PRODUCT
Kitov Raspberry Jelly Graham Cookies - NET WT. 10 OZ./284g. Recall # F-625-2.
CODE
All products manufactured prior to 4/23/01.
RECALLING FIRM/MANUFACTURER
Eddyleon Chocolate Company, Moosic, PA, issued a press release on November 30, 2001. Firm initiated recall is complete.
REASON Kitov Raspberry Jelly Graham Cookies contain undeclared milk. VOLUME OF PRODUCT IN COMMERCE
1440- 10 ounce retail units. DISTRIBUTION New York and Illinois ______________________ PRODUCT
Assorted Chocolates in 5 oz. and 16 oz. boxes. The 5 oz. box contains 12 pieces of chocolates and has a clear lid with a gold bottom. Top clear lid/label states "CAIAZZA.FINE CHOCOLATES.THE CAIAZZA CANDY COMPANY.CHOICE ASSORTED. Net Weight 5 oz." The 16 oz. box is purple/lavendar with a gold ribbon/band states "CAIAZZA FINE CHOCOLATES.THE CAIAZZA CANDY COMPANY DELUXE ASSORTED CHOCOLATES. NET WT 16 OZ (454.4g)" on top lid of box. Recall # F-626-2. CODE No code/lot numbers on package. The firm recalled all products on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Caiazza Candy Co., Inc., New Castle, PA, by press release on September 28, 2001. Firm initiated recall is complete. REASON Both the 5 oz. and the 16 oz. sizes contained undeclared dried egg yolk and FD&C Yellow No. 5. The 5 oz. size also contained undeclared FD&C Yellow No. 6. VOLUME OF PRODUCT IN COMMERCE 43 cases of 5 oz. product; 11 cases of 16 oz. product. DISTRIBUTION PA, NJ, NY, DC, MA, MN and OH. _______________________ PRODUCT Product consists of two oatmeal cookies with a creme filling identified as "cookie sandwich", "filled cookie", "pies", or "cakes." Brand Name UPC Net Weight Baker’s Treat Oatmeal Crème Filled Cookies 4149818842 16 oz. Bi-Lo Oatmeal Crème Pies 3825948082 16 oz. Bishop’s Oatmeal Crème Pies 7561405540 9.25 oz Bluebird Oatmeal Crème Filled Snack Cake 7235934553 2 oz. BlueBird Oatmeal Crème Pie 7235934546 9.25 oz Break Cake Oatmeal Crème Soft Cookie Sandwich 5040014639 2 oz. Break Cake Oatmeal Crème Soft Cookie Sandwich 4383146384 2 oz. Crackin’ Good Oatmeal Crème Pies 2114015917 11.5 oz Fiesta Oatmeal Crème Filled Cakes 1816135402 11.25 oz Food Lion Oatmeal Cakes 3582600430 11.25 oz Kash n’ Karry Oatmeal Cakes 9961461010 11.25 oz Keefe Kitchens Oatmeal Cakes and Creme 8738100680 11.25 oz Kroger Crème Filled Oatmeal Cookies 1111011581 9.25 oz Laura Lynn Oatmeal Snack Cakes 8685401124 11.25 oz Party World Oatmeal Crème Cakes 7624411181 9.25 oz Shurefine Oatmeal Snack Cakes 1116114541 9.25 oz. Southern Home Oatmeal Crème Pies 0788016334 16 oz. Recall # F-627-2. CODE This recall involves all package sizes and codes of Oatmeal
Crème Filled pies and Cookies except package codes preceded
with the letter "G"
Product, UPC Codes, Code Examples are as follows:
Baker's Treat Oatmeal Crème Filled Cookies, 4149818842, Mar 01 02 C Bi-Lo Oatmeal Crème Pies, 3825948082, Mar 08 02 C
Bishop Oatmeal Crème Pies, 7561405540, L03052, 03052, 13413
Bluebird Oatmeal Crème Filled Sandwiches, 7235934553 and
7235934546, L03052
Break Cake Oatmeal Crème Filled Soft Cookie Sandwich, 5040014639
and 4383146384, Mar 01 02 C
Crackin' Good Oatmeal Crème Pies, 2114015917, Mar 01 02 C
Fiesta Oatmeal Crème Filled Cakes, 1816135402, L03052
Food Lion Oatmeal Cakes, 3582600430, Mar 01 02 C
Kash n' Karry Oatmeal Cakes and Crème, 9961461010, L03052
Keefe Kitchen Oatmeal Cakes and Crème, 8738100680, L03052
Kroger Crème Filled Oatmeal Cookies, 1111011581, Mar 01 02 C
Laura Lynn Oatmeal Snack Cakes, 8685401124, L03052
Party World Oatmeal Crème Cakes, 7624411181, 20603
Shurfine Oatmeal Snack Cakes, 1116114541, L03052
Southern Home Oatmeal Crème Cakes, 0788016334, Mar 01 02 C
Taste Delight Oatmeal Cookies, 6450900701, ***Canadian distribution.
