October 9, 2002
02-40
_____________________________
PRODUCT
CAF brand SWEETENED GINGER, packed in rigid plastic containers. INGREDIENTS: Ginger, Sugar. NET WT. 200 G. PRODUCT OF VIETNAM. Recall # F-892-2.
CODE
Barcode # 52228 70017.
RECALLING FIRM/MANUFACTURER
Recalling Firm: CA First (NY) Trading, Inc., Brooklyn, NY, by telephone on April 26, 2002.
Manufacturer: Unknown. State initiated recall is complete.
REASON
The product contained undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
25 cases (48 - 7 oz. containers per case) were distributed.
DISTRIBUTION
NY, VA, MA and NY.
_____________________________
PRODUCT
"ASSORTED CANDY", NET WT. 16 oz. packed in clear red plastic container with clear cover.
a) "Assorted Candy" with a picture of a man & 2 children.
Recall # F-893-2.
b) "Assorted Candy" with a picture of a Chinese junk ship.
Recall # F-894-2.
CODE
None.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blooming Import Inc., Brooklyn, NY, by letter on January 17, 2002 and press release on January 18, 2002.
Manufacturer: Daxin Hua Feng Food Co., Ltd. Taishan City, Guangdong. State initiated recall is complete.
REASON
a) Undeclared sulfites, unapproved color Ponceau 4R,
and undeclared colors certifiable as FD&C Yellow No. 5,
FD&C Yellow No. 6 and FD&C Blue No. 1.
b) Undeclared sulfites).
VOLUME OF PRODUCT IN COMMERCE
145 cases (12 - 16 oz. packages per case) of each product were distributed.
DISTRIBUTION
NY.
_____________________________
PRODUCT
Homerun Ball Biscuits in 155g (5.46 oz) bags.
Recall # F-895-2.
CODE
T UP Trading Item No. 52389; Container No. 32498
Exp. 3/28/2003 and 5/12/2003.
RECALLING FIRM/MANUFACTURER
Recalling Firm: T Up Trading, Inc., Secaucus, NJ, by telephone on July 18, 2002 and by letters on July 22, 2002.
Manufacturer: Hai Tai Confectionery Co., Ltd Korea.
State initiated recall is complete.
REASON
The product contained undeclared eggs.
VOLUME OF PRODUCT IN COMMERCE
33 cases or 396 bags.
DISTRIBUTION
NY and NJ.
_____________________________
PRODUCT
Dried Apricots packed in flexible plastic bags, NET WT. 7 OZ. (200 g). Recall # F-896-2.
CODE
None.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mon Chong Loong Trading Corp., Maspeth, NY, by press release and letter on May 14, 2001.
Manufacturer: Tim Heung Yuen Nut & Confectionary Co., Kwai Chung, N.T. State initiated recall is complete.
REASON
The product contained undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
50 cases (45 - 7 oz. bags per case) were distributed.
DISTRIBUTION
NY.
_____________________________
PRODUCT
Carbolite brand Milk Chocolate bars, 1.75 ounce. The product is packaged by cases, 48 bars/case, and the case is labeled as Chocolate Almond. Recall # F-897-2.
CODE
T09002B with Best by 04/03.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Carbolite Foods, Inc., Evansville, IN, by press release on September 13, 2002.
Manufacturer: Thompson Candy Company LLC., Fairfield, CA.
Firm initiated recall is ongoing.
REASON
Individual bars labeled as Milk Chocolate actually contains Chocolate Almond bars.
VOLUME OF PRODUCT IN COMMERCE
1,977cases (48 bars/case).
DISTRIBUTION
Nationwide and Puerto Rico.
_____________________________
PRODUCT
Chocolate Covered Fudge Squares, ALASKA WILD BERRY PRODUCTS brand, in 5 oz., 8 1/2 oz., and 14 oz. boxes. Boxes include a variety of flavored fudge squares; the one candy that contains the undeclared colors is the Grand Marnier fudge square. Recall # F-883-2.
CODE
The products are not coded.
RECALLING FIRM/MANUFACTURER
Alaska Wild Berry Products, Anchorage, AK, by telephone on or about August 30, 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
947 5 oz. boxes; 243 8-1/2 oz. boxes; 63 - 14 oz. boxes.
DISTRIBUTION
AK, CA, IN, MA, NC, PA, and TN.
_____________________________
PRODUCT
Aunt Heddy's(R) brand Apricot Rugala, packaged in a rigid plastic container, net wt. 12 oz. (341 g).
Recall # F-884-2.
CODE
Barcode # 28718 03002.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zablocki Industries Inc. (DBA Aunt Heddy's Bakery), Brooklyn, NY, by letter dated August 2, 2001.
Manufacturer: Jesperson Bakery, Bridgeport, CT. State initiated recall is complete.
REASON
The product contained undeclared color FD&C Yellow No. 5.
VOLUME OF PRODUCT IN COMMERCE
19 cases (12 - 12 oz. containers per case).
DISTRIBUTION
NY.
_____________________________
PRODUCT
a) Corn cakes labeled as "MAIZ" packaged in boxes
containing 18 units of 1.5 oz each. Recall # F-885-2;
b) Cookies labeled as "Polvorones" packaged in boxes
containing 18 units of 1.5 oz each. Recall # F-886-2.
CODE
None.
REC ALLING FIRM/MANUFACTURER
Delis Bakery, Lares, Puerto Rico, by telephone May 16, 2002. FDA initiated recall is complete.
REASON
The products contained undeclared
undeclared color
FD&C Yellow No. 5.
VOLUME OF PRODUCT IN COMMERCE
1440 units.
DISTRIBUTION
Puerto Rico.
_____________________________
PRODUCT
Halal brand Jelly Crystals, Black Currant flavour, packaged in a papercard display box, net wt. 85 gms., 12 dozen boxes per carton. Recall # F-889-2.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Al-Nafea Inc., Springfield, VA, by visit commencing on August 28, 2002.
Manufacturer: Laziza International Convenience Food Industries Karachi, Pakistan. Firm initiated recall is complete.
REASON
The product contained colors that were unapproved for food use or whose safety was uncertain since we could not determine if the colors had been certified.
VOLUME OF PRODUCT IN COMMERCE
972 boxes.
DISTRIBUTION
VA and FL.
_____________________________
PRODUCT
French Kiss Body Painting Candy, Net 5.4 Fl. Oz.
Recall # F-891-2.
A translucent, semi-flexible plastic outer package/ rectangular box having silver colored lettering reading in part: "French Kiss Body Painting Candy***Net 5.4 fl.oz.(160mL)" on front of package, with a ~2" x 1/2" white colored stick-on label with a bar code, reading in part: "00562967 FK BODY PAINTS ABK 145926", plus a 5/8"x3/4" white colored stick-on label reading: "2004 JA", a white colored side label with black lettering reading in part: " ***BANANA ***TUTIFRUTI *** CHERRY *** VANILLA*** Nutrition Facts Serving Size 1 tbsp (15mL) Servings about 11 per box (about 3/jar) Calories 70*** INGREDIENTS: GLUCOSE, NATURAL AND ARTIFICIAL FLAVORS, TITANIUM DIOXIDE, BLUE 1, RED 2, YELLOW 5 *** containing four (4) glass jars with screw-on lids, containing a different flavor in each jar: (banana [yellow colored thick liquid], tutifruti [blue colored thick liquid], cherry [red colored thick liquid], and vanilla[white colored thick liquid] ). Jars have no labeling.
CODE
SKU # 00562967 FK Body Paints and 2004JA or Best Before 01 2004.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Spencer Gifts, Inc., Egg Harbor Township, NJ, by e-mail on May 10, 2002.
Manufacturer: Chocolate French Kiss Inc., Quebec, Canada J7J 2B6. Firm initiated recall is ongoing.
REASON
The product contains an unapproved color, amaranth (formerly known as FD&C Red No. 2).
VOLUME OF PRODUCT IN COMMERCE
3295 units.
DISTRIBUTION
NC.
_________________________
PRODUCT
Shellstock oysters packaged in bulk with no labeling other than the harvest tags which indicate harvest date and area. Recall # F-898-2.
