FDA

Enforcement Report

Egg Rolls, Wontons, Spring Rolls, and Potstickers:
F-633-8 Vegetable Cocktail Egg Rolls
        a) Tran Foods Vegetable Cocktail Egg Rolls, 4.5 lb (*) 
        b) Tran Foods 12 Vegetable Cocktail Egg Rolls,9 oz (*)
F-634-8 Vegetable Egg Rolls
        a) Tran's Vegetable Egg Rolls,12 oz 
        b) Tran Foods 50 Vegetable Egg Rolls, 9.38 lb (*)
        c) Cohen's Vegetable Egg Rolls, 6.75 lb (*)
        d) Cohen's Oriental Style Egg Rolls, 4.6 lb (*)
F-635-8 Mushroom Cocktail Egg Rolls
        a) Tran Foods Mushroom Cocktail Egg Rolls, 4.5 lb (*) 
F-636-8 Mushroom Egg Rolls
        a) Tran Foods 50 Mushroom Egg Rolls, 9.38 lb (*)
        b) Cohen's Oriental Style Egg Rolls With Mushroom, 5 lb 
F-637-8 Imperial Seafood Egg Rolls
        a) Tran Foods Imperial Seafood Egg Rolls, 4.5 lb (*)
        b) Tran Foods 50 Imperial Seafood Egg Rolls, 9.38 lb (*)

F-638-8 Imperial Seafood Cocktail Egg Rolls
        a) Tran Foods 12 Imperial Seafood Cocktail Egg Rolls, 
           9 oz (*)
F-639-8 Shrimp Egg Rolls
        a) Tran's Shrimp Egg Rolls, 12 oz 
        b) Casino Chef Oriental Style Shrimp Egg Rolls, 
           5 lbs. (*)
F-640-8 Shrimp & Vegetable Egg Rolls
        a) Casino Chef 50 Large Shrimp & Vegetable Egg Rolls, 
           3 oz (*)  
F-641-8 Assorted Vegetable Hors D'Oeuvres                        
        a) Tran Foods 32 Assorted Vegetable Hors D'Oeuvres        
          (Cocktail Egg Roll, Fried Wontons, Potstickers, Steamed 
          Dumplings), 18 oz (*)
F-642-8 Shrimp Spring Rolls
        a) Shrimp Spring Rolls, 4.6 lb
F-643-8 Vegetable Cocktail Spring Rolls
        a) Tran Foods Vegetable Cocktail Spring Rolls, 4.5 lb 
F-644-8 Vegetable Fried Wonton
        a) Tran Foods Vegetable Fried Wonton, 3.75 lb (*)
F-645-8 Vegetable Potstickers
        a) Tran Foods Vegetable Potstickers, 3.75 lb (*). 

CODE
All lots which fail to declare eggs or colors is under recall.

MANUFACTURER
Perfection Foods Company, Inc., Philadelphia, Pennsylvania.

RECALLED BY
Manufacturer, by telephone on June 3, 1998, by press release on June 4, 1998, and by letter on June 9, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
New Jersey, New York, Massachusetts.

QUANTITY
Product available in commercial channels is based on the amount of product returned to be relabeled, as of 6/08/98, which included the following:

a) 632 Cases of Cohen's Egg Roll
b) 136 Cases of Mushroom Egg Roll
c) 37 Cases of Spring Shrimp Egg Roll
d) 109 Cases of Bulk Egg Roll
e) 156 Cases Shrimp Egg Roll

REASON
The products contain undeclared eggs. In addition, products marked with (*) contain undeclared FD&C Yellow No. 5 and FD&C Yellow No. 6.

CODE
Aug. 25, 1997.

MANUFACTURER
Nidia's Bakery & Pizzeria, Bronx, New York.

RECALLED BY
Manufacturer, by visit on August 29, 1997. Completed recall resulted from sample analysis and follow-up by the New York Department of Agriculture and Markets.

DISTRIBUTION
New York.

QUANTITY
Undetermined.

REASON
Product contained undeclared FD&C Yellow No. 5 and FD&C Yellow No. 6.

PRODUCT
"Bukhara Sweets" brand "Coconut Cutlets" in rigid plastic containers, Net Wt. 16 oz.(454 g). Recall #F-631-8.

CODE
None.

MANUFACTURER
Bukhara Restaurant of Brooklyn Inc., doing business as Bukhara Sweets, Brooklyn, New York.

RECALLED BY
Manufacturer, by letter dated August 28, 1997. Completed recall resulted from sample analysis and follow-up by the New York Department of Agriculture and Markets.

DISTRIBUTION
New York and Pennsylvania.

QUANTITY
Approximately 500 1-pound containers were distributed.

REASON
Product contains undeclared FD&C Yellow No. 5 and FD&C Red No. 40.

PRODUCT
Tran Foods Vegetable Steamed Dumplings, 3.75 lb. Recall #F-646-8.

CODE
: All lots which fail to declare eggs or colors is under recall.

MANUFACTURER
Perfection Foods Company, Inc., Philadelphia, Pennsylvania.

RECALLED BY
Manufacturer, by telephone on June 3, 1998, by press release on June 4, 1998, and by letter on June 9, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
New Jersey, New York, Massachusetts.

