatedly reactive for the antibody, Western Blot negative.

________
PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma. Recall #B-249/250-9.

CODE
Unit numbers: a) W38929, W10671; b) W10671.

MANUFACTURER
Aurora Area Blood Bank, Aurora, Illinois.

RECALLED BY
Manufacturer, by telephone on September 24, 1998, followed by letter on September 28, 1998. Firm-initiated recall complete.

DISTRIBUTION
Illinois.

QUANTITY
a) 2 units; b) 1 unit.

REASON
Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (HIV-1), but were collected from a donor who previously tested repeatedly reactive for the antibody, Western Blot indeterminate.

________
PRODUCT
Immune Globulin Intravenous (Human), Venoglobulin-S 5% 5 grams in 100 mL vial. Recall #B-251-9.

CODE
Lot GL8504A.

MANUFACTURER
Alpha Therapeutic Corporation, Los Angeles, California.

RECALLED BY
Manufacturer, by fax dated October 23, 1998, followed by telephone, and by letter dated October 24, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Alabama, Connecticut, Florida, Georgia, Massachusetts, Maryland, Maine, Missouri, New Jersey, New York, Rhode Island, Tennessee, Hong Kong.

QUANTITY
4,259 vials were distributed; firm estimated that less than 200 vials remained on market at time of recall initiation.

REASON
Vials may be cracked or broken as a result of damage to shipping cartons.

________
PRODUCT
a) Whole Blood; b) Red Blood Cells; c) Platelets; d) Platelets, Pheresis; e) Cryoprecipitated AHF; f) Fresh Frozen Plasma; g) Fresh Frozen Plasma, for further manufacturing; h) Plasma, Cryosupernatant; i) Plasma, Cryosupernatant, for further manufacturing; j) Recovered Plasma. Recall #B-252/261-9.

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, Toledo, Ohio.

RECALLED BY
Manufacturer, by letters dated May 6, 1998, May 21, 1998, and June 23, 1998, and by FAX on May 20, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio, Tennessee, Georgia, Michigan, Massachusetts, North Carolina, Minnesota, New York, West Virginia, Arkansas, Indiana, Connecticut, Alabama, Maryland, Missouri, Oregon, California, Switzerland, and the Netherlands.

QUANTITY
a) 2 units; b) 82 units; c) 29 units; d) 47 units; e) 28 units; f) 7 units; g) 37 units; h) 1 unit; I) 23 units; j) 15 units were distributed.

REASON
Blood products tested repeatedly reactive for antibody to the human immunodeficiency virus type 1 (anti-HIV-1), but were subjected to additional retesting, or which tested initially reactive for anti-HIV-1, followed by a single negative repeat test, and subsequent donations, which tested negative for anti-HIV-1, but were collected from donors who previously tested repeatedly reactive or initially reactive for anti-HIV-1 as described above.

________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-269/270-9.

CODE
Unit numbers: a) 53L02118; b) 53F28651.

MANUFACTURER
American Red Cross Blood Services, Baltimore, Maryland.

RECALLED BY
Manufacturer, by letter dated September 10, 1998. Firm-initiated recall complete.

DISTRIBUTION
a) Maryland; b) California.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from an unsuitable donor.

________
PRODUCT
Corneas. Recall #B-271-9.

CODE
Lot Numbers 0056-98 and 0057-98.

MANUFACTURER
The Eye Bank for Sight Restoration, Inc., New York, New York.

RECALLED BY
Manufacturer, by letter dated April 19, 1998. Firm-initiated recall complete.

DISTRIBUTION
New York.

QUANTITY
2 lots.

REASON
Corneas were from a donor who tested repeatedly reactive for HBsAg.

________
PRODUCT
Corneas. Recall #B-272-9.

CODE
Unit numbers: 95209A, 95209B, 95237A, 95237B.

MANUFACTURER
Upstate New York Transplant Services, Inc. (UNYTS) Buffalo, New York.

RECALLED BY
Manufacturer, by telephone on or about October 20, 1998, and by letter dated October 20, 1998. Firm-initiated recall complete.

DISTRIBUTION
New York.

QUANTITY
4 units were distributed.

REASON
Corneas were from donors who tested repeatedly reactive for HBsAg.

