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U.S. Department of Health and Human Services

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Enforcement Report for October 20, 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.

October 20, 2004
04-42

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
Purity Premium Ice Cream, "Tennessee Titans, All-Out-Blitz, Chocolate and Vanilla Ice Cream with Chocolate Crunches", packaged in 1?2 gallon cartons. Recall # F-045-5.
CODE
12/05/04 PL# 47-215.
RECALLING FIRM/MANUFACTURER
Purity Dairies, Inc., Nashville, TN, by telephone on January 7, 2004 and by press release on January 8, 2004. Firm initiated recall is complete.
REASON
Product contains undeclared eggs.
VOLUME OF PRODUCT IN COMMERCE
1,350 half gallon units.
DISTRIBUTION
TN, AL, KY.

_______________________________
PRODUCT
Gloucester Pier Black Tiger Shrimp, easy-peel, uncooked, deveined, headless, shell on, individually quick frozen, 31-40 count. Product of Vietnam. Net Wt. 16 oz. Recall # F-046-5.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Penn Traffic Co., Syracuse, NY, by e-mail on May 5, 2004. Firm initiated recall is complete.
REASON
Shrimp contains undeclared sulfites based on NYSDAM's analysis.
VOLUME OF PRODUCT IN COMMERCE
Unknown.
DISTRIBUTION
NY, PA, VT, and NH.

_______________________________
PRODUCT
Penzeys Spices Hungary Half-Sharp Paprika in 2.5oz glass jars, 1.3 oz. plastic jars, and 4 oz, 8 oz., and 16 oz. bags. Recall # F-047-5.
CODE
All product on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Penzeys LTD, Brookfield, WI, by press release on May 27, 2004, and by letter on May 28, 2004. Firm initiated recall is ongoing.
REASON
The product is contaminated with Salmonella based on the Florida Department of Agriculture and Consumer Services' analysis.
VOLUME OF PRODUCT IN COMMERCE
About 1,200 jars of Hungary Half-Sharp and 1,968 of Hungary Sweet.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Archer Farms™ MARKET brand PREMIUM TRAIL MIX, TEX-MEX MIX. Peanuts, Sesame Sticks, Almonds, Cajun Corn Sticks & Chili Bits. NET WT. 14 OZ (397 g). CHILI BITS PRODUCT OF THAILAND. --- This product is packaged in a clear, stand-up Ziplock bag. The Tex-Mex Mix ingredient statement is actually the ingredient statement for the "Berry Mix" Trail Mix. Recall # F-048-5.
CODE
Lots/Codes: EXP 032905 and EXP 041305 (These represent expiration dates); UPC 085239 085332.
RECALLING FIRM/MANUFACTURER
Setton International Foods, Inc., Commack, NY, by e-mail on May 1, 2004. Firm initiated recall is complete.
REASON
The product contains undeclared ingredients including soy, wheat, and FD&C Yellow #5 due to an incorrect ingredient statement.
VOLUME OF PRODUCT IN COMMERCE
1,456 units (182 cases).
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Nabisco Carry Me Pack Mini Oreo Bite Size Chocolate Sandwich Cookies, Net Wt. 1.5 oz. box, UPC 44000-00950. These boxes were packaged into a Carry Me Pack tray case of 12 - 1.5 oz. boxes (UPC 44000-01015), consisting of 4 boxes each of Mini Oreos, Honey Teddy Grahams and Ritz Bits Cheese Sandwiches. Recall # F-049-5.
CODE
Mini Oreo 1.5 oz. box codes 20 JAN BK and 21 JAN BK; Variety Pack Tray case codes 4311RH, 4325RH, 4346RH, 5020RH and 5021RH.
RECALLING FIRM/MANUFACTURER
Kraft Inc, Northfield, IL, by press release on September 21, 2004. Firm initiated recall is ongoing.
REASON
Packages labeled as "Mini Oreo" actually contain a different product, Ritz Bits Cheese Sandwiches, which is formulated to contain milk ingredients. The label of the Mini Oreo cookies does not list any milk ingredient.
VOLUME OF PRODUCT IN COMMERCE
48,990 cases.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Rainbow Traders Alfalfa sprouts in plastic bag. Recall # F-050-5.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Rainbow Traders, Waialua, HI, by letters on June 14, 2003. Firm initiated recall is complete.
REASON
These sprouts were manufactured using alfalfa seed lot X3023 that was recalled by Caudill Seed & Warehouse, Inc. because of its association with an outbreak of Salmonella Bovismorbificans illness.
VOLUME OF PRODUCT IN COMMERCE
197 lbs.
DISTRIBUTION
HI.

