FDA

Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, U.S. Public Health Service, Department of Health and Human Services. It contains information on actions taken in connection with agency regulatory activities.


February 17, 1999                                     
99-07

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

________
PRODUCT

Sprout products under the Garden of Eatin and Pearson Living
Sprouts labels:  a) Alfalfa Sprouts
b) Clover Sprouts
c) Crunchy Sprouts (alfalfa, radish, wheat)
d) Dill Mix Sprouts (alfalfa, dill)
e) Gourmet Sprouts (cabbage, fenugreek, clover)
f) Mustard & Onion Sprouts (alfalfa, onion, mustard)
g) Onion Mix Sprouts (onion, clover)
h) Radish Sprouts
i) Spicy Sprouts (alfalfa, radish)
j) Spicy Sprouts (clover, radish)
k) Onion Sprouts (alfalfa, onion).  Recall #F-153/163-9.

CODE
All products on the market at the time of the recall.

MANUFACTURER
Windmill Farms Company, Grand Rapids, Michigan.

RECALLED BY
Manufacturer, by press release on September 4 and 5, 1998, and by letter on September 4, 1998. Firm-initiated recall complete.

DISTRIBUTION
Illinois, Indiana, Michigan, Ohio, Wisconsin.

QUANTITY
Firm estimates none remains on the market.

REASON
Products may be contaminated with Listeria monocytogenes.

________
PRODUCT

Various Slaws, Salads, Spreads, in 5 pound institutional size
containers:
a) Carolina Cole Slaw (cabbage, slaw dressing, carrots,
citric acid, potassium sorbate, sodium benzoate) under the
following labels:  Jubilee and Checkers;
b) Macaroni Salad (macaroni noodles, salad dressing,
pickle relish, carrots, potassium sorbate, sodium benzoate) under
the following label:  Jubilee;
c) Deli Style Pimento Spread (pasteurized processed American
cheese, American cheese substitute, salad dressing, pimento
puree, water, sugar, potassium sorbate) under the following
label:  Jubilee;
d) Cole Slaw (cabbage, slaw dressing, carrots) under the
following labels:  Jubilee and Lanier, Inc.;
e) Tuna Fish Salad (tuna fish, salad dressing, celery, textured
vegetable protein, pickle relish, lemon juice, red pepper, food
starch, onion powder, black pepper, potassium sorbate) under the
following label:  IFH Institution Food House
f) Tuna Fish Salad (tuna, salad dressing, celery, salad
cubes, red peppers) under the following labels:  Jubilee and  
Lanier, Inc.;
g) Pimento Spread (American cheese, process cheese, salad
dressing, pimentos, red peppers, sugar, potassium sorbate) under
the following label:  Lanier, Inc.;
h) Macaroni & Cheese Salad (cooked elbow macaroni, salad
dressing, pickle relish, imitation American cheese, water,
carrots, potassium sorbate, sodium benzoate) under the following
label:  IFH Institution Food House.  
Recall #F-164/171-9.

CODE
All products on the market at the time of the recall on October 15, 1998.

MANUFACTURER
Made Rite Foods, Inc., Greensboro, North Carolina.

RECALLED BY
Manufacturer, by telephone or by fax on October 15, 1998. Firm-initiated recall complete.

DISTRIBUTION
Florida, Georgia, North Carolina, Pennsylvania, South Carolina, Tennessee, Virginia.

QUANTITY
Firm estimates none remains on the market.

REASON
Products contain undeclared egg ingredients.

________
PRODUCT



Foil wrapped milk chocolate gold coins in the following packaging
styles:
a) One style is sold primarily for Hanukkah and is sold in
cartons containing 24 boxes, each box contains 24 5/8 oz. yellow
mesh bags, each bag containing one large gold coin and five
smaller coins.  The bags are secured with red tags labeled "elite
MILK CHOCOLATE COINS".  The UPC symbol for the individual mesh
bag is 77245-10184.  The inner box is labeled "elite***MADE BY
ELITE LTD., RAMAT GAN, ISRAEL***MILK CHOCOLATE GOLD COINS
CHOCOLATE AU LAIT LOUIS D'OR***ART. NO. 128705 5/8***24 BAGS***".
b) The other style identified as "Presidents Gold Coins" is sold
in cartons containing six unlabeled plastic containers, each
containing 48 mesh bags, each bag containing one large gold coin
and five smaller coins.  The bags are secured with dark blue tags
labeled "elite MILK CHOCOLATE COINS".  The UPC symbol for the
individual mesh bag is 77245-10617.  
Recall #F-179/180-9.

