FDA

Enforcement Report

May 02, 2001                                                01-17



RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________
PRODUCT: 
Marshall’s Best Smoked Nova Salmon Spread.  Recall #F-362-1.
CODE: 
8 oz. size coded batch 12146 and use by 4/16/01; 5 lb. coded batch 12146 and use 
by 4/16/01. 
MANUFACTURER:
Premier Smoked Fish, Inc., Bensalem, PA.
RECALLED BY: 
Manufacturer, by press release on 2/1/01 and fax on 2/2/01.    
DISTRIBUTION:
NY
QUANTITY:
20 cases of 8 oz containers and 47 containers of 5 lb containers.
REASON: 
The product was contaminated with Listeria monocytogenes.

_______
PRODUCT: Golden Lion Dried Melon Seeds in flexible plastic bags, net wt. 
12 oz. (430 g). Recall #F-363-1.
CODE: 
None.
MANUFACTURER:
Hua Feng Co. Ltd, Guangdong, China.
RECALLED BY: 
Blooming Import Company, Brooklyn, New York, by letter on 12/27/0l. Completed recall 
resulted from sample analysis by the New York State Department of Agriculture and Markets.
DISTRIBUTION:
NY
QUANTITY:
28 Cases (50-12 oz. Bags per case)
REASON: 
The product contained undeclared sulfites.  
________
PRODUCT:
a) Marshall’s Smoked Whitefish Salad.      Recall #F-364-1;
b) Marshall’s Best Kippered Salmon Salad.  Recall #F-365-1.
CODE:
a) Marshall's Best Smoked Whitefish Salad 8-oz containers: code date  1/19/01 batch 
#11891 and code date 1/26/01 batch # 11923.  

Marshall's Best Smoked Whitefish Salad 5 lb containers: code date 1/12/01 batch #11891 
and #11784.

b) Marshall's Best Smoked Kippered Salmon Salad 8 oz containers: 
code date 1/12/01 batch #11844 and code date 1/19/01 batch #01901.   

Marshall's Best Smoked Kippered Salmon Salad 5 lb containers: code date 1/12/01 batch 
#11790.
MANUFACTURER:
Premier Smoked Fish Inc., Bensalem, PA.
RECALLED BY:
Manufacturer by press release and fax on 1/4/01 and 1/9/01.  
Completed recall resulted from sample analysis by the New York State Department of 
Agriculture and Markets.
DISTRIBUTION:
New York.
QUANTITY:
White fish: 480 cases of 8 oz and 4500 lb of 5 lb; salmon: 60 cases of 
8 oz and 1500 lbs of 5 lb.
REASON:
The products were contaminated with Listeria monocytogenes.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_____
PRODUCT:
Orange Soda.  Recall #F-309-1.
CODE:
Two liter sizes lots: 01901,03601,03901,05301,and 05401.
12 fluid ounce size lots:  05101 and 03201.
MANUFACTURER:
Crystal Soda Water Company, Inc., Scranton, PA
RECALLED BY:
Manufacturer, by letter dated 3/21/01 delivered by drivers. 
The manufacturer also issued stick on labels stating that the product 
contains Yellow #6 for the drivers to affix.  Firm initiated recall 
complete.
DISTRIBUTION:
PA.
QUANTITY:
680 cases (24/12 oz cans per case) and 1868 cases (8/2 liter bottles 
per case).
REASON:
Product contains undeclared FD&C Yellow No.6.
________
PRODUCT:
a) Dudek brand Barszcz (Beet Soup) in 32 fl. oz. (1 QT) glass jars.
     Recall #F-366-1
b) Dudek brand Kapusniak (Cabbage Soup) in 32 fl. oz. (1 QT) glass jars. 
    Recall #F-367-1
CODE:
a) Beet Soup, Lot with expiration date “5 2301”. 
b) Cabbage Soup, Lot with expiration date “115 01”.
MANUFACTURER:
Dudek Foods, Inc., Hamtramck, MI.
RECALLED BY:
Manufacturer, by telephone and visit, beginning on March 3, 2001.  
Firm-initiated recall ongoing.
DISTRIBUTION:
Michigan.
QUANTITY:
Approximately 182 jars of Beet Soup and 210 jars of Cabbage Soup.
REASON:
Product contains undeclared wheat flour.  
________
PRODUCT:
STR brand Instant Egg Noodles, packed in flexible plastic packages,  
net wt. 14 oz. (400 grams). Recall F-368-1.
