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U.S. Department of Health and Human Services

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Enforcement Report for February 2, 2005

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.

Feb. 2, 2005
05-05

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
a) Cherry Republic brand Cherry Nut Mix in 8 ounce
and 1 pound packages. Recall # F-137-5;
b) Cherry Republic brand Cherry Trail Mix in 8 ounce
and 1 pound packages. Recall # F-138-5.
CODE
Units are uncoded; all units distributed prior to the May 1, 2004 are under recall.
RECALLING FIRM/MANUFACTURER
Cherry Republic, Glen Arbor, MI, by press release on June 2, 2004 and by letter on June 3, 2004. Firm initiated recall is complete.
REASON
The product was manufactured using almonds recalled by Paramount Farms due to their association with an outbreak of Salmonella Enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
Unknown.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Alfalfa Sprouts, Fuji Natural Foods brand Alfalfa
Sprouts in 4 oz. clear plastic container and 2
pound and 5 pound trays. Recall # F-139-5;
b) Fuji Natural Foods brand Spicy sprouts (alfalfa
and radish mix) in 4 oz. clear plastic containers.
Recall # F-140-5;
c) Fuji Natural Foods brand Zesty Sprouts (alfalfa
and onion mix) in 4 oz. clear plastic containers.
Recall # F-141-5.
CODE
a) 4 ounce: 6127, 6227, 6327, 6427, 6527, 4101,
4201, 4401, 4501. 2 pound: 2716, 2816, 4725, 2730,
2830 5 pound: 2816, 4825, 2830;
b), and c) 6527,4501.
RECALLING FIRM/MANUFACTURER
Fuji Natural Foods, Ontario, CA, by press release on June 4, 2004. Firm initiated recall is complete.
REASON
The product was manufactured using alfalfa seeds that were recalled due to their association with a Salmonella Bovismorbificans illness outbreak.
VOLUME OF PRODUCT IN COMMERCE
Undetermined.
DISTRIBUTION
CA, AZ, CO, and NV.

_______________________________
PRODUCT
Del Campo Brand Pimienta Molida (Ground Black Pepper) in 3?4 oz. plastic bags. Recall # F-142-5.
CODE
All product produced after February 13, 2004 is under recall..
RECALLING FIRM/MANUFACTURER
Del Campo Mexican Foods, San Pablo, CA, by telephone, press release and visits on June 25, 2004. Firm initiated recall is complete.
REASON
The product is contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Approx. 100 lbs. of pepper, packed into 3?4 oz. bags.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Provato BRAND MANOURI TRADITIONAL GREEK CHEESE --- Imported from Greece --- Made from Pasteurized Sheep's Milk. The Manouri cheese is white and vacuum-packed in plastic bags, square cut, bearing a red & blue label with the brand name of Provato, and having an expiration date of 21-06-2005. Recall # F-143-5.
CODE
All codes on the market at the time of recall initiation, expiration date 21.06.2005 (represents June 21, 2005).
RECALLING FIRM/MANUFACTURER
Greek Foods & Gifts Direct, Inc., Carlstadt, NJ, by visits starting on December 9, 2004 and press release on December 17, 2004. Firm initiated recall is ongoing.
REASON
The cheese is contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
1-7 cases (36 , 400 gram units per case) were distributed.
DISTRIBUTION
NY, NJ, VA, CA, IL, MI, and PA.

_______________________________
PRODUCT
SMAK brand Mushrooms salad, Net wt. 12,25 oz. (350 g). Product of Poland. Product is packed in a clear, glass jar. Recall # F-156-5.
CODE
Best before 05.20.2006.
RECALLING FIRM/MANUFACTURER
Desly International Corp., Brooklyn, NY, by press release on September 17, 2004. Firm initiated recall is complete.
REASON
The product contained undeclared sulfites (339 ppm) based on sampling & analysis by the New York State Department of Agriculture and Markets (NYSDAM).
VOLUME OF PRODUCT IN COMMERCE
31 cases (totaling 496 jars).
DISTRIBUTION
NY, MN, MA, WA, SC, FL, and PA.

