March 12, 2003
03-11
_____________________________
PRODUCT
Country Club Deluxe Cookies N' Cream Ice Cream, packed in one-half gallon cartons. The product is packaged under the Inter-American Products label, and distributed by Inter-American Products, Inc., Cincinnati, Ohio.
Recall # F-164-3.
CODE
198213-870 UPC. 11110-51883.
RECALLING FIRM/MANUFACTURER
Kroger Co., Cincinnati, OH, by fax and press release on November 22, 2002. Firm initiated recall is complete.
REASON
The product is misbranded because cartons may actually contain Country Club Deluxe Nutty Caramel Ice Cream, which is made with peanuts. The Cookies N'Cream label does not list peanuts.
VOLUME OF PRODUCT IN COMMERCE
6,208 one-half gallon containers.
DISTRIBUTION
AL, FL, GA, MS, PR and TN.
_____________________________
PRODUCT
Biochem brand Ultimate Lo Carb Bar, Chocolate Brownie Nut, wrapped in flexible foil-like film, Net wt. 60 g (2.1 oz.).
Recall # F-235-3.
CODE
UPC #15794-18809 with the following lot numbers. APR1803S1, APR1803S6, APR1803W6, APR1803W1, APR1803H7, APR1803N6, APR1903S7, APR1903N7 and APR1903W7.
RECALLING FIRM/MANUFACTURER
Elan Nutrition, L.L.C., Grand Rapids, MI, by press release, telephone and letter on January 17, 2003. FDA initiated recall is ongoing.
REASON
Product may contain undeclared peanut butter.
VOLUME OF PRODUCT IN COMMERCE
158,496 bars.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
A cake mix sold under the two brand names, Baker Girl brand White Cake mix in 18.5 oz. carton, distributed by Purity Foods, Inc., Clayton, OH. and County Fare brand White Cake mix, Ultra Moist, in 18.5 oz. Carton. Recall # F-236-3.
CODE
Products with expiration dates 9/20/02 through 12/31/03.
RECALLING FIRM/MANUFACTURER
Amendt Corporation, Monroe, MI, by press release and recall notification on January 13, 2003. FDA initiated recall is ongoing.
REASON
The product contains undeclared egg whites and non-fat dry milk.
VOLUME OF PRODUCT IN COMMERCE
298,150 units.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
a) Dudek brand Kapusniak (cabbage soup), 32 fl. oz. (1 QT),
Keep refrigerated. Recall # F-237-3;
b) Dudek brand:
1. Pierogi Mushroom (dumplings), Net Wt. 16 oz., keep
refrigerated. Recall # F-238-3.
2. Pierogi Potato (dumplings), Net Wt. 16 oz., keep
refrigerated. Recall # F-239-3;
3. Pierogi Potato Chive (dumplings), Net Wt. 16 oz.,
keep refrigerated. Recall # F-240-3;
4. Pierogi Potato Cheddar (dumplings), Net Wt. 16 oz.,
keep refrigerated. Recall # F-241-3.
CODE
a) Expiration date of before and including 12/29/02;
b) Expiration date of before and including 5/15/03.
RECALLING FIRM/MANUFACTURER
Dudek Foods, Inc. Hamtramck, MI, by a press release, telephone and letters dated May 23, 2002. FDA initiated recall is complete.
REASON
a) Undeclared whey and wheat;
b) Undeclared whey.
VOLUME OF PRODUCT IN COMMERCE
Undetermined.
DISTRIBUTION
a) MI;
b) IN, MI, and OH.
_____________________________
PRODUCT
Glace Winter Melon packed in a clear, heat-sealed, plastic bag in a cardboard box, NET WT. 12 oz. Product of China/Hong Kong/Japan. Recall # F-242-3.
CODE
"Consume Before: AUG 1 2002".
RECALLING FIRM/MANUFACTURER
Recalling Firm: 282 International Trading, Inc., Brooklyn, NY, by telephone on/about June 27, 2002 and followed up with onsite visits.
Manufacturer: Tuong Song Hong Hong Kong, China. State initiated recall is complete.
REASON
The product contained undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
129 cases (60 - 12 oz. Packages per case).
DISTRIBUTION
NY.