CODE:
Product has barcode # 4 920522 178369 & no other coding.
MANUFACTURER:
Xiamen Da Chong Hua Import & Export, Ltd.  Fuijan, China.
RECALLED BY:
Strong America Limited, Brooklyn, NY by letter on Oct.2, 2000. 
Completed recall resulted from sample analysis by the New York State 
Department of Agriculture and Markets.
DISTRIBUTION:
New York, Florida, Tennessee, North Carolina, Massachusetts.
QUANTITY:
647 cases (50 - 14 oz. packages per case)
REASON:
The product contained the uncertified color additive tartrazine 
(certifiable as FD&C Yellow #5).  Additionally, the product was labeled 
as "Egg Noodles" but did not contain whole egg solids or  egg yolk solids.
________
PRODUCT:
Rookies Snax (brand) Trail Mix, NET WT. 8 OZ.  Ingredients: Raisins, 
Peanuts, Sunflower Seeds, Dates, Papaya,  Pineapple, Cashews, Yogurt Chips.  
Recall #F-369-1.
CODE:
The firm does not code or date this product.
MANUFACTURER:
Melissa's (tm) World Variety Produce, Inc. Vernon, CA.
RECALLED BY:
Manufacturer by telephone beginning on February 7th, 2001. 
Ongoing recall resulted from sample analysis by the New York State 
Department of Agriculture and Markets.
DISTRIBUTION:
Nationwide.
QUANTITY:
120 bags.
REASON:
The product contains undeclared sulfites.
_______
PRODUCT:
Leslie Ann brand Orange Slices in 9 oz plastic bags.  
Recall #F-370-1.
CODE:
Product is uncoded.
MANUFACTURER:
Nabisco, Inc., East Hanover, N.J.
RECALLED BY:
The Becksmith Company, Cincinnati, Ohio, by phone, facsimile 
or mail on 3/20/01.  Firm-initiated recall ongoing.
DISTRIBUTION:
Ohio.
QUANTITY:
Approx. 20 lbs.
REASON:
The product contains undeclared FD&C colors: Yellow #6, Red #3, 
and Red #40. 
________
PRODUCT:
a) Banana Split Mix, sizes: 5.25 oz, 9.5 oz, 10.5 oz, and 13 oz; Recall #F-372-1
b) Caribbean Fruit & Nut Mix, sizes: 5.25 oz, 10 oz, and 12 oz.  Recall #F-373-1
c) Yogurt & Fruit Mix, sizes: 9 oz, 10.5 oz, and 13 oz. 
Recall #F-374-1
d) California Mix, sizes: 5.25 oz, 8 oz, 10 oz, and 11.5 oz. 
Recall #F-375-1
e) Mango Gold, size: 10.5 oz; Recall #F-376-1
f) Fruit Salad Mix, sizes: 5.25 oz, 9.5 oz, 10.5 oz, and 13 oz.  Recall #F-377-1
CODE:
All lots on the market at the time the recall was initiated.
MANUFACTURER:
Hickory Harvest Foods, Inc. Akron, OH
RECALLED BY:
Manufacturer by letter on 3/29/2001.  Firm-initiated recall ongoing.
DISTRIBUTION:
Nationwide.
QUANTITY:
7,029 cases
REASON:
The products contained FD&C Yellow No. 6.  
__________
PRODUCT:
Libby Brand Crispy Sauerkraut in 32 oz. Glass jars.  Recall #F-378-1.
CODE:
Lot number:  K07092b xx:xx (Where xx:xx is the military time.) 
MANUFACTURER:
Seneca Foods Corps, Geneva, NY.
RECALLED BY:
Seneca Foods Corp., Janesville, WI, by letter and press release on 
March 29, 2001.  Firm-initiated recall ongoing.
DISTRIBUTION:
MO,TX.  
QUANTITY:
450 cases (12 jars per case.)
REASON:
The product contains glass fragments.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________
PRODUCT:
Orca Bay brand frozen yellow fin tuna steaks, 8 oz. steaks, single  vac pac.
10 lb. cartons.  Recall #F-349-1.
CODE:
P57899
MANUFACTURER:
Orca Bay Seafoods, Renton, WA.
RECALLED BY:
Manufacturer by telephone and email on 3/8/01.  Firm-initiated recall complete.
DISTRIBUTION:
Florida.
