March 31, 1999 99-13
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.
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.
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.
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.
________
PRODUCT
AAN brand RemForce Oral Liquid (2-(3H)- Furanone dihydro), in 32
fluid ounce bottles, OTC product with night-time sleep aid claims
and also represented as a dietary supplement. Recall #D-152-9.
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.
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.
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.
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.
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.
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.
________
PRODUCT
Solar 7000 and Solar 8000 Patient Monitors with Version 5D
Software, used to display physiological data from modules which
monitor the patient for ECG, blood pressure, cardiac output,
respiration, pulse oximetry, etc. Recall #Z-727/728-9.
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.
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.
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.