March 26, 2003
03-13
_____________________________
PRODUCT
Always Save brand Taco Seasoning Mix, 1.25 oz metallized foil pouch, packed 24 pouches per case. Recall # F-252-3.
CODE
OCT2804BH.
RECALLING FIRM/MANUFACTURER
Ampacco, Inc., Hunt Valley, MD, by press release and letter on January 29, 2003. Firm initiated recall is ongoing.
REASON
Taco seasoning pouches were accidentally filled with brown gravy mix. The brown gravy mix contains milk, wheat, and soy ingredients, which are not listed on the taco pouch.
VOLUME OF PRODUCT IN COMMERCE
1344 cases.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Hearty Hero Cheeseburger Sandwiches (Cartons actually contain Hearty Hero Meatball Sandwiches). Recall # F-253-3.
CODE
Production codes: OCT2003 08012; OCT2003 08022; OCT2003 08052; OCT2003 08062; OCT2003 08072; NOV2003 08122; NOV2003 08132; NOV2003 08142; NOV2003 08202; NOV2003 08212; NOV2003 08262.
RECALLING FIRM/MANUFACTURER
Pinnacle Food Corp., Mountain Lakes, NJ, by press release and letters on January 16, 2003. Firm initiated recall is ongoing.
REASON
Meatball sandwiches which contain egg white protein is packaged in Cheeseburger cartons that do not declare egg white protein on the label.
VOLUME OF PRODUCT IN COMMERCE
128,400 cartons.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
a) America's Catch Brand breaded catfish: whole breaded
fish, breaded strips, breaded strips Dairy Queen, and breaded nuggets Description Case Size Product Code Whole 5-7 BRD 10 lb 1025 Whole 7-9 BRD 10 lb 1045 Strips BRD 10 lb 1625 Strips DQ-BRD 10 lb 1629 Strips BRD-1.25 oz 10 lb 1639 Nuggets BRD 10 lb 1645 Frosty Acres Brand breaded catfish: breaded strips and nuggets. Description Case Size Product Code Frosty Acres Strips BRD 10 lb 2625 Frosty Acres Nuggets BRD 10 lb 2645 America''s Catch Breaded Catfish Nuggets packaged in 2.5 lb plastic bags for retail sale Autocrat Brand: gourmet catfish breaded strips, breaded nuggets Description Case Size Product Code Strips-BRD Gourmet 15 lb 3639 Autocrat Nuggets BRD 15 lb 3646. Recall # F-255-3.
b) America's Catch Brand breaded catfish: Cajun breaded
strips and Cajun breaded nuggets. Description Case Size
Product Code Strips Cajun BRD 10 lb 1630 Nuggets Cajun
BRD 10 lb 1650. Recall # F-256-3.
c) America's Catch Brand breaded catfish: cracked black
pepper breaded strips Description case size product code
strips CRKD BLK Pepper BRD 10 lb 1635.
Recall # F-257-3.
CODE
106022 through 912022.
RECALLING FIRM/MANUFACTURER
America's Catch, Inc., Itta Bena, MS, by press release on December 4, 2002 and letters on December 5, 2002. FDA initiated recall is complete.
REASON
Undeclared egg whites in breaded fish product.
VOLUME OF PRODUCT IN COMMERCE
106,680 cases.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Chef's Choice brand Coconut Juice, 11.2 ounce aluminum cans. Recall # F-263-3.
CODE
AGCGAA on bottom of can.
RECALLING FIRM/MANUFACTURER
Kingston Miami Trading, Co, Miami, FL, by on-site visit beginning January 2, 2003 and by press release and letter on January 21, 2003. Florida State initiated recall is complete.
REASON
Undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
2010/24 can cases.
DISTRIBUTION
FL.
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PRODUCT
Taste of the East Rajbhog Sweets brand "AMARTI", Net Wt. 14 oz. (397 g), packed in a hard plastic tray.
Recall # F-265-3.
CODE
Lot 03202 (on the bottom of the label).
RECALLING FIRM/MANUFACTURER
Rajbhog Foods, Inc., Flushing, NY, by press release on February 22, 2002. State initiated recall is complete.
REASON
The product contained undeclared pistachio nuts.
VOLUME OF PRODUCT IN COMMERCE
275 - 14 oz. units.
DISTRIBUTION
NY, NJ, PA, MA, VA, and NC.
_____________________________
PRODUCT
Assorted processed fruit/vegetables with production date of 6-14-2002 to 6-24-02, Julian date of 165 to 175, or best used by date of 6-20-2002 to 6-28-02.
a) Mixed Fruit. Recall # F-267-3.
8oz Mixed Fruit Cubed;
6/16oz Mixed Fruit;
6/32oz Mixed Fruit;
6/7.5oz Mixed Fruit.
b) Honeydew Chunks. Recall # F-268-3.
6/16oz Honeydew Chunks;
6/7.5oz Honeydew Chunks;
2/5 LB Honeydew Chunks.
c) Cantaloupe/Honeydew Chunks. Recall # F-269-3.
6/16oz Cantaloupe/Honeydew Chunks
6/32oz Cantaloupe/Honeydew Chunks
d) 2/32oz Cantaloupe/Honeydew/Watermelon Chunks.
Recall # F-270-3.
e) 5 LB Fruit Bowl. Recall # F-271-3.
f) 1 EACH Watermelon Boats. Recall # F-272-3.
g) 3/2.3 LB Fruit Medley Tray. Recall # F-273-3.
h) 4/4CT Veggie Kabobs. Recall # F-274-3.
i) 4/36CT Kabob Kit. Recall # F-275-3.
j) 2/9" Fruit Trays. Recall # F-276-3.
k) 5 Lb. Onion Red Rings w/o Centers. Recall # F-277-3.
l) 10 LB Red Onion Kabob. Recall # F-278-3.
m) 5 LB Jicima Slaw. Recall # F-279-3.
n) 5 LB Onions Rd Sliced. Recall # F-280-3.
o) 5 LB Pickling Veg Mix Assorted. Recall #F-281-3.
CODE
Item # Pck/Sz Label
a) 16081 8oz No label
80675 6/16oz Malcomb's
81915 6/32oz Windmill
81920 6/7.5 oz Windmill
b) 81425 6/16oz Malcomb's
81945 6/7.5 oz Windmill
81355 2/5 LB No label
c) 80650 6/16oz Malcomb's
81910 6/32oz Windmill
d) 80590 2/32oz Windmill
e) 85027 5 LB Windmill
f) 81880 1 EACH Windmill
g) 85150 3/2.3 LB Windmill
h) 91035 4/4 CT Windmill
i) 910145 4/36 CT Windmill
j) 81805 2/9" Cub Food
k) 941166 5 LB No Label
l) 69286 10 LB Malcomb's
m) 816557 5 LB No Label
n) 966263 5 LB No Label
0) 307539 5 LB No Label
RECALLING FIRM/MANUFACTURER
FreshPoint of Denver, Denver, CO, by telephone on June 25, 2002. Firm initiated recall is complete.
REASON
The products may be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
1,838 cases of product.
DISTRIBUTION
CO and WY.
_____________________________
PRODUCT
Labrada Nutrition brand Lean Body Hi Protein Meal Replacement Bar - Cookies & Cream flavor, Net. Wt. 78g, single serve nutritional bar wrapped in flexible film. Recall # F-283-2.
CODE
Best by dates of 06/10/03 through 07/29/03.
RECALLING FIRM/MANUFACTURER
Elan Nutrition, L.L.C., Grand Rapids, MI, by letter on January 29, 2003. FDA initiated recall is ongoing.
REASON
Product contains undeclared almond butter.
VOLUME OF PRODUCT IN COMMERCE
327,339 bars.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Ha Que Rico California brand Mango Chilon, 1.5 oz. bags. Recall # F-259-3.
CODE
All codes on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Ha Que Rico California, Chula Vista, CA, by on-site visit beginning October 4, 2002. FDA initiated recall is complete.
REASON
The product contained undeclared colors, FD&C Yellow No. 5 and FD&C Yellow No. 6.
VOLUME OF PRODUCT IN COMMERCE
3,864 bags.
DISTRIBUTION
CA.
_____________________________
PRODUCT
a) Cool River brand Passion Fruit Juice beverage in 16 oz.
plastic bottle. Recall # F-260-3;
b) Cool River brand Light Passion Fruit Juice beverage in
16 oz. plastic bottle. Recall # F-261-3;
c) Cool River brand Orange Fruit Juice beverage in 16 oz.
plastic bottle. Recall # F-262-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
San Mar Manufacturing Corp., Rio Piedras, PR, by visit on November 7, 2002. FDA initiated recall is complete.
REASON
The products contain undeclared colors, FD&C Yellow #6 and FD&C Red #40.
VOLUME OF PRODUCT IN COMMERCE
a) 282/16 oz. bottles;
b) 435/16 oz. bottles;
c) 241/16 oz. bottles.
DISTRIBUTION
PR.
_____________________________
PRODUCT
Jamaican Country Style brand Jelly Coconut Juice, Net Weight 17.5 fl. Oz. and also 11.2 fl. Oz., in aluminum cans. Product of Thailand. Recall # F-264-3.
CODE
17.5 oz cans: CJL221, CJL226, CJL231, CJL256, CJL261,
CJL262, CJL263, CJL266 on bottom of can.
11.2 oz cans: CJL226, CJL227 and CJL246 on bottom of cans.
RECALLING FIRM/MANUFACTURER
Kingston Miami Trading, Co., Miami, FL, by on site-visit beginning January 2, 2003. Florida State initiated recall is complete.
REASON
Undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
756/24 can cases of 17.5 oz. cans;
1225/24 can cases of 11.5 oz. cans.
DISTRIBUTION
FL.
_____________________________
PRODUCT
Old El Paso Refried Beans Traditional, 16 oz. net wt. In cans. The UPC Code on the can's printed label is 4600082121. Recall # F-282-3.
CODE
Production code (printed on top or bottom of the can), begins with H2FF15.
RECALLING FIRM/MANUFACTURER
Recalling Firm: General Mills, Inc., Minneapolis, MN, by press release on October 22, 2002 and by e-mail dated October 23, 2002.
Manufacturer: Faribault Foods, Inc., Faribault, MN. Firm initiated recall is complete.
REASON
The product may not have been adequately processed to eliminate pathogens of public health concern.
VOLUME OF PRODUCT IN COMMERCE
340 cases/12-16 oz. cans per case/4080 cans.
DISTRIBUTION
IL, IA, IN, KS, KY, and MO.
_____________________________
PRODUCT
YIMEI Candy Series brand "Huashengsu" (peanut butter cookie wafers), net wt. 3 oz., packaged in a clear, flexible plastic bag. Recall # F-287-3.
CODE
All codes on the market at the time of recall initiation including "2001.11.03". Barcode # 920081 703321.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Strong America Limited, Brooklyn, NY, by press release and recall notice on June 12, 2002.
Manufacturer: Xiamen Da Chang Hua Imp. & Exp. Co., Ltd. Xiamen, Fujian, China. State initiated recall is complete.
REASON
The product does not bear mandatory English labeling, including listing ingredients such as peanuts.
VOLUME OF PRODUCT IN COMMERCE
38 cases (160 - 3 oz. packages per case).
DISTRIBUTION
NY.
_____________________________
PRODUCT
a) Almonds in honey, net wt. 430 grams (15 oz).
Recall # F-288-3;
b) Walnuts in honey, net wt. 320 grams (11 oz).
Recall # F-289-3.
The products were packaged in glass jars and labeled in Russian (no English labeling).
CODE
a) Production date - November 25, 2001;
b) Production date - May 30, 2002.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LIR International Wholesale, Inc, Brooklyn, NY, by two separate press releases and letters dated October 4, 2002.
Manufacturer: PII Sky Limited Kiev, Ukraine, State initiated recall is complete.
REASON
The products do not bear mandatory English labeling, including listing ingredients such as walnuts or almonds.
VOLUME OF PRODUCT IN COMMERCE
a) 16 cases (15 jars per case);
b) 21 cases (18 jars per case).
DISTRIBUTION
NY.
_____________________________
PRODUCT
Franczoz brand Original Recipe, Kosher, Home Style Donuts, Parve, net wt. 9 oz. (258 g), packed in a cardboard box. Recall # F-254-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Franczoz Baking Corp., Brooklyn, NY, by visit in late May/early June 2002. State initiated recall is complete.
REASON
Product contained undeclared color FD&C Red No 40 based on New York State Department of Agriculture and Markets analysis.
VOLUME OF PRODUCT IN COMMERCE
60 packages.
DISTRIBUTION
NY.
_____________________________
PRODUCT
Duchess brand sliced peaches in light syrup, net wt. 106 oz. (6 lb. 10 oz.) 3.01 Kg. Product of China. Product is packaged in #10 cans. There are 6 cans per case. Recall # F-284-3.
CODE
Barcode # 32460 00010. "H22/020706/6131Y" for 431 cartons;
"H22/020707/6131Y" for 539 cartons (codes are in ink only, not impressed into lids).
RECALLING FIRM/MANUFACTURER
Royal Food Import Corp., New York, NY, by telephone on February 3, 2003. State initiated recall is ongoing.
REASON
The product is unfit for food. State of Ohio laboratory analysis revealed the cans were de-tinned and the contents were discolored.
VOLUME OF PRODUCT IN COMMERCE
970 cases (6 cans per case).
DISTRIBUTION
OH.
_____________________________
PRODUCT
a) Antacid Liquid (Aluminum hydroxide 200mg, Magnesium
hydroxide 200mg and Simethicone 20mg) 6 fl oz (177mL),
12 fl oz (355mL) and 24 fl oz (710mL) bottles, Fast-
Acting, Antacid/Antigas, Original Flavor. Also sold
under other brands as: Liquid Antacid, Distributed by:
Dolgencorp, Inc., Goodlettsville, TN; Liquid Antacid,
Distributed By: Foodhold U.S.A. Incorporated,
Chantilly, VA; Liquid Antacid, Distributed By:
Super G, Inc., Landover, MD; Antacid plus
Simethicone, Distribution By Family Dollar Services,
Inc., Charlotte, NC; Antacid Liquid with
Simethicone, Distributed By Quality Choice, Novi, MI;
Antacid plus Simethicone, Distributed by Fred's
Inc., Memphis, TN. Recall # D-130-3;
b) Antacid Supreme Liquid (Calcium carbonate 400mg,
Magnesium hydroxide 135mg) 12 fl oz (355mL) bottles,
Fast Acting, Cherry flavor. Also sold under other
brands as: Antacid Supreme, Cherry flavor, Distributed
by Ingles, Asheville, NC; Antacid Supreme, Cherry
flavor, Distributed by: Food Lion Stores, LLC,
Salisbury, NC; Antacid Supreme, Cherry flavor,
Distributed by: Dolgencorp Inc., Goodlettsville, TN.
Recall # D-131-3.
c) Antacid Liquid, ( Aluminum hydroxide 200mg, Magnesium
hydroxide 200mg, Simethicone 20mg) 6 fl oz (177ml) and
12 fl oz (355mL) bottles, Antacid/Anti-Gas, Mint flavor,
Also sold under other brands as: Antacid Liquid, Cooling
Mint flavor, Distributed By: Super G, Inc., Landover,
MD; Antacid Liquid, Mint flavor, Distributed By Quality
Choice, Novi, MI; Antacid Liquid, Cooling Mint flavor,
Distributed By: Foodhold U.S.A. Incorporated, Chantilly,
VA; Antacid Liquid, Cooling Mint flavor, Distributed
By: The Stop & Shop Supermarket Co., Boston, MA.
Recall # D-132-3.
d) Antacid II, (Aluminum hydroxide 400mg, Magnesium
hydroxide 400mg, Simethicone 40mg) 12 Fl oz (355mL)
bottles, Maximum Strength, Original flavor, Fast-Acting,
Antacid/Antigas, Distributed by Fred''s, Inc., Memphis,
TN. Recall # D-133-3.
e) Antacid Liquid (Aluminum hydroxide 400mg, Magnesium
hydroxide 400mg, Simethicone 40mg), 5 Fl oz (148mL)
bottle, Maximum Strength, Lemon flavor, Antacid,
Anti-Gas. Recall # D-134-3.
f) Antacid Liquid (Aluminum hydroxide 500mg, Magnesium
hydroxide 450mg, Simethicone 40mg) 12 Fl oz (355mL)
bottles, Extra Strength, Fast-Acting, Antacid/Anti Gas,
Lemon Creme Flavor, Distributed by Fred's, Inc.,
Memphis, TX. Recall # D-135-3.
g) Antacid Liquid (Aluminum hydroxide 500mg, Magnesium
hydroxide 450mg, Simethicone 40mg) 5 Fl oz (148mL)
bottles, Extra Strength, Fast Relief, Antacid Anti-Gas
Plus, Lemon Flavor. Recall # D-136-3.
h) Antacid Liquid (Aluminum hydroxide 225mg and Magnesium
hydroxide 200mg) 12 Fl oz (355mL) bottle, Mint Creme
flavor, Distributed By Warehouse Concepts, Inc., West
Sacramento, CA. Recall # D-137-3.
i) Antacid Supreme Liquid (Calcium Carbonate 400mg and
Magnesium hydroxide 135mg) 12 Fl oz (355mL) bottle, Fast Acting, Mint Creme flavor, Distributed by Longs Drugs, Walnut Creek, CA. Recall # D-138-3.
j) Antacid Supreme Liquid (Calcium carbonate 400mg and
Magnesium hydroxide 135mg) 12 Fl oz (355mL) bottle, Fast
Acting, Cherry Creme flavor, Distributed by Longs Drugs,
Walnut Creek, CA. Recall # D-139-3.
CODE
a) Lots 11933; 11970; 11971; 11972; 11973; 11998; 12119;
12120; 12183; 12184; 12468; 12469; 12558; 12605; 12606; 12607; 12645; 12646; 12647; 12666; 12700; 12709; 12710; 12817; 12819; 12820; 12833; 12859; 12860; 12863; 12889; 12917.
b) Lots 12041; 12171; 12298; 12339; 12465; 12816; 12821;
12890.
c) Lots 11978; 12651; 12652; 12711; 12712; 12885.
d) Lots 12086; 12578.
e) Lot 12115.
f) Lots 12087; 12701; 12702B.
g) Lot 12663; 12664.
h) Lot 11979.
i) Lots 11866; 12662.
j) Lots 11865; 12825.
RECALLING FIRM/MANUFACTURER
Aaron Industries, Inc., Lynwood, CA, by letter on November 30, 2002. Firm initiated recall is ongoing.
REASON
Microbial contamination (Enterobacter cloacae, Citrobacter freundii, Klebsiella terrigena, Flavimonas oryzihabitans and Salmonella arizonae).