QUANTITY:
18/10 lb. cases
REASON:
Product is decomposed. 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
 
________
PRODUCT: 
Source Plasma.  Recall #B-904-1.
CODES: 
Units:  S0495544, S0495479, 07146497, 07145315, 07096655, 
07093708, 08076878, 08069993, 05174003, 05171910, 05187591, 05183579, 05181131.
MANUFACTURER: 
Sera-Tec Biologicals Limited Partnership, Athens, Ohio.
RECALLED BY:
Sera-Tec Biologicals Limited Partnership, North Brunswick, NJ, 
by fax on January 25, 1999.  Firm-initiated recall complete.
DISTRIBUTION:
California.
QUANTITY:
13 Units.
REASON: 
Blood products, collected from an ineligible donor due to a 
history of incarceration, were distributed.
________
PRODUCT: 
Red Blood Cells, Recall #B-953-1.
CODES: 
Unit K124776.
MANUFACTURER: 
Puget Sound Blood Center and Program, Seattle, WA. 
RECALLED BY:
Manufacturer, by letter on December 26, 2000.  Firm-initiated 
recall complete.
DISTRIBUTION:
Washington.
QUANTITY:
One unit.
REASON: 
Blood product, collected from a donor who reported travel to an area 
designated as endemic for malaria, was distributed.
________
PRODUCT:
Red Blood Cells.  Recall #B-954-1
CODES:
Units C137729, C134519.
MANUFACTURER:
Puget Sound Blood Center & Program, Seattle Wa.
RECALLED BY:
Manufacturer, recalled by letter dated December 26, 2000. 
Firm-initiated recall complete.
DISTRIBUTION:
Washington.
QUANTITY:
Two units.
REASON: 
Blood products, collected from a donor who reported travel to an area 
designated as endemic for malaria, were distributed.
________
PRODUCT:
a) Red Blood Cells.    Recall B-955-1;
b) Platelets, Pooled.  Recall B-956-.1
CODE:
a) and b) Unit B142214.
MANUFACTURER:
Puget Sound Blood Center & Program, Seattle, WA.
RECALLED BY:
Manufacturer, by letters dated December 28, 2000.  Firm-initiated 
recall complete.
DISTRIBUTION:
Washington
QUANTITY:
Two Units
REASON: 
Blood products, collected from a donor who reported travel to an 
area designated as endemic for malaria, were distributed.
________
PRODUCT:
Source Plasma.  Recall B-957-1.
CODE:
Units G-35185-070, G35385-070.
MANUFACTURER:
Alpha Therapeutic Corporation, Vancouver, WA.
RECALLED BY:
Alpha Therapeutic Corporation, Los Angeles, CA., by facsimile 
dated October 4, 2000.  Firm initiated recall complete. 
DISTRIBUTION:
Spain.
QUANTITY:
Two Units.
REASON: 
Blood products, were distributed after receiving post donation information 
that the donor had been incarcerated.
______
PRODUCT:
Red Blood Cells.  Recall #B-959-1.
CODES:
Unit 4077265.
MANUFACTURER:
Community Blood Center, Dayton, OH.
RECALLED BY:
Manufacturer, by letter dated December 21, 2000.  Firm initiated recall complete.
DISTRIBUTION:
Ohio
QUANTITY: 
One unit.
REASON: 
Blood product, collected from a donor who reported travel to an 
area designated as endemic for malaria, was distributed. 
________
PRODUCT:
Red Blood Cells, Leukoreduced.  Recall #B-960-1.
CODE:
Unit 53L24335.
MANUFACTURER:
American Red Cross, Greater Chesapeake and Potomac Region, 
Baltimore, MD.
RECALLED BY:
Manufacturer, by letter dated December 20, 2000.  Firm-initiated recall complete.
DISTRIBUTION:
Maryland.
QUANTITY: 
One unit.
REASON: 
Blood product, collected from a donor who reported having lived 
in an area designated as endemic for malaria, was distributed. 
________
PRODUCT:
Red Blood Cells, Leukoreduced.  Recall #B-961-1.
CODE:
Unit 29GF10020.
MANUFACTURER:
American Red Cross Mid-Atlantic Region, Norfolk, VA.
RECALLED BY:
Manufacturer, by letter dated September 22, 2000. Firm-initiated recall complete.  
DISTRIBUTION:
North Carolina.
QUANTITY:
One Unit.