_______________________________
PRODUCT
a) Living Alfalfa sprouts, Labeled in part as
"Marjon Living Alfalfa Sprouts, a Natural Food,
Keep refrigerated, Ready to Eat, Net WT. 6 oz.
UPC code 077554 00004. Recall # F-164-5;
b) Brassica Broccoli Sprouts Salad Blend, Labeled
in part as "broccoli, clover & radish sprouts
with long lasting antioxidant activity.
Brocco Sprouts, 100% natural, Net WT. 4.0 oz.
(113g). Recall # F-165-5.
CODE
a) Lot Number 3038;
b) Broccoli HPP-60,
Radish #31536,
Clover #WB-3-cc-346.
RECALLING FIRM/MANUFACTURER
Marjon Specialty Foods, Inc., Plant City, FL, by telephone, fax and press release beginning on July 21, 2004. Firm initiated recall is complete.
REASON
This product is potentially contaminated with Escherichia coli O157:H7 bacteria.
VOLUME OF PRODUCT IN COMMERCE
2,613 units.
DISTRIBUTION
FL, TN, GA, AL, KY, NC, and SC.

_______________________________
PRODUCT
a) Jumbo English Almond Butter Toffee packaged in
5 pound bags; 2 bags per case. Sold under the
following labels: Redstone Foods and National Bulk
Foods, Taylor. Recall # F-166-5;
b) Milk Choc English Alm Butter Toffee packaed in
8 ounce tubs and in 5 pound bags; 2 bags per case.
Sold under the following labels: Redstone Foods;
National Bulk Foods; J. Sosnick & Son; Garvey Nut
Company; Mrs. Carrol's, and Produce Station.
Recall # F-167-5;
c) Gourmet S/F Almond Butter Toffee packaged in
8 ounce tubs and in 5 pound bags; 2 bags per
case. Sold under the following labels: Redstone
Foods; National Bulk Foods; J. Sosnick & Son;
Garvey Nut Company; Mrs. Carrol's; Natural Foods;
and City Nut & Candy, Inc. Recall # F-168-5.
CODE
a) Lots 2563,2963 and 3243;
b) Lots 2113, 2763, 2793, 2933, 2973, 3103, 3253,
3423, 3453 and 3533;
c) Lots 2523, 2683, 2793, 2873, 2953, 2963, 2973,
3283, 3423, 3543 and 0904.
RECALLING FIRM/MANUFACTURER
GKI Foods, Inc., Brighton, MI, by press release and e-mail on May 26, 2004. Firm initiated recall is complete.
REASON
The product was manufactured using almonds that were recalled by Paramount Farms due to their association with an outbreak of Salmonella Enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
11,000 pounds.
DISTRIBUTION
CA, IL, MI, OH, and TX.

_______________________________
PRODUCT
SnackSoft® brand Pitted Dried Apricots --- NET WEIGHT 12 OZ (340 g) --- Produce of Turkey --- Serving Size 6 pieces (40g) --- Servings Per Container varied. --- The product is packaged in a poly wrapped styrofoam tray. Barcode # 8696132422. Recall # F-169-5.
CODE
Best Before 31.12.2005 (this represents December 31, 2005).
RECALLING FIRM/MANUFACTURER
Kadouri International Food Inc., Brooklyn, NY, by press release and letter on December 15, 2004. Firm initiated recall is complete.
REASON
The product contained undeclared sulfites (1460 ppm) based on sampling & analysis by the New York State Department of Agriculture & Markets (NYSDAM).
VOLUME OF PRODUCT IN COMMERCE
100 cases (24 - 12 oz. packages per case).
DISTRIBUTION
NY, NJ, IL, VA, and CT.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

_______________________________
PRODUCT
ASIAN Noodle Bowl Yakisoba w/Vegetables, Pan seared thin egg noodles, high in protein, with crispy vegetables. Net wt. 16 oz. or Net wt. 10 oz. Keep Refrigerated. Recall # F-144-5.
CODE
Five day pull date codes: 1218, 1219, 1220, 1221.
RECALLING FIRM/MANUFACTURER
M&P Fine Foods, Inc. dba Bento Foods, Lynnwood, WA, by email on December 15, 2004. Firm initiated recall is complete.
REASON
The product contains undeclared color, FD&C Yellow #6.
VOLUME OF PRODUCT IN COMMERCE
212 bowls.
DISTRIBUTION
Firm delivers product via delivery truck to local retail establishments and hospital food service facilities.