CODE
The recall involves all oysters harvested from Louisiana, Growing Area 6, Black bay during the time period 3/12-28/2002.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Louisiana Fresh Seafood, Breaux Bridge, LA, by telephone on March 29, 2002. State initiated recall is complete.
REASON
Oysters were associated with a foodborne illness outbreak (Norwalk-like virus).
VOLUME OF PRODUCT IN COMMERCE
528 sacks.
DISTRIBUTION
LA and TX.
_____________________________
PRODUCT
Shellstock oysters packaged in
bulk with no labeling other than
the harvest tags which indicate harvest
date and area. Recall # F-899-2.
CODE
The recall involves all oysters harvested from
Louisiana, Growing Area 6, Black bay during the time period
3/12-28/2002.
RECALLING FIRM/MANUFACTURER
Inland Seafood, New Orleans, LA, by telephone on March 24, 2002. State initiated recall is complete.
REASON
Oysters were associated with a foodborne illness outbreak (Norwalk-like virus).
VOLUME OF PRODUCT IN COMMERCE
13 boxes.
DISTRIBUTION
LA and MS.
_____________________________
PRODUCT
Shellstock oysters packaged in bulk with no labeling other than the harvest tags which indicate harvest date and area. Recall # F-900-2.
CODE
The recall involves all oysters harvested from
Louisiana, Growing Area 6, Black bay during the time period
3/12-28/2002.
RECALLING FIRM/MANUFACTURER
Eddie's Quality Oysters Port, Sulphur, LA, by telephone on March 29, 2002. State initiated recall is complete.
REASON
Oysters were associated with a foodborne illness outbreak (Norwalk-like virus).
VOLUME OF PRODUCT IN COMMERCE
1328 sacks.
DISTRIBUTION
VA, MS, FL, LA and NC.
_____________________________
PRODUCT
Shucked oysters packaged in bulk with no labeling other than the harvest tags which indicate harvest date and area. Recall # F-901-2.
CODE
The recall involves all oysters harvested from Louisiana, Growing Area 6, Black bay during the time period 3/12-28/2002.
RECALLING FIRM/MANUFACTURER
Louisiana Pride Oysters, Violet, LA, by telephone on March 28, 2002. State initiated recall is complete.
REASON
Oysters were associated with a foodborne illness outbreak (Norwalk-like virus).
VOLUME OF PRODUCT IN COMMERCE
435 gallons.
DISTRIBUTION
LA.
_____________________________
PRODUCT
Oysters packaged in bulk with no labeling other than the harvest tags which indicate harvest date and area.
Recall # F-902-2.
CODE
The recall involves all oysters harvested from Louisiana, Growing Area 6, Black bay during the time period 3/12-28/2002.
RECALLING FIRM/MANUFACTURER
Louisiana Seafood Express, Franklinton, LA, by telephone beginning on April 1, 2002. State initiated recall is complete.
REASON
Oysters were associated with a foodborne illness outbreak (Norwalk-like virus).
VOLUME OF PRODUCT IN COMMERCE
552 -1/2 gallons.
DISTRIBUTION
LA and MS.
_____________________________
PRODUCT
Oysters packaged in bulk with no labeling other than the harvest tags which indicate harvest date and area.
Recall # F-903-2.
CODE
The recall involves all oysters harvested from Louisiana, Growing Area 6, Black bay during the time period 3/12-28/2002.
RECALLING FIRM/MANUFACTURER
Melerine Seafood, St. Bernard, LA, by telephone April 1, 2002. State initiated recall is complete.
REASON
Oysters were associated with a foodborne illness outbreak (Norwalk-like virus).
VOLUME OF PRODUCT IN COMMERCE
123 sacks.
DISTRIBUTION
LA and AL.
_____________________________
PRODUCT
Oysters packaged in bulk with no labeling other than the harvest tags which indicate harvest date and area.
Recall # F-904-2.
CODE
The recall involves all oysters harvested from
Louisiana, Growing Area 6, Black bay during the time period
3/12-28/2002.
RECALLING FIRM/MANUFACTURER
Motivatit Seafood, Houma, LA, by telephone beginning April 2, 2002. State initiated recall is complete.
REASON
Oysters were associated with a food borne illness outbreak (Norwalk-like virus).
VOLUME OF PRODUCT IN COMMERCE
1524 sacks.
DISTRIBUTION
LA, MI, AL, MD, AZ, FL, TX, IL, MO, CA, PA and Puerto Rico.
_____________________________
PRODUCT
Oysters packaged in bulk with no labeling other than the harvest tags which indicate harvest date and area.
Recall # F-905-2.
CODE
The recall involves all oysters harvested from Louisiana, Growing Area 6, Black bay during the time period 3/12-28/2002.
RECALLING FIRM/MANUFACTURER
New Orleans Gulf Seafood, New Orleans, LA, by telephone on March 29, 2002. State initiated recall is complete.
REASON
Oysters were associated with a foodborne illness outbreak (Norwalk-like virus).
VOLUME OF PRODUCT IN COMMERCE
17 sacks.
DISTRIBUTION
AL and MS.
_____________________________
PRODUCT
Shellstock oysters packaged in bulk with no labeling other than the harvest tags which indicate harvest date and area. Recall # F-906-2.
CODE
The recall involves all oysters harvested from
Louisiana, Growing Area 6, Black bay during the time period
3/12-28/2002.
RECALLING FIRM/MANUFACTURER
P & J Oysters, Inc., New Orleans, LA, by telephone on March 28, 2002. State initiated recall is complete.
REASON
Oysters were associated with a foodborne illness outbreak (Norwalk-like virus).
VOLUME OF PRODUCT IN COMMERCE
942 sacks.
DISTRIBUTION
LA and TX.
_____________________________
PRODUCT
Oysters packaged in bulk with no labeling other than the harvest tags which indicate harvest date and area.
Recall # F-907-2.
CODE
The recall involves all oysters harvested from Louisiana, Growing Area 6, Black bay during the time period 3/12-28/2002.
RECALLING FIRM/MANUFACTURER
Port Sulphur Fisheries, Port Sulphur, LA, by telephone on March 30, 2002. State initiated recall is complete.
REASON
Oysters were associated with a foodborne illness outbreak (Norwalk-like virus).
VOLUME OF PRODUCT IN COMMERCE
400 sacks.
DISTRIBUTION
LA.
_____________________________
PRODUCT
Oysters packaged in bulk with no labeling other than the harvest tags which indicate harvest date and area.
Recall # F-908-2.
CODE
The recall involves all oysters harvested from Louisiana, Growing Area 6, Black bay during the time period 3/12-28/2002.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Robin & Cohn Distributors, Chalmette, LA, by telephone on March 28, 2002.
Manufacturer: Robin & Cohn, Chalmette, LA. State initiated recall is complete.
REASON
Oysters were associated with a foodborne illness outbreak (Norwalk-like virus).
VOLUME OF PRODUCT IN COMMERCE
513 sacks.
DISTRIBUTION
LA.
_____________________________
PRODUCT
Shucked Oysters packaged in bulk with no labeling other than the harvest tags which indicate harvest date and area. Recall # F-909-2.
CODE
The recall involves all oysters harvested from Louisiana, Growing Area 6, Black bay during the time period 3/12-28/2002.
RECALLING FIRM/MANUFACTURER
Seafood Wholesalers, Westwego, LA, by telephone on March 30, 2002. State initiated recall is complete.
REASON
Oysters were associated with a foodborne illness outbreak (Norwalk-like virus).
VOLUME OF PRODUCT IN COMMERCE
8 gallons.
DISTRIBUTION
LA.
_____________________________
PRODUCT
Oysters packaged in bulk with no labeling other than the harvest tags which indicate harvest date and area.
Recall # F-910-2.
CODE
The recall involves all oysters harvested from Louisiana, Growing Area 6, Black bay during the time period 3/12-28/2002.
RECALLING FIRM/MANUFACTURER
Shamrock Seafood, Raceland, LA, by telephone on March 29, 2002. State initiated recall is complete.
