October 2, 2002
02-39
_______________________
PRODUCT
Imported Irish Belleek(tm) food service items consisting of:
a) Belleek Teapot, item #H22701. Recall # F-804-2;
b) Nadine 8" Fruit Bowl, item #H24994. Recall # F-805-2;
c) Belleek Creamer-Sugar Set, item #H27935. Recall # F-806-2;
d) Dalraida Shamrock Fruit Bowl, item #H42984. Recall # F-807-2;
e) Belleek Shell Bowl, item #H44648. Recall # F-808-2;
f) Belleek Milk Pitcher, item #H48303. Recall # F-809-2;
g) Belleek Neptune Cup & Saucer Set, item #H48308.
Recall # F-810-2;
h) Neptune Seashell Teapot, item #H48307. Recall # F-811-2;
i) Neptune Seashell Sugar/Creamer Set, item #H48309.
Recall # F-812-2;
j) Shamrock Tea Kettle, item #H48310. Recall # F-813-2;
k) Belleek Finner Cup & Saucer Set, item #H49760.
Recall # F-814-2;
l) Belleek Coffee Pot, item #H50126. Recall # F-815-2;
m) Kylemore Fruit Bowl, item #H74685. Recall # F-816-2.
CODE
Individual pottery products are not coded. A product watermark can be found on the bottom of items.
RECALLING FIRM/MANUFACTURER
Recalling Firm: QVC, Inc., West Chester, PA, by letter on January 15, 2001.
Manufacturer: Belleek Pottery Limited Belleek, County Fermanaugh, IE. Firm initiated recall is complete.
REASON
Food service pottery items may be contaminated with lead.
VOLUME OF PRODUCT IN COMMERCE
1503 items.
DISTRIBUTION
Nationwide.
_______________________
PRODUCT
Segarra brand Lime flavor syrup (Sirop de Lima-Limon), packaged in 700 ml/23.70 oz glass bottles. Recall # F-818-2.
CODE
RU-93.
RECALLING FIRM/MANUFACTURER
Caribe Tropical Corp., San Sebastian, Puerto Rico, by letter dated June 24, 2002. Firm initiated recall is ongoing.
REASON
The product contained undeclared FD& C Yellow No. 5 and FD&C Blue No. 1.
VOLUME OF PRODUCT IN COMMERCE
21 boxes/12 bottles/23.70 fl. oz.
DISTRIBUTION
Puerto Rico.
_______________________
PRODUCT
Item #/Product Description
a) FA0665 Hot & Spicy Batter (1 lot). Recall # F-819-2;
b) FA0853 Wendy's H&S Filet Batter (1 lot). Recall # F-820-2;
c) FA0854 Wendy's Chicken Nugget (1 lot). Recall # F-821-2;
d) FA1097 Chicken Batter (1 lot). Recall # F-822-2;
e) FA2032 Chicken Batter (1 lot). Recall # F-823-2;
f) FA2033 Chicken Breader (1 lot). Recall # F-824-2;
g) FA2250 Chicken Fritter Breader (2 lots). Recall # F-825-2;
h) FA2359 McD Flt Bttr w/Btrmillk (2 lots). Recall # F-826-2;
i) FA2360 McD Flt Bttr w/C&B (2 lots). Recall # F-827-2;
j) FA2503 KFC OR Sandwich Batter (2 lots). Recall # F-828-2;
k) FA2836 Wendy's Nugget Batter (1 lot). Recall # F-829-2;
l) FA3357 Chicken Fillet Predust (1 lot). Recall # F-830-2;
m) FA3545 KFC FTF Popcorn Batter (1 lot). Recall # F-831-2;
n) F15768 Wendy's Chicken Nugget Batter (1 lots).
Recall # F-832-2;
o) F16306 Wendy's Filet Batter (1 lot). Recall # F-833-2;
p) F18902 Chicken Wing Batter (1 lots). Recall # F-834-2;
q) F18903 Chicken Wing Breader (2 lots). Recall # F-835-2;
r) F19816 Wendy's Chicken Predust (1 lots). Recall # F-836-2;
s) F70705 Wendy's Filet Breader H&S (3 lots). Recall # F-837-2;
t) F71191 Chicken Batter (1 lot). Recall # F-838-2;
u) F73942 Wendy's Filet Batter H&S (1 lots). Recall # F-839-2;
v) F74517 Chicken Breader (1 lot). Recall # F-840-2;
w) F75006 Chicken Liver Batter (1 lot). Recall # F-841-2;
x) F75707 Chicken Batter (1 lot). Recall # F-842-2;
y) F76282 Chicken Batter (3 lots). Recall # F-843-2;
z) F76283 Chicken Breader (5 lots). Recall # F-844-2;
aa) F76484 KFC Crispy Strip Breader (2 lots). Recall # F-845-2;
bb) F76487 KFC Crispy Strip Batter (2 lots). Recall # F-846-2;
cc) F76744 MRB Breader (1 lot). Recall # F-847-2;
dd) F79270 KFC OR Sandwich Predust (2 lots). Recall # F-848-2.
CODE
Item # Lot # Product Description
FA0665 01L0993 Hot & Spicy Batter
FA0853 01L1174 Wendy's H&S Filet Batter
FA0854 01L1175 Wendy's Chicken Nugget
FA1097 01L0886 Chicken Batter
FA2032 01L1009 Chicken Batter
FA2033 01L1010 Chicken Breader
FA2250 01L0879 Chicken Fritter Breader
01L0900 Chicken Fritter Breader
FA2359 01L0956 McD Flt Bttr w/Btrmillk
01L0959 McD Flt Bttr w/Btrmillk
FA2360 01L0957 McD Flt Bttr w/C&B
01L0964 McD Flt Bttr w/C&B
FA2503 01L0800 KFC OR Sandwich Batter
01L1187 KFC OR Sandwich Batter
FA2836 01L1216 Wendy's Nugget Batter
FA3357 02A1520 Chicken Fillet Predust
FA3545 01L1208 KFC FTF Popcorn Batter
F15768 01L0922 Wendy's Chicken Nugget Batter
F16306 01L1211 Wendy's Filet Batter
F18902 01L1132 Chicken Wing Batter
F18903 01L0987 Chicken Wing Breader
01L1294 Chicken WIng Breader
F19816 01L0914 Wendy's Chicken Predust
F70705 01K0484 Wendy's Filet Breader H&S
01L1262 Wendy's Filet Breader H&S
01L1286 Wendy's Filet Breader H&S
F71191 01L1020 Chicken Batter
F73942 01L1103 Wendy's Filet Batter H&S
F74517 01L1375 Chicken Breader
F75006 01L0975 Chicken Liver Batter
F75707 01L0981 Chicken Batter
F76282 01K0469 Chicken Batter
01K0613 Chicken Batter
01L0906 Chicken Batter
F76283 01K0625 Chicken Breader
01K0626 Chicken Breader
01L0908 Chicken Breader
01L0910 Chicken Breader
01L1254 Chicken Breader
F76484 01L0791 KFC Crispy Strip Breader
01L1026 KFC Crispy Strip Breader
F76487 01L0943 KFC Crispy Strip Batter
01L1105 KFC Crispy Strip Batter
F76744 01L1016 MRB Breader
F79270 01L0992 KFC OR Sandwich Predust
01L1213 KFC OR Sandwich Predust
RECALLING FIRM/MANUFACTURER_______________________
PRODUCT
Fraternity brand Banh Men Gai Coconut Cookies, packed in rigid plastic containers, Net Weight: 8.8 oz. (250 grs). Product of Vietnam. Firms on label - Packed by: Vina Hung. Recall # F-860-2.