_______________________________
PRODUCT
Archway brand Holiday Cashew Nougat Cookies in 10 oz. packages; Product Code 2750002054. Recall # F-145-5.
CODE
Packages with date codes of FEB2005, FEB2805, FEB2905, MAR0305, MAR0405, MAR0505, MAR1005, MAR1105 and MAR2405.
RECALLING FIRM/MANUFACTURER
Ellison Bakery, Inc., Fort Wayne, IN, by product removal from store on December 16, 2004, fax on December 17, 2004, press release on December 18, 2004 and by letter on December 20, 2004. Firm initiated recall is ongoing.
REASON
Cookies may contain glass fragments.
VOLUME OF PRODUCT IN COMMERCE
312,216.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) E'OLA Ultra-S, Super Strength, 8 oz liquid.
Product labeling reads in part: "Ultra S SUPER
STRENGTH *** DIETARY SUPPLEMENT NET WEIGHT 8
FLUID OZ (24O ml)". Recall # F-160-5;
b) E'OLA Ultra-S, 8oz liquid. Product label reads
in part: "E'OLA ULTRA-S *** Purified Silver in
Solution Dietary Supplement NET WEIGHT 8 FLUID Oz.
(240 ml.)". Recall # F-161-5.
CODE
a) Item code 11365;
b) Item code 11363.
RECALLING FIRM/MANUFACTURER
Biogenics, Inc., Saint George, UT, by letter on August 28, 2003. Firm initiated recall is complete.
REASON
Product makes drug claims.
VOLUME OF PRODUCT IN COMMERCE
6,397 units.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III

_______________________________
PRODUCT
Strawberry product (shipped either fresh or frozen) packed in 4.125 white gallon plastic pails. Recall # F-146-5.
CODE
Lot ROPAK 407-6.
RECALLING FIRM/MANUFACTURER
Frozen Foods, Placentia, CA, by telephone, e-mail and overnight courier on August 20, 2004. Firm initiated recall is ongoing.
REASON
Product may have had excess "flash" break off the top of the lid and fall into product.
VOLUME OF PRODUCT IN COMMERCE
82,556.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
Bulk Frozen Strawberries packed in 28 pound plastic buckets. Recall # F-147-5.
CODE
All 2004 lot codes 24### with bucket stamp code 407-6. Bucket stamp code can be found on the bottom of the container.
RECALLING FIRM/MANUFACTURER
California Splendor, Inc., San Diego, CA, by telephone and memo on August 12, 2004. Firm initiated recall is complete.
REASON
Frozen strawberries are contaminated with plastic flashing from buckets used to hold the product.
VOLUME OF PRODUCT IN COMMERCE
43,922 units.
DISTRIBUTION
CA, OH, and TX.

_______________________________
PRODUCT
a) 28# STPK strawberry puree with Anacapa Foods
label in white gallon plastic pails with
ROPACK 407-6 embossed on bottom of pail.
Recall # F-148-5;
b) 30# Whole 4+1 Frozen strawberries with
Anacapa Foods label in white gallon plastic
pails with ROPACK 407-6 embossed on bottom
of pail. Recal # F-149-5.
CODE
a) Lots 472101, 471801, 471802, 471803, 471804,
471805, 471808, 471821, and 471822 identified
as ROPACK 407-6 on bottom of 4 gallon plastic
pails;
b) Lots 474207, 474208, 474214, 474215, 474217,
474218, 474220, 474221, 474222, 474224, 474225,
474215, 474223 identified as ROPACK 407-6 on
bottom of 4 gallon plastic pails.
RECALLING FIRM/MANUFACTURER
Anacapa Foods, LLC, Watsonville, CA, by notice on September 7, 2004. Firm initiated recall is complete.
REASON
Product is contaminated with plastic flashing from buckets used to hold the product.
VOLUME OF PRODUCT IN COMMERCE
30,748.
DISTRIBUTION
CA, HI, OK, and WA.

_______________________________
PRODUCT
a) 4 + 1 sliced stabilized frozen strawberries.
Recall # F-150-5;
b) 4 + 1 sliced , extra stabilized frozen
strawberries. Recall # F-151-5;
c) 4 + 1 puree frozen strawberries.
Recall # F-152-5;
d) 28# STPK puree Stabilized frozen strawberries.
Recall # F-153-5.
CODE
a) Lots 4-9626, 4-9577, 4-9578, 4-9581, 4-9582,
4-9589, 4-9579, 4-9580 identified as ROPACK
407-6 on bottom of plastic pail.
b) Lots 4-9875, 4-9876, 4-9877, 4-9878, 4-9879,
4-9880, 4-9881, 4-9882, 4-9283 identified as
ROPACK 407-6 on bottom of plastic pail.
c) Lot 4-9463 identified as ROPACK 407-6
on bottom of plastic pail.
d) Lots 4-9275, 4-9276, 4-9277, 4-9278, 4-9279
identified as ROPACK 407-6 on bottom of plastic
pail.
RECALLING FIRM/MANUFACTURER
Cal-Sun Produce Co., Oxnard, CA, by letter dated September 9, 2004, and October 1, 2004. Firm initiated recall is complete.
REASON
Product is contaminated with plastic flashing from buckets used to hold the product.
VOLUME OF PRODUCT IN COMMERCE
27,274 pails.
DISTRIBUTION
CA, IA, and WI.

