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U.S. Department of Health and Human Services

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Enforcement Report for April 7, 2004

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.


April 7, 2004
04-14

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
Mixed Fruit Cup. Fresh cut cantaloupe, cut honeydew,
fresh cut pineapple & red grapes net weight 8 oz.
Charlie's Produce brand. Recall # F-160-4.
CODE
USE BY JUL 18 2003.
RECALLING FIRM/MANUFACTURER
Triple B Corporation, Seattle, WA, by telephone on July 22, 2003. Washington State initiated recall is complete.
REASON
The product is contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
73 cases of 6/8 oz. containers.
DISTRIBUTION
WA and OR.

_______________________________
PRODUCT
Weight Watchers Smart Ones brand Vanilla Low Fat Ice Cream Sandwiches, 98% Fat Free, packaged as 6-4 fl oz sandwiches in clear plastic cylindrical retail containers with a "clamshell" opening. The product is fat free vanilla flavored ice cream between cookie wafers, (contains allergenic un-refined peanut oil added as a flavor). The retail packages are shipped in cases labeled as Peanut Butter 'N Fudge Low Fat Ice Cream Sandwiches, 12 retail packages per case. Recall # F-161-4.
CODE
Code on retail package: 1053 RD SAND 3990;
Code on shipping case: WW p-BUTTER RD SAND 1053 6 PK 655913.
RECALLING FIRM/MANUFACTURER
Frostbite Brands Division of Dean Foods Southeast, Toledo, OH, by telephone and email on May 5, 2003. Firm initiated recall is complete.
REASON
Product container labeled as Vanilla Lowfat Ice Cream Sandwiches actually contains Peanut Butter'N Fudge Lowfat Ice Cream Sandwiches.
VOLUME OF PRODUCT IN COMMERCE
1,782 cases.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
DUTCH COUNTRY SOFT POTATO BREAD ORIGINAL RECIPE, NET WT. 22
OZ. (1 LB 6 OZ) (624 g). Packaged in a polyethylene bag
with plastic lock-tab bag closure. Recall # F-165-4.
CODE
UPC 73410 13865. Production Codes (printed on the plastic lock-tab bag closure): DEC 26, DEC 27, DEC 29, DEC 30, DEC 31, JAN 02, JAN 03, JAN 04, JAN 05, JAN 06, JAN 09, JAN 10, JAN 13, JAN 14, JAN 16, JAN 17, JAN 19, JAN 20, JAN 21, JAN 23, JAN 24, JAN 26, JAN 27, JAN 28, JAN 30, FEB 02, FEB 03. These are considered "sell by dates".
RECALLING FIRM/MANUFACTURER
George Weston Bakeries, Bay Shore, NY, by press release on January 22, 2004. Firm initiated recall is complete.
REASON
Potato bread contains undeclared whey, non-fat milk, and soy flour.
VOLUME OF PRODUCT IN COMMERCE
182,206 units.
DISTRIBUTION
AL, FL, GA, KY, NC, SC, TN, VA, and WV.