REASON: 
Blood product, collected from a donor who reported travel to an 
area designated as endemic for malaria, was distributed.   
_______
PRODUCT:
a) Red Blood Cells Leukoreduced.  	Recall B-962-1; 
b) Platelets.  					Recall B-963-1; 
c) Fresh Frozen Plasma.  			Recall B-964-1.
CODES:
a), b) and c) 42X28476.
MANUFACTURER:
American Red Cross Blood Services, Northern Ohio Region, Cleveland, OH.
RECALLED BY:
Manufacturer, by telephone on December 4, 2000, and by letters dated December 13, 2000.  
Firm initiated recall complete.  
DISTRIBUTION:
Ohio
QUANTITY:
Three units
REASON: 
Blood products, collected from a donor taking the drug Proscar, were 
distributed.
________
PRODUCT:
a) Red Blood Cells.  Recall B-965-1
b) Recovered Plasma  Recall B-966-1
CODE:
a) and b) Unit 42FQ77885.
MANUFACTURER:
American Red Cross Blood Services, Northern Ohio Region, Cleveland, OH
RECALLED BY:
Manufacturer, by letter dated December 14, 2000.  Firm-initiated recall complete. 
DISTRIBUTION:
Ohio, California.
QUANTITY:
Two units.
REASON: 
Blood products, collected from a donor who gave a history of idiopathic thrombocytopenia 
purpura, were distributed.
________
PRODUCT:
a) Red blood Cells.  		Recall #B-968-1
b) Platelets.  			Recall #B-969-1
c) Fresh Frozen Plasma.  	Recall #B-970-1
CODES:
a), b) and c) Unit 1633091.
MANUFACTURER:
Central Kentucky Blood Center, Lexington, KY.
RECALLED BY:
Manufacturer, by letters dated January 11, 2001.  Firm initiated recall complete.
DISTRIBUTION:
Kentucky.
QUANTITY:
Three units
REASON: 
Blood products, collected from a donor who had a history of having  sexual contact 
with someone who may have lived in an area that is considered at risk for HIV Group O, 
were distributed.    
________
PRODUCT:
a) Red Blood Cells.        			Recall #B-971-1
b) Platelets, Irradiated.  			Recall #B-972-1
c) Cryoprecipitated AHF.   			Recall #B-973-1
d) Plasma, Cryoprecipitate Reduced.  	Recall #B-974-1
CODES:
a) Units Y33803, Y16247;
b) Unit Y33803;
c) and d) Unit Y16247.
MANUFACTURER:
Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL.
RECALLED BY:
Manufacturer, by letter dated February 27, 2001. Firm-initiated 
recall complete.
DISTRIBUTION:
Illinois.
QUANTITY:
Five units.
REASON: 
Blood products, collected from a donor who had lived in the United Kingdom 
from 1976 to 1981, were distributed.
________
PRODUCT:
Source Plasma.  Recall #B-975-1.
CODES:
Units 30906204, 30908673.
MANUFACTURER:
NABI, Medford, OR.
RECALLED BY:
Manufacturer, by facsimiles on August 18, and October 30, 2000. 
Firm initiated recall complete.
DISTRIBUTION:
California.
QUANTITY:
Two units.
REASON: 
Blood products, collected from a donor who had not completed the CJD/nvCJD increased risk 
questions, were distributed.
________
PRODUCT:
a) Red Blood Cells.  Recall #B-997-1;
b) Recovered Plasma.  Recall #B-998-1.
CODES:
a) and b) Unit 40GV52651. 
MANUFACTURER:
American Red Cross Blood Services, Heart of America Region, Peoria, IL.
RECALLED BY:
Manufacturer, by letter and Questionable Plasma Inquiry on June 1, 2000. 
Firm-initiated recall complete.
DISTRIBUTION:
Illinois and California.
QUANTITY:
Two units.
REASON:
Blood products, collected from an unsuitable donor due to previous HIV 
test results, were distributed. 
________
PRODUCT:
Red Blood Cells.  Recall #B-1023-1
CODES:
Unit 21FS21749.
MANUFACTURER:
American Red Cross, Pacific Northwest Regional Blood Services, Portland, 
OR.
RECALLED BY:
Manufacturer, by telephone on September 13, 2000, and by letters dated 
September 20,2000 and October 30, 2000.  Firm-initiated recall complete.
DISTRIBUTION:
Oregon.
QUANTITY:
One unit.