QUANTITY
Undetermined.

REASON
The product contains undeclared FD&C Yellow No. 5 and FD&C Yellow No. 6.

CODE
Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled.

MANUFACTURER
The Blood Center, New Orleans, Louisiana.

RECALLED BY
Manufacturer, by telephone or fax by letter on May 1, 1998. Firm-initiated recall complete.

DISTRIBUTION
Louisiana and Mississippi.

QUANTITY
a) 2 units; b) 202 units; c) 2 units; d) 54 units; e) 5 units; f) 9 units; g) 77 units; h) 2 units; I) 1 unit was distributed.

REASON
Firm failed to follow manufacturer's product insert for HBsAg testing and blood products.

PRODUCT
a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-1457/1459.

CODE
Unit #J12746.

MANUFACTURER
HCSC Blood Center, Bethlehem, Pennsylvania.

RECALLED BY
Manufacturer, by letter dated January 28, 1998. Firm-initiated recall complete.

DISTRIBUTION
Pennsylvania and New Jersey.

QUANTITY
1 unit of each component was distributed.

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

PRODUCT
Red Blood Cells. Recall #B-1503-8.

CODE
Unit #G50467.

MANUFACTURER
Carolina-Georgia Blood Center, Greenville, South Carolina.

RECALLED BY
Manufacturer, by telephone on September 6, 1996. Firm-initiated recall complete.

DISTRIBUTION
Georgia.

QUANTITY
1 unit was distributed.

REASON
Blood product was incorrectly tested for the Human Immunodeficiency Virus Type 1 (HIV-1 p24 Antigen).

PRODUCT
Red Blood Cells. Recall #B-1522-8.

CODE
Unit #1467448.

MANUFACTURER
Central Kentucky Blood Center, Lexington, Kentucky.

RECALLED BY
Manufacturer, by telephone on February 27, 1998. Firm-initiated recall complete.

DISTRIBUTION
Kentucky.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor taking the drugs, Tolectin, for rheumatoid arthritis and Minocycline, an antibiotic.

PRODUCT
Red Blood Cells. Recall #B-1523-8.

CODE
Unit #1028609.

MANUFACTURER
Community Blood Center, Dayton, Ohio.

RECALLED BY
Manufacturer, by letter dated July 8, 1997. Firm-initiated recall complete.

DISTRIBUTION
Indiana.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who traveled to a malarial endemic area.

PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-1524/1525-8.

CODE
Unit numbers: a) 1038065, 1032807, 1028067, 1021677; b) 1028067, 1021677.

MANUFACTURER
: Community Blood Center, Dayton, Ohio.

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

DISTRIBUTION
Ohio.

QUANTITY
a) 4 units; b) 2 units were distributed.

REASON
Blood products were collected from a donor who traveled to a malarial endemic area.

PRODUCT
Red Blood Cells. Recall #B-1543-8.

CODE
Unit #2407458.

MANUFACTURER
Armed Services Blood Bank Center, Tacoma, Washington.

RECALLED BY
Manufacturer, by memorandum dated March 4, 1998, and faxed on March 5, 1998. Firm-initiated recall complete.

DISTRIBUTION
Washington state.

QUANTITY
1 unit was distributed.

REASON
Blood product tested repeatedly reactive for the antibody to the human T-lymphotropic virus type 1 (anti-HTLV-1), and Western Blot indeterminate.

PRODUCT
Red Blood Cells. Recall #B-1550-8.

CODE
Unit numbers: E28479 and E31085.

MANUFACTURER
Central California Blood Center, Fresno, California.

RECALLED BY
Manufacturer, by letter dated December 29, 1995. Firm-initiated recall complete.

DISTRIBUTION
California.

QUANTITY
2 units were distributed.

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

PRODUCT
Platelets, Pooled. Recall #B-1556-8.

CODE
Unit numbers: P63978 and P63980.

MANUFACTURER
Carter Blood Center, Fort Worth, Texas.

RECALLED BY
Manufacturer, by telephone on August 8, 1998, and by letter dated August 10, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas.

QUANTITY
2 units were distributed.

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

PRODUCT
Platelets. Recall #B-1557-8.

CODE
Unit #H30464.

MANUFACTURER
Regional Health Resources Center, Community Blood Services of Illinois, Urbana, Illinois.

RECALLED BY
Manufacturer, by telephone on July 10, 1998, and by letter dated August 12, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor taking the drug Zovirax.

PRODUCT
Sterile Water for Injection, USP, packaged as diluent with Gammar-P I.V., Immune Globulin Intravenous (Human). Recall #B-1558-8.

CODE
Sterile Water for Injection, lot T63803, Exp. March 2001, packaged with Gammar-P I.V., lots T501904, Exp. 3/30/00, and T502104, Exp. 4/14/00.

MANUFACTURER
L.L.C., Bradley, Illinois.

RECALLED BY
Centeon, a company of Armour and Behring, King of Prussia, Pennsylvania, by telephone on August 14, 1998, followed by letter dated August 14, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and Puerto Rico.

QUANTITY
8,036 vials were distributed; firm estimated that 20-25% of product remained on market at time of recall initiation.

