FDA

Enforcement Report

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

CODE
None - all product on the market as of July 11, 1998.

MANFACTURER
Sprout House, San Bruno, California.

RECALLED BY
Manufacturer, by letter dated July 10, 1998. California Department of Health Services issued press release on July 10, 1998. Completed recall resulted from sample analysis by the California Department of Health Services.

DISTRIBUTION
California and Nevada.

QUANTITY
Firm estimates none remains on the market.

REASON
The products may be contaminated with Salmonella and Escherichia coli O157:NM.

PRODUCT

Frozen Mexican Appetizers:
1.  "APPLE WALNUT & CHEDDAR CHEESE QUESADILLA": - 0.5 lb.     
pkgs & 2 lb. pkgs; both packed in 12 lb. domestic MO GRANDE
cases. International MO GRANDE brand - 2 lb. pkgs. packed 6 X 2
lbs. in cases.
2.  "GRILLED VEGETABLES & SMOKED GOUDA QUESADILLA": - 0.5 lb.
& 2 lb. pkgs; both packed in domestic MO GRANDE 12 lb. cases.  
3.  Cheese quesadillas labeled in part:
a) "MINI CHEESE & JALAPENO QUESADILLA": - 0.5 lb. and 2 lb. pkgs;
both packed in domestic MO GRANDE 12 lb. cases.  
b) "QUESADILLAS": - 2 Kgs. pkgs packed in 5X2 Kgs. cs/both the
pkg and the case bear the international MO GRANDE labeling
4.  "CREAM CHEESE FLAUTA": MO GRANDE brand, 120 pieces in
13.87 lb. cases
5.  "APPLE FLAUTA": MO GRANDE brand, 120 pieces in 13.87 lb.
cases
6.  "CHERRY FLAUTA": MO GRANDE brand, 120 pieces in 13.87 lb.
cases
7.  "BUTTERMILK BATTERED CHEESE POBLANO CHILE RELLENO": MO
GRANDE brand, 48 pieces in 12 lb. cases
8.  "BUTTERMILK BATTERED CHEESE ANAHEIM CHILE RELLENO": MO
GRANDE brand, 48 pieces in 12 lb. cases
9.  Cream cheese stuffed jalapenos labeled in part:
a) "BAJA BANDITS CREAM CHEESE STUFFED JALAPENOS***", 0.5 lb. and
2 lb. pkgs both packed in 12 lb. cases with the MO GRANDE
label. (This product is par-fried). 
b) "IQF CREAM CHEESE STUFFED JALAPENOS", 16 lb. cases that do not
bear the MO GRANDE brand (This product is double battered and
double fried because the batter did not adhere to the product the
first time it was battered and fried).
c) "HOT CREAM CHEESE PEPPERS", 2 Kgs pkgs in 5X2 Kgs. cases
bearing the MO GRANDE and international label. (This product
is battered and frozen, but not fried).
10.  Cheddar cheese stuffed jalapenos labeled in part:
a) "BAJA BANDITS CHEDDAR CHEESE STUFFED JALAPENOS", 0.5 lb and 2
lb. pkgs both in 12 lb. cases labeled with MO GRANDE. (This
product is par-fried).
b) "IQF CHEDDAR CHEESE STUFFED JALAPENOS" 16 lb. cases/cases do
NOT bear MO GRANDE label.  (This product is double battered and
double fried).
c) "HOT CHEDDAR CHEESE PEPPERS", 2 Kgs. pkgs. in 5x2 Kgs
cases, both the pkg and case bear the MO GRANDE international
label. (This product is battered and frozen, but not fried).
11.  Cheddar cheese jalapeno rings labeled in part :
a) "Baja Bites CHEDDAR CHEESE JALAPENO RINGS", in 0.5 lb. and 2
lb. pkgs both in 12 lb. cases/cases labeled with MO GRANDE label. 
(This product is par-fried).
b) "IQF CHEDDAR CHEESE STUFFED JALAPENO RINGS", 16 lb.
cases do NOT bear MO GRANDE label.  (This product is double
battered and double fried).
c) "HOT CHEDDAR CHEESE JALAPENO RINGS", in 2 lb. pkgs packed in
6X2 lb. cases/both the pkg and the case bear the MO GRANDE
international label.  (This product is battered and frozen, but
not fried).  Recall #F-053/063-9.