VOLUME OF PRODUCT IN COMMERCE
500,422.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
a) Children's Pain Reliever, (Acetaminophen) 80 mg per 1/2
teaspoon, 4 Fl. oz. bottles, Bubble Gum flavor, Equate brand; Also sold under other brands as: Brite-Life brand, Distributed By Bergen Brunswig Drug Company, Orange, CA; Longs brand, Longs Drugs, Walnut Creek, CA; Western Family brand, Western Family Foods, Inc., Portland, OR; HomeBest brand, Preferred Products, Inc., Eden Prairie, MN; Good Neighbor Pharmacy, Bergen Brunswig Drug Company, Orange, CA; Top Care brand, Topco Assoc, Inc., Skokie, IL; Leader brand, Cardinal Distribution Dublin, OH; Shaw's brand, Shaw's Supermarkets, Inc., E. Bridgewater, MA; Kroger brand, The Kroger Co., Cincinnati, OH; Good Sense brand, Perrigo, Allegan, MI; Food Lion brand, Food Lion, LLC, Salisbury, NC; Sav-on Osco by Albertson's brand, Albertson's Inc., Boise, ID Children's Acetaminophen Suspension, Equate brand, Manufactured By Perrigo Company, Allegan MI, Imported By Shandex Sales Group, LTD, Pickering, Ontario; Brooks brand, Maxi Drug, Inc., d/b/a Brooks Pharmacy, Warwick, RI; Safeway brand, Prepared For Canada Safeway Limited, Calgary Alberta, By Perrigo Company, Allegan, MI, Imported By Shandex Sales Group, LTD, Pickering, Ontario; Life brand, Manufactured for Shoppers Drug Mart, Pharmaprix, Toronto, by Perrigo Co., Allegan, MI Imported by Shandex Sales Group, LTD, Pickering, Ontario; Personnelle brand, Manufactured By; Perrigo Co., Allegan, MI, For Le Groupe Jean Coutu (PJC) Inc., The Jean Coutu Group, Inc., Longueuil (Quebec), Imported By: Shandex Sales Group, LTD, Pickering (Ontario) Children's Pain Relief Oral Suspension, American Fare brand, Made for Kmart Corporation, Troy, MI, CVS Pharmacy brand, CVS Pharmacy, Inc., Woonsocket, RI; Finast brand, Foodhold USA, Inc., Chantilly, VA; Giant Eagle brand, Giant Eagle, Inc., Pittsburgh, PA; H-E-B Pharmacy brand, H-E-B, San Antonio, TX; Hy-Vee brand, Hy-Vee, Inc., West Des Moines, IA; Stop & Shop brand, The Stop & Shop Supermarket Co., Boston, MA; Children's Aspirin Free Suspension Liquid, Meijer brand, Meijer Distribution, Inc., Grand Rapids, MI; Non-Aspirin Children's Suspension, Eckerd brand, Eckerd Drug Company, Clearwater, FL; Rite Aid brand, Rite Aid Corporation, Harrisburg, PA; ShopRite brand, Wakefern, Food Corporation, Elizabeth, NJ; Walgreens brand, Walgreen Co., Deerfield, IL; ValuRite brand, McKessonHBOC, San Francisco, CA; Recall # D-164-3.
b) Children's Pain Reliever Suspension Liquid,
(Acetaminophen) 80 mg per 1/2 teaspoon, 4 Fl. oz and 8
Fl. oz. bottles, Grape flavor, Equate brand.
Also sold under other brands as: Leader brand, Cardinal
Distribution, A Division of Cardinal Health, Inc.,
Dublin, OH; Best Yet brand, Fleming, Oklahoma, OK Drug
Emporium brand, Packaged by Perrigo Company, Allegan,
MI, For Drug Emporium, Inc., Powell, OH; Elect Health
brand, ShopKo Stores, Inc., Green Bay, WI; Top Care
brand, Topco Associates LLC, Skokie, IL; HomesBest
brand, Preferred Products, Inc., Eden Prairie, MN; Good
Neighbor Pharmacy, Bergen Brunswig Drug Company, Orange,
CA; Brite-Life brand, Bergen Brunswig Drug Company,
Orange, CA Western Family brand, Western family Foods,
Inc., Portland, OR; Good Sense brand, Perrigo, Allegan,
MI; Today's Health brand, Warehouse Concepts, Inc.,
West Sacramento, CA; Kroger brand, The Kroger, Co.,
Cincinnati, OH; Longs brand, Longs Drugs, Walnut Creek,
CA; Hannaford brand, Hannaford Bros., Co., Scarborough,
ME; Family Pharmacy brand, Family Pharmacy,
Southeastern, PA; Children's Acetaminophen Suspension
Liquid, Brooks brand, Maxi Drug, Inc., d/b/a Brooks
Pharmacy, Warwick, RI Life brand, manufactured for
Shoppers Drug Mart Pharmaprix, Toronto, by Perrigo Co.,
Allegan, MI, Imported by Shandex Sales Group, Ltd.,
Pickering, Ontario Equate brand, Manufactured By Perrigo
Company, Allegan, MI, Imported By Shandex Sales Group
LTD., Pickering, Ontario Safeway brand, Prepared For
Canada Safeway Limited, Calgary, Alberta, By Perrigo
Company, Allegan, MI, Imported By Shandex Sales Group
LTD., pickering, Ontario Personnelle brand, Manufactured
By: Perrigo Co., Allegan, MI, For Le Groupe Jean Coutu
(PJC) Inc., The Jean Coutu Group (PJC) Inc., Longueuil
(Quebec), Imported By: Shandex Sales Group, LTD.,
Pickering (Ontario) Kaiser Permanente brand, Kaiser
Foundation Hospitals, Livermore, CA Target brand, Target
Corporation, Minneapolis, MN Children's Mapap
Suspension Liquid, Major brand, Major Pharmaceuticals,
Livonia, MI Children's Pain Relief Oral Suspension,
Wegmans brand, Wegmans Food Markets, Inc., Rochester,
NY; Finast brand, Foodhold U.S.A., Incorporated,
Chantilly, VA; Stop&Shop brand, The Stop&Shop
Supermarket Company, Boston, MA; Hy-Vee brand, Hy-Vee,
Inc., West Des Moines, IA; Super G brand, Super G, Inc.,
Landover, MD; Giant Eagle brand, Giant Eagle, Inc.,
Pittsburgh, PA Children's Non-Aspirin Oral Suspension,
H-E-B brand, H-E-B, San Antonio, TX; Best Choice brand,
Valu Merchandisers, Co., Kansas City, MO; CVS Pharmacy
brand, CVS Pharmacy, Inc., Woonsocket, RI; Walgreens
brand, Walgreens Co., Deerfield, IL; Rite Aid brand,
Rite Aid Corporation, Harrisburg, PA; Eckerd brand,
Eckerd Drug Company, Clearwater, FL; ValuRite brand,
McKessonHBOC, San Francisco, CA; ShopRite brand,
Wakefern Food Corporation, Elizabeth, NJ; Kirkland
brand, Manufactured by: Perrigo Co., Allegan, MI;
Children's Aspirin Free Suspension Liquid, Meijer
Distribution, Inc., Grand Rapids, MI Medi-Tabs Oral
Suspension, The Medicine Shoppe brand, Medicine Shoppe
International, Inc., St. Louis, MO. Recall # D-165-3.
c) Children's Pain Reliever Suspension Liquid,
(Acetaminophen) 80 mg per 1/2 teaspoon, 4 Fl. oz
bottles, Cherry flavor, Equate brand. Also sold under
other brands as: Good Sense brand, Perrigo, Allegan,
MI; Leader brand, Cardinal Distribution, A Division of
Cardinal Health, Inc., Dublin, OH; Best Yet brand,
Fleming, Oklahoma, OK Drug Emporium brand, Packaged by
Perrigo Company, Allegan, MI, For Drug Emporium, Inc.,
Powell, OH; HomesBest brand, Preferred Products, Inc.,
Eden Prairie, MN; Good Neighbor Pharmacy, Bergen
Brunswig Drug Company, Orange, CA; Brite-Life brand,
Bergen Brunswig Drug Company, Orange, CA Western Family
brand, Western Family Foods, Inc., Portland, OR; Kroger
brand, The Kroger, Co., Cincinnati, OH; Longs brand,
Longs Drugs, Walnut Creek, CA; Hannaford brand,
Hannaford Bros., Co., Scarborough, ME; Family Pharmacy
brand, Family Pharmacy, Southeastern, PA; DG brand,
Dolgencorp, Inc., Goodlettsville, TN; Shaw's brand,
Shaw's Supermarkets, Inc., E. Bridgewater, MA; Food Lion
brand, Food Lion LLC, Salisbury, NC; CounterAct brand,
Melaleuca, Inc., Idaho Falls, ID; Sav-on Osco by
Albertson's brand, Albertson's, Inc., Boise, ID;
Children's Acetaminophen Suspension Liquid, Equate
brand, Manufactured By Perrigo Company, Allegan, MI,
Imported By Shandex Sales Group LTD., Pickering, Ontario
Safeway brand, Prepared For Canada Safeway Limited,
Calgary, Alberta, By Perrigo Company, Allegan, MI,
Imported By Shandex Sales Group LTD., pickering, Ontario
Personnelle brand, Manufactured By: Perrigo Co.,
Allegan, MI, For Le Groupe Jean Coutu (PJC) Inc., The
Jean Coutu Group (PJC) Inc., Longueuil (Quebec),
Imported By: Shandex Sales Group, LTD., Pickering
(Ontario) Life brand, manufactured for Shoppers Drug
Mart Pharmaprix, Toronto, by Perrigo Co., Allegan, MI,
Imported by Shandex Sales Group, Ltd., Pickering,
Ontario Brooks brand, Maxi Drug, Inc., d/b/a Brooks
Pharmacy, Warwick, RI Kaiser Permanente brand, Kaiser
Foundation Hospitals, Livermore, CA Target brand, Target
Corporation, Minneapolis, MN Children's Pain Relief
Oral Suspension, Wegmans brand, Wegmans Food Markets,
Inc., Rochester, NY ; American Fare brand, Made for
Kmart Corporation, Troy, MI; Hy-Vee brand, Hy-Vee, Inc.,
West Des Moines, IA; Super G brand, Super G, Inc.,
Landover, MD; Giant Eagle brand, Giant Eagle, Inc.,
Pittsburgh, PA Children's Non-Aspirin Oral Suspension,
H-E-B brand, H-E-B, San Antonio, TX; Best Choice brand,
Valu Merchandisers, Co., Kansas City, MO; CVS Pharmacy
brand, CVS Pharmacy, Inc., Woonsocket, RI; Walgreens
brand, Walgreens Co., Deerfield, IL; Rite Aid brand,
Rite Aid Corporation, Harrisburg, PA; Eckerd brand,
Eckerd Drug Company, Clearwater, FL; ValuRite brand,
McKessonHBOC, San Francisco, CA; Children's Aspirin
Free Suspension Liquid, Meijer Distribution, Inc.,
Grand Rapids, MI Medi-Tabs Oral Suspension, The Medicine
Shoppe brand, Medicine Shoppe International, Inc., St.
Louis, MO Children's Mapap, Major brand, Major
Pharmaceuticals, Livonia, MI APAP brand Paracetamolum,
ZAWIESNIA DOUSTNA DLA DZIECI, 160 mg/5mL, 120ml, SMAK
OWOCOWY, US Pharmacia (this product label is written in
Polish for the intent of distribution in Poland.
Recall # D-166-3.
CODE
a) Lots 1BD0043, 1BD0044,0 1DD0285, 1ED0272, 1FD0069,
1FD0339, 1DD0223, 1DD0037, 1ED0090, 1ED0091, 1ED0092, 1FD0340, 1FD0027, 1FD0293, 1GD0074, 1GD0075, 1GD0077, 1HD0023, 1HD0022, 1HD0065, 1HD0299, 1HD0300, 1HD0301, 1HD0364, 1HD0336, 1HD0346, 1KK0061 and 1JK0029.
b) Lots 1BD0191, 1BD0045, 1BD0302, 1DD0078, 1DD0034,
1DD0079, 1DD0080, 1ED0088, 1ED0023, 1ED0089, 1FD0273,
1FD0272, 1FD0023, 1FD0024, 1HD0365, 1FD0337, 1FD0336,
1FD0335, 1FD0289, 1GV0443, 1FD0290, 1FD0291, 1FD0292,
1GD0305, 1GD0306, 1GD0308, 1GD0309, 1GD0310, 1JK0027,
1HD0366, 1HD0330, 1HD0332 and 1JK0026.
c) Lots 1BV0152, 1CV0205, 1BD0041, 1BD0042, 1BD0193V,
1CK0082, 1BD0196V, 1CD0277, 1CD0276, 1BD0293V, 1CK0083,
1CD0279, 1ED0002, 1ED0003, 1FD0305, 1FD0118, 1GD0316,
1ED0003B, 1FD0118B, 1FD0118R, 1GD0086, 1GD0084, 1FD0086,
1GK0016, 1GD0024, 1GV0508, 1GV0467, 1GD0024R, 1HV0375,
1HV0510, 1GD0025, 1GD0026 1GD0028, 1GD0027, 1HD0066,
1HD0066R, 1JV0338, 1HV0705, 1HV0665, 1HV0619, 1JV0460,
1HV0617, 1HD0067, 1HK0092, 1HD0335, 1JK0038, 1JK0037 and
1HD0067B.
RECALLING FIRM/MANUFACTURER
L. Perrigo Co., Allegan, MI, by letters on January 28, 2003. Firm initiated recall is ongoing.
REASON
Super-potency; inadequate validation of manufacturing operation.
VOLUME OF PRODUCT IN COMMERCE
a) 851,581 units;
b) 954,494 units;
c) 930,767 units.
DISTRIBUTION
Nationwide, Canada and Poland.
_____________________________
PRODUCT
a) Betaxolol Ophthalmic Solution USP, 0.5%, 5mL , 10mL and
15mL dropper tip bottles, Rx only, Sterile Ophthalmic Solution, For Topical Ophthalmic Use Only.
Recall # D-167-3;
b) Timolol Maleate Ophthalmic Solution USP, 0.5%, 10mL and
15mL dropper tip bottles, Rx only, Sterile Ophthalmic
Solution. Recall # D-168-3;
c) Carteolol Hydrochloride Ophthalmic Solution USP, 1%,
5mL, 10mL and 15mL dropper tip bottles, Rx only, Sterile
Ophthalmic Solution, For Topical Ophthalmic Use Only.
Recall # D-169-3.
d) Levobunolol HCl Ophthalmic Solution USP, 0.5%, 5mL, 10mL
and 15mL dropper tip bottles, Rx only, Sterile
Ophthalmic Solution, For Topical Eye Use.
Recall # D-170-3.
e) Timolol Maleate Ophthalmic Solution USP, 0.25%, 10mL and
15mL dropper tip bottles, Rx only, Sterile Ophthalmic
Solution. Recall # D-171-3.
f) Cromolyn Sodium Ophthalmic Solution USP, 4%, 10mL
dropper tip bottle, Rx only, Sterile: For topical
application in the eye. Recall # D-172-3.
g) Tobramycin Ophthalmic Solution USP, 0.3%; 5mL dropper
tip bottle, Rx only, Sterile Ophthalmic Solution, For
Topical Ophthalmic Use Only. Recall # D-173-3.
CODE
All lots of all sizes.
RECALLING FIRM/MANUFACTURER
Novex Pharma, Richmond Hill, Ontario, Canada, by letters on December 16, 2002. Firm initiated recall is ongoing.
REASON
Defective container; insufficient tightness of caps resulting in evaporation of water in solution which may cause product to become super-potent.
VOLUME OF PRODUCT IN COMMERCE
a) 29,319 bottles;
b) 142,560 bottles;
c) 725 bottles;
d) 59,887 bottles;
e) 15,804 bottles;
f) 12,328 bottles;
g) 1,937 bottles.
DISTRIBUTION
Nationwide and Puerto Rico.
_____________________________
PRODUCT
Estrace Tablets (estradiol tablets, USP), 2 mg, bottles of 100 tablets, Rx only. Recall # D-180-3.
CODE
Lots: #011137, Exp. APR 16 03;
#011780, Exp. JUN 23 03;
#011851, Exp. JUL 06 03; and
#012022, Exp. AUG 29 03.
RECALLING FIRM/MANUFACTURER
Recalling Firm: AmeriSource Health Services Corp., Columbus, OH, by letters on February 19, 2003.
Manufacturer: Bristol-Myers Squibb Co., Princeton, NJ. Firm initiated recall is ongoing.
REASON
Dissolution Failure: by manufacturer (Bristol-Myers Squibb).
VOLUME OF PRODUCT IN COMMERCE
5,000 bottles.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
a) Nature's Remedy Tablets, (Cascara sagrada 150mg and
Aloe 100mg) Laxative, 15, 30 and 60 count foil-backed blistercard packages. Recall # D-174-3.
b) Nature's Remedy Tablets (Sennosides, USP 8.6mg)
Stimulant Laxative, 15, 30, and 60 count foil-backed
blistercard packages. Recall # D-175-3.
CODE
a) Lot Number/Exp. Date: M0013 exp. 3/03; M0014 exp.3/03;
M0015 exp. 4/03; M0016 exp. 4/03; M0017 exp. 4/03; M0018
exp. 4/03; M0019 exp. 4/03; M0020 exp. 4/03; M0021 exp.
4/03; M0023 exp. 4/03; M0024 exp. 4/03; M0025 exp. 4/03;
M0026 exp. 4/03; M0028 exp. 4/03. 0022/TAX015 exp 4/03;
0029/TAZ016 exp. 4/03.
b) Lot No./Exp. Date: M 100133 1/03; M100133A 1/03; M103412
5/03; M103413 6/03; M103414 6/03; M106408 10/03; M106457
10/03; M106458 10/03; M106531 10/03; M106532 10/03;
M200112 1/04; M200113 1/04; M200114 1/04; M201715 3/04;
M201716 3/04; M201717 3/04; M202573 4/04; M202574 4/04;
M202575 5/04; M202576 5/04; M202577 5/04; M202578 5/04;
M202579 5/04; M202580 5/04; M202580A 5/04; M202581 6/04;
M203643 6/04; M203757 6/04; M203758 6/04; M203759 6/04;
M204427 7/04; M204427A 7/04; M204428 7/04; 140100637/LOT
H MA/2003; 140103412/LOT I MA/2003; 140200097/LOT J and
LOT M200097 JA/2004; 140202576/LOT K MA/2004.
RECALLING FIRM/MANUFACTURER
Glaxo Smith Kline, Parsippany, NJ, by letters on January 23, 2003. Firm initiated recall is ongoing.
REASON
a) Subpotent; active ingredient (Aloe) (stability 12 month timepoint).
b) Superpotent; active ingredient (stability 12 month timepoint)
VOLUME OF PRODUCT IN COMMERCE
1,289,220 units.
DISTRIBUTION
Nationwide and Canada.