_______________________________
PRODUCT
a) Tenpura Fried Fish Cake, Fully cooked, ready to eat.
Frozen or refrigerated, net wt. 6 oz, 170 g. Recall #
F-166-4;
b) Jalapeno Tenpura Spicy Fried Fish Cake, Fully Cooked,
Ready to eat. Frozen or refrigerated, net wt.5 oz,
142 g. Recall # F-167-4;
c) Chashu-Tenpura Fried Fish Cake, with sweet Pork-Hawaiian
Style. Fully cooked, ready to eat. Frozen or
refrigerated, net wt. 6 oz, 170 g. Recall # F-168-4;
d) Ebi-Tenpura Fried Fish Cake with Shrimp, Fully cooked,
ready to eat. Frozen or refrigerated, net wt. 6 oz, 170
Recall # F-169-4;
e) Gobo-Tenpura Fried Fish Cake with Burdock Root-Hawaiian
Style, Fully Cooked, Ready to eat. Frozen or
refrigerated, net wt.5 oz, 141 g. Recall # F-170-4;
f) Chinese Tenpura Fried Fish Cake with Chinese Vegetables,
Fully Cooked, Ready to eat. Frozen or refrigerated, net
wt. 6 oz, 170 g. Recall # F-171-4;
g) Vege-Tenpura Fried Fish Cake with green beans, peas,
carrots and onions, Fully Cooked, Ready to eat. Frozen
or refrigerated, net wt.5 oz, 141 g. Recall # F-172-4;
h) Bulk Tenpura Fried Fish Cake, Net wt. 14 oz (397 g) and
an unspecified weight, Fully Cooked, Ready to eat.
Marutama and Shirakiku brand on one label.
Recall # F-173-4;
i) Kamaboko Steamed Fish Cake, Net wt. 6 oz (170 g). Fully
Cooked, Ready to eat. Refrigerated or Frozen.
Recall # F-174-4;
j) Boardless Kamaboko, Steamed, Ready to eat fish cake, 6
oz (170 g). Recall # F-175-4;
k) Narutomaki, Steamed Fish Cake, Fully Cooked, Ready to
Eat. 5 oz (141 g). Recall # F-176-4;
l) Chikuwa Broiled Fish Cake, Fully Cooked, Ready to eat,
net Wt. 4 oz. (113g). Recall # F-177-4;
m) Mini Size Oden PAC with Soup Base, Various Fish Cakes,
Net Wt 9 oz. (254g). Recall # F-178-4.
CODE
Exp dates from 4/18 to 5/19.
RECALLING FIRM/MANUFACTURER
Marutama Company, Inc., Los Angeles, CA, by press release on April 16, 2003, and by letter on April 17, 2003. FDA initiated recall is complete.
REASON
Fish cakes contain undeclared egg whites.
VOLUME OF PRODUCT IN COMMERCE
19,326.
DISTRIBUTION
CA, WA, OR, and CO.
 

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

_______________________________

PRODUCT
a) American Ginseng, 500 mg, 30 capsules. Product No.
5595. Distributed in plastic bottles under the following
labels & labeling: (1) VITAMIN WORLD AMERICAN GINSENG,
Panax quinquefolium, 100% Pure Grown in America, Minimum
4% Ginsenosides (or Minimum 8% Ginsenosides depending on
label) 500 mg, 30 CAPSULES. 2) Puritan's Pride AMERICAN
GINSENG, Panax quinquefolium, 100% Pure grown in
America, 500 mg, 30 CAPSULES. Recall # F-153-4;
b) KOREAN GINSENG, 500 mg, 100 CAPSULES, PROD. NO. 5021.
Distributed in plastic bottles under the following
labels & labeling: (1) VITAMIN WORLD KOREAN GINSENG,
Panax ginseng, 500 mg, 100 CAPSULES. (2) Puritan's Pride
KOREAN GINSENG, Panax ginseng, NATURAL WHOLE HERB, 500
mg, 100 CAPSULES. Recall # F-154-4.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
NBTY, Inc., Bohemia, NY, by memorandums dated October 31, 2003 and November 14, 2003. FDA initiated recall is ongoing.
REASON
Certain lots of Ginseng were found to be contaminated with pesticides based on FDA's analyses.
VOLUME OF PRODUCT IN COMMERCE
Unknown.
DISTRIBUTION
Nationwide, HA, PR, Guam and St. Thomas, VI.

_______________________________
PRODUCT
SAFOCO Egg Noodles. Product of Vietnam (500g) bag. Recall # F-159-4.
CODE
All lot codes.
RECALLING FIRM/MANUFACTURER
Asiatic Trading Co. LLC, Manchester, CT, by letter on February 10, 2004. Firm initiated recall is ongoing.
REASON
Egg noodles contain color additive tartrazine (certifiable as FD&C Yellow No. 5) and unpermitted color additive, Ponceau 4R (Acid Red No. 18).
VOLUME OF PRODUCT IN COMMERCE
Approx 85 cases (20 bags/case).
DISTRIBUTION
NY, NJ, PA, RI, MA, ME, and CT.