REASON
Oysters were associated with a foodborne illness outbreak (Norwalk-like virus).
VOLUME OF PRODUCT IN COMMERCE
4 sacks.
DISTRIBUTION
LA.
_____________________________
PRODUCT
Oysters packaged in bulk with no labeling other than the harvest tags which indicate harvest date and area. Recall # F-911-2.
CODE
The recall involves all oysters harvested from Louisiana, Growing Area 6, Black bay during the time period 3/12-28/2002.
RECALLING FIRM/MANUFACTURER
Southern Foods, St. Bernard, LA, by telephone on March 29, 2002. State initiated recall is complete.
REASON
Oysters were associated with a foodborne illness outbreak (Norwalk-like virus).
VOLUME OF PRODUCT IN COMMERCE
1444 large sacks, 495 small sacks.
DISTRIBUTION
LA, AL, VA, FL and NC.
_____________________________
PRODUCT
Shellstock oysters packaged in burlap sacks labeled "Growing Area 6". Recall # F-912-2.
CODE
The recall involves all oysters harvested from LA Growing Area 6, Black Bay, during March 12-28, 2002.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bez Oysters & Seafood, Inc., Belle Chase, LA, by telephone on March 30 and April 1, 2002.
State initiated recall is complete.
REASON
Oysters were associated with a foodborne illness outbreak (Norwalk-like virus).
VOLUME OF PRODUCT IN COMMERCE
400 sacks.
DISTRIBUTION
LA.
_____________________________
PRODUCT
Oysters packaged in bulk with no labeling other than the harvest tags which indicate harvest date and area.
Recall # F-913-2.
CODE
The recall involves all oysters harvested from Louisiana, Growing Area 6, Black bay during the time period 3/12-28/2002.
RECALLING FIRM/MANUFACTURER
Brant’s Oysters, Pointe a la Hache, LA, by telephone on March 29, 2002. State initiated recall is complete.
REASON
Oysters were associated with a foodborne illness outbreak (Norwalk-like virus).
VOLUME OF PRODUCT IN COMMERCE
49 sacks.
DISTRIBUTION
LA.
_____________________________
PRODUCT
Spring Flower Sugar Cookies, Item Sm0105. Recall # F-914-2.
CODE
None. (There are no production codes on the product.)
RECALLING FIRM/MANUFACTURER
Cheese Cake City, Berkeley, CA, by telephone on or about February 24, 2002. FDA initiated recall is complete.
REASON
Undeclared food colors: FD&C Yellow #5 & #6, and Red #40.
VOLUME OF PRODUCT IN COMMERCE
28 dozens.
DISTRIBUTION
CA.
_____________________________
PRODUCT
LOTUS KPC brand DRIED SHREDDED TAPIOCA, packaged in a flexible plastic bag, NET WT. 7 oz. (200 GR).
Ingredients: Tapioca, Water, FD&C # Red No. 40 (E129), CI 44090 E142 Green S and FD&C Yellow No. 5. PRODUCT OF VIETNAM. Recall # F-918-2.
CODE
None.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kien Import Corporation, Brooklyn, NY, by letters dated June 15, 2001.
Manufacturer: Nam Hai Company, Ltd., Ho Chi Minh City, Vietnam. State initiated recall is complete.
REASON
The product contained carmoisine (E122, Acid Red 14) an unapproved color additive.
VOLUME OF PRODUCT IN COMMERCE
23 cases (50 - 7 oz. packages per case).
DISTRIBUTION
Asian retail markets in NY, NJ, CT, RI, MA, PA, OH, FL.
_____________________________
PRODUCT
DRIED PLUM, packaged in a rigid plastic box, Net Wt. 6 oz. (170 g). INGS: PRUNE SUGAR SALT WATER. PRODUCT OF CHINA. Recall # F-919-2.
CODE
None.
RECALLING FIRM/MANUFACTURER
YBL World Wide Trading Inc., Brooklyn, NY, by visit in April - May 2001. State initiated recall is complete.
REASON
The product contained undeclared saccharin, which is not permitted for use in this type of food.
VOLUME OF PRODUCT IN COMMERCE
236 cases (100 - 6 oz. packages per case) were distributed in 1998.
DISTRIBUTION
NY.
_____________________________
PRODUCT
Dried Ginger packaged in a rigid plastic tube, Net Wt. 6 oz. (170 g). INGREDIENT: GINGER, SALT, SUGAR. PRODUCT OF CHINA. Recall # F-920-2.
CODE
Barcode # 908723 380291.
RECALLING FIRM/MANUFACTURER
YBL World Wide Trading Inc., Brooklyn, NY, by visit April - May 2001. State initiated recall is complete.
REASON
The product contained Ponceau 4R (E124, Acid Red 18), an unapproved color additive, and undeclared saccharin, a food additive not allowed for use in this type of food.
VOLUME OF PRODUCT IN COMMERCE
142 cases (50 - 6 oz. packages per case) were distributed in 1998.
DISTRIBUTION
NY.
_____________________________
PRODUCT
Sysco Brand Imperial Rice Pilaf, chicken flavored rice with toasted orzo pasta, net weight 36 ounces (2lbs, 4oz) 1.02 kg. Recall # F-890-2.
CODE
All products shipped from 02/09/02 until 08/09/02 are subject to recall.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Producers Rice Mill, Inc., Little Rock, AR, by e-mail beginning August 9, 2002.
Manufacturer: Precision Foods, Inc., Tupelo, MS. FDA initiated recall is ongoing.
REASON
The product does not list the subingredients of pasta.
VOLUME OF PRODUCT IN COMMERCE
2500 cases
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Products are three different flavored rice mixes:
a) Chef's Originals Garlic & Herb Risotto, 6.5 oz.
Recall # F-915-2;
b) Chef's Originals Portobello Risotto, 6.9 oz.
Recall # F-916-2;
c) Chef's Originals Parmesan Risotto, 6.5 oz.
Recall # F-917-2.
CODE
a) UPC Code# 7440101276;
Lot Numbers: 2910110D, 0930204D,
b) UPC Code # 7440101277;
Lot Numbers: 2910110D, 0930204D,1280204D,
c) UPC Code # 7440101275;
Lot Numbers: 2910110D; 0930204D; 1280204D.
RECALLING FIRM/MANUFACTURER
RiceTec, Inc., Alvin, TX, by letter on or about June 7, 2002. Firm initiated recall is complete.
REASON
Sodium content exceeds amount indicated on label.
VOLUME OF PRODUCT IN COMMERCE
4687 total units.
DISTRIBUTION
IL, FL, NJ, MI, MA and NY.
_____________________________
PRODUCT
NX Stage Dialysis Solution, Formula A, Optioncare brand, 3000 mL bags, Rx Only. Recall # D-003-3.
CODE
All lot codes are under recall.
RECALLING FIRM/MANUFACTURER
Option Care, Inc., Columbia, MD, by letter on May 24, 2002.
Firm initiated recall is complete.
REASON
Microbial contamination.
VOLUME OF PRODUCT IN COMMERCE
3134 bags.
DISTRIBUTION
IN, CA, MA, NJ, VA, MA and MS.
_____________________________
PRODUCT
a) Vancocin HCl Injection (sterile vancomycin
hydrochloride, USP) IntraVenous, Equiv. to 500 mg
Vancomycin, VIAL No. 657, traypak of 25, Lyophilized,
Rx. NDC 0002-1444-25. Recall # D-424-2;
b) Vancocin HCl (sterile vancomycin hydrochloride, USP)
IntraVenous, Equiv. to 1 g Vancomycin, VIAL No. 7321,
traypak of 25, Lyophilized, Rx only. Recall # D-425-2;
c) Vancocin HCl for Injection (vancomycin hydrochloride for
injection, USP) IntraVenous, Equiv. to 10 g Vancomycin,
100 mL vials, Lyophilized, PHARMACY BULK PACKAGE NOT FOR
DIRECT INFUSION, Rx. NDC-0002-7355-01 (VIAL No. 7355).