RECALLING FIRM/MANUFACTURER Keebler/Bishop Baking Company, Cleveland, TN, by press release, fax and telephone on December 7, 2001. Firm initiated recall is complete. REASON The product contained undeclared eggs. VOLUME OF PRODUCT IN COMMERCE 377,519 cases. DISTRIBUTION Nationwide, including Puerto Rico and Canada. _______________________ PRODUCT Chocolate Candy Products:
a) "Assorted Milk" Recall # F-628-2;
b) "Assorted Milk & Dark" Recall # F-629-2;
"Assorted" boxes contain various chocolate covered
nuts/clusters, chocolate covered nut & caramels, chocolate
covered cremes, and chocolate covered cremes with nuts.
c) "Nut & Caramel Milk" Recall # F-630-2;
d) "Nut & Caramel Milk & Dark" Recall # F-631-2;
"Nut & Caramel" contains various chocolate covered nuts, and
chocolate covered nuts & caramels
e) Novelty chocolates (cars, golf balls, cell phones) in box with clear cover, labeled in part "Florence's EXQUISITE CANDIES", no ingredient statement. Recall # F-632-2.
CODE Codes prior to 02-63
Codes are Julian date: year - day (02-63 = 2002 - March 4)
Code stamped on bottom of boxes.
RECALLING FIRM/MANUFACTURER Mom's Kandy Kitchen, Rexburg, ID, by telephone on March 5, 2002.
FDA initiated recall is complete.
REASON a) - d) undeclared peanuts, macadamias, yellow 5, yellow 6;
e) undeclared milk.
VOLUME OF PRODUCT IN COMMERCE 500 boxes. DISTRIBUTION ID. _______________________ PRODUCT Caravelle brand Preserved Sliced Ginger Sliced (Mut Gung Lat) in 8.8 oz. clear plastic trays. Product of Vietnam. Recall # F-636-2. CODE All Codes. RECALLING FIRM/MANUFACTURER Recalling Firm: Anhing Corporation, Los Angeles, CA, by press release on February 20, 2002. Manufacturer: Unknown at this time. State initiated recall is complete. REASON The product contained undeclared sulfites. VOLUME OF PRODUCT IN COMMERCE 151cases. DISTRIBUTION Nationwide. _______________________ PRODUCT Shrimp, cooked and peeled, individually quick frozen (IQF), in 5 lb. plastic bags under the "Sea Rock" and "Newport" brands, 4/5 lb. bags/case; and in 1 lb. bags under "Village Market" label. 16/1 lb. bags/case.
Product labeled in part "SeaRock BRAND Cooked & Peeled IQF SHRIMP ** NET WT. 5 lbs. ** Packed by WASHINGTON CRAB PRODUCERS Westport, WA ***".
Product labeled in part "Newport Shrimp Shrimp Meat ** NET WT. 5 LBS. KEEP FROZEN ** Packed for the Pacific Group of Companies Portland, Oregon ***".
Product labeled part "VILLAGE MARKET SALAD SHRIMP COOKED & PEELED NET WT. 16 OZ. **
Recall # F-637-2.
CODE Pacific Seafood Group utilizes a coding system that designates the plant, Julian date, plus year. The first 2 digits represent the plant, the next 3 digits represent the Julian date, and the next 1 or 2 digits represent the year (ie. 01 and 1 both represent 2001).
02 = Washington Crab Producers
08 = Pacific Shrimp/Depoe Bay Newport and Sea Rock labels manufactured by Washington Crab
Producers: 020971, 020981, 020991, 021001, 021011, 021021, 021031,
021041, 021051, 021061, 021071, 021081, 021091, 021101, 021111,
021121, 021131, 021141, 021151, 021161, 021171, 021181, 021191,
021201, 021211, 021221, 021231, 021241, 021251, 021261, 021271,
021281, 021291
Village Market label manufactured by Washington Crab Producers:
021261
Newport label manufactured by Pacific Shrimp Company/Depoe Bay:
0810101, 0812001, 0810301.
RECALLING FIRM/MANUFACTURER Recalling Firm: Pacific Seafood Group Portland, OR, by telephone on May 14, 2001 and by letter dated May 18 and 21, 2001. Firm initiated recall is complete. REASON The product may be contaminated with listeria monocytogenes. VOLUME OF PRODUCT IN COMMERCE 146,041 lbs. by Washington Crab Producers; 3,700 lbs. by Pacific Shrimp. DISTRIBUTION WA, OR, CA, MT and MD.