CODE
Barcode # 935005 305619 and no other coding.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ho's Trading, Inc., Brooklyn, NY, by letters on November 24, 2001.
Manufacturer: Vina Hung Ho, Chi Minh City, Vietnam. State initiated recall is complete.
REASON
The product contained an unidentified blue color and undeclared tartrazine (certifiable as FD&C Yellow #5).
VOLUME OF PRODUCT IN COMMERCE
44 cases (24 - 8.8 oz. containers per case) were distributed.
DISTRIBUTION
Asian retail markets in NY, OH, MD, VA, IL, NC, GA and FL.
_______________________
PRODUCT
HAITAI Sunny10 GRAPE SOFT DRINK (PODO), packaged in a plastic bottle, NET WT. 52.91 FL. OZ. (1.5 L). PRODUCT OF KOREA.
Recall # F-861-2.
CODE
F3 15:16 2000 12:01
Barcode # 801105 003512.
RECALLING FIRM/MANUFACTURER
Recalling Firm: C. Kenneth Imports Co., Inc., Bronx, NY, by letter on April 24, 2001.
Manufacturer: Unknown. State initiated recall is complete.
REASON
The product contained an unidentified red color & brilliant blue FCF (certifiable as FD&C Blue #1).
VOLUME OF PRODUCT IN COMMERCE
25 cases (12 bottles per case) were distributed and 20 cases were voluntarily held by the importer.
DISTRIBUTION
NY and NJ.
_______________________
PRODUCT
Frozen Ready to Bake Desserts -
a) Sysco Imperial 1041086 10" Old Fashion Ready-to-Bake IQF
Apple. Recall # F-862-2;
b) Mrs. Smith's 37 oz. 9" Ready-to-Bake Retail Cherry.
Recall # F-863-2;
c) Mrs. Smith's 37 oz. 9" Retail Dutch Apple. Recall # F-864-2;
d) Mrs. Smith's 37 oz. 9" ISB Old Fashion IQF No Sugar Added
Peach. Recall # F-865-2;
e) Mrs. Smith's 37 oz. 9" ISB Old Fashion IQF No Sugar Added
Apple. Recall # F-866-2;
f) Mrs. Smith's 37 oz. 9" ISB Old Fashion IQF No Sugar Added
Cherry. Recall # F-867-2;
g) Mrs. Smith's 37 oz. 9" ISB Old Fashion IQF Cherry.
Recall # F-868-2;
h) Mrs. Smith's 37 oz. 9" Retail Ready-to-Bake Peach.
Recall # F-869-2;
i) Mrs. Smith's 37 oz. 9" Retail Ready-to-Bake Blueberry.
Recall # F-870-2;
j) Temptables 755348 49 oz. 10" Fruit of the Forest.
Recall # F-871-2;
k) Mrs. Smith's 46 oz. 10" Retail Deepdish Apple Crumb.
Recall # F-872-2;
l) Mrs. Smith's Bakeries 42 oz. 9" Deepdish Peach Full Top. Recall # F-873-2.
CODE
Products contain one of the following codes:
320 0041 2
320 0051 2
320 0061 2
320 0071 2
320 0081 2
320 0091 2.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mrs. Smith's Bakeries, Inc., Suwanee, GA, by fax on January 15, 2002.
Manufacturer: Mrs. Smith's Bakery of Stilwell, LLC, Stilwell, OK.
Firm initiated recall is ongoing.
REASON
The products were manufactured using flour that ADM Milling Co., Overland Park, KS recalled due to Salmonella contamination.
VOLUME OF PRODUCT IN COMMERCE
55,788 cases of the various products.
DISTRIBUTION
Nationwide.
_______________________
PRODUCT
a) Untreated soft wheat flour in bulk or packaged in 50-lb. bags labeled as Pastry Flour or 100-lb. bags labeled as Soft Wheat Flour. Recall # F-874-2;
b) Enriched soft wheat flour in bulk or packaged in 50-lb. bags labeled as Biscuit Flour, 50-lb. bags and 100-lb. bags labeled as Soft Wheat Flour, or 100-lb. bags labeled as McKee Cookie Flour. Recall # F-875-2;
c) Enriched and chlorinated soft wheat flour in bulk and 100-lb. bags labeled as McKee Cake Flr or Chlorinated Flour. Recall # F-876-2;
d) Soft bleached flour in 100-lb. bags labeled as KS. Dia.
Bleached Flour (KS. Dia. = Kansas Diamond). Recall # F-877-2.
CODE
Product received by the customer between 12/13/01-1/8/02 and
1/21/02-1/29/02.
RECALLING FIRM/MANUFACTURER
ADM Milling Co., Overland Park, KS, by telephone on January 14, 2002. Firm initiated recall is ongoing.
REASON
The products were contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Untreated bulk-3,107,800 lbs.,
untreated bagged-6,300/50-lb.&5,927/100-lb.;
enriched bulk-1,210,380 lbs.;
enriched bagged-620/50-lb&672/100-lb.;
enriched & chlorinated bulk-1,963,680 lbs. bagged-1,680/100-lb.; bleached-912/100-lb. bags
DISTRIBUTION
TX, AR, and OK.
_______________________
PRODUCT
Blue Ridge Farms brand Blue Cheese Potato Salad in a rigid plastic, bulk container, net wt. 10 lbs. Recall # F-817-2.
CODE
All codes on the market at the time of recall initiation.
RECALLING FIRM/MANUFACTURER
Blue Ridge Farms Inc., Brooklyn, NY, by fax, e-mail and letter dated July 19, 2001. State initiated recall is complete.
REASON
The product contained the undeclared preservative, potassium sorbate.
VOLUME OF PRODUCT IN COMMERCE
74 cases (10 - 10 lb. containers per case).
DISTRIBUTION
NY.
_______________________
PRODUCT
Arla Mediterra Danish Feta in Oil and Spices, packaged in a 300g (10.5oz)glass jar. Recall # F-878-2.
CODE
Order Number 44642
Produced between 3/11/2002 to 6/29/2002 (case info)
Best before date 10/11/2002 to 1/29/2003 (unit info).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arla Foods Inc., Union, NJ, by fax on July 15, 2002.
Manufacturer: Arla Foods, Amba Videaek, Denmark. Firm initiated recall is ongoing.
REASON
The product was contaminated with glass fragments.
VOLUME OF PRODUCT IN COMMERCE
4158 cases (24948 jars).
DISTRIBUTION
Nationwide.