Recall # D-426-2;
d) Vancomycin Hydrochloride for Injection, USP, Equiv. to
10 g Vancomycin, 100 mL vial, PHARMACY BULK PACKAGE, NOT
FOR DIRECT INFUSION, Rx only, Lyophilized, AmeriNet
Choice (Trademark) label, Vancomycin Hydrochloride for
Injection, USP, NDC 0002-9509-01. Recall # D-427-2.
e) NEBCIN (Tobramycin for Injection, USP) Equiv. to 1.2 g
Tobramycin, PHARMACY BULK PACKAGE NOT FOR DIRECT
INFUSION, Rx only, VIAL No. 7040, Traypak of 6.
Recall # D-428-2;
f) Tobramycin for Injection, USP, Equivalent to 1.2 g
Tobramycin, per 30mL, Multiple Dose Vial,(40 mg/mL)
traypaks of 6, Rx only, NOVAPLUS, USA Novation, the
supply company of VHA and UHC, and NOVAPLUS are
trademarks of Novation,LLC, NDC 0002-7382-16.
Recall # D-429-2.
g) Dobutrex Solution (Dobutamine Injection, USP) Equiv. to
250 mg, Dobutamine per 20 mL, Single Dose Vial, Rx, 20
mL VIAL No. 7175, For I.V. Use Only, Recall # D-430-2;
h) Dobutamine Injection, USP, Equivalent to 250 mg
Dobutamine per 20 mL, 20 mL Single Dose Vial, Rx only,
NOVAPLUS, For I.V. Use Only, USA. Recall # D-431-2;
i) GEMZAR (Gemcitabine HCl For Injection) 200 mg equivalent
to base, For I.V. use only, Sterile Single Use Vial, Rx,
VIAL 7501, NDC 0002-7501-01. Recall # D-432-2;
j) GEMZAR (Gemcitabine HCl For Injection) 1 g equivalent to
base, For I.V. use only, Sterile Single Use Vial, Rx,
VIAL No. 7502, NDC 0002-7502-01. Recall # D-433-2;
k) Dolophine Hydrochloride (Methadone Hydrochloride
Injection,USP) 10 mg per mL, Multiple Dose Vial, NDC-
0054-1218-42. Recall # D-434-2;
l) Brevital Sodium (Methohexital Sodium for Injection,
USP),500 mg, Anesthetic Barbiturate, Multiple Dose Vial,
Rx Only. Recall # D-435-2;
m) Brevital Sodium (Methohexital Sodium for Injection, USP)
2.5 g, Multiple Dose Vial, Anesthetic Barbiturate,
Rx Only. Recall # D-436-2.
CODE
Lot (Exp. Date)
Vancocin:
USA Distribution
500 mg
4MK94M (1-Aug-02) and 4MP18N (1-Oct-02)
1 gm
5MG16W (1-Apr-03), 5MA16M (1-Feb-03), 4MT59T (1-Sep-02), 4MT60M (1-Sep-02) and 4MX34M (1-Oct-02)
10gm
4MN09M (1-Sep-03), 4MH51M (1-May-03), 5MZ89M (1-Nov-04), and 5MZ89N (1-Nov-04)
Foreign Distribution:
4MP20XA (1-Oct-02), 4MP20XB (1-Oct-02), 5MA16M (1-Feb-03), 5MG16R (1-Apr-03), 5MG16U (1-Apr-03), 5MG16T (1-Apr-03), 4MX34P (1-Oct-02), 4MN09N (1-Sep-03), 4MP20P (1-Oct-02), 4MP20R (1-Oct-02), 4MP20S (1-Oct-02), 4MP20V (1-Oct-02), 4MP20W (1-Oct-02), 5MU91M (1-Nov-03), 5MX28M (1-Nov-03), 5MX28P (1-Nov-03), 4MK15N (1-Sep-02), 4MK15P (1-Sep-02), 5MG16S (1-Apr-03), 5MG16V (1-Apr-03), 4MP20Y (1-Oct-02), 4MP16P (1-Sep-02), 5NA70M (1-Nov-03), 4MP20T (1-Oct-02), 4MP20X (1-Oct-02), 4MP20U (1-Oct-02), and 4MK15R (1-Sep-02)
Nebcin:
USA Distribution
1.2 gm
4MK03M (1-Aug-03), 4MP21M (1-Sep-03), 4MT55M (1-Jan-04), 3MY51M (1-Oct-02), 3NG79M (1-Mar-03), 4MS30M (1-Sep-03), 4MT54M (1-Oct-03), 4MT55M (1-Jan-04), 4MW41M (1-Feb-04), 5MG75M (1-Jun-04), 5MH80M (1-Jun-04), 4MR25M (1-Sep-03) and 5MM86M (1-Jun-04), 5MX32M (1-Feb-04)
Foreign Distribution:
3NG79M (1-Mar-03), 4MK03M (1-Aug-03), 4MR25M (1-Sep-03), 4MW41M (1-Feb-04), 5MG75M (1-Jun-04), 5MH80M (1-Jun-04), 5MM86M (1-Jun-04), 4MT54N (1-Oct-03), 4MT55N (1-Jan-04) and 5MH80N (1-Jun-04)
Dobutrex:
USA Distribution:
5MF45P (1Apr-03), 4MY39P(1-Feb-03), 5MA94M(1-Feb-03), 5MM00M (1-Jun-03), 4MX96P (1-Jan-03) and 5MW48N (1-Oct-03)
Foreign Distribution:
4MY39N (1-Feb-03), 5MF45N (1-Apr-03), 5MX82M (1-Feb-04), 5MX82N (1-Feb-04), 5MX82P (1-Feb-04), 5MX82R (1-Feb-04), and 5MW48M (1-Oct-03)
Gemzar:
USA Distribution:
200 mg
4MS42M (1_Sep-02)
1gm
4MT36M (1-Sep-02), 4MT37M (1-Sep-02), 4MT63M (1-Oct-02), 5MC30M (1-Mar-03), 5MG22M(1-May-03) and 5NG88M (1-Mar-04)
Foreign Distribution:
4MT63M (1-Oct-02), 5MG22N (1-May-03), 4MT62M (1-Sep-02), 4MT62T (1-Sep-02), 4MT62P (1-Sep-02), 4MT62N (1-Sep-02), 4MT62S (1-Sep-02)
Brevital Sodium
USA Distribution
2.5 mg/20mL vials
5MT41M (8/1/2003)
4NF766M (6/1/2003)
500mg/50mL vials
3MN14M, 3MN14N (9/1/2002)
3MN33M, 3MN33P (10/1/2002)
3MN34P, 3MN34R, 3MN34S (10/1/2002)
3MY48M, 3MY48N, 3MY48P (11/1/2002)
4MP65M (9/1/2002)
4MA84M, 4MA84N, 4MA84P (11/1/2002)
4MF88M, 4MF88N (6/1/2003)
4MJ99M (7/1/2003)
5MP44M, 5MP44N (8/1/2003)
5MU47M, 5MU47P, 5MU47R (12/1/2003)
5MN77M, 5MN77N (10/1/2003)
Dolophine Hydrochloride
USA Distribution
10mg/mL 20 mL vial
5MP72M (Jun-03)
5MW93M (Sep-03).
RECALLING FIRM/MANUFACTURER
Eli Lilly and Co., Indianapolis, IN, by letters dated July 16, 2002. Firm initiated recall is ongoing.
REASON
Particulates and/or cracked vials.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
Oxygen, USP, Compressed, type D, E and M aluminum cylinders. Recall # D-437-2.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Tri-State Home Care Inc., Pittsburgh, PA, by exchange unknown. Firm initiated recall is ongoing.
REASON
Good Manufacturing Practice (GMP) deviations, including but not limited to, failure to test for purity and identity.
VOLUME OF PRODUCT IN COMMERCE
37 cylinders.
DISTRIBUTION
PA.
_____________________________
PRODUCT
Allegra 60 mg (Fexofenadine HCl Capsules), 14 and 60 count bottles, Rx only. Recall # D-001-3.
CODE
Lot no. 1044325, exp. 5/2004 and
Lot no. 1048818, exp. 10/2004.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pharmaceutical Corp. of America, Indianapolis, IN, by phone on September 10, 2002.