_____________________________
PRODUCT
Frozen Biscuit Sandwiches:
a) Deli Pride Egg Sausage and Cheese Biscuit. 4.4 oz.
Recall # F-243-3;
b) Breakfast in a Minit Egg, Sausage, & Cheese Biscuit.
5.1 oz. Recall # F-244-3;
c) Breakfast in a Minit Sausage & Biscuit. 3.8 oz.
Recall # F-245-3;
d) Smiley's Egg, Sausage & Cheese Biscuit. 5.1 oz.
Recall # F-246-3;
e) Marketfare All Stars Country Sausage & Biscuit. 3.7 oz.
Recall # F-247-3;
f) Marketfare All Stars Egg, Sausage & Cheese Buttermilk
Biscuit. 5.6 oz. Recall # F-248-3;
g) Wil's Kitchen Egg, Sausage & Cheese Biscuit. 5.1 oz.
Recall # F-249-3.
CODE
All sandwiches coded 345143 through 365143 and 001243 through 080243.
RECALLING FIRM/MANUFACTURER
MarketFare Foods, Phoenix, AZ, by press releases on March 22, 2002, and April 5, 2002 and recall letters dated March 21, 2002 and April 9, 2002. State initiated recall is complete.
REASON
The products may be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
Nationwide.
DISTRIBUTION
Undetermined.
_____________________________
PRODUCT
LAT CHIU PRODUCTS brand RED CHERRIES Spicy, 3.5 oz., 100 gm, packaged in a flexible plastic bag. Est., Serving Size: 100 g, Servings per Container: 1 Barcode # 05847 54121. Recall # F-233-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Tai Pan Industries, U.S.A., Brooklyn, NY, by visit on/about June 13, 2002. State initiated recall is complete.
REASON
The product contained undeclared sulfites based on New York State Department of Agriculture and Markets analysis.
VOLUME OF PRODUCT IN COMMERCE
8 cases (96 packages per case).
DISTRIBUTION
NY.
____________________________
PRODUCT
Hale's Blue Boy brand SALA syrup, net wt 24 oz, packaged in glass bottle with metal screw-on cap, 12 bottles per carton and labeled, in part, "Product of Thailand". Recall # F-234-3.
CODE
05-2545-151.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Eastland Food Corporation, Columbia, MD, by letter on February 7, 2003.
Manufacturer: Hale's Trading, Thailand. Firm initiated recall is ongoing.
REASON
The product contained an unapproved color additive, carmoisine (formerly Ext. D&C Red No. 10).
VOLUME OF PRODUCT IN COMMERCE
675 cartons.
DISTRIBUTION
MS.
_____________________________
PRODUCT
Rhinaris, Lubricating Nasal Mist, non-medicated, Mixture of polyethylene glycol 15%, and propylene glycol 5% in a solution containing 0.02% benzalkonium chloride as a preservative. 33 FL. OZ. (10 mL) and 1 FL. OZ. (30 mL) bottles. NDC 51817-071-01(.33 fl oz), NDC 51817-071-02
(1 fl oz). Recall # D-160-3.
CODE
209281, Exp. MA 07 (MA = May)-----.33 fl oz. bottles; 209280, Exp. MA 07 (MA=May)-------1 fl. oz bottles.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pharmascience, Inc., Tonawanda, NY, by letters on February 5, 2003 and February 11, 2003.
Manufacturer: Pharmascience¸ Inc., Montreal, Canada. Firm initiated recall is ongoing.
REASON
Microbial Contamination: Pseudomonas fluorescens.
VOLUME OF PRODUCT IN COMMERCE
10,000 bottles (.33);
1,345 bottles (1 fl. Oz.).
DISTRIBUTION
Nationwide.
____________________________
PRODUCT
Premarin Tablets (conjugated estrogens tablets, USP) 0.625 mg, unit dose packages of 100, and bottles of 1,000 count, Rx only. NDC numbers: 0046-0867-95 (bottles of 1000) and 0046-0967-99 (unit dose packages). Recall # D-158-3.
CODE
1,000 tablet bottles: LOT #1A03925, EXP 12/02;
100 unit dose tablets: LOT #1A03960, EXP 05/05;
LOT #1B00084, EXP 05/05.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Amerisource Health Services, Corp. Columbus, OH, by mail and faxed recall notices on January 20, 2003 and February 25, 2003.
