FDA

Enforcement Report

February 9, 2000                                           00-06

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS I
________
PRODUCT
Deli Express Ham & Swiss on Rye Sandwich, net weight, 4.4 ounces 
(product #122).  Recall #F-092-0.
CODE
593265 (printed on the product packages followed by various sell 
by dates).
MANUFACTURER
E.A. Sween Company, Eden Prairie, Minnesota.
RECALLED BY
Manufacturer, by voice mail and letter faxed on January 7, 2000. 
Firm-initiated recall complete.
DISTRIBUTION
Nationwide.
QUANTITY
11,580 sandwiches were distributed; firm estimated that less than 
25% of product remained on market at time of recall initiation.
REASON
Product was contaminated with Listeria monocytogenes.
________
PRODUCT
Imitation crabmeat products:
a) Smart Choice, Flake Style; b) Sea Legs Brand, Fit Fare;
c) Smart Choice, Leg Style; d) Sea Legs, Supreme.
Recall #F-093/096-0.
CODE
a) Pack 5/2.0 lbs Net Wt. 10. lbs "USE BY 27 SEP 99", lot 29189
Pack 5/2.0 lbs Net Wt. 10. lbs "USE BY 03 OCT 99", lot 19195
Pack 12/0.66 lbs Net Wt. 7.9 lbs "USE BY 27 SEP 99", lot 39189 
Pack 12/0.66 lbs Net Wt. 7.9 lbs "USE BY 03 OCT 99", lot 49195
b) Pack 12/0.66 lbs Net Wt. 7.9 lbs "USE BY 02 OCT 99", lot 59194
c) Pack 12/0.66 lbs Net Wt. 7.9 lbs "USE BY 03 OCT 99", lot 39195
d) Net Wt.  ** 2 lb 8 oz***", lot 69196.
MANUFACTURER
Trident Seafoods Corporation, Fife, Washington.
RECALLED BY
Manufacturer, by telephone on July 28, 1999, followed by fax.  
Firm-initiated recall complete.
DISTRIBUTION
Canada.
QUANTITY
Firm estimates none remains on the market.
REASON
Products were contaminated with Listeria monocytogenes.
________
PRODUCT
Mayfair brand Trail Mix, in 2 ounce cellophane bags.
Recall #F-097-0.
CODE
None.
MANUFACTURER
Holiday Candy Corporation, Buffalo, New York.
RECALLED BY
Manufacturer, by telephone followed by letter on October 19, 
1999, and by press release on October 20, 1999.  Ongoing recall 
resulted from inspection and follow-up by the New York State 
Department of Agriculture and Markets.
DISTRIBUTION
New York and New Jersey.
QUANTITY
31 cases (12 units per case) were distributed.
REASON
Product contains undeclared peanuts, sunflower kernels, carob 
chips, and soybeans.
________
PRODUCT
Keo Chuoi brand Sweet Banana Candy, in 8.8-ounce (250 g) rigid 
plastic containers.  Recall #F-098-0.
CODE
None.
MANUFACTURER
Unknown.  Product of Vietnam.
RECALLED BY
Tai Wing Hong Importer, Inc., Brooklyn, New York (distributor), 
by letter dated July 10, 1999, and by press release on on July 
10, 1999. Completed field correction (relabeling) resulted from 
sample analysis and follow-up by the New York State Department of 
Agriculture and Markets.
DISTRIBUTION
Florida, New York, Massachusetts, Connecticut, New Jersey, 
Maryland, Illinois.
QUANTITY
19 cases (54 packages per case) were distributed.
REASON
Product contained undeclared peanuts and sesame seeds.
________
PRODUCT
Gourmet Banana Pound Cake, net weight 5 ounces (142 g).
Recall #F-099-0.
CODE
None.
MANUFACTURER
Daisy's Bakery, Inc., Passaic, New Jersey.
RECALLED BY
Manufacturer, by letter dated October 19, 1999.  Firm-initiated 
field correction (relabeling) complete.
DISTRIBUTION
New Jersey.
QUANTITY
44 dozen 5-ounce units were distributed; firm estimates none
remains on the market.
REASON
Product contained undeclared walnuts.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________
PRODUCT
Stop & Shop Chocolate Mini Cupcakes (Iced with Jimmies)
packed in plastic 12/package. Recall #F-090-0.