REASON:
Blood product, collected from a donor who reported having lived in an 
area designated as endemic for malaria, was distributed. 
________
PRODUCT:
Red Blood Cells, Leukoreduced.  Recall #B-1024-1
CODES:
Unit 21GY64975.
MANUFACTURER:
American Red Cross, Pacific Northwest Regional Blood Services, Portland, 
OR.
RECALLED BY:
Manufacturer, by letter dated December 14, 2000.  Firm initiated recall complete.
DISTRIBUTION:
Oregon.
QUANTITY:
One unit
REASON: 
Blood product, collected from a donor who reported having lived in an 
area designated as endemic for malaria, was distributed.
________
PRODUCT:
Red Blood Cells, Leukoreduced.  Recall #B-1025-1.
CODES:
Unit 10618-9868.
MANUFACTURER:
Blood Systems, Scottsdale, AZ.
RECALLED BY:
Manufacturer, by letter on September 20,2000.  Firm initiated recall 
complete.
DISTRIBUTION:
Arizona.
QUANTITY:
One unit.
REASON:
Blood product, collected from a donor who reported having lived in an 
area designated as endemic for malaria, was distributed. 
________
PRODUCT:
a) Red Blood Cells.  Recall #B-1031-1;
b) Recovered Plasma. Recall #B-1032-1.
CODES:
a) and b) Unit 38FK06303.
MANUFACTURER:
American Red Cross Blood Services, Fort Wayne, IN.
RECALLED BY:
Manufacturer, by letter dated February 15, 2000.  Firm initiated recall complete. 
DISTRIBUTION:
Indiana and New York.
QUANTITY:
Two Units.
REASON: 
Blood products, collect from a donor with a history of hepatitis, were distributed.
______
PRODUCT:
a) Red Blood Cells.  	Recall #B-1033-1;
b) Platelets.  		Recall #B-1034-1;
c) Recovered Plasma.  Recall #B-1035-1.
CODES:
a), b) and c)  Unit 38H38780.
MANUFACTURER:
American Red Cross Blood Services, Fort Wayne, IN.
RECALLED BY:
Manufacturer, by letters on June 15, 2000.  Firm-initiated recall complete. 
DISTRIBUTION:
Indiana, California.
QUANTITY:
Three units.
REASON: 
Blood products, collected from a donor whose partner had been diagnosed 
with Hepatitis B and C, were distributed. 
_______
PRODUCT:
Platelets, Pheresis.  Recall#B-1036-1.
CODES:
Unit 6038291.
MANUFACTURER:
Central Indiana Regional Blood Center, Indianapolis, IN.
RECALLED BY:
Manufacturer, by telephone on January 31, 2001.  Firm initiated recall complete.
DISTRIBUTION:
Indiana.
QUANTITY:
One unit.
REASON: 
Blood product, which was labeled with an incorrect platelet yield, was distributed.
_______
PRODUCT:
Platelets.  Recall #B-1037-1.    
CODES:
Unit FH48955.
MANUFACTURER:
Sacramento Medical Foundation, Sacramento, CA.
RECALLED BY:
Manufacturer, by telephone on 3/12/98.  Firm initiated recall complete.
DISTRIBUTION:
Texas.
QUANTITY:
One unit.
REASON: 
Blood product, collected from a donor who had not answered a question 
regarding sexual contact with someone who had tested positive for AIDS, 
was distributed.
_______
PRODUCT:
a) Platelets.  			Recall #B-1040-1;
b) Fresh Frozen Plasma.  	Recall #B-1041-1.
CODES:
a) and b) Unit 81-28466.
MANUFACTURER:
Michigan Community Blood Center, Grand Valley Blood Program, 
Grand Rapids, MI.
RECALLED BY:
Manufacturer, by letter dated October 8, 1989.  Firm initiated recall complete. 
DISTRIBUTION:
Michigan.
QUANTITY:
Two Units.
REASON: 
Blood products, collected from a donor who was taking the drug Halcion, 
were distributed. 
______
PRODUCT:
Red Blood Cells, Leukoreduced.  Recall #B-1046-1.
CODES:
a) 29FJ40377;
b) 29FF36372.
MANUFACTURER:
American Red Cross, Mid-Atlantic Region, Norfolk, VA.
RECALLED BY:
Manufacturer, by letters dated October 20, 2000, and November 20, 2000.  
Firm-initiated recall complete.