_______________________
PRODUCT
The products are drink boxes, each box is 6.75 fl oz and pasteurized, packed either 30 or 40 to a case as noted below:
a) Hi-C 10-pak: each case contains 4 x 10-paks (40 units total) of Hi-C Orange Lavaburst. Recall # F-879-2.
b) Hi-C 10-pak: each case contains 4 x 10-paks (40 units total) of Hi-C Fruit Punch. Recall # F-880-2;
c) Hi-C Variety Pak: each case contains 3 x 10-paks, each a different flavor,(30 units total), Hi-C Orange/Fruit
Punch/Boppin Berry. Recall # F-881-2;
d) Minute Maid Variety Pak: each case contains 3 x 10-paks, each a different flavor,(30 units total), Orange/Apple/Grape. Recall # F-882-2.
CODE
XX:XX is military time
Hi-C 10-pak:
Hi-C Orange Lavaburst: DEC0902 TI XX:XX; DEC0902 TJ XX:XX
Hi-C Fruit Punch: JAN0903 TI XX:XX; JAN0903 TJ XX:XX
Hi-C Variety Pak:
Hi-C Orange/Fruit Punch/Boppin Berry: DEC0902 T77641A 00139;
DEC1402 T77642A 00139; DEC0902 T77646A 00139; DEC0902 T77649A 00139;
DEC1402 T77650A 00139; DEC0902 T77812D 00139; DEC0402 T78005A 00139;
Minute Maid Variety Pack:
Minute Maid Orange/Apple/Grape: OCT1002 T77236G 00203;
OCT0502 T77648E 00203; OCT2302 T77806B 00203;
OCT2402 T77807C 00203; OCT0502 T77936D 00203;
OCT0502 T77943E 00203.
RECALLING FIRM/MANUFACTURER
Recalling Firm: The Minute Maid Company, Houston, TX, by letter on May 3, 2002.
Manufacturer: The Minute Maid Company, Paw Paw, MI.
Firm initiated recall is complete.
REASON
The products were spoiled due to yeast contamination.
VOLUME OF PRODUCT IN COMMERCE
84,305 cases.
DISTRIBUTION
Nationwide.
_______________________
PRODUCT
MS Contin Tablets (morphine sulfate) controlled-release, 15 mg, 25 count blister packs, 100 and 500 count bottles.
Recall # D-412-2.
CODE
5H31 (500's)Exp 7/04
5H32 (25's) Exp 7/02
5H33 (25's) Exp 7/02
5H34 (25's) Exp 7/02
5H35 (25's) Exp 7/02
5H36 (100's) Exp 7/04.
RECALLING FIRM/MANUFACTURER
Recalling Firm: The Purdue Frederick Co., Norwalk, CT, by letters on August 15, 2002.
Manufacturer: The P.F. Laboratories, Inc., Totowa, NJ. Firm initiated recall is complete.
REASON
Tablet mixup; 30 mg tablets may be in bottles and/or blister packs labeled as containing 15 mg tablets.
VOLUME OF PRODUCT IN COMMERCE
4,571 bottles of 500's; 4,968 bottles of 100's; and 26,455 blisters of 25's.
DISTRIBUTION
Nationwide and the Dominican Republic.
_______________________
PRODUCT
Quinine Sulfate Tablets, USP, 260 mg, 100 count bottle, Rx only. Recall # D-413-2.
CODE
Lot No. Exp. date
3001-105631A Apr/04.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ivax Pharmaceuticals, Inc., Miami, FL, by letter on August 29, 2002.
Manufacturer: Ivax Pharmaceutical Caribe, Inc., Cidra, Puerto Rico. Firm initiated recall is ongoing.
REASON
Tablet mixup; a bottle labeled as containing Quinine Sulfate tablets was found to contain Quinine Sulfate tablets and one tablet of Labetalol 100 mg, an antihypertensive.
VOLUME OF PRODUCT IN COMMERCE
12,000 bottles.
DISTRIBUTION
Nationwide.
_____________________
PRODUCT
Benadryl Allergy/Sinus Headache Caplets co-packaged with a Bonus 4 mL bottle of Visine Tears (Diphenhydramine Hydrochloride
12.5 mg, Pseudoephedrine Hydrochloride 30 mg, Acetaminophen 500 mg), 24 count package. Recall # D-415-2.
CODESRECALLING FIRM/MANUFACTURER
Codes: Lot Numbers: 01222CD01 Exp Date: 4/2003 01222CM01 " 01322CD01 " 01322CM01 " 01422CN01 " 01522CD01 " 01522CN01 "
_______________________
PRODUCT
a) HALLS Sugar Free Cough Drops (Menthol 5.8 mg) 25 DROPS per bag, Mountain Menthol. Recall # D-420-2;
b) HALLS Sugar Free Cough Drops (Menthol 5 mg) 25 DROPS per bag, Black Cherry. Recall # D-421-2.
CODE
a) Lot # 0722E, Exp. 2/7/2004;
b) Lot #00832E, Exp. 3/8/2004.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Adams USA (Div. of Warner Lambert, a Subsidiary of Pfizer, Inc.), Parsippany, NJ, by letter on April 18, 2002.
Manufacturer: Parke Davis & Co. Limited, Manchester M26 2QT, England. Firm initiated recall is ongoing.
REASON
Product may contain metal particles.
VOLUME OF PRODUCT IN COMMERCE
a) 1053 cases;
b) 189 cases.
DISTRIBUTION
Nationwide.
_______________________
PRODUCT
a) Listerine Essential Care Gel Toothpaste, 0.9 oz tube (Eucalyptol 0.738%, Menthol 0.340%, Methyl salicylate 0.480%, Thymol 0.511%, Sodium monofluorophosphate 0.76% (0.13% Fluoride Ion). Recall # D-422-2;
b) Listerine Essential Care Tartar Control Gel Toothpaste, 0.9 oz tube, (Eucalyptol 0.738%, Menthol 0.340%, Methyl salicylate 0.480%, Thymol 0.511%, Sodium monofluorophosphate 0.76% (0.13% Fluoride Ion). Recall # D-423-2.
CODE
All Lots packaged as follows:
Professional Samples -- Not for Retail Sale
Trial Size Tartar Control Gel Case UPC 1 03 12547 43450 5
Case containing 72/0.9 ounce tubes
Trial Size Gel
Case UPC 1 03 12547 43470 3
Case containing 72/0.9 ounce tubes.
Promotional Items as an on-pack with
Listerine 1.0 L and 1.5 L (Gold,
CoolMint, Fresh Burst, Tartar Control,
Mixed Displays)
Bottles.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer, Consumer Healthcare Group, Morris Plains, NJ, by letters on May 22, 2002.
Manufacturer: Accupac, Inc., Mainland, PA. Firm initiated recall is ongoing.
REASON
Subpotent; active ingredient Methyl salicylate (stability).
VOLUME OF PRODUCT IN COMMERCE
12,649,365 tubes.
DISTRIBUTION
Nationwide and Puerto Rico.
_______________________
PRODUCT
Oxygen, USP, High Pressure Cylinders, Compressed.
Recall #D-414-2.