CODE
UPC Code 02000-04440, product sold at Stop & Shop retail bakeries
prior to 12/29/99.-
MANUFACTURER
LaBree's, Old Town, Maine.
RECALLED BY
The Stop & Shop Supermarket Company, Boston, Massachusetts,
by E-mail on December 29, 1999. Firm-initiated recall complete.
DISTRIBUTION
Massachusetts, New York, Connecticut, Rhode Island.
QUANTITY
Firm estimates none remains on the market.
REASON
Product contains undeclared FD&C Yellow No. 5, FD&C
Yellow #6, FD&C Red #3, FD&C Red #40, and FD&C Blue #1.
________
PRODUCT
Stop & Shop Iced Angel Cake packed in plastic.  Recall #F-091-0.
CODE
Product sold at Stop & Shop retail bakeries prior to 11/23/99. 
MANUFACTURER
Meurer Bakeries, Inc., Muskego, Wisconsin. 
RECALLED BY
The Stop & Shop Supermarket Company, Boston, Massachusetts, by E-
mail on November 23, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Massachusetts, New York, Connecticut, Rhode Island.
QUANTITY
Firm estimates none remains on the market.
REASON
Product contains undeclared FD&C Yellow #5, FD&C Yellow #6,
FD&C Red #3, FD&C Red #40, FD&C Blue #1, and FD&C Blue #2.
________
PRODUCT
Lemon Flavored Drink, in 16-ounce cartons.  Recall #F-101-0.
CODE
All non expired product is covered by the recall (although all 
product including expired product was recovered if found) at the 
time the following codes were involved in the recall action:  
JAN 04 12-283    JAN 13 12-283    JAN 21 12-283
JAN 27 12-283    FEB 12 12-283    FEB 18 12-283.
MANUFACTURER
Velda Farms, Miami, Florida.
RECALLED BY
Manufacturer, by visit January 4-6, 2000.  Firm-initiated recall 
complete.
DISTRIBUTION
Florida.
QUANTITY
19,979 units were distributed; firm estimates none remains on the 
market.
REASON
Product contains undeclared FD&C Yellow #5.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________
PRODUCT
Adenoscan (r) Adenosine (90 mg/30 mL), in 30 mL single-dose vial, 
for intravenous infusion only, Rx intravenous infusion nucleoside 
vasolidator used as an adjunct to thallium-201 myocardial 
perfusion scintigraphy in patients unable to exercise adequately.
NDC #0469-0871-.  Recall #D-208-0.
CODE
Lot Numbers: 190244, 190249, 190258, 190613, 190665 and 190677.
MANUFACTURER
American Pharmaceutical Partners, Inc (APP), Melrose Park, 
Illinois.
RECALLED BY
Manufacturer, by telephone on January 11, 2000, followed by 
letter dated January 13, 2000. Firm-initiated recall ongoing. 
DISTRIBUTION
Nationwide.
QUANTITY
275,151 vials were distributed; FDA estimated that 100,000 vials 
remained on the market at time of recall initiation.
REASON
Chipped and leaking vials - Possible presence of glass particles in 
vials.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________
PRODUCT
Cyndal HD Cough Syrup (Hydrocodone Bitartrate 1.57mg/ 
Phenylephrine Hydrochloride 5mg/Chlorpheniramine Maleate 2mg), in 
16 fluid ounce and 1 gallon containers.  NDC 60258-703-16 (16 oz) 
and 60258-703-28 (1 gallon). Recall #D-209-0.
CODE
Lot #91949.
MANUFACTURER
Great Southern Laboratories (GSL), Houston, Texas.
RECALLED BY
Manufacturer, by verbal communication on December 15, 1999, 
followed by letters dated December 21 and 30, 1999.  Firm-
initiated recall ongoing.
DISTRIBUTION
Southeastern United States.
QUANTITY
118 gallon bottles and 7,032 pint bottles were distributed.
REASON
Subpotency of the phenylephrine (50%) due to incorrect weight 
addition in batch production.
________
PRODUCT
Esgic-Plus? Tablets (butalbital 50mg, acetaminophen 500mg, 
caffeine 40mg), in 100 tablet bottles. NDC #0456-0618-01.