_______________________________
PRODUCT
a) See Best brand Simulated Lobster Ball, flexible plastic
pouch, 200 g net wt. Recall # F-051-5;
b) See Best brand Simulated Crab Ball, flexible plastic
pouch, 200 g net wt. Recall # F-052-5;
c) See Best brand Fish Dumpling, flexible plastic pouch,
140 g net wt. Recall # F-053-5;
d) See Best brand Colorful Fish Roll w/Roe, flexible plastic
pouch, 200 g net wt. Recall # F-054-5;
e) See Best brand Codfish Ball with Mushroom, flexible plastic
pouch, 200 g net wt. Recall # F-055-5;
f) See Best brand 2-Color Ball (English label states "2-collor
ball) flexible plastic pouch, 200 g net wt. Recall # F-056-5;
g) See Best brand Codfish Ball, flexible plastic pouch, 200 g
net wt. Recall # F-057-5;
h) See Best brand Cuttlefish Ball, flexible plastic pouch, 200 g
net wt. Recall # F-058-5.
CODE
All codes.
RECALLING FIRM/MANUFACTURER
Walong Marketing Inc., Hayward, CA, by telephone, e-mail and press release on June 29, 2004. Firm initiated recall is ongoing.
REASON
The products contain undeclared egg.
VOLUME OF PRODUCT IN COMMERCE
3,050 cartons.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
WS (Wing Shing) brand Dried Lily Flower, Net Wt. 6 oz. (170 g+/-0.5 g). Product is packed in a sealed, clear plastic bag. Recall # F-059-5.
CODE
All product on the market at the time recall was initiated.
RECALLING FIRM/MANUFACTURER
Murry International Trading Co., Inc., Brooklyn, NY, by press release on August 10, 2004. Firm initiated recall is complete.
REASON
Undeclared sulfites (1520 ppm) based on sampling and analysis by the New York State Department of Agriculture & Markets (NYSDAM).
VOLUME OF PRODUCT IN COMMERCE
20 cases (100 -- 6 oz. packages per case).
DISTRIBUTION
NY.

_______________________________
PRODUCT
World Classics Pesto, Product of Italy, 3 oz. glass jars, 12 jars per case. UPC 36800-18876. Recall # F-060-5.
CODE
Lot 255183.
RECALLING FIRM/MANUFACTURER
J.C.M. Ltd. Dba Racconto, Melrose Park, IL, by letter on September 14, 2004 and by press release on September 16, 2004. Firm initiated recall is ongoing.
REASON
The pesto contains walnuts and wheat meal, which are not declared in the ingredients statement on the label.
VOLUME OF PRODUCT IN COMMERCE
972 jars.
DISTRIBUTION
SC, GA, MA, VT, and CT.

_______________________________
PRODUCT
Fresh Green Onions (Scallions) stalks wrapped with a rubber band, Product is sold in loose packed 6 oz. bunches (6-8 onions), Product is distributed in Safeway and Pak'n Save stores; it is bulk shipped in cases of 48 bunches each; bulk Onions is Product of Mexico. (Muranaka Invoice #s are: 53429 and 53430.) Recall # F-061-5.
CODE
There are no production codes on the product. Products sold from August 3rd through 7, 2004 are implicated.
RECALLING FIRM/MANUFACTURER
Safeway Stores, Inc., Pleasanton, CA, by press release, telephone and e-mails on August 12, 2004. Firm initiated recall is complete.
REASON
Sample analysis by the California Department of Food and Agriculture (CDFA) found the product to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
2,016 cases/48 bunches.
DISTRIBUTION
CA, and NV.
 

