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
Office of Public Affairs
Hypertext uploaded by jch 2002-JUL-17
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