Manufacturer: Ayerst Laboratories Inc., A Wyeth-Ayerst Company, Philadelphia, PA. Firm initiated recall ongoing.
REASON
Dissolution Failure: by manufacturer.
VOLUME OF PRODUCT IN COMMERCE
26 packages and 3,870 bottles.
DISTRIBUTION
Nationwide and Puerto Rico.
_____________________________
PRODUCT
Human Tissue for Transplantation, Cornea. Recall # B-0534-3.
CODE
Number 2002-11-6042.
RECALLING FIRM/MANUFACTURER
Heartland Lions Eye Bank, Columbia, MO, by telephone on November 21, 2002. Firm initiated recall is complete.
REASON
Cornea, collected from a donor whose serum tested repeatedly reactive for antibody to Hepatitis C Virus (Anti-HCV), and Recombinant Immunoblot Assay (RIBA) positive, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MO.
___________________________
PRODUCT
Platelets. Recall # B-0417-3.
CODE
Unit R70544.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Inc., Richmond, VA, by telephone on September 27, 2002,
and by letter dated October 18, 2002. Firm initiated recall is complete.
REASON
Platelets, corresponding to a unit of Red Blood Cells that were positive for
Klebsiella pneumonia, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Unit (1 unit). Recall # B-0434-3.
CODE
Unit 740-1644.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on October 11, 2002. Firm initiated recall is complete.
REASON
Blood product, that was not quality control tested, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AZ.
_____________________________
PRODUCT
Fresh Frozen Plasma. Recall B-0491-3.
CODE
Unit 3418916.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by telephone on June 11, 2002. Firm initiated recall is complete.
REASON
Blood products, that may have contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.
_____________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced, Irradiated. Recall # B-0496-3.
CODE
Unit C41781 - Part B.
RECALLING FIRM/MANUFACTURER
Stanford Medical School Blood Center, Pal Alto, CA, by facsimile dated March 31, 2002. Firm initiated recall is complete.
REASON
Platelets, that may have had a decreased plasma volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_____________________________
PRODUCT
Source Plasma. Recall # B-0497-3.
CODE
G-34705-118, G-34505-118, G-34303-118, G-34003-118, G-32971-118,
G-32765-118, G-32059-118, G-31802-118, G-30385-118, G-30146-118,
G-29898-118, G-29670-118, G-29401-118, G-29123-118, G-28886-118,
G-28611-118, G-27351-118, G-27102-118, G-25435-118, G-25147-118,
G-24377-118, G-24130-118, G-23881-118, G-23642-118, G22758-118,
G-19237-118, G-18975-118, G-15159-118, G-14934-118.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Los Angeles, CA, by facsimile dated October 8, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of tattoo application within the prior 12 months, were distributed.
VOLUME OF PRODUCT IN COMMERCE
29 units.
DISTRIBUTION
NC and Switzerland.
_____________________________
PRODUCT
Source Plasma. Recall # B-0554-3.
CODE
units 01GMIA7860, 01GMIA8157, 01GMIA8938, 01GMIA9230, 01GMIA9961, 01GMIB0273, 01GMIB1037, 01GMIB1354, 01GMIB2108, and 01GMIB2425.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, Walker, MI, by letter dated July 5, 2001. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who admitted to engaging in multiple high risk behaviors,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units.
DISTRIBUTION
AL.
_____________________________
PRODUCT
a) Red Blood Cells. Recall # B-0578-3;
b) Platelets. Recall # B-0579-3;
c) Fresh Frozen Plasma. Recall # B-0580-3.
CODE
a); b) and c) Unit 66213555.
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL. by telephone on September 5, 2002. Firm initiated recall complete.
REASON
Blood products, collected from a donor who had a sexual partner who lived in a HIV Group O risk area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
IL.
_____________________________
PRODUCT
Misys Blood Bank System. Recall # B-0581-3.
CODE
Version 5.2, 5.23 and 5.3.
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Inc. (formerly Sunquest Information Systems), Tucson, AZ, by a Product Safety Notification, dated April 2, 2002. Firm initiated recall ongoing.
REASON
Defect in the design of blood bank software programs could result in the release of unsuitable blood product.