MANFACTURER
S.A.N.A. Internacional, S. De R.L. De C.V. Av. Migael De La Madrid, Sonora, Mexico.

RECALLED BY
J.R. Simplot Company/S.A.N.A. U.S.A., Boise, Idaho (importer/distributor), by letter faxed beginning October 5, 1998, and by press release on October 8, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and Canada.

QUANTITY
Undetermined.

REASON
The products may be contaminated with Listeria monocytogenes.

PRODUCT
Butterfield Foods Sweet-N-Sour Coleslaw, in 5 pound tubs. Recall #F-052-9.

CODE
0038/100898.

MANFACTURER
Butterfield Foods, Pennville, Indiana.

RECALLED BY
Manufacturer, by press release on September 22, 1998, and by telephone and letter on September 23, 1998. Firm-initiated recall complete.

DISTRIBUTION
Illinois, Indiana, Ohio.

QUANTITY
1,970 tubs were distributed.

REASON
Product was contaminated with Salmonella ohio.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

Astra Pharmaceuticals, L.P. ( Westborough, Mass.) Recall of:  a)
Metaproterenol Sulfate Inhalation Solution, USP, 0.4%, in 2.5 mL
Arm-a-Med Plastic Vials, NDC 0186-4131 -01;
b) Metaproterenol Sulfate Inhalation Solution, USP, 0.6%, in 2.5
mL Arm-a-Med Plastic Vials, NDC 0186-4130-01 
c) Sodium Chloride Solution, 0.45% for Respiratory Therapy, 3 mL
Arm-a-Vial Plastic Vials, NDC 0186-4101-01, and in 5 mL
Arm-a-Vial Plastic Vials, NDC  01 86-4101-03;
d) Sodium Chloride Solution, 0.9% for Respiratory Therapy, in 3
mL Arm-a-Vial Plastic Vials, NDC 0 1 86-41 00-01, and in 5 mL
Arm-a-Vial Plastic Vials, NDC  0 1 86-4100-03;
e) Sterile Water for Respiratory Therapy in 3 mL Arm-a-Med
Plastic Vials, NDC 0186-4102-01, and in 5 mL Arm-a-Vial Plastic
Vials, NDC 0 1 86-4102-03.  Recall #D-013/017-9, which appeared
in the November 18, 1998 Enforcement Report should read:   
RECALLED BY Manufacturer, by letter October 26, 1998.  Firm-initiated recall
ongoing.

CODE
Unit #04E94688.

MANFACTURER
American Red Cross, Dedham, Massachusetts.

RECALLED BY
Manufacturer, by telephone on May 13, 1998. Firm-initiated recall complete.

DISTRIBUTION
Massachusetts.

QUANTITY
1 unit was distributed.

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

PRODUCT
Red Blood Cells. Recall #B-128-9.

CODE
Unit numbers: 04FF00894, 04FF00895.

MANFACTURER
American Red Cross, Dedham, Massachusetts.

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

DISTRIBUTION
Massachusetts and Maine.

QUANTITY
2 units were distributed.

REASON
Blood products were collected from donors who reported travel to an area designated as endemic for malaria.

PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-129/130-9.

CODE
Unit #10585-4560.

MANFACTURER
United Blood Services, Phoenix, Arizona.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on August 3, 1998, and by letter dated August 27, 1998. Firm-initiated recall complete.

DISTRIBUTION
Arizona.

QUANTITY
1 unit of each component was distributed.