Manufacturer: Aventis Pharmaceuticals, Inc., Kansas City, MO. Firm initiated recall is complete.
REASON
Label mixup; bottles labeled as containing 60mg capsules actually contain 60mg tablets.
VOLUME OF PRODUCT IN COMMERCE
17 units.
DISTRIBUTION
CA and MI.
_____________________________
PRODUCT
Liquid Oxygen, USP, Refrigerated, transfilled into 46 liter Cryogenic Home Vessels, Rx Only. Recall # D-002-3.
CODE
Serial numbers: 02182013, 01253095, 01190133, 01190112, 01190110, 02204388, 01180794, 01180787, 01180187, 01150090, 01150072.
RECALLING FIRM/MANUFACTURER
Laurel Home Healthcare, Ann Arbor, MI, by telephone on September 20, 2002. Firm initiated recall is ongoing.
REASON
Good Manufacturing Practice (GMP) deviations, including but not limited to, lack of all batch records and use of an improperly calibrated oxygen analyzer.
VOLUME OF PRODUCT IN COMMERCE
11 units.
DISTRIBUTION
MI.
_____________________________
PRODUCT
a) MEIJER ORAL SALINE Laxative (Monobasic Sodium Phosphate
2.4g, Dibasic Sodium Phosphate 0.9g) Sugar Free, 3 FL OZ
(90 mL) MULTI-DOSE CONTAINER, LEMON FLAVOR;
b) Oral Saline Laxative Sav-on Osco brand by Albertson's
(Monobasic Sodium Phosphate 2.4g, Dibasic Sodium
Phosphate 0.9g) 3 FL OZ (90 mL) Multi-Dose Container,
Lemon Flavor, Recall # D-416-2.
CODE
Lot # 2093L Expiration Date: 04/04
Lot # 2114L Expiration Code: 04/04
Lot # 2119L Expiration Code: 04/04
Lot # 2155L Expiration Code: 06/04.
RECALLING FIRM/MANUFACTURER
Unico Holdings, Inc., Lake Worth, FL, by e-mail and telephone on June 5, 2002. Firm initiated recall is complete.
REASON
Mislabeling; outer carton dosage instructions (by manufacturer) incorrectly declare dosage for Adults & children as "12 years & under" rather than correctly as "12 years & over"
VOLUME OF PRODUCT IN COMMERCE
1398/12 bottle cases.
DISTRIBUTION
MI and AZ.
_____________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1993-2.
CODE
Unit numbers 50P29342, 50P29820, 50P29948, 50P30179, 50P30259, 50P30887, 50P31046, and 50P31571.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Western Lake Erie Region, Toledo, OH, by letters on February 25 and March 11, 2002.
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
8 units.
DISTRIBUTION
OH.
_____________________________
PRODUCT
Source Plasma. Recall # B-2013-2.
CODE
Unit 71 FPBGCJ.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Greenville, SC, by letter dated March 3, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm preparation was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Germany.
_____________________________
PRODUCT
Ethicon J-VAC Reservoir is a single-use, disposable device that provides suction and fluid collection for wound drains. Recall # Z-0001-3.
CODE
DOMESTIC
U.S
Product Codes Lot/Control Numbers
216111 (150 mL) 210711, 212777, 212778
216211 (450 mL) 210706, 210707, 210709, 212334
216311 (300 mL) 213246
INTERNATIONAL
ITALY
Product Codes Lot/Control Numbers
216111 (150 mL) 210711, 212777, 212778
216211 (450 mL) 210707, 210709,
216311 (300 mL) 213246
PORTUGAL
Product Codes Lot/Control Numbers
216111 (150 mL) 210711
216211 (450 mL) 210706
SAUDI ARABIA
Product Codes Lot/Control Numbers
216111 (150 mL) 210711, 212777, 212778
216211 (450 mL) 210707
SOUTH AFRICA
Product Codes Lot/Control Numbers
216111 (150 mL) 210711, 212777, 212778
216211 (450 mL) 210706, 210709
216311 (300 mL) 213246
TAIWAN
Product Codes Lot/Control Numbers
216111 (150 mL) 210711
UNITED ARAB EMIRATES
Product Codes Lot/Control Numbers
216111 (150 mL) 210711, 212777
216311 (300 mL) 213246
JAPAN
Product Codes Lot/Control Numbers
217711 (150 mL) 210697, 210698, 210699, 211645,
211646, 211647, 211648, 211649
217811 (450 mL) 208678, 208679, 208680
217911 (300 mL) 201500, 210168, 210169, 210170,
210171, 210176, 210177, 210178,
210179, 210180.
_____________________________
PRODUCT
Misys Laboratory. Recall # Z-0002-3.
CODE
Versions 5.2, 5.23 and 5.3.
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Inc., Tucson, AZ, by fax July 5, 2002. Firm initiated recall is complete.
REASON
Software anomaly. Quality assurance flags were not appearing as they should on cumulative reports.
VOLUME OF PRODUCT IN COMMERCE
477.
DISTRIBUTION
Nationwide and United Kingdom, Ireland, Canada, Saudi Arabia, Denmark and Bermuda.
_____________________________
PRODUCT
Mono-plus Immunometric Assay In Vitro Diagnostic Kit. For
Qualitative Detection (used in the diagnosis) of Infectious
Mononucleosis Heterophile Antibodies in Serum, Plasma or Whole Blood.
Outer carton labeled in part, "PRODUCT NO. 84M4 30 TESTS For In Vitro Diagnostic Use MONO-plus***P-4204*** Immunometric Assay for Qualitative Detection of Infectious Mononucleosis Heterophile Antibodies in Serum, Plasma or Whole Blood***An aid in the diagnosis of Infectious Mononucleosis***For Professional Use Only***THIS PRODUCT CONTAINS DRY NATURAL RUBBER*** ***KIT CONTENTS: 30 EACH MONO-plus TEST DEVICES:Contain a membrane strip coated with bovine erythrocyte extracts and a pad impregnated with antibody-dye conjugate in a protein matrix containing 0.1% sodium azide. ***DEVELOPER SOLUTION (D):***MONO-plus POSITIVE CONTROL:***MONO-plus NEGATIVE CONTROL:***CAPILLARY TUBES***PACKAGE INSERT"Wampole Pouch labeled in part, "1 TEST DEVICE***MONO-plus***For In Vitro Diagnostic Use***Store at 2ú -30úC *** ***P-3201***FL-084M2-01***WB LOT 222B21 EXP MAR03***US. PATENT NO. 5,559,041"
BioSign Pouch labeled in part, "BioSign Mono***One Step IM — IgM Test One Test Device*** For In Vitro Diagnostic Use.***Store at 4ú -30úC (40ú -86ú* F) sealed.***PBM***
Insert labeled in part, "P-5207-B***MONO-plus***Immunometric Assay for Qualitative Detection of Infectious Mononucleosis Heterophile Antibodies in Serum, Plasma or Whole Blood*** An aid in the diagnosis of Infectious Mononucleosis.***For In Vitro Diagnostic Use***CLIA COMPLEXITY: MODERATE***CDC ANALYTE IDENTIFIER CODE: 2809***CDC TEST SYSTEM IDENTIFIER CODE: 70084*** ***PRINTED IN USA 1997, 2000 CARTER-WALLACE, INC. IN-084M4-02 ISSUED: SEPTEMBER, 2000". Recall # Z-0003-3.
CODE
Product Code: 84M4
Lot Numbers:
WB222B21 Pouch exp. MAR03 Carton Exp. FEB03 & MAR03
WB222B37 033103 033103
WB222B47 033103 033103.
_____________________________
PRODUCT
Product is an Ophthalmic Sponge under the brand name "Rhein PVAc Eye Spears" Product Code 09-70012. This product is for all anterior segment surgery of the eye and helps prevent line and other fibers from affecting the surgical site. The soft distal sponge tip conforms to the cornea and us used to absorb fluids during surgery. Recall # Z-0004-3.
CODE
1022B and 1190B.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rhein Medical Tampa, FL, by fax and letter beginning on May 20, 2002.