VOLUME OF PRODUCT IN COMMERCE
3 Versions.
DISTRIBUTION
Nationwide, Canada, United Kingdom, Bermuda and Saudi Arabia.
_____________________________
PRODUCT
a) Red Blood Cells. Recall # B-0590-3;
b) Platelets. Recall # B-0591-3;
c) Fresh Frozen Plasma. Recall # B-0592-3.
CODE
a); b) and c) Units 8082260, 8080030, 6320672.
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on October 9, 10, and November 27, 2002. Firm initiated recall complete.
REASON
Blood products, collected from a donor with a history of having tested positive for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units.
DISTRIBUTION
IL.
_____________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0593-3.
CODE
Unit 53GR43504.
RECALLING FIRM/MANUFACTURER
American Red Cross, Chesapeake Region, Baltimore, MD, by letter dated April 2, 2002. Firm initiated recall complete.
REASON
Blood product, corresponding to a unit of Red Blood Cells that was implicated in a transfusion reaction and found to be contaminated with Bacillus species, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MD.
_____________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0594-3.
CODE
Unit 8725624.
RECALLING FIRM/MANUFACTURER
Union Memorial Hospital, Baltimore, MD, by telephone on November 11, 2002. Firm initiated recall is complete.
REASON
Blood product, which tested reactive for syphilis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MD.
___________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0599-3.
CODE
Unit 29FF49956.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by telephone on June 26, 2002 and letter on July 12, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for the antibodies to human T lymphotropic virus, types I and II (anti-HTLV-I/II), but was collected from an ineligible donor due to a subsequent disclosure of previous positive testing for anti-HTLV-I/II, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.
___________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0600-3.
CODE
Unit number 29FN42246.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by letter dated April 24, 2002. 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
VA.
___________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0601-3.
CODE
Unit number 29KH33786.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by letters dated September 23, 2002 and October 23, 2002. 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
VA.
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall B-0492-3.
CODE
Unit 3418916.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by telephone on June 11, 2002. Firm initiated recall is complete.
REASON
Blood products, that may have contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.
___________________________
PRODUCT
X-Cel MB-700 A/C Podiatry X-Ray System. Recall #Z-0424-03.
CODE
Model MB-700 A/C, serial numbers 622686, 622687,622688, 622689, 320367, and
325120.
RECALLING FIRM/MANUFACTURER
X-Cel X-Ray Corp., Crystal Lake, IL, by telephone on November 19, 2002 and letters
dated February 27, 2003. Firm initiated recall is complete.
REASON
The X-Ray system contained a defective X-Ray tube shield.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
IL.
b) Serial# 4102A00874 4102A00889 4102A00890 4102A00894 4102A00905 4102A00920 4102A00945 4102A00957 4102A00971 4102A00972 4102A00984 4102A01011 4102A01029 4102A01030 4102A01031 4102A01032 4136A01100 4136A01101 4136A01102 4136A01103 4136A01104 4136A01105 4136A01106 4136A01116 4136A01117 4143A01190 4143A01191 4143A01192 4143A01213 4143A01227 4143A01244 4143A01289 4143A01290 4143A01291 4143A01292 4143A01311 4143A01312 4213A01338 4213A01345 4213A01346 4213A01383 4213A01386 4213A01398 4213A01399 4213A01400 4213A01401 4213A01402 4213A01403 4213A01404 4213A01405 4213A01406 4213A01407 4213A01412 4213A01416 4213A01420 4213A01421 4213A01425 4213A01442 4213A01452 4213A01468 4213A01472 4213A01479 4213A01481 4213A01482 4213A01483 4213A01484 4213A01485 4213A01486 4213A01490 4213A01491 4143A01175 4143A01249 4143A01250 4143A01251 4143A01252 4143A01253 4213A01347 4143A01178 4213A01469 4102A00903 4102A00904 4102A00892;
c) Serial 4225A00106 4225A00107 4225A00108 4225A00111 4225A00112 4225A00113 4225A00114 4225A00116 4225A00117 4225A00118 4225A00119 4225A00127 4225A00145 4225A00149 4225A00150 4225A00151 4225A00152 4225A00164 4225A00165 4225A00166 4225A00167 4225A00169 4225A00188 4225A00189 4213A13698 4213A13700 4225A00122 4225A00136 4225A00138 4225A00137 4225A00139 4225A00140 4225A00142 4225A00143 4225A00144 4225A00101 4225A00102 4225A00103 4225A00104;
d) 4225A00169 4225A00171 4225A00181 4225A00182 4213A13456
4131A13457.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc. Cardiac & Monitoring Systems,
Andover, MA, by letter on/about February 19, 2003. Firm initiated recall is ongoing.