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
Spectrum Purified Water (Distilled Water) USP, 20L and 200L
containers, For manufacturing, processing or repacking. Not
sterile. Recall # D-029-5.
CODE
Lot numbers: ST1136, SI0041, SU0227, SI0897, SI1226, SW0169, TM0905, TO0079, TC0516, TP0214, TD0594, TQ0018, TQ0010, TE0282, TQ0447, TQ0674, TF0423.
RECALLING FIRM/MANUFACTURER
Spectrum Laboratory Products, Inc., Gardena, CA, by letter dated September 28, 2004. Firm initiated recall is ongoing.
REASON
Microbial contamination; burkholderia cepacia.
VOLUME OF PRODUCT IN COMMERCE
537.
DISTRIBUTION
Nationwide and PR.

_______________________________
PRODUCT
Apria Healthcare, Oxygen, Compressed USP, B size aluminum high pressure gas cylinder, UN1072, Rx only. Recall # D-030-5.
CODE
Lot CE01R189B C = Airgas Intermountain, E = Idaho Falls, 01 = Number of bulk medical oxygen received in a month, R = corresponds to the year (2004), 189 = Julian date (July 7), B = second fill (batch) of the day.
RECALLING FIRM/MANUFACTURER
Apria Healthcare, Inc., Idaho Falls, ID, by telephone on July 16, 2004. Firm initiated recall is complete.
REASON
Cylinder contaminated with carbon tetrafluoride.
VOLUME OF PRODUCT IN COMMERCE
47 cylinders.
DISTRIBUTION
ID.
 

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_______________________________
PRODUCT
Oxygen, Cryogenic liquid in bulk form, converted to gas. Recall # D-032-5.
CODE
Lot number: 264MERA04022B.
RECALLING FIRM/MANUFACTURER
Praxair Inc., Danbury, CT, by telephone on September 21, 2004. Firm initiated recall is complete.
REASON
Manufacturer not registered with FDA for the production of medical Oxygen, Industrial grade Oxygen delivered to medical facilities.
VOLUME OF PRODUCT IN COMMERCE
700,200 Cubic feet.
DISTRIBUTION
FL.
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced. Recall # B-0001-5;
b) Platelets Pheresis, Leukocytes Reduced, Irradiated.
Recall # B-0002-5.
CODE
a) and b) Unit number: 027P68152.
RECALLING FIRM/MANUFACTURER
American Red Cross, Greater Alleghenies Region, Johnstown, PA, by telephone on March 25, 2004, and by letter, dated March 30, 2004. Firm initiated recall is complete.
REASON
Blood products, associated with a positive bacterial culture, which identified Sphingomonas paucimobilis as the isolate, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
WV, and PA.

___________________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall # B-0003-5.
CODE
Unit E04500.
RECALLING FIRM/MANUFACTURER
Rock River Valley Blood Center, Rockford, IL, by telephone on August 11, 2004. Firm initiated recall is complete.
REASON
Platelets, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Source Plasma. Recall # B-0004-5.
CODE
Units BY0081013, BY0081234, BY0081539, BY0081749, BY0082116, BY0082324, BY0082909, BY0082977.
RECALLING FIRM/MANUFACTURER
DCI Biologicals Bryan, LLC, Bryan, TX, by facsimile dated November 6, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who lived in western Europe, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
NY.

___________________________________
PRODUCT
Source Plasma. Recall # B-0038-5.
CODE
Units CS0179785, CS0195693.
RECALLING FIRM/MANUFACTURER
Westgate Biologicals, LLC, College Station, TX, by letter dated January 2, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NY.

