Enforcement Report

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.

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June 15, 2005
05-24

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS I

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PRODUCT
Ghandour Tahina Extra Sesame Butter, Ingredients: 100% Crushed Sesame Seeds; the product is packaged in white plastic containers with red and green silk screened labels; Net Wt. 16 oz. (1 lb.) 454 g, 12 jars per case, UPC 74265-00407, item #A0052; Net Wt. 32 oz. (2 lb.) 908 g, 12 jars per case, UPC 74265-00408, item #A0052A; and 640 oz. (40 lb.) 18.160 kgs pails, item #A0053. Recall # F-424-5.
CODE
There are no lot numbers on the containers or cases
RECALLING FIRM/MANUFACTURER
Recalling Firm: Syrian Bakery Company, Inc. D.B.A. Ziyad Brothers Importing, Cicero, IL, by Talk Paper on May 18, 2005 and telephone on May 19, 2005.
Manufacturer: A. O. Ghandour Sons S.A.L., Beirut, Lebanon. Firm initiated recall is ongoing.
REASON
The product is contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
660 -- 1 lb jars, 1,944 -- 2 lb jars, 7,063 --40 lb pails
DISTRIBUTION
Nationwide including PR

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PRODUCT
Frozen Cooked Mackerel Fish, vacuum packed, 2 fish per basket (1 lb). Each fish is approximately 8-10 inches in length. The product is not labeled. The product is imported from Vietnam. Recall # F-425-5.
CODE
Product is not coded
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kien Import Corp, Brooklyn, NY, by press release and letter on March 9, 2005.
Manufacturer: Vinh Hiep Co. Ltd. Ho Chi Minh, Vietnam. Firm initiated recall is complete.
REASON
The product is processed uneviscerated fish based on inspectional findings by the New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
1,824 packages
DISTRIBUTION
NY, NJ, CT, FL, and NC

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PRODUCT
FORTUNER'S Selected Food brand DRIED VEGETABLE, N.W. 12oz(340g). Made in China. Product is packaged in a clear plastic package. --- SERVING SIZE: ABOUT 454 grams, SERVING CONTAINER: 1. Recall # F-426-5.
CODE
Not coded
RECALLING FIRM/MANUFACTURER
Recalling Firm: Star Mark Management Inc., Brooklyn, NY, by press release and letter dated July 21, 2004.
Manufacturer: Heifei HuaShu Food Company Ltd., Hefei, Anhui, China. Firm initiated recall is complete.
REASON
The product contained undeclared sulfites (467 ppm) based on sampling & analysis by the New York State Department of Agriculture & Markets (NYSDAM).
VOLUME OF PRODUCT IN COMMERCE
10 cases (50 -- 12 oz. bags 10 cases (50 -- 12 oz. bags per case)
DISTRIBUTION
NY

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PRODUCT
M & F brand Ham and Swiss on Rye Bread Sandwich, Net. Wt.4 oz. Recall # F-427-5.
CODE
Product recalled has a 1 week expiration date as follows: 03/29/05, 03/30/05, and 03/31/05.
RECALLING FIRM/MANUFACTURER
M & F Distributing Co., Inc, Bedford, IN, by visit on or about March 28, 2005. Firm initiated recall is complete.
REASON
The product contains undeclared soy flour, a sub-ingredient of the rye bread used to prepare the sandwiches.
VOLUME OF PRODUCT IN COMMERCE
21/4 oz. sandwiches
DISTRIBUTION
IN

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PRODUCT
SUN DRIED TOMATOES, Casale brand , Net Wt. 5 lbs., Crop: 2004, Product of Turkey. Each case contains a 5-lb. vacuum packed plastic bag. Per case labeling, there are two different cuts: (1) Julienne Ready to Eat and (2) Regular Halves. These cuts are not identified on the bag labeling. There is no firm name/address identified on the label. Recall # F-428-5.
CODE
2004 crop
RECALLING FIRM/MANUFACTURER
Recalling Firm: Atlantic International Products, Utica, NY, by letters dated April 18, 2005.
Manufacturer: Kareks Tarim Orman Ve Tekstil, Izmir, Turkey. Firm initiated recall is ongoing.
REASON
Product contains undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
642 cases
DISTRIBUTION
CO, CT, FL, LA, MA, MD, NJ, and NY