_______________________________
PRODUCT
a) Smoked Tofu in 7.5 oz. vacuum packaged container with
the Dae Han label. 12 pkgs/case. Recall # F-162-4;
b) Teriyaki Tofu in 7.5 oz. vacuum package with Dae Han
label. 12 packages/case. Recall # F-163-4;
c) Hot-N-Spicy Tofu in 7.5 oz. vacuum package, Dae Han
label. 12 packages/case. Recall # F-164-4.
CODE
All dates up to and including USE BY 04/11/04.
RECALLING FIRM/MANUFACTURER
Dae Han Tofu, Portland, OR, by store visit on February 28 and 29, 2004. FDA initiated recall is complete.
REASON
Tofu contains undeclared wheat.
VOLUME OF PRODUCT IN COMMERCE
480 packages/week
DISTRIBUTION
OR.
 

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III

_______________________________
PRODUCT
Meista Gourmet Sundried Tomato Spread, in glass jars, Net
Wt. 6.5 oz. Product of Turkey, Serving size: 28 gm.
Recall # F-155-4.
CODE
TR-183-03.
RECALLING FIRM/MANUFACTURER
Opal International Ltd., Columbus, OH, by telephone on December 19, 2003. New York State initiated recall is complete.
REASON
The product contains undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
5,760 jars.
DISTRIBUTION
PA.

_______________________________
PRODUCT
a) Belly Washers(r), Bunny Berry, Vitamin C Juice Drink.
Product is packed in 12 oz reusable plastic sports
bottles. Recall # F-156-4;
b) Belly Washers(r), Tropi-Ghoul, Scooby Doo, Vitamin C Juice
Drink, In Zone Brands, Inc. 7775 The Bluffs, Suite H,
Austell, GA 30168. Product is packed in 12 oz reusable
plastic sports bottles. Recall # F-157-4;
c) Belly Washers(r), Pack-A-Punch, Mucha Lucha brand, Vitamin
C Juice Drink. Product is packed in 12 oz reusable
plastic sports bottles. Recall # F-158-4.
CODE
a) Lot #04013 (Military Time Code) - Red 01F, Lot #04034 -
Red 01F, Lot #04035 - Red 01F & Lot #04036 - Red 01F;
b) Lot #04028 (Military Time Code) - Red 01F & Lot #04029 -
Red 01F;
c) Lot #04041 (Military Time Code) - Red 01F & Lot #04042 -
Red 01F, Lot #04048 - Red 01F, & Lot #04049 - Red 01F.
RECALLING FIRM/MANUFACTURER
In Zone Brands, Inc., Austell, GA, by telephone, e-mail or fax on March 2, 2004 through March 5, 2004. Firm initiated recall is ongoing.
REASON
The product contains yeast and lactic acid bacteria.
VOLUME OF PRODUCT IN COMMERCE
574,563 bottles.
DISTRIBUTION
Nationwide.
 

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I

_______________________________
PRODUCT
VANTIN Tablets (cefpodoxime proxetil tablets), 200 mg, 20
tablet bottle, Rx only. Made in Belgium. Recall # D-133-45.
CODE
K08210301; Exp. 04/2008.
RECALLING FIRM/MANUFACTURER
Graham Development Inc., Oneonta, NY, by letter on January 30 and 31, 2004. Firm initiated recall is ongoing.
REASON
Mislabled; bottles labeled as Vantin 200 mg may actually contain Lanoxin 0.25 mg.
VOLUME OF PRODUCT IN COMMERCE
500 bottles.
DISTRIBUTION
Nationwide.
 