________
PRODUCT
Platelets, Pheresis. Recall #B-273-9.

CODE
Unit #6240871.

MANUFACTURER
Long Island Blood Services, a Division of New York Blood Center, Melville, New York.

RECALLED BY
Manufacturer, by telephone on January 26, 1998. Firm-initiated recall complete.

DISTRIBUTION
New York.

QUANTITY
1 unit was distributed.

REASON
Blood product had an unacceptable platelet count.

________
PRODUCT
Platelets, Pheresis. Recall #B-274-9.

CODE
Unit #4700212.

MANUFACTURER
LifeSource, Glenview, Illinois.

RECALLED BY
Manufacturer, by telephone on June 25, 1998. Firm-initiated recall complete.

DISTRIBUTION
Illinois.

QUANTITY
1 unit was distributed.

REASON
Blood product had an unacceptable platelet count.

________
PRODUCT
Red Blood Cells. Recall #B-282-9.

CODE
Unit #04FJ83959.

MANUFACTURER
American Red Cross, Dedham, Massachusetts.

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

DISTRIBUTION
New York.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who reported travel to an area designated as endemic for malaria.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

CODE
Unit #20263-7824.

MANUFACTURER
Blood Systems, Inc., Lafayette, Louisiana.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letters dated January 23, 1997 and on June 24, 1998. Firm-initiated recall complete.

DISTRIBUTION
Louisiana.

QUANTITY
1 unit was distributed.

REASON
Blood product was labeled with an extended expiration date.

________
PRODUCT
Cryocyte Freezing Containers with Label Pocket, 250 ml. Recall #B-160-9.

CODE
Lot Numbers: H98G14462R, H98G23463R.

MANUFACTURER
Baxter Healthcare Corporation, Cleveland, Mississippi.

RECALLED BY
Nexell Therapeutics, Inc., Irvine, California, by letter dated September 10, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide and Canada.

QUANTITY
2,472 units were distributed.

REASON
Cracks were observed on the surface of containers used for freezing blood components with liquid nitrogen.

________
PRODUCT
Red Blood Cells. Recall #B-204-9.

CODE
Unit #M49772.

MANUFACTURER
Lane Memorial Blood Bank, Eugene, Oregon.

RECALLED BY
Manufacturer, by letter dated June 19, 1998. Firm-initiated recall complete.

DISTRIBUTION
Oregon.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who reported having lived in an area designated as endemic for Chagas disease.

________
PRODUCT
Red Blood Cells. Recall #B-248-9.

CODE
Unit #07FF47266.

MANUFACTURER
American Red Cross, Tucson, Arizona.

RECALLED BY
Manufacturer, by letter dated September 3, 1998. Firm-initiated recall complete.

DISTRIBUTION
Arizona.

QUANTITY
1 unit was distributed.

REASON
Blood product was exposed to unacceptable shipping temperatures.

________
PRODUCT
a) Red Blood Cells; b) Red Blood Cells-Leukocytes Removed; c) Platelets; d) Fresh Frozen Plasma; e) Cryoprecipitate AHF. Recall #B-275/279-9.

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

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

RECALLED BY
Manufacturer, by letters dated September 18 and 19, 1997. Firm-initiated recall complete.

DISTRIBUTION
Kentucky, Louisiana, North Carolina, Texas.

QUANTITY
a) 489 units; b) 61 units; c) 174 units; d) 136 units; e) 16 units were distributed.

REASON
Failure of the firm to adequately perform the correct incubation time for the substrate in that the Auszyme Monoclonal test procedure did not conform to the manufacturer's specifications, and products.

________
PRODUCT
Recovered Plasma. Recall #B-280-9.

CODE
Unit #GS40291.

MANUFACTURER
Metropolitan Washington Blood Bank, Bethesda, Maryland.

RECALLED BY
Manufacturer, by letter dated September 21, 1998. Firm-initiated recall complete.

DISTRIBUTION
Switzerland.

QUANTITY
1 unit was distributed.

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

________
PRODUCT
Recovered Plasma. Recall #B-281-9.

CODE
Unit #GZ35884.

MANUFACTURER
Metropolitan Washington Blood Bank, Bethesda, Maryland.