Recall D-210-0.
CODE
Lot #90248A 1 EXP 8/01.
MANUFACTURER
Med-Pro, Inc., Lexington, Nebraska (repacker/responsible firm).
RECALLED BY 
Repacker, by fax on December 27, 1999. Firm-initiated recall 
ongoing. 
DISTRIBUTION
New York.
QUANTITY
999 bottles were distributed.
REASON
Mislabeling - Bottles contain capsule form of the same ingredient 
product; not the labeled tablet form of product.
________
PRODUCT
Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Solution, 
USP, Rx, 3.5mg/10,000 units/10mg (1%), 10 mL with sterile dropper.
Recall #D-212-0.
CODE
Lot #205101 EXP 4/01.
MANUFACTURER
Bausch and Lomb Pharmaceuticals Inc., Tampa, Florida.
RECALLED BY
Manufacturer, by letter December 7, 1999.  Firm-initiated recall 
ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
45,808 units were distributed.
REASON
One unit was found to contain Hydrocortisone Otic Suspension not 
Hydrocortisone Solution as labeled.

RECALLS AND FIELD CORRECTINS BIOLOGICS -- CLASS II
________
PRODUCT
Fresh Frozen Plasma. Recall #B-318-0.
CODE
Unit Numbers: 5080576, 5128888, 5146851, 5176575, 5089839 
5132166, 5153745, 5109490, 5136996, 5161373, 5109590, 5136999, 
5161744, 5111489, 5137000, 5163767, 5115703, 5140186, 5165860, 
5115910, 5140673, 5166034, 5123364, 5140727, 5168253, 5123513, 
5140906, 5169734, 5124132, 5146182, 5169739.
MANUFACTURER
Carter BloodCare, Bedford, Texas. 
RECALLED BY
Manufacturer, by telephone on February 16, 1999. Firm--initiated 
recall complete.
DISTRIBUTION
Texas.
QUANTITY
31 units were distributed.
REASON 
Thirty one units of Cryoprecipitate-poor Plasma ware labeled as 
Fresh Frozen Plasma.
________
PRODUCT
Platelets.  Recall #B-323-0.
CODE
Unit #l8FQ41930.
MANUFACTURER 
American Red Cross, Lansing, Michigan
RECALLED BY
Manufacturer, by telephone and letter on March 5, 1999. 
Firm-initiated recall complete. 
DISTRIBUTION
Michigan.
QUANTITY 
1 unit was distributed.
REASON
Platelets were not stored under continuous agitation, and for 
which storage temperature was not documented.
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Cryoprecipitated AHF;
d) Recovered Plasma.  Recall #B-330/333-0.
CODE
Unit #18FE47353.
MANUFACTURER
American Red Cross, Lansing, Michigan. 
RECALLED BY 
Manufacturer, by letters on either July 15 or 17, 1998, and by 
telephone on July 15, 1998. Firm-initiated recall complete.
DISTRIBUTION
Michigan and Switzerland.
QUANTITY 
1 unit of each component was distributed.
REASON 
Blood products were collected from an unsuitable donor.
________
PRODUCT
Red Blood Cells. Recall B-334-0. 
CODE
Unit #l8FR27172.
MANUFACTURER
American Red Cross, Lansing, Michigan.
RECALLED BY
Manufacturer, by letter on December 7, 1998. Firm-initiated 
recall complete. 
DISTRIBUTION
Indiana and California.
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-336-0.
CODE
Unit #21KFO9513. 
MANUFACTURER
American Red Cross, Pacific Northwest Regional Blood Services,
Portland, Oregon. 
RECALLED BY
Manufacturer, by letter dated October 7, 1999.Firm--initiated 
recall complete. 
DISTRIBUTION
California.
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
Platelets.  Recall #B-338-0.
CODE
Unit Numbers: L58411 and K95606.
MANUFACTURER
HCSC Blood Center, doing business as Miller Memorial Blood Center, 
Bethelhem, Pennsylvania.
RECALLED BY
Manufacturer, by telephone on October 11, 1996, and November 11, 
1996, and by letter dated December 13, 1999. Firm-initiated recall 
complete.
DISTRIBUTION
Pennsylvania.
QUANTITY
2 units were distributed.