REASON
Possibility of vial closure damaged due to exposure of the vials from this lot of Sterile Water for Injection to high pressure conditions during sterilization.

PRODUCT
a) Whole Blood; b) Red Blood Cells; c) Platelets d) Platelets, Pheresis; e) Fresh Frozen Plasma; f) Single Donor Plasma; g) Cryoprecipitated AHF; h) Source Leukocytes; I) Source Plasma; j) Red Blood Cells, for further manufacture; k) Platelets, for further manufacture; l) Recovered Plasma. Recall #B-1559/1570-8.

CODE
Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled.

MANUFACTURER
ARC National Reference Laboratory of Infectious Diseases (NRLID), Rockville, Maryland.

RECALLED BY
The American National Red Cross, Arlington, Virginia, by letters between April 2, 1996, and April 5, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
4,198 units were distributed.

REASON
Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1) and the hepatitis B surface antigen (HBsAg), but were collected from donors who previously tested either: 1) Western blot indeterminate; 2) Western blot indeterminate with only a 70kD band; or 3) confirmatory positive for HBsAg by neutralization.

PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-1571/1572-8.

CODE
Unit #GZ35067.

MANUFACTURER
Metropolitan Washington Blood Bank, Bethesda, Maryland.

RECALLED BY
Manufacturer, by letter dated May 13, 1998, and by fax on or about May 13, 1998. Firm-initiated recall complete.

DISTRIBUTION
Virginia and Switzerland.

QUANTITY
1 unit of each component was distributed.

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

PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-1574/1575-8.

CODE
Unit #GW44833.

MANUFACTURER
Metropolitan Washington Blood Bank, Bethesda, Maryland.

RECALLED BY
Manufacturer, by telephone on April 29, 1998, and by letter dated May 15, 1998. Firm-initiated recall complete.

DISTRIBUTION
Maryland.

QUANTITY
1 unit of each component was distributed.

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

PRODUCT
a) Red Blood Cells; b) Platelets; c) Plasma; d) Buffy Coat. Recall #B-1577/1580-8.

CODE
Unit numbers: a) 53KF44597, 53H50261; b) 53KF44597, 53H50261; c) 53KF44597, 53H50261; d) 53H50261.

MANUFACTURER
American Red Cross Blood Services, Baltimore, Maryland.

RECALLED BY
Manufacturer, by telephone on July 2, 1998, and by letter dated July 14, 1998. Firm-initiated recall complete.

DISTRIBUTION
Maryland, Pennsylvania, New Jersey, District of Columbia.

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

REASON
Blood products were collected from a donor who had engaged in high risk behavior.

PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-1583/1584-8.

CODE
Unit #4112977.

MANUFACTURER
Department of the Navy, Naval Hospital, Bremerton, Washington.

RECALLED BY
Manufacturer, by letter dated December 4, 1997. Firm-initiated recall complete.

DISTRIBUTION
Utah.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor who had received an MMR vaccination within four weeks of donation.

PRODUCT
Platelets. Recall #B-1585-8.

CODE
Unit #24KH27118.

MANUFACTURER
American Red Cross Blood Services, Louisville, Kentucky.

RECALLED BY
Manufacturer, by telephone on July 9, 1998. Firm-initiated recall complete.

DISTRIBUTION
Kentucky.>P> QUANTITY
1 unit was distributed.

REASON
Blood product was labeled with an extended expiration date.

PRODUCT
Recovered Plasma. Recall #B-1586-8.

CODE
Unit #49Y42337.

MANUFACTURER
American Red Cross Blood Services, Tulsa, Oklahoma.

RECALLED BY
Manufacturer, fax on October 13, 1997, and on October 14, 1997. Firm-initiated recall complete.

DISTRIBUTION
California.

QUANTITY
1 unit was distributed.

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

PRODUCT
Recovered Plasma. Recall #B-1587-8.

CODE
Unit #0044077.

MANUFACTURER
Meek Blood Center, Abilene, Texas.

RECALLED BY
Manufacturer, by fax on June 18, 1998. Firm-initiated recall complete.

DISTRIBUTION
Colorado.

QUANTITY
1 unit was distributed.

REASON
Blood product tested negative for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), but was collected from a donor who previously tested repeatedly reactive for anti-HIV-1/2, Western blot negative.

PRODUCT
Red Blood Cells. Recall #B-1588-8.

CODE
Unit #2315787.

MANUFACTURER
LifeSource, Glenview, Illinois.

RECALLED BY
Manufacturer, by telephone on June 21, 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.

CODE
Unit #61-72393.

MANUFACTURER
Michigan Community Blood Centers, Grand Rapids, Michigan.

RECALLED BY
Manufacturer, by telephone on February 2, 1998. Firm-initiated recall complete.

DISTRIBUTION
Michigan.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who answered yes to having seen a doctor or having had surgery within 12 months of donation.

PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-1499/1500-8.

CODE
Unit #8858880.

MANUFACTURER
New York Blood Services, New York, New York.

RECALLED BY
New York Blood Center, Inc., New York, New York, by telephone and fax on November 26, 1997. 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 with an elevated body temperature at the time of donation.

PRODUCT
Platelets, Pheresis. Recall #B-1505-8.