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

DISTRIBUTION
Switzerland.

QUANTITY
1 unit was distributed.

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

________
PRODUCT
Red Blood Cells, Washed. Recall #B-288-9.

CODE
Unit #36253-0547.

MANUFACTURER
United Blood Services, Ventura, California.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on August 8, 1998. Firm-initiated recall complete.

DISTRIBUTION
California.

QUANTITY
1 unit was distributed.

REASON
Blood product was labeled with an extended expiration date.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

CODE
All old design units produced before October 1996.

MANUFACTURER
Invacare Corporation, Respiratory Products Division, Sanford, Florida.

RECALLED BY
Manufacturer, by letter on January 30, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide.

QUANTITY
1,744 units were distributed between 11/93 and 9/96.

REASON
If the flowmeter falls over with water in the humidifier bottle and the concentrator running, water could travel through the cannula and into the patient.

________
PRODUCT
Sterile devices and non-sterile device packs/kits. Recall #Z-156-9.

CODE

Goretex Gown Packs - Nos. 1001 - 1018; 
Liquid Resistant Gown Pack - Nos. 2001 - 2019; 
Towel Packs - Nos. 3001 - 3032; 
Wrappers/Drapes/Sheets - Nos. 4001 - 4031;
Custom Packs - 5001 - 5011.

MANUFACTURER
Associated Hospital Services, Inc., New Orleans, Louisiana.

RECALLED BY
Manufacturer, by visit beginning November 3, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Louisiana and Mississippi.

QUANTITY
1,349 packs/kits were distributed.

REASON
Lack of sterility validation and inadequate good manufacturing practices.

________
PRODUCT
Novelty Condom labeled "Midnight Treasures Glow Rider-in-the-Dark Novelty Sheath". Recall #Z-157-9.

CODE
None known.

MANUFACTURER
Eagle T.W.E. Industries, Avondale Estates, Georgia.

RECALLED BY
Manufacturer, by visit on or about September 10, 1998. Firm-initiated recall complete.

DISTRIBUTION
Alabama, Florida, Georgia, Mississippi, North Carolina, South Carolina.

QUANTITY
Firm estimated that 14,400 pieces remained on market at time of recall initiation.

REASON
Although the condoms are marketed as "novelty condoms", upon visual inspection the "novelty" condoms may be mistaken for those used for contraceptive and prophylactic purposes, and was not rendered unusable in any way as suggested in FDA/CDRH's letter to "Manufacturers, Distributors and Importers of Condom Products" dated February 23, 1994.

________
PRODUCT
Certain custom made Maxxim brand surgical trays/kits packaged with graphic Controls (Devon) brand non-sterile (NS) needle counters, and distributed between 6/97-6/98. Recall #Z-214/219-9.