_______________________________
PRODUCT
Dynasty Brand SHIITAKE Dried Black Mushrooms in 1 oz. (28.35 g) plastic bags. Product of China. Recall # F-157-5.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
JFC International, Inc., South San Francisco, CA, by letters on December 21, 2004. Firm initiated recall is ongoing.
REASON
Product contains undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
6,329 cases, 12 packages per case.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Simply Potatoes Plain Shredded Hash Browns. Net Wt. 1 lb. 4 oz. (567 g). Keep Refrigerated. UPC code 2016922233. Recall # F-158-5.
CODE
USE BY dates of Jan 23 2005 and USE BY Jan 24 2005.
RECALLING FIRM/MANUFACTURER
Northern Star Co., Minneapolis, MN, by telephone and press release on December 22, 2004 and by letter on December 23, 2004. Firm initiated recall is ongoing.
REASON
Reports of 4 bags in SD containing small bits of glass.
VOLUME OF PRODUCT IN COMMERCE
4,161 cases of 12 or 49,932 individual bags.
DISTRIBUTION
Nationwide and the Caribbean.

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
Power Plus Energy Supplement N-3, 4 oz;
Power Plus Energy Supplement C-3, 4 oz;
Power Plus Normal Kit; and
Power Plus Chemically Treated Kit.
Recall # D-105-5.
CODE
Product Numbers: B18604, B18605, KT5520,
and KT5515. All lots remaining on the market.
RECALLING FIRM/MANUFACTURER
Farouk Systems, Inc., Houston, TX, by letter on November 30, 2004. Firm initiated recall is ongoing.
REASON
Unapproved new drug, hair regrowth claims,
contains minoxidil.
VOLUME OF PRODUCT IN COMMERCE
17,140 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) Metoclopramide Tablets, USP, 5 mg tablets,
Rx only, packaged in 30 and 31 count grid cards.
NDC 0615-3546-39 and NDC 0615-3546-31.
Recall # D-107-5;
b) Folic Acid Tablets, USP, 1 mg, Rx only,
packaged in 30 and 31 count grid cards.
NDC 0615-0664-39 and NDC 0615-0664-31.
Recall # D-108-5.
CODE
a) Lot 3546-4009, exp. Date 10/31/05 and
Lot 3546-4009, exp. Date 10/31/05;
b) Lot 0664-4010, exp. Date 10/31/05 and
Lot 0664-4010, exp. Date 10/31/05.
RECALLING FIRM/MANUFACTURER
NCS Healthcare of Kentucky, Inc., Glasgow, KY, by facsimile on November 30, 2004 and by letter on December l, 2004. Firm initiated recall is ongoing.
REASON
Mislabeling, the outside grid card package is labeled as Metoclopramide, 5 mg, however, individual blister packages contained within the grid cards are labeled as, and contain, Folic Acid, 1 mg.
VOLUME OF PRODUCT IN COMMERCE
38,354 packages.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_______________________________
PRODUCT
Biosilk Dandruff Control Conditioner 11.6 oz and 34 oz. Recall # D-106-5.
CODE
Product Numbers: BI9111 and BI9134. All lots remaining on the market.
RECALLING FIRM/MANUFACTURER
Farouk Systems, Inc., Houston, TX, by letter on November 30, 2004. Firm initiated recall is ongoing.
REASON
cGMP deficiencies.
VOLUME OF PRODUCT IN COMMERCE
1,413 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Premarin (conjugated estrogens) tablets USP, 0.625 mg, 100 count tablet bottles, NDC # 0046-0867-81. Recall # D-110-5.
CODE
Lot #034039 and 040349.
RECALLING FIRM/MANUFACTURER
Amerisource Health Services Corp., Columbus, OH, by email and letter dated December 17, 2004. Firm initiated recall is ongoing.
REASON
Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE
48,883/100 tablet bottles.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
USept Tablets, Urinary Antiseptic Antibacterial/Analgesic, Rx only, 100 count tablets, NDC 51991-027-01. Recall # D-111-5.
CODE
Lots S04C01 (exp. 3/07), S04E05 (exp. 5/07), S04F03 (exp. 6/07).
RECALLING FIRM/MANUFACTURER
Syntho Pharmaceuticals, Inc., Farmingdale, NY, by e-mail on November 1, 2004. Firm initiated recall is ongoing.
REASON
Presence of foreign substance.
VOLUME OF PRODUCT IN COMMERCE
29,659 bottles.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0452-5.
CODE
Unit 1674048.
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ, by telephone on July 5, 2004. Firm initiated recall is complete.
REASON
Platelets, with a positive bacterial culture, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.