_______________________________
PRODUCT
Plasma Cryoprecipitate Reduced. Recall # B-0040-5.
CODE
Unit 21KL69179.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Portland, OR, by telephone on June 9, 2003, and by letters dated June 18, and August 15, 2003. Firm initiated recall is complete.
REASON
Blood product, which did not have a documented time for which it was placed into the freezer, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0041-5.
CODE
Unit 2372493 (split unit).
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on March 7, 20, and 27, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was at risk for Creutzfeldt-Jakob Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Platelets Irradiated. Recall # B-0042-5.
CODE
Unit E00934.
RECALLING FIRM/MANUFACTURER
Tacoma-Pierce County Blood Bank, Tacoma, WA, by telephone, and by letter dated March 6, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WA.

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # 0044-5;
b) Fresh Frozen Plasma. Recall # B-0045-5.
CODE
a) and b) Unit 2374447.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on January 22, and February 21, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who was at risk for Creutzfeldt-Jakob Disease (CJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.

_______________________________
PRODUCT
a) Plasma, Frozen, Recall # B-0046-5;
b) Cryoprecipitated AHF. Recall # B-0047-5;
c) Plasma, Cryoprecipitate Reduced. Recall # B-0048-5.
CODE
a) Units 21FJ29806, 21V85993, 21V85990, 21KE16498, 21FL66734,
21FL68118, 21FL68141, 21GE37589, 21GW36060;
b) 21KC65264, 21KC69754, 1KJ82663, 21KJ82674, 21KC69699,
21KC69682, 21V86488, 21KC63737, 21KG81250, 21KJ77581,
21KJ78082, 21KK69077, 21KL60199, 21KH80670, 21KK69069,
21KZ14945, 21Y77016, 21KC58883, 21Y77029, 21Y77202;
c) Unit 21KC63737.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Portland, OR, by telephone beginning November 20, 2002, and by letters beginning November 26, 2002. Firm initiated recall is complete.
REASON
Blood products, corresponding to Red Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
30 units.
DISTRIBUTION
WA, OR, CA, TX, OK, and GA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0049-5;
b) Recovered Plasma. Recall # B-0050-5.
CODE
a) and b) Unit 2368943.
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by facsimile dated February 13, 2003, and April 10, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who lived in western Europe, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
Vienna, Austria, and TX.

_______________________________
PRODUCT
a) Platelets. Recall # B-0051-5;
b) Fresh Frozen Plasma. Recall # B-0052-5.
CODE
a) and b) Unit GE70829.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile dated April 27, 2004. Firm initiated recall is complete.
REASON
Blood products, corresponding to a unit of clotted red cells, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
PA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0053-5.
CODE
Units 38FV12108 -- split unit.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by telephone on January 5, 2004. Firm initiated recall is complete.
REASON
Blood products, not properly quarantined after the receipt of post donation information, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IN.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0056-5;
b) Cryoprecipitated AHF. Recall # B-0057-5;
c) Recovered Plasma. Recall # B-0058-5.
CODE
a), b), and c) Unit number 2372945.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on February 25, 2003. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TX, and Switzerland.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0059-5;
Recovered Plasma. Recall # B-0060-5.
CODE
a) and b) Unit number 2348391.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on February 12, and 19, 2003. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX and Austria.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # 0062-5;
b) Platelets, Leukocytes Reduced. Recall # 0063-5;
c) Recovered Plasma. Recall # B-0064-5.
CODE
a), b) and c) Unit number FK96334.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by telephone and facsimile on August 5, 2004. Firm initiated recall is complete.
REASON
Blood products that tested initially reactive for antibodies to hepatitis C virus (anti-HCV) were not re-tested in duplicate and were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
RI and Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0065-5;
b) Fresh Frozen Plasma. Recall # B-0066-5.
CODE
a) and b) Unit number 5550901.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSource, Glenview, IL, by telephone on August 12, 2004.
Manufacturer:  LifeSource Oak Lawn, Oak Lawn, IL. Firm initiated recall is complete.
REASON
Blood products, that tested negative for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but were collected from a donor that subsequently reported a previous reactive test for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0067-5;
b) Recovered Plasma. Recall # B-0068-5.
CODE
a) and b) Unit number: 18N89811.
RECALLING FIRM/MANUFACTURER
American Red Cross, Great Lakes Region, Lansing, MI, by facsimile on July 1, 2004, by letter, dated July 7, 2004, and electronically on July 8, 2004. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised their sterility, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MI, and Switzerland.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0069-5.
CODE
Unit 030GV12197.
RECALLING FIRM/MANUFACTURER
American Red Cross, Northeastern Pennsylvania Region, Ashley, PA, by telephone on July 29, 2004, and by letter dated August 4, 2004. Firm initiated recall is complete.
REASON
Red Cells, collected from a donor whose hemoglobin was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