_____________________________
PRODUCT
Conray 43 (Iothalamate meglumine Injection USP 43%), 202 mg/mL Organically Bound Iodine, 100mL bottle, Rx only, For Intravascular Use, Sterile Solution, Mallinckrodt Inc., St Louis, MO. NDC 0019-3183-07. Recall # D-176-3.
CODE
Lot number B371D.
RECALLING FIRM/MANUFACTURER
Tyco Healthcare, Raleigh, NC, by telephone on June 25, 2001. Firm initiated recall is ongoing.
REASON
Misbranding; product has no immediate bottle label.
VOLUME OF PRODUCT IN COMMERCE
696 cases (12 units per case).
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
AVODART Soft Gelatin Capsules, (dutasteride), 0.5 mg, unit dose pack, 70 capsules, 10 blistercard package containing 7 capsules each, Rx only. NDC 0173-0712-01. Recall # D-177-3.
CODE
Lot number RP 44904BB, Exp. Date SEP 30 2006.
RECALLING FIRM/MANUFACTURER
SmithKline Beecham, Corp., Zebulon, NC, by letters on February 11, 2003. Firm initiated recall is ongoing.
REASON
Mislabeled; blistercard labeling is incorrectly printed as "Sample-Not for Sale".
VOLUME OF PRODUCT IN COMMERCE
3,059 units.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Thyrolar 1/4 (liotrix tablets, USP), (Liothyronine sodium (T3) 3.1mcg and Levothyroxine sodium (T4) 12.5mcg, 100-tablet bottles, Rx only. Recall # D-178-3.
CODE
Lot #60135, Exp. 06/2003.
RECALLING FIRM/MANUFACTURER
Forest Pharmaceuticals, Inc., Earth City, MO, by letters on October 24, 2002. Firm initiated recall is ongoing.
REASON
Superpotent; excessive tablet weight specification limits.
VOLUME OF PRODUCT IN COMMERCE
8,235/100-tablet bottles.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
a) PREMARIN Tablets, 0.9 mg (conjugated estrogens tablets,
USP), 100 tablet bottles, Rx Only. Recall # D-183-3.
b) Premarin tablets, 1.25 mg, (conjugated estrogens
tablets, USP), 5,000 count bottles, Rx Only.
Recall # D-184-3.
CODE
a) 9981732, Exp. August 2003; 9990073, Exp. August 2003.
b) 9000073, Exp. July 2004; 9010066, Exp. August 2003;
9010248, Exp. August 2003.
RECALLING FIRM/MANUFACTURER
Robins, A.H./Division of American Home Products, Richmond, VA, by letters on February 21, 2003. Firm initiated recall is ongoing.
REASON
Dissolution Failure: 5 hour time point.
VOLUME OF PRODUCT IN COMMERCE
a) 74,211 units;
b) 1,893 units.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
a) Red Blood Cells, Irradiated. Recall B-0639-3;
b) Platelet Pheresis, Irradiated. Recall B-0640-3.
CODE
a) Units 0823836, 0893692.
b) Unit 0882574.
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by letter dated September 19, 2002. Firm initiated recall is complete.
REASON
Blood products, for which documentation of irradiation was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
OH.
_____________________________
PRODUCT
Platelet, Pheresis, Leukoreduced (Split unit). Recall # B-0641-3.
CODE
Unit 12793-2258.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Albuquerque, MN, by telephone on December 2, 2002. Firm initiated recall is complete.
REASON
Blood products, incorrectly labeled as leukoreduced, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NM.
_____________________________
PRODUCT
Platelet, Pheresis, Leukoreduced (Split unit). Recall # B-0642-3.
CODE
Unit 083646.
RECALLING FIRM/MANUFACTURER
Blood Center of the Pacific, San Francisco, CA, by telephone on May 4, 2001. Firm initiated recall is complete.
REASON
Blood products, which were labeled leukoreduced but were not tested to determine the white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.
_____________________________
PRODUCT
Platelet, Pheresis, Leukoreduced (Split unit). Recall # B-0644-3.
CODE
Unit 9254519.
RECALLING FIRM/MANUFACTURER
Blood Bank of Delaware, Inc., Newark, DE, by telephone on November 28, 2001. Firm initiated recall is complete.
REASON
Blood products, which were below the firm's specification for product volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
DE and MD.
_____________________________
PRODUCT
a) Red Blood Cells Leukocytes Removed. Recall # B-0661-3;
b) Red Blood Cells Leukocytes Removed Irradiated.
Recall # B-0662-3.
CODE
a) Unit 24FC13377;
b) Unit 24FC13375.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, River Valley Region, Louisville, KY, by letters dated December 13, 2002. Firm initiated recall is complete.
REASON
Blood product was collected from donors who had traveled to a malarial endemic area.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
KY.
_____________________________
PRODUCT
a) Red Blood Cells Leukocytes Removed. Recall # B-0663-3;
b) Recovered Plasma. Recall # B-0664-3.
CODE
a) and b) Unit 12K70760.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Carolinas Region, Charlotte, NC, by letter dated February 5, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor with a medical history of hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NC and CA.
_____________________________
PRODUCT
a) Red Blood Cells, Leukoreduced. Recall # B-0673-3;
b) Red Blood Cells, Leukoreduced, Irradiated.
Recall # B-0674-3.
CODE
a) Units 12791-2145 (Split product),
Units 12791-2149 (Split product), 12791-2114.
b) Unit 12791-2114.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Albuquerque, MN, by telephone on September 12, 2002 and by letter dated September 26, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected by automated equipment that was not validated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 5 units;
b) 1 unit.
DISTRIBUTION
NM.
_____________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-0675-3.
CODE
Units 012FZ03927, 012FZ03929, 012FZ03934, 012FZ03949,
012FZ03969.
RECALLING FIRM/MANUFACTURER
American Red Cross, Carolinas Regional Blood Services, Charlotte, NC, by telephone and by letter on January 30, 2002. Firm initiated recall is complete.
REASON
Blood products, manufactured from a Whole Blood unit that was below the firm's specification for product volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
NC.
_____________________________
PRODUCT
Human Tissue, Femoral Vein SG. Recall # B-0681-3.
CODE
Units Model No. SGV060, Serial No. 7912874.
RECALLING FIRM/MANUFACTURER
CryoLife, Inc., Kennesaw, GA, by letter dated January 10, 2003. Firm initiated recall is complete.
REASON
Human Tissue, which was collected from a donor who had tested initially reactive for the hepatitis B surface antigen (HbsAg), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_____________________________
PRODUCT
a) Red Blood Cells. Recall # B-0682-3;
b) Recovered Plasma. Recall # B-0683-3.
CODE
a) and b) Unit J50192.
RECALLING FIRM/MANUFACTURER
Regional Health Resource Center, Urbana, IL, by telephone and fax on December 24, 2002 and by letter dated February 5, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who previously tested reactive for hepatitis B core antigen (anti-HBc) on two prior occasions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL and Switzerland.
_____________________________
PRODUCT
Source Plasma. Recall # B-0684-3.
CODE
Unit 0280400981.
RECALLING FIRM/MANUFACTURER
Nabi Biomedical Center, Jackson, NC, by fax on or about August 21, 2002. Firm initiated recall is complete.
REASON
Blood product, which was collected in a manner that compromised sterility, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
South Korea.
_____________________________
PRODUCT
Source Plasma. Recall # B-0685-3.
CODE
Unit 0280401106.
RECALLING FIRM/MANUFACTURER
Nabi Biomedical Center, Jackson, NC, by fax on or about August 21, 2002. Firm initiated recall is complete.
REASON
Blood product, which was collected in a manner that compromised sterility, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
_____________________________
PRODUCT
Source Plasma. Recall # B-0686-3.
CODE
Unit 0280402755.
RECALLING FIRM/MANUFACTURER
Nabi Biomedical Center, Jackson, NC, by fax on or about August 21, 2002. Firm initiated recall is complete.
REASON
Blood product, which was collected in a manner that compromised sterility, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0687-3;
b) Fresh Frozen Plasma. Recall # B-0688-3.
CODE
a) Unit numbers 18229-2848, 18229-5720, and 18229-8898;
The following units were distributed as two split units:
18229-2850, 18229-2852, 18229-2855, 18229-2878,
18229-8751, 18229-8851, and 18229-8860;
b) Unit number 18229-5720.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on October 10 and 11, 2002.
Manufacturer: Blood Systems, Inc., Cheyenne, WY. Firm initiated recall is complete.
REASON
Blood products were collected in a manner that may compromise the sterility of the products.
VOLUME OF PRODUCT IN COMMERCE
18 units.
DISTRIBUTION
WY, TX, CA, and NY.
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0689-3.
CODE
Unit number 04F97796.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by letter dated November 18, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NY.
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated.
Recall # B-0692-3.
CODE
Unit number 04C55564.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by letter dated November 19, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
ME.
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated. Recall # B-0693-3.
CODE
Unit number 04LF81754.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by letter dated November 13, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NH.
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0694-3.
CODE
Unit numbers 04GF24261 and 04GF19990.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by letter dated November 18, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NH and NY.
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0695-3.
CODE
Unit numbers 04GF21818 and 04GF19991.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by letter dated November 18, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
ME and NY.
_____________________________
PRODUCT
a) Red Blood Cells. Recall # B-0696-3;
b) Cryoprecipitated AHF. Recall # B-0697-3;
c) Recovered Plasma. Recall # B-0698-3.
CODE
a) and c) Units 0859308, 0815807;
b) Unit 0815807; pool ID # 0080261.
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by letter dated July 22, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of self-injecting steroids, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
OH.
_____________________________
PRODUCT
a) Red Blood Cells. Recall # B-0700-3;
b) Recovered Plasma. Recall # B-0701-3.
CODE
a) and b) Unit 04V16665X.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Gainesville, FL, by facsimile dated August 10, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had lived in an HIV Group O risk area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
FL.
_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0702-3;
b) Red Blood Cells, Leukocytes Reduced, Irradiated.
Recall # B-0703-3;
c) Platelets, Leukocytes Reduced. Recall # B-0704-3.
CODE
a) and c) Unit 16LZ18810;
b) Unit 16LZ19235.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Central Ohio Region, Columbus, OH, by letter dated November 5, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
OH.
_____________________________
PRODUCT
Platelets. Recall # B-0589-3.
CODE
Unit 18FX38301.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Great Lakes Region, Lansing, MI, by telephone on December 3, 2001. Firm initiated recall is complete.
REASON
Platelets, collected from a donor who failed to accurately answer the question regarding having had any shots or vaccinations in the past 4 weeks, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
_____________________________
PRODUCT
a) Red Blood Cells. Recall # B-0604-3;
b) Platelets. Recall # B-0605-3;
c) Cryoprecipitated AHF. Recall # B-0606-3;
d) Fresh Frozen Plasma. Recall # B-0607-3;
e) Plasma. Recall # B-0608-3.
CODE
a) unit numbers FG96246, FG96248, FG96251, FG96252, FG96257, FG96259, FG96263, FG96264, FG96265, FG96266, FG96267, FG96268, FG96269, FG96273, FG96276, FG96277, FG96279, FG96282, FG96283, FG96284, FG96285, FG96287, FG96289, FG96290, FG96292, FG96294, FG96296, FG96297, FG96298, FG96301, FG96303, FG96305, FG96306, FG96308, FG96309, FG96310, FG96312, FG96313, FG96314, FG96316, FG96317, FG96318, FG96319, FG96321, FG96322, FG96324, FG96325, FG96326, FG96327, FG96329, FG96330, FG96334, FG96335, FG96336, FG96337, FG96339, FG96340, FG96342, FG96343, FG96344, FG96345, FG96346, FG96347, FG96350, FG96351, FG96353, FG96354, FG96356, FG96357, FG96358, FG96359, FG96360, FG96361, FG96362, FG96363, FG96365, FG96366, FG96368, FG96373, FG96374, FG96378, FG96381, FG96382, FG96386, FG96388, FG96397, FG96404, FG96647, FG96667, FG96669, FG96673, FG96687, FG96688, FG96693, FG96694, FG96701, FG96703, FG96705, FG96769, FG96771, FG96772, FG96773, FG96776, FG96779, FG96783, FG96784, FG96786, FG96789, FG96792, FG96801, FG96802, FG96803, FG96804, FG96805, FG96806, FG96807, FG96814, FG96816, FG96818, FG96821, FG96825, FG96829, FG96830, FG96833, FG96835, FG96836, FG96837, FG96838, FG96839, FG96840, FG96841, FG96842, FG96845, FG96846, FG96847, FG96848, FG97068, FG97074, FG97076, FG97079, FG97084, FG97088, FG97090, FG97092, FG97136, FG97139, FG97143, FG97147, FG97149, FG97151, FG97152, FG97153, FG97154, FG97155, FG97156, FG97157, FG97159, FG97160, FG97165, FG97166, FG97167, FG97169, FG97171, FG97174, FG97175, FG97176, FG97177, FG97179, FG97181, FG97184, FG97186, FG97187, FG97188, FG97189, FG97190, FG97191, FG97192, FG97194, FG97195, FG97197, FG97198, FG97201, FG97202, FG97203, FG97204, FG97205, FG97208, FG97209, FG97210, FG97211, FG97212, FG97214, FG97215, FG97218, FG97219, FG97220, FG97222, FG97223, FG97224, FG97225, FG97227, FG97228, FG97229, FG97230, FG97231, FG97232, FG97233, FG97234, FG97235, FG97236, FG97237, FG97241, FG97242, FG97243, FG97244, FG97245, FG97249, FG97250, FG97251, FG97252, FG97253, FG97254, FG97255, FG97256, FG97257, FG97258, FG97261, FG97263, FG97264, FG97265, FG97267, FG97394, FG97395, FG97398, FG97401, FG97404, FG97407, FG97408, FG97418, FG97682, FG97685, FG97689, FG97690, FG97692, FG97700, FG97702, FG97704, FG97706, FG97707, FG97708, FG97709, FG97711, FG97712, FG97718, FL01216, FL01220, FL01241, FL01243, FL01244, FL01247, FL01363, FL01629, FL01630, FL01631, FL01633, FL01635, FL01637, FL01639, FL01650, FM03825, FM03826, FM03827, FM03908, FM03909, FM03912, FM03913, FM04082, FM04083, FM04085, FM04086, FM04088, FM04106, FM04108, FM04109, FM04110, FM04114, FM04118, FM04119, FM04121, FM04122, FM04125, FM04127, FM04131, FM04133, FM04137, FM04139, FM04140, FM04143, FM04147, FM04149, FM04152, FM04153, FM04155, FM04156, FM04159, FM04165, FM04166, FM04168, FM04169, FM04170, FM04173, FM04190, FM04197, FM04198, FS46614, FS46617, FS46619, FS46622, FS46626, FS46627, FS46688, FS46707, FS46767, FS46772, FS46780, FS46782, FS46783, FS46784, FS46785, FS46786, FS46787, FS46788, FS46789, FS46791, FS46800, FS46812, FS46819, FS46827, FS46830, FS46832, FS46833, FS46834, FS46891, FS46893, FS46905, FS46912, FS46919, FS46921, FS46931, FT02679, FT02683, FT02684, FT02753, FT02761, GE46484 , GE46491, GE47192, GE47198, GE47210, GE47211, GE47212, GE47218, GE47222, GE47224, GE47226, GE47228, GE47230, GE47231, GE47239, GE47256, GE47263, GE47265, GE47269, GE47270, GE47273, GE47275, GG69531, GG69534, GG69619, GG69652, GG69758, GG69766, GG69771, GG69777, GG70085, GG70090, GJ64410, GJ66372, GJ66373, GJ66376, GJ66380, GJ66382, GJ66383, GJ66386, GJ66387, GJ66390, GJ66392, GJ66400, GJ66401, GJ66405, GJ66407, GJ66409, GJ66436, GJ66448, GJ66451, GJ66454, GJ66459, GJ66463, GJ66466, GJ66467, GJ66469, GJ66472, GJ66475, GJ66476, GJ66481, GJ66482, GJ66483, GJ66484, GJ66485, GJ66486, GJ66487, GJ66490, GJ66492, GJ66494, GJ66499, GJ66502, GJ66504, GJ66506, GJ66507, GJ66510, GJ66511, GJ66888, GJ66901, GJ66904, GJ66915, GJ66916, GJ66917, GJ66921, GJ66924, GJ66985, GJ67015, GJ67016, GJ67018, GJ67019, GJ67020, GJ67022, GJ67023, GJ67025, GJ67210, GJ67212, GJ67216, GJ67219, GJ67315, GJ967013, GL08264, GL08266, GL08267, GL08268, GL08269, GL08272, GL08274, GL08275, GL08276, GL08331, GL08333, GL08334, GL08335, GL08343, GL08344, GL08347, GL08351, GL08352, GL08354, GL08357, GL08360, GL08394, GL08402, GL08410, GL08411, GL08412, GL08413, GL08414, GN14442, GN14473, GN14478, GN14480, GP43428, GP43711, GP43713, GP43715, GP43717, GP43718, GP43719, GP43727, GP43729, GP43730, GP43731, GP43735, GR33061, GR33063, GR33065, GR33068, GR33069, GR33070, GR33071, GR33073, GR33078, GR33392, GR33402, GR33403, GV37210, GV37214, GV37216, GV37219, GV37230, GV37238, GV37239, GV37278, GV37280, GV37291, GV37354, GV37458, GV37475, GV37478, GV37480, GV37483, GV37486, GV37489, GV37491, GV37498, GV37517, GV37523, GV37529, GV37570, GV37572, GV37579, GV37663, GV37664, GV37666, GV37668, GV37670, GV37673, GV37675, GV37676, GV37680, GV37683, GV37727, GV37733, GV37735, GV37740, GV37746, GV37757, GV37760, GV37764, GV37768, GV37771, GV37773, GV37779, GV37781, GV37783, GV37787, GV37789, GV37792, GV37803, GV37842, GV37845, GV37851, GV37860, GV37863, GV37866, GV37871, GV37875, GV37879, GV37881, GV37884, GV37886, GV37890, GV37898, GV37899, GV37905, GV37916, GV37970, GV37973, GV37974, GV37977, GV37977, GV37980, GV37982, GV37984, GV37986, GV37987, GV37990, GV37994, GV37995, GV38000, GV38004, GV38005, GV38007, GV38011, GV38017, GV38057, GV38181, GV38186, GV38237, GV38238, GV38241, GV38245, GV38248, GV38253, GV38254, GV38258, GV38520, GV38522, GV38523, GV38525, GV38594, GV38629, GV38652, GV38656, GV38899, GV38906, GV38923, GV38924, GV38952, GV38983, GV38994, GV39007, GV39023, GV39027, GV39051, GV39053, GV39065, GV39079, GV39081, GV39083, GV39093, GV39094, GV39096, GV39098, GV39103, GV39109, GV39111, GV39115, GV39119, GV39120, GV39121, GV39123, GV39130, GV39132, GV39141, GV39147, GV39149, KC53635, KC53637, KC53647, KC53648, KC53650, KC53655, KC53660, KC53663, KC53669, KC53682, KC53683, KC53684, KC53689, KC53692, KC53695, KC53812, KC53814, KC53822, KC53825, KC53827, KC53829, KC53831, KC53832, KC53834, KC53835, KC53838, KC53841, KC53843, KC53850, KC53851, KC53858, KC53865, KC53940, KC53946, KC53948, KC53950, KC53959, KC53961, KC53975, KC53977, KC53988, KC54009, KC54011, KC54012, KC54013, KC54015, KC54016, KC54019, KC54021, KC54022, KC54045, KC54046, KC54048, KC54053, KC54057, KC54059, KC54061, KC54067, KC54068, KC54366, KC54374, KC54377, KC54379, KC54385, KC54426, KC54428, KC54431, KC54436, KC54442, KC54478, KC54479, KC54480, KC54480, KC54481, KC54482, KC54483, KC54485, KC54488, KC54494, KC54495, KC54499, KC54508, KC54511, KC54630, KC54636, KC54637, KC54639, KC54644, KC54649, KC54651, KC54709, KC54718, KC54722, KC54722, KC54757, KC54761, KC54764, KC54765, KC54770, KC54777, KC54778, KC54782, KC54783, KC54808, KC54812, KC54813, KC54815, KC54817, KC54821, KC54844, KC54946, KC54947, KC54949, KC54951, KC54959, KC54966, KC54967, KC54968, KC54983, KC54985, KC54986, KC54988, KC54989, KC54991, KC54994, KC55071, KC55072, KC55073, KC55075, KC55101, KC55111, KC5513, KC55162, KC55169, KC55171, KC55173, KC55183, KC55191, KC55202, KC55220, KC5525, KC55258, KC55301, KC55302, KC55303, KC55304, KC55305, KC55306, KC55307, KC55309, KC55310, KC55314, KC55321, KC55322, KC55324, KC55343, KC55400, KC55402, KC55465, KC55470, KC55476, KC55485, KC55505, KC55509, KC55511, KC55515, KC55517, KC55529, KC55576, KC55590, KC55592, KC55595, KC55596, KC55599, KC55601, KC89748, KE51321, KE51326, KE51329, KE51331, KE51408, KE51412, KE51413, KE51418, KE51419, KE51432, KE51433, KE51434, KE51436, KE51438, KE51440, KE51442, KE51444, KE51449, KE51453, KE51477, KE51517, KE51520, KE51522, KE51523, KE51526, KE51529, KE51533, KE51535, KE51538, KE51556, KE51558, KE51560, KE51561, KE51562, KE51563, KE51565, KE51626, KE51630, KE51634, KE51638, KE51653, KE51655, KE51753, KE51890, KE51895, KE51897, KE51902, KE51904, KE51906, KE51907, KE51909, KE51918, KE51932, KE51934, KE51935, KE51936, KE51960, KE51961, KE51962, KE51963, KE51964, KE51965, KE51966, KE51967, KE51968, KE51969, KE51970, KE51972, KE51975, KE51980, KE51988, KE52003, KE52005, KE52007, KE52009, KE52011, KE52017, KE52019, KE52021, KE52022, KE52027, KG89661, KG89678, KG89679, KG89680, KG89681, KG89682, KG89683, KG89684, KG89685, KG89686, KG89688, KG89689, KG89691, KG89692, KG89693, KG89694, KG89697, KG89698, KG89699, KG89700, KG89702, KG89703, KG89704, KG89705, KG89706, KG89707, KG89709, KG89710, KG89711, KG89712, KG89713, KG89714, KG89715, KG89716, KG89717, KG89718, KG89719, KG89721, KG89722, KG89723, KG89724, KG89725, KG89726, KG89727, KG89728, KG89729, KG89730, KG89731, KG89732, KG89733, KG89734, KG89735, KG89736, KG89738, KG89739, KG89740, KG89741, KG89742, KG89743, KG89744, KG89745, KG89747, KG89749, KG89750, KG89751, KG89752, KG89753, KG89754, KG89755, KG89756, KG89757, KG89758, KG89759, KG89760, KG89761, KG89762, KG89763, KG89764, KG89765, KG89766, KG89767, KG89768, KG89769, KG89770, KG89771, KG89772, KG89773, KG89774, KG89775, KG89776, KG89777, KG89778, KG89779, KG89780, KG89782, KG89783, KG89784, KG89784, KG89786, KG89788, KG89790, KG89791, KG89792, KG89793, KG89795, KG89796, KG89797, KG89798, KG89799, KG89800, KG89801, KG89802, KG89803, KG89804, KG89805, KG89806, KG89807, KG89808, KG89809, KG89810, KG89811, KG89813, KG89814, KG89815, KG89816, KG89817, KG89818, KG89819, KG89820, KG89821, KG89822, KG89823, KG89824, KG89825, KG89826, KG89827, KG89828, KG89829, KG89830, KG89831, KG89832, KG89833, KG89835, KG89836, KG89837, KG89838, KG89839, KG89840, KG89841, KG89842, KG89844, KG89845, KG89846, KG89847, KG89848, KG89849, KG89852, KG89853, KG89854, KG89855, KG89856, KG89857, KG89859, KG89861, KG89862, KG89864, KG89865, KG89866, KG89867, KG89868, KG89869, KG89870, KG89871, KG89872, KG89873, KG89874, KG89875, KG89876, KG89877, KG89878, KG89879, KG89881, KG89882, KG89883, KG89884, KG89886, KG89887, KG89889, KG89890, KG89891, KG89893, KG89894, KG89895, KG89896, KG89897, KG89898, KG89899, KG89900, KG89901, KG89903, KG89904, KG89905, KG89907, KG89909, KG89910, KG89911, KG89912, KG89913, KG89914, KG89915, KG89916, KG89917, KG89918, KG89919, KG89920, KG89921, KG89922, KG89925, KG89926, KG89928, KG89933, KG89935, KG89936, KG89938, KG89940, KG89941, KG89942, KG89943, KG89945, KG89947, KG89948, KG89949, KG89950, KG89951, KG89952, KG89953, KG89954, KG89955, KG89956, KG89957, KG89958, KG89959, KG89960, KG89962, KG89963, KG89964, KG89966, KG89967, KG89968, KG89971, KG89972, KG89973, KG89975, KG89977, KG89978, KG89979, KG89980, KG89982, KG89983, KG89984, KG89986, KG89987, KG89990, KG89993, KG89994, KG89995, KG89996, KG89997, KG90003, KG90004, KG90005, KG90006, KG90009, KG90022, KG90023, KG90024, KG90028, KG90029, KG90031, KG90035, KG90038, KG90040, KG90043, KG90045, KG90047, KG90048, KG90049, KG90056, KG90057, KG90059, KG90060, KG90061, KG90062, KG90063, KG90065, KG90066, KG90067, KG90068, KG90072, KG90077, KG90080, KG90091, KG90092, KG90094, KG90096, KG90097, KG90103, KG90106, KG90107, KG90108, KH0006, KH39535, KH39540, KH39541, KH39542, KH39543, KH39544, KH39545, KH39546, KH39547, KH39548, KH39549, KH39550, KH39551, KH39552, KH39554, KH39555, KH39556, KH39558, KH39559, KH39560, KH39561, KH39562, KH39563, KH39565, KH39566, KH39567, KH39568, KH39569, KH39570, KH39571, KH39572, KH39573, KH39575, KH39576, KH39577, KH39578, KH39579, KH39580, KH39582, KH39583, KH39584, KH39585, KH39586, KH39587, KH39589, KH39590, KH39592, KH39593, KH39596, KH39597, KH39598, KH39599, KH39600, KH39602, KH39603, KH39604, KH39605, KH39606, KH39608, KH39609, KH39610, KH39611, KH39612, KH39613, KH39615, KH39616, KH39617, KH39618, KH39619, KH39620, KH39621, KH39622, KH39623, KH39624, KH39625, KH39626, KH39627, KH39629, KH39630, KH39631, KH39632, KH39635, KH39638, KH39640, KH39642, KH39643, KH39644, KH39645, KH39647, KH39648, KH39649, KH39650, KH39651, KH39652, KH39653, KH39654, KH39655, KH39656, KH39657, KH39658, KH39659, KH39660, KH39661, KH39662, KH39663, KH39664, KH39665, KH39666, KH39667, KH39668, KH39669, KH39670, KH39671, KH39672, KH39673, KH39674, KH39675, KH39676, KH39677, KH39678, KH39679, KH39680, KH39681, KH39682, KH39683, KH39684, KH39685, KH39686, KH39688, KH39689, KH39690, KH39692, KH39693, KH39694, KH39695, KH39696, KH39697, KH39698, KH39699, KH39700, KH39701, KH39702, KH39703, KH39704, KH39705, KH39706, KH39708, KH39709, KH39710, KH39711, KH39715, KH39717, KH39719, KH39721, KH39722, KH39723, KH39725, KH39726, KH39727, KH39728, KH39729, KH39730, KH39732, KH39733, KH39734, KH39735, KH39736, KH39737, KH39738, KH39739, KH39740, KH39741, KH39742, KH39743, KH39746, KH39747, KH39748, KH39749, KH39750, KH39752, KH39753, KH39754, KH39755, KH39756, KH39757, KH39758, KH39759, KH39760, KH39761, KH39762, KH39763, KH39764, KH39765, KH39766, KH39767, KH39768, KH39769, KH39770, KH39771, KH39772, KH39773, KH39776, KH39777, KH39778, KH39780, KH39781, KH39782, KH39785, KH39787, KH39789, KH39791, KH39792, KH39794, KH39795, KH39796, KH39797, KH39798, KH39801, KH39802, KH39803, KH39804, KH39805, KH39806, KH39807, KH39808, KH39809, KH39811, KH39812, KH39813, KH39814, KH39815, KH39816, KH39817, KH39818, KH39820, KH39821, KH39823, KH39824, KH39825, KH39826, KH39827, KH39828, KH39830, KH39831, KH39833, KH39834, KH39835, KH39837, KH39838, KH39840, KH39841, KH39842, KH39844, KH39846, KH39847, KH39849, KH39850, KH39852, KH39853, KH39854, KH39855, KH39856, KH39857, KH39858, KH39859, KH39860, KH39861, KH39862, KH39863, KH39864, KH39865, KH39866, KH39867, KH39869, KH39870, KH39871, KH39872, KH39873, KH39874, KH39876, KH39877, KH39878, KH39879, KH39880, KH39882, KH39883, KH39884, KH39885, KH39886, KH39887, KH39888, KH39889, KH39891, KH39893, KH39895, KH39896, KH39897, KH39898, KH39899, KH39902, KH39903, KH39904, KH39906, KH39907, KH39908, KH39910, KH39912, KH39914, KH39915, KH39916, KH39917, KH39919, KH39920, KH39921, KH39922, KH39924, KH39927, KH39928, KH39929, KH39931, KH39939, KH39940, KH39947, KH39950, KH39951, KH39954, KH39955, KH39956, KH39957, KH39959, KH39962, KH39964, KH39966, KH39967, KH39968, KH39969, KH39970, KH39974, KH39979, KH39980, KH39984, KH39990, KH39992, KH39995, KH39996, KH39998, KH39999, KH40000, KH40001, KH40002, KH40004, KH40005, KH40007, KH40008, KH40010, KH40011, KH40012, KH40013, KH40014, KH40015, KH40016, KH40017, KH40021, KH40028, KH40032, KH40045, KH40047, KH40053, KH40054, KH40061, KH40063, KH40065, KH40066, KH40069, KH40076, KH40083, KH40086, KH40091, KH40097, KH40099, KH40102, KH40106, KJ47030, KJ47037, KJ47089, KJ47122, KJ47127, KJ47132, KJ47141, KJ47144, KJ47145, KJ47147, KJ47152, KJ47155, KJ47159, KJ47165, KJ47167, KJ47170, KJ47174, KJ47179, KJ47180, KJ47182, KJ47183, KJ47185, KJ47186, KJ47187, KJ47188, KJ47190, KJ47191, KJ47193, KJ47195, KJ47197, KJ47199, KJ47200, KJ47448, KJ47450, KJ47631, KJ47763, KJ47764, KJ47766, KJ47771, KJ47775, KJ47784, KJ47786, KJ47792, KL04258, KL04259, KL04262, KL04263, KL04264, KL04265, KL04268, KL04269, KL04270, KL04271, KL04272, KL04273, KL04275, KL04276, KL04278, KL04279, KL04281, KL04282, 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KM04167, KM04170, KM04171, KM04172, KM04173, KM04174, KM04177, KM04178, KM04180, KM04181, KM04182, KM04186, KM04187, KM04188, KM04189, KM04191, KM04192, KM04193, KM04194, KM04196, KM04197, KM04198, KM04201, KM04202, KM04203, KM04205, KM04211, KM04215, KM04216, KM04220, KM04226, KM04227, KM04229, KM04231, KM04238, KM04239, KM04240, KM04241, KM04243, KM04244, KM04245, KM04246, KM04249, KM04256, KM04257, KM04258, KM04259, KM04261, KM04263, KM04264, KM04268, KM04278, KM04279, KM04281, KM04289, KM04290, KM04295, KM04296, KM04297, KM04302, KM04303, KM04306, KM04310, KM04315, KM04317, KM04318, KM04319, KM04320, KM04322, KM04323, KM04328, KM04330, KM04336, KM04338, KM04340, KM04341, KM04342, KN03926, KN03929, KN03930, KN03932, KN03944, KN03947, KN03950, KN03955, KN03960, KN03963, KN03965, KN03966, KN03968, KN03969, KN03970, KN03975, KN03976, KN03979, KN03981, KN03983, KN03984, KN03986, KN03987, KN03988, KN03989, KN03990, KN03994, KN03995, KN03997, KN04000, KN04022, KN04025, KN04027, KN04029, KN04032, KN04037, KN04039, KN04041, KN04044, KN04062, KN04066, KN04068, KN04071, KN04072, KN04074, KN04078, KN04079, KN04080, KN04081, KN04082, KN04083, KN04084, KN04085, KN04088, KN04090, KN04091, KN04092, KN04093, KN04094, KN04095, KN04096, KN04097, KN04098, KN04099, KN04100, KN04102, KN04103, KN04104, KN04105, KN04106, KN04107, KN04108, KN04109, KN04110, KN04111, KN04113, KN04114, KN04115, KN04116, KN04117, KN04118, KN04119, KN04120, KN04121, KN04122, KN04123, KN04124, KN04124, KN04125, KN04126, KN04127, KN04128, KN04129, KN04131, KN04133, KN04134, KN04135, KN04137, KN04138, KN04139, KN04140, KN04141, KN04142, KN04144, KN04145, KN04147, KN04150, KN04152, KN04153, KN04154, KN04155, KN04156, KN04159, KN04160, KN04161, KN04162, KN04163, KN04164, KN04165, KN04166, KN04168, KN04169, KN04170, KN04171, KN04173, KN04174, KN04175, KN04176, KN04177, KN04178, KN04179, KN04180, KN04181, KN04182, KN04183, KN04185, KN04187, KN04188, KN04189, KN04190, KN04191, KN04192, KN04194, KN04195, KN04196, 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KS58667, KS58669, KS58670, KS58671, KS58674, KS58675, KS58677, KS58679, KS58680, KS58682, KS58683, KS58684, KS58685, KS58686, KS58688, KS58690, KS58691, KS58692, KS58693, KS58695, KS58696, KS58701, KS58702, KS58703, KS58707, KS58709, KS58710, KS58711, KS58714, KS58715, KS58716, KS58717, KS58718, KS58721, KS58727, KS58730, KS58731, KS58732, KS58733, KS58735, KS58736, KS58737, KS58738, KS58739, KS58740, KS58742, KS58743, KS58744, KS58747, KS58748, KS58752, KS58753, KS58754, KS58755, KS58757, KS58760, KS58761, KS58762, KS58764, KS58765, KS58766, KS58767, KS58769, KS58770, KS58772, KS58773, KS58774, KS58776, KS58778, KS58779, KS58782, KS58783, KS58784, KS58786, KS58787, KS58788, KS58791, KS58794, KS58796, KS58797, KS58799, KS58802, KS58804, KS58805, KS58807, KS58808, KS58810, KS58812, KS58813, KS58814, KS58815, KS58818, KS58821, KS58823, KS58825, KS58826, KS58828, KS58829, KS58830, KS58832, KS58833, KS58834, KS58837, KS58839, KS58840, KS58841, KS58842, KS58845, KS58846, KS58847, KS58848, KS58850, KS58851, KS58852, KS58853, KS58854, KS58855, KS58856, KS58857, KS58858, KS58859, KS58860, KS58862, KS58863, KS58865, KS58866, KS58867, KS58868, KS58869, KS58870, KS58871, KS58872, KS58873, KS58874, KS58875, KS58876, KS58878, KS58879, KS58880, KS58881, KS58882, KS58883, KS58886, KS58888, KS58892, KS58893, KS58895, KS58896, KS58899, KS58900, KS58903, KS58904, KS58905, KS58906, KS58907, KS58908, KS58909, KS58911, KS58913, KS58916, KS58918, KS58919, KS58928, KS58931, KS58933, KS58934, KS58935, KS58939, KS58940, KS58942, KS58944, KS58946, KS58949, KS58951, KS58955, KS58958, KS58959, KS58960, KS58961, KS58962, KS58963, KS58964, KS58965, KS58966, KS58967, KS58968, KS58970, KS58973, KS58976, KS58978, KS58980, KS58981, KS58982, KS58985, KS58986, KS58987, KS58990, KS58991, KS58992, KS58996, KS58997, KS58999, KS59001, KS59003, KS59005, KS59007, KS59013, KS59014, KS59018, KS59022, KS59023, KS59024, KS59028, KS59032, KS59033, KS59034, KS59035, KS59036, KS59038, KS59040, KS59042, KS59043, KS59044, KS59045, KS59046, KS59047, KS59048, KS59049, KS59050, KS59051, KS59052, KS59053, KS59054, KS59056, KS59057, KS59060, KS59061, KS59062, KS59063, KS59064, KS59066, KS59067, KS59068, KS59069, KS59070, KS59072, KS59073, KS59074, KS59076, KS59077, KS59078, KS59079, KS59080, KS59081, KS59084, KS59085, KS59086, KS59087, KS59088, KS59091, KS59092, KS59093, KS59094, KS59095, KS59096, KS59097, KS59098, KS59099, KS59102, KS59103