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

PRODUCT
a) Red Blood Cells; b) Red Blood cells, Leukocytes Reduced; c) Platelets. Recall #B-131/133-9.

CODE
Unit numbers: a) 10581-1247; b) 10585-7794; c) 10581-1247.

MANFACTURER
United Blood Services, Chandler, Arizona.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on August 20, 1998, and by letter dated September 4, 1998. Firm-initiated recall complete.

DISTRIBUTION
Arizona.

QUANTITY
1 unit of each component was distributed.

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

PRODUCT
Platelets, Pheresis. Recall #B-134-9.

CODE
Unit #FM07236.

MANFACTURER
American Red Cross, AZ Blood Institute-Apheresis, Tucson, Arizona.

RECALLED BY
American Red Cross, Tucson, Arizona, by letter dated July 15, 1998. Firm-initiated recall complete.

DISTRIBUTION
Arizona.

QUANTITY
1 unit was distributed.

REASON
Blood product was labeled with an extended expiration date.

PRODUCT
Platelets, Pheresis. Recall #B-135-9.

CODE
Unit 04LP32755.

MANFACTURER
American Red Cross, Dedham, Massachusetts.

RECALLED BY
Manufacturer, by letter dated March 11, 1998. Firm-initiated recall complete.

DISTRIBUTION
Massachusetts.

QUANTITY
1 unit was distributed.

REASON
Platelets, Pheresis had a high white cell count.

PRODUCT
Platelets, Pheresis. Recall #B-136-9.

CODE
Unit #04P3799A and 04P3799B.

MANFACTURER
American Red Cross, Dedham, Massachusetts.

RECALLED BY
Manufacturer, by telephone and letter on March 9, 1998. Firm-initiated recall complete.

DISTRIBUTION
Maine and Massachusetts.

QUANTITY
2 units were distributed.

REASON
Blood products had an unacceptable platelet count.

PRODUCT
Platelets, Pheresis. Recall #B-137-8.

CODE
Unit #04GP37247.

MANFACTURER
American Red Cross, Dedham, Massachusetts.

RECALLED BY
Manufacturer, by telephone on May 11, 1998. Firm-initiated recall complete.

DISTRIBUTION
Maine.

QUANTITY
1 unit was distributed.

REASON
Blood product corresponded to a sample that had fibrin clots present.

PRODUCT
Red Blood Cells. Recall #B-138-9.

CODE
Unit #E94075.

MANFACTURER
Central California Blood Center, Fresno, California.

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

DISTRIBUTION
California.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who admitted to receiving clotting factor concentrates.

PRODUCT
Recovered Plasma. Recall #B-139-9.

CODE
Unit #N72504.

MANFACTURER
Blood Centers of the Pacific-Peninsula South Bay, Burlingame, California.

RECALLED BY
Manufacturer, by fax on June 18, 1996. Firm-initiated recall complete.

DISTRIBUTION
California.

QUANTITY
1 unit was distributed.

REASON
Blood product was not tested for the HIV-1 antigen.

PRODUCT
Red Blood Cells. Recall #B-140-9.

CODE
Unit #FR00628.

MANFACTURER
Blood Centers of the Pacific-Peninsula South Bay, Burlingame, California.

RECALLED BY
Manufacturer, by telephone on August 2, 1997. Firm-initiated recall complete.

DISTRIBUTION
California.

QUANTITY
1 unit was distributed.

REASON
Autologous Red Blood Cells tested initially reactive for HIV-1/2 antibodies were not labeled with "Biohazard" label.

PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-141/142-9.

CODE
Unit #04M71185.

MANFACTURER
American Red Cross, Dedham, Massachusetts.

RECALLED BY
Manufacturer, by, telephone on April 14, 1998, or by letter dated April 17, 1998. Firm-initiated recall complete.

DISTRIBUTION
Massachusetts.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products tested non-reactive for the antibody to the Hepatitis B core antigen (anti-HBc), but were collected from a donor who was previously repeatedly reactive for anti-HBc on two separate donations.