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS III

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PRODUCT
a) Minute MaidÆ Premium Orange Juice * Original * Low Pulp * 100% Pure
Squeezed Orange Juice From Concentrate * 96 FL.OZ. (3 QTS) 2.84L *
[and 128 FL OZ (1 GAL) 3.78 L ] *. Product is packed in rigid plastic
bottles. UPC #250002623 (96 FL OZ) and UPC #250002622 (128 FL OZ).
Recall # F-429-5;
b) Minute MaidÆ Premium * Calcium + Vitamin D, Original * Low Pulp *
100% Pure Squeezed Orange Juice, From Concentrate * 96 FL OZ (3 QTS)
2.84 L * [and 128 FL OZ (1 GAL) 3.78 L ] *. Product is packed in rigid
plastic bottles. UPC #250002641 (96 FL OZ) and UPC #250002619 (128 FL OZ).
Recall # F-430-5;
c) Minute MaidÆ Premium * Pulp Free * 100% Pure Squeezed Orange Juice From
Concentrate * 96 FL.OZ. (3 QUTS) 2.84L * [and 128 FL OZ (1 GAL) 3.78 L ] *
Product is packed in rigid plastic bottles. UPC #250002693 (96 FL OZ) and
UPC #250005557 (128 FL OZ). Recall # F-431-5.
CODE
a), b) and c) Bottle Code: XX:XX FC4 APR 08;
RECALLING FIRM
Recalling Firm: Coca Cola Enterprises, Atlanta, GA, by telephone, fax and email of March 30, 2005.
Manufacturer: Freshco Ltd., Fort Pierce, FL. Firm initiated recall is ongoing.
REASON
Orange juice may not reach shelf life before spoiling.
VOLUME OF PRODUCT IN COMMERCE
82,460 cases (includes 96 FL OZ packed 6/case & 128 Fl Oz packed 4 per case)
DISTRIBUTION
AL, FL, GA, LA, MA, MS, NC, PA, SC & TN

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

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PRODUCT
Zanosar Sterile Powder for Injection (streptozocin sterile powder), 1 gm Single Dose Vial, For Intravenous Use Only, Rx only. NDC 0703-4636-01. Recall # D-245-5.
CODE
Lot 04K901 EXP 12/05
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cardinal Health Inc., Columbus, OH, by telephone on April 1, 2005 and fax on April 4, 2005.
Manufacturer: Sicor Pharmaceuticals, Inc., Irvin, CA. Firm initiated recall is complete.
REASON
Degradation: product stored at uncontrolled temperature
VOLUME OF PRODUCT IN COMMERCE
59 vials
DISTRIBUTION
WA and FL

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PRODUCT
Ranitidine HC1, 150mg, USP, 30 count bottles, Rx only, NDC #67544027830. Recall # D-250-5.
CODE
Batch number H21685, Lot number GP7746J
RECALLING FIRM/MANUFACTURER
PrePak Systems Inc., Cookeville, TN, by email on May 19, 2005. Firm initiated recall is ongoing.
REASON
Adulterated: A complaint was received from a patient stating that there was a foreign pill in his sealed prescription bottle of ranitidine.
VOLUME OF PRODUCT IN COMMERCE
2,501 bottles of 30
DISTRIBUTION
IL