REASON
Central Station Monitoring Information Centers may experience screen freeze, i.e. loss of display, keyboard or mouse lock up.
VOLUME OF PRODUCT IN COMMERCE
a) 972 units;
b) 82 units;
c) 39 units;
d) 6 units.
DISTRIBUTION
Nationwide and Canada, Europe, Asia, Latin America.
___________________________
PRODUCT
a) Bard Stinger Ablation Catheter: Item Numbers 210001
218501 L210001 210002 218502 L210002 210003 218503
L210003 210004 218504 L210004 210005 218505 L210005
210006 218506 L210006 210007 218507 L210007 210015
218516 L210008 210016 218518 L210009 210017 218519
L210010 210018 218520 L210011 210019 218521 L210012
210020 218523 L210013 210023 218524 L210014 210024
218525 L210015 210025 218526 L210016 210026 218527
L210017 210027 218528 L210018 210028 218529 210029
210030. Recall # Z-0598-03;
b) Bard Stinger M Ablation Catheters: Item Numbers 210001M
218501M 210002M 218502M 210003M 218503M 210004M 218504M
210005M 218505M 210006M 218506M 210007M 218507M 210015M
218516M 210016M 218518M 210017M 218519M 210018M 218520M
210019M 218521M 210020M 218523M 210023M 218524M 210024M
218525M 210025M 218526M 210026M 218527M 210027M 218528M
210028M 218529M 210029M 210030M. Recall # Z-0599-03;
c) Bard Stinger S Ablation Catheter: Item Numbers 210001S
218501S 6210015S 210002S 218502S 6210016S 210003S
218503S 6210017S 210004S 218504S 6210018S 210005S
218505S 6210019S 210006S 218506S 6210020S 210007S
218507S 210015S 218516S 210016S 218518S 210017S 18519S
210018S 218520S 210019S 218521S 210020S 218523S 210023S
218524S 210024S 218525S 210025S 218526S 210026S 218527S
210027S 218528S 210028S 218529S 210029S 210030S.
Recall # Z-0600-03;
d) Bard Stinger SM Ablation Catheter Item Numbers 210001SM
218501SM 210002SM 218502SM 210003SM 218503SM 210004SM
218504SM 210005SM 218505SM 210006SM 218506SM 210007SM
218507SM 210015SM 218516SM 210016SM 218518SM 210017SM
218519SM 210018SM 218520SM 210019SM 218521SM 210020SM
218523SM 210023SM 218524SM 210024SM 218525SM 210025SM
218526SM 210026SM 218527SM 210027SM 218528SM 210028SM
218529SM 210029SM 210030SM. Recall # Z-0601-03;
e) Bard Orbiter ST Artrial Mapping Steerable Catheter Item
Numbers 320001 7FAM00001 7FAM00010 7FAM00019 7FAM0008B
7FAM0017B 320002 7FAM00002 7FAM00011 7FAM00020 7FAM0009B
7FAM0018B 320003 7FAM00003 7FAM00012 7FAM0001B 7FAM0010B
7FAM0019B 320004 7FAM00004 7FAM00013 7FAM0002B 7FAM0011B
7FAM0020B 320005 7FAM00005 7FAM00014 7FAM0003B 7FAM0012B
320006 7FAM00006 7FAM00015 7FAM0004B 7FAM0013B 320007
7FAM00007 7FAM00016 7FAM0005B 7FAM0014B 320008 7FAM00008
7FAM00017 7FAM0006B 7FAM0015B 320009 7FAM00009 7FAM00018
7FAM0007B 7FAM0016B. Recall # Z-0602-03;
f) Bard Orbiter PV Steerable Catheter Item #: 320100
(Marketed in Europe Only). Recall # Z-0603-03.
CODE
All lot numbers where the 4th digit contains the letter A
through M. Ex. 07A"A"1234.