_______________________________
PRODUCT
a) Cryoprecipitated AHF. Recall # B-0459-5;
b) Plasma. Recall # B-0460-5.
CODE
a) and b) Unit K43643.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by phone on August 26, 2004 and by letter dated September 20, 2004. Firm initiated recall is complete.
REASON
Blood Products, corresponding to a unit of clotted Red Blood Cells, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0463-5.
CODE
Unit 5423364.
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ, by telephone on June 17, 2004. Firm initiated recall is complete.
REASON
Platelets, with a positive bacterial culture, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0486-5;
b) Recovered Plasma. Recall # B-0487-5.
CODE
a) and b) Unit number 1620469.
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA, by telephone on July 7, 2003, and by facsimile on July 9, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jacob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
ID, and Austria.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0522-5.
CODE
Unit E88636.
RECALLING FIRM/MANUFACTURER
HSCS Blood Center, Bethlehem, PA, by letter dated July 13, 2004. Firm initiated recall is complete.
REASON
Platelets, with a low platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0528-5.
CODE
Units 0758932, 0833349 , split unit, 0832859 , split unit.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by letter dated April 22, 2002. Firm initiated recall is complete.
REASON
Platelets, which had an unacceptable platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0534-5.
CODE
Unit number 0599531.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by letter on January 28, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that had an unsuitable hemoglobin test during the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0535-5.
CODE
Unit number 1201788 (distributed as two split products).
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by telephone on February 11, 2002 and by letter on April 17, 2002. Firm initiated recall is complete.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0536-5.
CODE
Unit numbers 1621946 and 1621946A.
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA, by telephone on October 28, 2003. Firm initiated recall is complete.
REASON
Blood products, that were labeled leukoreduced but were not tested to determine the white blood cell count as required in the firm's standard operating procedures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
WA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0557-5;
b) Fresh Frozen Plasma. Recall # B-0558-5.
CODE
a) and b) Unit number 20037-2971.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc. Scottsdale, AZ, by telephone on January 15, 2004, and by letter on February 19, 2004.
Manufacturer: Blood Systems, Inc., Lafayette LA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose health history screening was inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
LA.

_______________________________
PRODUCT
Red Blood Cells (Apheresis), Leukocytes Reduced. Recall # B-0559-5.
CODE
Unit numbers 20036-9971 (distributed as two split products).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc. Scottsdale, AZ, by telephone on December 10, 2003.
Manufacturer: Blood Systems, Inc., Lafayette LA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose health history screening was inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
LA.

________________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced.
Recall # B-0565-5;
b) Platelets Pheresis, Leukocytes Reduced
Irradiated. Recall # B-0566-5.
CODE
a) Unit numbers 01P63784, 01P63738, 01P63646,
01P63584, 01P63503, 01P63484, and 01P63054;
b) Unit numbers 01P63784, 01P63738, 01P63646,
01P63012, 01P63011, 01P63049, and 01P63054;
and the following unit was distributed as
two split products: unit number 01P63681.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New York-Penn Region, West Henrietta, NY, by letters on February 13, 2004. Firm initiated recall is complete.
REASON
Blood products, collected in an apheresis collection kit that possibly had exceeded the acceptable time period for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units.
DISTRIBUTION
NY.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0453-5.
CODE
Unit 53L66445.
RECALLING FIRM/MANUFACTURER
American Red Cross, Chesapeake Region, Baltimore, MD, by letter dated March 23, 2004. Firm initiated recall is complete.
REASON
Red Cells, after receiving post donation information concerning an arm infection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MD.