CODE
Unit 04KC03901.

MANUFACTURER
American Red Cross, New England Region, Dedham, Massachusetts.

RECALLED BY
Manufacturer, by letter dated September 10, 1997. Firm-initiated recall complete.

DISTRIBUTION
Maine.

QUANTITY
1 unit was distributed.

REASON
Product exceeded the acceptable standard for a leukoreduced blood component.

PRODUCT
Red Blood Cells. Recall #B-1518-8.

CODE
Unit #E67274.

MANUFACTURER
Central California Blood Center, Fresno, California.

RECALLED BY
Manufacturer, by visit on March 28, 1997. Firm-initiated recall complete.

DISTRIBUTION
California.

QUANTITY
1 unit was distributed.

REASON
Blood product was stored at unacceptable temperatures.

PRODUCT
Source Leukocytes, for manufacturing non-injectable products. Recall #B-1519-8.

CODE
Unit #3221822.

MANUFACTURER
Gulf Coast Regional Blood Center, Houston, Texas.

RECALLED BY
Manufacturer, by fax on September 18, 1997. Firm-initiated recall complete.

DISTRIBUTION
New Jersey.

QUANTITY
1 unit was distributed.

REASON
Blood product tested reactive for the antibody to the human T-lymphotropic virus type 1 (anti-HTLV-1).

PRODUCT
Red Blood Cells. Recall #B-1521-8.

CODE
Unit numbers: 21FT17674, 21GG97827, 21GG98605, 35GG46841, 35J47540, 35K83631, 35V25994, 35FH20349, 35FH20589, 35FM00577, 35Y34215.

MANUFACTURER
American Red Cross Blood Services, Baltimore, Maryland.

RECALLED BY
Manufacturer, by telephone on May 26, 1998, and by letter on June 1, 1998. Firm-initiated recall complete.

DISTRIBUTION
Maryland and District of Columbia.

QUANTITY
11 units were distributed.

REASON
Blood products were in transit for more than 24 hours and therefore, lack the assurance of proper shipping temperatures.

PRODUCT
Red Blood Cells. Recall #B-1526-8.

CODE
Unit #1035344.

MANUFACTURER
Community Blood Center, Dayton, Ohio.

RECALLED BY
Manufacturer, by telephone on September 15, 1997, and by letter dated September 27, 1997. Firm-initiated recall complete.

DISTRIBUTION
Ohio.

QUANTITY
1 unit (3 aliquots) was distributed.

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

PRODUCT
Platelets. Recall #B-1531-8.

CODE
Unit #03LM61412.

MANUFACTURER
American Red Cross Blood Services, Atlanta, Georgia.

RECALLED BY
Manufacturer, by telephone on September 16, 1996. Firm-initiated recall complete.

DISTRIBUTION
Georgia.

QUANTITY
1 unit was distributed.

REASON
Blood product was prepared from a unit of whole blood designated as a difficult collection.

PRODUCT
Allergenic Extract - Tobacco Leaf - Stock concentrate. Recall #B-1535-8.

CODE
Lot # H8-41-2X (D).

MANUFACTURER
Greer Laboratories, Lenoir, North Carolina.

RECALLED BY
Manufacturer, by telephone on May 6, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Arizona, New York, Ohio, Tennessee, Texas.

QUANTITY
8 vials were distributed.

REASON
Eight vials (one lot) of allergenic extract manufactured and labeled with an extended expiration date.

PRODUCT
Platelets. Recall #B-1536-8.

CODE
Unit #24GQ19010.

MANUFACTURER
American Red Cross Blood Services, Louisville, Kentucky.

RECALLED BY
Manufacturer, by telephone on July 20, 1998, and by letter dated July 28, 1998. Firm-initiated recall complete.

DISTRIBUTION
Illinois.

QUANTITY
1 unit was distributed.

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

PRODUCT
Fresh Frozen Plasma. Recall #B-1538-8.

CODE
Unit #24KK80422.

MANUFACTURER
American Red Cross Blood Services, Louisville, Kentucky.

RECALLED BY
Manufacturer, by telephone on July 17, 1998, and by letter dated July 22 1998. Firm-initiated recall complete.

DISTRIBUTION
Kentucky.

QUANTITY
1 unit was distributed.

REASON
Failure to quarantine a blood product after discovering that it had been produced from a Whole Blood unit that should have been designated as a traumatic bleed.

PRODUCT
Platelets, Pheresis. Recall #B-1549-8.

CODE
Unit #36252-2480.

MANUFACTURER
United Blood Services, Ventura, California.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on May 20, 1998, and by letter on June 11, 1998. Firm-initiated recall complete.

DISTRIBUTION
California.

QUANTITY
1 unit was distributed.

REASON
Blood product was stored at unacceptable temperatures.

PRODUCT
Red Blood Cells. Recall #B-1551-8.

CODE
Unit #12005819.

MANUFACTURER
W.E. & Lela I. Stewart Regional Blood Center, Tyler, Texas.

RECALLED BY
Manufacturer, by telephone on May 21, 1998 and by letter dated June 15, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas.

QUANTITY
1 unit was distributed.

REASON
Blood product was labeled with an extended expiration date.