Manufacturer: M-Pact Corp., Eudora, KS. Firm initiated recall is ongoing.
REASON
Field complaints of device causing keratitis of the stoma.
VOLUME OF PRODUCT IN COMMERCE
Lot 1190B-10,000 units, Lot 10022B-9,000 units.
DISTRIBUTION
MD, KY and Hong Kong and Belguim.
_____________________________
PRODUCT
CNS-9303A Series Central Monitor Station.
Recall # Z-1386-2.
CODE
Serial Numbers:
NK100006
NK100012
NK100018
NK100019
NK100051
NK100054
NK100055.
RECALLING FIRM/MANUFACTURER
NKUS Lab (Nihon Koden), Irvine, CA, by telephone and in-person visit on June 28, 2002. Firm initiated recall is complete.
REASON
Capacitor failure causes screen to blank.
VOLUME OF PRODUCT IN COMMERCE
7.
DISTRIBUTION
CA, NY and FL.
_____________________________
PRODUCT
CryoValve Allograft, Human Heart Valve. Recall # Z-1388-2.
CODE
Serial No. 6242596, Model Number PV05.
RECALLING FIRM/MANUFACTURER
Cryolife, Inc., Kennesaw, GA, by letter dated August 8, 2002. Firm initiated recall is ongoing.
REASON
Failure to meet serodilution of plasma guidelines.
VOLUME OF PRODUCT IN COMMERCE
One valve.
DISTRIBUTION
CA.
_____________________________
PRODUCT
CryoValve Allograft, Human Heart Valve. Recall # Z-1389-2.
CODE
Serial Number 6171214, Model Number PV05.
RECALLING FIRM/MANUFACTURER
Cryolife, Inc., Kennesaw, GA, by letter dated August 8, 2002. Firm initiated recall is complete.
REASON
Failure to meet serodilution of plasma guidelines.
VOLUME OF PRODUCT IN COMMERCE
One valve.
DISTRIBUTION
NY.
_____________________________
PRODUCT
Nuclear Resonance Magnetic Imaging System, Diagnostic Imaging. Recall Z-1390-2/Z-1393-2.
Magnetom Harmony
Magnetom Symphony
Magnetom Harmony Upgrade Syngo MR
Magnetom Symphony Upgrade Syngo MR
CODE
All codes under Model Numbers:
Harmony 4759309 K2200
Symphony 4760265 K2210
Harmony Upgrade Syngo MR 7106714 K2200
Symphony Upgrade Syngo MR 7106557 K2210
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Systems, Inc., Iselin, NJ, by hardware modification on May 23, 2002.
Manufacturer: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing.
REASON
Smoke generating from gradient cabinet.
VOLUME OF PRODUCT IN COMMERCE
304.
DISTRIBUTION
Nationwide and Puerto Rico.
_____________________________
PRODUCT
Insight-Plus 9000 Phased Array Torso & Pelvis Coil, 1.5T field strength. The device is sold under the GE label. Recall # Z-1394-2.
CODE
Part Number: 100189 (GE Medical Part #2289043-2);
Serial Numbers: 302 through 500.
RECALLING FIRM/MANUFACTURER
USA Instruments, Inc., Aurora, OH, by letter on August 30, 2002. Firm initiated recall is complete.
REASON
The coil may overheat and cause skin burns during an MRI scan.
VOLUME OF PRODUCT IN COMMERCE
198 coils.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
Recall # Z-1395-2/Z-1401-2.
a) Telemetry Digital Processors Models 90342, 90344,
90346, 90348. Recall # Z-1395-2/Z-1398-2;
b) Integrated Multiparameter Module Model 90470.
Recall # Z-1399-2;
c) Telemetry Receiver Module Model 90478.
Recall # Z-1400-2;
d) Ultarview Command Module Model 90496.
Recall # Z-1401-2.
CODE
a) Models 90342, 90344, 90346, 90348 -
software version 3.05.17EN
b) Model 90470 - software version 2.02.30EN
c) Model 90478 - software version 3.02.02EN
d) Model 90496 - software version 1.02.08EN.
RECALLING FIRM/MANUFACTURER
Spacelabs Medical, Inc., Redmond, WA, by letter on October 22, 2001. Firm initiated recall is ongoing.
REASON
ECG software fails to detect low heart rates in range of 12 to 15 bpm.
VOLUME OF PRODUCT IN COMMERCE
69,293 to domestic consignees and 38,769 to international consignees.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
AEROSET Magnesium Reagent, List Number 7D70-01.
Recall # Z-1401-2.
CODE
All nonexpired material with Lot Numbers:
68067HW00
72032HW00
75093HW00
82014HW00
84028HW00
89051HW00.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., South Pasadena, CA, by letter during the week of July 15, 2002.
Manufacturer: Thermo Trace Noble Park, Victoria, Australia.
Firm initiated recall is complete.
REASON
Elevated results.
VOLUME OF PRODUCT IN COMMERCE
1,751.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
DPC Immulite 2000 System. Recall # Z-1404-2.
This product uses the Longwell LS-7C gray two prong power cord sold with Hewlett Packard DeskJet Printers 800 and 900 Series. The power cords were recalled by Hewlett Packard.
CODE
Immulite systems using HP DeskJet Printers
Serial Numbers F1340 through G1882, plus any system upgrade to an 800 or 900 HP printer series.
RECALLING FIRM/MANUFACTURER
DPC Cirrus Inc., Flanders, NJ, by fax on June 21, 2002.
Firm initiated recall is ongoing.
REASON
Power cord may crack posing electrical hazard.
VOLUME OF PRODUCT IN COMMERCE
542.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
Misys laboratory version 5.3 with custom Result Interface 11. Recall # Z-1405-2.
CODE
Version 5.3 with custom Result Interface 11.
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Inc., Tucson, AZ, by fax on June 13, 2002. Firm initiated recall is ongoing.
REASON
Software anomaly causing mixing of patient data.
VOLUME OF PRODUCT IN COMMERCE
1.
DISTRIBUTION
MN.
_____________________________
PRODUCT
Custom Latex Tubing, sterile, packaged in sterile paper wrapper and labeled as "Custom Latex Tubing" and additionally labeled as "Latex Safe", for use in cardiovascular surgery, 5/16" x1/2 x12 ft, 25 tubes per case. Catalog #32-1526. Recall # Z-1406-2.
CODE
Lot 273191, 273931, 274501.
RECALLING FIRM/MANUFACTURER
Deroyal Surgical, Rose Hill, VA, by fax and letter on August 15, 2002. Firm initiated recall is ongoing.
REASON
Latex surgical tubing is labeled as latex-safe.
VOLUME OF PRODUCT IN COMMERCE
1 case, 25 tubes per case.
DISTRIBUTION
NE.
_____________________________
PRODUCT
Custom Angiography Procedure Kits which contain Heparin Sodium Injection that has been recalled. There are 43 different configurations of the kits involved. Recall # Z-1407-2/Z-1449-2.