_______________________________
PRODUCT
Capture Solid Phase Test Systems, Capture-R Ready Screen Test Kits. Recall # B-0523-5.
CODE
Lots 37591, 37592, 39599, 39635.
RECALLING FIRM/MANUFACTURER
Immucor, Inc., Norcross, GA, by letter or fax dated November 12, 2004. Firm initiated recall is complete.
REASON
Capture-R test kits, with an increased rate of positive reactions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 lots.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
Capture Solid Phase Test Systems. Recall # B-0524-5.
a) Capture R Ready-Screen (Pooled Cells);
b) Capture-R Ready Screen (I and II).
CODE
a) Lots 31395, 31396, 33425, 33426, 35481,
35482, 33427, 33428, 35483, 35484, 37542,
37543;
b) Lots 33420, 33421, 35475, 35476, 35477,
37537, 35479, 35480, 37538, 37539, 35478,
37544.
RECALLING FIRM/MANUFACTURER
Immucor, Inc.  Norcross, GA, by letter or fax dated October 22, 2004. Firm initiated recall is complete.
REASON
Capture-R test kits, with an increased rate of positive reactions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
24 lots.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Capture Solid Phase Test Systems. Recall # B-0525-5.
a) Capture R Ready Id;
b) Capture-R Ready Screen (I and II).
CODE
a) Lot 37545;
b) Lots 37588, 37589, 37590, 39624, 39634.
RECALLING FIRM/MANUFACTURER
Immucor, Inc.  Norcross, GA, by letter or fax dated December 6, 2004. Firm initiated recall is complete.
REASON
Capture-R test kits, with an increased rate of positive reactions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 lots.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Source Plasma. Recall # B-0538-5.
CODE
Unit number F-17246-011.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Portland, OR, by facsimile on October 16, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not answer medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Spain.

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0539-5.
CODE
Unit numbers 0375452A, 0375452B, 0375444A, 0375444B, 0375404A, 0375404B, 0375325A, 0375325B, 5301718A, and 5301718B.
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA, by telephone on July 21, 2003. Firm initiated recall is complete.
REASON
Blood products, manufactured in expired processing bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units.
DISTRIBUTION
WA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0560-5;
b) Recovered Plasma. Recall # B-0561-5.
CODE
a) and b) Unit number 20037-1877.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by facsimile on January 12, 2004, by telephone on January 21, 2004, and by letter on January 28, 2004.
Manufacturer: Blood Systems, Inc., Lafayette LA. Firm initiated recall is complete.
REASON
Blood products, that were not properly quarantined after the donor of the products reported a post donation illness, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
LA and Switzerland.

_______________________________
PRODUCT
Red Blood Cells (Apheresis), Leukocytes Reduced. Recall # B-0562-5.
CODE
Unit number 20035-9196 (distributed as two split units).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on November 18, 2003, and by letter on December 12, 2003.
Manufacturer: Blood Systems, Inc., Lafayette LA. Firm initiated recall is complete.
REASON
Blood products, collected on an apheresis machine where there was no documentation of evaluation of the filter assemblies as required, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
LA.