CODE
There are no manufacturing codes or expiration dates. See above for UPC codes.

MANUFACTURER
Elite Industries, Ltd., Ramat Gan, Israel.

RECALLED BY
Elite Confections USA, Inc., Bronx, New York, by letters on December 29, 1998, and by press release on December 30, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
a) Nationwide; b) New York, New Jersey, Michigan, California, Texas, Illinois, Massachusetts, South Dakota, Washington state, Florida.

QUANTITY
Firm estimates none remains on the market.

REASON
Product may be contaminated with peanut residue.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

________
PRODUCT

Various Slaws, Salads, and Dressings in 5 pound institutional size containers: a) Seafood Salad (imitation crabmeat, mayonnaise, celery, onion, vinegar, food starch, potassium sorbate, sodium benzoate) under the following labels: Jubilee and IFH Institution Food House; b) Carrot & Raisin Salad (carrots, mayonnaise, pineapple, raisins, sugar, food starch, salt, potassium sorbate) under the following label: IFH Institution Food House; c) Mustard Potato Salad (cooked potatoes, mayonnaise, salad cubes, celery, onion, mustard, red pepper, FD&C Yellow No.5 under the following label: Jubilee; d) Seafood Dressing (mayonnaise, celery, green onion, seasoning salt, lemon pepper, black pepper) under the following label: Lowe's Food Stores; e) Carolina Cole Slaw (cabbage, mayonnaise, sugar, vinegar, salt) under the following label: Lanier, Inc.; f) Carolina Cole Slaw and Cole Slaw (ingredients for both are cabbage, mayonnaise, sugar, carrots, vinegar, food starch, citric acid, salt, potassium sorbate, and sodium benzoate) under the following labels: IFH Institution Food House and Southern Foods. Recall #F-172/177-9.

CODE
All products on the market at the time of the recall on October 15, 1998.

MANUFACTURER
Made Rite Foods, Inc., Greensboro, North Carolina.

RECALLED BY
Manufacturer, by telephone or by fax on October 15, 1998. Firm-initiated field correction (relabeling) complete.

DISTRIBUTION
Florida, Georgia, North Carolina, Pennsylvania, South Carolina, Tennessee, Virginia.

QUANTITY
Firm estimates none remains on the market.

REASON
Products' label does not declare the ingredients of mayonnaise.

RECALLS AND FIELD CORRECTIONS: FOODS-- CLASS III

________
PRODUCT
Refrigerated Cookie Dough products packaged in 18 ounce unit size containers, 12/18 ounce containers per case: a) Nestle' Tollhouse Chocolate Chip Cookie Dough; b) Nestle' Tollhouse Peanut Butter Chocolate Chip Cookie Dough. Recall #F-151/152-9.

CODE
a) 8258 QN207 through 8258 QN214; b) 8258 QN214 through 8258 QN223.

MANUFACTURER
Earthgrains Refrigerated Dough Products, Inc., Carrolton, Texas.

RECALLED BY
Nestle' USA Foods Division, Inc., Solon, Ohio, letter on January 15 and 20, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
a) 2,804 cases; b) 4,376 cases were distributed.

REASON
Product may be contaminated with filth.

________
PRODUCT
Premium Potato Salad (fresh potatoes, mayonnaise, salad cube (cucumbers, corn syrups, vinegar, salt, alum, .1% sodium benzoate, xanthan gum, natural and artificial flavors, polysorbate 80, FD&C Yellow #5, egg, celery, onion, red pepper, green pepper, mustard, sugar, salt, black pepper, potassium sorbate) under the following label: Lanier, Inc. Recall #F-178-9.

CODE
All product on the market at the time of recall on October 15, 1998.

MANUFACTURER
Made Rite Foods, Inc., Greensboro, North Carolina.

RECALLED BY
Manufacturer, by telephone or by fax on October 15, 1998. Firm-initiated field correction (relabeling) complete.

DISTRIBUTION
Florida, Georgia, North Carolina, Pennsylvania, South Carolina, Tennessee, Virginia.

QUANTITY
1,511 cases were distributed.