PRODUCT
Platelets, Pheresis. Recall #B-1573-8.

CODE
Unit #GZ37334.

MANUFACTURER
Metropolitan Washington Blood Bank, Bethesda, Maryland.

RECALLED BY
Manufacturer, by letter dated May 13, 1998. Firm-initiated recall complete.

DISTRIBUTION
Virginia.

QUANTITY
1 unit was distributed.

REASON
Unlicensed blood product was distributed in interstate commerce.

PRODUCT
Red Blood Cells. Recall #B-1576-8.

CODE
Unit #39J96659.

MANUFACTURER
American Red Cross, Huntington, West Virginia.

RECALLED BY
Manufacturer, by letter dated July 10, 1998. Firm-initiated recall complete.

DISTRIBUTION
West Virginia.

QUANTITY
1 unit was distributed.

REASON
Blood product was exposed to unacceptable shipping temperatures.

PRODUCT
a) Red Blood cells; b) Recovered Plasma. Recall #B-1589/1590-8.

CODE
Unit #6067783.

MANUFACTURER
LifeSource, Glenview, Illinois.

RECALLED BY
Manufacturer, by telephone on July 9, 1998. Firm-initiated recall complete.

DISTRIBUTION
Illinois.

QUANTITY
1 unit of each component was distributed.

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

Compact Airway Gas Modules, M-NESTPR Family Modules and
Light Monitors:
Compact Airway Gas Modules:
Recall No.    Model
Z-789-8       M-C
Z-790-8       M-CO
Z-791-8       M-CAiO
Z-792-8       M-CAiOV
M-NESTPR Family Modules:
Recall No.    Model
Z-793-8       M-NESTRP
Z-794-8       M-NETPR
Z-795-8       M-NESTR
Light Monitors:     
Recall No.    Model
Z-796-8       F-LM
Z-797-8       F-LMP
CODE