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
FOAM CARE Mild, Medicated Handwash 0.5% pCMX, For External
Use Only, 500 ml (16.9 fl. Oz). Recall # D-135-4.
CODE
Lot Numbers 200951, 201440, 202839, 203115, 210036, 211817.
RECALLING FIRM/MANUFACTURER
Ballard Medical Products, Draper, UT, by letter on February 3, 2004. Firm initiated recall is complete.
REASON
Microbial Contamination: Medicated handwash may be contaminated with Pseudomonas spinosa.
VOLUME OF PRODUCT IN COMMERCE
5,160 bottles.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Halls Sugarfree Citrus Blend Mentho-Lyptus Cough Drops, (Menthol 5mg), Vapor Action Formula, 25 Drops. Recall # D-136-4.
CODE
Lot Number: 03114E.
RECALLING FIRM/MANUFACTURER
Cadbury Adams USA Llc, Parsippany, NJ, by letter dated on February 27, 2004. Firm initiated recall is ongoing.
REASON
Mislabeling: Presence of undeclared yellow #5 color additive.
VOLUME OF PRODUCT IN COMMERCE
960 cases.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection,
USP) 0.5% with Epinephrine 1:200,000 (as bitartrate),
Sterile Pak, Contains Five Presterilized 30 mL Single Dose
Vials, Rx only. Recall # D-137-4.
CODE
Lot Number: 310080 Exp. Date: October 2005.
RECALLING FIRM/MANUFACTURER
AstraZeneca LP, Wilmington, DE, by letter on February 12, 2004. Firm initiated recall is ongoing.
REASON
Lack of assurance of sterility - small hole or crack present in Sterile-Pak compromising the sterility of the vial exterior (not the drug).
VOLUME OF PRODUCT IN COMMERCE
6,650 sterile-paks.
DISTRIBUTION
Nationwide.
 

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

______________________________
 

PRODUCT
Microgestin Fe 1/20 (Norethindrone Acetate and Ethinyl
Estradiol Tablets, USP and Ferrous Fumarate Tablets),
28-Day Regimen, Each white tablet (21) contains 1 mg
norethindrone acetate and 20 mcg ethinyl estradiol. Each
brown tablet (7) contains 75 mcg ferrous fumarate, 6
Tablet Dispensers, 28 Tablets Each, Rx only.
Recall # D-131-4.
CODE
Lot 63001H02.
RECALLING FIRM/MANUFACTURER
Watson Pharmaceuticals, Inc., Corona, CA, by letters on March 3, 2004. Firm initiated recall is ongoing.
REASON
Subpotent; ethinyl estradiol component (18 month stability).
VOLUME OF PRODUCT IN COMMERCE
21,005.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Tebamide Suppositories, (Trimethobenzamide HCl) 100 mg,
Pediatric Suppositories, 10 count boxes, Rx Only.
Recall # D-132-4.
CODE
Lot 2137-6, Exp. 6/04.
RECALLING FIRM/MANUFACTURER
G & W Labs, Inc., South Plainfield, NJ, by letters on February 25, 2004. Firm initiated recall is ongoing.
REASON
Subpotent; benzocaine (stability).
VOLUME OF PRODUCT IN COMMERCE
36,096 boxes of 10s.
DISTRIBUTION
Nationwide.
 

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
Weber SolarJet S CO2 Vector Laser Coder System.
Recall # Z-0153-04.
CODE
Serial number 09333451.
RECALLING FIRM/MANUFACTURER
Weber Marking System, Inc., Arlington Heights, IL, by letter dated September 12, 2003. Firm initiated recall is ongoing.
REASON
The laser product failed to comply with the performance standards, including certification, identification, warning logotype label, aperture label and submission of a product report.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Carbomedics VT-200 Valve Tester. Recall # Z-0738-04.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Carbomedics, Inc., Austin, TX, by letters in mid-May 2002. Firm initiated recall is complete.
REASON
Excessive cleaning and resterilization cause cracking and crazing of device causing the device to malfunction during use.
VOLUME OF PRODUCT IN COMMERCE
4,606 instruments.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Asahi APS Series Dialyzers, Model Nos. APS-100S, APS-550S, APS-650S, APS-750S, APS-900S, APS-1050S. The dialyzers are intended for single or initial use and under reprocessing and reuse conditions for up to 15 reuse cycles. Recall # Z-0739-04.
CODE
The recall is no lot specific.
RECALLING FIRM/MANUFACTURER
Asahi Medical Co., Ltd, Chiyoda Ku, JP, by visit starting on October 1, 2001. Firm initiated recall is complete.
REASON
Customer reprocessing methods for the reusable hollow fiber dialyzers may damage the hollow fibers and result in blood leaks during dialysis.
VOLUME OF PRODUCT IN COMMERCE
180,000 units estimated.
DISTRIBUTION
NJ, OH, TX, CA, GA, PA, IL, and IN.