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PRODUCT
a) LAMICTALÆ Tablets, (lamotrigine), 25mg/100mg Dose
Escalation Sample Packs (Green), 20 unit blister packs,
Each Escalation pack contains 84/25 mg tablets for use
in weeks 1-4 of treatment and 14/100mg tablets for use
in week 5 of treatment, Rx only, NDC 0173-0594-00.
Recall # D-251-5;
b) LAMICTALÆ Tablets (lamotrigine), 25mg/100mg Bipolar
Sample Kit (Orange), 20 units blister packs, Each
escalation pack contains 42/25mg tablets for use in
weeks 1-4 of treatment, Rx only, **** NDC 0173-0594-03.
Recall # D-252-5.
CODE
a) Lot #2ZP1447A, 2ZP1496, 2ZP1697, 2ZP2109, 2ZP2110,
2ZP2111, 3ZP0032, 3ZP0033, 3ZP0310B, 3ZP0618A, 3ZP0618B,
3ZP0620A, 3ZP1260, 3ZP1410, 3ZP0310A;
b) Lot #3ZP0159A, 3ZP0620B, 3ZP1072A, 3ZP1072B, 3ZP1072C,
3ZP1072D, 3ZP1072E, 3ZP1072ER, 3ZP1613, 3ZP1732,
3ZP1733, 3ZP1889, 3ZP1890, 3ZP2227, 3ZP2228, 3ZP2614,
3ZP2614A, 4ZP1049B, 4ZP1470A, 4ZP1626A, 4ZP219A,
4ZP8181A, 4ZP8183A, 4ZP1049A
RECALLING FIRM/MANUFACTURER
GlaxoSmithKline, Inc, Zebulon, NC, by letters on April 4, 2005. Firm initiated recall is ongoing.
REASON
Mispacked; The week 5 treatment package may contain 25mg tablets instead of 100mg tablets.
VOLUME OF PRODUCT IN COMMERCE
1,406,738 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

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PRODUCT
Reyataz Capsules (atazanavir sulfate) 100 mg capsules in 60 count bottles, Rx only, NDC 0003-3623-12. Recall # D-244-5.
CODE
Lot 5A3117A; Exp. Jan 2008
RECALLING FIRM/MANUFACTURER
Bristol Myers Squib Co, Evansville, IN, by letters on May 12, 2005. Firm initiated recall is ongoing.
REASON
Mislabeled; expiration date incorrectly declared as 2008 instead of 2007.
VOLUME OF PRODUCT IN COMMERCE
700 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

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PRODUCT
Source Plasma. Recall # B-0840-5.
CODE
Unit numbers: 6270233812, 6270233343, 6270232575, 6270231874, 6270231253, 6270230437, 6270230043, 6270229405, 6270228572, 6270226633, 6270216031, 6270213965, 6270213347, 6270212674, 6270212027, 6270211322, 6270211084, 6270210632, 6270210412, 6270209843.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., South Salt Lake City, UT, by facsimile on September 16, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on previous deferral for IV drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
20 units.
DISTRIBUTION
NC.

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PRODUCT
Source Plasma. Recall # B-1241-5.
CODE
Units 2518A, 2218AY, 01683T, 01269T, 00753T, 00406T, 99907R, 99561R, 99245R, 98712R, 98209R, 53812T, 53324T, 52980T, 52481T, 52120T, 51672T, 51231T, 65820R, 65435R, 64928R, 64534R, 64170R, 63878R, 63381R, 62981R, 62420R, 62164R, 65512N, 65283N, 64658N, 64391N, 63889N, 63426N, 62877N, 62491N, 62076N, 67546H, 67142H, 66671H, 66266H, 65661H, 65012H, 64480H, 64110H, 59618H, 59353H, 58861H, 58657H, 58158H, and 57835H.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Lakeland, FL, by facsimile on March 26, 1998. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had previously tested repeatedly reactive for the antibody to human immunodeficiency virus types 1 and 2 (anti-HIV-1/2), were distributed.
VOLUME OF PRODUCT IN COMMERCE
51 units.
DISTRIBUTION
NC.

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PRODUCT
Red Blood Cells. Recall # B-1249-5.
CODE
Unit numbers: F139536, F137949, F136288.
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center, Seattle, WA, by letter, dated September 24, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
WA.

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PRODUCT
Red Blood Cells. Recall # B-1250-5.
CODE
Unit number: P128645.
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center, Seattle, WA, by letter, dated August 16, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WA.

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1285-5;
b) Red Blood Cells (Apheresis), Leukocytes Reduced.
Recall # B-1286-5;
c) Red Blood Cells. Recall # B-1287-5;
d) Platelets. Recall # B-1288-5.
CODE
a) and d) Unit number: 4126710;
b) Unit number: 4304813;
c) Unit number: 4050736.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Oklahoma Blood Institute, Oklahoma City, OK, by facsimiles on January 26, and 27, and May 3, 2004.
Manufacturer: Oklahoma Blood Institute, East Central Oklahoma Blood Institute, Ada, OK. Firm initiated recall is ongoing.
REASON
Blood products, collected from a donor who had a history of malaria, and donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
OK and MO.