PRODUCT
Red Blood Cells. Recall #B-143-9.

CODE
Unit 04KK95274.

MANFACTURER
American Red Cross, Dedham, Massachusetts.

RECALLED BY
Manufacturer, by telephone on May 7, 1998. Firm-initiated recall complete.

DISTRIBUTION
Maine.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected in a manner that compromises the sterility of the unit.

PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-146/147-9.

CODE
Unit #W83085.

MANFACTURER
Healthcare Provider Services, Inc., doing business as Rhode Island Blood Center, Providence, Rhode Island.

RECALLED BY
Manufacturer, by letter on August 25, 1998. Firm-initiated recall complete.

DISTRIBUTION
Rhode Island.

QUANTITY
1 unit of each component was distributed.

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

PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-148/149-9.

CODE
Unit #W79204.

MANFACTURER
Healthcare Provider Services, Inc., doing business as Rhode Island Blood Center, Providence, Rhode Island.

RECALLED BY
Manufacturer, by letter dated September 11, 1998. Firm-initiated recall complete.

DISTRIBUTION
Rhode Island and Massachusetts.

QUANTITY
1 unit of each component was distributed.

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

PRODUCT
Corneas. Recall #B-151-9.

CODE
Lot numbers: 1573-97 and 1574-97.

MANFACTURER
EBSR, New York, New York.

RECALLED BY
The Eye Bank for Sight Restoration, Inc., New York, by letter dated January 29, 1998. Firm-initiated recall complete.

DISTRIBUTION
New York.

QUANTITY
2 units were distributed.

REASON
Corneas from a donor who tested repeatedly reactive for the antibody to the Hepatitis C virus.

PRODUCT
Red Blood Cells. Recall #B-152-9.

CODE
Unit #7437097.

MANFACTURER
New York Blood Services (Center West), New York, New York.

RECALLED BY
New York Blood Center, Inc., New York, New York, by telephone on July 8, 1998, and by letter dated July 15, 1998. Firm-initiated recall complete.

DISTRIBUTION
New York.

QUANTITY
1 unit was distributed.

REASON
Resting of the Recovered Plasma found that the product tested repeat reactive and confirmed positive by RIBA for the Hepatitis C Virus (HCV).

PRODUCT
Platelets, Pheresis. Recall #B-154-9.

CODE
Unit #07FM07239.

MANFACTURER
American Red Cross Blood Services, Tucson, Arizona.

RECALLED BY
Manufacturer, by letter dated September 11, 1998. Firm-initiated recall complete.

DISTRIBUTION
Arizona.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected in a manner that could compromise the sterility of the product.

PRODUCT
Platelets, Pheresis. Recall #B-155-9.

CODE
Unit #07FM07616.

MANFACTURER
American Red Cross Blood Services, Tucson, Arizona.

RECALLED BY
Manufacturer, by letter dated September 11, 1998. Firm-initiated recall complete.

DISTRIBUTION
Arizona.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected in a manner that could compromise the sterility of the product.

PRODUCT
Platelets, Pheresis. Recall #B-156-9.

CODE
Unit #07FM07487.

MANFACTURER
American Red Cross Blood Services, Tucson, Arizona

RECALLED BY
Manufacturer, by letter dated September 11, 1998. Firm-initiated recall complete.

DISTRIBUTION
Arizona.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected in a manner that could compromise the sterility of the product.

PRODUCT
Various Human Tissues for Transplant: Bone, Skin; Corneas, Vertebral Bodies, Sapheinous Veins. Recall #B-157-8.

CODE
Bone - Donor Numbers: 10196, 10397, 10597, 10797, 11695, 14397, 14895, 15297, 15495, 17097, 18395, 94001, 94062 Skin - Donor Numbers: 10196, 10397, 10597, 10797, 11695, 14397, 14895, 15297, 16197, 17097, 18395, 19595, 94062 Corneas - Donor Numbers: 10196, 10397, 10597, 11695, 15297, 15495, 16197, 17097 Vertebral Bodies - Donor Numbers 10797, 11695, 18395, 94062 Sapheinous Veins from Source Number 94062.