_______________________________
PRODUCT
Source Plasma. Recall # B-0563-5.
CODE
Unit number DNQGBG.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Lawton, OK, by facsimile on December 12, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Source Plasma. Recall # B-0564-5.
CODE
Unit number DNGJSY.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Lawton, OK, by facsimile on June 18, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not answer the medical history questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
Stryker brand Bioabsorbable ACL Interference Screw, 10mm X 35mm; 12mm X 35mm Part Numbers: 234-010-078; 234-010-080. Recal # Z-0401-05.
CODE
Lot # 32101; Lot # 32103.
RECALLING FIRM/MANUFACTURER
Stryker Endoscopy, San Jose, CA, by telephone on December 16, 2004, and advisory notice on December 27, 2004. Firm initiated recall is complete.
REASON
The label on the outside of the shipping box has an incorrect description of the screw diameter.
VOLUME OF PRODUCT IN COMMERCE
16 units of 078, 284 units of 080.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Hill-Rom brand VersaCare Bed; product P3200. Recall # Z-0402-05.
CODE
All serial numbers distributed prior to November 22, 2004.
RECALLING FIRM/MANUFACTURER
Hill-Rom, Inc., Batesville, IN, by letter dated December 29, 2004. Firm initiated recall is ongoing.
REASON
A potential trip hazard exists when the fracture frame adaptor bracket is installed on the bed without the fracture frame.
VOLUME OF PRODUCT IN COMMERCE
324 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) VAXCEL PASV Peripherally Inserted Central
Catheter, 3F, single lumen. Catalog #45-450,
UPN #M001454500; sold as individual catheters.
DEVICE DESCRIPTION: A radiopaque, polyurethane
catheter with a hub/suture wing, polyurethane
extension leg(s) and luer locking adapter(s).
A peel away sheath introducer allows for
percutaneous insertion of the catheter.
The hub/suture wing promotes fixation of the
catheter hub to the patient's skin.
Recall # Z-0403-05;
b) VAXCEL PASV Peripherally Inserted Central
Catheter, 3F, single lumen, sold in a kit,
Catalog #45-451, UPN #M001454510, DEVICE
DESCRIPTION: A radiopaque, polyurethane
catheter with a hub/suture wing, polyurethane
extension leg(s) and luer locking adapter(s).
A peel away sheath introducer allows for
percutaneous insertion of the catheter. The
hub/suture wing promotes fixation of the
catheter hub to the patient's skin. Each KIT
contains catheter, cap; tape measure, 60 cm
length; stylet; stylet guide/flush assembly;
attachable suture wing; StatLock Catheter
Securement Device, Instructions for Use;
Peelaway Sheath Introducer; 10 mL Syringe;
CSR Wrap. Recall # Z-0404-05;
c) VAXCEL PASV Peripherally Inserted Central
Catheter, 3F, single lumen, sold in a kit,
Catalog #45-452; UPN #M001454520. DEVICE
DESCRIPTION: A radiopaque, polyurethane
catheter with a hub/suture wing, polyurethane
extension leg(s) and luer locking adapter(s).
A peel away sheath introducer allows for
percutaneous insertion of the catheter. The
hub/suture wing promotes fixation of the
catheter hub to the patient's skin. Each
KIT contains: Catheter; caps; tape measure,
60 cm length;stylet; stylet guide/flush
assembly; attachable suture wing; statlock
catheter securement device; instructions for
use; 21 gauge, 1.5 inch introducer needle with
echogenic tip; 30 cm floppy tip guidewire; 5cm
peelable introducer sheath with locking dilator;
10 ml syringe; scalpel, CSR wrap.
Recall # Z-0405-05;
d) VAXCEL PASV Peripherally Inserted Central
Catheter, 3F, single lumen, sold in kits,
Catalog #45-454, UPN #M001454540; DEVICE
DESCRIPTION: A radiopaque, polyurethane
catheter with a hub/suture wing, polyurethane
extension leg(s) and luer locking adapter(s).
A peel away sheath introducer allows for
percutaneous insertion of the catheter.
The hub/suture wing promotes fixation of
the catheter hub to the patient''s skin.
Each KIT contains: catheter; cap; tape measure,
60 cm length; stylet; stylet guide/flush
assembly; attachable suture wing; statlock
catheter securement device; instructions for
use; 21 gauge, 2.75 inch introducer needle with
echogenic tip; 60 cm guidewire with floppy tip
platinum tip; 10cm peelable introducer sheath
with locking dilator; 10 mL syringe, scalpel;
exact length measurement chart.
Recall # Z-0406-05;
e) VAXCEL PASV Peripherally Inserted Central
Catheter, 3F, single lumen: CUSTOM KIT , Catalog
#60M120521, UPN # M00160M1205210; DEVICE
DESCRIPTION: A radiopaque, polyurethane
catheter with a hub/suture wing, polyurethane
extension leg(s) and luer locking adapter(s).
A peel away sheath introducer allows for
percutaneous insertion of the catheter. The
hub/suture wing promotes fixation of the
catheter hub to the patient's skin.
Recall # Z-0407-05;