CODE
Lot OP895 and Lot OP901.
RECALLING FIRM/MANUFACTURER
Oxygen Support Systems, Riverside, NJ, by telephone on November 5, 2001. Firm initiated recall is complete.
REASON
Subpotent.
VOLUME OF PRODUCT IN COMMERCE
12.
DISTRIBUTION
NJ and PA.
_______________________
PRODUCT
Source Plasma, Recall # B-1924-2.
CODE
Unit G48509-076.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alpha Therapeutic Corporation, Los Angeles, CA, by fax on December 20, 2000.
Manufacturer: Alpha Therapeutic Corporation, Fayetteville, NC.
Firm initiated recall is complete.
REASON
Blood product, collected under conditions in which sterility may have been compromised, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
_______________________
PRODUCT
a) Red Blood Cells, Recall # B-1937-2;
b) Platelets, Recall # B-1938-2;
c) Fresh Frozen Plasma, Recall # B-1939-2;
d) Recovered Plasma, Recall # B-1940-2.
CODE
a) Units 1396250, 1396251, 1396252, 1396253, 1396254, 1396255, 1396256, 1396258, 1396260, 1396261, 1396262, 1396263, 1396264, 1396266, 1396267, 1396268, 1396269, 1396270, 1396272, 1396273, 1396274, 1396275, 1396276, 1396277, 1396278, 1396279, 1396280, 1396281, 1396282, 1396283, 1396286, 1396287, 1396288, 1396289, 1396290, 1396291, 1396295, 1396296, 1396297, 1396299, 1396300, 1396301, 5108316, 5108317, 5108318, 5108319, 5108320, 5108321, 5108322, 5108323, 5108324, 5108325, 5108326, 5108327, 5108328, 5108329, 5108330, 5108331, 5108332, 5108333, 5108334, 5108335, 5108336, 5108337, 5108338, 5108339, 5108340, 5108341, 5108342, 5108343, 5108344, 5108345, 5108346, 5108347, 5108348, 5108349, 5108350, 5108351, 5108352, 5108354, 5108355, 5108356, 5108357, 5108358, 5108359, 5108360, 5108361, 5108362, 5108363, 5108364, 5108365, 5108366, 5108367, 5108368;
b) Units 5108320, 5108323, 5108324, 5108326, 5108328, 5108331, 5108336, 5108340, 5108342, 5108344, 5108348, 5108363, 5108365;
c) Units 5108316, 5108317, 5108319, 5108320, 5108321, 5108324, 5108326, 5108328, 5108329, 5108330, 5108331, 5108332, 5108333, 5108335, 5108336, 5108338, 5108340, 5108342, 5108344, 5108345, 5108347, 5108348, 5108349, 5108350, 5108351, 5108352, 5108354, 5108355, 5108357, 5108359, 5108361, 5108362, 5108363, 5108364, 5108365, 5108366, 5108367, 5108368, 5108334;
d) Units 1396250, 1396251, 1396252, 1396253, 1396254, 1396255, 1396256, 1396258, 1396259, 1396260, 1396261, 1396262, 1396263, 1396264, 1396266, 1396267, 1396268, 1396269, 1396270, 1396272, 1396273, 1396274, 1396275, 1396276, 1396277, 1396278, 1396279, 1396280, 1396281, 1396282, 1396283, 1396285, 1396286, 1396288, 1396289, 1396290, 1396291, 1396295, 1396296, 1396297, 1396299, 1396300, 1396301, 5108323, 5108339, 5108343, 5108346, 5108360.
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood and Tissue Center, Austin, TX, by letter dated September 1, 1999. Firm initiated recall is complete.
REASON
Blood products, incorrectly tested for antibody to the human immunodeficiency virus (anti-HIV-1/2), were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 94 units;
b) 13 units;
c) 39 units;
d) 48 units.
DISTRIBUTION
TX, IL, FL and NY.
_______________________
PRODUCT
a) Red Blood Cells. Recall # B-1989-2;
b) Platelets. Recall # B-1990-2;
c) Fresh Frozen Plasma. Recall # B-1991-2;
CODE
a) and c) Unit 22LY41039, 22LW28926, 22LJ25952, 22FQ25666;
b) Units 22LJ25952, 22FQ25666.
RECALLING FIRM/MANUFACTURER
American Red Cross, Penn-Jersey Region, Philadelphia, PA, by letter dated November 23, 2001 or December 21, 2001.
Firm initiated recall is ongoing.
REASON
Blood products, collected from a donor who provided post donation information regarding having tested positive for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units.
DISTRIBUTION
PA and NJ.
_______________________
PRODUCT
a) Red Blood Cells. Recall # B-2000-2;
b) Red Blood Cells Leukocytes Removed. Recall # B-2001-2;
c) Fresh Frozen Plasma. Recall # B-2002-2;
d) Plasma. Recall # B-2003-2;
e) Cryoprecipitated AHF. Recall # B-2004-2;
f) Recovered Plasma. Recall # B-2005-2;
CODE
a) and c) Unit 30GG94854;
b) Units 30GH75705, 30GN42595, 30GN33180, 30GW08370, and
30GH61013;
d) unit 30GN42595;
e) units 30GH75707, 30GN42595, 30GN33180, and 30GW08370;
f) units 30GH75705, 30GN37242, 30GN33180, 30GW08370, and
30GH61013.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Northeastern Pennsylvania Region, Ashley, PA, by telephone on October 24, 2001 and by letter dated October 26, 2001. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had taken the medication Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE
17 units.
DISTRIBUTION
PA, NY, MA and Switzerland.
_______________________
PRODUCT
Source Plasma, Recall # B-2006-2.
CODE
Unit 71FPBBXM.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Greenville, SC, by letter dated March 3, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm preparation was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
_______________________
PRODUCT
Source Plasma. Recall # B-2007-2.
CODE
Unit (1 unit) 71 96D669.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Greenville, SC, by letter dated March 3, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm preparation was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
_______________________
PRODUCT
Source Plasma. Recall # B-2008-2.
CODE
Unit 71 FPCBYT.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Greenville, SC, by letter dated March 3, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm preparation was
not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Germany.
_______________________
PRODUCT
Source Plasma. Recall # B-2010-2.
CODE
Unit 71 FPCBQF.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Greenville, SC, by letter dated March 5, 2002. Firm initiated recall is complete.
REASON
Blood product, which was not tested for syphilis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Germany.
_______________________
PRODUCT
Source Plasma. Recall # B-2011-2.
CODE
Units 71 96D210, 71 96D173, 71 96D005, 71 96C982.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Greenville, SC, by letter dated March 3, 2002. Firm initiated recall is complete.
REASON
Blood products, which were not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
Switzerland.
_______________________
PRODUCT
Source Plasma. Recall # B-2012-2.
CODE
Units 71 FPBGFR, 71 FPBGCR, 71 FPBGBB, 71 FPBFYC, 71 FPBFXB.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Greenville, SC, by letter dated March 3, 2002. Firm initiated recall is complete.
REASON
Blood products, which were not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
Germany.