DISTRIBUTION:
Maryland, Pennsylvania.
QUANTITY:
Two units.
REASON: 
Blood products, collected from a donor who report having lived in an area designated 
as endemic for malaria, were distributed.
________
PRODUCT:
a) Red Blood Cells.  Recall #B-1090-1;
b) Recovered Plasma.  Recall #B-1091-1.
CODES:
a) and b) 01GL38432.
MANUFACTURER:
American Red Cross Blood Services, New York-Penn Region, Syracuse, New York.
RECALLED BY:
American Red Cross Blood Services, New York-Penn Region, West Henrietta, NY, by letter 
dated June 26, 2000.  Firm initiated recall complete.
DISTRIBUTION:
New York & Switzerland.
QUANTITY:
Two Units
REASON: 
Blood products, collected from donor with a history of having tested positive for 
hepatitis, were distributed.
________
PRODUCT:
a) Red Blood Cells.  	Recall #B-1092-1;
b) Platelets.  		Recall #B-1093-1;
c) Recovered Plasma.  Recall #B-1094-1.
CODES:
a), b) and c) 0119488.
MANUFACTURER:
Blood Bank of Hawaii, Honolulu, HI.
RECALLED BY:
Manufacturer, by letter dated April 26, 1997.  Firm-initiated recall complete. 
DISTRIBUTION:
Hawaii and New York.
QUANTITY:
Three units.
REASON: 
Blood products, collected from a donor with a history of having  tested positive 
for Hepatitis B (HbsAG), were distributed.
________
PRODUCT:
a) Whole Blood.                 	Recall #B-1105-1;
b) Red Blood Cells.             	Recall #B-1106-1;
c) Red Blood Cells Irradiated.	Recall #B-1107-1;
d) Platelets.	           	Recall #B-1108-1;
e) Fresh Frozen Plasma.   		Recall #B-1109-1;
f) Cryoprecipitated AHF.  		Recall #B-1110-1;
g) Recovered Plasma.      		Recall #B-1111-1.
CODES:
a) Unit 33LK79274;
b) Units 33LM46251, 33LF30128, 33KS80088, 33LR68528, 33KM73942, 33LR68528, 
33KM73942, 33KL05831, 33LK05831, 33LF56980, 33LJ53048, 33LJ61263, 33LK46181, 
33LG17134, 33KK36151, 33LM46251;
c) Units 33LT72686;
d) Units 33LJ53048, 33LG17134,33LT72686,33LR68528,33LJ61263,33KK36151;
e) Units 33LM46251, 33LG17134, 33LK46181, 33LJ61263;
f) Units 33LF56980;
g) Units 33KK36151, 33KL05831, 33LJ53048, 33LR68528, 33LT72686, 33LF30128, 
33LF56890, 33KS80088.
MANUFACTURER:
American Red Cross, Connecticut Region, Farmington, CT.
RECALLED BY:
Manufacturer, by letters dated August 1, 2000.  Firm initiated recall 
complete.
DISTRIBUTION:
Connecticut and New York and California.
QUANTITY:
Thirty-seven units
REASON: 
Blood products, collected from a donor with a history of having tested 
positive for Heptitis B, were distributed.
________
PRODUCT:
a) Whole Blood.       Recall #B-1117-1;
b) Red Blood Cells.   Recall #B-1118-1;
c) Recovered Plasma.  Recall #B-1119-1.
CODE:
a) Units 18H14460 and 18K22598;
b) Units 18L06416 and 18H97152;
c) Units 18L06416, 18L05843, and 18H97152.
MANUFACTURER:
American Red Cross, Great Lakes Region, Lansing, MI.
RECALLED BY:
Manufacturer, by letter dated February 16, 1999.  Firm-initiated recall complete.
DISTRIBUTION:
Michigan.
QUANTITY:
Seven units.
REASON: 
Blood products, which were collected from a donor who reported having a 
history of liver disease of unknown origin and having close contact with 
a spouse who was diagnosed with  Heptitis A, were distributed.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
 
_______
PRODUCT:
Red Blood Cells.   Recall # B-912-1. 
CODE:
Unit  4616317.
MANUFACTURER:
Blood Center of New Jersey, East Orange, NJ.
RECALLED BY:
Manufacturer, by telephone on April 13, 1998.  Firm initiated recall 
complete.
DISTRIBUTION:
New Jersey.
QUANTITY:
One unit.