RECALLING FIRM/MANUFACTURER
C. R. Bard, Inc. Electrophysiology Division, Billerica, MA, by letter on January 8, 2003. Firm initiated recall is ongoing.
REASON
Sterile barrier maybe perforated compromising sterility of the device.
VOLUME OF PRODUCT IN COMMERCE
25,502 units;
DISTRIBUTION
Nationwide.
___________________________
PRODUCT
External Drainage Sets labeled NMT NeuroSciences Implants or Integra NeuroSciences Implants, S.A. Recall # Z-0606-03.
CODE
The External Drainage Sets lot numbers: 60300370, 60306608, 60306609, 60321387,
60300373, and 60376191. These lots of EDS may be included in the following set
configurations:
Catalog #: 910-109
Lot#: 0118080; 0118369; 0118572;
0118981; 0119845; 0117525.
Catalog# 910-110A
Lot #: 60300370; 60300373; 60306608;
60300370-1; 60321387; 60306608-1;
60306609; 60321387-1; 60306609-1;
60321387-2; 60376191; 60321387-3.
Catalog # 910-112A
Lot #: 0117569; 0117609; 0117834;
0117478; 0117833; 0117957;
0118062; 0118175; 0118420;
0118421; 0118573; 0118693.
Catalog #910-118A
Lot #: 0117570; 0117479; 0118023;
0118489; 0119150; 0119505.
Catalog #910-120A
Lot #: 0117536; 0117371; 0117453;
0117537; 0117902; 0117948;
0118047; 0118161; 0118422;
0118543; 0118616; 0118744;
0118808; 0118912; 0118955;
0119020; 0119081; 0119348;
0119500; 0119582.
Catalog #910-123A
Lot #: 0117805; 0118576; 0118845;
0118957.
RECALLING FIRM/MANUFACTURER
Integra LifeSciences Corp., Plainsboro, NJ, by letter and reply form on December 16, 2002. Firm initiated recall ongoing.
REASON
The check valve in the patient line may stick in the closed position.
VOLUME OF PRODUCT IN COMMERCE
8952.
DISTRIBUTION
Nationwide and Internationally.
___________________________
PRODUCT
a) Compat Enteral Delivery Pump Set with Piercing Spike.
Recall # Z-0607-03;
b) Compat 500 mL Baggle Top Fill Enteral Feeding Container
with Preattached Enteral Delivery Pump Set.
Recall # Z-0608-03.
c) Compat DualFlo Enteral Delivery Pump Set with 1000-mL
Twist Cap Formula Vinyl Bag and 1000-mL Twist Cap Water
Bag. Recall # Z-0609-03.
CODE
a) Item number 19930700, lot 3092D;
b) Item number 19931200, lots 3152A and 3182A;
c) Item number 19944700, lot 3232E.
RECALLING FIRM/MANUFACTURER
Novartis Nutrition Corp., St Louis Park, MN, by letter dated January 31, 2003. Firm initiated recall ongoing.
REASON
Some of the sets may leak or disconnect near the pump adapter during use. The patient could ingest air and vomit causing a safety concern.
VOLUME OF PRODUCT IN COMMERCE
930 administration sets.
DISTRIBUTION
Nationwide and Canada.
___________________________
PRODUCT
a) Datex-Ohmeda S/5 Oxygen Saturation Module (M-OSAT).
Recall # Z-0610-03;
b) Datex-Ohmeda Cardiocap/5 Anesthesia Monitor with N-XOSAT
SpO2 measurement option. Recall # Z-0611-03.
CODE
a) All serial numbers of the units distributed prior to the
recall. September 16, 2002.
b) All units with N-XOSAT SpO2 measurement option
distributed prior to the recall. September 16, 2002.
RECALLING FIRM/MANUFACTURER
Datex-Ohmeda, Madison, WI, by letters dated September 16, 2002. Firm initiated recall ongoing.
REASON
Falsely high blood oxygen saturation readings in some circumstances, which could result in no alarm in a critical life-threatening situation.
VOLUME OF PRODUCT IN COMMERCE
a) 1019;
b) 85.
DISTRIBUTION
Nationwide and Internationally.
___________________________
PRODUCT
Scimed ChoICE PT "J" Tip 182 cm Guide Wire, a single use, sterile (EO), device
packaged in a carrier tube, which is held in a coil by plastic clips. The carrier
tube assembly of the guide wire is sealed into a pouch. The pouch assemblies
are packaged in a five-pack product box.