f) PASV PICC CUSTOM KIT, 3F, single lumen , Catalog
# 60M195071, UPN # M00160M1950710. DEVICE
DESCRIPTION: Each kit contains a radiopaque,
polyurethane catheter with a hub/suture wing,
polyurethane extension leg(s) and luer locking
adapter(s). A peel away sheath introducer
allows for percutaneous insertion of the
catheter. The hub/suture wing promotes fixation
of the catheter hub to the patient's skin.
Recall # Z-0408-05;
g) VAXCEL WITH PASV PICC, 3F, single lumen.
CUSTOM KIT - Catalog # 60M210624, UPN
#M00160M2106240. DEVICE DESCRIPTION:
Each kit contains a radiopaque, polyurethane
catheter with a hub/suture wing, polyurethane
extension leg(s) and luer locking adapter(s).
A peel away sheath introducer allows for
percutaneous insertion of the catheter. The
hub/suture wing promotes fixation of the catheter
hub to the patient's skin. Recall # Z-0409-05;
h) PASV PICC, 3F, single lumen, CUSTOM KIT.
Catalog #60M220991, UPN #M00160M2209910.
DEVICE DESCRIPTION: Each kit contains a
radiopaque, polyurethane catheter with a
hub/suture wing, polyurethane extension leg(s)
and luer locking adapter(s). A peel away
sheath introducer allows for percutaneous
insertion of the catheter. The hub/suture
wing promotes fixation of the catheter hub
to the patient's skin. Recall # Z-0410-05.
CODE
a) 913404; 913661; 917962; 924521; 930616; 936038;
943745; 950540; 950969; 3010403046; 3010403102;
3010803014; 3010803015; 3010803016; 3010803178;
3011002259; 3011102034; 3011102035;
b) 933284;
c) 933285; 982726;
d) 913405; 924522; 930838; 939045; 950541; 977138;
982727; 3010303254; 3010403103; 3010403104;
3011002260; 3011002261; 3011102036; 3011102037;
e) 898658; 898990; 901923; 921920; 931621; 933875;
938673; 939255; 942560; 960665; 961989; 970713;
975113; 982649;
f) 876451; 880973; 895705; 895840; 902035; 904140;
912436; 914101; 917478; 920964; 924386; 930246;
933161; 936220; 937349; 941261; 944296; 950194;
951521; 952701; 953969; 956599; 959868; 961578;
963203; 966369; 970121; 977692; 980758; 983865;
985575;
g) 909873; 910390; 910849; 964847; 966372; 969263;
972284; 973904;
h) 975342.
RECALLING FIRM/MANUFACTURER
Boston Scientific Corporation, Natick, MA, by letters dated November 22, 2004. Firm initiated recall is ongoing.
REASON
Catheter separation immediately distal to the nose of the suture wing.
VOLUME OF PRODUCT IN COMMERCE
3,461 units.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
a) Harvard 2 Dual Channel Syringe Infusion Pump
P/N 20001-001. Recall # Z-0431-05;
b) Harvard 1 Single Channel Syringe Infusion Pump
P/N 2003-001. Recall # Z-0432-05;
c) Harvard 2 Syringe Pump, Model Number 2005-001.
Recall # Z-0433-05.
CODE
a) Serial number range: 208002251 - 408203175;
b) Serial number range: 308102012 - 408102213;
c) Serial number range 218002222 - 218002382
02R00222 - 02R002382 318002383 - 318002426.
RECALLING FIRM/MANUFACTURER
Harvard Clinical Technology, Natick, MA, by letter on November 3, 2004. Firm initiated recall is ongoing.
REASON
Potential pump motor/encoder assembly failure may cause over infusing medication in patients.
VOLUME OF PRODUCT IN COMMERCE
1,334
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
B12 Reagent (6C09-20 and 6C09-25) for use with the ARCHITECT i2000 and i2000SR Analyzers, List numbers 8C89-01 and 3M74-01. Recall # Z-0435-05.
CODE
All lots manufactured.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by letter on December 14, and 16, 2004. Firm initiated recall is ongoing.
REASON
Falsely elevated B-hCG results can occur when running B12 and B-hCG assays on the same analyzer due to carryover. B-12 results are not impacted.
VOLUME OF PRODUCT IN COMMERCE
6,860 units.
DISTRIBUTION
Internationally.

_______________________________
PRODUCT
Arctic Sun Temperature Management System. Catalog No. 2000-02 (115 volt) and 2000-03 (230 volt). Recall # Z-0436-05.
CODE
Serial numbers 3001 thru 3080.
RECALLING FIRM/MANUFACTURER
Medivance Inc., Louisville, CO, by telephone and letter on January 5,6, 2005. Firm initiated recall is ongoing.
REASON
Potential for an inaccuracy of the primary patient temperature reading that is used to monitor and control patient temperature.
VOLUME OF PRODUCT IN COMMERCE
67 units.
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
VISTA Brite Tip RDC(1) Guiding Catheter. Product Code 67021055, Percutaneous Catheter. Recall # Z-0434-05.
CODE
Lot X0704002.
RECALLING FIRM/MANUFACTURER
Cordis Corporation, Miami Lakes, FL, by letter on December 7, 2004. Firm initiated recall is ongoing.
REASON
The product was manufactured such that the distal end had an "RDC" shape rather than the "RDC(1)" shape. The RDC shape has a larger curve.
VOLUME OF PRODUCT IN COMMERCE
153 units.
DISTRIBUTION
Nationwide and Internationally.


END OF ENFORCEMENT REPORT FOR February 2, 2005

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