CODE

Model/lot numbers:  a) Graphic Control Model No. Ns-1314: 
Packaged into Maxxim Brand Tray No. OBF975 (Tray C-section)/Lot
Number(s): 67090310, 67110017 Packaged into Maxxim Brand Tray No.
OB6028D (Tray C-section)/Lot Number(s):  7091257, 67101045,
68030092, Packaged into Maxxim Brand Tray No. OPN594 (Shoulder
Pack)/Lot Number(s):  67090818 Packaged into Maxxim Brand Tray
No. Obr598 (Delivery Pack)/Lot Number(s):  68030155 Packaged into
Maxxim Brand Tray No. OPF531 (Pack Arthroscopy)/Lot Number(s):
67090986, 67110804 Packaged into Maxxim Brand Tray No. OPF531A
(Pack Arthroscopy) /Lot Number(s): 68030127 Packaged into Maxxim
Brand Tray No. Pl3272E (Special Tray)/Lot Number(s):  67100069,
67101264, 68010624 Packaged into Maxxim Brand Tray No. GSF229A
(Adult  Appendectomy/hernia)/Lot Number(s): 67111050, 68020269
Packaged into Maxxim Brand Tray No. BXF257 (Basic Biopsy/line
Plcmnt)/Lot Number(s):  67090571, 67100967; 
b) Graphic Control Model No. NS-1315: Packaged into Maxxim Brand
Tray No. CVG040A (Pack Dr Wakabayashi)/Lot Number(s):  67090593
Packaged into Maxxim Brand Tray No. OPF439 (Pack Total Joint)/Lot
Number(s): 67071257 Packaged into Maxxim Brand Tray No.
OCG193A/BOG1931 (Pack Heart A/B)/Lot Number(s): 27090080,
67090123, 27090258, 67090260,   Packaged into Maxxim Brand Tray
No. OCG192B/BOG193B (Pack Heart A/B)/Lot Number(s):
27090459, 67090458 Packaged into Maxxim Brand Tray No. OPG197A
(Pack Total Hip)/Lot Number(s):  67071400 Packaged into Maxxim
Brand Tray No. GSM592A (Major Pack)/Lot Number(s):  67080499,
67090587 Packaged into Maxxim Brand Tray No. GSM593A (Minor
Pack)/Lot Number(s):  67080033, 67080878, 67090246;
c) Graphic Control Model No. NS-1330:  Packaged into Maxxim Brand
Tray No. OBG142 (Pack C-section)/Lot Number(s):  67081079
Packaged into Maxxim Brand Tray No. OPC924B (Laminectomy
Pack)/Lot Number(s):  67081369, 67090958 Packaged into Maxxim
Brand Tray No. LZ8297E (Lap Chole Pack)/Lot Number(s):  67100095 
Packaged into Maxxim Brand Tray No. OPL221A (Shoulder Arthroscopy
Pack)/Lot Numbers(s):  67080800 Packaged into Maxxim Brand Tray
No. OPL223A (ACL Add-on-pack)/Lot Number(s): 67090295, 67100384
Packaged into Maxxim Brand Tray No. NRF677 (Basic Neuro)/Lot
Number(s):  67080350, 67100484 Packaged into Maxxim Brand Tray
No. CCF175E/AOF175B (Cart Lap/Chole)/Lot  Number(s):  27090381,
67081150 Packaged into Maxxim Brand Tray No. OBF163 (Pack
C-section) Lot Number(s): 67080727, 67100676 Packaged into Maxxim
Brand Tray No. NRM591A (Neuro Pack)/Lot Number(s):  67080916,
67090526; 
d) Graphic Control Model No. NS-1614:  Packaged into Maxxim Brand
Tray No. OPM935A (Extremity Pack)/Lot Number(s):  67120253,
Packaged into Maxxim Brand Tray No. GSB262B (Custom Minor Lap 
Pack)/Lot Number(s):  67120243 Packaged into Maxxim Brand Tray
No. Lzf699 (Pack Lap/chole)/ Lot Number(s):  67120172 Packaged
into Maxxim Brand Tray No. OBG190 (Pack C-section)/Lot Number(s): 
67120578;
e) Graphic Control Model No. NS-1630:  Packaged into Maxxim Brand
Tray No. GS9491H (Minor Set-up Pack)/Lot Number(s):  67100184,
67110977 Packaged into Maxxim Brand Tray No. GS9492G (Major
Set-up Pack)/Lot Number(s):  67100396  Packaged into Maxxim Brand
Tray No. OP64541G (Neuro Tray)/Lot Number(s):  67090153   
Packaged into Maxxim Brand Tray No. OPB199B (Shoulder Tray)Lot
Number(s):  67100680 Packaged into Maxxim Brand Tray No. OPM942A
(Hip Pack)/Lot Number(s):  67100555; 
f) Graphic Controls Model No. Ns-1660:  Packaged into Maxxim
Brand Tray No. GS8529E (Major Basic Pack)/Lot Number(s): 
67090536, 67101246 Packaged into Maxxim Brand Tray
CCG047B/AOGO47B (Open Heart A/B)/Lot Number(s):  27080933,
27100009, 67080535, 67091093.

MANUFACTURER
Graphic Controls Corporation, Chatsworth, California (Devon needle counters).

RECALLED BY
Maxxim Medical, Temecula, California (surgical kits), by letter on July 22, 1998. Firm-initiated recall complete.

DISTRIBUTION
California, Colorado, New Mexico, Texas.

QUANTITY
4,272 custom made surgical kits were distributed.