Metal flakes list
S/N      MODEL
391509   M-CAiOV-23-1
391511   M-CAiOV-23-1
391512   M-CAiOV-23-1
391515   M-CAiOV-23-1
391664   M-CAiOV-23-1
391665   M-CAiOV-23-1
391727   M-CAiOV-23-1
391728   M-CAiOV-23-1
391779   M-CAiOV-23-1
391783   M-CAiOV-23-1
391791   M-CAiOV-23-1
391794   M-CAiOV-23-1
391957   M-CAiOV-23-1
392059   M-CAiOV-23-1
392066   M-CAiOV-23-1
392070   M-CAiOV-23-1
392077   M-CAiOV-23-1
392176   M-CAiOV-23-1
392180   M-CAiOV-23-1
392190   M-CAiOV-23-1
391470   M-CAiO-23-0
391546   M-CAiO-23-0
391550   M-CAiO-23-0
391551   M-CAiO-23-0
391554   M-CAiO-23-0
391555   M-CAiO-23-0
391556   M-CAiO-23-0
391557   M-CAiO-23-0
391558   M-CAiO-23-0
391559   M-CAiO-23-0
391562   M-CAiO-23-0
391563   M-CAiO-23-0
391564   M-CAiO-23-0
391565   M-CAiO-23-0
391567   M-CAiO-23-0
391568   M-CAiO-23-0
391569   M-CAiO-23-0
391570   M-CAiO-23-0
391571   M-CAiO-23-0
391573   M-CAiO-23-0
391629   M-CAiO-23-0
391631   M-CAiO-23-0
391633   M-CAiO-23-0
391634   M-CAiO-23-0
391635   M-CAiO-23-0
391636   M-CAiO-23-0
391639   M-CAiO-23-0
391640   M-CAiO-23-0
391641   M-CAiO-23-0
391644   M-CAiO-23-0
391645   M-CAiO-23-0
391647   M-CAiO-23-0
391649   M-CAiO-23-0
391650   M-CAiO-23-0
391651   M-CAiO-23-0
391654   M-CAiO-23-0
391656   M-CAiO-23-0
391658   M-CAiO-23-0
391661   M-CAiO-23-0
391716   M-CAiO-23-0
391717   M-CAiO-23-0
391718   M-CAiO-23-0
391719   M-CAiO-23-0
391721   M-CAiO-23-0
391729   M-CAiO-23-0
391737   M-CAiO-23-0
391738   M-CAiO-23-0
391740   M-CAiO-23-0
391743   M-CAiO-23-0
391744   M-CAiO-23-0
391745   M-CAiO-23-0
391749   M-CAiO-23-0
391795   M-CAiO-23-0
391797   M-CAiO-23-0
391801   M-CAiO-23-0
391802   M-CAiO-23-0
391804   M-CAiO-23-0
391805   M-CAiO-23-0
391806   M-CAiO-23-0
391808   M-CAiO-23-0
391809   M-CAiO-23-0
391810   M-CAiO-23-0
391927   M-CAiO-23-0
391931   M-CAiO-23-0
391934   M-CAiO-23-0
391935   M-CAiO-23-0
391936   M-CAiO-23-0
391938   M-CAiO-23-0
391939   M-CAiO-23-0
391941   M-CAiO-23-0
391970   M-CAiO-23-0
391972   M-CAiO-23-0
391995   M-CAiO-23-0
392001   M-CAiO-23-0
392009   M-CAiO-23-0
392010   M-CAiO-23-0
392012   M-CAiO-23-0
392131   M-CAiO-23-0
392132   M-CAiO-23-0
392145   M-CAiO-23-0
392205   M-CAiO-23-0
392214   M-CAiO-23-0
392215   M-CAiO-23-0
392348   M-CAiO-23-0
391463   M-CAiO-23-0
391817   MC-23-0
391819   MC-23-0
391823   MC-23-0
391830   MC-23-0
391842   MC-23-0
391843   MC-23-0
391896   MC-23-0
391906   MC-23-0
391908   MC-23-0
391909   MC-23-0
391919   MC-23-0
391922   MC-23-0
391966   MC-23-0
392026   MC-23-0
392153   MC-23-0
391881   M-CO-23-0
391882   M-CO-23-0
Flux Residue
S/N      Model
392545   M-CAiOV-23-1
392548   M-CAiOV-23-1
392756   M-CAiOV-23-1
392821   M-CAiOV-23-1
393008   M-CAiOV-23-1
392561   M-CAiO-23-0
392565   M-CAiO-23-0
392575   M-CAiO-23-0
392692   M-CAiO-23-0
392713   M-CAiO-23-0
392725   M-CAiO-23-0
392726   M-CAiO-23-0
392729   M-CAiO-23-0
392730   M-CAiO-23-0
392733   M-CAiO-23-0
392736   M-CAiO-23-0
392738   M-CAiO-23-0
392739   M-CAiO-23-0
392741   M-CAiO-23-0
392743   M-CAiO-23-0
392744   M-CAiO-23-0
392746   M-CAiO-23-0
392752   M-CAiO-23-0
392753   M-CAiO-23-0
392778   M-CAiO-23-0
392939   M-CAiO-23-0
782586   M-NESTR-23-0
782919   M-NESTR-23-0
782914   M-NESTR-23-0
782980   M-NESTR-23-0
782981   M-NESTR-23-0
782984   M-NESTR-23-0
782985   M-NESTR-23-0
782987   M-NESTR-23-0
782989   M-NESTR-23-0
783176   M-NESTR-23-0
783177   M-NESTR-23-0
783182   M-NESTR-23-0
782814   M-NETPR-23-0
782927   M-NETPR-23-0
782930   M-NETPR-23-0
783006   M-NETPR-23-0
783166   M-NETPR-23-0
783168   M-NETPR-23-0
783227   M-NETPR-23-0
783228   M-NETPR-23-0
783230   M-NETPR-23-0
782366   M-NESTPR-23-0
782747   M-NESTPR-23-0
782778   M-NESTPR-23-0
782784   M-NESTPR-23-0
782789   M-NESTPR-23-0
782796   M-NESTPR-23-0
782797   M-NESTPR-23-0
782802   M-NESTPR-23-0
782803   M-NESTPR-23-0
782808   M-NESTPR-23-0
782836   M-NESTPR-23-0
782837   M-NESTPR-23-0
782859   M-NESTPR-23-0
782866   M-NESTPR-23-0
782869   M-NESTPR-23-0
782881   M-NESTPR-23-0
782883   M-NESTPR-23-0
782884   M-NESTPR-23-0
782885   M-NESTPR-23-0
782886   M-NESTPR-23-0
782887   M-NESTPR-23-0
782970   M-NESTPR-23-0
783019   M-NESTPR-23-0
783024   M-NESTPR-23-0
783026   M-NESTPR-23-0
783030   M-NESTPR-23-0
783042   M-NESTPR-23-0
783063   M-NESTPR-23-0
783073   M-NESTPR-23-0
702012   LM
702014   LM
702007   LM
702008   LM
702016   LM
701996   LM
701992   LM
701969   LM
701991   LM
701998   LM
701979   LM
701977   LM
701983   LM
701981   LM
701942   LM
701863   LM
701836   LM
701908   LM
701839   LM
702238   LM
702052   LMP
702029   LMP
702050   LMP
702001   LMP
702041   LMP
702040   LMP
702045   LMP
702048   LMP
702042   LMP
702039   LMP
702047   LMP
702034   LMP
701932   LMP
701902   LMP
701887   LMP
701890   LMP
702214   LMP
702218   LMP.

MANUFACTURER
: Datex-Ohmeda, Division of Instrumentarium Corporation, Helsinki, Finland.

RECALLED BY
: Datex-Ohmeda, Tewksbury, Massachusetts, by letter on July 28, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
: Nationwide.

QUANTITY

Model     Units
M-C       14 units
M-CO       3 units
M-CAiO   108 units
M-CAiOV   23 units
M-NESTRP  29 units
M-NETPR    9 units
M-NESTR   12 units
F-LM      20 units
F-LMP     18 units were distributed.

PRODUCT

IVAC Signature
Edition Infusion Pump:
a) Model 7000, a single channel, general purpose infusion pump;
b) Model 7100, a single channel, advanced feature pump, domestic
   110V Version;
c) Model 7200, a dual channel, advanced feature pump, domestic
   110V Version;
d) Model 7101, a single channel, advanced feature pump,
   international 220V Version;   
e) Model 7201, a dual channel, advanced feature pump,
   international 220V Version.  Recall #Z-799/803-8.