REASON
Products' label did not declare the ingredients of mayonnaise, but did list eggs as a separate ingredient.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

________
PRODUCT
Timoptic-XE Ophthalmic (Timolol Maleate 6.8 mg/mL Ophthalmic Gel Forming Solution), 0.5% Timolol equivalent, in 5 mL ocumeter ophthalmic dispenser. Recall #D-097-9.

CODE
1138H, 1140H, 1193H, 1194H, 1206H, 1207H, 1318H, 1419H.

MANUFACTURER
Merck Manufacturing Division, Division of Merck & Company, Inc., West Point, Pennsylvania.

RECALLED BY
Manufacturer, by letter on December 15, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide.

QUANTITY
485,804 units were distributed.

REASON
Gel strength test failures (stability).

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

________
PRODUCT
Red Blood Cells. Recall #B-369-9.

CODE
Unit #40GH20510.

MANUFACTURER
American Red Cross Blood Services, Peoria, Illinois.

RECALLED BY
Manufacturer, by letter dated November 17, 1998. Firm-initiated recall complete.

DISTRIBUTION
Illinois.

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-370-9.

CODE
Unit numbers: 1479873 and 2139211.

MANUFACTURER
LifeSource, Glenview, Illinois.

RECALLED BY
Manufacturer, by telephone on July 18, 1998, followed by letter dated August 28, 1998. Firm-initiated recall complete.

DISTRIBUTION
Illinois.

QUANTITY
2 units were distributed.

REASON
Blood products tested reactive for syphilis.

________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-371/372-9.

CODE
Unit #4611807.

MANUFACTURER
Naval Hospital, Great Lakes, Illinois.

RECALLED BY
Manufacturer, by letter dated October 2, 1998. Firm-initiated recall complete.

DISTRIBUTION
Georgia and Florida.

QUANTITY
1 unit of each component was distributed.

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

________
PRODUCT
Red Blood Cells. Recall #B-442-9.

CODE
Unit #9783083.

MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, Ohio.

RECALLED BY
Manufacturer, by letter dated May 20, 1997. Firm-initiated recall complete.

DISTRIBUTION
Ohio.

QUANTITY
1 unit was distributed.

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

________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall #B-453-9.

CODE
Split unit 18217-3545-01.

MANUFACTURER
United Blood Services, Cheyenne, Wyoming.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on December 4, 1998, and by letter dated January 8, 1999. Firm-initiated recall complete.

DISTRIBUTION
Wyoming.

QUANTITY
1 unit was distributed.

REASON
Blood product had a high white cell count.

________
PRODUCT
Source Plasma. Recall #B-457-9.

CODE
Unit #0021205.

MANUFACTURER
DCI Biologicals, Carbondale, Inc., Carbondale, Illinois.

RECALLED BY
Manufacturer, by telephone on October 15, 1998, and by visit on October 16, 1998. Firm-initiated recall complete.

DISTRIBUTION
Kentucky.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from an unsuitable donor

. ________
PRODUCT
Platelets. Recall #B-458-9.

CODE
Unit #19GF26051.

MANUFACTURER
American Red Cross Blood Services, Nashville, Tennessee.

RECALLED BY
Manufacturer, by letter dated October 22, 1996. Firm-initiated recall complete.

DISTRIBUTION
Tennessee.

QUANTITY
1 unit was distributed.

REASON
Blood product corresponded to a unit of clotted fresh frozen plasma.

________
PRODUCT
a) Red Blood Cells; b) Platelets, Irradiated; c) Fresh Frozen Plasma. Recall #B-459/461-9.

CODE
Unit #19GG49942.

MANUFACTURER
American Red Cross Blood Services, Nashville, Tennessee.

RECALLED BY
Manufacturer, by letter dated June 13, 1996, or by telephone on June 4, 1996. Firm-initiated recall complete.

DISTRIBUTION
Tennessee.

QUANTITY
1 unit of each component was distributed.

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

________
PRODUCT
Red Blood Cells. Recall #B-462-9.

CODE
Unit #19GJ30254.

MANUFACTURER
American Red Cross Blood Services, Nashville, Tennessee.

RECALLED BY
Manufacturer, by telephone on May 21, 1996, and by letter dated May 31, 1996. Firm-initiated recall complete.