REASON
Blood products were collected from donors who had taken aspirin 
within 72 hours of donation.
________
PRODUCT
Red Blood Cells.  Recall #B-339-0.
CODE
Unit #0113650.
MANUFACTURER
Marequette General Hospital, Upper Peninsula Regional Blood 
Center, Marquette, Michigan.
RECALLED BY
Manufacturer, by telephone on September 21, 1998.  
Firm--initiated recall complete.
DISTRIBUTION
Michigan.
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 
Gs National Weed Mix, in 50 ml vials, labeled as containing 
40,000 PNU/mL. Recall #B-340-0.
CODE
Lot #P3-198-lPl.
MANUFACTURER
Greer Laboratories, Inc., Lenoir, North Carolina.
RECALLED BY
Manufacturer, by telephone on September 2, 1999. Firm-initiated 
recall complete.
DISTRIBUTION
New York.
QUANTITY
5 vials were distributed.
REASON
Allergenic extract was labeled with a concentration of 40,000 
PNU/mL rather than 4,000 PNU/mL.
________
PRODUCT
Platelets.  Recall #B-341-0.
CODE
Unit Numbers: 8S95133, 18S95145, 18S95147, 18S95150, 18S95154, 
18S95158.
MANUFACTURER
American Red Cross, Lansing, Michigan.
RECALLED BY
Manufacturer, by telephone and letter on July 27, 1999.
Firm-initiated recall complete.
DISTRIBUTION
Michigan and Ohio.
QUANTITY
6 units were distributed.
REASON
Blood products were collected in a manner that may have compromised 
the sterility of the units.
________
PRODUCT
Red Blood Cells.  Recall #B-342-0.
CODE
Unit #1721378.
MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, 
Indiana.
RECALLED BY
Manufacturer, by letter on June 17, 1999. Firm-initiated recall 
complete.
DISTRIBUTION
Indiana.
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-343-0.
CODE
Unit #C32179.
MANUFACTURER
South Bend Medical Foundation, Inc., South Bend, Indiana.
RECALLED BY
Manufacturer, by letter on or about January 25, 1999.
Firm-initiated recall complete.
DISTRIBUTION
Indiana.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor with a history of 
jaundice.
________
PRODUCT
a) Red Blood Cells; b) Platelets.  Recall #B-345/346-0.
CODE
Unit Numbers: a) 9977238, 9930746, 9880380; b) 9977238, 9948702, 
9880380.
MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, 
Cincinnati, Ohio. 
RECALLED BY
Manufacturer, by letter Dated December 31, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Ohio and Florida.
QUANTITY
3 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
Red Blood Cells. Recall #B-348-0.
CODE
Unit #04MB1784.
MANUFACTURER
American Red Cross, Dedham, Massachusetts.
RECALLED BY
Manufacturer, by letter dated August 2, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Pennsylvania.
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-349-0.
CODE
Unit #0392373.
MANUFACTURER 
Hoxworth Blood Center, University of Cincinnati Medical Center, 
Cincinnati, Ohio.
RECALLED BY
Manufacturer, by letter dated May 20, 1999.  Firm initiated 
recall complete.
DISTRTBUTION
Tennessee.
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
a) Red Blood Cells; b) Platelets; c) Source Leukocytes for
Further Manufacture.  Recall B-350/352-0.
CODE
Unit Numbers: a) 9875870, 9912090; b) 9966178, 9913055, 9875870, 
9912090; c) 9875870.
MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, 
Cincinnati, Ohio.
RECALLED BY
Manufacturer, by letters dated March 28, 1999, or April 5, 1999. 
Firm-initiated recall complete.
DISTRIBUTION
Ohio and Florida.
QUANTITY
a) 2 units; b) 4 units; 1 unit distributed.
REASON
Blood products were collected from a donor who traveled to an 
area designated as endemic for malaria.
________
PRODUCT
a) Red Blood Cells; b) Platelets. #B-353/354-0.
CODE
Unit Numbers: 9964722 (parts A and B), 9930556, 9927899,
9878452; b) 9930556, 9927899.
MANUFACTURER
Hoxworth Blood Center, Cincinnati, Ohio.
RECALLED BY
Manufacturer, by letter dated March 22, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Ohio and Kentucky.
QUANTITY
a) 2 units and 1 split unit; b) 2 units were distributed.