Recall # Z-0589-03.
CODE
Pouch codes are: Catalog No. 12160-01J, UPN H7491216001J1, batch 4536936, expiration
date of 2004-01.
The five pack box codes are: Catalog No. 12160-01J, UPN H7491216001J2, batch
4562262, expiration date 2004-01.
RECALLING FIRM/MANUFACTURER
Symbiosis Corp., Miami, FL, by letter on July 16, 2002. Firm initiated recall
is complete.
REASON
Labeled as J tip but may be straight tip.
VOLUME OF PRODUCT IN COMMERCE
24 units.
DISTRIBUTION
FL, KS, NH, IA, PA, MI and CA.
___________________________
PRODUCT
a) Scimed ChoICE PT Extra Support PTCA Guide Wire with ICE
Hydrophilic Coating, 300 cm length. Recall Z-0590-03.
b) Scimed PT Graphix Intermediate PTCA Guide Wire with ICE
Hydrophilic Coating, 300 cm length. Recall Z-0591-03.
CODE
a) Individual Devices in Pouches with Catalog No. 12155-01,
UPN H74912155011, Lot Number 4773987, exp. Date 2004-5.
These pouches were packaged in two lots of five-pack
boxes with the following codes: Catalog 12155-01, lot
4791304 Catalog 12155-011, lot 4798294.
b) Individual devices in pouches as follows: Catalog No.
14914-01 UPN H74914914011 Lot Number Expiration Date
4772607 2004-0 4772610 " 4762379 " 4762384 " 4772618 "
4766619 " 4758393 " 4758432 " 4753775 " 4758389 "
4758427 " 4756521 " 4762390 " 4756485 " 4753781 "
4758397 " 4758423 " 4753783 " 4753785 " 4740328
2004-4 4753779 2004-5 4753759 " 4753769 " 4756534 "
4756536 " 4756531 " 4724690 2004-4 4740329 " 4736552 "
The above PT Graphix(tm) guide wire pouch lots were
packaged in 18 lots of five-pack boxes with the
following codes: Catalog No. 1215T UPN H74914914012
Lot Number Expiration Date 4789558 2004-05 4791600 "
4789558 " 4791126 " 4785009 " 4787988 " 4786427 "
4783177 " 4780051 " 4780186 " 4783316 " 4780190 "
4782079 " 4780939 " 4771889 " 4777410 " 4775761 "
4776272 " 4766792 "
RECALLING FIRM/MANUFACTURER
Symbiosis, Corp., Miami, FL, by letters on August 22, 2002. Firm initiated recall
is ongoing.
REASON
Product labeled as Scimed Choice PT Extra Support PTCA Guide Wire 300 cm were
actually Scimed PT Graphix Intermediate PTCA Guide Wire 300 cm.
VOLUME OF PRODUCT IN COMMERCE
a) 27/5 pack boxes.
b) 228/5 pack boxes.
DISTRIBUTION
Nationwide and Internationally.
___________________________
PRODUCT
Baxter Meridian Hemodialysis Instrument. The instrument is part of a high permeability
hemodialysis system which consists of a controlled dialysate delivery system
that incorporates an ultra filtration controller to prevent excessive loss of
water from the patient's blood, an extra corporeal blood set, and a high permeability
dialyzer. The standard features of the Meridian instrument include a high blood
flow rate capacity (for shortened hemodialysis treatment time), automatic ultra
filtration control, standard and variable bicarbonate and sodium capabilities
and automated chemical disinfection. The Meridian will operate in either the
bicarbonate or acetate mode for concentrates. Recall # Z-0605-03.
CODE
Product codes 5M5576, 5M5576R,
serial numbers 200000 through 202864.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare, Corp., Round Lake, IL, by letter dated November 15, 2002.
Firm initiated recall ongoing.
REASON
Meridian hemodialysis instrument may reset when in shutdown mode causing the
system to reset with potential for patient increased bioburden exposure.
VOLUME OF PRODUCT IN COMMERCE
2,864 units.
DISTRIBUTION
Nationwide, Mexico, China, South Korea, Hong Kong.
END OF ENFORCEMENT REPORT FOR MARCH 12, 2003
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