CODE
Angiography Drape Pack Cardiac Cath Lab Reorder # 398163, Lots:
99078949, 99089770, 99099771, 99128841, 99129632, 99151931,
99163515, 99168394, 99174255, 99178868, 99181345, 99182241,
99184093, 99190587, 9192213, 99194461, 99199681, 99204602,
99208694, 99214198, 99215867, 99220783
Angiography Drape Pack, Reorder # 398517, Lots:
99062209, 99078110, 99078719, 99089640, 99099065, 99099727,
99099860, 99109473, 99109817, 99129378, 99146106, 99148890,
99150973, 99160161, 99161041, 99166391, 99169689, 99173812,
99176358, 99176802, 99181415, 99182800, 99184720, 99188767,
99188995, 99191483, 99195501, 99204325
Angiography Drape Pack, Reorder # 398527, Lots:
99099333, 99119737, 99148880, 99174204, 99190243, 99218706
Angiography Drape Pack, Reorder # 398816, Lots:
99099172, 99129638, 99149775, 99168060, 99176768, 99182052,
99193329, 99214471
Angiography Drape Pack, Reorder # 398838, Lots:
99068803, 99099107, 99099823, 99109753, 99119823, 99128793,
99148691, 99153962, 99154711, 99163112, 99173650, 99173729,
99179858, 99180973, 99182668, 99184808, 99185307, 99186552,
99188908, 99188909, 99190443, 99190820, 99199679, 99208899,
99211427, 99214832, 99217574, 99221240, 99068149, 99089091
Angiography Drape Pack, Reorder #399086, Lots:
99068099, 99078018, 99078208, 99085435, 99089139, 99089567,
99099142, 99099392, 99099419, 99109357, 99109819, 99119260,
99119318, 99119511, 99129509, 99145571, 99146523, 99146960,
99148683, 99149965, 99153557, 99155314, 99160312, 99160938,
99163859, 99163862, 99164815, 99164981, 99167050, 99167629,
99170565, 99171515, 99171516, 99172108, 99173755, 99177247,
99178507, 99178780, 99181856, 99183069, 99183679, 99185313,
99188551, 99189966, 99191787, 99193363, 99196516, 99196948,
99199793, 99200133, 99200735, 99201231, 99202261, 99203627,
99209668, 99209859, 99211855, 99213753, 99217545, 99217898,
99220847, 99222318
Angiography Drape Pack, Reorder # 399360, Lots:
99078030, 99089152, 99099297, 99109386, 99109847, 99119811,
99145059, 99147408, 99149950, 99160863, 99164974, 99169679,
99175639, 99177832, 99183075, 99186877, 99192543, 99197468,
99205484, 99214169, 99217267, 99221017
Angiography Drape Pack, Reorder # 399452, Lots:
9907868 , 99089085, 99099119, 99099194, 99099608, 99109531,
99119162, 99129159, 99129491, 99148997, 99150935, 99154087,
99155321, 99164967, 99170367, 99171937, 99176231, 99181340,
99184530, 99188136, 99190449, 99192501, 99197525, 99206132,
99209987, 99213026, 99221043, 99222782, 99223248
Angiography Drape Pack, Reorder # 399580, Lots:
99089164, 99099425, 99109616, 99139095, 99148249, 99150575,
99154905, 99164214, 99168865, 99174207, 99179342, 99186979,
99193729, 99194452, 99195655, 99198225, 99202546, 99205069,
99208964, 99214049, 99218110, 99221259
Angio Procedure Pack Arteriogram, Reorder # 399835, Lots:
99062378, 99066992, 99078151, 99089581, 99099136, 99109275,
99119269, 99119831, 99119870, 99147538, 99149212, 99151080,
99155219, 99166276, 99170178, 99175386, 99176777, 99180433,
99182031, 99182528, 99186656, 99193851, 99196210, 99199433,
99205962, 99209085, 99212889, 99218676, 99221785
Angiography Drape Pack, Reorder # 399927, Lots:
99078189, 99085422, 99119489, 99149454, 99164971, 99173624,
99183232, 99185959, 99201364, 99207565, 99221563
Angiography Drape Pack, Reorder # 400086, Lots:
99078283, 99078409, 99079976, 99099553, 99099710, 99109742,
99119798, 99146817, 99148845, 99150871, 99154276, 99155233,
99162574, 99164726, 99167248, 99170804, 99173383, 99174223,
99175338, 99176457, 99185713, 99189231, 99195216, 99198044,
99205071, 99208602, 99213216, 99215603, 99216723, 99222194
Angiography Drape Pack Angio-Echo Tray, Reorder # 400164, Lots:
99078981, 99085447, 99161666, 99165918, 99169859, 99173032,
99176949, 99178516
EP Pack, Reorder # 400252, Lots:
99068805, 99078477, 99078935, 99099355, 99099945, 99119122,
99128728, 99129017, 99147545, 99151687
Angiography Drape Pack, Reorder # 400293, Lots:
99089044, 99206141
Special Procedure Pack, Reorder # 400452, Lots:
99062203, 99089060, 99089900, 99254899
Angiography Drape Pack, Reorder # 400601, Lots:
99085419, 99099936, 99109699, 99119651, 99145331, 99152142,
99166066, 99174189, 99177653, 99184132, 99186920, 99189402,
99194935, 99201420, 99204496, 99210165, 99216720, 99221232
Angiogram Drape Pack, Reorder # 400800, Lots:
99078046, 99078192, 99085671, 99089568, 99099141, 99099478,
99109138, 99109813, 99145721, 99145882, 99151522, 99153770,
99168047, 99170338, 99174210, 99174832, 99177156, 99182807,
99183281, 99184795, 99185518, 99190667, 99191359, 99199990,
99200241, 99202954, 99209458, 99216164, 99217515
Permanent Pacing Drape Pack, Reorder # 400801, Lots:
99078224, 99109645, 99119601, 99164336, 99167784
Cath Lab Angio Pack, Reorder # 400852, Lots:
99078478, 99089760, 99099224, 99109608, 99119469, 99129326,
99147004, 99150239, 99160407, 99166096, 99173622, 99176804,
99181334, 99183088, 99185370, 99190759, 99195941, 99198888,
99204242, 99207907, 99209052, 99220055
Angiography Drape Pack Arteriogram Tray, Reorder # 400907, Lots:
99099051, 99099360, 99099535, 99119242, 99129125, 99129514,
99145225, 99152026, 99164460, 99175021, 99178601, 99184240,
99185299, 99190119, 99194325, 99200019, 99204538, 99210435, 99216160
Angiography Drape Pack Imaging Sterile, Reorder # 401090, Lots:
99099302, 99109661, 99128518, 99149458, 99162341, 99171348,
99173958, 99182678, 99187285, 99195790, 99198722, 99207295,
99213377, 99221581
Angiography Drape Pack Infant Pack, Reorder # 401185, Lots:
99099429, 99109349, 99119514, 99139001, 99147503, 99148946,
99151387, 99164229, 99171351, 99176753, 99178566, 99180800,
99182755, 99188325, 99195585, 99199653, 99201739, 99209515,
99214107, 99219058
Angiography Drape Pack, Reorder # 401240, Lots:
99060681, 99089753, 99099686, 99109372, 99109453, 99119607,
99145536, 99148112, 99154892, 99166546, 99174190, 99181597,
99185300, 99190767, 99196992, 99200678, 99204204, 99205979,
99209520, 99211004, 99216152, 99221778, 99255398
Angiography Drape Pack, Reorder # 401307, Lots:
99089031, 99099417, 99109452, 99129494, 99147032, 99151244,
99161534, 99167216, 99171152, 99178350, 99178404, 99190869,
99195628, 99197839, 99207989, 99208073, 99215120, 99215125
Angiography Drape Pack, Reorder # 401380, Lots:
99078049, 99089675, 99099438, 99109554, 99119218, 99129129,
99129709, 99146396, 99149919, 99152755, 99161008, 99166021,
99168198, 99171889, 99175447, 99177621, 99181489, 99181932,
99186240, 99191932
99193993, 99197793, 99203000, 99203170, 99209538, 99210989,
99215285,99218066, 99219843, 99223283
Catheter Placement Pack, Reorder # 401510, Lots:
99109229, 99109291
E. P. Tray, Reorder # 401518, Lots:
99099528
Angiography Drape Pack Special Procedure, Reorder # 401535, Lots:
99109674, 99151374, 99161395, 99166381, 99169683, 99172134
Angiography Drape Pack Cardiac Cath, Reorder # 401536, Lots:
99129722, 99166354, 99176725, 99182319, 99186806, 99189584
Cardiac Cath Pack, Reorder # 401561, Lots:
99148017, 99171932, 99173225, 99176007, 99182229, 99189134,
99195082, 99195624, 99206909, 99210988, 99213021, 99223832
Cardiac Cath Pack, Reorder # 401601, Lots:
99164614, 99168713, 99169374, 99171755, 99176348, 99176739,
99179798, 99180545, 99189159, 99192616, 99195107, 99197544,
99200751, 99201831, 99203005, 99208413, 99210858, 99212973, 99214314
Angiography Drape Pack, Reorder # 401685, Lots:
99183355, 99185882, 99197775, 99211142, 99220903
Pedi Heart Cath Tray, Reorder # 401688, Lots:
99187653, 99190140, 99192885, 99197670, 99208827, 99209641, 99214893
Acute Hemodialysis Tray, Reorder # 500323, Lots:
99079333, 99108050, 99147023, 99149272, 99152256, 99205131,
99218806, 99221457
Hemodialysis Pack, Reorder # 500326, Lots:
99064999, 99079389, 99088647, 99098058, 99108190, 99118774,
99148274, 99161069, 99163526, 99175004, 99178926, 99183741,
99185101, 99186382, 99192510, 99201536, 99209638, 99219146
Angiography Drape Pack, 500502, 99078691, 99147031, 99154219,
99163787, 99169653, 99170876, 99178544, 99178571, 99182908,
99189995, 99194556, 99194926, 99197429, 99201305, 99203958,
99212059, 99217023, 99218395
Advantec MLD, Reorder # 500507, Lots:
99151350
Pack, George Wash Diagnostic, Reorder # 0c-cp31303, Lots:
99200156, 99208565, 99209888, 99212999, 99213734, 99213734,
99219313, 99220732
Pack, Fairfield MC Cath Lab, Reorder # 0c-cp31445, Lots:
99200162, 99205373, 99210962, 99216945, 99220917, 99226918
Pack George Wash Interventional, Reorder # 0c-cp31465, Lots:
99203444, 99209868, 99210873, 99221727
Pack MC of Delaware, Reorder # 0c-cp32409, Lots:
99199893, 99199897, 99205537, 99208311, 99208548, 99211744,
99214516, 99215022, 99219063, 99219750, 99220302
Pack, Southwest Hosp Cath, Reorder # 0m-cp31863, Lots:
99195935.