, KS59105, KS59108, KS59109, KS59111, KS59112, KS59114, KS59115, KS59116, KS59117, KS59119, KS59120, KS59121, KS59122, KS59123, KS59124, KS59125, KS59126, KS59128, KS59129, KS59132, KS59133, KS59134, KS59135, KS59137, KS59138, KS59140, KS59144, KS59145, KS59146, KS59148, KS59150, KS59151, KS59152, KS59153, KS59154, KS59155, KS59156, KS59157, KS59163, KS59164, KS59165, KS59167, KS59168, KS59169, KS59170, KS59172, KS59173, KS59174, KS59177, KS59178, KS59180, KS59181, KS59182, KS59184, KS59185, KS59187, KS59188, KS59189, KS59190, KS59193, KS59194, KS59195, KS59196, KS59199, KS59203, KS59204, KS59205, KS59209, KS59211, KS59212, KS59217, KS59218, KS59228, KS59257, KS59258, KS59260, KS59261, KS59262, KS59263, KS59264, KS59267, KS59268, KS59269, KS5927, KS59270, KS59271, KS59272, KS59274, KS59276, KS59277, KS59278, KS59279, KS59280, KS59281, KS59282, KS59283, KS59284, KS59285, KS59286, KS59290, KS59292, KS59294, KS59305, KS59307, KS59308, KS59309, KS59310, KS59311, KS59312, KS59313, KS59314, KS59315, KS59317, KS59319, KS59320, KS59321, KS59322, KS59323, KS59324, KS59326, KS59327, KS59328, KS59329, KS59330, KS59331, KS59333, KS59334, KS59335, KS59336, KS59337, KS59341, KS59342, KS59343, KS59344, KS59345, KS59346, KS59347, KS59348, KS59349, KS59350, KS59351, KS59352, KS59353, KS59354, KS59355, KS59355, KS59356, KS59357, KS59358, KS59359, KS59360, KS59362, KS59364, KS59365, KS59366, KS59367, KS59370, KS59371, KS59372, KS59373, KS59374, KS59375, KS59376, KS59377, KS59378, KS59379, KS59381, KS59382, KS59386, KS59387, KS59388, KS59389, KS59390, KS59391, KS59392, KS59393, KS59394, KS59397, KS59398, KS59399, KS59401, KS59402, KS59403, KS59404, KS59405, KS59406, KS59407, KS59408, KS59411, KS59414, KS59415, KS59416, KS59418, KS59419, KS59421, KS59425, KS59427, KS59428, KS59429, KS59430, KS59431, KS59432, KS59433, KS59434, KS59439, KS59441, KS59447, KS59448, KS59449, KS59450, KS59452, KS59454, KS59456, KS59458, KS59461, KS59464, KS59466, KS59467, KS59469, KS59470, KS59471, KS59473, KS59476, KS59482, KS59484, KS59487, KS59489, KS59490, KS59491, KS59498, KS59499, KS59500, KS59502, KS59504, KS59505, KS59509, KS59510, KS59512, KS59513, KS59515, KS59516, KS59518, KS59520, KS59522, KS59529, KS59531, KS59533, KS59535, KS59536, KS59540, KS59542, KS59545, KS59546, KS59548, KS59549, KS59552, KS59553, KS59555, KS59558, KS59560, KS59562, KS59563, KS59564, KS59565, KS59566, KS59568, KS59569, KS59570, KS59571, KS59574, KS59575, KS59578, KS59581, KS59582, KS59583, KS59584, KS59585, KS59586, KS59587, KS59588, KS59589, KS59590, KS59593, KS59596, KS59597, KS59598, KS59600, KS59602, KS59603, KS59605, KS59606, KS59608, KS59615, KS59616, KS59619, KS59620, KS59621, KS59622, KS59624, KS59626, KS59628, KS59629, KS59630, KS59631, KS59633, KS59635, KS59636, KS59637, KS59638, KS59641, KS59642, KS59643, KS59644, KS59645, KS59647, KS59648, KS59649, KS59650, KS59652, KS59653, KS59656, KS59657, KS59658, KS59660, KS59662, KS59663, KS59664, KS59665, KS59666, KS59670, KS59675, KS59676, KS59681, KS59682, KS59683, KS59684, KS59687, KS59690, KS59693, KS59696, KS59699, KS59700, KS59702, KS59704, KS59706, KS59707, KS59708, KS59710, KS59711, KS59713, KS59717, KS59719, KS59722, KS59723, KS59724, KS59725, KS59729, KS59733, KS59735, KS59739, KS59741, KS59742, KS59743, KS59744, KS59769, KS59772, KS59774, KS59780, KS59782, KS59783, KS59785, KS59786, KS59787, KS59789, KS59791, KS59792, KS59794, KS59798, KS59799, KS59806, KS59813, KS59815, KS59818, KS59820, KS59821, KS59823, KS59824, KS59854, KS59858, KS59865, KS59871, KS59875, KS59881, KS59883, KS59885, KS59886, KS59893, KS59894, KS59901, KS59904, KS59910, KS59913, KS59915, KS59925, KS59936, KS59943, KS59949, KS59952, KS59953, KS59954, KS59966, KS59968, KS59971, KS59972, KS59974, KS59976, KS59977, KS59986, KS59988, KS59991, KS59992, KS59995, KS59999, KS60001, KS60003, KS60004, KS60007, KS60009, KS60010, KS60014, KS60087, KS60099, KS60100, KS60111, LF56796, LF56804, LF56810, LR23024, LR30649, LR30652, LR30657, LR30662, LR30667, LR30955, LR30957, LR30958, LR30961, LR30962, LR30964, LR30965, LR30967, LR30968, LR31228, LR31487, LR31616, LR31617, LR31619, LR31620, LR31622, LR31623, LR31625, LR31628, LR31675, LR31676, LR31678, LR31681, LR31689, LR31703, LR31741, LR31742, LR31743, LR31751, LR31752, LR31755, LR31760, LR31762, LR31764, LR31809, LR31811, LR31814, LR31815, LR31816, LR31817, LR31823, LR31824, LR31826, LR31827, LR31828, LR31832, LR31843, LR31845, LR31854, LR31858, LR31867, LR31868, LR31902, LR31903, LR31907, LR31914, LR31927, LR31928, LR31930, LR31931, LR31932, LR31938, LR31941, LR31945, LR31950, LR31952, LR31955, LR31959, LR31963, LR31970, LR31972, LR31976, LR31979, LR31982, LR31983, LR32019, LR32020, LR32023, LR32026, LR32030, LR32034, LR32035, LR32036, LR32080, LR32081, LR32092, LR32094, LR32282, LR32284, LV18860, LV18861, LV18863, LV18867, LV18873, LV18875, LV18876, LV18878, LV18882, LV18884, LV18886, LV18893, LV18897, LV18899, LV18907, LV18933, LV19093, LV19098, LV19100, LV19102, LV19105, LV19107, LV19114, LV19125, LV19146, LV19161, LV19162, LV19223, LV19226, LV19228, LV19231, LV19232, LV19235, LV19236, LV19240, LV19242, LV19247, LV19251, LV19252, LV19267, LV19272, LV19275, LV19276, LV19278, LV19284, LV19286, LV19288, LV19291, LV19294, LV19300, LV19304, LV19307, LV19309, LV19310, LV19311, LV19371, LV19390, LV19404, LV19405, LV19410, LV19414, LV19422, LV19423, LV19424, LV19425, LV19426, LV19427, LV19428, LV19429, LV19430, LV19431, LV19432, LV19433, LV19434, LV19435, LV19436, LV19437, LV19439, LV19440, LV19441, LV19442, LV19443, LV19444, LV19446, LV19447, LV19449, LV19452, LV19453, LV19456, LV19457, LV19458, LV19459, LV19460, LV19461, LV19462, LV19463, LV19465, LV19514, LV19516, LV19519, LV19528, LV19533, LV19538, LV19612, LV19613, LV19614, LV19616, LV19617, LV19618, LV19619, LV19624, LV19626, LV19643, LV19644, LV19645, LV19646, LV19649, LV19650, LV19652, LV19653, LV19656, LV19658, LV19747, LV19751, LV19755, LV19756, LV19773, LV19777, LV19779, LV19780, LV19786, LV19788, LV19789, LV19828, LV19832, LV19836, LV19840, LV19841, LV19849, LV19911, LV19938, LV19979, LV19984, LV19996, LV20003, LV20017, LV20018, LV20024, LV20026, LV20027, LV20031, LV20043, LV20044, LV20048, LV20078, LV20080, LV20081, LV20157, LV20162, LV20163, LV20168, LV20201, LV20202, LV20203, LV20206, LV20210, LV20212, LV20215, LV20216, LV20219, LV20220, LV20223, LV20224, LV20226, LV20231, LV20232, LV20234, LV20235, LV20236, LV20238, LV20240, LV20241, LV20244, LV20245, LV20250, LV20252, LV20261, LV20270, LV20271, LV20276, LV20279, LV20281, LV20282, LV20284, LV20285, LV20286, LV20306, LV20309, LV20382, LV20391, LV20410, LV20417, LV20433, LV20436, LV20440, LV20451, LV20505, LV20555, and LV20643
b) unit numbers FG96373, FG96374, FG96378, FG96388, FG96647, FG96667, FG96673, FG96688, FG96769, FG96773, FG96776, FG96779, FG96783, FG96784, FG96786, FG96818, FG96821, FG96825, FG96829, FG96830, FG96835, FG96836, FG96837, FG96839, FG96840, FG96842, FG96845, FG96847, FG97065, FG97068, FG97074, FG97079, FG97084, FG97088, FG97090, FG97092, FG97139, FG97143, FG97147, FG97149, FG97151, FG97153, FG97154, FG97156, FG97157, FG97160, FG97162, FG97165, FG97166, FG97167, FG97171, FG97174, FG97175, FG97179, FG97181, FG97184, FG97186, FG97187, FG97188, FG97189, FG97190, FG97191, FG97192, FG97194, FG97197, FG97198, FG97202, FG97203, FG97392, FG97394, FG97395, FG97398, FG97401, FG97404, FG97407, FG97408, FG97412, FG97418, FG97702, FG97708, FG97709, FG97711, FG97712, FG97718, FL01216, FL01220, FL01241, FL01243, FL01244, FL01247, FL01363, FL01629, FL01633, FL01635, FL01637, FL01639, FL01640, FM03825, FM03826, FM03908, FM03909, FM03912, FM03913, FM04108, FM04109, FM04110, FM04114, FM04119, FM04121, FM04122, FM04125, FM04127, FM04131, FM04133, FM04137, FM04139, FM04140, FM04143, FM04149, FM04152, FM04153, FM04155, FM04159, FM04170, FM04173, FM04190, FM04192, FM04197, FM04198, FS46614, FS46624, FS46627, FS46688, FS46767, FS46772, FS46812, FS46819, FS46828, FS46833, FS46834, FS46934, FS46938, FT02679, FT02753, FT02761, GE47198, GE47200, GE47201, GE47211, GE47214, GE47218, GE47224, GE47226, GE47227, GE47228, GE47258, GE47261, GE47263, GE47265, GE47266, GE47272, GE47273, GE47275, GE47401, GE47403, GG69534, GG69758, GG69766, GG69767, GG69777, GG70063, GG70085, GG70090, GJ66370, GJ66372, GJ66373, GJ66376, GJ66380, GJ66382, GJ66383, GJ66386, GJ66387, GJ66400, GJ66405, GJ66407, GJ66409, GJ66410, GJ66445, GJ66461, GJ66463, GJ66466, GJ66467, GJ66469, GJ66470, GJ66472, GJ66475, GJ66476, GJ66479, GJ66481, GJ66484, GJ66485, GJ66486, GJ66490, GJ66888, GJ66890, GJ66892, GJ66901, GJ66904, GJ67012, GJ67209, GJ67215, GJ67219, GJ6724, GJ67304, GJ67315, GJ67317, GJ67319, GL08264, GL08267, GL08268, GL08269, GL08272, GL08331, GL08335, GL08343, GL08347, GL08354, GL08357, GL08394, GP43428, GP43711, GP43713, GP43719, GP43723, GP44498, GP47321, GR33061, GR33063, GR33065, GR33067, GR33068, GR33069, GR33070, GR33071, GR33073, GR33077, GR33392, GR33402, GR33403, GR33412, GR33413, GV37210, GV37214, GV37216, GV37239, GV37354, GV37458, GV37475, GV37486, GV37489, GV37491, GV37498, GV37517, GV37523, GV37529, GV37570, GV37572, GV37579, GV37663, GV37666, GV37668, GV37670, GV37673, GV37675, GV37676, GV37680, GV37683, GV37727, GV37733, GV37735, GV37760, GV37764, GV37768, GV37771, GV37773, GV37779, GV37783, GV37787, GV37789, GV37792, GV37799, GV37800, GV37803, GV37845, GV37851, GV37860, GV37863, GV37866, GV37871, GV37875, GV37879, GV37881, GV37884, GV37886, GV37899, GV37905, GV37967, GV37969, GV37969, GV37970, GV37973, GV37974, GV37976, GV37977, GV37980, GV37981, GV37982, GV37984, GV37987, GV37990, GV37991, GV37994, GV37995, GV37997, GV37999, GV38004, GV38005, GV38011, GV38057, GV38181, GV38186, GV38251, GV38253, GV38258, GV38510, GV38513, GV38515, GV38518, GV38520, GV38525, GV38583, GV38620, GV38629, GV38631, GV38640, GV38641, GV38649, GV38652, GV38656, GV38899, GV38906, GV38918, GV38923, GV38932, GV38940, GV38943, GV38963, GV38974, GV38983, GV38994, GV39007, GV39023, GV39027, GV39030, GV39042, GV39045, GV39076, GV39079, GV39081, GV39083, GV39093, GV39094, GV39096, GV39103, GV39109, GV39111, GV39115, GV39119, GV39120, GV39121, GV39123, GV39126, GV39130, GV39133, GV39134, GV39136, GV39138, GV39141, GV39143, GV39147, GV39149, GV39152, GV39157, GV39280, GV39288, GV39292, GV39300, GV39362, KC53812, KC53814, KC53822, KC53825, KC53827, KC53829, KC53831, KC53975, KC53977, KC53980, KC53984, KC54009, KC54011, KC54012, KC54013, KC54016, KC54019, KC54021, KC54045, KC54046, KC54048, KC54053, KC54057, KC54061, KC54067, KC54068, KC54366, KC54369, KC54374, KC54377, KC54385, KC54418, KC54428, KC54436, KC54442, KC54478, KC54479, KC54480, KC54481, KC54482, KC54483, KC54485, KC54488, KC54493, KC54494, KC54495, KC54499, KC54704, KC54709, KC54712, KC54714, KC54764, KC54765, KC54767, KC54769, KC54770, KC54772, KC54778, KC54782, KC54783, KC54808, KC54810, KC54812, KC54813, KC54815, KC54817, KC54821, KC54940, KC54951, KC54953, KC54955, KC54959, KC54966, KC54980, KC54983, KC54985, KC54986, KC54987, KC54988, KC54989, KC54990, KC54991, KC54993, KC54994, KC55065, KC55067, KC55070, KC55071, KC55072, KC55073, KC55075, KC55082, KC55095, KC55101, KC55111, KC55141, KC55146, KC55151, KC55155, KC55158, KC55160, KC55162, KC55166, KC55169, KC55171, KC55173, KC55175, KC55177, KC55179, KC55181, KC55183, KC55184, KC55191, KC55193, KC55197, KC55199, KC55214, KC55221, KC55223, KC55231, KC55238, KC55240, KC55245, KC55248, KC55251, KC55256, KC55257, KC55258, KC55300, KC55301, KC55302, KC55303, KC55304, KC55305, KC55307, KC55309, KC55314, KC55316, KC55317, KC55321, KC55322, KC55324, KC55341, KC55408, KC55465, KC55470, KC55476, KC55480, KC55485, KC55505, KC55507, KC55509, KC55511, KC55512, KC55517, KC55576, KC55590, KC55592, KC55595, KC55596, KC55599, KC55600, KE51321, KE51408, KE51412, KE51413, KE51418, KE51419, KE51432, KE51433, KE51434, KE51436, KE51438, KE51440, KE51444, KE51449, KE51477, KE51517, KE51520, KE51522, KE51523, KE51526, KE51529, KE51533, KE51535, KE51538, KE51556, KE51630, KE51648, KE51653, KE51655, KE51753, KE51882, KE51887, KE51888, KE51890, KE51892, KE51894, KE51895, KE51896, KE51897, KE51902, KE51904, KE51907, KE51909, KE51911, KE51929, KE51931, KE51932, KE51934, KE51961, KE51965, KE51969, KE51974, KE52003, KE52005, KE52007, KE52009, KE52013, KG89827, KG89828, KG89829, KG89830, KG89831, KG89832, KG89833, KG89836, KG89837, KG89935, KG89936, KG89938, KG89939, KG89941, KG89943, KG89970, KG89971, KG89972, KG89973, KG89974, KG89975, KG89976, KG89977, KG89978, KG90009, KG90010, KG90011, KG90012, KG90043, KH39629, KH39631, KH39858, KH39931, KH39933, KH39934, KH39959, KH39986, KH39988, KH39990, KH39992, KH39995, KH40013, KH40014, KH40015, KH40016, KH40017, KH40098, KH40099, KH40100, KH40102, KH40104, KJ44763, KJ47089, KJ47141, KJ47144, KJ47145, KJ47152, KJ47155, KJ47159, KJ47167, KJ47450, KJ47492, KJ47760, KJ47764, KJ47766, KJ47771, KJ47775, KL04292, KL04295, KL04296, KL04400, KL04407, KL04408, KL04411, KL04412, KL04413, KL04414, KL04415, KL04417, KL04418, KL04419, KL04420, KL04422, KL04423, KL04424, KL04425, KL04427, KL04428, KL04468, KL04468, KL04470, KL04522, KL04523, KL04524, KL04525, KL04526, KL04591, KL04592, KL04593, KL04594, KL04595, KL04596, KL04597, KL04598, KL04599, KL04600, KL04601, KL04678, KL04679, KL04680, KL04681, KL04682, KL04684, KL04685, KL04686, KL04687, KL04688, KL04689, KL04690, KL04691, KL04692, KL04693, KM03864, KM03865, KM03866, KM03867, KM03868, KM03869, KM03871, KM03872, KM03873, KM03874, KM03875, KM03876, KM03891, KM03899, KM03902, KM03949, KM03950, KM03952, KM03953, KM03954, KM03956, KM03957, KM03958, KM03960, KM03962, KM03963, KM03964, KM03980, KM03981, KM03982, KM03983, KM03984, KM03985, KM03986, KM03987, KM03988, KM03989, KM03994, KM04032, KM04034, KM04046, KM04047, KM04048, KM04049, KM04051, KM04052, KM04053, KM04054, KM04055, KM04058, KM04071, KM04130, KM04133, KM04134, KM04177, KM04186, KM04194, KM04198, KM04201, KM04236, KM04237, KM04238, KM04239, KM04240, KM04242, KM04243, KM04244, KM04245, KM04246, KM04248, KM04249, KM04252, KM04253, KM04318, KM04320, KM04321, KM04322, KN04025, KN04027, KN04029, KN04032, KN04039, KN04044, KN04078, KN04079, KN04081, KN04082, KN04083, KN04084, KN04085, KN04088, KN04090, KN04115, KN04116, KN04129, KN04131, KN04133, KN04134, KN04135, KN04136, KN04137, KN04138, KN04152, KN04154, KN04155, KN04156, KN04158, KN04159, KN04162, KN04163, KN04164, KN04165, KN04166, KN04168, KN04212, KN04213, KN04214, KN04216, KN04218, KN04219, KN04220, KN04221, KN04222, KN04223, KN04224, KN04225, KN04226, KN04227, KN04228, KN04229, KN04230, KN04231, KN04232, KN04233, KN04234, KN04235, KN04236, KN04237, KN04238, KN04239, KN04240, KN04286, KP03122, KP03318, KP03353, KP03354, KP03355, KP03356, KP03358, KP03359, KP03360, KP03361, KS29729, KS29733, KS58196, KS58311, KS58313, KS58314, KS58316, KS58321, KS58326, KS58330, KS58333, KS58335, KS58343, KS58346, KS58348, KS58352 , KS58355, KS58363, KS58375, KS58377, KS58378, KS58388, KS58393, KS58394, KS58400, KS58405, KS58406, KS58411, KS58412, KS58414, KS58416, KS58541, KS58549, KS58554, KS58560, KS58566, KS58578, KS58593, KS58601, KS58602, KS58607, KS58613, KS58615, KS58622, KS58623, KS58624, KS58625, KS58627, KS58642, KS58693, KS58695, KS58701, KS58702, KS58703, KS58707, KS58744, KS58747, KS58748, KS58752, KS58753, KS58754, KS58755, KS58760, KS58761, KS58762, KS58764, KS58765, KS58766, KS58769, KS58772, KS58773, KS58774, KS58776, KS58779, KS58779, KS58782, KS58783, KS58786, KS58787, KS58791, KS58794, KS58796, KS58797, KS58799, KS58804, KS58805, KS58807, KS58808, KS58810, KS58812, KS58814, KS58815, KS58818, KS58821, KS58823, KS58825, KS58826, KS58828, KS58829, KS58830, KS58832, KS58833, KS58837, KS58839, KS58842, KS58845, KS58846, KS58847, KS58848, KS58850, KS58882, KS58883, KS58885, KS58886, KS58888, KS58892, KS58893, KS58894, KS58895, KS58896, KS58899, KS58900, KS58902, KS58903, KS58904, KS58905, KS58906, KS58908, KS58909, KS58911, KS58913, KS58916, KS58918, KS58919, KS58928, KS58931, KS58932, KS58933, KS58934, KS58939, KS58942, KS58944, KS58946, KS58949, KS58951, KS58955, KS58958, KS58959, KS58961, KS58962, KS58963, KS58964, KS58965, KS58966, KS58967, KS58968, KS58970, KS58972, KS58973, KS58976, KS58978, KS58982, KS58985, KS58986, KS58987, KS58990, KS58991, KS58996, KS58997, KS59001, KS59003, KS59007, KS59013, KS59014, KS59018, KS59022, KS59023, KS59024, KS59034, KS59035, KS59036, KS59038, KS59042, KS59043, KS59044, KS59045, KS59047, KS59048, KS59050, KS59052, KS59054, KS59056, KS59057, KS59059, KS59060, KS59061, KS59062, KS59064, KS59066, KS59067, KS59068, KS59069, KS59070, KS59072, KS59073, KS59074, KS59075, KS59076, KS59078, KS59079, KS59080, KS59081, KS59084, KS59085, KS59086, KS59087, KS59088, KS59091, KS59092, KS59093, KS59094, KS59095, KS59096, KS59097, KS59098, KS59102, KS59103, KS59105, KS59108, KS59109, KS59111, KS59112, KS59114, KS59115, KS59116, KS59117, KS59119, KS59120, KS59122, KS59123, KS59124, KS59125, KS59126, KS59127, KS59129, KS59131, KS59132, KS59133, KS59134, KS59135, KS59137, KS59138, KS59140, KS59142, KS59144, KS59145, KS59146, KS59148, KS59149, KS59151, KS59152, KS59154, KS59155, KS59156, KS59157, KS59159, KS59189, KS59195, KS59197, KS59257, KS59258, KS59260, KS59261, KS59262, KS59263, KS59266, KS59267, KS59268, KS59269, KS59270, KS59271, KS59272, KS59274, KS59276, KS59277, KS59278, KS59279, KS59283, KS59320, KS59321, KS59322, KS59323, KS59324, KS59325, KS59326, KS59327, KS59328, KS59329, KS59330, KS59331, KS59332, KS59333, KS59334, KS59335, KS59336, KS59337, KS59338, KS59339, KS59341, KS59342, KS59343, KS59344, KS59345, KS59346, KS59347, KS59349, KS59350, KS59351, KS59352, KS59354, KS59355, KS59356, KS59357, KS59359, KS59360, KS59366, KS59369, KS59371, KS59373, KS59374, KS59375, KS59376, KS59377, KS59379, KS59382, KS59384, KS59386, KS59387, KS59388, KS59389, KS59390, KS59391, KS59415, KS59418, KS59419, KS59421, KS59423, KS59427, KS59428, KS59430, KS59431, KS59432, KS59434, KS59435, KS59439, KS59440, KS59442, KS59446, KS59449, KS59450, KS59451, KS59452, KS59453, KS59454, KS59455, KS59458, KS59461, KS59462, KS59463, KS59464, KS59470, KS59471, KS59472, KS59473, KS59474, KS59475, KS59476, KS59477, KS59478, KS59479, KS59480, KS59484, KS59485, KS59487, KS59493, KS59494, KS59495, KS59496, KS59498, KS59499, KS59502, KS59504, KS59505, KS59506, KS59518, KS59520, KS59522, KS59525, KS59534, KS59536, KS59541, KS59549, KS59554, KS59559, KS59562, KS59563, KS59566, KS59567, KS59569, KS59571, KS59615, KS59616, KS59619, KS59620, KS59621, KS59624, KS59626, KS59628, KS59629, KS59630, KS59631, KS59633, KS59636, KS59637, KS59638, KS59641, KS59642, KS59648, KS59653, KS59655, KS59656, KS59661, KS59662, KS59666, KS59701, KS59702, KS59705, KS59706, KS59707, KS59708, KS59709, KS59710, KS59711, KS59712, KS59713, KS59714, KS59715, KS59717, KS59719, KS59720, KS59722, KS59723, KS59724, KS59725, KS59727, KS59728, KS59731, KS59732, KS59732, KS59734, KS59735, KS59736, KS59739, KS59741, KS59742, KS59743, KS59744, KS59746, KS59754, KS59757, KS59766, KS59835, KS59843, KS59844, KS59848, KS59850, KS59852, KS59853, KS59854, KS59858, KS59859, KS59860, KS59862, KS59865, KS59867, KS59868, KS59869, KS59871, KS59872, KS59874, KS59875, KS59876, KS59881, KS59885, KS59886, KS59887, KS59889, KS59890, KS59893, KS59896, KS59897, KS59899, KS59901, KS59903, KS59904, KS59905, KS59906, KS59907, KS59910, KS59913, KS59917, KS59918, KS59922, KS59923, KS59925, KS59927, KS59928, KS59929, KS59930, KS59932, KS59933, KS59934, KS59935, KS59937, KS59938, KS59940, KS59941, KS59943, KS59944, KS59947, KS59949, KS59950, KS59951, KS59952, KS59953, KS59954, KS59957, KS59958, KS59960, KS59962, KS59968, KS59972, KS59974, KS59976, KS59977, KS59978, KS59980, KS59982, KS59985, KS59986, KS59987, KS59988, KS59989, KS59990, KS59991, KS59993, KS59997, KS59998, KS59999, KS60000, KS60001, KS60003, KS60006, KS60007, KS60008, KS60009, KS60010, KS60011, KS60012, KS60014, KS60017, KS60084, KS60087, KS60097, KS60099, KS60100, KS60107, KS60111, KS60112, LF56796, LF56797, LF56810, LR30652, LR30955, LR30957, LR30958, LR30961, LR30962, LR30964, LR30967, LR30968, LR31610, LR31626, LR31675, LR31678, LR31681, LR31689, LR31691, LR31703, LR31708, LR31735, LR31741, LR31742, LR31748, LR31752, LR31823, LR31824, LR31825, LR31826, LR31827, LR31828, LR31832, LR31843, LR31845, LR31853, LR31854, LR31858, LR31867, LR31868, LR31876, LR31881, LR31887, LR31889, LR31892, LR31893, LR31899, LR31900, LR31902, LR31903, LR31907, LR31927, LR31928, LR31930, LR31932, LR31938, LR31941, LR31943, LR31945, LR31947, LR31950, LR31977, LR31982, LR31983, LR31985, LR32018, LR32019, LR32020, LR32022, LR32023, LR32024, LR32025, LR32026, LR32026, LR32028, LR32029, LR32030, LR32031, LR32032, LR32033, LR32034, LR32035, LR32038, LR32073, LR32080, LR32081, LR32092, LR32094, LR69065, LV18860, LV18861, LV18863, LV18867, LV18882, LV18884, LV18886, LV18893, LV18897, LV18899, LV18907, LV19093, LV19098, LV19146, LV19162, LV19223, LV19226, LV19228, LV19231, LV19232, LV19235, LV19236, LV19240, LV19242, LV19251, LV19252, LV19267, LV19272, LV19276, LV19284, LV19286, LV19288, LV19291, LV19294, LV19371, LV19390, LV19404, LV19405, LV19423, LV19424, LV19426, LV19427, LV19427, LV19428, LV19429, LV19431, LV19432, LV19433, LV19434, LV19435, LV19436, LV19437, LV19439, LV19440, LV19441, LV19442, LV19443, LV19444, LV19446, LV19449, LV19452, LV19453, LV19456, LV19457, LV19458, LV19459, LV19460, LV19461, LV19462, LV19463, LV19465, LV19514, LV19516, LV19519, LV19525, LV19528, LV19533, LV19537, LV19538, LV19610, LV19612, LV19613, LV19616, LV19617, LV19618, LV19619, LV19751, LV19773, LV19777, LV19780, LV19783, LV19788, LV19789, LV19828, LV19832, LV19836, LV19938, LV19979, LV19984, LV19991, LV19996, LV20003, LV20006, LV20009, LV20011, LV20031, LV20062, LV20068, LV20157, LV20159, LV20162, LV20163, LV20166, LV20201, LV20210, LV20212, LV20214, LV20215, LV20216, LV20218, LV20219, LV20220, LV20223, LV20224, LV20226, LV20231, LV20232, LV20234, LV20236, LV20238, LV20240, LV20241, LV20242, LV20243, LV20244, LV20245, LV20248, LV20250, LV20252, LV20261, LV20267, LV20270, LV20271, LV20281, LV20286, LV20306, LV20379, LV20391, LV20410, LV20414, LV20416, LV20417, LV20423, LV20436, LV20440, LV20441, LV20450, LV20451, LV20555, and LV20643
c) unit numbers FM04165, FM04166, FM04169, FS46927, FS46930, KC54705, KC54963, KC54968, KC55074, KC55076, KC55306, KC55308, KC55345, KC59467, KE51634, KE51638, KE51739, KE51740, KE51741, KE51743, KE51975, KH39898, KH39961, KM04193, KM04195, KM04196, KM04197, KM04199, KM04200, KM04203, KM04266, KM04268, KS59416, KS59447, KS59568, KS59574, KS59575, KS59578, KS59752, KS59759, KS59762, KS59763, KS59765, KS59827, KS59838, LR31809, LR31815, LR31816, LR31817, LR31952, LR31972, LR31986, LV19747, LV19779, LV19786, LV20276, LV20279, LV20427, and LV20437;
d) unit numbers FG96246, FG96248, FG96251, FG96373, FG96374, FG963811, FG96382, FG96388, FG96669, FG96839, FG96845, FG97065, FG97068, FG97074, FG97088, FG97090, FG97092, FG97136, FG97139, FG97143, FG97147, FG97149, FG97151, FG97153, FG97156, FG97157, FG97160, FG97162, FG97165, FG97167, FG97175, FG97177, FG97179, FG97184, FG97186, FG97188, FG97189, FG97192, FG97194, FG97197, FG97198, FG97202, FG97394, FG97395, FG97398, FG97401, FG97404, FG97407, FG97408, FG97412, FG97418, FG97692, FG97702, FG97709, FG97712, FG97718, FL01629, FL01633, FL01635, FL01639, FM03826, FM03909, FM04108, FM04109, FM04122, FM04133, FM04137, FM04139, FM04153, FM04159, FM04173, FM04198, FS46614, FS46624, FS46819, FS46938, GE47198, GE47200, GE47201, GE47214, GE47224, GE47226, GE47227, GE47228, GE47263, GE47266, GE47272, GE47272, GE47273, GG69767, GG70063, GJ66387, GJ66467, GJ66469, GJ66482, GJ66486, GJ66888, GJ66890, GJ66892, GJ66904, GJ67215, GJ67219, GJ67224, GL08267, GL08268, GL08272, GL08274, GL08276, GL08343, GL08344, GL08347, GP43428, GP43711, GP43713, GP43718, GP43719, GP43721, GP43723, GR33061, GR33063, GR33067, GR33068, GR33077, GR33392, GR33402, GR33403, GV37210, GV37214, GV37216, GV37230, GV37291, GV37354, GV37475, GV37480, GV37489, GV37498, GV37529, GV37781, GV37783, GV38210, GV38253, GV38258, GV38510, GV38513, GV38515, GV38520, GV38620, GV38629, GV38631, GV38641, GV38649, GV38918, GV38923, GV38940, GV38994, GV39007, GV39027, GV39079, GV39081, GV39083, GV39096, GV39111, GV39119, GV39120, GV39121, GV39132, GV39133, GV39136, GV39143, GV39149, GV39152, GV39153, GV39157, GV39159, KC53822, KC53825, KC53827, KC53831, KC53843, KC53850, KC53851, KC53858, KC53865, KC53940, KC53946, KC53959, KC53980, KC53984, KC54009, KC54011, KC54012, KC54021, KC54059, KC54061, KC54067, KC54479, KC54488, KC54709, KC54714, KC54764, KC54808, KC54813, KC54821, KC54940, KC54951, KC54953, KC54955, KC54959, KC54966, KC54983, KC54985, KC54989, KC54990, KC54993, KC54994, KC55070, KC55073, KC55101, KC55111, KC55141, KC55146, KC55151, KC55155, KC55158, KC55160, KC55169, KC55171, KC55173, KC55175, KC55181, KC55183, KC55184, KC55191, KC55223, KC55231, KC55238, KC55240, KC55245, KC55248, KC55250, KC55251, KC55256, KC55257, KC55258, KC55301, KC55309, KC55341, KC55408, KC55465, KC55470, KC55480, KC55505, KC55507, KC55511, KC55529, KC55599, KC55600, KC55601, KE51408, KE51413, KE51418, KE5144, KE51655, KE51884, KE51888, KE51890, KE51895, KE51897, KE51902, KE51907, KE51929, KE51931, KE51932, KE51974, KG89698, KG89699, KG89700, KG89702, KG89703, KG89705, KG89706, KG89707, KG89709, KG89710, KG89712, KG89735, KG89736, KG89738, KG89740, KG89744, KG89747, KG89831, KG89833, KG89835, KG89837, KG89935, KG89936, KG89937, KG89939, KG89941, KG89942, KG89947, KG89970, KG89971, KG90009, KG90012, KG90043, KG90045, KH39541, KH39544, KH39545, KH39548, KH39575, KH39602, KH39603, KH39605, KH39606, KH39607, KH39608, KH39609, KH39610, KH39612, KH39629, KH39931, KH39933, KH39934, KH39986, KH39988, KH39990, KH39992, KH39995, KH40013, KH40014, KH40015, KH40016, KH40017, KH40099, KH40105, KJ47089, KJ47122, KJ47132, KJ47140, KJ47145, KJ47147, KJ47165, KJ47170, KJ47760, KJ47763, KJ47764, KJ47766, KJ47771, KJ47775, KL04316, KL04317, KL04318, KL04319, KL04320, KL04321, KL04322, KL04325, KL04524, KL04526, KL04527, KL04591, KL04592, KL04593, KL04594, KL04595, KL04596, KL04597, KL04598, KL04599, KL04601, KL04686, KL04687, KL04688, KL04689, KL04690, KL04691, KL04692, KL04693, KL04694, KM03868, KM03869, KM03872, KM03873, KM03874, KM03875, KM03893, KM03895, KM03897, KM03898, KM03900, KM03901, KM03902, KM04130, KM04134, KM04177, KM04186, KM04198, KM04201, KM04238, KM04239, KM04244, KM04245, KM04246, KM04248, KM04249, KM04320, KM04322, KN04027, KN04029, KN04032, KN04037, KN04039, KN04041, KN04044, KN04074, KN04079, KN04081, KN04085, KN04088, KN04090, KN04115, KN04116, KN04129, KN04135, KN04163, KN04164, KN04286, KP03122, KP03355, KP03356, KP03361, KS58311, KS58313, KS58314, KS58316, KS58321, KS58329, KS58330, KS58343, KS58348, KS58363, KS58375, KS58378, KS58382, KS58393, KS58397, KS58405, KS58406, KS58411, KS58451, KS58465, KS58469, KS58522, KS58529, KS58566, KS58578, KS58584, KS58593, KS58602, KS58613, KS58616, KS58623, KS58629, KS58633, KS58637, KS58640, KS58642, KS58643, KS58654, KS58664, KS58665, KS58669, KS58670, KS58693, KS58696, KS58702, KS58711, KS58714, KS58715, KS58717, KS58730, KS58738, KS58743, KS58752, KS58754, KS58757, KS58761, KS58765, KS58773, KS58774, KS58776, KS58779, KS58783, KS58786, KS58787, KS58788, KS58797, KS58807, KS58808, KS58810, KS58814, KS58815, KS58821, KS58825, KS58829, KS58833, KS58837, KS58839, KS58840, KS58842, KS58845, KS58846, KS58847, KS58848, KS58850, KS58902, KS58906, KS58908, KS58942, KS58951, KS58955, KS58966, KS58976, KS58978, KS58981, KS58982, KS58985, KS58987, KS59024, KS59075, KS59149, KS59341, KS59342, KS59343, KS59344, KS59345, KS59346, KS59349, KS59351, KS59352, KS59353, KS59354, KS59357, KS59360, KS59366, KS59369, KS59370, KS59371, KS59372, KS59373, KS59374, KS59375, KS59378, KS59387, KS59388, KS59401, KS59418, KS59419, KS59421, KS59423, KS59425, KS59427, KS59428, KS59432, KS59433, KS59434, KS59435, KS59440, KS59441, KS59442, KS59449, KS59451, KS59452, KS59461, KS59462, KS59470, KS59472, KS59478, KS59480, KS59484, KS59485, KS59487, KS59491, KS59492, KS59493, KS59494, KS59495, KS59496, KS59498, KS59499, KS59502, KS59504, KS59505, KS59506, KS59518, KS59520, KS59522, KS59534, KS59536, KS59554, KS59559, KS59562, KS59563, KS59565, KS59566, KS59571, KS59636, KS59638, KS59666, KS59710, KS59722, KS59724, KS59725, KS59729, KS59734, KS59735, KS59736, KS59739, KS59741, KS59742, KS59743, KS59744, KS59746, KS59835, KS59843, KS59844, KS59848, KS59850, KS59853, KS59858, KS59859, KS59860, KS59862, KS59867, KS59869, KS59874, KS59875, KS59876, KS59881, KS59885, KS59889, KS59896, KS59897, KS59901, KS59903, KS59904, KS59905, KS59906, KS59907, KS59910, KS59913, KS59915, KS59917, KS59918, KS59922, KS59923, KS59927, KS59928, KS59929, KS59930, KS59932, KS59933, KS59935, KS59937, KS59943, KS59944, KS59947, KS59949, KS59950, KS59951, KS59952, KS59953, KS59954, KS59960, KS59962, KS59968, KS59974, KS59976, KS59977, KS59978, KS59980, KS59988, KS59989, KS59992, KS59997, KS59999, KS60000, KS60001, KS60007, KS60008, KS60009, KS60010, KS60011, KS60112, KS60112, LR30649, LR30652, LR30958, LR30964, LR31610, LR31625, LR31626, LR31708, LR31748, LR31823, LR31824, LR31825, LR31826, LR31827, LR31828, LR31832, LR31843, LR31845, LR31853, LR31858, LR31867, LR31876, LR31881, LR31887, LR31889, LR31892, LR31899, LR31900, LR31903, LR31905, LR31907, LR31914, LR31927, LR31977, LR31982, LR31983, LR31985, LR32018, LR32019, LR32022, LR32023, LR32024, LR32025, LR32026, LR32028, LR32029, LR32031, LR32032, LR32033, LR32034, LR32035, LR32036, LR32038, LR32081, LR32282, LV18861, LV18863, LV18867, LV18882, LV18886, LV18893, LV18897, LV18899, LV18907, LV18917, LV18928, LV19093, LV19098, LV19100, LV19102, LV19105, LV19114, LV19162, LV19223, LV19226, LV19231, LV19232, LV19235, LV19236, LV19240, LV19276, LV19291, LV19294, LV19516, LV19538, LV19751, LV19755, LV19756, LV19773, LV19777, LV19780, LV19783, LV19788, LV19789, LV19828, LV19832, LV19836, LV19840, LV19841, LV19849, LV20003, LV20009, LV20011, LV20159, LV20162, LV20163, LV20166, LV20201, LV20218, LV20224, LV20231, LV20232, LV20234, LV20236, LV20241, LV20242, LV20243, LV20245, LV20250, LV20252, LV20261, LV20267, LV20271, LV20391, LV20417, LV20423, LV20433, LV20440, LV20441, LV20450, LV20451, LV20502, and LV20643;
e) unit numbers FG97079, FG97084, FG97154, FG97166, FG97181, FG97187, FM03908, GJ66463, GJ66465, GJ66476, GJ66490, GJ67209, GL08264, GL08351, GL08354, GL08357, GV37238, GV37280, GV37478, GV37486, GV37491, GV38057, GV38251, GV38656, GV39109, GV39115, KC54013, KC54810, KC54812, KC54817, KC54987, KC55166, KC55179, KC55324, KC55485, KC55512, KE51419, KE51904, KE52003, KG89711, KG89737, KG89944, KH39604, KH39917, KL04522, KL04523, KL04525, KL04600, KL04685, KM03891, KM04194, KM04240, KM04242, KM04243, KM04252, KM04253, KN04131, KN04133, KS58326, KS58414, KS58586, KS58624, KS58796, KS58841, KS58903, KS58905, KS58986, KS59023, KS59377, KS59379, KS59386, KS59407, KS59430, KS59450, KS59454, KS59560, KS59567, KS59723, KS59728, KS59731, KS59879, KS59883, KS59886, KS59887, KS59893, KS59899, KS59925, KS59926, KS59934, KS59995, LR30962, LR30965, LR31681, LR31752, LR31868, LR31902, LR32080, LV18860, LV19228, LV19284, LV19288, LV19525, LV20168, LV20226, LV20270, and LV20436.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on November 9 and 14, 2001. Firm initiated recall is complete.