REASON
Blood products were collected from a donor who traveled to an area 
designated as endemic for malaria.
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Recovered Plasma. 
Recall #B-355/357-0.
CODE
Unit Numbers: a) 13FH41882, 13W87318; b) 13W87318; c) 13FH41882, 
13W87318. 
MANUFACTURER
American Red Cross, Detroit, Michigan. 
RECALLED BY
Manufacturer, by letter and/or telephone on December 1, 1998. 
Firm-initiated recall complete.
DISTRIBUTION 
Michigan, California, New York.
QUANTITY
a) 2 units; b) 1 unit; c) 2 units were distributed. 
REASON
Blood products were collected from a donor taking Megace
________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-359/360-0.
CODE
Unit #01KK46138.
MANUFACTURER
American Red Cross Blood Services, Rochester, New York.
RECALLED BY
Manufacturer, by letter on either June 11 or 13, 1999. Firm-
initiated recall complete. 
DISTRIBUTION
New York and Switzerland.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who had received a 
rabies vaccination.
________
PRODUCT
Platelets, Irradiated.  Recall #B-364-0.
CODE
Unit #01KK50956.
MANUFACTURER
American Red Cross Blood Services, Rochester, New York.
RECALLED BY
Manufacturer, by telephone on June 2, 1999, and by letter dated 
June 17, 1999.  Firm-initiated recall complete.
DISTRIBUTION
New York.
QUANTITY
1 unit was distributed.
REASON
Blood product was mislabeled as CMV antibody.
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma.
Recall #B-365/367-0.
CODE
Unit #13FG77321.
MANUFACTURER
American Red Cross, Detroit, Michigan.
RECALLED BY
Manufacturer, by telephone on January 21, 1999, and by letter on 
February 4, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Michigan.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were prepared from a whole blood unit designated as 
overweight.
________
PRODUCT
a) Red Blood Cells; b) Platelets.  Recall #B-368/369-0.
CODE
Unit #36-19539.
MANUFACTURER
Michigan Community Blood Centers, Grand Rapids, Michigan.
RECALLED BY
Manufacturer, by letter on March 22, 1999.  Firm-initiated recall 
complete.
DISTRIBUTION
Michigan.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor with a history of 
cancer.
________
PRODUCT
Platelets.  Recall #B-370-0.
CODE
Unit #42FH89224.
MANUFACTURER
American Red Cross Blood Services, Cleveland, Ohio.
RECALLED BY
Manufacturer, by telephone on November 4, 1999, followed by 
letter dated November 8, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Ohio.
QUANTITY
1 unit was distribution.
REASON
Blood product was prepared from an overweight unit of whole 
blood.
________
PRODUCT
Platelets, Pheresis.  Recall #B-372-0.
CODE
Unit #8784574.
MANUFACTURER
New York Blood Services (Center West), New York, New York.
RECALLED BY
Manufacturer, by telephone on September 30, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
New York.
QUANTITY
1 unit was distributed.
REASON
Blood product had a platelet yield that exceeded the acceptable 
limit.
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma.
Recall #B-373/375-0.
CODE
Unit #42H10965.
MANUFACTURER
American Red Cross Blood Services, Cleveland, Ohio.
RECALLED BY
Manufacturer, by letter dated October 20, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Ohio.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor taking the drug 
Methotrexate.
________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma.  Recall #B-404/405-0.
CODE
Unit Numbers:  24KZ05186, 24KZ05187, 24KZ05188, 24KZ05189, 
24KZ05190, 24KZ05191, 24KZ05192.
MANUFACTURER
American Red Cross Blood Services, Louisville, Kentucky.
RECALLED BY
Manufacturer, by letter dated March 27, 1998, and by telephone on 
March 23, 1998.  Firm-initiated recall complete.
DISTRIBUTION
Kentucky, Indiana, Switzerland.
QUANTITY
7 units were distributed.
REASON
Blood products were incorrectly tested for syphilis.
________
PRODUCT
Platelets, Pheresis.  Recall #B-412-0.
CODE
Unit #FJ14071.
MANUFACTURER
Healthcare Provider Services, Inc., doing business as Rhode 
Island Blood Center, Providence, Rhode Island.