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PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1289-5.
CODE
Unit 4569970.
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, OK, by telephone and facsimile on November 14, 2002. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who was taking medication for an upper respiratory infection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OK.

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PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-1293-5;
b) Recovered Plasma. Recall # B-1294-5.
CODE
a) and b) Unit number 2287278.
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on August 7, 2003, or by facsimile on November 4, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who admitted to risk factors for variant Creuztfeldt Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
FL, and Austria.

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PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-1304-5;
b) Red Blood Cells (Apheresis) Leukocytes Reduced.
Recall # B-1305-5.
CODE
a) Unit numbers: 18228-6240, 18228-6267;
b) Unit number: 18228-6239.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on May 2, 2002.
Manufacturer: Blood Systems, Inc., Cheyenne, WY. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NB

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PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1310-5.
CODE
Unit number: T35787
RECALLING FIRM/MANUFACTURER
Tacoma-Pierce County Blood Bank, Tacoma, WA, by telephone and facsimile on September 25, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose medical history screening was incomplete regarding risk factors for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1333-5;
b) Cryoprecipitated AHF. Recall # B-1334-5;
CODE
a) and b) Unit number: 21KJ72224
RECALLING FIRM/MANUFACTURER
American Red Cross, Pacific Northwest Region, Portland, OR, by electronically and by letter, dated November 13, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OR, AL, and Switzerland

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-1345-5;
b) Fresh Frozen Plasma. Recall # B-1346-5.
CODE
a) and b) Unit numbers 23147-2334 and 23147-6230
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on January 17, 2003 and March 29, 2004, and by letters on February 20, 2004, and March 29, 2004. Manufacturer: Blood Systems, Inc., Billings, MT. 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 was subsequently determined to have a previous reactive test for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
MO. and WY

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PRODUCT
Red Blood Cells. Recall # B-1347-5.
CODE
Unit number R24576
RECALLING FIRM/MANUFACTURER
Tacoma-Pierce County Blood Bank, Tacoma, WA, by telephone on September 30, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health history screening was inadequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA

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PRODUCT
Source Plasma. Recall # B-1349-5.
CODE
Unit numbers 10429075, 10427989, 10425930, 10423363, 10422397, 09079984, 09077614, 09076716, and 09074262
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Jackson, TN, by facsimile on May 28, 2004. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were not properly quarantined after the receipt of deferral information related to the application of a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
CA

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PRODUCT
Source Plasma. Recall # B-1350-5.
CODE
Unit numbers 76268144 and 76266966
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Memphis, TN, by facsimile on May 16, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent determination of previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA

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PRODUCT
a) Red Blood Cells. Recall # B-1351-5;
b) Recovered Plasma. Recall # B-1352-5.
CODE
a) and b) Unit number 21GV05733
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pacific Northwest Region, Portland, OR, by telephone on December 15, 2003 and by facsimile on December 17, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OR, and Switzerland

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1354-5;
b) Recovered Plasma. Recall # B-1355-5.
CODE
a) and b)Unit number M13398
RECALLING FIRM/MANUFACTURER
Northern Illinois Blood Bank, Inc, Rockford, IL, by telephone and facsimile on March 21, 2005. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a possible history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL and CA

_______________________________
PRODUCT
Source Plasma. Recall # B-1356-5.
CODE
Unit numbers OJ094123, OJ093796, OJ092869, OJ092507, OJ091787, OJ091080, OJ090764, OJ089973, OJ089620, OJ088637, OJ088493, OJ087193, OJ086641, OJ086280, OJ085775, OJ085346, OJ085034, OJ084503, OJ084142, OJ083500, OJ083199, OJ081583, OJ081496, OJ080277, OJ079976, OJ079442, OJ078683, OJ078374, OJ077235, OJ076531, OJ076225, OJ075673, OJ075293, OJ074870, OJ074522, OJ073985, OJ073516, OJ073125, and OJ072769
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Jacksonville, FL, by facsimile on April 10, 2000. 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 was subsequently determined to have a previous reactive test for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
39 units
DISTRIBUTION
UK