MANFACTURER
Southwest Tissue Services, Inc. (SWTSI), San Antonio, Texas.

RECALLED BY
Manufacturer, by letter dated either September 11, 14, or 22, 1998, or October 16, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Texas and Colorado.

QUANTITY
518 bone allografts, skin tissue from 13 donors, corneas from 8 donors, vertrabal bodes from 4 donors and sapheinous veins from 1 donor.

REASON
Human tissues for transplant lacked complete testing records or tested repeatedly reactive for HIV 1/2, HBsAg, HTLV-1, or anti-HBc.

PRODUCT
a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-161/163-9.

CODE
Unit #3U0907.

MANFACTURER
Puget Sound Blood Center, Seattle, Washington.

RECALLED BY
Manufacturer, by letter dated June 12, 1998. Firm-initiated recall complete.

DISTRIBUTION
Washington state and Switzerland.

QUANTITY
1 unit of each component was distributed.

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

PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-164/165-9.

CODE
Unit numbers: 49F998388 and 49GF06094.

MANFACTURER
American Red Cross Blood Services, Tulsa, Oklahoma.

RECALLED BY
Manufacturer, by letter dated September 4, 1998. Firm-initiated recall complete.

DISTRIBUTION
Oklahoma and Texas.

QUANTITY
2 units of each component were distributed.

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

PRODUCT
a) Red Blood Cells; b) Platelets for Use in Manufacturing Noninjectable Products; c) Recovered Plasma. Recall #B-169/171-9.

CODE
Unit numbers: a) 61153 and 59366; b) 59366; c) 61153 and 59366.

MANFACTURER
Lane Memorial Blood Bank, Eugene, Oregon.

RECALLED BY
Manufacturer, by letter dated April 27, 1998 or May 18, 1998. Firm-initiated recall complete.

DISTRIBUTION
Oregon and Florida.

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

REASON
Blood products were collected from a donor who had ear piercing within 12 months of donation.

PRODUCT
Platelets. Recall #B-176-9.

CODE
Unit 16LL35750.

MANFACTURER
American Red Cross Blood Services, Columbus, Ohio.

RECALLED BY
Manufacturer, by telephone on September 11, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected in a manner that compromises the sterility of the unit.

PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-178/179-9.

CODE
Unit numbers: 29GP46623, 29GV13683.

MANFACTURER
American Red Cross Blood Services, Norfolk, Virginia.

RECALLED BY
Manufacturer, by letter dated August 11, 1998. Firm-initiated recall complete.

DISTRIBUTION
Virginia.

QUANTITY
2 units of each component was distributed.

REASON
Blood products were collected from an unsuitable donor.

PRODUCT
Platelets. Recall #B-183-9.

CODE
Unit #39F67248.

MANFACTURER
American Red Cross, Huntington, West Virginia.

RECALLED BY
Manufacturer, by telephone on September 9, 1998, and by letter dated September 10, 1998. Firm-initiated recall complete.

DISTRIBUTION
West Virginia.

QUANTITY
1 unit was distributed.

REASON
Blood product tested negative for the Hepatitis C Virus (anti-HCV), but was collected from a donor who previously tested HCV reactive.

PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-184/185-9.

CODE
Unit numbers: 1206641, 2252994, 1198136.

MANFACTURER
Inland Northwest Blood Center, Spokane, Washington.

RECALLED BY
Manufacturer, by letter dated July 9, 1998. Firm-initiated recall complete.

DISTRIBUTION
Washington state and Florida.

QUANTITY
3 units of each component were distributed.

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

PRODUCT
a) Red Blood Cells; b) Cryoprecipitated AHF. Recall #B-187/188-9.

