FDA

Enforcement Report

September 8, 1999                                     99-36


RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS I
________
PRODUCT
Keebler: E.L. Fudge Butter Flavored Sandwich Cookies with Fudge 
Cream Filing. Recall #F-665-9.
CODE
G10209B
MANUFACTURER
Keebler Co., Grand Rapids, MI.
RECALLED BY
Manufacturer, on September 14, 1999, by letter. Firm-initiated 
recall complete.
DISTRIBUTION
Nationwide.
QUANTITY
320 cases.
REASON
Undeclared peanut butter.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________
PRODUCT
Platelets, Pheresis
CODE
Units 40P68486, 40P68040, 40P673000, 40P67158.
MANUFACTURER
American Red Cross.
RECALLED BY
American Red Cross Blood Services Heart of America Region on July 2, 1999 by letter.
DISTRIBUTION
Illinois and Missouri.
QUANTITY
4 units.
REASON
Blood Products collected from a donor who reported travel to an 
area designated as endemic for malaria, were distributed.
________
PRODUCT
Cryoprecipitate. Recall# B-1173-9
CODE
Units 8057065

MANUFACTURER
LifeShare, Inc., Elyria, OH.
RECALLED BY
Manufacturer, on May 28, 1999 by telephone and by letter on June 
30, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Ohio.
QUANTITY
1 units.
REASON
Blood Products, prepared from an overweight Whole Blood unit were 
distributed
________
PRODUCT
Whole Blood, Red Blood Cells. Recall # B-1178/1179-9
CODE
Units 42FP78065-68,42FP78093, 42Y98251, 4298253.
Units 42S65553, 42Q58149, 42Q58150, 42Q58152, 42y98277.
MANUFACTURER
American Red Cross Blood Services, Northern Ohio Region.
RECALLED BY
Manufacturer, on April 19, 1999 by telephone and by letter on 
April 27, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Ohio.
QUANTITY
13 units.
REASON
Blood Products which were inappropriately collected in 450 ml 
collection sets, and labeled as having been collected in a 500 ml 
collection set, were distributed. 
________
PRODUCT
Red Blood Cells, Plasma frozen within 24 Hours after Phlebotomy. 
Recall # B-1183/1184-9.
CODE
Units 49GS46443
MANUFACTURER
American Red Cross Blood Services, Heart of America Region, 
Peoria, IL.
RECALLED BY
Manufacturer, on June 24,1999 by letter.  Firm-initiated recall 
complete.
DISTRIBUTION
Illinois.
QUANTITY
1 unit.
REASON
Blood products wre collected from a donor who had a history of 
illegal IV drug use, were distributed.
________
PRODUCT
Red Blood cells, Platelets. Recall # B-1186/1187-9
CODE
Unit 1077037.
MANUFACTURER
Community Blood Center, Dayton Oh.
RECALLED BY
Manufacturer, on April 21 ,1999 by letter.  Firm-initiated recall 
complete.
DISTRIBUTION
Ohio.
QUANTITY
1 unit.
REASON
Blood products were collected from a donor who had traveled to an 
area designated as endemic for malaria, were distributed.
_______
PRODUCT
Red Blood cells, Platelets. Recall #B-1188/1189-9
CODE
Unit 8737584.
MANUFACTURER
New York Blood Services [Center West], New York, NY.
RECALLED BY
Manufacturer, on June 25,1998 by telephone and by letter on/or 
about February 24, 1999.  Firm-initiated recall complete.
DISTRIBUTION
New York.
QUANTITY
1 unit.
REASON
Blood products were collected from a donor who had traveled to an 
area designated as endemic for malaria, were distributed.
_______
PRODUCT
Red Blood cells, Recall # B-1192-9.
CODE
Unit 1075689, 1065959.
MANUFACTURER
Community Blood Center, Dayton Oh.
RECALLED BY
Manufacturer, on April 23,1999 by letter.  Firm-initiated recall 
complete.
DISTRIBUTION
Ohio.
QUANTITY
2 units.
REASON
Blood products wre collected from a donor who had traveled to an 
area designated as endemic for malaria, were distributed.
_______
PRODUCT
Platelets, Pheresis. Recall # B-1197-9
CODE
Unit 24197-9496
MANUFACTURER
Unitied Blood Services, Rapid City, SD.
RECALLED BY
Manufacturer, on May 20, 1998 by telephone.  Firm-initiated 
recall complete.
DISTRIBUTION
Ohio.
QUANTITY
2 unit.
REASON
Blood products labeled with an extended expiration date were 
distributed.
_______
PRODUCT
Red Blood cells, Platelets. Recall # B-1198-9. Recall# B-1199-9 
(Class III)
CODE
Unit 24195-1473,24197-0453, 24197-7052, 24197-7436, 2418-7720, 
24197-0453.
MANUFACTURER
United Blood Services, Rapid City, SD.
RECALLED BY
Blood Systems Inc., Scottsdale, AZ., on April 14 ,1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Arizona.
QUANTITY
6 units.
REASON
Blood products wre collected from a donor who had traveled to an 
area designated as endemic for malaria, were distributed.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________
PRODUCT
Passport Recessed Patella Reamer Shaft.  Recall # Z-1231-9
CODE
Catalog No. 7650-1433(All Case Code Numbers)
MANUFACTURER
Howmediea Osteonies, Allandale, NJ.  
RECALLED BY
Manufacturer, on July 13, 1998 by telephone.   Firm-initiated 
recall ongoing.     
DISTRIBUTION
Nationwide.
QUANTITY
120 each.
REASON
Case slippage of the reamer stop component which results in 
removal of to much material from the patella.
________
PRODUCT
Model 1200 Mini Digital Hanging Scale Recall # Z-1237-9
CODE
FRW 1424423
MANUFACTURER
Integrated Measurement Systems, Inc., Elk Grove Village, IL.
RECALLED BY
Manufacturer, by letter on 8/7-10/99.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
113 scales.
REASON
The scale may disconnect fro the lifter boom. 
________
PRODUCT
Hemodialysers.  Recall # Z-1238-9.
CODE
Lot:  757980911A.
MANUFACTURER
Althin Medical, Inc., Miami Lakes, FL.
RECALLED BY
Manufacturer, on August 26, 1999 by letter via courier.
DISTRIBUTION
Senko Medical Instrument Mfr., Toyko Japan.
QUANTITY
3876 units.
REASON
Crack blood ports which may compormise the sterility barrier and 
cause leakage.
________
PRODUCT
Tracheostomy Care Trays.  Recall # Z-1232/1235-9 
CODE
Catalog #4118
MANUFACTURER
Sterling Disposable Products, Inc., Chicago, Ill.
RECALLED BY
Premium Plastics, Chicago, Ill., August 30, 1999 by letter.
DISTRIBUTION
Nationwide.
QUANTITY
122,840 trays.
REASON
Trays were contaminated with ETO resistant mold.

END OF ENFORCEMENT REPORT FOR  September 8, 1999. 

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