_______________________
PRODUCT
Source Plasma. Recall # B-2014-2.
CODE
Unit 71 FPBMVS.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Greenville, SC, by letter dated March 3, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm preparation was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Germany.
_______________________
PRODUCT
Corneas. Recall # B-2035-2.
CODE
Tissue numbers 02-0968 OD and 02-0968 OS.
RECALLING FIRM/MANUFACTURER
Northwest Lions Eye Bank, Seattle, WA, by telephone on August 23, 2002 and by letter on August 27, 2002. Firm initiated recall is complete.
REASON
Human tissue for transplantation, that tested repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBc), was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
Japan.
_______________________
PRODUCT
Source Plasma. Recall # B-2040-2.
CODE
Unit numbers 71FPCGQJ, 71FPCGCF, 71FPCFYF, 71FPCFSH, 71FPCFMV, 71FPCFJS, 71FPCFBY, 71FPCDLT, 71FPCDFX, 71FPCCZG, 71FPCCNN, 71FPCCJH, 71FPCCCB, 71FPCBWZ, 71FPCBLZ, 71FPCBJK, 7196G664, and 7197F760.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aventis Bio-Services, Inc., King of Prussia, PA, by letter on March 21, 2002.
Manufacturer: Aventis Bio-Services, Inc., Greenville, SC.
Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from a donor who disclosed a risk factor for increased incidence of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units.
DISTRIBUTION
IL, NC, MA and Germany.
_______________________
PRODUCT
Source Plasma. Recall # B-2041-2.
CODE
Unit numbers 71FPBHKR, 71FPBHHQ, 71FPBHFL, 71FPBHCZ, 71FPBHBR, 71FPBGZC, 71FPBGVJ, 71FPBGRK, 71FPBGPJ, 71FPBGMT, 71FPBGKY, 71FPBGJM, 71FPBGCW, 71FPBGCC, 71FPBFYP, 71FPBFXH, 71FPBFVW, 71FPBFVC, 7196J034, 7196J080, 7196J211, 7196J291, 7196J344, 7196J356, 7196J457, 7196J493, 7196J505, 7196J884, 7196J966, 7196J536, 7196J549, 7196J580, 7196J596, 7196J638, 7196J650, 7196J676, 7196J690, 7186J724, 7196J741, 7196J777, 7196J791, 7196J825, 7196J838, 7196J875, 7196J912, 7196J934, 7196J983, 7196K012, 7196K026, 7196K052, 7196K069, 7196K101, 7196K114, 71FPBFLV, 71FPBFMX, 71FPBFPP, 71FPBFQH, and 71FPBFRV.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aventis Bio-Services, Inc., King of Prussia, PA, by letter on March 3, 2002.
Manufacturer: Aventis Bio-Services, Inc., Greenville, SC.
Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to illegal drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
58 units.
DISTRIBUTION
IL, NC, Switzerland and Germany.
_______________________
PRODUCT
Source Plasma. Recall # B-2042-2.
CODE
Unit numbers G51468-178, G51263-178, G50939-178, G50755-178, G50203-178, G49124-178, G48693-178, G48493-178, G42443-178, G41953-178, G41752-178, G40158-178, G39770-178, G39555-178, G38986-178, G37271-178, G37066-178, G36700-178, G36486-178, G36109-178, G35738-178, G35284-178, G34529-178, G34243-178, G34028-178, G33719-178, G33426-178, G32971-178, G32778-178, G31798-178, G31529-178, G31236-178, G30955-178, G30663-178, G30394-178, G30162-178, G29817-178, G28736-178, G28636-178, G27783-178, G27449-178, G27265-178, G26655-178, G26846-178, G26104-178, G25947-178, G25592-178, G25422-178, G25055-178, G24834-178, G24493-178, G24359-178, G23904-178, G23744-178, G23392-178, G23214-178, G22852-178, G22659-178, G21514-178, G21394-178, G21011-178, G20842-178, N-06491-178, and N-06476-178.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Melrose Park, IL, by fax on April 10, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to illegal drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
64 units.
DISTRIBUTION
CA.
_______________________
PRODUCT
Source Plasma. Recall # B-2043-2.
CODE
Unit numbers DDCLYK-A, DDCLST-A, DDCLMS-A, DDCLHT-A, DDCKRN-A, DDCKNH-A, DDCKDG-A, DDCJZQ-A, DDBMCG-A, DDBLRD-A, DDBLNC-A, DDBLGT-A, DDBKZX-A, DDBKSQ-A, DDBKNF-A, DDBKGY-A, DDBKCX-A, DDBJVL-A, DDBJRZ-A, DDBJMC-A, DDBJKB-A, DDBDYG-A, DDBDVC-A, DDBDNW-A, and DDBDLG-A.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Melrose Park, IL, by fax on April 11, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to illegal drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
25 units.
DISTRIBUTION
IL.
_______________________
PRODUCT
Red Blood Cells. Recall # B-2045-2.
CODE
Unit number KC06511.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on June 13, 2002 and by letter dated July 12, 2002.
Manufacturer: Tri-Counties Blood Bank, Santa Barbara, CA.
Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not have a hematocrit or hemoglobin test during the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-2049-2.
CODE
Unit numbers 10732-0373, 10732-0396, and 10732-0411.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on June 7, 2002. Firm initiated recall is complete.
REASON
Blood products, that were not tested for pH or platelet count as required by the firm's standard operating procedures (SOPs), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
AZ.
_______________________
PRODUCT
Platelets Pheresis. Recall # B-2050-2.
CODE
Unit number 07FP14357.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Arizona Region, Tucson, AZ, by telephone on June 16, 2002. Firm initiated recall is complete.
REASON
Platelets with an elevated platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AZ.
______________________
PRODUCT
Platelets, Leukoreduced. Recall # B-1992-2.
CODE
Unit 22LJ49273.
RECALLING FIRM/MANUFACTURER
American Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on November 11, 2001. Firm initiated recall is complete.
REASON
Blood product, which was not properly quarantined after the donor of the product reported a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
_______________________
PRODUCT
Source Plasma. Recall # B-2036-2.
CODE
Unit number 71FPBMQM.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aventis Bio-Services, Inc., King of Prussia, PA, by letter on March 26, 2002.
Manufacturer: Aventis Bio-Services, Inc., Greenville, SC.
Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health history screening was not performed correctly, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Germany.
_______________________
PRODUCT
Source Plasma. Recall # B-2037-2.
CODE
Unit number 71FPBMNZ.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aventis Bio-Services, Inc., King of Prussia, PA, by letter on March 27, 2002.
Manufacturer: Aventis Bio-Services, Inc., Greenville, SC.
Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health history screening was not performed correctly, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Germany.
_______________________
PRODUCT
Source Plasma. Recall # B-2038-2.
CODE
Unit number 71FPCCHJ.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aventis Bio-Services, Inc., King of Prussia, PA, by letter on March 26, 2002.
Manufacturer: Aventis Bio-Services, Inc., Greenville, SC.
Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health history screening was not performed correctly, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Germany.
_______________________
PRODUCT
Source Plasma. Recall # B-2039-2.