REASON
Kits contain a Devon Needle Counter whose foam insert (strip) has the potential to detach from the plastic box.

_______
PRODUCT
Narkomed MRI Anesthesia Machine/Core-M NAD Omicron Monitor, used to administer anesthesia. Recall #Z-220-9.

CODE
AU

MANUFACTURER
Core-M Precision Instruments, West Newton, Massachusetts.

RECALLED BY
North American Drager, Telford, Pennsylvania, by letter on October 7, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and Puerto Rico.

QUANTITY
29 Anesthesia machines were distributed.

REASON
If a Core-M/NAD Omicron Monitor is not warmed up properly prior to calibration, the value store for calibration may be invalid.

________
PRODUCT
Image Intensified Fluoroscopic X-ray System. Recall #Z-221-9.

CODE
All serial numbers.

MANUFACTURER
General Electric Medical System, Waukesha, Wisconsin.

RECALLED BY
Manufacturer, by field modification instruction #10686 on November 2, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
130 units were distributed.

REASON
The image intensifier of the device can move down toward the table without operator control of this movement.

________
PRODUCT
RFX R&F X-Ray Tables: a) Model 46-262751G2; b) Model 46-262751G3; c) 46-262751G4. Recall #Z-222/224-9.

CODE
Tables manufactured 12/90 to 11/91 are affected. The month and year of manufacture are stated on the identification plates attached to each table.

MANUFACTURER
General Electric Medical System, Waukesha, Wisconsin.

RECALLED BY
Manufacturer, by a field modification instruction (FMI #10692)issued on November 11, 1998. Firm-initiated field corrections ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
304 units were distributed.

REASON
The X-Ray tables can fall. There have been five reported incidents of the problem. The problem has been attributed to breakage of an angulation drive chain.

________
PRODUCT

Osteonics Resurfacing Patellar Components:
a) Osteonics Resurfacing Patella Component, Model No.
3042-0007/Serial No. D064/Size 7;
b) Scorpio Total Knee Resurfacing Component, Model No.
73-0170/Serial No. D081/Size 7.   Recall #Z-228/229-9.

CODE
a) Serial No. D064/Size 7; b) Serial No. D081/Size 7.

MANUFACTURER
Osteonics Corporation, Allendale, New Jersey.

RECALLED BY
Manufacturer, by telephone on April 27, 1998. Firm-initiated recall complete.

DISTRIBUTION
a) Illinois, Alabama, Maryland, Oklahoma, Ohio, Indiana, California, Michigan, Germany, France; b) Illinois, Pennsylvania, Maryland, Texas, New Jersey, Pennsylvania, Massachusetts, Michigan.

QUANTITY
a) 25 units; b) 15 units were distributed.

REASON
One lot of Osteonics Resurfacing Patellar Components, Model No. 3042-0007/Serial No. D064/Size 7 was labeled as Scorpio Total Knee Resurfacing Patellar Components, Model No. 73-0170/Serial No. D081/Size 7, and one Lot of Scorpio Total Knee Resurfacing Patellar Components, Model No. 73-0170/Serial No. D081/Size 7 was labeled as Osteonics Resurfacing Patellar Components, Model No. 3042-0007/Serial No. D064/Size 7.

______
UPDATE:
Recall #Z-149/150-9, Elan Pharma EP80 Enteral Feeding Pump and O'Brien/KMI KM80 Feeding Pumps which appeared in the December 2, 1998 Enforcement Report should read: Firm-initiated field correction ongoing.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

CODE
Lot number 75980391.

MANUFACTURER
Lifecore Biomedical, Inc., Chaska, Minnesota.

RECALLED BY
Manufacturer, by telephone on November 16, 1998. Firm-initiated recall complete.

DISTRIBUTION
Colorado, North Dakota, Argentina, Japan.

QUANTITY
13 implants were distributed.

REASON
Mislabeled as to size - The patient chart label, which was placed on the cap of each outer vial holding the product, mis-states the size of the implant as being 4 mm X 8 mm. The correct size is 4 mm X 18 mm. A review of production records indicated that the entire lot of 13 units was mislabeled on the patient chart label. The device label on the side of the outer product vial, and the secondary label on the inner vial are both correct.