_______________________
PRODUCT The product is flavored tortilla chips packaged in a foil bag, labeled in part: "Dortitos Nacho Cheesier!***Net Wt. 13 1/2 oz.***Tortilla Chips***FRITO-LAY, INC., PLANO, TX", packed 6 to a case. Recall # F-642-2. CODE Code 319309350, pull by date Jun 4. RECALLING FIRM/MANUFACTURER Recalling Firm: Frito Lay, Inc., Plano, TX, by press release on April 17, 2002 and by visits beginning April 17, 2002. Manufacturer: Frito Lay, Inc., Franfort, IN. Firm initiated recall is complete. REASON Product contained undeclared soy grits. VOLUME OF PRODUCT IN COMMERCE 8,772 bags. DISTRIBUTION OH, IN and IL. ______________________ PRODUCT Soft Biscuits with fruit fillings as follows: a) Le PIM'S Orange Flavor. Recall # F-643-2; b) Le PIM'S Raspberry Flavor. Recall # F-644-2; c) Le PIM'S Orchard Pear Flavor. Recall # F-645-2. CODE a) UPC codes 6-94990-00850-6; b) UPC codes 6-94990-08370-1; c) UPC codes 6-94990-00855-1. RECALLING FIRM/MANUFACTURER Recalling Firm: Great Brands of Europe, Inc., Wilton, CT, by fax and press release on March 14, 2000. Manufacturer: Lu Debeukelaer Pareinlann. Firm initiated recall is complete. REASON Products contained undeclared milk protein. VOLUME OF PRODUCT IN COMMERCE 70,000 cases (15 units per case). DISTRIBUTION Nationwide. _______________________ PRODUCT Mixed Nuts in round metal tin with label affixed to bottom of tin. Catalog advertises the product as "NUTS NUTS NUTS". Product label states in part "MIXED NUTS INGREDIENTS: CASHEWS, ALMONDS, PECANS, PEANUT OIL, SALT. MAY CONTAIN PEANUTS OR TRACE AMOUNTS OF ALLERGENS NOT LISTED IN THE INGREDIENTS NET WT 567 g (1 lb 4 oz) ***". Recall # F-648-2. CODE "0362" stamped on the label. 0362 represents the Julian date the label was made. "0382" is stamped on the shipping container, which is the Julian date the gift was packaged. Catalog gift #H07414-0000. RECALLING FIRM/MANUFACTURER Recalling Firm: Bear Creek Corporation/Harry and David Medford, OR, by letter on May 15 and 16, 2002. Firm initiated recall is complete. REASON The product contained undeclared Brazil nuts and peanuts. VOLUME OF PRODUCT IN COMMERCE 93. DISTRIBUTION Nationwide.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_______________________
PRODUCT Chocolate Candy Products: a) "Assorted Milk", 4 piece/net wt. 2.6 oz, box labeled the same as the other "Assorted Milk". This box contains an orange creme, haystack (chocolate covered coconut), almond cluster and chocolate covered caramel. Recall # F-633-2; b) "Cherry Cordials Light" Recall # F-634-2; c) "Cherry Cordials Dark" Recall # F-635-2. "Cherry Cordials" is a box containing only chocolate covered cherry cordials. CODE Codes prior to 02-63 Codes are Julian date: year - day (02-63 = 2002 - March 4) Code stamped on bottom of boxes. RECALLING FIRM/MANUFACTURER Mom's Kandy Kitchen, Rexburg, ID, by telephone on March 5, 2002. FDA initiated recall is complete. REASON a)Undeclared yellow 6; b-c) Undeclared yellow 5 & 6. VOLUME OF PRODUCT IN COMMERCE 500 boxes. DISTRIBUTION ID. ______________________ PRODUCT a) JALEBI Dessert. Nirala Sweet House, Sunrise, FL. **INGREDIENTS: WHITE FLOUR, VEGETABLE OIL, SUGAR, FOOD COLOR SUNSET YELLOW #5, WATER** 1/2 lB. **1 LB." Recall # F-638-2. b) MIXED MITHAAI Dessert. Nirala Sweet House, Sunrise, FL. **INGREDIENTS: VEGETABLE OIL, SUGAR, CORN SYRUP, BISQUICK POWDER, DRY MILK, FRESH MILK, ALMOND, PISTACHIO, FOOD COLOR**1/2 LB. Recall # F-639-2. CODE Product is not coded. RECALLING FIRM/MANUFACTURER Recalling Firm: Nirala Sweet House, Sunrise, FL, by telephone around April 9, 2002. State initiated recall is complete. REASON The products contained unapproved color additives. VOLUME OF PRODUCT IN COMMERCE 400 lbs. DISTRIBUTION FL. _______________________ PRODUCT Sliced manzanilla olives in 1 gallon glass jars, labeled in part: "*** Ottimo SPANISH SLICED MANZANILLA OLIVES**NET DR. WT. 4 LBS. 11 OZ. (2126G)Product of Spain** Distributed by Sysco Corp. Houston, Texas**15RV-A**" Product is packed 4 jars per case. Recall # F-641-2. CODE Product item # 3591088, Code Date 15RV-A. RECALLING FIRM/MANUFACTURER Recalling Firm: A. Camacho Inc., Plant City, FL, by fax on April 24, 2002. Manufacturer: Angel Camacho SA, Sevailla, Spain. State initiated recall is complete. REASON Olives may contain glass fragments. VOLUME OF PRODUCT IN COMMERCE 450/4 jar cases. DISTRIBUTION IA, WI, MI, MN, and TX. _______________________ PRODUCT Calcium Tropicana Pure Premium Orange Juice, Not from concentrate No Pulp, 128 oz. (1 gallon), Pasteurized, in a white plastic bottle. Recall # F-646-2. CODE Container has the expiration date "APR 15" printed on the neck of the bottle. RECALLING FIRM/MANUFACTURER Tropicana Products, Inc., Bradenton, FL, by phone, letter, and fax on February 19, 2002. Firm initiated recall is complete. REASON Product contains nitric acid sanitizer residue. VOLUME OF PRODUCT IN COMMERCE 7 0,248 bottles or 17,562 cases. DISTRIBUTION Nationwide.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I
______________________
PRODUCT Combivir Tablets (lamivudine 150 mg/zidovudine 300 mg) 60 tablet bottles, NDC #0173-0595-00, GlaxoWellcome. Recall # D-350-2. CODE Lots 1ZP0848, 1ZP2346, 1ZP2347. RECALLING FIRM/MANUFACTURER Recalling Firm: Alliance Wholesale Distributor, Richton Park, IL, by telephone on May 10, 2002. Manufacturer: Unknown. Firm initiated recall is ongoing. REASON Counterfeit: bottles labeled to contain Combivir tablets may contain Ziagen tablets. VOLUME OF PRODUCT IN COMMERCE 1,756 bottles. DISTRIBUTION IL, CA, IN, NY, TN, PA, MD and NJ.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I