CODE
All serial numbers below 3346688 and shipped prior to 2/28/98.

MANUFACTURER
Alaris Medical Systems, Inc., San Diego, California.

RECALLED BY
Manufacturer, by letter on July 24, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
22,655 units were distributed.

REASON
The pumps were designed without a hermetically sealed in-line EMI filter.

PRODUCT
Vision FX Series Digital Nuclear Imaging System, Models FX-40 and FX-80 Series, used in hospitals and diagnostic centers to produce tomographic images of the body which can aid in the diagnosis of ailments such as cancer and heart disease. Recall #Z-820/821-8.

CODE
Serial numbers: 93-96, 98, 100-207. All Vision FX series Model Numbers are affected.

MANUFACTURER
SMV America, Twinsburg, Ohio.

RECALLED BY
Manufacturer, by telephone beginning on February 20, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide, Puerto Rico, France, Guatamala, Argentina, Paraguay, Colombia.

QUANTITY
113 units were distributed.

REASON
The collimators may fall off the server if the operator has not properly set the collimator in the exchange unit.

PRODUCT

Laerdal Silicone Resuscitators, adult, child, and infant sizes,
intended to provide emergency respiratory support by means of a
face mask, valve, and ventilation bag:
a) Laerdal Silicone Resuscitators, Adult, Child and Infant Sizes:
Adult, Model Nos. 870000, 870001, 870003, 870005, 870016, 870022
Child, Model Nos. 860000, 860001, 860003, 860005, 860016, 860022
Infant, Model Nos. 850000, 850001, 850003, 850005, 850022 
NOTE:  The resuscitators are available in varying 
configurations which results in various model numbers.
b) Patient Valve Assembly (5-piece) a component of the Laerdal
Silicone Resuscitators, sold separately as Model No. 851200.
Recall #Z-839/840-8.

CODE
a) Lot Numbers (Resuscitators): 81198, 81298, 81398, 81498, 81598, 81798, 81898, 81998, 82098, 82198, 82298. b) Lot Number (Patient Valve Assembly): 02073SL.

MANUFACTURER
Laerdal Medical Corporation, N-4001 Stavanger, Norway (responsible firm).

RECALLED BY
Laerdal Medical Corporation, Wappingers Falls, New York, by letter on July 17 and 24, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
728 resuscitators and 200 patient valve assemblies were distributed.

REASON
The small plastic particles may shed from the valve housing, patient side, which could potentially be transferred to the patient during use of the device.

PRODUCT
I-125 Seeds, (Iodine-125) Therapeutic for Interstitial Brachytherapy, Model 6711, a welded titanium capsule containing radioactive Iodine-125 absorbed onto silver rod, used as radioactive implants for the treatment of prostate cancer. Recall #Z-843-8.

CODE
Lot #W81760.

MANUFACTURER
Nycomed Amersham Imaging, doing business as Medi-Physics, Inc., Arlington Heights, Illinois.

RECALLED BY
Manufacturer, by telephone on August 21, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Massachusetts, Oregon, Texas, New York.

QUANTITY
399 seeds were distributed.

REASON
The seeds were mislabeled with an incorrect apparent radioactivity range.

PRODUCT
Sunrise Medical Breezy Model No 510 Recliner Wheelchair. Recall #Z-845-8.

CODE
Serial Numbers: 410763, 410506, 411139, 411201, 411090, 411203, 411133, 411150, 410509, 411202.

MANUFACTURER
Sunrise Medical, also known as Quickie Designs, Inc., Avon Lake, Ohio.

RECALLED BY
Sunrise Medical, also known as Quickie Designs, Inc., Mobility Products Division, Longmont, Colorado, by letter on July 21, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
Maryland, North Carolina, Canada.

QUANTITY
10 wheelchairs were distributed.

REASON
Excess weight placed on top of a folded wheelchair may damage the mechanical locks, resulting in an inability of the chair to hold the back in the desired upright position; wherein if the user also removes the anti-tip tubes from the device, the wheelchair could potentially tip over.

PRODUCT
Zimmer CPT Hip System Femoral Stem for use with bone cement. Recall #Z-846/847-8.

CODE
Catalog number 32-8333-000-02, lot 57181600. Catalog number 32-8333-000-05, lot 57181700.

MANUFACTURER
Zimmer, Inc., Warsaw, Indiana.

RECALLED BY
Manufacturer, by letter dated July 29, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
California, Kansas, Maryland, Minnesota, New York, Ohio and Canada.

QUANTITY
26 units were distributed.

REASON
The Osteotomy Inserter Line is etched into the device at the incorrect location.

PRODUCT
Zimmer Trilogy Acetabular System Liner: a)Zimmer Trilogy Acetabular System Liner, 10 Deg. Elevated Rim. Catalog number 00-6110-048-28; b) Zimmer Trilogy Acetabular System Liner, 20 Deg. Elevated Rim. Catalog number 00-6120-048-28. Recall #Z-848/849-8.