_______________________________
PRODUCT
a) Red Blood Cells Pheresis, Leukocytes Reduced. Recall # B-0070-5;
b) Platelets Pheresis, Leukocytes Reduced. Recall # B-0071-5.
CODE
a) and b) Unit 8107897.
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Service, Inc., Elyria, OH, by letter dated August 25, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor using condylox gel, a medication for the treatment of venereal warts, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MD and OH.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0072-5;
b) Fresh Frozen Plasma. Recall # B-0073-5.
CODE
a) Units 18FJ72211 and 18GN29726;
b) Unit 18FJ72211.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Great Lakes Region, Lansing, MI, by facsimile on July 23, 2004 and by letter dated July 29, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor using Tazorac, a topical medication for the treatment of psoriasis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MI.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0080-5;
b) Fresh Frozen Plasma. Recall # B-0081-5.
CODE
a) and b) Unit 2356608.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on March 20, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was at risk for Creuztfeldt Jakob Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0082-5;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0083-5;
c) Cryoprecipitated AHF, Recall # B-0084-5;
d) Cryoprecipitated AHF Pooled, Recall # B-0085-5.
CODE
a) Unit 21KJ44430;
b) and c) Unit 21KK45412;
d) Unit 21KK44430.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Portland, OR, by telephone on July 11, 2003 and by letters dated July 15 and August 21, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who tested negative for the antibody to the hepatitis B core antigen (anti-HBc) but had previously tested positive for anti-HBc on two separate occasions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
OR and WA.

_______________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B-0086-5;
b) Plasma Cryoprecipitate Reduced, Recall # B-0087-5;
c) Cryoprecipitated AHF, Recall # B-0088-5.
CODE
a) Units 21KF31604, 21GL82596, 21FT42805, and 21FS27945;
b) and c) Units 21KZ16988 and 21GY86431.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Portland, OR, by telephone on April 4, 2003, and by letters dated April 10, May 19, and June 9, 2003. Firm initiated recall is complete.
REASON
Blood products, which were manufactured from whole blood units in which the corresponding red blood cell components contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
WA, OR, CA, and GA.

_______________________________
PRODUCT
Sterile Water for Injection USP 30 ml (Used as diluent with Antihemophilic Factor/von Willebrand's Factor Complex (human) Dried, Pasteurized, Humate-P. Recall # B-0089-5.
CODE
Lots: 02111011, 05311011, 10411011, 12111011, 13511011, 18011011, 19211011.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aventis Behring, King of Prussia, PA, by telephone, and by facsimile dated November 3, 2003.
Manufacturer: Aventis Behring Gmbh, Marburg, Germany. Firm initiated recall is complete.
REASON
Sterile Water, in which sterility could not be assured due to cracked vials, was distributed.
VOLUME OF PRODUCT IN COMMERCE
7 lots, 36,935 vials.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
Red Blood Cells. Recall # B0090-5.
CODE
Unit number: 1221945.
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by letter, dated May 20, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0091-5.
CODE
Unit number 04R08358.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by facsimile and letter on July 16, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced Irradiated. Recall # B-
0092-5:
b) Recovered Plasma. Recall # B-0093-5.
CODE
a) and b) Unit number 04Y95608.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by facsimile, letter, and electronic message on July 23, 2004. Firm initiated recall is complete.
REASON
Blood products, that tested negative for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but were collected from a donor that subsequently reported a previous reactive test for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MA and CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-0094-5.
CODE
Unit numbers: 0057788, 0057951, 0058201, 0058485, 0058713, 0059068, 0059218, 0059651, 0059801, 0060203, 0060336, 0060722, 0061275, 0061327, 0061943, 0062003, 0064125, 0064444, 0065568, 0067813, 0067843, 0072446, 0072647, 0073446, 0073717, 0073823, and 0074147. 
RECALLING FIRM/MANUFACTURER
DCI Biologicals Bryan, LLC, Bryan, TX, by letter, dated July 25, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was permanently deferred, were distributed.   
VOLUME OF PRODUCT IN COMMERCE
27 units.
DISTRIBUTION
Austria and the United Kingdom.