CODE
Unit #1C0151

MANFACTURER
Puget Sound Blood Center, Seattle, Washington.

RECALLED BY
Manufacturer, by letter dated November 7, 1997. Firm-initiated recall complete.

DISTRIBUTION
Washington state.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products tested non-reactive for the antibody to the Hepatitis B core antigen (anti-HBc), but were collected from a donor who was deferred for having previously tested reactive for anti-HBc.

CODE
Unit numbers: 1025268, 1030507, 103463.

MANFACTURER
Community Blood Center, Dayton, Ohio.

RECALLED BY
Manufacturer, by letter dated November 13, 1997. Firm-initiated recall complete.

DISTRIBUTION
California and Switzerland.

QUANTITY
3 units were distributed.

REASON
Blood products tested negative for anti-HCV, but were collected from a donor who had previously tested reactive for anti-HCV.

PRODUCT
Platelets. Recall #B-116-9.

CODE
Unit #9801139.

MANFACTURER
Sound Shore Medical Center (SSMC), New Rochelle, New York (responsible firm).

RECALLED BY
Greater Metropolitan Community Blood Service (GMCBS), Yonkers, New York, by fax dated February 18, 1998. Firm-initiated recall complete.

DISTRIBUTION
New York.

QUANTITY
1 unit was distributed.

REASON
Blood products tested negative for the anti-HCV, but were collected from a donor who had previously tested repeat reactive for anti-HCV.

PRODUCT
a) Platelets; b) Source Leukocytes for Manufacturing. Recall #B-123/124-9.

CODE
Unit numbers: a) 01KF35048, 01Q26176; b) 01Q26176.

MANFACTURER
American Red Cross Blood Services, Syracuse, New York.

RECALLED BY
American Red Cross Blood Services, Rochester, New York, by telephone on April 1 and 2, 1998, and by letter dated April 9, 1998. Firm-initiated recall complete.

DISTRIBUTION
New York.

QUANTITY
a) 2 units; b) 1 unit.

REASON
Blood products were not quarantined after receiving post donation information concerning illness.

PRODUCT
Cryoprecipitate AHF. Recall #B-144-9.

CODE
Unit #10586-7671.

MANFACTURER
United Blood Services, Scottsdale, Arizona.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on July 28, 1998, and by letter dated August 11, 1998. Firm-initiated recall complete.

DISTRIBUTION
Arizona.

QUANTITY
1 unit was distributed.

REASON
Blood product was prepared from a unit of whole blood identified as a difficult draw.

PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall #B-145-9.

CODE
Unit #36252-4578.

MANFACTURER
United Blood Services, Ventura, California.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on June 16, 1998. Firm-initiated recall complete.

DISTRIBUTION
California.

QUANTITY
1 unit was distributed.

REASON
Red blood cells failed red cell recovery ratio.

PRODUCT
Red Blood Cells. Recall #B-150-9.

CODE
04M70801, 04M70823, 04N61508, 94FR11831, 04FR11833, 04FR11848, 04FS88777, 04M70809.

MANFACTURER
American Red Cross, Dedham, Massachusetts.

RECALLED BY
Manufacturer, by telephone on April 21, 1998. Firm-initiated recall complete.

DISTRIBUTION
Massachusetts and Maine.

QUANTITY
8 units were distributed.

REASON
Blood products were exposed to unacceptable shipping temperatures.

PRODUCT
Recovered Plasma. Recall #B-153-9.

CODE
Unit #7437097.

MANFACTURER
New York Blood Services (Center West), New York, New York.

RECALLED BY
New York Blood Center, Inc., New York, New York, by telephone on July 8, 1998, and by letter dated July 15, 1998. Firm-initiated recall complete.

DISTRIBUTION
New York.

QUANTITY
1 unit was distributed.

REASON
Resting of the Recovered Plasma found that the product tested repeat reactive and confirmed positive by RIBA for the Hepatitis C Virus (HCV).

PRODUCT
Platelets. Recall #B-168-9.