_______________________ PRODUCT Human Tissues, Recall # B-1512-2. CODE 004811 (PLIF Spacer 11 mm) Tissue ID #s 005265601014, 005265601015, 005265601016, 005265601017; 004813 (PLIF Spacer 13 mm) Tissue ID #s 005265601011, 005265601012; 004815 (PLIF Spacer 15mm) Tissue ID #s 005265601006, 005265601007, 005265601008, 005265601009, 005265601010; 038050 (DBX Putty 5 cc) Tissue ID #s 005265601112; 239001 (ATSI BTB, Hemi) Tissue ID #s 005265601072; 460300 (Femur Distal Left OA Graft Cryopreserved) Tissue ID# 005265601001; 800150 (Canc. Chips 1.7-10 mm, 30cc) Tissue ID #s 005265601056, 005265601057, 005265601058, 005265601059, 005265601060, 005265601061, 005265601063; 800250 (Fascia Lata - Large) Tissue ID # 005265601074; 800405 (Iliac Crest Wedge) Tissue ID # s 005265601066, 005265601068, 005265601069; 800585 (Patella Wedge) Tissue ID # 005265601065 830010 (BTB W/Quad, Hemi) Tissue ID # 005265601071 830200 (Achilles Tendon w/ Calcaneus) Tissue ID # 005265601073; 830340 (Posterior Tibialis) Tissue ID # 005265601076, 05265601077; 830335 (Anterior Tibialis Tendon) Tissue ID #s 005265601078, 005265601079; 850100 (Femur Head) Tissue ID # 005265601070. RECALLING FIRM/MANUFACTURER Musculoskeletal Transplant Foundation, Edison, NJ, by telephone on April 23, 2002 and by letter on April 24, 2002. Firm initiated recall is ongoing. REASON Tissues for transplant, that caused post-op infection due to Enterobacter cloacae, and corresponded to tissue that was contaminated with Enterobacter cloacae, were distributed VOLUME OF PRODUCT IN COMMERCE 77 units. DISTRIBUTION Nationwide. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II _______________________ PRODUCT Red Blood Cells, Recall # B-1386-2. CODE Unit number 6490720. RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Shreveport, LA, by telephone on November 20, 2000 and by letter on January 4, 2001. 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 LA. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1404-2; b) Cryoprecipitated AHF, Recall # B-1405-2; c) Plasma, Recall # B-1406-2. CODE a), b) and c) Unit number 11FM56341. RECALLING FIRM/MANUFACTURER The American National Red Cross, Missouri-Illinois Region, St. Louis, MO, by letter on May 18, 2000. Firm initiated recall is complete. REASON Blood products, that tested negative for the antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but were collected from a donor that previously tested repeatedly reactive for anti-HIV-1/2, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION GA, IL and AK. _______________________ PRODUCT Baxter Fenwal Open System and Closed System Apheresis Kits (for use with the CS-3000 or CS-3000 Plus Blood Cell Separators) a) Open System Apheresis Kit. Recall # B-1547-2; b) Semi-Closed System Apheresis Kit. Recall # B-1548-2; c) Closed System Apheresis Kit. Recall # B-1549-2. CODE a) Product code 4R2210T, Lot H01G23055; b) Product code F4R2234, Lot H01G09104; c) Product code 4R2180T, Lot H01G02117. RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Healthcare Corporation, Fenwal Division, Round Lake, IL, by fax on May 7, 2002 and letter on May 22, 2002. Manufacturer: Baxter Healthcare Corporation, Mountain Home, AR. Firm initiated recall is complete. REASON Apheresis Kits, manufactured with a restriction in the Y-site above the separation container, were distributed. VOLUME OF PRODUCT IN COMMERCE a)1,212; b)1,182; c)1,131. DISTRIBUTION TX, CA, LA and CO. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1559-2. CODE Unit numbers 03L32520, 03R20627, and 03H16581. RECALLING FIRM/MANUFACTURER The American National Red Cross, Southern Region, Atlanta, GA, by letter dated April 2, 2002. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION GA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1560-2. CODE Unit numbers 04P46773 and 04P46669. RECALLING FIRM/MANUFACTURER The American National Red Cross, New England Region, Dedham, MA, by letter dated March 18, 2002. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION MA. _______________________ PRODUCT Red Blood Cells, Recall # B-1561-2. CODE Unit numbers 1119451, 1463023, and 2855530. RECALLING FIRM/MANUFACTURER New York Blood Center, Inc., New York, NY, by letter dated February 20, 2002. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on living in an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION NY and NJ. _______________________ PRODUCT a)Red Blood Cells, Recall # B-1562-2; b)Platelets, Recall # B-1563-2. CODE a) and b) Unit number 50LJ24330. RECALLING FIRM/MANUFACTURER The American National Red Cross, Western Lake Erie Region, Toledo, OH, by letter dated October 17, 2001. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on living in an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION OH and MI. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1566-2; b) Platelets, Recall # B-1567-2; c) Fresh Frozen Plasma, Recall # B-1568-2. CODE a) Unit numbers 1549026, 1622559, 1720632, 1853103, and 1659032 b) Unit numbers 1549026 and 1659032 c) Unit number 1659032 RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Shreveport, LA, by letter on March 12, 2001. Firm initiated recall is complete. REASON Blood products, that tested negative for antibodies to human immunodeficiency virus (anti-HIV), but were collected from a donor that previously tested repeatedly reactive for anti-HIV, were distributed. VOLUME OF PRODUCT IN COMMERCE 8 units. DISTRIBUTION LA and MI. _______________________ PRODUCT Source Plasma, Recall # B-1571-2. CODE Unit numbers 29582075, 27554142, and 27555316. RECALLING FIRM/MANUFACTURER Recalling Firm: BioLife Plasma Services L.P., Sera-Tec Biologicals L.P., Deerfield, IL, by letter on January 8, 2002. Manufacturer: BioLife Plasma Services L.P., Sera-Tec Biologicals L.P., Richmond, KY. Firm initiated recall is complete. REASON Blood products, collected from an ineligible donor due to previous incarceration, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION CA and NY. _______________________ PRODUCT Source Plasma, Recall # B-1572-2. CODE Unit numbers 57108100, 57113395, 57115399, 59105503, and 59108832. RECALLING FIRM/MANUFACTURER Recalling Firm: BioLife Plasma Services L.P., Sera-Tec Biologicals L.P., Deerfield, IL, by letter on February 11, 2002. Manufacturer: BioLife Plasma Services L.P., Sera-Tec Biologicals L.P., Louisville, KY. Firm initiated recall is complete. REASON Blood products, collected from an ineligible donor due to previous blood product administration, were distributed. VOLUME OF PRODUCT IN COMMERCE 5 units. DISTRIBUTION CA. _______________________ PRODUCT Source Plasma, Recall # B-1573-2. CODE Unit numbers N-09822-046, N-09816-046, and VP-30144. RECALLING FIRM/MANUFACTURER Pyramid Biological Corporation, Van Nuys, CA, by letters dated June 16 and July 18, 2001. Firm initiated recall is complete REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a history of hepatitis, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION CA and Austria. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1575-2; b) Platelets, Leukocytes Reduced, Recall # B-1576-2; c) Fresh Frozen Plasma, Recall # B-1577-2. CODE a), b), and c) Unit number 42FW86254. RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern Ohio Region, Cleveland, OH, by telephone on February 14, 2002 and by letter on February 21, 2002. Firm initiated recall is complete. REASON Blood products, that tested negative for viral markers, but were collected from a donor that subsequently admitted to multiple risk factors for increased incidence of infection with human immunodeficiency virus (HIV), were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION OH. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1578-2; b) Platelets, Recall # B-1579-2; c) Recovered Plasma, Recall # B-1580-2. CODE a), b) and c) Unit numbers 04LE83445 and 04LE81781. RECALLING FIRM/MANUFACTURER The American National Red Cross, New England Region, Dedham, MA, by letter dated March 4, 2002. Firm initiated recall is complete. REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed. VOLUME OF PRODUCT IN COMMERCE 6 units. DISTRIBUTION MA, ME and CA. _______________________ PRODUCT Platelets Pheresis, Leukocytes Reduced, Recall # B-1581-2. CODE Unit numbers 04P46592, 04P46595, 04P46605, and 04P46588 (distributed as two split units). RECALLING FIRM/MANUFACTURER The American National Red Cross, New England Region, Dedham, MA, by telephone on January 17, 2002 and by letter dated February 12, 2002. Firm initiated recall is complete. REASON Blood products, that were labeled leukoreduced but were not tested to determine the white blood cell count as required in the firm's standard operating procedures, were distributed. VOLUME OF PRODUCT IN COMMERCE 5 units. DISTRIBUTION MA, ME, PA and NJ. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1582-2; b) Red Blood Cells, Leukocytes Reduced, Recall # B-1583-2; c) Platelets, Recall # B-1584-2; d) Cryoprecipitated AHF, Recall # B-1585-2; e) Fresh Frozen Plasma, Recall # B-1586-2; f) Recovered Plasma, Recall # B-1587-2. CODE a), c, d, and f) Unit number 7768581; b)and e) Unit number 7845245. RECALLING FIRM/MANUFACTURER New York Blood Center, Inc., New York, NY, by letter dated February 20, 2002. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor due to a history of residing in the United Kingdom for more than 6 months, were distributed. VOLUME OF PRODUCT IN COMMERCE 6 units. DISTRIBUTION NY and Switzerland. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1588-2. b) Recovered Plasma, Recall # B-1589-2. CODE a) and b) Unit number 7412994; RECALLING FIRM/MANUFACTURER New York Blood Center, Inc., New York, NY, by letter dated February 20, 2002. Firm initiated recall is complete. REASON Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from a donor that previously tested repeatedly reactive for anti-HCV, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION NY and CA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1593-2; b) Red Blood Cells, Leukocytes Reduced, Recall # B-1594-2; c) Recovered Plasma, Recall # B-1595-2. CODE a) Unit number 04S30056; b) Unit number 04R76437; c) Unit numbers 04S30056 and 04R76437. RECALLING FIRM/MANUFACTURER The American National Red Cross, New England Region, Dedham, MA, by letters dated February 28, 2002 and March 4, 2002. Firm initiated