REASON: 
Blood product, which was not quarantined after receiving information 
indicating a post donation illness, was distributed.
_______
PRODUCT:
Red Blood Cells, Divided Unit.  Recall # B-967-1 
CODE:
Units  0274974, 0275849.
MANUFACTURER:
Community Blood Center of Greater Kansas, Kansas City, MO.
RECALLED BY:
Manufacturer, by telephone on February 10th, 1998.  Firm initiated recall complete.
DISTRIBUTION:
Kansas.
QUANTITY:
Two units.
REASON: 
Unlicensed blood products were distributed in interstate commerse.
_______
PRODUCT:
Fresh Frozen Plasma, Pooled.  Recall # B-1026-1. 
CODES:
Poll number P10420.
MANUFACTURER:
Coffee Memorial Blood Center, Inc., Amarillo, TX.
RECALLED BY:
Manufacturer, by letter dated August 25, 2000.  Firm initiated recall 
complete.
DISTRIBUTION:
Texas.
QUANTITY:
One pool.
REASON: 
Blood product, labeled with the incorrect expiration time, was distributed.
_______
PRODUCT:
Gamma Screening Cells, Duet (I & II), Liquid Red Cell Suspension 3-5%. Recall #B-1042-1.
CODE:
Lot 0926/4.
MANUFACTURER:
Gamma Biologicals, Inc., Houston, TX.
RECALLED BY:
Manufacturer, by letter or facsimile on or about November 20, 2000.  
Firm-initiated recall complete.
DISTRIBUTION:
Nationwide, Mexico, Italy, New Zealand, Argentine, Paraguay, Germany, Brazil, and 
Singapore.
QUANTITY:
One lot.
REASON:
Reagent red blood cells which, tested positive for Lu(a+) antigen but 
were labeled as Lu(a-), were distributed.
_______
PRODUCT:
Red Blood Cells.  Recall Number:	B-1086-1.
CODE:
Unit 2211402.
MANUFACTURER:
LifeShare, Inc. Elyria, OH.
RECALLED BY:
Manufacturer, by letter dated December 12, 2000.  Firm initiated recall complete.
DISTRIBUTION:
Ohio.
QUANTITY:
One unit.
REASON:
Blood product, which was collected from a donor who was taking an 
antibiotic at the time of donation, was distributed.
________
PRODUCT:
Fresh Frozen Plasma.  Recall #B-1098-1.
CODE:
Unit 22417-1013.
MANUFACTURER:
United Blood Service, Las Vegas, NV.
RECALLED BY:
Blood Systems, Inc., Scottsdale, AZ., by telephone on September 19, 2000 
and by letter dated October 23, 2000.  Firm initiated recall complete.
DISTRIBUTION:
Nevada.
QUANTITY:
One unit.
REASON: 
Blood product, prepared more than eight hours from the time of collection, 
was distributed.
_______
PRODUCT:
Platelets.  Recall #B-1099-1. 
CODE:
Unit 01FF24644.
MANUFACTURER:
American Red Cross Blood Services, 
Binghamton, NY.
RECALLED BY:
American Red Cross Blood Services, New York-Penn Region, West Henrietta, 
NY, by letter dated December 2, 1999.  Firm initiated recall complete.
DISTRIBUTION:
New York.
QUANTITY:
One Unit.
REASON:
Blood product, collected in an expired blood collection bag, was distributed.
__ _____
PRODUCT:
Red Blood Cells.  Recall #B-1116-1. 
CODES:
Unit H28512.
MANUFACTURER:
Sacramento Medical Foundation Blood Center Sacramento, CA.
RECALLED BY:
Manufacturer, by fax dated February 24, 1999.  Firm initiated recall complete.
DISTRIBUTION:
Tennessee.
QUANTITY:
One Unit.
REASON:
Blood product, collected from donor whose arm preparation was not 
documented, was distributed. 

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS 
II
________
PRODUCT:
Infant Umbilical Clamp with Security Transponder Device. 
Recall #Z-296-1.
CODES:
None.
MANUFACTURER:
Prosec Protection Systems, Inc., Lakewood, NJ.
RECALLED BY:
Manufacturer, by telephone on September 1, 2000.  Firm-initiated recall completed.
DISTRIBUTION:
Nationwide.
QUANTITY:
4395 clamps.
REASON:
Device to be adulterated in that the device sometimes slips off and 
may lead to infection (skin and bacteria) and blood loss. 