RECALLING FIRM/MANUFACTURER
Maximm Medical, Inc., Athens, TX, by letter dated May 15, 2002.
Firm initiated recall is ongoing.
REASON
Kits contain recalled heparin sodium injection.
VOLUME OF PRODUCT IN COMMERCE
47,973 kits.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
LifeScan brand OneTouch® SureStep® Test Strip and SureStep® Pro Test Strip used in OneTouch® SureStep® Blood Glucose Meter. Recall # Z-1450-2.
CODE
All Codes.
RECALLING FIRM/MANUFACTURER
Lifescan, Inc., Milpitas, CA, by letters on August 26, 2002. Firm initiated recall is ongoing.
REASON
Use of Test Strips may give inaccurate very low glucose results.
VOLUME OF PRODUCT IN COMMERCE
Approx. 749,000,000 units.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
Architect CA 19-9 Reagent Kit; Recall # Z-1451-1.
a) list 6C04-20: 4 x 100 tests;
b) list 6C04-25: 1 x 100 tests.
CODE
a) lot 82267M300;
b) lot 82267M301.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Abbott Park, IL, by letter dated September 6, 2002. Firm initiated recall is complete.
REASON
MCC1 control out of range low.
VOLUME OF PRODUCT IN COMMERCE
1262 - 400 test kits, 129 - 100 test kits.
DISTRIBUTION
Canada, Germany, United Kingdom, Japan and Australia.
_____________________________
PRODUCT
Portex Continous Epidural Tray- 18 Gauge Hustead
Catalog No. 15536-22. Recall # Z-1458-2.
CODE
Lot Number: K131991
USe By: 2003-12.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Portex, Inc., Keene, NH, by telephone on September 12, 2002.
Manufacturer: Sims Portex, Inc., Keene, NH.
Firm initiated recall is ongoing.
REASON
Trays may contain ampules of Bupivacaine HCl Inj. 0.50% instead of 0.25%.
VOLUME OF PRODUCT IN COMMERCE
1200 trays.
DISTRIBUTION
FL, NC, ID and PA.
_____________________________
PRODUCT
Freshlook Toric (Phemfilcon A) Soft Contact Lenses for Astigmatism with Handling Tint, the soft contact lenses are
individually packaged in sterile foil-sealed plastic packages, 3 packs per box. Recall # Z-1459-2.
CODE
Lot 30726, exp. 2006-08 and lot 30729, exp. 2006-03.
RECALLING FIRM/MANUFACTURER
Wesley Jessen Corp., Des Plaines, IL, by letters dated March 5, 2002. Firm initiated recall is complete.
REASON
Mislabeled for corrective power, cylinder & axis.
VOLUME OF PRODUCT IN COMMERCE
33 3-packs.
DISTRIBUTION
Germany, Great Britain and Italy.
_____________________________
PRODUCT
Stryker M-1 roll-in system rugged ambulance cot, model 6100-003-000. Recall # Z-1460-2.
CODE
Cots distributed from 11/1/00 through 7/19/01.
RECALLING FIRM/MANUFACTURER
Stryker Corp., Kalamazoo, MI, by letters on August 22, 2002. Firm initiated recall is ongoing.
REASON
Legs supports may become loose and the cot may tip.
VOLUME OF PRODUCT IN COMMERCE
525 cots.
DISTRIBUTION
Internationally.
_____________________________
PRODUCT
AEROSET Magnesium Reagent, List Number 7D70-01.
Recall # Z-1464-2.
CODE
All nonexpired material with Lot Numbers:
68067HW00
72032HW00
75093HW00
82014HW00
84028HW00
89051HW00.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Inc., South Pasadena, CA, by letter during the week of July 15, 2002.
Manufacturer: Thermo Trace Noble Park, Victoria Australia.
Firm initiated recall is ongoing.
REASON
Elevated results.
VOLUME OF PRODUCT IN COMMERCE
1,751.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
Cytomics RXP software. Recall # Z-1387-2.
CODE
Version 1.0.
RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc., Brea, CA, by letters dated May 15, 2002. Firm initiated recall is ongoing.
REASON
When analyzing multiple listmode files using a multi-file analysis protocol, incorrect percentage results may occur if "% in Regions" is selected.
VOLUME OF PRODUCT IN COMMERCE
6.
DISTRIBUTION
IL, Germany and Canada.
_____________________________
PRODUCT
Nasal Dorsum Style 7
a) Size 2; P/N: 400-724S L/N: 8221. Recall # Z-1402-2;
b) Size 3; P/N: 400-734S L/N: 8228. Recall # Z-1403-2.
CODE
a) Serial numbers WC4465 thru WC4474;
b) Serial numbers WC4433 thru WC4442.
RECALLING FIRM/MANUFACTURER
Spectrum Designs, Inc., Carpineteria, CA, by telephone and letter on July 2, 2002.
REASON
Wrong sizes in packages.
VOLUME OF PRODUCT IN COMMERCE
10.
DISTRIBUTION
CA.
_____________________________
PRODUCT
Roche COBAS Integra ferritin, catalog # 753556.
Recall # Z-1457-2.
CODE
Lots 624570 (exp. 9/02), 626487 (exp. 12/02),
629938 (exp. 3/03), 634050 (exp. 6/03) and
636549 (exp. 9/03).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by notice dated September 6, 2002.
Manufacturer: Roche Diagnostics GmbH Mannheim, Germany.
Firm initiated recall is ongoing.
REASON
Some sera may under-recover ferritin by up to 35%.
VOLUME OF PRODUCT IN COMMERCE
10,897.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
12% Horse Feed, packaged under the Griffith & Sons label, in 100 lb
bags. Recall # V-001-3.
CODE
The bags are not coded. All of their 12% Horse Feed product manufactured and distributed from 5/14/2002 to 6/21/2002 is subject to this recall.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Griffith & Sons Feed and Farm Supply, Staffordsville, KY, by telephone and visits on June 21, 2002.
Manufacturer: Griffith & Sons Feed and Farm Supply, Staffordsville, OH. Firm initiated recall is complete.
REASON
The Horse Feed product contains beef protein and is not labeled with the required BSE cautionary statement.
VOLUME OF PRODUCT IN COMMERCE
1,200 lbs (12 / 100 lb bags).
DISTRIBUTION
OH.
END OF ENFORCEMENT REPORT FOR
OCTOBER 09, 2002
####
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2002-OCT-09.