___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0095-5.
CODE
Unit number 3077581.
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by letter, dated July 20, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had resided in an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0096-5.
CODE
Unit 38C14528.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Fort Wayne, IN, by telephone on March 1, 2004. Firm initiated recall is complete.
REASON
Blood product, which may have not met the acceptable hematocrit specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.

_______________________________
PRODUCT
Source Plasma. Recall # B-0097-5.
CODE
Unit 03GMIF4831.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Walker, MI, by facsimile on January 22, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected in a manner that may have compromised the sterility of the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0043-5.
CODE
Unit 7061901.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on December 20, 2002. Firm initiated recall is complete.
REASON
Blood product, which was stored at unacceptable storage temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0061-5.
CODE
Unit number FG97391.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by telephone on July 25, 2004. Firm initiated recall is complete.
REASON
Blood product, that was found to be out of specification for red blood cell recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
RI.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0098-5;
b) Red Blood Cells Leukocytes Reduced. Recall # B-0099-5.
CODE
a) Units 38FH23971, 38FH23972, 38FH23973, 38FH23974, 38FH23978,
38FH23980, 38FH23982, 38FH23983, 38FH23984, 38FH23985,
38FH23986 and 38FH23987;
b) Units 38FH22293, 38FH22294, 38FH22295, 38FH22296, 38FH22297,
38LC73361, 38LC73362, 38LC73363, 38LC73364, 38LC73365,
38LC73366, 38LC73367, 38LC73368, 38LC73369, 38LC73370,
38LC73372, 38LC73373, 38LC73374, 38LC73375, and 38LC73376.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Fort Wayne, IN, by letters dated July 19 and August 17, 2004. Firm initiated recall is complete.
REASON
Blood products, which may have been exposed to unacceptable shipping temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
32 units.
DISTRIBUTION
IN.
 

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
a) Mouse anti-TTF-1 concentrate used in a panel designed to
differentiate between different types of cancer when used to
test a patient. Recall # Z-0014-05;
b) Mouse anti-TTF-1 2nd Gen Predilute used in a panel designed to
differentiate between different types of cancer when used to
test a patient. Recall # Z-0015-05.
CODE
a) Product Number 18-0221, no 510(k) number, Product Code MXZ,
lot code 40280262;
b) Product Number 18-1221, no 510(k) number, Product Code MXZ,
lot code 40180205.
RECALLING FIRM/MANUFACTURER
Zymed Laboratories Inc., South San Francisco, CA, by telephone, visits and fax on April 6, 2004. Firm initiated recall is complete.
REASON
Mouse anti-TTF-1 had become contaminated by immunoglobulins from mouse serum that was co-eluted during purification leading to false readings.
VOLUME OF PRODUCT IN COMMERCE
24 vials of concentrate, and 4 vials of 2nd Gen Predilute.
DISTRIBUTION
MD, GA, TX, OH, IL, DC, NY, CA, France, Portugal, China, Italy, Israel, Philippines, and Germany.