CODE
Unit number 71FPBMWB.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aventis Bio-Services, Inc., King of Prussia, PA, by letter on March 26, 2002.
Manufacturer: Aventis Bio-Services, Inc., Greenville, SC.
Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health history screening was not performed correctly, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Germany.
_______________________
PRODUCT
Source Plasma. Recall # B-2044-2.
CODE
Unit number G-92240-046.
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, Van Nuys, CA, by letter on March 21, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-2046-2.
CODE
Unit numbers 10728-7559 and 10728-4792.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on May 6, 2002. Firm initiated recall is complete.
REASON
Blood products possibly exposed to unacceptable shipping temperatures were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AZ.
_______________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-2047-2.
CODE
Unit numbers 10729-7307; 10729-7318; 10729-7319; 10729-7343; 10730-1518; 10730-1991; 10730-1992; 10730-2512; 10730-3037; 10730-3336; 10730-3338; 10730-3451; 10730-3925; 10730-3931; 10730-4959; 10730-5556.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on May 12, 2002. Firm initiated recall is complete.
REASON
Blood products possibly exposed to unacceptable shipping temperatures were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units.
DISTRIBUTION
AZ.
_______________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-2048-2.
CODE
Unit number 10731-5872.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter on July 18, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose body temperature was improperly recorded, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AZ.
_______________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced Irradiated.
Recall # B-2051-2.
b) Platelets Pheresis, Irradiated. Recall # B-2052-2.
CODE
a) Unit numbers 07FV09363, 07FN23715, and 07FF94964;
b) Unit number 20R13450.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Arizona Region, Tucson, AZ, by letter on April 1, 2002. Firm initiated recall is complete.
REASON
Blood products that were subjected to irradiation twice were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
AZ.
_______________________
PRODUCT
Automated differential cell counters:
a) Coulter LH 700 Series Hematology Analyzers.
Recall # Z-1322-2;
b) Coulter GEN S Hematology Analyzers. Recall # Z-1323-2.
CODE
Lot numbers do not apply.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letters on June 4, 2002.
Manufacturer: Coulter Corp., Hialeah, FL. Firm initiated recall is ongoing.
REASON
Incorrectly gates Neutrophil population in patient samples.
VOLUME OF PRODUCT IN COMMERCE
1268.
DISTRIBUTION
Nationwide and Canada.
_______________________
PRODUCT
a) P645 Specialite Patient Light. Recall # Z-1346-2;
b) P696IL Integris 1000 Patient Light. Recall # Z-1347-2;
c) P2003B Integris B Patient Lite Rail. Recall # Z-1348-2.
d) P780D Deep Impression Light for use with the Impression
Series Headwall. Recall # Z-1349-2.
CODE
All units distributed between May 24, 2002 and June 21, 2002.
RECALLING FIRM/MANUFACTURER
Hill-Rom Co. Inc., Batesville, IN, by letter dated August 16, 2002. Firm initiated recall is ongoing.
REASON
Switch fails to function as intended due to incorrect amp size switch.
VOLUME OF PRODUCT IN COMMERCE
843.
DISTRIBUTION
Nationwide and Canada.
_______________________
PRODUCT
Disetronic D-TRON Insulin Infusion Pump, Models 8100001 D-TRON (blue) and 8100005 D-TRON (anthracite). Recall # Z-1350-2.
CODE
All Serial numbers.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Disetronic Medical Systems, Inc., St. Paul, MN, by letter dated June 17, 2002.
Manufacturer: Disetronic Medical Systems AG, Burgdorf, Switzerland. Firm initiated recall is ongoing.
REASON
Some pumps started programming a bolus that was not initiated by the pump user, and the delivery of an unintended bolus was made unless interrupted by the device user.
VOLUME OF PRODUCT IN COMMERCE
3357 insulin infusion pumps in the U.S.
DISTRIBUTION
Nationwide.
_______________________
PRODUCT
Aeroset Software Version 1.01ER000. Recall # Z-1352-2.
CODE
Catalog number 2-94815-01, The AEROSET Software is not controlled by lot or control numbers.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by telephone on July 16, 2002. Firm initiated recall is complete.
REASON
Sample results may be skewed by failure to properly 'blank' the sample.
VOLUME OF PRODUCT IN COMMERCE
1.
DISTRIBUTION
FL.
_______________________
PRODUCT
a) Hill-Rom brand Advanta 1600 series hospital beds as follows: Model P1600B; full featured general hospital bed.
Recall # Z-1353-2;
b) Model P1603B; semi-de-featured general hospital bed.
Recall # Z-1354-2;
c) Model P1604B; de-featured general hospital bed.
Recall # Z-1355-2.
CODE
All units distributed prior to July 24, 2002.
RECALLING FIRM/MANUFACTURER
Hill-Rom, Inc., Batesville, IN, by letter dated August 15, 2002.
Firm initiated recall is ongoing.
REASON
Unintentional movement of the bed.
VOLUME OF PRODUCT IN COMMERCE
50,000.
DISTRIBUTION
Nationwide and Internationally.
_______________________
PRODUCT
Sterile 4" x 4", 16-ply gauze sponges packaged 10 sponges per formed plastic tray with tyvek lid,
The following gauze products are being recalled:
a) Medline Accu-Sorb X-Ray Detectable USP Type VII Gauze.
Recall # Z-1357-2;
b) Medline Gauze Sponge USP Type VII Gauze. Recall # Z-1358-2.
CODE
a) Product number NON21430LF, lot numbers 02EA0473, 02FA0432;
b) Product number NON21428, lot numbers 02EA0297, 02FA0317,
02FA0431.
RECALLING FIRM/MANUFACTURER
Medline Industries, Inc., Mundelein, IL, by letters dated August 16, 2002. Firm initiated recall is ongoing.
REASON
Compromised packaging integrity - questionable sterility.
VOLUME OF PRODUCT IN COMMERCE
809 cases.
DISTRIBUTION
Nationwide.
_______________________
PRODUCT
Defibrillator/ Pacer
Medical Research Laboratories external adult defibrillator paddle set- used with Medical Data Electronics Escort defibrillator pacer models 20201 and 20202. Recall # Z-1360-2.
CODE
Serial Numbers 10392 thru 10540.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medical Data Electronics, Inc., Arleta, CA, by letter on August 1, 2002.
Manufacturer: Medical Research Laboratories, Arleta, CA.
Firm initiated recall is ongoing.
REASON
Intermittent operation of the paddles.
VOLUME OF PRODUCT IN COMMERCE
54 sets of two paddles each.
DISTRIBUTION
Nationwide and Pakistan and Mexico.
_______________________
PRODUCT
Parallax Medical brand EZFlow Cement Delivery System
Catalog #s:
a) CDS-110;
b) CDS-122;
c) CDS-132;
d) CDS-2210;
e) CDS-2212. Recall # Z-1361-2.