recall is complete. REASON Blood products, that tested negative for the antibody to human immunodeficiency virus (anti-HIV), but were collected from a donor that subsequently admitted to a previous positive test for HIV, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION MA, NH, CA and Switzerland. _______________________ PRODUCT Red Blood Cells, Recall # B-1596-2. CODE Unit number 6763115. RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Shreveport, LA, by telephone on December 15, 1999 and by letter on January 3, 2000. Firm initiated recall is complete. REASON Blood product, that was not properly quarantined after the donor of the product reported a post donation illness, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION LA. _______________________ PRODUCT Platelets, Pheresis, Recall # B-1597-2. CODE Unit number 0884087. RECALLING FIRM/MANUFACTURER West Tennessee Regional Blood Center, Jackson, TN, by letter on August 9, 2000. Firm initiated recall is complete. REASON Platelets Pheresis with an elevated platelet count based on volume of product collected were distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION TN. _______________________ PRODUCT Red Blood Cells, Recall # B-1607-2. CODE Unit 22FF73390. RECALLING FIRM/MANUFACTURER American Red Cross, Penn-Jersey Region, Philadelphia, PA, by letter dated September 27, 1999. Firm initiated recall is complete. REASON Blood product that tested negative for hepatitis, but was collected from an unsuitable donor based on previous positive hepatitis testing, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION PA. _______________________ PRODUCT Source Plasma, Recall # B-1609-2. CODE Unit 19-7100-011. RECALLING FIRM/MANUFACTURER Sera-Tec Biologicals Limited Partnership, Huntsville, AL, by fax on October 9, 2000. Firm initiated recall is complete. REASON Blood product, collected from a donor who engaged in high-risk behaviors, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION NC. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced. Recall # B-1617-2. CODE Unit numbers FM52007, FK57694, FK54986, FJ92338, FK54339. RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by telephone on March 14, 2002. Firm initiated recall is complete. REASON Blood products, corresponding to units of Platelets that were pooled and were possibly contaminated with coagulase negative Staphylococcus sp. bacteria, were distributed. VOLUME OF PRODUCT IN COMMERCE 5 units. DISTRIBUTION RI. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1618-2. b) Fresh Frozen Plasma, Recall # B-1619-2. CODE a) and b) Unit number FK58254. RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by telephone on April 9, 2002. Firm initiated recall is complete. REASON Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from a donor that previously tested repeatedly reactive for anti-HCV, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION RI and MA _______________________ PRODUCT Red Blood Cells, Recall # B-1620-2. CODE Unit number 01LN24736. RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red Cross, New York-Penn Region, West Henrietta, NY, by letters on November 19, 2001 and December 11, 2001. Manufacturer: American Red Cross Blood Services, Binghamton, NY. Firm initiated recall is complete. REASON Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION NY. _______________________ PRODUCT Red Blood Cells, Recall # B-1621-2. CODE Unit number 4205111. RECALLING FIRM/MANUFACTURER Blood Bank of Alaska, Inc., Anchorage, AK, by letter dated October 11, 2001. 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 CA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1622-2; b) Platelets, Recall # B-1623-2. CODE a) and b) Unit number 1842882. RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Inc., Lexington, KY, by letter dated April 30, 2002. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION KY. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1624-2; b) Platelets, Leukocytes Reduced, Recall # B-1625-2. CODE a) and b) Unit number 42FY29335. RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern Ohio Region, Cleveland, OH, by letter dated May 10, 2002. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on living in an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION OH. _______________________ PRODUCT Platelets Pheresis, Leukocytes Reduced, Recall # B-1626-2. CODE Unit number 42KW12375 (distributed as two split units). RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern Ohio Region, Cleveland, OH, by letters dated May 15, 2002 and June 7, 2002. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION OH. _______________________ PRODUCT a) Platelets Pheresis, Leukocytes Reduced, Recall # B-1627-2. b) Platelets Pheresis, Irradiated, Recall # B-1628-2. CODE a) Unit numbers 1155292, 1153582, 1151367, 1148738, 1146544, 1143037; b) numbers 1151233, 1146437, 1144625, 1143132. RECALLING FIRM/MANUFACTURER Community Blood Center, Dayton, OH, by letter on January 14, 2002. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 10 units. DISTRIBUTION OH. _______________________ PRODUCT Platelets Pheresis, Recall # B-1629-2. CODE Unit number 7047562. RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by fax on October 19, 2001. Firm initiated recall is complete. REASON Platelets with a decreased platelet count were distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION TX. _______________________ PRODUCT Platelets Pheresis, Recall # B-1630-2. CODE Unit number GS10124. RECALLING FIRM/MANUFACTURER Blood Bank of San Bernadino and Riverside Counties, San Bernadino, CA, by letter on March 1, 2002. Firm initiated recall is complete. REASON Platelets with a decreased platelet count were distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________ PRODUCT Source Plasma, Recall # B-1519-2. CODE Units 3378I853, 3378I968, 3378J211, 3378J400. RECALLING FIRM/MANUFACTURER Recalling Firm: Aventis Bio-Services, Inc., Knoxville, TN, by letter dated July 28, 2000. Manufacturing Firm: Aventis Bio-Services, Inc., West Allis, WI. Firm initiated recall is complete. REASON Blood products, collected from an ineligible donor due to a history of the disease Lupus, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION IL. _______________________ PRODUCT Source Plasma, Recall # B-1520-2. CODE Units 339LF526, 339LF562, 339LF576, 339LF. RECALLING FIRM/MANUFACTURER Recalling Firm: Aventis Bio-Services, Inc., Knoxville, TN, by letter dated November 14, 2001. Manufacturing Firm: Aventis Bio-Services, Inc., West Allis, WI. Firm initiated recall is complete. REASON Blood products, collected from a donor previously deferred for taking anti-malarial medication, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION IL. _______________________ PRODUCT Red Blood Cells, Recall # B-1569-2. CODE Unit number 6952743. RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Shreveport, LA, by telephone on October 11, 2000. Firm initiated recall is complete. REASON Blood product, that did not have the additive solution included within the time frames specified by the manufacturer's instructions, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION LA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1570-2. CODE Unit number 0948210. RECALLING FIRM/MANUFACTURER West Tennessee Regional Blood Center, Jackson, TN, by letter on August 9, 2000. Firm initiated recall is complete. REASON Blood product, that did not have the additive solution included within the time frames specified by the manufacturer's instructions, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION TN. _______________________ PRODUCT Source Plasma, Recall # B-1574-2. CODE Unit number G-29993-181. RECALLING FIRM/MANUFACTURER Pyramid Biological Corporation, Colton, CA, by letter on November 7, 2001. Firm initiated recall is complete. REASON Blood product, that tested negative for viral markers, but was collected from a donor whose health history was inadequately determined, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1590-2; b) Red Blood Cells, Leukocytes Reduced Irradiated, Recall # B-1591-2. CODE a) Unit numbers 22KW35955, 22GW75482, 22KY58191, 22KY58192, 22KK41745, 22LW55894, 22GE59219, 22GE59190, 22KW35948, 22LW55910, 22LJ45497, 22KT37256, 22LW55914, 22LW55913, 22KW35959, 22LW55928, 22LW55916, 22LW55898, 22LW55927, 22LW55903, 22GE59210, 22GE59198, 22GE59208, 22LW55909, 22GE59211, 22GE59200, 22GE59193, 22GE59196, 22GE59194, 22GE59204, 22GE59213, 22GE59197, 22LW55892, 22LW55924, 22LW55908, 22LW55921, 22KW35954, 22GE59218, 22KW35960, 22GE59220, 22LJ45558, 22LJ45634, 22LJ45633, 22KV36532, 22KT37260, 22LJ45572, 22KX40126, 22LJ45604, 22KN28549, 22KZ46693, 22KX40115, 22LJ45609, 22KN28546, 22LJ45541, 22LV76700, 22LJ45643, 22KK41708, 22LJ45573, 22KT37262, 22LJ45566, 22FJ67772, 22KK41701, 22FJ67782, 22LJ45556, 22KX40124, 22FJ67780, 22FJ67779, 22LJ45546, 22KX40129, 22LJ45557, 22LJ45564, 22LJ45611, 22KZ46699, 22LJ45575, 22KX40116, 22KN28545, 22LJ45602, 22KX40141, 22GK84781, 22LJ45580, 22KZ46691, 22LJ45591, 22KX40125, 22LJ45640, 22LJ45629, 22KZ46700, 22LV76694, 22LV76688, 22KV36525, 22LJ45585, 22LV76709, 22KT37258, 22KT37259, 22LJ45582, 22LV76701, 22LJ45614, 22KZ46690, 22LV76716, 22LJ45542, 22FJ67792, 22KX40122, 22LJ45553, 22KX40120, 22FJ67773, 22KN2853, 22KK41700, 22LJ45641, 22KX40145, 22LJ45615, 22GK84796, 22KX40140, 22LV76696, 22LJ45626, 22KZ46695, 22GK84791, 22GK84795, 22KV36522, 22KX40133, 22LJ45548, 22KZ46697, 22LJ45616, 22KN28542, 22LJ45607, 22KN28547, 22LV76689, 22LV76697, 22LV76707, 22LJ45545, 22KK41702, 22KX40123, 22KX40138, 22FJ67790, 22KX40132, 22LJ45577, 22LJ45567, 22LJ45594, 22LV76695, 22LJ45569, 22GK84785, 22LJ45603, 22LJ45600, 22GE59267, 22GK84826, 22LW55972, 22KR73004, 22FJ67821, 22FJ67811, 22KY57945, 22KZ46719, 22KR72953, 22KR72969, 22KR72984, 22FJ67825, 22KR72965, 22KT37270, 22KX40169, 22KX40157, 22KX40172, 22KX40168, 22KX40170, 22KX40152, 22FJ67822, 22KY57946, 22KY57936, 22GK84799, 22FJ67832, 22KT37280, 22KR73009, 22KR72986, 22KR73001, 22KX40121, 22KR72959, 22KR72962, 22KY57942, 22GW75486, 22KZ46727, 22KR72974, 22GK84801, 22LJ45645, 22GK84810, 22KR72992, 22KZ46711, 22KZ46726, 22KX40161, 22FJ67810, 22KR72941, 22KT37273, 22GW75484, 22GE59259, 22GK84827, 22GE59270, 22KZ46721, 22FJ67816, 22GK84797, 22KR72947, 22KX40154, 22KR72964, 22FJ67827, 22KY57943, 22KT37265, 22KR72999, 22LW55956, 22KR72988, 22KT37278, 22KR72977, 22LJ45646, 22LJ45665, 22KZ46714, 22KC33159, 22KV36655, 22KV36666, 22KC33153, 22KR72982, 22KC33157, 22GW75485, 22KT37264, 22GE59261, 22GK84798, 22KX40151, 22KR72997, 22KR72994, 22KT37268, 22KX40147, 22KX40150, 22KZ46715, 22GK84803, 22GK84822, 22KZ46720, 