RECALLED BY
Manufacturer, by telephone on August 30, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Rhode Island.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who traveled to an area 
considered endemic for malaria.
________
PRODUCT
Red Blood Cells.  Recall #B-413-0.
CODE
Unit #LR30416.
MANUFACTURER
The Blood Center of Central Iowa, Des Moines, Iowa.
RECALLED BY
Manufacturer, by letter dated April 15, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
New York.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who traveled to an area 
considered endemic for malaria.
________
PRODUCT
a) Red Blood Cells; b) Platelets.  Recall #B-414/415-0.
CODE
Unit #LT11115.
MANUFACTURER
The Blood Center of Central Iowa, Des Moines, Iowa.
RECALLED BY
Manufacturer, by letter dated September 17, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Illinois and Iowa.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who traveled to an 
area considered endemic for malaria.
________
PRODUCT
Red Blood Cells.  Recall #B-416-0.
CODE
Unit #KW22166.
MANUFACTURER
The Blood Center of Central Iowa, Des Moines, Iowa.
RECALLED BY
Manufacturer, by letter dated March 3, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Iowa.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who traveled to an area 
considered endemic for malaria.
________
PRODUCT
Red Blood Cells.  Recall #B-417-0.
CODE
Unit Numbers:  KE93751 and LR14268.
MANUFACTURER
The Blood Center of Central Iowa, Des Moines, Iowa.
RECALLED BY
Manufacturer, by letter dated March 10, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Virginia and Iowa.
QUANTITY
2 units were distributed.
REASON
Blood products were collected from a donor who traveled to an 
area considered endemic for malaria.
________
PRODUCT
a) Red Blood Cells; b) Platelets.  Recall #B-418/419-0.
CODE
Unit numbers: a) LT10849 and LR28233; b) LT10849.
MANUFACTURER
The Blood Center of Central Iowa, Des Moines, Iowa.
RECALLED BY
Manufacturer, by letter dated December 28, 1998.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Illinois and Iowa.
QUANTITY
a) 2 units; b) 1 unit dated.
REASON
Blood products collected from a donor who traveled to an area 
considered endemic for malaria.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________
PRODUCT
Platelets For Further Manufacture of Non-injectable Products.
Recall #B-335-0.
CODE
Unit #18FR27172.
MANUFACTURER
American Red Cross, Lansing, Michigan.
RECALLED BY 
Manufacturer, by letter on December 7, 1998.  Firm-initiated recall 
complete.
DISTRIBUTION
Indiana and California.
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-337-0.
CODE
Unit #68463.
HANUFACTURER
Lane Memorial Blood Bank, Eugene, Oregon.
RECALLED BY
Manufacturer, by letter dated August 19, 1999. 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
Platelets. Recall #B-344-0.
CODE
Unit #13FG78817.
MANUFACTURER
American Red Cross, Detroit, Michigan.
RECALLED BY
Manufacturer, by letter on March 5, 1999.  Firm-initiated recall 
complete.
DISTRIBUTION
Michigan.
QUANTITY
1 unit was distributed.
REASON
Blood product was prepared from a unit of whole blood with an 
extended collection time.
________
PRODUCT
Platelets For Further Manufacture. Recall #B-347-0.
CODE
Unit #9914756.
MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, 
Cincinnati, Ohio.
RECALLED BY
Manufacturer, by letter dated December 31, 1998.  Firm--initiated 
recall complete. 
DISTRIBUTION
Ohio and Florida.
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
Platelets.  Recall #B-358-0.
CODE
Unit #01GN25083.
MANUFACTURER
American Red cross Blood Services, Rochester, New York.
RECALLED BY
Manufacturer, by telephone on February 9, 1999, and by letter dated 
February 10, 1999.  Firm-initiated recall complete.
DISTRIBUTION
New York.
QUANTITY
1 unit was distributed.
REASON
Blood product was prepared from a whole blood unit that had 
discrepant start and end times documented.
________
PRODUCT
Platelets.  Recall #B-361-0.
CODE
Unit #04LE13582.
MANUFACTURER
American Red Cross, Dedham, Massachusetts.
RECALLED BY
Manufacturer, by letter dated September 24, 1999.  Firm-initiated 
recall complete.
DISTIRBUTION
Maine.
QUANTITY
1 unit was distributed.