_______________________________
PRODUCT
Fresh Frozen Plasma, [Apheresis]. Recall # B-1357-5.
CODE
Unit number 18228-8366 (distributed as three split units)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on May 30, 2002.
Manufacturer: Blood Systems, Inc., Cheyenne, WY. Firm initiated recall is complete.
REASON
Blood products were collected in a manner that may compromise the sterility of the products.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NE

_______________________________
PRODUCT
Source Plasma. Recall # B-1358-5.
CODE
Unit numbers: 77395863, 58164105, 41702642, 27381465, 77404510, 47422209, 47113961, 47367395, 47431454, 41710074, 41708897, and 41703540
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Memphis, TN, by facsimile on October 28, 2003. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD) were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
CA

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1359-5.
CODE
Unit number 027P72224
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by telephone on January 9, 2005. Firm initiated recall is complete.
REASON
Blood product was manufactured in a bag that may have leaks and was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WV

_______________________________
PRODUCT
Source Plasma. Recall # B-1361-5.
CODE
Unit BNBXTP
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biomat USA, Inc., Baton Rouge, LA, by facsimile on March 28, 2003.
Manufacturing Firm: Biomat USA, Inc., Clarksville, TN. Firm initiated recall is complete.
REASON
Blood product, mislabeled as testing negative for HIV, HBV, and HCV by NAT, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Germany

_______________________________
PRODUCT
Platelets. Recall # B-1363-5.
CODE
Unit 238849
RECALLING FIRM/MANUFACTURER
Aultman Hospital Blood Bank, Canton, OH, by telephone on November 2, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was previously deferred for a history of intravenous (IV) drug use, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated. Recall # B-1392-5.
CODE
Unit 4513820
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, OK, by facsimile on May 29, 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
OK

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

________________________
PRODUCT
Source Plasma. Recall # B-1263-5.
CODE
Unit number: 04844303
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc, Jackson, TN, by facsimile on October 8, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that was not properly
asked the medical history questions, including those
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
CA

________________________
PRODUCT
Source Plasma. Recall # B-1264-5.
CODE
Unit number: 04846321
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Jackson, TN, by facsimile on October 7, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that was not properly asked the medical history questions, including those 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
CA

_______________________________
PRODUCT
Source Plasma. Recall # B-1265-5.
CODE
Unit numbers: 05829620, 05828821, 05822645, 05820528, 04489733, and 04488170
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Jackson, TN, by facsimile on November 7, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that was not properly asked the medical history questions, including those questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
CA

_______________________________
PRODUCT
Platelets. Recall # B-1266-5.
CODE
Unit number: 4725408
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by fax on December 19, 2003. Firm initiated recall is complete.
REASON
Blood product, which may have been prepared from a Whole Blood unit with and extended collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

_______________________________
PRODUCT
Recovered Plasma. Recall # B-1335-5.
CODE
Unit number: 21KJ72224
RECALLING FIRM/MANUFACTURER
American Red Cross, Pacific Northwest Region, Portland, OR, by electronically and by letter, dated November 13, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OR, AL, and Switzerland

_______________________________
PRODUCT
Source Plasma. Recall # B-1343-5.
CODE
Unit number: 91443465
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Memphis, TN, by facsimile on February 24, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that was not asked the medical history questions, including those 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
CA

_______________________________
PRODUCT
Source Plasma. Recall # B-1344-5.
CODE
Unit number: 90623141
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Memphis, TN, by facsimile on February 24, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that was not asked the medical history questions, including those 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
CA

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1348-5.
CODE
Unit number V54855
RECALLING FIRM/MANUFACTURER
Tacoma-Pierce County Blood Bank, Tacoma, WA, by telephone on October 30, 2003. Firm initiated recall is complete.
REASON
Blood product, that was not properly quarantined after the receipt of post donation information concerning medication with an antibiotic, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA

_______________________________
PRODUCT
Source Plasma. Recall # B-1353-5.
CODE
Unit number 04DILD5716
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., DeKalb, IL, by facsimile on January 27, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor due to recent antibiotic use, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
Nichols Advantage Sample hGH Diluent Set, Catalog No. 62-7756. Recall # Z-0873-05.
CODE
All codes
RECALLING FIRM/MANUFACTURER
Nichols Institute Diagnostics, San Clement, CA, by letter on May 2, 2005. