FDA

Enforcement Report

March 31, 1999                                     99-13

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

CODE
None.

MANUFACTURER
Imported from: DIK Company, Kowloon, Hong Kong.

RECALLED BY
CBK, Ltd. LLC, Union City, Tennessee, by letters September 30, 1998, and October 30, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
1,629 assortments (6 plates per assortment) were distributed.

REASON
Plates contain high levels of leachable lead and cadmium.

________
PRODUCT
Spring Roll Shells. Product is used as a wrapper for food fillings and it is to be fully cooked prior to consumption. Product package contains 25 spring roll sheets enclosed in 11 oz purple plastic bags. Recall #F-290-9.

CODE

All product codes produced and distributed between August 29,
1998 - February 3, 1999.  Individual packages are not coded. 
Master cases are coded.
Aug. Production:  QH29A/B, QH30A/B, QH31A/B (for Aug 29-31, 1998)
Sep. Production:  QI01A/B to QI30A/B (for entire month of Sep.
      1998)
Oct. Production:  QJ01A/B to QJ31A/B (for entire month of
      Oct.1998)
Nov. Production:  QK01A/B to QK30A/B (for entire month of Nov. 
      1998)
Dec. Production:  QL01A/B to QL31A/B (for entire month of Dec.
     1998)
Jan. Production:  RA01A/B to RA31A/B (for entire month of Jan.
     1999)
Feb. Production:  RB01A/B, RB02A/B, RB03A/B (for Feb 1-3,
1999).

MANUFACTURER
O=Tasty Foods, Inc., City of Industry, California. Manufacturer, by letter on February 19, 1999, and by press release February 27, 1999. Firm-initiated recall complete.

DISTRIBUTION
California, Colorado, Illinois, Montana, New Jersey, Texas, Utah, Washington state, Mexico.

QUANTITY
9,040 packages were distributed.

REASON
Product contains undeclared egg whites.

________
PRODUCT

Chocolate Chip Cookie Dough Ice Cream packaged under the 
following labels:
a) Dean's Country Charm Ice Cream, Chocolate Chip Cookie Dough
Vanilla Ice Cream with Chocolate Chips and Cookie Dough,
Distributed By Dean Foods Company, Franklin Park, IL 60131  Plant
No. 17-81; packaged in 2 gallon rectangular cartons (UPC
41900-04771) and round one pint containers (UPC 41900-04798)
b) Reiter Chocolate Chip Cookie Dough Ice Cream, Reiter Dairy,
Inc., Akron, OH 44314; packaged in round one pint containers (UPC
70554-01760).  Recall #F-291-9.

CODE
All production codes with plant #17-81.

MANUFACTURER
Dean Food Company, Belvidere, Illinois.

RECALLED BY
Dean Foods Company, Franklin Park, Illinois, by telephone on February 25, 1999, and by press release on February 26, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Indiana, Illinois, Kentucky, Ohio, Michigan, Wisconsin, Iowa, Florida, Georgia, Virginia, North Carolina, South Carolina, Pennsylvania.

QUANTITY
35,528 1/2 gallon cartons and 17,784 round pints were distributed; firm estimated that 20 percent of the product remained on market at time of recall initiation.

REASON
Product contains undeclared eggs.

________
PRODUCT
Chippedy Chocolaty Ice Cream in 1/2 gallon cartons. Recall #F-292-9.

CODE
1-25-OO.

MANUFACTURER
H.P. Hood, Inc., Ice Cream Division, Suffield, Connecticut.

RECALLED BY
H.P. Hood, Inc., Chelsea, Massachusetts issued press release on February 12, 1999 to PR Newswire. Each wholesale account was contacted by voice mail February 13, 1999 followed on February 16, 1999 by a copy of the press release. Firm-initiated recall complete.

DISTRIBUTION
Connecticut, Rhode Island, Massachusetts, Vermont, New Hampshire, Maine.

QUANTITY
2,550 half-gallon containers were distributed.

REASON
Product contains undeclared walnuts. Some cartons actually contain Maple Walnut Ice Cream.

________
PRODUCT
Breaded Clam Strips, 6 and 6.5 lb. bulk 9 ct., 12 ct., 18 ct., 24 ct., or 112 ct. packs/case, distributed under the following labels Sea Watch, Rykoff/Sexton, Nugget Black, White Castle, All Kitchens, Golden Corral, Pocahontas , Nifda Prime Pack, Mr. Frosty, Monarch Regency, JP Blue, Garden Delight, Frosty Sea, Comsource Medallion, Code Red, Capt. Fred, and Old Salt. Recall #F-293-9.

CODE

AY31, AV31, AO31, A331, AU31, A631, AN31, A131, AL31, AC31, AO97,
A81D, A145, A345, A645, A609, A109, A309, A009, A11A, A105, A194,
A620, A321, A121, A151, A053, A100, A300, A600, A62M, A12M, A62M,
A617, A655, A152, A652, A64C, A04C, A14C, A103, A003, A403, A61J,
A601, A501, AH01, A001, A101, A301, A701, AH01.

MANUFACTURER
Sea Watch International, Ltd., Easton, Maryland.

RECALLED BY
Manufacturer, by letter on or about February 11, 1999, followed by telephone. Firm-initiated field correction (relabeling) ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
72,237 cases were distributed.

REASON
Product contains undeclared eggs and milk.

________
PRODUCT

Lumpia (Philippine style egg rolls) and wrappers:
a) Vegetable Lumpia in 18 oz. boxes (12 boxes/case) labeled
"Philippine Style Egg Rolls LUMPIA Savory Vegetables in a Thin
Crispy Wrapper" and in 72 oz. plastic bags labeled "Family
Loompya Brand Vegetable Lumpia"
b) Vegetable and Shrimp Lumpia in 18 oz. boxes (12
boxes/case) and 48 oz. boxes (5 boxes/case) labeled "Philippine
Style Egg Rolls LUMPIA Savory Vegetables and Shrimp in a Thin
Crispy Wrapper"
c) Family Loompya Brand Wrappers in plastic bags with net
wt. 13 oz.  Recall #F-294/296-9.

CODE
All Lumpia with "Best If Used By:" dates of 6/11/99 to 2/11/00 and all wrappers on the market at the time of the recall (wrappers are not coded).

MANUFACTURER
Family Loompya Corporation, National City, California.

RECALLED BY
Manufacturer, fax on February 25, 1999 and by press release on February 26, 1999. See also USDA press release on February 25, 1999.

DISTRIBUTION
Nationwide, Japan, South Korea, Guam, Iceland.

QUANTITY
2,000 cases of egg rolls and 330 cases of wrappers were distributed.

REASON
Products contain undeclared egg whites.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

CODE
"USE BY" dates of 3/16/99, 3/18/99, 3/22/99, 3/29/99.

MANUFACTURER
Green Garden Food Products, Inc., Kent, Washington.

RECALLED BY
Manufacturer, by visit on March 11, 1999. Firm-initiated field correction (relabeling) complete.

DISTRIBUTION
Washington state.

QUANTITY
Firm estimated that 14 cases remained on market at time of recall initiation.

REASON
Product contains undeclared semolina.

________
PRODUCT

Snack Mixes in 4.75 ounce to 14 ounce clear plastic bags, and in
bulk 25 pound cases under the Hickory Harvest Foods label: 
a) Diet Trail Mix, in 5 oz., 9.5 oz., and 11.5 oz. bags and in
bulk 25 lb. cases;
b) Banana Split Mix, in 14 oz. and 5.25 oz. bags and in bulk 25
lb. cases;
c) Caribbean Fruit & Nut Mix, in 10 oz. and 12 oz. bags and in
bulk 25 lb. cases;
d) Oriental Mix, in 12 oz. bags and in bulk 25 lb. cases
e) Mikey's Mix, in 10.5 oz. and 13 oz. bags and in bulk 25
lb. cases
f) Yogurt & Fruit Snack, in 13 oz. bags and in bulk 25 lb. cases
g) Fancy Nut Mix, in 10 oz. bags and in bulk 25 lb. cases;
h) California Mix, in 5.25 oz. bags and in bulk 25 lb. cases;
i) Nature's Snack Mix, in 4.75 oz. bags and in bulk 25 lb. cases. 
Recall #F-271/279-9.

CODE
"BEST IF SOLD BY" expiration dates range from 11-22-99 through 12-8-99. Below the expiration dates are consecutive production run numbers: 9035 through 9054.

MANUFACTURER
Hickory Harvest Foods, Akron, Ohio.

RECALLED BY
Manufacturer, by telephone on March 1, 1999, and by letter mailed on March 9-10 and 15, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
312 cases were distributed.

REASON
Products may contain large fragments of almond shell.

________
PRODUCT

Papaya Chunks and Trail Mixes as listed below.
a) Papaya Chunks packed as follows: 
        (1)  44 lb. box (bulk).  Responsible firm on the label:
             Mayfair Sales Inc., Buffalo, NY
        (2)  Walter's brand PAPAYA CHUNKS, in 16 oz. plastic
             cartons.  Responsible firm on the label: Packed for
             TOPS Markets, Inc., Williamsville, NY 14221
b) Fat Free Fruit Delight packed as follows: 
        (1)  12.5 oz. plastic carton, labeled as "Walter's". 
             Firm on the label is TOPS Markets, Williamsville,
             NY; and  
        (2)  15 lb. box (bulk), labeled as "Select Gourmet" Fat
             Free Fruit Delight Mix.  Firm on the label is
             Mayfair Sales Inc., Buffalo, NY.
c) "Select Gourmet" Tropical Trail Mix, 15 lb. bulk box
d) "Select Gourmet" California Dream Mix, 15 lb. bulk box
e) "Select Gourmet" Super Trail Deluxe Mix, 15 lb. bulk box
f) "Select Gourmet" Sweet Satisfaction Mix, 15 lb. bulk box. 
Recall #F-283/288-9.

CODE
All product which fails to list FD&C Yellow No. 5 on the ingredient statement.

MANUFACTURER
Tzetzo Brothers, Inc., Buffalo, New York.

RECALLED BY
Manufacturer, by telephone, followed by letter dated February 26, 1999. Firm-initiated recall complete.

DISTRIBUTION
New York, Ohio, Pennsylvania, Massachusetts, Vermont, New Hampshire.

QUANTITY
Undetermined.

REASON
Product contains undeclared FD&C Yellow No. 5.

________
PRODUCT
SAIL(r) brand 41/50 IQF Raw E-Z Peel Shrimp - Frozen Product. Each case contained 10 x 2 lb. Bags, 20 lbs. per case. Recall #F-298-9.

CODE
Lot #90327.

MANUFACTURER
Expalsa, Exportadora De Alimentos, S.A., Guayaquil, Ecuador.

RECALLED BY
Eastern Fish Company, Teaneck, New Jersey, by telephone and faxed letter on December 18, 1998. Firm-initiated recall complete.

DISTRIBUTION
Maryland and Pennsylvania.

QUANTITY
40 cases (10 bags per case) were distributed.

REASON
Product contains undeclared sulfites.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III

CODE
Lot numbers: 325450, 325460, 325470, 325480 and 325490.

MANUFACTURER
Newly Wed Foods, Inc., Seasonings Division, Yorkville, Illinois.

RECALLED BY
Manufacturer, by telephone on or about January 11, 1999. Firm-initiated recall complete.

DISTRIBUTION
Minnesota and Nebraska.

QUANTITY
146 boxes were distributed.

REASON
The product contained substantially less nitrite than the amount declared on the label. The lower amount does not provide the expected preservative effect.

RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS II

CODE
8HA

MANUFACTURER
Elizabeth Arden Company, Roanoke, Virginia.

RECALLED BY
Elizabeth Arden Company, Stamford, Connecticut, by telephone on February 23-24, 1999 and March 5, 1999, and by letter. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
2,896 units were distributed.

REASON
Product is contaminated with Citrobacter freundii.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I

CODE
All lot codes.

MANUFACTURER
Ameri-Kal, Inc./SOE Trading & Management, Auburn, California.

RECALLED BY
Advanced Athletic Nutrition (AAN), Roseville, California, by letter on January 28, 1999. Firm-initiated recall ongoing. See also FDA talk paper T99-5, January 21, 1999.

DISTRIBUTION
Arizona, California, Colorado, Delaware, Florida, Georgia, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New York, Oklahoma, Oregon, Texas.

QUANTITY
Undetermined.

REASON
Product is an unapproved new drug.

________
PRODUCT
INSOM-X Oral Liquid (2-(3H)- Furanone dihydro), OTC, in 32 fluid ounce bottles. Product contains GBL (gamma butyrolactone). Recall #D-153-9.

CODE
All lot codes.

MANUFACTURER
Miracle Marketing Distributors, Inc., Jacksonville, Florida.

RECALLED BY
Manufacturer, by letter e-mail. Firm-initiated recall complete. See also FDA talk paper T99-5, January 21, 1999.

DISTRIBUTION
California, Arizona, Canada.

QUANTITY
Firm estimates none remains on the market.

REASON
Product is an unapproved new drug.

________
PRODUCT
a) Povidone-Iodine Solution, USP 10%, packaged in 3/4 fluid ounce (22mL) packets, distributed under one brand name - Professional Disposables, Inc., labeled as an antiseptic and germicide; b) Povidone-Iodine Prep Pad, sold in small and medium sizes, saturated with a 10% povidone-iodine solution, labeled as an antiseptic and germicide, distributed under the following brand names: Professional Disposables, Inc., ABCO, Allegiance, Bergen Brunswig, Medline, and Total Resources. Recall #D-154/155-9.

CODE

Lot numbers:  a) 7006741 EXP 12/00, Item #L57725.
b) Brand          Lot No.         Item No.        EXP
   PDI            9700009438,     B40600,       12/2000
                  9700009695,     B40600,       12/2000
                  9700009939,     B40600,       12/2000
                  9700010027,     B40600,       12/2000
                  9800000781      B40600,       12/2000
                  9800000533      B40600        01/01
                  9800001356      B40600        01/01
                  9800001493      B40600        01/01
                  9800002497      B40600        01/01
                  9800003002      B40600        01/01
                  9800000161      B40673        12/2000
                  9800002312      B40701        01/01)
   ABCO           9700010542      B14200        12/00)
   Allegiance     9700009572      B87500        12/00
                  9700010571      B87500        12/00
                  9800002492      B87500        01/01
Bergen Brunswig   9800002175      B60600        01/01
Medline           9800000615      B64200        01/00)
                  9800002320      B64204        01/01)
Total Resources   9800000069      B08589        12/00).

MANUFACTURER
Nice-Pak Products, Inc., Orangeburg, New York.

RECALLED BY
Manufacturer, by letters on February 2 and 19, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide, Canada, Ireland, Portugal.

QUANTITY
a) 352 cases (250 packets per case); b) 7,125 cases (1,000 prep pads per case) were distributed.

REASON
Microbial contamination with Pseudomonas putida, Salmonella spp. Poly D, and Aeromonas sobria.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

CODE
Control Nos. 7B92085 (Lot #9709023 EXP 02/99) and 7B92086 (Lot #9709024 EXP 02/99).

MANUFACTURER
Marsam Pharmaceuticals, Inc., Cherry Hill, New Jersey.

RECALLED BY
Manufacturer, by letter on November 30, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide.

QUANTITY
777 units were distributed.

REASON
Subpotency.

________
PRODUCT
Clinipad Antiseptic Towelette (Benzalkonium Chloride, USP 1:750, individually wrapped, 100 towelettes/folding box. Recall #D-147-9.

CODE
Lot #814188.

MANUFACTURER
Clinipad Corporation, Charlotte, North Carolina.

RECALLED BY
Clinipad Corporation, Rocky Hill, Connecticut, by telephone on November 20, 1998, followed by letter on November 23, 1998. Firm-initiated recall complete.

DISTRIBUTION
Arizona, California, Connecticut, Florida, Illinois, Iowa, Kentucky, Louisiana, Massachusetts, Maryland, New Jersey, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Washington state.

QUANTITY
108 cases (10 boxes per case) were distributed.

REASON
Microbial contamination - Pseudomonas Cepacia (Burkholderia Cepacia).

________
PRODUCT

a) (OTC) Ballistic Tablets, Expectorant/Bronchodilator (Ephedrine
HCL 25mg Guaifenesin 100 mg) in 100 tablet bottles;
b) (OTC) SinuCheck Capsules (Pseudoephedrine HCL from Ephedra
Sinensis-30mg) in 60 capsule bottles;
c) (OTC) AllerClear Capsules (Pseudoephedrine HCL from Ephedra
Sinensis-30mg) in 90 capsule bottles.  Recall #D-148/150-9.

CODE

Lot Numbers:  a) 0798-08, 0798-38, and 0998-11
b) 0898-10, 0898-07, and 0998-48
c) 0898-09, 0998-08, and 0998-09.

MANUFACTURER
Nassmith Pharmaceuticals, Inc., Oceanside, California.

RECALLED BY
Manufacturer, by fax and letter on February 11, 1999. Firm-initiated recall complete.

DISTRIBUTION
Utah and Wisconsin.

QUANTITY

     Lot No.    Amt.dist.   Amt. In Commerce
a)  0798-08     728,648     728,648 Tablets
    0798-38     731,497     731,497 Tablets
    0998-11     736,600     736,600 Tablets
b)  0898-10     199,821     199,821 Capsules
    0898-07     394,890     394,890 Capsules
    0998-48     198,959     198,959 Capsules
c)  0898-09     273,361     273,361 Capsules
    0998-08     275,853     275,853 Capsules
    0998-09     264,953     264,953 Capsules.

REASON
Current good manufacturing practice deviations including but limited to; Lack of raw material, in-process and finished product testing and Lack of manufacturing validation and stability data to support labeled expiry.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

CODE
Lot #8342 EXP 5/00.

MANUFACTURER
Luitpold Pharmaceuticals, Inc., also known as American Regent Laboratories, Inc., Shirley, New York.

RECALLED BY
Manufacturer, by telephone on February 10, 1999, followed by letter. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
61,825 vials were distributed.

REASON
Particulate matter.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

CODE
Unit numbers: a) 228436, 257123, 299388, 327732, 0583966; b) 257123, 299388, 327732; c) 299388; d) 228436, 257123, 327732.

MANUFACTURER
Memorial Blood Centers of Minnesota, Minneapolis, Minnesota.

RECALLED BY
Manufacturer, by letter dated July 9 or 15, 1998. Firm-initiated recall complete.

DISTRIBUTION
Minnesota, California, and Switzerland.

QUANTITY
a) 5 units; b) 3 units; c) 1 unit; d) 3 units were 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-603-9.

CODE
Unit numbers: 0530275 and 0530635.

MANUFACTURER
Memorial Blood Centers of Minnesota, Minneapolis, Minnesota.

RECALLED BY
Manufacturer, by letter dated December 16, 1997. Firm-initiated recall complete.

DISTRIBUTION
Minnesota.

QUANTITY
2 units were distributed.

REASON
Blood products were shipped at an unacceptable temperature.

________
PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-604/605-9.

CODE
Unit #1250952.

MANUFACTURER
Community Blood Center of Greater Kansas City, Kansas City, Missouri.

RECALLED BY
Manufacturer, by letter dated July 24, 1998. Firm-initiated recall complete.

DISTRIBUTION
Missouri.

QUANTITY
1 unit of each component was distributed.

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

________
PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-609/610-9.

CODE
Unit numbers: a) 0282322, 6112135; b) 6112135.

MANUFACTURER
Community Blood Center of Greater Kansas City, Kansas City, Missouri.

RECALLED BY
Manufacturer, by telephone on May 20 and 21, 1998. Firm-initiated recall complete.

DISTRIBUTION
Kansas, Arkansas, Missouri.

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

REASON
Blood products tested reactive for syphilis.

________
PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-613/614-9.

CODE
Unit numbers: a) 3138291, 7540339, 3143381; b) 3138291.

MANUFACTURER
Community Blood Center of Greater Kansas City, Kansas City, Missouri.

RECALLED BY
Manufacturer, by letter dated June 25, 1998. Firm-initiated recall complete.

DISTRIBUTION
Missouri and Kansas.

QUANTITY
a) 3 units; b) 1 unit was distributed.

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

________
PRODUCT
Source Plasma. Recall #B-615-9.

CODE
Unit #96415T.

MANUFACTURER
Seramed Biocenter, Sioux City, Iowa.

RECALLED BY
Manufacturer, by fax on September 22, 1997. Firm-initiated recall complete.

DISTRIBUTION
North Carolina.

QUANTITY
1 unit was distributed.

REASON
Blood product that was not tested for syphilis.

________
PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-616/617-9.

CODE
Unit #42FW52796.

MANUFACTURER
American Red Cross Blood Services, Cleveland, Ohio.

RECALLED BY
Manufacturer, by letter dated November 23, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio.

QUANTITY
1 unit of each component was distributed.

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

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

CODE

Unit numbers:  1634255, 1636913, 1637125, 1637520, 1638614,
1639676, 1640458, 1640540, 1643116, 1643307, 1643374, 1643925, 
1643942, 1644225, 1645042, 1645301, 1645361, 1645557, 
1646933, 1647008, 1647053, 1647755, 1647817, 1647827, 
1647868, 1648321, 1648533, 1648934, 1649632, 1650010, 
1650276, 1650627, 1650869, 1650874, 1652300, 1652399, 
1652602, 1652603, 1652751, 1652752, 1652875, 1653278,
1653285, 1653557, 1653595, 1653659, 1653726, 1653772, 
1654017, 1654403, 1654416, 1654536, 1654825, 1654872, 
1654936, 1654980, 1655051, 1655054, 1655080, 1655344, 
1655356, 1655423, 1655479, 1655589, 1655608, 1655622, 
1655653, 1655861, 1655949, 1655973, 1656038, 1656059, 
1656082, 1656083, 1656145, 1656159, 1656161, 1656162, 
1656229, 1656403, 1656420, 1656579, 1656588, 1656589
1656627, 1656640, 1656641, 1656654, 1656663, 1656694, 
1656697, 1656804, 1656837, 1656860, 1657282, 1657291, 
1657444, 1657506, 1657526, 1657566, 1657595, 1657828, 
1657831, 1657837, 1657839, 1657858, 1657866, 1657878, 
1657921, 1657942, 1657943, 1657961, 1657997, 1658126, 
1658545, 1658573, 1658586, 1658781, 1659037, 1659269, 
1659312, 1659432, 1659437, 1659633, 1659771, 1659850,
1659903, 1660050, 1660073, 1660092, 1660096, 1660215, 
1660258, 1660261, 1660437, 1660445, 1660509, 1660625, 
1660626, 1660635, 1660828, 1660839, 1660845, 1660925, 
1660936, 1661017, 1661058, 1661133, 1661164, 1661194, 
1661360, 1661404, 1661489, 1661698, 1661725, 1661773, 
1661774, 1661780, 1661788, 1661812, 1661828, 1661873, 
1661883, 1661886, 1661889, 1661890, 1661971, 1661995,
1662076, 1662079, 1662228, 1662262, 1662266, 1662316, 
1662347, 1662350, 1662358, 1662396, 1662399, 1662405, 
1662406, 1662413, 1662414, 1662416, 1662610, 1662767, 
1662797, 1662800, 1662885, 1662914, 1662916, 1662930, 
1662940, 1662976, 1662977, 1662995, 1663002, 1663013, 
1663019, 1663026, 1663058, 1663059, 1663060, 1663068, 
1663223, 1663227, 1663238, 1663333, 1663348, 1663437,
1663466, 1663477, 1663544, 1663553, 1663987, 1664178, 
1664198, 1664902, 1664904, 1664916, 1664996, 1665053, 
1665138, 1665157, 1665223, 1665395, 1665472, 1665482, 
1665614, 1665632, 1665681, 1665803, 1665917, 1665966, 
1665994, 1666096, 1666231, 1666262, 1666263, 1666270, 
1666273, 1666274, 1666276, 1666277, 1666292, 1666301, 
1666368, 1666395, 1666396, 1666417, 1666419, 1666460, 
1666461, 1666470, 1666474, 1666475, 1666477, 1666507, 
1666508, 1666521, 1666526, 1666531, 1666535, 1666536, 
1666540, 1666547, 1666563, 1666572, 1666576, 1666597, 
1666819, 1666621, 1666632, 1666634, 1666635, 1666838, 
1666639, 1666645, 1666656, 1666705, 1666706, 1666717, 
1668718, 1666720, 1666721, 1666734, 1666738, 1666739, 
1666740, 1666741, 1666746, 1666759, 1666760, 1666811, 
1666820, 1666828, 1666839, 1666865, 1666879, 1666903, 
1666941, 1666942, 1666990, 1667000, 1667022, 1667053, 
1667071, 1667086, 1667088, 1667098, 1667101, 1667120, 
1667126, 1667132, 1667176, 1667178, 1667183, 1667204, 
1667225, 1667230, 1667237, 1667248, 1667264, 1667288, 
1667290, 1667292, 1667293, 1667303, 1667325, 1667327, 
1667336, 1667346, 1667352, 1667356, 1667362, 1667370,
1667372, 1667376, 1667389, 1667409, 1667423, 1667546, 
1667616, 1667681, 1667682, 1667770, 1667777, 1667780, 
1667781, 1667784, 1667797, 1667798, 1667802, 1667807, 
1667889, 1667951, 1667961, 1667963, 1668019, 1668045, 
1668106, 1668109, 1668153, 1668171, 1668179, 1668194, 
1668331, 1668339, 1668477, 1668750, 1668752, 1668754, 
1668825, 1668827, 1668843, 1669153, 1669161, 1669581,
1670004, 1670306, 1670596, 1670657, 1670775, 1670776, 
1671721, 1671722, 1671723, 1673186, 1673654, 1674085, 
1674086, 1674087, 1674097, 1674100, 1674398, 1674402, 
1674717, 6002051, 6002196, 6002337, 6002339, 6002342, 
6002344, 6002345, 6002370, 6002445, 6002461, 6002474, 
6002478, 6002512, 6002523, 6002528, 6002690, 6002747, 
6002810, 6002811, 6002821, 6002828, 6002888, 6002912,
6003041, 6003042, 6003046, 6003061, 6003220, 6003282, 
6003311, 6003333, 6003334, 6003361, 6003362, 6003371, 
6003374, 6003380, 6003407, 1653737, 1653751, 1656157, 
1658094, 1659719, 1660443, 1663010, 1666889, 1667954, 
1669709, 1670795, 6001755, 6003469, 6003661, 6003795, 
6003881, 1656436, 1661908, 1662492, 1663937, 1672619, 
1672639, 1672641, 6001972, 6003888, 6004128, 6004228.

MANUFACTURER
Mississippi Blood Services, Inc., Jackson, Mississippi.

RECALLED BY
Manufacturer, by fax on December 2, 1997. Firm-initiated recall complete.

DISTRIBUTION
Mississippi, Louisiana, New Jersey, Pennsylvania, Virginia. QUANTITY
462 units were distributed.

REASON
Fresh Frozen Plasma units may not have been frozen within eight hours of collection.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

CODE
Unit #2140087.

MANUFACTURER
Community Blood Center of Greater Kansas City, Kansas City, Missouri.

RECALLED BY
Manufacturer, by letter dated either May 8, 1997, or May 12, 1996 (typographical error as correct date should have been 5/12/97). Firm-initiated recall complete.

DISTRIBUTION
Kansas and California.

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.

________
PRODUCT
Red Blood Cells. Recall #B-611-9.

CODE
Unit #0280332.

MANUFACTURER
Community Blood Center of Greater Kansas City, Kansas City, Missouri.

RECALLED BY
Manufacturer, by telephone on April 23, 1998. Firm-initiated recall complete.

DISTRIBUTION
Missouri.

QUANTITY
1 unit was distributed.

REASON
Blood product had an expired preservative added.

_________
PRODUCT
Red Blood Cells. Recall #B-612-9.

CODE
Unit #6129734.

MANUFACTURER
Community Blood Center of Greater Kansas City, Kansas City, Missouri.

RECALLED BY
Manufacturer, by telephone on August 7, 1998. Firm-initiated recall complete.

DISTRIBUTION
Missouri.

QUANTITY
1 unit was distributed.

REASON
Blood product was labeled with an extended expiration date.

________
PRODUCT
Fresh Frozen Plasma. Recall #B-618-9.

CODE

411524, 411658, 413718, 413742, 414049, 414195, 414709, 414735,
414853, 415904, 417159, 418314, 418807, 418939, 419033, 419224,
433275, 434438, 435296.

MANUFACTURER
Memorial Blood Centers of Minnesota, Minneapolis, Minnesota.

RECALLED BY
Manufacturer, by telephone on January 25, 1997, followed by letter dated February 4, 1997. Firm-initiated recall complete.

DISTRIBUTION
Minnesota.

QUANTITY
19 units were distributed.

REASON
Blood products were stored at an unacceptable temperature.

________
PRODUCT
Platelets. Recall #B-619-9.

CODE
Unit #10512-8332.

MANUFACTURER
United Blood Services, Scottsdale, Arizona.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated July 2, 1996. Firm-initiated recall complete.

DISTRIBUTION
Texas.

QUANTITY
1 unit was distributed.

REASON
Blood product was prepared from a unit of whole blood identified as a difficult draw.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I

CODE
Solar 7000/8000 Patient Monitors with 5D software, which had been updated from Version 5A, B or C software, are affected. New units, which only had 5D software installed at the manufacturing plant, are not affected if they never had an earlier software version. There were, however, some units in stock which were updated at the manufacturer from Version 5C to Version 5D software when this became available on 12/18/98. Some of these new units were distributed. The affected new units were shipped between 12/18/98 and 2/10/99, but do not have consecutive serial numbers. These units, plus units which were updated with 5D software at users, are to be corrected in the field in the firm=s recall action.

MANUFACTURER
Marquette Electronics, Inc., Milwaukee, Wisconsin.

RECALLED BY
Manufacturer, by letters on February 5 and 15, 1999. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
607 new units affected by the problem and 97 Version 5D software update kits were distributed. It is unknown how many of the 97 software update kits have been installed on units which previously had Version 5A, B, or C software.

REASON
A software deviation can affect the alarm default settings, which may result in incorrect or missed alarm notification.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

CODE

AMS 700 Ultrex Plus Penile Prostheses:  
   Model Number   Lot
   72401463       EE451
   72401464       EE452
   72401466       EE453 and EE785
   72401467       EE787
AMS 700 Inflate/Deflate Pump Prefilled:
   Model Number   Lot
   72400154       EE638
                  EE689
                  EE639
AMS Ambicor Penile Prostheses:  
   Model Number   Lot
   72401450       EE307 and EE310
   72401451       ED756
   72401452       EE456
   72401454       EE846 and ED847
   72401455       ED849, ED850, and ED851.

MANUFACTURER
American Medical Systems, Inc. Minnetonka, Minnesota.

RECALLED BY
Manufacturer, by telephone on March 5, 1999, and by letter dated March 8, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide, Australia, Bahrain, Canada, France, Italy, Germany, Spain.

QUANTITY
110 units were distributed.

REASON
Sterile packaging of some of the device units was found to be leaking.

_________
PRODUCT
BARD 6 F Envision Pigtail Cardiovascular Angiographic Catheters, intravascular diagnostic catheters used to record intracardiac pressures, to sample blood, and to introduce substances into the heart: Catalog Numbers: 061085, 061086, 061088, 061089, 662005, 662009. Recall #Z-766/771-9.

CODE

             Item #       Lot #       Mfg. Date
XS Straight/12 sideholes
Z-766-9    061085         08FI0841    Jun-98
           061085         08FI0842    Jun-98
XS 145 Degree/12 sideholes
Z-767-9    061086         08FI0850    Jun-98
           061086         08FI0849    Jun-98
           061086         08GI1186    Jul-98
           061086         08GI1185    Jul-98
XS Straight/6 sideholes
Z-768-9    061088         08EI2365    May-98
           061088         08FI1945    Jul-98
           061088         08FI1944    Jul-98
XS 145 Degree/6 sideholes
Z-769-9    061089         08EI2453    May-98
           061089         08FI2156    Jun-98
BTO Angiokit
Z-770-9    662005         08FI1210    Jun-98
BTO Kit            
Z-771-9    662009         08EI1536    May-98
           662009         08FI1211    Jun-98
           662009         08AJ0486    Jan-99
           662009         08LI0622    Dec-98
           662009         08KI0148    Nov-98.

MANUFACTURER
C.R. Bard, Inc., Billerica, Massachusetts.

RECALLED BY
Manufacturer, by letter dated March 16, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Alabama, Florida, Indiana, Louisiana, Massachusetts, Maryland, Missouri, North Carolina, New York, Pennsylvania, Texas, Virginia, District of Columbia, Ireland.

QUANTITY
3,055 units were distributed.

REASON
The tip may detach from catheter.

________
PRODUCT
Philips Medical Sonodiagnost 800, intended for endovaginal biopsy for various gynecologic and obstetric procedures including follicular retrieval, endometrial biopsy, and fluid aspiration of any type in a potentially pregnant patient. Recall #Z-772-9.

CODE

All SD800's with Software versions 2.1. and 2.1.1 used with
Endovaginal Transducer EV7014, serial numbers are as follows:
3424A00105   3434A00109   3434A00133   3441A00122   3441A00130  
3510A00142   3510A00145   3510A00185   3510A00188   3514A00160  
3514A00168   3527A00052   3527A00204   3624A00471   3640A00626  
3728A00051   3728A00120   3728A00165   3728A00519   3728A00611  
3728A00612   3728A00614   3728A00635   3728A00637 through
3728A00750,  3728A00752 through 3628A00756.

MANUFACTURER
Hewlett-Packard Company, Andover, Massachusetts

RECALLED BY
Manufacturer, by letter dated March 5, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
145 units were distributed.

REASON
Software used with Transducer EV7014 incorrectly indicates track of the biopsy needle.

________
PRODUCT
Omega-21 Slotted Connector, Part No. 1280-08, pectide screw fixation and non-pectide hook and sacroiliace screw fixation of the non-cervical spine. Recall #Z-773-9.

CODE
Lot No. 35573.

MANUFACTURER
Industrias Quirurgicas De Levante S.L., Valencia, Spain.

RECALLED BY
EBI Medical Systems, Inc., Parsippany, New Jersey, by letter March 24, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
12 units were distributed.

REASON
The screw in the connector could not be properly fixed to the connector once the fixing nut was at the end of the threaded tail of the screw.

________
PRODUCT
3M Sarns Sternal Saw II and Saw Protector: a) 3M Sarns Sternal Saw II, Catalog No. 5590, Part No. 98-0702-0597-0, used only in medical sternotomies; b) 3M Sarns Sternal Saw II Protector, Part No. 78-8067-9735-9. Recall #Z-774/775-9.

CODE
a) Serial Nos. 13176 thru 13365, and any Sarns Sternal Saw II serviced by 3M Health Care from 6/1/98 thru 2/4/99; b) All units.

MANUFACTURER
3M Health Care, Ann Arbor, Michigan.

RECALLED BY
Manufacturer, by letter dated March 15, 1999. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
Approximately 225 saws sold or repaired since the change plus 126 replacement protectors.

REASON
The saw blade protector is subject to breakage.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

CODE
Lot numbers (medium spray): 1850 through 1879.Lot numbers (fine spray): 802 through 828.

MANUFACTURER
Gebauer Company, Cleveland, Ohio.

RECALLED BY
Manufacturer, by letter on March 6, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
444,627 bottles were distributed.

REASON
Product failed the 18 month stability testing for non-volatile residue.

END OF ENFORCEMENT REPORT FOR MARCH 31, 1999.