DISTRIBUTION
Tennessee.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from an unsuitable donor.

________
PRODUCT
Platelets. Recall #B-463-9.

CODE
Unit #19GJ31931.

MANUFACTURER
American Red Cross Blood Services, Nashville, Tennessee.

RECALLED BY
Manufacturer, by letter dated September 25, 1996. Firm-initiated recall complete.

DISTRIBUTION
Tennessee.

QUANTITY
1 unit was distributed.

REASON
Blood product corresponded to a unit of clotted red blood cells.

________
PRODUCT
Platelets, Pheresis Irradiated. Recall #B-465-9.

CODE
Unit #19GL12299.

MANUFACTURER
American Red Cross Blood Services, Nashville, Tennessee.

RECALLED BY
Manufacturer, by letter dated January 15, 1997. Firm-initiated recall complete.

DISTRIBUTION
Tennessee.

QUANTITY
1 unit was distributed.

REASON
Blood product was inadequately irradiated.

________
PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-471/472-9.

CODE
Unit #19GZ11545.

MANUFACTURER
American Red Cross Blood Services, Nashville, Tennessee.

RECALLED BY
Manufacturer, by letter dated July 26, 1996 or August 1, 1996. Firm-initiated recall complete.

DISTRIBUTION
Tennessee.

QUANTITY
1 unit was distributed.

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

________
PRODUCT
Red Blood Cells, Autologous. Recall #B-474-9.

CODE
Unit numbers: 19LC05739 and 19LC05813.

MANUFACTURER
American Red Cross Blood Services, Nashville, Tennessee.

RECALLED BY
Manufacturer, by telephone on November 29, 1996 and by letter dated December 9, 1996. Firm-initiated recall complete.

DISTRIBUTION
Kentucky.

QUANTITY
2 units were distributed.

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

________
PRODUCT
Red Blood Cells. Recall #B-478-9.

CODE
Unit #9832288.

MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, Ohio.

RECALLED BY
Manufacturer, by letter dated August 1, 1997. Firm-initiated recall complete.

DISTRIBUTION
Ohio and Florida.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor with a history of cancer.

________
PRODUCT
Red Blood Cells. Recall #B-482-9.

CODE
Unit numbers: 5725237 and 9542771.

MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, Oklahoma.

RECALLED BY
Manufacturer, by letter dated either December 17, 1996 or April 21, 1997. Firm-initiated recall complete.

DISTRIBUTION
Oklahoma and Massachusetts.

QUANTITY
2 units were distributed.

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

________
PRODUCT
a) Platelets; b) Fresh Frozen Plasma. Recall #B-484/485-9.

CODE
Unit #13FL79734.

MANUFACTURER
American Red Cross, Detroit, Michigan.

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

DISTRIBUTION
Michigan.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products corresponded to a unit of clotted red blood cells.

________
PRODUCT
Platelets. Recall #B-486-9.

CODE
Unit #13GX07596.

MANUFACTURER
American Red Cross, Detroit, Michigan.

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

DISTRIBUTION
Michigan.

QUANTITY
1 unit was distributed.

REASON
Blood product corresponded to a unit of clotted red blood cells.

________
PRODUCT
Red Blood Cells and Platelets. Recall #B-490/491-9.

CODE
Unit #18FE53927.

MANUFACTURER
American Red Cross Blood Services, Lansing, Michigan.

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

DISTRIBUTION
Michigan.

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
a) Red Blood Cells; b) Recovered Plasma. Recall #B-492/493-9.

CODE
Unit #13GR03186.

MANUFACTURER
American Red Cross Blood Services, Detroit, Michigan.

RECALLED BY
Manufacturer, by letters dated September 16, 1998, and October 19, 1998. Firm-initiated recall complete.

DISTRIBUTION
Michigan and California.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor who reported previously testing positive for antibody to the hepatitis C virus encoded antigen (anti-HCV).

________
PRODUCT
Platelets, Pheresis. Recall #B-494-9.

CODE
Unit numbers: 42FR66433, 42FR65613, 42FR65440, 42FR64590, 42FR63868.

MANUFACTURER
American Red Cross Blood Services, Cleveland, Ohio.

RECALLED BY
Manufacturer, by letters dated September 16, 1998, and October 1, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio and Utah.

QUANTITY
5 units were distributed.