CODE
Lot numbers: a) 55500700; b) 55498400.

MANUFACTURER
Zimmer, Inc., Warsaw, Indiana.

RECALLED BY
Manufacturer, by letter dated July 28, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
California, Colorado, Connecticut, Delaware, Florida, Georgia, Kansas, Illinois, Indiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Mexico, New York, North Carolina, Ohio, Pennsylvania, Texas, Virginia, West Virginia, Wisconsin, Korea, Canada, England, France, Italy and Spain.

QUANTITY
66 units were distributed.

REASON
The outer carton is labeled as containing a 10 Degree Elevated Rim, but the device inside actually contains a 20 Degree Elevated Rim.

PRODUCT
System 12(r) Acetabular Insert, a component of the Osteolock Hip System and is used for hip arthroplasty. The insert acts as a liner between the shell and the femoral head. Recall #Z-850-8.

CODE

Catalog Numbers:    Lot Codes
5260-4-460          UXBIA
5260-4-420          UXBGA.

MANUFACTURER
Howmedica, Inc., Pfizer Hospital Products Group, Rutherford, New Jersey.

RECALLED BY
Manufacturer, by telephone on December 16-17, 1997, and by letter faxed on December 17, 1997 and by mail on January 20, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide, Australia, New Zealand, Canada.

QUANTITY
95 units were distributed; firm estimated that 57 units remained on market at time of recall initiation.

REASON
The inserts have a shallow bearing surface which reduces the coverage of the mating femoral head.

PRODUCT
a) Inspiratory Muscle Trainer, DHD Part No. 22-7500; b) Non-Rebreathing T Piece (Nif-Tee) with Reducer, DHD Part No. 33-3500; c) Non-Rebreathing T Piece (Nif-Tee) with 4" Extension Tube, DHD Part No. 33-3505, d) Nif-Tee Kit with Positive/Negative Gauge, DHD Part No. 55-4900. Recall #Z-865/868-8.

CODE
Lot numbers: a) 808906, 811901, 816020; b) 807811, 808309, 809606, 810321, 810710, 811304, 812102, 813203, 813506, 814114, 816302, 817510, 818003, 818302, 819411, 819901; c) 810613, 811808; d) Lot Nos. 808908, 815508.

MANUFACTURER
DHD Healthcare, Wampsville, New York.

RECALLED BY
DHD Healthcare, Canastota, New York, by fax on August 5, 1998, and by letter dated August 13, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
a) 47 cases (472 kits); b) 381 packs (28,572 pieces); c) 71 packs (852 pieces) d) 21 kits (176 pieces) were distributed.

REASON
An incorrect valve assembly was used in the devices under recall.

CODE
Lot #982307.

MANUFACTURER
Alexon-Trend, Inc., Ramsey, Minnesota.

RECALLED BY
Manufacturer, by letter dated August 12, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide, New Zealand, Portugal.

QUANTITY
633 kits were distributed.

REASON
Bacterial contamination/possible false positive test results.

PRODUCT
V40 Femoral Head, part of the femoral component of an orthopedic hip implant: a) V40 Femoral Head 26mm Size, Catalog No. 6264-5-026; b) V40 Femoral Head 28mm Size. Recall #Z-863/864-8.

CODE
Lot Numbers: a) C4RCA, C4RCB, C4RCC, C4RCD, C4RCE, C4RCF, C4RCG, C4RCH; b) Catalog No. 6264-5-028 Lot No. BXJWG, Catalog No. 6264-5-128, Lot No. BXJWH, Catalog No. 6264-5-228, Lot No. BXJWI, Catalog No. 6264-5-428, Lot No. BXJWK, Catalog No. 6264-5-528, Lot No. BXJWL.

MANUFACTURER
Howmedica, Inc., Pfizer Hospital Products Group, Rutherford, New Jersey.

RECALLED BY
Manufacturer, by letters sent on December 23 and 30, 1997. Firm-initiated recall complete.

DISTRIBUTION
Nationwide, Australia, Ireland, Canada, Japan.

QUANTITY
337 units were distributed.

REASON
A ridge inside the tapered hole in the femoral head prevents it from fully sliding onto the stem trunnion and locking into place.

UPDATE
Recall #Z-835-8 (Abbott Laboratories, Barceloneta, Puerto Rico), which appeared in the September 9, 1998 Enforcement Report is a Class III recall and should read:
PRODUCT
TDx/TDxFLx T4 Reagent Pack, List No. 2A02-60/69, a reagent system for the quantitative measurement of total (free and protein bound) thyroxin (thyroid hormone) in serum or plasma.

CODE
Lot # 00881298.

MANUFACTURER
Hoffman LaRoche Inc., Parsippany, New Jersey (drug premix).

RECALLED BY
Purina Mills, Inc., Orrville, Ohio, by telephone on August 18, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Ohio.

QUANTITY
18,000 pounds of feed were distributed.

REASON
Product mislabeled. Labeled to contain 100 g/t chlortetracycline HCL, but actually contained 38.9 g/t each of sulfamethazine and chlortetracycline HCL.

END OF ENFORCEMENT REPORT FOR SEPTEMBER 23, 1998. BLANK PAGES MAY FOLLOW.