22KR73006, 22GK84814, 22KX40153, 2KT37267, 22KY57947, 22LW55962, 22KX40148, 22GK84802, 22KZ46728, 22KR72950, 22KP66346, 22KY57938, 22KR72952, 22GK84819, 22GK84816, 22KR72943, 22GW75490, 22KZ46722, 22GK84815, 22LW55955, 22KV36711, 22KM69135, 22KC33185, 22LJ45787, 22KT37376, 22KJ69399, and 22LW55971 b) Unit numbers 22GK84825, 22GK84820, 22GK84833, 22KR72996, 22KR72998, 22KZ46725, 22KW35952, 22GE59222, and 22LW55929 RECALLING FIRM/MANUFACTURER The American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on July 12, 2001 and by letter dated August 10, 2001. Firm initiated recall is complete. REASON Blood products, that were labeled as leukoreduced but were collected with collection sets that were experiencing an increase in failed quality control testing due to an elevated white blood cell count, were distributed. VOLUME OF PRODUCT IN COMMERCE 264 units. DISTRIBUTION PA and NJ. _______________________ PRODUCT Source Plasma, Recall # B-1592-2. CODE Unit number 0100421336. RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc. (formerly Nabi), Chattanooga, TN, by fax on March 7, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor that did not answer the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION NC. _______________________ PRODUCT Source Plasma, Recall # B-1598-2. CODE Unit numbers CP-15929 and G-32402-181. RECALLING FIRM/MANUFACTURER Pyramid Biological Corporation, Colton, CA, by letters on April 9, 2001 and May 1, 2001. Firm initiated recall is complete. REASON Blood products, collected from an ineligible donor based on previous elevated testing for alanine aminotransferase (ALT), were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION CA and Austria. _______________________ PRODUCT Platelets, Recall # B-1608-2. CODE Unit 22KM69875. RECALLING FIRM/MANUFACTURER American Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on August 3, 2001 and by letter dated August 13, 2001. Firm initiated recall is complete. REASON Blood product, prepared from a unit of Whole Blood with a documented extended collection time, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION PA. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I _______________________ PRODUCT LTV Series Ventilators LTV 1000, Catalog No. 10130. Recall # Z-1132-2; LTV 950, Cat. No. 10950. Recall # Z-1133-2; LTV 900, Cat. No. 10638. Recall # Z-1134-2; LTV 800, Cat. No. 11800. Recall # Z-1135-2. CODE Unavailable at this time. RECALLING FIRM/MANUFACTURER Pulmonetic Systems, Inc., Colton, CA, by letters on June 3 and June 11, 2002. Firm initiated recall is ongoing. REASON Capacitor malfunction leading to quit with no alarm. VOLUME OF PRODUCT IN COMMERCE 3,348. DISTRIBUTION Nationwide and Internationally.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________________ PRODUCT Fresenius brand Hemodialysis Delivery Systems, Model 2008K Software version 2.12. Recall # Z-1139-2. CODE Model 2008K. RECALLING FIRM/MANUFACTURER Recalling Firm: Fresenius Medical Care North America, Dialysis Product Division, Walnut Creek, CA, by telephone and letter on February 22, 2002. Firm initiated recall is ongoing. REASON Firm has received reports of excessive ultrafiltration. VOLUME OF PRODUCT IN COMMERCE 4,829 units. DISTRIBUTION Nationwide. _______________________ PRODUCT Silicone Double Lumen Hemo Cath Kit. Each kit contains a Lidocaine HCl 1%, 5 cc ampule. Recall # Z-1140-2. CODE Catalog Number MCDLTSL28. Kit Lot number M929970 exp 5/02. RECALLING FIRM/MANUFACTURER Medical Components, Inc., Harleysville, PA, by letters on April 30, 2002. Firm initiated recall is ongoing. REASON Kit contains expired drug component. VOLUME OF PRODUCT IN COMMERCE 250 kits. DISTRIBUTION Nationwide. _______________________ PRODUCT 16F Vascu Sheath and 17F Dilator. Recall # Z-1141-2/Z-1142-2. CODE The list below is Work Order Lot# (with the corresponding catalog # in brackets) for the 16F Vascu Sheath: M207840 (ASPC28), M207850 (ASPC28), M207900 (ASPC24), M207940 (PD472S), M207950 (PDC621S), M207980 (TRAY #553), M208000 (TRAY #552), M208100 (TRAY #594), M208110 (ASPC32), M208120 (ASPC32), M208290 (ASPC28-XL), M208300 (ASPC28-XL), M208520 (ASPC28), M208580 (MCVS116S), M208630 (ASPC36-2), M208700 (ASPC32-XL), M209070 (PDC5652S), M209280 (ASPC24), M209290 (ASPC28), M209750 (ASPC28), M209890 (ASPC28), M209910 (ASPC32), M209920 (ASPC28), M210180 (ASPC28-XL), M210570 (ASPC55), M210880 (ASPC24-XL), M210930 (ASPC28-XL), M210990 (ASPC24), M211170 (ASPC28MP), M211330 (ASPC32), M211380 (TRAY #593), M211800 (TRAY #552), M211810 (TRAY #553), M211820 (ASPC36), M211840 (TRAY #553-XL), M212200 (TRAY #552), M212300 (ASPC32I), M212280 (ASPC28-2), M212290 (ASPC32-2), M212430 (TRAY #552), M212800 (ASPC32-XL), M213050 (ASPC24), M213060 (ASPC28), and M214290 (ASPC28). The list below is Work Order Lot # (with the corresponding catalog # in brackets) for the 17F Dialtor: M210580 (ASPC2816), M210820 (ASPC3216), M211770 (ASPC2416), M211790 (ASPC3216), and M212450 (ASPC2416). RECALLING FIRM/MANUFACTURER Medical Components, Inc., Harleysville, PA, by letter on April 30, 2002. Firm initiated recall is ongoing. REASON Reduced image contrast of dilator. VOLUME OF PRODUCT IN COMMERCE 8,917 units. DISTRIBUTION Nationwide and Canada.
END OF ENFORCEMENT REPORT FOR JULY 17, 2002
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