CODE
a) Lot # 021202 (Part # 40001);
b) Lot #s 082701 (Part # 40004), 021302 (Part # 40004),
021302A (Part # 40004);
c) Lot # 030102 (Part # 40032);
d) Lot #s 083101 (Part # 40008), 082301 (Part # 40008),
082301A (Part # 40008), 103001, (Part # 40008),
103001A (Part # 40008), 103101 (Part # 40008),
103101A (Part # 40008);
e) Lot #s 100401, (Part # 40009), 103001, (Part # 40009),
103001A (Part # 40009), 040202 (Part # 40009),
021402 (Part # 40009).
RECALLING FIRM/MANUFACTURER
Parallax Medical, Inc., Scotts Valley, CA, by letters, telephone and visits beginning on July 19, 2002. Firm initiated recall is ongoing.
REASON
Firm has identified a number of units which may have breaches in the pouch seal.
VOLUME OF PRODUCT IN COMMERCE
3626 units.
DISTRIBUTION
Nationwide and Internationally.
_______________________
PRODUCT
MDE Escort Prisim SE
A portable patient monitor. Recall # Z-1362-2.
CODE
Too numerous to detail.
RECALLING FIRM/MANUFACTURER
Medical Data Electronics, Inc., Arleta, CA, by letter beginning August 2002. Firm initiated recall is ongoing.
REASON
Printed circuit board flaw might allow cuff to overinflate.
VOLUME OF PRODUCT IN COMMERCE
3,569.
DISTRIBUTION
Nationwide and Internationally.
_______________________
PRODUCT
a) REF 220039, MicroJect 30 Pump, continuous low flow.
Recall # Z-1363-2;
b) REF 220041, MicroJect 200 Pump, intermittent or continuous
flow. Recall # Z-1364-2.
CODE
All MicroJect Ambulatory Infusion Pump, Model #30 and #200, manufactured from 5/1/2000 through 11/19/2001.
Model #30 serial numbers in the range 37037 thru 64215.
Model #200 serial numbers in the range 40069 thru 64008.
RECALLING FIRM/MANUFACTURER
Sorenson Medical, Inc., West Jordan, UT, by letter on August 23, 2002. Firm initiated recall is ongoing.
REASON
Reports of under-infusion and pump housing separation.
VOLUME OF PRODUCT IN COMMERCE
4,725.
DISTRIBUTION
Nationwide and Internationally.
_______________________
PRODUCT
a) Balanced Knee System, PS Tibial Insert Size 6 16mm;
b) Balanced Knee System, PS Tibial Insert Size 4 20mm.
Each insert is a component of the Balanced Knee System, packaged individually. Recall # Z-1365-2.
CODE
a) Catalog Number 163-1616, Lot Number W012563;
b) Catalog Number 163-1420, Lot Number W012536.
RECALLING FIRM/MANUFACTURER
Ortho Development Corp., Draper, UT, by telephone and letters on May 28, 2002. Firm initiated recall is complete.
REASON
Outer box product label showed incorrect size.
VOLUME OF PRODUCT IN COMMERCE
39 units.
DISTRIBUTION
Nationwide.
_______________________
PRODUCT
Somatom Smile
Computed tomography system, Diagnostic Imaging -- Model #7053502. Recall # Z-1366-2.
CODE
4 units under the Siemens part # SMILE 7053502 Serial Numbers:
20041
20035
20031
20032.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Systems, Inc., Iselin, NJ, by letter on or about May 2002.
Manufacturer: Siemens Shanghai, Medical Equipment, Ltd., Shanghai, China 200090. Firm initiated recall is complete.
REASON
Errors can occur when performing gantry tilt examinations.
VOLUME OF PRODUCT IN COMMERCE
3.
DISTRIBUTION
Nationwide and Internationally.
_______________________
PRODUCT
Vitek GNS-204, product #V4526, gram negative susceptibility cards individually wrapped in a mylar pouch, 20 cards per box, for use in the antimicrobial susceptibility testing of rapidly growing aerobic and/or facultatively anaerobic, gram-negative bacilli. Recall # Z-1370-2.
CODE
S51B, Exp. 6/11/03.
RECALLING FIRM/MANUFACTURER
bioMerieux, Inc., Hazelwood, MO, by telephone on August 5, 2002.
Firm initiated recall is ongoing.
REASON
Mislabeled. This results in an incorrect susceptible/resistant result for the AST's included in the GNS 204 card.
VOLUME OF PRODUCT IN COMMERCE
2,572/20-card boxes.
DISTRIBUTION
Nationwide.
_______________________
PRODUCT
Proteus XR/a Stationary X-ray System, Model Numbers: 2244165, 2259976, 2212259, 2259973 and 2268970. Recall # Z-1371-2.
CODE
All serial numbers of units in distribution prior to the start of the field correction in January 2001 are affected.
RECALLING FIRM/MANUFACTURER
General Electric Medical Systems, Waukesha, WI, by field engineer visits beginning January 2001. Firm initiated recall is ongoing.
REASON
Screws that mount the collimator interface plate may loosen and fall out allowing the collimator to fall.
VOLUME OF PRODUCT IN COMMERCE
73 units.
DISTRIBUTION
Nationwide and Internationally.
_______________________
PRODUCT
Thoratec TLC-II Portable VAD Driver System
Driver Model numbers: 20010-0000-081, 20010-0000-132.
Recall # Z-1373-2.
CODE
Controller Board Lot # 2001-36, 2002-17.
RECALLING FIRM/MANUFACTURER
Thoratec Corp., Pleasant, CA, by letter and fax on August 14, 2002. Firm initiated recall is ongoing.
REASON
Component defects that can cause TLC-II driver to abruptly stop functioning.
VOLUME OF PRODUCT IN COMMERCE
34 units.
DISTRIBUTION
Nationwide and Australia, Canada and Singapore.
_______________________
PRODUCT
Ti Cann Troch Fixation Nail. The generic name is Trochanteric Fixation Nail. Recall # 1374-2/Z-1376-2.
CODE
These devices expired in 5/2011.
Part number 456.318S Lot number 4417099
Part number 456.322S Lot numbers 4417109, 4417111, and
4417112
Part number 456.416S Lot number 4417280.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Synthes (USA), Paoli, PA, by letters on August 2, 2002.
Manufacturer: Synthes (USA), Monument, CO. Firm initiated recall is ongoing.
REASON
Manufactured outside design specifications The medial side of the oblique hole may be oval instead of round.
VOLUME OF PRODUCT IN COMMERCE
66 units.
DISTRIBUTION
Nationwide.
_______________________
PRODUCT
Misys Laboratory. Recall # Z-1377-2.
CODE
Version 5.3.
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Inc., Tucson, AZ, by fax on August 16, 2002. Firm initiated recall is ongoing.
REASON
Software anomaly. Footnotes are incomplete and do not print on reports.
VOLUME OF PRODUCT IN COMMERCE
458.
DISTRIBUTION
Nationwide and Internationally.
_______________________
PRODUCT
Misys Laboratory. Recall # Z-1378-2.
CODE
Versions 5.2, 5.23, 5.3.
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Inc., Tucson, AZ, by fax July 5, 2002.
Firm initiated recall is ongoing.
REASON
Software anomaly. When original results were modified or deleted in function MEH, original/unmodified results were saved.