CODE
Unit #39H09052.

MANFACTURER
American Red Cross, Huntington, West Virginia.

RECALLED BY
Manufacturer, by telephone on September 9, 1998 and letter dated September 10, 1998. Firm-initiated recall complete.

DISTRIBUTION
West Virginia.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a unit of whole blood with an extended collection time.

PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma. Recall #B-172/174-9.

CODE
Unit #1X7801.

MANFACTURER
Puget Sound Blood Center, Seattle, Washington.

RECALLED BY
Manufacturer, by letter dated April 6, 1998. Firm-initiated recall complete.

DISTRIBUTION
Washington state.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor who received a cornea transplant within a year of donation.

PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall #B-175-9.

CODE
Unit numbers: 21GV02350, 21GV02354, 21GV02357, 21GV02358, 21GY46010, 21KG04747, 21KG04753, 21FJ12715, 21FJ12716, 21KH07087.

MANFACTURER
American Red Cross, Portland, Oregon.

RECALLED BY
Manufacturer, by telephone on September 9, 1998, and by letter on September 18, 1998. Firm-initiated recall complete.

DISTRIBUTION
Oregon and Washington state.

QUANTITY
10 units were distributed.

REASON
Blood products were leukodepleted greater than five days after collection.

PRODUCT
Platelets. Recall #B-177-9.

CODE
Unit numbers: 49S78301 and 49Y51765.

MANFACTURER
American Red Cross Blood Services, Tulsa, Oklahoma.

RECALLED BY
Manufacturer, by telephone on June 29, 1998. Firm-initiated recall complete.

DISTRIBUTION
Oklahoma.

QUANTITY
2 units were distributed.

REASON
Blood products that were stored at unacceptable temperatures.

a) Integris H 1000; b) Integris H 3000; c) Integris BH 3000; d) Integris HM 2000; e) Integris HM 3000; f) Integris H 5000F; g) Integris H 5000C; h) Integris BH 5000; I) PolyDiagnost H; j) Integris V 3000; k) Integris BV/BN 3000; l) Integris V 4000; m) Integris V 5000. Recall #Z-128/140-9.

CODE
See model numbers above.

MANFACTURER
Phillips Medical Systems, Shelton, Connecticut.

RECALLED BY
Manufacturer. FDA approved the firm's corrective action plan on November 18, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
1,086 units were distributed.

REASON
The units are defective under 21 CFR 1020.32(d) and (e) in that they do not limit the entrance exposure rate (EER) to 10 R/min when in the high fluoroscopy mode and recording is not activated. This can result in the patient receiving excess or unnecessary exposure above the limits of the standard.

PRODUCT
Poliovirus Devices:

a) Poliovirus 2 Monoclonal Antibody, Catalog No. 3332; b) Poliovirus Blend, Catalog No. 3336; c) Poliovirus Antibody Set (Set containing the Antibody and the Blend), Catalog No. 3355; d) Enterovirus Screen Set (Kit containing the Blend), Catalog No. 3365. Recall #Z-145/148-9.

CODE

Lot No.           EXP DATE
a) 17120221        06/99
   69196205A       08/98
   18040333        10/99
   18050504        11/99
b) 17100622        04/99
   18020569        08/99
   18040391        10/99
   18070076        02/00
c) 17120219        01/99
   18040394        09/99
d) 17100623        01/99
   18040395        09/99
   18020571        04/99.

RECALLED BY
Manufacturer, by letter on or about October 6, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
a) 59 vials; b) 97 vials; c) 43 sets; d) 142 sets were distributed.

REASON
The above lots of the subject devices demonstrated an apparent cross reactivity to Cytometgalovirus (CMV), and could delay the patients' true diagnosis and appropriate specific therapy.