___________________________________
PRODUCT
Aeroset Analyzer Systems Operation Manual. Recall # Z-0016-05.
CODE
All Systems Operations Manuals.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by letter on September 24, 2004. Firm initiated recall is ongoing.
REASON
Changes to the printer default settings made by users/operators cause printed data to be truncated and misidentified.
VOLUME OF PRODUCT IN COMMERCE
736 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Fresenius Peritoneal Dialysis Premier Luer Lock Transfer Set 8", Sterile with Female Safe Lock Connector Luer Lock and Slide Clamp Catalog Number: 050-30034. Recall # Z-0017-05.
CODE
Lot Numbers: 3LR240, 3NR190, 3SR074, 4AR119, 4BR187, 4CR290.
RECALLING FIRM/MANUFACTURER
Fresenius Medical Care North America, Lexington, MA, by telephone starting September 20, 2004, and by letter on September 27, 2004. Firm initiated recall is ongoing.
REASON
Peritoneal Dialysis Transfer Set may have occluded pathway.
VOLUME OF PRODUCT IN COMMERCE
3,510 units.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm). Recall # Z-0018-05.
CODE
Serial Number: MC02017-I3; MC02134-I3; MC02138-I3; MC02148-I3; MC02321-K3; MC02002-I3; MC02005-I3; MC02006-I3; MC02008-I3; MC02020-I3; MC02023-I3; MC02025-I3; MC02027-I3; MC02030-I3; MC02034-I3; MC02043-I3; MC02044-I3; MC02048-I3; MC02052-I3.
RECALLING FIRM/MANUFACTURER
Datascope Corp., Mahwah, NJ, by letter on September 24, 2004. Firm initiated recall is ongoing.
REASON
Software anomaly where the variable heart rates may be displayed inaccurately or intermittent "dashes" may be displayed when the patient's heart rate is derived from ECG.
VOLUME OF PRODUCT IN COMMERCE
19 units.
DISTRIBUTION
CA, IN and SC.
______________________________
PRODUCT
HealthPax (HP-1). Cranial Electrotherapy Stimulator GZJ. Recall # Z-0019-05.
CODE
HP-1.
RECALLING FIRM/MANUFACTURER
Health Directions, Inc., Morrisville, PA, by letter dated April 8, 2004. Firm initiated recall is complete.
REASON
Implied claims (extremes of compulsive or addictive behavior) are outside the scope of clearance for the device.
VOLUME OF PRODUCT IN COMMERCE
3,475 units.
DISTRIBUTION
CA, MA, NJ, NY, PA, TX and WA.
 

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II

_______________________________
PRODUCT
Product is custom made steer/cattle feed packaged in 100 lb. poly bags. The product has no labeling. Recall # V-001-5.
CODE
The product has no lot code. All custom made feed purchased between June 24, 2004 and September 8, 2004.
RECALLING FIRM/MANUFACTURER
Farmers Elevator Co, Houston, OH, by telephone and letter dated September 27, 2004. Firm initiated recall is ongoing.
REASON
Feed may contain protein derived from mammalian tissues which is prohibited in ruminant feed.
VOLUME OF PRODUCT IN COMMERCE
Approximately 80 1?2 tons of steer/cattle feed.
DISTRIBUTION
OH.

_______________________________
PRODUCT
Product is custom made sheep/goat feed packaged in 100 lb. poly bags. The product has no labeling. Recall # V-002-5.
CODE
The product has no lot code. All custom made feed purchased between June 24, 2004 and September 8, 2004.
RECALLING FIRM/MANUFACTURER
Farmers Elevator Co, Houston, OH, by telephone and letter dated September 27, 2004. Firm initiated recall is ongoing.
REASON
Feed may contain protein derived from mammalian tissues which is prohibited in ruminant feed.
VOLUME OF PRODUCT IN COMMERCE
Approximately 8 tons.
DISTRIBUTION
OH.

_______________________________
PRODUCT
Product is custom made deer feed packaged in 100 lb. poly bags. The product has no labeling. Recall # V-003-5.
CODE
The product has no lot code. All custom made feed purchased between June 24, 2004 and September 8, 2004.
RECALLING FIRM/MANUFACTURER
Farmers Elevator Co, Houston, OH, by telephone and letter dated September 27, 2004. Firm initiated recall is ongoing.
REASON
Feed may contain protein derived from mammalian tissues which is prohibited in ruminant feed.
VOLUME OF PRODUCT IN COMMERCE
Approximately 6 tons.
DISTRIBUTION
OH.

END OF ENFORCEMENT REPORT FOR October 20, 2004

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