_______________________________
PRODUCT
a) NEONATE 1 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a
disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn label with Part #5082-101-1, and sold as part of a multi-pack (1 of each size) with Part #5082-241-9; Allegiance "Tactics" label with Part #30502-110S; and Arden label with Part #5084-101-1. Recall # Z-0748-04;
b) NEONATE 1 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a
disposable 1 piece cuff, for single patient use only.
Sold under the Welch Allyn "Tycos" label with Part #s
5082-101-2, 5082-101-2CL, and sold as part of a multi-
pack (1 of each size) with Part #5082-241-10; Allegiance
"Tactics" label with Part #s 30502-110 and 30502-210;
and Arden label with Part #s 5084-101-2 and 633-5084-
101-2. Recall # Z-0749-04;
c) NEONATE 2 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a
disposable 1 piece cuff for single patient use only.
Sold under the Welch Allyn "Tycos" label with Part #
5082-102-1 and sold as part of a multi-pack (1 of each
size) with Part #5082-241-9; Allegiance Healthcare
"Tactics" label with Part # 30502-111S; and Arden label
with Part # 5084-102-1. Recall # Z-0750-04;
d) NEONATE 2 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a
disposable 1 piece cuff for single patient use only.
Sold under the Welch Allyn "Tycos" label with Part #
5082-102-2, 5082-102-2CL, 671-5082-102-2, and sold as
part of a multi-pack (1 of each size) with Part #5082-
241-10; Allegiance Healthcare "Tactics" label with Part
# 30502-111 and 30502-211; and Arden label with Part #
5084-102-2 and 634-5084-102-2. Recall # Z-0751-04;
e) NEONATE 3 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a
disposable 1 piece cuff for single patient use only.
Sold under the Welch Allyn "Tycos" label with Part #
5082-103-1 and sold as part of a multi-pack (1 of each
size) with Part #5082-241-9; Allegiance Healthcare
"Tactics" label with Part # 30502-112S; and Arden label
with Part # 5084-103-1. Recall # Z-0752-04;
f) NEONATE 3 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a
disposable 1 piece cuff for single patient use only.
Sold under the Welch Allyn "Tycos" label with Part #
5082-103-2, 5082-102-2CL , and sold as part of a multi-
pack (1 of each size) with Part #5082-241-10; Allegiance
Healthcare "Tactics" label with Part # 30502-112 and
30502-212; and Arden label with Part # 5084-103-2, and
635-5084-103-2. Recall # Z-0753-04;
g) NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a
disposable 1 piece cuff for single patient use only.
Sold under the Welch Allyn "Tycos" label with Part #
5082-104-1 and sold as part of a multi-pack (1 of each
size) with Part #5082-241-9; Allegiance Healthcare
"Tactics" label with Part # 30502-113S; and Arden label
with Part # 5084-104-1. Z-0754-04;
h) NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a
disposable 1 piece cuff for single patient use only.
Sold under the Welch Allyn "Tycos" label with Part #
5082-104-2, 5082-104-2CL, and sold as part of a multi-
pack (1 of each size) with Part #5082-241-10; Allegiance
Healthcare "Tactics" label with Part # 30502-113 and
30502-213; and Arden label with Part # 5084-104-2 and
636-5084-104-2. Recall # Z-0755-04;
i) NEONATE 5 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a
disposable 1 piece cuff for single patient use only.
Sold under the Welch Allyn "Tycos" label with Part #
5082-105-1 and sold as part of a multi-pack (1 of each
size) with Part #5082-241-9; Allegiance Healthcare
"Tactics" label with Part # 30502-114S; and Arden label
with Part # 5084-105-1. Recall # Z-0756-04;
j) NEONATE 5 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a
disposable 1 piece cuff for single patient use only.
Sold under the Welch Allyn "Tycos" label with Part #
5082-105-2, 5082-105-2CL, and sold as part of a multi-
pack (1 of each size) with Part #5082-241-10; Allegiance
Healthcare "Tactics" label with Part # 30502-114 and
30502-214; and Arden label with Part # 5084-105-2 and
637-5084-105-2. Recall # Z-0757-04.
CODE
Code dates between May 13, 2003 and January 23, 2004. (Codes found on outer carton only).
RECALLING FIRM/MANUFACTURER
Welch Allyn, Inc, Skaneateles Falls, NY, by letters dated March 1, 2004. Voluntary recall is ongoing. [Text originally read "FDA initiated recall is ongoing" and was changed July 21, 2004.]
REASON
GMP deficiencies.
VOLUME OF PRODUCT IN COMMERCE
221,200 units.
DISTRIBUTION
Nationwide and worldwide.