PRODUCT
Sterile Staple Remover & Tray: a) Staple Remover, Catalog No. 716, used to remove staples from skin; b) Dressing Change Tray, Catalog Nos. 759, 6292, 8722, to be used for dressing change procedures; c) Laceration Tray, Catalog Nos. 1892, 3697, used for minor laceration treatment; d) Central Line Dressing Tray, Catalog No. 5880, for Central Line maintenance. Recall #Z-152/155-9.

CODE
Lot numbers: a) No. 9820543; b) 9810231, 9830218, 9830244; c) 9830223, 9830226, 9830222; d) 9820569;

MANFACTURER
Busse Hospital Disposables, Hauppauge, New York.

RECALLED BY
Manufacturer, by telephone on September 30, 1998, and by letter faxed on October 1, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
a) Nationwide and Canada; b) New York, Florida, Illinois, Connecticut, California, Ohio; c) Massachusetts, Missouri; d) New York.

QUANTITY

Staple Remover (48/case), lot 9820543:           290 cases
Dressing Change Tray (20/case), lot 9810231:      13 cases
Laceration Tray (20/case), lot 9830223:           15 cases
Laceration Tray (20/case), lot 9830226:           15 cases
Laceration Tray (20/case), lot 9830222:           20 cases
Central Line Dressing Tray(50/case), lot 9820569: 60 cases
Dressing Change Tray (30/case), lot 9830218:      25 cases
Dressing change Tray (20/case), lot 9830244:      15 cases

PRODUCT
Dade Thromboplastin C Plus Test Reagent, dried Rabbit Brain Thromboplastin with Calcium, for use in prothrombin time (PT) determinations and prothrombin time based assays: a) Dade Thromboplastin C Plus, Catalog No. B4216-2; b) Dade Thromboplastin C Plus, Catalog No. B4216-1. Recall #Z-183/184-9.

CODE
Lot Numbers: a) TPC-415; b) TPC-416.

MANFACTURER
Dade Behring, Inc., Miami, Florida.

RECALLED BY
Manufacturer, by telephone on September 8, 1998, followed by letter on September 9, 1998. Firm-initiated field correction complete.

DISTRIBUTION
Nationwide and international.

QUANTITY
a) 11,438 units; b) 3,246 units were distributed.

REASON
The product package insert includes incorrect International Sensitivity Index values for photo-optical instruments.

PRODUCT
Enteral Nutrition Pumps: a) Nestle 2200 Enteral Nutrition Pump; b) Clintec 2200 Enteral Feeding Pump (also distributed under the names: c)"Elan Pharma EP80 Enteral Feeding Pump"; and d) O'Brien/KMI KM80 Feeding Pump". Recall #Z-197/200-9.

CODE
All serial numbers.

MANFACTURER
Elan Pharma, Inc., Smithfield, Rhode Island; V.R. Industries, Warwick, Rhode Island.

RECALLED BY
Nestle Clinical Nutrition, Deerfield, Illinois, by issuing a "Customer Safety Notification" dated August 28, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
Approximately 21,000 pumps were distributed.

REASON
The devices can produce a "free flow" situation where the patient may receive an unintended large volume of feeding solution at a rapid rate.

CODE
Model CD111, Lot #8H145C.

MANFACTURER
Contech Packaging, Inc., Providence, Rhode Island.

RECALLED BY
Core Dynamics, Inc., Jacksonville, Florida, by letter on September 24, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Pennsylvania, Tennessee, Washington state, Minnesota, Canada.

QUANTITY
41 boxes (20 units per box) were distributed.

REASON
The contract manufacturer (packer) packed the wrong size cannula seal, 10/12mm (actually product no. CD112) into the tyvek packs labeled for product no. CD 111, size 10/11mm.

UPDATE
Dental Impression Material & Liquid Hardener, (Heraeus Kulzer, South Bend, IN), which appeared in the November 18, 1998 Enforcement Report should read: Recall #Z-173/175-9.

END OF ENFORCEMENT REPORT FOR NOVEMBER 25, 1998. BLANK PAGES MAY FOLLOW.