REASON
Blood products, manufactured from units of Whole Blood that may have been collected in a manner not in accordance with standard procedures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 3784 units;
b) 1719 units;
c) 59 units;
d) 831 units;
e) 106 units.
DISTRIBUTION
PA, OH, WV, and IL.
_____________________________
PRODUCT
Platelets. Recall #B-0609-3.
CODE
Unit 65-368166.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Grand Rapids, MI, by facsimile dated November 1, 1999. Firm initiated recall is complete.
REASON
Blood product, collected from a donor taking tetracycline for acne medication, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-610-3.
CODE
012FK39230, 012FK39231, 012FK39232, 012FK39237, 012FK39238, 012FK39239, 012FK39243, 012FK39245, 012FK39252, 012FK39260, 012FK39264, 012FK39266, 012FK39267, 012FK39270, 012FK39272, 012FV07621, 012FV07623, 012FV07628, 012FV07630, 012FV07636, 012FV07638, 012FV07639, 012FV07641, 012FV07642, 012FZ97380, 012FZ97391, 012FZ97396, 012FZ97397, 012FZ97401, 012FZ97404, 012FZ97408, 012FZ97411, 012GR04690, 012GS35945, 012GS35946, 012GS35948, 012GS35950, 012GS35954, 012GS35956, 012LG39711, 012LG39713, 012LG39717, 012LG39719, 012LG39720, 012LG39721, 012LG39723, 012LG39726, 012M10523, 012M10525, 012M10539, 012M10541, 012M10543.
RECALLING FIRM/MANUFACTURER
American Red Cross, Carolinas Blood Services Region, Charlotte, NC, by facsimile dated July 13 and July 24, 2001. Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but did not meet the requirements for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
52 units.
DISTRIBUTION
NC.
_____________________________
PRODUCT
PF-1 High Flow 340 Micron Pre-Filter. Recall # B-0614-3.
CODE
Lot number 200111A.
RECALLING FIRM/MANUFACTURER
SIMS Level l, Inc., Rockland, MA, by letter on May 16, 2002. Firm initiated recall is complete.
REASON
Blood pre-filters were subjected to higher than normal sterilization temperatures.
VOLUME OF PRODUCT IN COMMERCE
1 lot.
DISTRIBUTION
Nationwide, Canada, and the Netherlands.
_____________________________
PRODUCT
Source Plasma. Recall # B-0629-3.
CODE
Unit 53DDCLFZA.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Melrose Park, IL, by fax dated October 14, 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
IL.
_____________________________
PRODUCT
Source Plasma (For Manufacturing use only).
Recall # B-0630-3.
CODE
Unit DLG007009.
RECALLING FIRM/MANUFACTURER
SeraCare, Inc., Beaumont, TX, by fax dated November 24, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was incorrectly documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
_____________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-0631-3.
CODE
Units 40GK44718, 40GN95305, 40GN95298, 40GJ43536, 40GJ43531.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Heart of America, Peoria, IL, by telephone on November 27, 2002 and by letter dated December 6, 2002. Firm initiated recall is complete.
REASON
Blood products, which may have been shipped at unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
IL.
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0633-3.
CODE
Unit numbers 40FF52061, 40FW26642, 40GC72310, 40GE70103.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Heart of America Region, Peoria, IL, by telephone on December 10, 2002,and by letter dated December 23, 2002. Firm initiated recall is complete.
REASON
Blood products possibly exposed to unacceptable shipping temperatures were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
IL and MA.
_____________________________
PRODUCT
Source Plasma. Recall # B-0645-3.
CODE
Unit number HP89668.
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank, Inc. of Chicago, Chicago, IL, by telephone on October 9, 2002. Firm initiated recall is complete.
REASON
Blood product, that tested negative for human immunodeficiency virus (HIV) p24 antigen, but was collected from a donor that subsequently tested repeatedly reactive for HIV p24 antigen, was not properly quarantined and was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NY.
_____________________________
PRODUCT
Remicade (infliximab) recombinant for IV injection (20mL vial). Recall #B-0660-3.
CODE
Lots 02F053A, 02F103A.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, McPherson, KS, by letter dated November 19, 2002. Firm initiated recall is complete.
REASON
Products, which potentially lack specified vacuum in the vial, were released.
VOLUME OF PRODUCT IN COMMERCE
2 lots.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
a) Red Blood Cells, Leukoreduced. Recall # B-0676-3;
b) Fresh Frozen Plasma. Recall # B-0677-3;
c) Platelet, Pheresis, Leukoreduced. Recall # B-0678-3;
d) Cryoprecipitate. Recall # B-0679-3;
e) Plasma. Recall # B-0680-3.
CODE
a) Units FM50573, FJ94029;
b) and c) Unit FJ94029;
d) and e) Unit FM50573;
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by telephone and by letter on November 1, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of Lyme Disease, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
MA and RI.
_____________________________
PRODUCT
SKBM Microkeratome cutting tool. Recall # Z-0612-03.
CODE
All codes are affected by Safety Alert: 98-3002-005; 98-3002-01-017; 98-3002-02-001; 98-3002-02-002; 98-3002-02-007-03; 98-3002-03-001; 98-3002-03-003; 98-3002-03-004; 98-3002-03-006; 98-3002-03-007; 98-3002-03-010; 98-3002-03-013; 98-3002-03 018; 092K14; 98-3002-04-001; 98-3002-04-002; 98-3002-04-003; 98-3002-04-004; 98 3002-04-005; 98-3002-04-006; 98-3002-04-007; 98-3002-04-008; 98-3002-04-009; 98-3002-04-010; 98-3002-04-011; 98-3002-04-012; 98-3002-04-013; 98-3002-04-014; 98-3002-04-015; 98-3002-04-016; 98-3002-04-017; 98-3002-04-018; 98-3002-04-019; 98-3002-04-020; 98-3002-04-021; 98-3002-04-022; 98-3002-04-023; 98-3002-04-024; 98-3002-04-025; 98-3002-04-026; 98-3002-04-027; 98-3002-04-028; 98-3002-04-029; 98-3002-04-030; 99-0204-001-IR; 99-0204-002-IR; 99-0304-003-IR; 99-0304-004-IR; 99-0304-005-IR; 99-0304-006-IR; 99-0304-007-IR; 99-0304-008-IR; 99-0304-009-IR; 99-0304-010-IR; 99-0504-011 -IR; 99-0404-001-GE; 99-0404-002-GE; 99-0404-003-GE; 99-0404-004-GE; 99-0404-005-GE; 99-0404-006-GE; 99-0404-007-GE; 99-0404-011-IR; 99-0404-012-IR; 99-0404-013-IR; 99-0404-014-IR; 99-0404-015-IR; 99-0404-016-IR; 99-0404-017-IR; 99-0404-018-IR; 99-0504-001-GE; 99-0504-002-GE; 99-0504-003-GE; 99-0504-004-GE; 99-0504-005-GE; 99-0504-006-GE; 99-0504-007 GE; 99-0504-008-GE; 99-0504-009- GE; 99-0504-010-GE; 99-0504-019-IR; 99-0504-020-IR; 99-3002-04-001; 99-3002-04-002; 99-3002-04-003; 99-3002-04-004; 99-3002-04-005; 99-3002-04-006; 99-3002-04-007; 99-3002-04-008; 99-3002-04-009; 99-3002-04-010; 99-3002-04-011; 99-3002-04-012; 99-3002-04-013; 99-3002-04-014; MK31001; MK31002; MK31003; MK31004; MK31005; MK31006; MK31007; MK31008; MK31009; MK31010; MK31011; MK31012; MK31013; MK31014; MK31015; MK31016; MK31017; MK31018; MK31019; MK31020; MK31021; MK31022; MK31023; MK31024; MK31025; MK31026; MK31027; MK31028; MK31029; MK31030; MK31031; MK31032; MK31033; MK31034; MK31035; MK31036; MK31037; MK31038; MK31039; MK31040; MK31041; MK31042; MK31043; MK31044; MK31045; MK31046; MK31047; MK31048; MK31049; MK31050; MK31051; MK31052; MK31053; MK31054; MK31055; MK31056; MK31057; MK31058; MK31059; MK31060; MK31061; MK31062; MK31063; MK31064; MK31065; MK31066; MK31067; MK31068; MK31069; MK31070; MK31071; MK31072; MK31073; MK31074; MK31075; MK31076; MK31077; MK31078; MK6021/G; MK6022/G; MK6023/G; MK6024/G; MK6025/G; MK6026/G; MK6027/G; MK6028/G; MK6029/G; MK6030/G; MK6031/G; MK6032/G; MK6033/G; MK6034/G; MK6035/G; MK6036/G; MK6037/G; MK6038; MK6039; MK6040; MK6041/J; MK6042; MK6043/G; MK6044; MK6045; MK6046; MK6047; MK6048; MK6060E; MK7000; MK7001; MK7002; MK7003; MK7004; MK7005; MK7006; MK7007; MK7008; MK7009; MK7010; MK7011; MK7012; MK7013; MK7014; MK7015; MK7016; MK7017; MK7018; MK7019; MK7020; MK7021; MK7022; MK7023; MK7024; MK7025; MK7026; MK7027; MK7028; MK7029; MK7030; MK7031; MK7032; MK7033; MK7034; MK7035; MK7036; MK7037; MK7038; MK7039; MK7040; MK7041; MK7042; MK7043; MK7044; MK7045; MK7046; MK7047; MK7048; MK7049; MK7050; MK7051; MK7052; MK7053; MK7054; MK7055; MK7056; MK7057; MK7058; MK7059; MK7060; MK7061; MK7062; MK7063; MK7064; MK7065; MK7066; MK7067; MK7068; MK7069; MK7070; MK7071; MK7072; MK7073; MK7074; MK7075; MK7076; MK7077; MK7078; MK7079; MK7080; MK7081; MK7082; MK7083; MK7084; MK7085; MK7086; MK7087; MK7088; MK7089; MK7090; MK7091; MK7092; MK7093; MK7094; MK7095; MK7096; MK7097; MK7098; MK7099; MK7100; MK7101; MK7102; MK7103; MK7104; MK7105; MK7106; MK7107; MK7108; MK7109; MK7110; MK7111; MK7112; MK7113; MK7114; MK7115; MK7116; MK7117; MK7118; MK7119; MK7120; MK7121; MK7122; MK7123; MK7124; MK7125; MK7126; MK7127; MK7128; MK7129; MK7130; MK7131; MK7132; MK7133; MK7134; MK7135; MK7136; MK7137; MK7138; MK7139; MK7140; MK7141; MK7142; MK7143; MK7144; MK7145; MK7146; MK7147; MK7148; MK7149; MK7150; MK7151; MK7152; MK7153; MK7154; MK7155; MK7156; MK7157; MK7158; MK7159; MK7160; MK7161; MK7162; MK7163; MK7164; MK7165; MK7166; MK7167; MK7168; MK7169; MK7170; MK7171; MK7172; MK7173; MK7174; MK7175; MK7176; MK7177; MK7178; MK7179; MK7180; MK7181; MK7182; MK7183; MK7184; MK7185; MK7186; MK7187; MK7188; MK7189; MK7190; MK7191; MK7192; MK7193; MK7194; MK7195; MK7196; MK7197; MK7198; MK7199; MK7200; MK7201; MK7202; MK7203; MK7204; MK7205; MK7206; MK7207; MK7208; MK7209; MK7210; MK7211; MK7212; MK7213; MK7214; MK7215; MK7216; MK7217; MK7218; MK7219; MK7220; MK7221; MK7222; MK7223; MK7224; MK7225; MK7226; MK7227; MK7228; MK7229; MK7230; MK7231; MK7232; MK7233; MK7234; MK7235; MK7236; MK7237; MK7238; MK7239; MK7240; MK7241; MK7242; MK7243; MK7244; MK7245; MK7246; MK7247; MK7248; MK7249; MK7250; MK7251; MK7252; MK7253; MK7254; MK7255; MK7256; MK7257; MK7258; MK7259; MK7260; MK7261; MK7262; MK7263; MK7264; MK7265; MK7266; MK7267; MK7268; MK7269; MK7270; MK7271; MK7272; MK7273; MK7274; MK7275; MK7276; MK7277; MK7278; MK7279; MK7280; MK7281; MK7282; MK7283; MK7284; MK7285; MK7286; MK7287; MK7288; MK7289; MK7290; MK7291; MK7292; MK7293; MK7294; MK7295; MK7296; MK7297; MK7298; MK7299; MK7300; MK7301; MK7302; MK7303; MK7304 MK7305; MK7306; MK7307; MK7308; MK7309; MK7310; MK7311; MK7312; MK7313; MK7314; MK7315; MK7316; MK7317; MK7318; MK7319; MK7320; MK7321; MK7322; MK7323; MK7324; MK7325; MK7326; MK7327; MK7328; MK7329; MK7330; MK7331; MK7332; MK7333; MK7334; MK7335; MK7336; MK7337; MK7338; MK7339; MK7340; MK7341; MK7342; MK7343; MK7344; MK7345; MK7346; MK7347; MK7348; MK7349; MK7350; MK7351; MK7352; MK7353; MK7354; MK7355; MK7356; MK7357; MK7358; MK7359; MK7360; MK7361; MK7362; MK7363; MK7364; MK7365; MK7366; MK7367; MK7368; MK8000; MK8001; MK8002; MK8003; MK8004; MK8005; MK8006; MK8007; MK8008; MK8074; MK8075; MK8076; MK8077; MK8078; MK8079; MK8080; MK8081; MK8082; MK8083; MK8084; MK8085; MK8086; MK8087; MK8088; MK8089; MK8090; MK8091; MK8092; MK8093; MK8094; MK8095; MK8096; MK8097; MK8098; MK8099; MK8100; MK8101; MK8102; MK8103; MK8104; MK8105; MK8106; MK8107; MK8108; MK8109; MK8110; MK8111; MK8112; MK8113; MK8114; MK8115; MK8116; MK8117; MK8118; MK8119; MK8120; MK8121; MK8122; MK8123; MK8124; MK8125; MK8127; MK9001; MK9002; MK9003; MK9004; MK9005; MK9006; MK9007; MK9008; MK9009; MK9010; MK9012; MK8009; MK8010; MK8011; MK8012; MK8013; MK8014; MK8015; MK8016; MK8017; MK8018; MK8019; MK8020; MK8021; MK8022; MK8023; MK8024; MK8025; MK8026; MK8027; MK8028; MK8029; MK8030; MK8031; MK8032; MK8033; MK8034; MK8035; MK8036; MK8037; MK8038; MK8039; MK8040; MK8041; MK8042; MK8043; MK8044; MK8045; MK8046; MK8047; MK8048; MK8049; MK8050; MK8051; MK8052; MK8053; MK8054; MK8055; MK8056; MK8057; MK8058; MK8059; MK8060; MK8061; MK8062; MK8063; MK8064; MK8065; MK8066; MK8067; MK8068; MK8069; MK8070; MK8071; MK8072; MK8073.