REASON
Blood product was prepared from a whole blood unit that had 
discrepant start and end times documented.
________
PRODUCT
Platelets.  Recall #B-362-0.
CODE
Unit #13FG80560, 13FH58793, 13GC68182.
MANUFACTURER
American Red Cross, Detroit, Michigan
RECALLED BY
Manufacturer, by telephone on May 14, 1999, and letter on July 2, 
1999.  Firm-initiated recall complete.
DISTRIBUTION
Michigan.
QUANTITY
3 units were distributed.
REASON
Blood products were prepared from three units of whole blood with 
extended collection times.
________
PRODUCT
Fresh Frozen Plasma.  Recall #B-363-0.
CODE
Unit #G94666.
MANUFACTURER
HCSC Blood Center, doing business as Miller Memorial Blood 
Center, Bethelhem, Pennsylvania.
RECALLED BY
Manufacturer, by letter dated May 14, 1997.  Firm-initiated 
recall complete.
DISTRIBUTION
Pennsylvania.
QUANTITY
1 unit was distributed.
REASON
Blood product was prepared from a unit of whole blood with an 
extended collection time.
________
PRODUCT
Platelets.  Recall #B-371-0.
CODE
Unit #1138117.
MANUFACTURER
New York Blood Services (Center West), New York, New York.
RECALLED BY
Manufacturer, by letter dated November 2, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
New York.
QUANTITY
1 unit was distributed.
REASON
Blood product was prepared from a unit of whole Blood with an 
extended collection time.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________
PRODUCT
Olympic Mini Bili-Lite (halogen phototherapy light),
Models 77 and 78.  Recall #Z-331/332-0.
CODE
Catalog Numbers:  51477 and 51478.
MANUFACTURER
Olympic Medical, Seattle, Washington.
RECALLED BY
Manufacturer, by telephone, followed by letter on or about 
October 15, 1999.  Firm-initiated field correction ongoing.
DISTRIBUTION
Nationwide, Canada, Argentina, Croatia, Hong Kong, India, Panama.
QUANTITY
797 lights.
REASON
Potential for light to fall due to a broken spring.
________
PRODUCT
System 98 Intra-Aortic Balloon Pumps containing software Revision 
B, used to inflate and deflate intra-aortic balloons:
a) Model No. 0998-00-0466-51
b) Model No. 0998-00-0466-53
c) Model No. 0998-00-0466-55
d) Model No. 0998-00-0466-57
e) Model No. 0998-00-0466-58
f) Model No. 0998-00-0466-61
g) Model No. 0998-00-0466-64
h) Model No. 0998-00-0466-65
i) Model No. 0998-00-0466-67
j) Model No. 0998-00-0466-83
k) Model No. 0998-00-0466-94.  Recall #Z-337/347-0.
CODE
Pumps containing software revision B.
MANUFACTURER
Datascope Corporation, Patient Monitoring Division, Paramus, 
New Jersey.
RECALLED BY 
Manufacturer, by letter dated November 25, 1999.  Firm-initiated 
field correction ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
550 units were distributed.
REASON
Some units may fail to power-up and displays "Electrical Code 
Failure #5" on the pump screen.

RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS III
________
PRODUCT
Contrast hCG Urine/Serum Test, a rapid immunoassay for the 
qualitative detection of Human Chorionic Gonadotropin in urine or 
serum for the early detection of pregnancy.
Recall #Z-325-0.
CODE
Catalog No.               Lot No.
BHF 1003 (30 test kit)    B14016
BHF 1003                  B13984
BHF 1203(individual test) B13989.  Lots Expire 10-2001 
BHF  1203                 B13961.  Lot Expires 11-2001.
MANUFACTURER
Genzyme Diagnostics, San Carlos, California.
RECALLED BY
Genzyme Corporation Diagnostics Division, Cambridge, 
Massachusetts, by letters on January 5 and 7, 2000. 
Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide, Colombia, Venezuela.
QUANTITY
Lot B14016=785 kits; Lot B13984=245 kits; Lot B13989=9,500 tests; 
Lot B13961=11,250 pouches.
REASON
Increase incidence of false positive results using serum specimens.

END OF ENFORCEMENT REPORT FOR FEBRUARY 9, 2000.

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