REASON
Blood products were collected from a donor who traveled to an area considered endemic for malaria.

________
PRODUCT
Red Blood Cells. Recall #B-495-9.

CODE
Unit #13GC54894.

MANUFACTURER
American Red Cross Blood Services, Detroit, Michigan.

RECALLED BY
Manufacturer, by letter dated May 14, 1998. Firm-initiated recall complete.

DISTRIBUTION
Michigan.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor whose hemoglobin/hematocrit was not recorded during screening.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

________
PRODUCT
Fresh Frozen Plasma. Recall #B-368-9.

CODE
Unit numbers: H41948 and H40985.

MANUFACTURER
Northern Illinois Blood Bank, Rockford, Illinois.

RECALLED BY
Manufacturer, by telephone on September 23, 1998 and by letter dated September 24, 1998. Firm-initiated recall complete.

DISTRIBUTION
California.

QUANTITY
2 units were distributed.

REASON
Unlicensed blood products were distributed in interstate commerce.

________
PRODUCT
Platelets, Pheresis. Recall #B-464-9.

CODE
Unit numbers: 19GL11250, 19GL11252, 19GL11275, 19LP02624, 19LP02625, 19LP02626, 26FH02601, 40P48874.

MANUFACTURER
American Red Cross Blood Services, Nashville, Tennessee.

RECALLED BY
Manufacturer, by letter dated September 26, 1996, followed by letter dated October 24, 1996. Firm-initiated recall complete.

DISTRIBUTION
Tennessee.

QUANTITY
8 units were distributed.

REASON
Blood products were stored at an unacceptable temperature.

________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma. Recall #B-466/468-9.

CODE
Unit #19GS32310.

MANUFACTURER
American Red Cross Blood Services, Nashville, Tennessee.

RECALLED BY
Manufacturer, by letters dated October 14, 1996, and February 27, 1997. Firm-initiated recall complete.

DISTRIBUTION
Tennessee.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor who may have had an elevated body temperature.

________
PRODUCT
Red Blood Cells. Recall #B-469-9.

CODE
Unit #19GT13951.

MANUFACTURER
American Red Cross Blood Services, Nashville, Tennessee.

RECALLED BY
Manufacturer, by telephone on September 20, 1996, and by letter dated September 25, 1996. Firm-initiated recall complete.

DISTRIBUTION
Tennessee.

QUANTITY
1 unit was distributed.

REASON
Blood product tested reactive for syphilis.

________
PRODUCT
Red Blood Cells for Further Manufacture. Recall #B-473-9.

CODE
Unit #19GZ11536.

MANUFACTURER
American Red Cross Blood Services, Nashville, Tennessee.

RECALLED BY
Manufacturer, by letter dated July 26, 1998 or August 1, 1996, and by a follow-up letter dated August 19, 1996. Firm-initiated recall complete.

DISTRIBUTION
Tennessee.

QUANTITY
1 unit was distributed.

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

________
PRODUCT
Platelets. Recall #B-475-9.

CODE
Unit #19LM02284.

MANUFACTURER
American Red Cross Blood Services, Nashville, Tennessee.

RECALLED BY
Manufacturer, by letter dated January 31, 1997. Firm-initiated recall complete.

DISTRIBUTION
Tennessee.

QUANTITY
1 unit was distributed.

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

________
PRODUCT
Autologous Whole Blood. Recall #B-476-9.

CODE
Unit #0678892.

MANUFACTURER
Bergen Community Regional Blood Center, doing business as Community Blood Services, Paramus, New Jersey.

RECALLED BY
Manufacturer, by letter dated August 27, 1998. Firm-initiated recall complete.

DISTRIBUTION
New Jersey.

QUANTITY
1 unit was distributed.

REASON
Autologous blood product which tested initially reactive for anti-HTLV-I/II, followed by a single negative retest, was distributed without a biohazard label.

_______
PRODUCT
Fresh Frozen Plasma for Manufacturing Non-Injectable Products. Recall #B-478-9.

CODE
Unit #9832288.

MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, Ohio.

RECALLED BY
Manufacturer, by letter dated August 1, 1997. Firm-initiated recall complete.

DISTRIBUTION
Ohio and Florida.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor with a history of cancer.

________
PRODUCT
Red Blood Cells. Recall #B-480-9.

CODE
Unit #287258.

MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, Indiana.