_______________________________
PRODUCT
Baxter Meridian Hemodialysis Instrument, product codes
5M5576 and 5M5576R. Recall # Z-0758-04.
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Renal Div., Mc Gaw Park, IL, by letters dated March 11, 2004. Firm initiated recall is ongoing.
REASON
Microbubbles of air in the extracorporeal blood circuit during hemodialysis therapy on the Meridian.
VOLUME OF PRODUCT IN COMMERCE
2,949 units.
DISTRIBUTION
Nationwide, Mexico, China and Korea.

_______________________________
PRODUCT
Hill-Rom brand TotalCare bed system; model P1900 - remanufactured only. Recall # Z-0761-04.
CODE
All remanufactured beds distributed between August 2003 and February 2004.
RECALLING FIRM/MANUFACTURER
Hill-Rom, Inc., Batesville, IN, by letter dated March 15, 2004. Firm initiated recall is ongoing.
REASON
A warning label, advising users not to use oxygen tents with this equipment because of the potential for a fire, was not placed on these remanufactured beds.
VOLUME OF PRODUCT IN COMMERCE
52.
DISTRIBUTION
AZ, FL, GA, NV, PR, TX, VA, and Canada.
 

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
a) VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains
a radiopaque Coaxial Dilator (4 Fr), a 21 Ga. echogenic
entry needle, and a .018 in. / 0,46 mm guidewire with a
floppy lip. Cat. #45-988. Recall # Z-0759-04;
b) VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains
a radiopaque Coaxial Dilator (5 Fr), a 21 Ga. Echogenic
entry needle, and a .018 in. / 0,46 mm guidewire with a
floppy lip. Cat. #45-994. Recall # Z-0760-04.
CODE
a) 912502, Exp. 10/31/05;
b) 910482, Exp. 10/31/05.
RECALLING FIRM/MANUFACTURER
Boston Scientific Corporation, Natick, MA, by letter dated March 5, 2004. Firm initiated recall is ongoing.
REASON
Kits containing 5 Fr dilators may be labeled as 4 Fr. Kits containing 4 Fr dilators may be labeled as 5 Fr.
VOLUME OF PRODUCT IN COMMERCE
175 boxes.
DISTRIBUTION
Nationwide and Canada.
 

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II

______________________________
PRODUCT
Custom deer feed made for a Wisconsin farm. The product was in bags holding about 40 pounds each. Recall # V-122-4.
CODE
1-30-04 on the product invoice and mixing record.
RECALLING FIRM/MANUFACTURER
Crivitz Feed Mill, Crivitz, WI, by telephone on February 20, 2004. Wisconsin State initiated recall is complete.
REASON
The recalled deer feed contained steamed bone meal which is prohibited material in feed for ruminants.
VOLUME OF PRODUCT IN COMMERCE
515 pounds.
DISTRIBUTION
WI.

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END OF ENFORCEMENT REPORT FOR APRIL 7, 2004

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