________
PRODUCT:
Midas Rex MRIV Motor System Catalog #MRIVMO.  Recall #Z-515-1.
CODES:
9500 to 9523, 96064-2, 962012, 2259.
MANUFACTURER:
Midas Rex, Fort Worth, TX.
RECALLED BY:
Manufacturer, by letter March 12, 2001.  Firm-initiated recall ongoing.
DISTRIBUTION:
Nationwide and Japan, Germany, Israel, Norway, and Switzerland.
QUANTITY:
27
REASON:
The motor overheats when operating within the active MRI field.
________
PRODUCT:
Res-Q Micron Automated Implantable cardioverter
a) Model No. 101-05.  	Recall#Z-516-1
b) Model No. 101-09.		Recall#Z-517-1
c) Model No. 101-10.  	Recall#Z-518-1
CODE:
All serial numbers
MANUFACTURER:
Sulzer Intermedics Inc. , Angleton, TX 
RECALLED BY:
Guidant Corporation, Cardiac Rhythm Management, St. Paul, MN, by visit 
and letter dated March 23, 2001.  Firm-initiated recall ongoing.
DISTRIBUTION:
Nationwide, worldwide.
QUANTITY:
2271 
REASON:
The unit indicates an improper end of service message and enters into 
backup mode disabling defibrillation therapy.  
________
PRODUCT:
a) Osteonics Omnifit Cemented Long Stem Femoral Hip Component - Left #9 35mm, Catalog 
No. 6088-0935-300L.  Recall#Z-520-1.
b) Osteonics Omnifit Cemented Long Stem Femoral Hip Component - Left #11 40mm, Catalog 
No. 6088-1140-300L. 
CODE:
a) Lot No. S00L127; b) Lot No. S00L128.
MANUFACTURER:
Howmedica Osteonics Corporation, Allendale, N.J.
RECALLED BY:
Manufacturer, by letter dated February 16, 2001.  Firm-initiated recall ongoing.
DISTRIBUTION:
Maryland
QUANTITY:
6 units -- 3 units of S00L127 and 3 units of S00L128
REASON:
The Osteonics Omnifit Cemented Long Stem Femoral Hip Component - 
Left #9 35mm was labeled as the Osteonics Omnifit Cemented Long Stem 
Femoral Hip Component - Left # 11 40mm, and the Osteonics Omnifit 
Cemented Long Stem Femoral Hip Component - Left # 11 40mm was labeled as 
The Osteonics Omnifit Cemented Long Stem Femoral Hip Component - Left #9 35mm.

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDS -- CLASS II
_________
PRODUCT:
a) Manna Pro Floating Fish Food for Catfish .  Recall #V-028-1; 
b) Manna Pro Floating Fish Food - 26% For All Freshwater Fish.  
Recall #V-029-1.
Both are packaged in 50 pound, plastic-lined, paper sacks.
CODE:
a) 10160164, 12090164, 01050264, 03020264, and 03140264;
b) 09110164, 09190164, 09230164, 10090164, 10160164, 11170164,
12090164 and 3200264.
MANUFACTURER:
Doane Pet Care,  Brentwood, Tennessee.
RECALLED BY:
Manufacturer, by telephone on March 26, 2001.  Firm-initiated recall complete.
DISTRIBUTION:
California, Pennsylvania, Ohio, Kansas, Colorado, Georgia, and Florida.
QUANTITY:
27,300 pounds of Catfish Food and 86,100 pounds of Freshwater Fish.
REASON:
The products, which contain meat by-products, were shipped without the 
required BSE warning label.
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDS -- CLASS 
III
________
PRODUCT:
Elanco brand Tylan 200 injection, 500 ml, (tylosin injection 200 mg per mL) 
for use in cattle and swine only.  NADA 12-965.  NDC 000986-020.  
Recall #V-030-1.
CODE:
Product number AH020625XAM; Lot 3NG70M; Exp. January 1, 2002.
MANUFACTURER:
Elanco Animal Health, Division of Eli Lilly and Company, Indianapolis, IN.
RECALLED BY:
Manufacturer, by letter on January 31, 2000. Firm-initiated recall complete. 
DISTRIBUTION:
United States.
QUANTITY:
720 vials. 
REASON:
The lot had been release prior to the completion of all quality assurance laboratory tests.

END OF ENFORCEMENT REPORT FOR May 2, 2001.

####

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