RECALLED BY
Manufacturer, by telephone on October 22, 1998. Firm-initiated recall complete.

DISTRIBUTION
Indiana.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who exceeded the donation acceptance criteria for body temperatures.

________
PRODUCT
Red Blood Cells. Recall #B-481-9.

CODE
Unit #2006271.

MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, Indiana.

RECALLED BY
Manufacturer, by telephone on September 17, 1998. Firm-initiated recall complete.

DISTRIBUTION
Indiana.

QUANTITY
1 unit was distributed.

REASON
Blood product was exposed to unacceptable shipping temperatures.

________
PRODUCT
Red Blood Cells. Recall #B-483-9.

CODE
Unit #1916921.

MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, Indiana.

RECALLED BY
Manufacturer, by telephone on August 5, 1998. Firm-initiated recall complete.

DISTRIBUTION
Indiana.

QUANTITY
1 unit was distributed.

REASON
Blood product was labeled with an extended expiration date.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

________
PRODUCT
CSF (Cerebrospinal fluid) Flow Control Valve, designed to provide controlled CSF flow from the ventricles of the brain into the right atrium or the peritoneum. Recall #Z-528-9.

CODE
Catalog #42324, Lot #R1091.

MANUFACTURER
Medtronics PS Medical, Goleta, California.

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

DISTRIBUTION
Nationwide and international.

QUANTITY
120 units were distributed.

REASON
Mislabeling - The package of the CSF Flow Control Valve, Contoured Regular, Medium Pressure, Lot R1091 may contain a high pressure valve.

________
PRODUCT

Nuclear Magnetic Resonance Imaging System:
a) ECLIPSE 1.5T System; 
b) ECLIPSE 1.5T EXP System;
c) POLARIS 1.0T System
d) POLARIS 1.0T MOBILE System
e) POLARIS 1.0T System.  Recall #Z-582/586-9.

CODE

Serial numbers:  a) BA100 through BA192 
b) BG101 through BG107
c) BB101 through BB165
d) BE101 through BE116
e) BH101 through BH104.

MANUFACTURER
Picker International, Inc., Highland Heights, Ohio.

RECALLED BY
Manufacturer, by letter dated May 29, 1998, and January 15, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
185 MRI units (100/1.5T systems and 85/1.0T systems) were distributed.

REASON
Patient burns during MRI exams due to skin-to-bore or skin-to-skin contact.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

________
PRODUCT

Lipase, Calcium, Iron and Direct Bilirubin Reagent Application
Sheets contained in Aeroset Applications Manuals: 
Application Sheet Commodity Numbers:     
30-0871/R1 - Lipase
30-0852/R2 - Calcium
30-0859/R2 - Iron
30-0850/R1 - Direct Bilirubin.  Recall #Z-578/581-9.

CODE

Application Sheet List Numbers:
7D80-01 - Lipase
7D61-01 - Calcium
7D68-01 - Iron
7D58-01 - Direct Bilirubin.

MANUFACTURER
Abbott Laboratories, Irving, Texas.

RECALLED BY
Abbott Laboratories, Chicago, Illinois, telephone and letter on September 14, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
Application sheets were distributed in 176 Aeroset Application manuals.

REASON
The Aeroset Lipase range appears to run lower than the range referenced in the Application Sheet.

________
PRODUCT
General radiographic film: a) Kodak Insight Thoracic Imaging Film, 35 x 43 cm, Catalog No. 8288201, Expiration Date 2000-10; b) Kodak T-Mat G/RA Film, 35 x 43 cm, Catalog No. 1373125,Expiration Date 2000-11. Recall #Z-587/588-9.

CODE
a) Lot No. 452-016-11 through Lot No. 452-016-15, Lot No. 452-033-11 through Lot No. 452-033-15; b) Lot No. 819-049-12.

MANUFACTURER
Eastman Kodak Company, Windsor, Colorado.

RECALLED BY
Eastman Kodak Company, Health Imaging Division, Rochester, New York, by letters dated December 18 and 22, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
a) 935 boxes (100 sheets per box); b) 113 boxes 100 sheets per box) were distributed.

REASON
Films have been identified to contain a plus-density artifact in the center of the film which could impair a diagnosis or result in the need for a repeat examination.

END OF ENFORCEMENT REPORT FOR FEBRUARY 17, 1999.