VOLUME OF PRODUCT IN COMMERCE
477.
DISTRIBUTION
Nationwide and Internationally.
_______________________
PRODUCT
Genuine ONE TOUCH *** Test Strips *** Lot No. *** Exp. Date ***
LIFESCAN INC a Johnson & Johnson company Milpitas, California. Recall # Z-1379-2;
***".
UNI-CHECK Test Strips *** Catalog No.1702720 *** QTY: 24 Packages of 50 Strips/Package *** Lot No.: *** Expires: ***". Recall # Z-1380-2.
CODE
Johnson and Johnson One Touch, Lots 170814A, 170815A, 170892A and any other lots purchased from Medsource. Johnson and Johnson Uni-check, Lots 12115A7W and any other lots purchased from Medsource.
RECALLING FIRM/MANUFACTURER
Farnes Enterprises dba MedSource Direct, Woods Cross, UT, by letter on August 17, 2002. FDA initiated recall is complete.
REASON
Blood glucose test strips were not approved for sale in the U.S. and Canada.
VOLUME OF PRODUCT IN COMMERCE
2,198 units.
DISTRIBUTION
Nationwide.
_______________________
PRODUCT
Caleo Infant Warming System. The product is an incubator.
Recall # Z-1381-2.
CODE
Catalog Numbers: 4117025-006, 4117025-007, 4117025-008, 4117025-009, and 4117025-018.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Drager Medical, Telford, PA, by telephone on September 13, 2002. Firm initiated recall is complete.
REASON
Temperature measurement error.
VOLUME OF PRODUCT IN COMMERCE
66 units.
DISTRIBUTION
CA, FL, GA, NC, NE, OH, PA and Canada.
___________
PRODUCT
Microject 30 Pump, Ref 220039. Packaged individually or in cases of 10. Recall # Z-1382-2.
CODE
Lots 201139 and 202070.
RECALLING FIRM/MANUFACTURER
Sorenson Medical, Inc., West Jordan, UT, by letter on September 5, 2002. Firm initiated recall is complete.
REASON
Pumps were released after failing established AQL acceptance levels.
VOLUME OF PRODUCT IN COMMERCE
178 units.
DISTRIBUTION
CA, CO, GA, IL, MO, NY, TX, and Canada, France, Singapore and Venezuela.
_______________________
PRODUCT
Solan Trephine Blade, 9 mm and also the 10mm sizes (different products), packed one unit per box. Corneal Trephine,
Recall # Z-1384-02/
CODE
Catalog Number 00-09717, lot 25209500 and Catalog Number 00-09721, lot number 23214300.
RECALLING FIRM/MANUFACTURER
Xomed, Inc., Jacksonville, FL, by letter on July 19, 2002.
Firm initiated recall is complete.
REASON
Outer box mislabeled as 9mm when product is 10mm.
VOLUME OF PRODUCT IN COMMERCE
8.
DISTRIBUTION
MO, TX, IL KY and MI.
_______________________
PRODUCT
Freshlook Color Enhancers (phemfilcon A) Contact Lenses; the soft contact lenses are individually packaged in sterile foil-sealed plastic packages, 6 packs per box. Recall # Z-1351-2.
CODE
Lot 024909, exp. 2006-07, Blue, base curve: median, diameter: 14.5, sphere: -2.25.
RECALLING FIRM/MANUFACTURER
Wesley Jessen Corp., Des Plaines, IL, by letters dated March 5, 2002. Firm initiated recall is complete.
REASON
Mislabeled for corrective power.
VOLUME OF PRODUCT IN COMMERCE
560 6-packs.
DISTRIBUTION
Nationwide and Canada.
_______________________
PRODUCT
MeriFluor CMV IgM IFA/IFT, packaged under the Gull label.
Recall # Z-1356-2.
CODE
Lot Number: CM150.022, Exp. 20 DEC 02
Lot Number: CM150.023, Exp. 20 DEC 02
Lot Number: CM150.024, Exp. 20 DEC 02
Lot Number: CM150.025, Exp. 05 JAN 03.
RECALLING FIRM/MANUFACTURER
Meridian Bioscience, Inc., Cincinnati, OH, by letters dated August 27, 2002. Firm initiated recall is ongoing.
REASON
The Negative Control does not meet labeled specifications.
VOLUME OF PRODUCT IN COMMERCE
189 kits.
DISTRIBUTION
Nationwide and Canada, Belgium, Italy and Australia.
_______________________
PRODUCT
BD 5 ml preservative Urine Culture and Sensitivity (C&S) Tube). Recall # Z-1359-2.
CODE
Catalog #364976 -- Lot 1026345.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Co., Franklin Lakes, NJ, by letters on July 17, 2002.
Manufacturer: Becton Dickinson Vacutainer Systems, Broken Bow, NE. Firm initiated recall is ongoing.
REASON
Label placement on urine tube is incorrect which could cause filling below specs.
VOLUME OF PRODUCT IN COMMERCE
60,000.
DISTRIBUTION
Nationwide.
_______________________
PRODUCT
BD Unopette Brand Capillary Pipettes for use with Unopette Blood Diluting Pipette System. Recall # Z-1367-2.
CODE
Lot Code: 1G107 Exp 9/20/2002.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Co., Franklin Lakes, NJ, by letter on April 5, 2002.
Manufacturer: Becton Dickinson Caribe Ltd., San Lorenzo, Puerto Rico. Firm initiated recall is ongoing.
REASON
Mispackaging of 20uL pipettes in 10uL containers.
VOLUME OF PRODUCT IN COMMERCE
9,000 units.
DISTRIBUTION
Nationwide and Japan.
_______________________
PRODUCT
Digene Corporation's Hybrid Capture(tm)2 High Risk Human Papillomavirus (HPV) In-vitro diagnostic test kit, containing one vial of High Risk HPV Calibrator. Recall # Z-1368-2.
CODE
HPV Kit Lot 832, containing Calibrator, lot #35, Exp 8/15/2003.
RECALLING FIRM/MANUFACTURER
Digene Corp., Gaithersburg, MD, by telephone and fax on August 13, 2002. Firm initiated recall is ongoing.
REASON
Human Papilloma Virus IVD Test kit contains incorrect calibrator.
VOLUME OF PRODUCT IN COMMERCE
361 kits.
DISTRIBUTION
Nationwide and Canada.
_______________________
PRODUCT
VITAMIN B12 CALIBRATORS; For in vitro diagnostic use only. Catalog #154 0525. Recall # Z-1369-2.
CODE
Lot Numbers:
231, Exp. 8/28/02
750, Exp. 10/27/02
751, Exp. 11/1/02.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ortho-Clinical Diagnostics, Inc., Rochester, NY, by letter on August 19, 2002.
Manufacturer: Ortho-Clinical Diagnostics, Inc., Cardiff, Wales. Firm initiated recall is ongoing.
REASON
Calibration Failures when restricted limits used.
VOLUME OF PRODUCT IN COMMERCE
603 units.
DISTRIBUTION
Nationwide and Internationally.
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2002-OCT-02.