RECALLING FIRM/MANUFACTURER
Alcon Laboratories, Inc., Fort Worth, TX, by letter on November 18, 2002. Firm initiated recall is ongoing.
REASON
Degradation of glue causes glass movement resulting in misalignment that can cause deeper cuts than anticipated.
VOLUME OF PRODUCT IN COMMERCE
567 units.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
Misys Laboratory System. Recall # Z-0614-03.
CODE
Versions 5.2, 5.23 and 5.3.
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by fax on January 31, 2003. Firm initiated recall is ongoing.
REASON
Software anomaly. Rejecting the selected Autofiling status may result in the change being accepted rather than rejected.
VOLUME OF PRODUCT IN COMMERCE
542.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
a) Chlamydia OIA. For in vitro diagnostic use.
Recall # Z-0615-03;
b) Chlamydia OIA. For in vitro diagnostic use.
Recall # Z-0616-03.
CODE
a) Catalog No. CHL30, Lot No. 132117, 132117A, 133101;
b) Catalog No. CHLINT, Lot No. 133354, 133174.
Foreign distribution.
RECALLING FIRM/MANUFACTURER
Thermo Biostar, Inc., Louisville, CO, by telephone on February 6, 2003 and by letter on February 10, 2003. Firm initiated recall is ongoing.
REASON
Chlamydia IVD test kits may contain diluted conjugate reagent. Use may produce a false negative result with a low positive patient sample.
VOLUME OF PRODUCT IN COMMERCE
342 units.
DISTRIBUTION
Nationwide, France, New Zealand and Spain.
_____________________________
PRODUCT
Integrated Orbiter Single Detector General Purpose Gamma Camera System. Recall # Z-0617-03.
CODE
Model 35-26-932, serial numbers 102, 1001/1217, 1169A;
Model 35-44-637, serial numbers 0101/0142, 120A.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Hoffman Estates, IL., by letters dated February 10, 2003. Firm initiated recall is ongoing.
REASON
Unintended yoke rotational motion.
VOLUME OF PRODUCT IN COMMERCE
256 units.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
Atakr II RF Power Generator, Models 4802 and 4803. Recall # Z-0618-03.
CODE
All units.
RECALLING FIRM/MANUFACTURER
Medtronic, Inc., Rice Creek Facility, Fridley, MN, by 'Important Product Management Information' letter, dated November 25, 2002. Firm initiated recall is ongoing.
REASON
An RF pulse occurs each time the temperature set point increase button is activated while ablating and this can result in heart rhythm disturbances.
VOLUME OF PRODUCT IN COMMERCE
775 units.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Access and Access 2 Immunoassay Systems Discrete photometric chemistry analyzer for clinical use.
Recall #Z-0619-03.
CODE
Not applicable.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by a mandantory field modification was issued on December 19, 2002. Firm initiated recall is ongoing.
REASON
Spring failure, design defect in component.
VOLUME OF PRODUCT IN COMMERCE
2418.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
a) Custom Angiographic Kit. Recall # Z-0620-03;
b) Custom Angiographic Kit. Recall # Z-0621-03;
c) Custom Angiographic Kit. Recall # Z-0622-03.
CODE
a) Model Number: L04-00278/A. Lot Numbers: A2253131;
b) Model Number: K08-MP5130. Lot Numbers: A146066.
A188604;
c) Model Number: K11-MPT2023/D. Lot Numbers: A145200,
A156200, A191561.
RECALLING FIRM/MANUFACTURER
Merit Medical Systems, Inc., South Jordan, UT, by telephone and fax on February 12, 2003. Firm initiated recall is complete.
REASON
A recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization.
VOLUME OF PRODUCT IN COMMERCE
a) 250 kits;
b) 100 kits;
c) 82 kits.
DISTRIBUTION
FL and Japan.
_____________________________
PRODUCT
e.cam Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures. Recall # Z-0623-03.
CODE
All e.cam towers, serial numbers 00013 through 08543, utilizing e.soft, ICON-S and duet acquisition systems, and e.soft and ICON-S COIN systems.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions, USA, Inc., Hoffman Estates, IL, by letters dated February 10, 2003. Firm initiated recall is ongoing.
REASON
Unexpected release of the radial and rotate brakes in the case of multiple simultaneous fault conditions.
VOLUME OF PRODUCT IN COMMERCE
1927 units.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
NEEDLEZAP, a battery operated needle destruction device. The product is labeled and marketed for use only in the law enforcement market or veterinary market. Recall # Z-0624-03.
CODE
The devices are not identified with lot numbers or serial numbers.
RECALLING FIRM/MANUFACTURER
E Med Future, Inc., Columbus, OH, by telephone on August 15, 2002. Firm initiated recall is ongoing.
REASON
Their NeedleZap devices were not manufactured in accordance with the Quality System Regulations, and were shipped without an approved PMA.
VOLUME OF PRODUCT IN COMMERCE
1,572 devices.
DISTRIBUTION
Nationwide, Canada, Greece and Ireland.
_____________________________
PRODUCT
Medtronic AVE Everest PTCA Inflation Catheter 20 cc Item #AC2200. Recall # Z-0625-03.
CODE
Lot Numbers: 122851, 12852, 122853.
RECALLING FIRM/MANUFACTURER
Medtronic, Inc., Danvers, MA, by letter, on January 31, 2003. Firm initiated recall is ongoing.
REASON
PTCA balloon catheter contains a pressure gauge that does not accurately reflect the pressure of the balloon.
VOLUME OF PRODUCT IN COMMERCE
602 units.
DISTRIBUTION
Japan.
_____________________________
PRODUCT
Misys Laboratory System. Recall # Z-0626-03.
CODE
Versions 5.2, 5.23 and 5.3.
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by fax on January 31, 2003. Firm initiated recall is ongoing.
REASON
Software anomaly. Patient results may be filed in the incorrect patient file.
VOLUME OF PRODUCT IN COMMERCE
542.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
AFP Control Kit distributed under the following label: AxSYM and Imx, Abbott Laboratories USA, North Chicago, IL. Recall # Z-0627-03.
CODE
Product list number: 9C05-10 Lot No.: 91533Q100. Exp. Date 10/20/2003.
RECALLING FIRM/MANUFACTURER
Abbott Health Products, Inc., Barceloneta, PR, by letters on December 11, 2002. Firm initiated recall is ongoing.
REASON
Results lower than package insert ranges.
VOLUME OF PRODUCT IN COMMERCE
826 kits.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
BIOMERieux, Thromboplastin Reagent, Simplastin Excel S, 6 ml Diluent. Recall # Z-0628-03.
CODE
Product # 252182 - Lot #161553, 161580, 161581 and 161661.
Additional Catalog 252183, Lot number: 161662.
RECALLING FIRM/MANUFACTURER
Biomerieux, Inc., Durham, NC, by letter on December 23, 2002. Firm initiated recall is ongoing.
REASON
Vial to vial variability which can result in prolonged clot times.
VOLUME OF PRODUCT IN COMMERCE
17,130 kits.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
Simplasitin Excel, 10 x 6ml, 25200, For Prothrombin Time determinations. The product consists of two vials, a thromboplastin reagent and a diluent (the vials are mixed together before use). Recall # Z-0629-03.
CODE
Lot numbers: 161402, 161431, 161432, 161477, 161448, 161479, 161507, 161508, 161550, 161551, 161583, 161585, 161595, 161657, and 161658.
RECALLING FIRM/MANUFACTURER
Biomerieux, Inc, Durham, NC, by letter on/about February 4, 2003. Firm initiated recall is ongoing.
REASON
Product is being recalled due to vial variability of clotting time results.
VOLUME OF PRODUCT IN COMMERCE
62,435 units.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
One Touch SureStep Glucose Test Strips; One Touch SureStep Pro Glucose Test Strips (hospital use). Recall # Z-0630-03.
CODE
Test Strips with Off-Center Confirmation Dot Part Number Lot Number Exp. Date Description 010-797-02, 191303A005, 10/03, SureStepPro Strips (50), 010-797-02, 192113A005, 10/03, SureStepPro Strips (50), 010-797-02, 194382A004, 11/03, SureStepPro Strips (50), 020-052-01, E-187250A, 9/03, 100-Count OneTouch SureStep Test Strips, 020-052-03, E-187250B, 9/03, 100-Count OneTouch SureStep Test Strips, 020-052-01, F-189831A, 9/03, 100-Count OneTouch SureStep Test Strips, 020-052-01, F-192063A, 10/03, 100-Count OneTouch SureStep Test Strips, 010-359-04, G-190477A, 10/03, 50-Count OneTouch SureStep Test Strips, 020-052-01, E-182852A, 5/03, 100-Count OneTouch SureStep Test Strips, Defective Test Strip Bottle Cap Part Number Lot Number Exp. Date Description 010-797-02, 205206A004, 02/04, 50-Count SureStepPro Test Strips, 010-797-02, 205913A012, 03/04, 50-Count SureStepPro Test Strips, 010-797-02, 205946A004, 03/04, 50-Count SureStepPro Test Strips, 020-052-02, F-204252B, 2/04, 100-Count OneTouch SureStep Test Strips, 020-052-01, G-204296A, 1/04, 100-Count OneTouch SureStep Test Strips, 020-052-01, G-204620A, 2/04, 100-Count OneTouch SureStep Test Strips, 020-052-01, G-204668B, 2/04, 100-Count OneTouch SureStep Test Strips, 020-052-01, G-205519A, 3/04, 100-Count OneTouch SureStep Test Strips, 010-359-04, H-204583A, 12/03, 50-Count OneTouch SureStep Test Strips, 010-359-04, H-205890B, 3/04, 50-Count OneTouch SureStep Test Strips, F-204098B, 2/04, 50-Count OneTouch SureStep Medicare Test Strips.
RECALLING FIRM/MANUFACTURER
Lifescan, Inc., Milpitas, CA, by letters on January 13, 2003. Firm initiated recall is ongoing.
REASON
The Test Strips have manufacturing errors, in that the "Confirmation Dot" is off-center or split in half, and defective bottle cap.
VOLUME OF PRODUCT IN COMMERCE
3,374,000 Test Strips.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
Misys Laboratory System. Recall # Z-0631-03.
CODE
Versions 5.2, 5.23 and 5.3.
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by fax on February 7,2003. Firm initiated recall is ongoing.
REASON
Missing patient data on Location Chart Copy Cumulative Reports.
VOLUME OF PRODUCT IN COMMERCE
478.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
VARiS 1.4G and Vision/Soma Vision Radiation Therapy Systems; VARiS versions 6.1.33 and 6.2.19 in conjunction with Eclipse 6.x/Soma Vision 6.x. Recall # Z-0633*03.
CODE
Serial Numbers: 44, 260, 315, 495, 746, 751, 873, 907, 984, 1098, 1131, and 9045.
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc., Palo Alto, CA, by letters on January 16, 2003 and February 4, 2003. Firm initiated recall is ongoing.
REASON
The product has a software problem. This could result in a treatment without a motorized wedge where one had been planned.
VOLUME OF PRODUCT IN COMMERCE
12 units.
DISTRIBUTION
CA, MA, NC, SC, PA, LA, Canada, Austria, Germany and Finland.
_____________________________
PRODUCT
BD K-3000 Microkeratome Blade REF378607. Recall # D-0634-03.
CODE
Manufacturing Lot Numbers: 959, 962, 964, 965, and 966.
RECALLING FIRM/MANUFACTURER
BD Opthalmic Systems, Waltham, MA, by telephone and email on January 24, 2003. Firm initiated recall is ongoing.
REASON
Microkeratome Blade may cause irregular corneal flap which may delay patients procedure.
VOLUME OF PRODUCT IN COMMERCE
1539 Blades.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Latex examination gloves, Uniseal drand.
Recall # Z-0635-03.
CODE
Lot numbers: 41991221, 41991223,
41001105, 41001120, 41010428, 41010530, 41010613, 41010618.
RECALLING FIRM/MANUFACTURER
American Healthcare Products, Inc, Signal Hill, CA, by letter on July 23, 2002. Firm initiated recall is ongoing.
REASON
Unfit for intended use due to stickiness.
VOLUME OF PRODUCT IN COMMERCE
6,121 cases.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
a) MediSense Precision PCx Blood Glucose Test Strips, List
Number: 98757-12. Recall # Z-0636-03.
b) MediSense Precision Plus Blood Glucose Test Strips List
Number: 99565-01. Recall # Z-0637-03.
c) MediSense QID Blood Glucose Test Strips. List Number:
97401-12. Recall # Z-0638-03.
d) MediSense Precision Plus List Number: 97430-12
Internalional: Norway. Recall # Z-0639-03.
e) MediSense Precision Plus Blood Glucose Test Strips.
List Number: 97345-12 International: Australia.
Recall # Z-0640-03.
f) MediSense Precision QID Blood Glucose Test Strips
List Number: 98433-12 Internalional: Greece,
Ireland, Portugal, Spain, and UK. Recall # Z-0641-03.
g) MediSense Precision Plus List Number: 98430-12
Internalional: Denmark, Norway, Finland, and Sweden.
Recall # Z-0642-03.
h) MediSense Precision Plus List Number: 98724-12
International: Germany. Recall # Z-0643-03.
CODE
a) Lot Numbers: 135755 Exp. 21-Feb-03,
135635 Exp. 14-Feb-03, 135745 Exp. 21-Feb-03;
b) Lot Numbers: 135635 Exp. 14-Feb-03,
13745 Exp 21-Feb-03;
c) Lot Number: 88145 Exp 31-Jan-03;
d) Lot Number: 88144 Exp. Date 31*Jan-03;
e) Lot Number: 88145 Exp. Date: 31-Jan-03;
f) Lot Number: 88146 Exp. Date: 31-Jan-03;
g) Lot Number: 88152 Exp. Date: 31-Jan-03;
h) Lot Number: 88152 Exp. Date: 14-Nov-03.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Bedford, MA, by letters dated January 21, 2003. Firm initiated recall ongoing.
REASON
Glucose test strips may give high falsely positive readings.
VOLUME OF PRODUCT IN COMMERCE
a) 18,118 boxes;
b) 18,172 boxes;
c) 1,496 boxes;
d) 1,322 boxes;
e) 2,565 boxes;
f) 10,440 boxes;
g) 7,732 boxes;
h) 3,572 boxes.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
a) Sterile 8 Fr Suction Catheter Kit - Latex Free; 50 kits
per case. Recall # Z-0644-03.
b) Sterile Dressing Change Tray with CloraPrep - Latex
Free, 28 trays per case. Recall # Z-0645-03.
CODE
a) reorder #DYND40978, lot 021A0387;
b) reprder #DYND75221, lot 02KA0269.
RECALLING FIRM/MANUFACTURER
Medline Industries, Inc., Mundelein, IL, by letter dated February 11, 2003. Firm initiated recall is ongoing.
REASON
Some of the kits labeled as latex free contain latex gloves which are properly labeled.
VOLUME OF PRODUCT IN COMMERCE
960 cases.
DISTRIBUTION
Nationwide and Canada.
_____________________________
PRODUCT
Misys Laboratory System. Recall # Z-0646-03.
CODE
Version 5.3.
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by fax on February 6, 2003. Firm initiated recall ongoing.
REASON
Two customers report that the organism identified on the patient's lab file do not match the reported susceptibility battery.
VOLUME OF PRODUCT IN COMMERCE
465.
DISTRIBUTION
Nationwide, and Internationally.
_____________________________
PRODUCT
Misys Laboratory System. Recall # Z-0647-03.
CODE
Version 5.3 with Reference Laboratory Interface.
RECALLING FIRM/MANUFACTURER
Sunquest Information Systems, Tucson, AZ, by facsimile on October 18, 2002. Firm initiated recall is complete.
REASON
Software anomaly, incorrect coding. Some comments were not transfered when coming from the Reference Laboratory Interface.
VOLUME OF PRODUCT IN COMMERCE
2.
DISTRIBUTION
WI and IL.
_____________________________
PRODUCT
Abbott brand Diluent/Sheath, Cell-Dyn 4000 System Cell-Dyn Reagent Model/List Number 01H73-01. Recall # Z-0648-03.
CODE
Product Control/Lot # 9274912, (Exp. Date: 8/31/2003) Product Control/Lot # 9275012, (Exp. Date: 8/31/2003)
Product Control/Lot # 9275212, (Exp. Date: 8/31/2003).
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Santa Clara, CA, by letters on October 16, 2002. Firm initiated recall ongoing.
REASON
Product elicits fluorescent signal interference due to contamination.
VOLUME OF PRODUCT IN COMMERCE
1383 units.
DISTRIBUTION
Nationwide, Argentina, Canada and Puerto Rico.
_____________________________
PRODUCT
REMEL CXM 30 Cefuroxime 30 mcg, Antimicrobial Susceptibility Test Disk, 50 disks to a cartridge, 5 cartridges to a kit, catalog Number 33999.
Recall # Z-0613-03.
CODE
Lot Number: 254243 - Exp. 09/04.
RECALLING FIRM/MANUFACTURER
Remel, Inc., Lenexa, KS, by letters dated December 5, 2002. Firm initiated recall is complete.
REASON
Packages of Cefuroxime susceptibility disks erroneously contained Cefaclor susceptibility disks.
VOLUME OF PRODUCT IN COMMERCE
104 packages.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Bulk Land O'Lakes Farmland Feed Dairy Beef Feedlot Finisher Plus R250 T90 Medicated, For Growing and Finishing Beef Cattle, containing monensin 250 g/ton, and tylosin phosphate 90 g/ton, for improved feed efficiency and for reduction of liver abscesses caused by Fusobacterium necrophorum and Actinomyces pyogenes. Recall # V-013-3.
CODE
Batch 18.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Land O'Lakes Farmland Feed, Ft. Dodge, IA, by telephone on March 26, 2002.
Manufacturer: Land O'Lakes Farmland Feed, Clarence, IA. Firm initiated recall is complete.
REASON
Feed maybe superpotent for monensin.
VOLUME OF PRODUCT IN COMMERCE
12,200 lbs. Bulk.
DISTRIBUTION
IA.
END OF ENFORCEMENT REPORT FOR MARCH 26, 2003
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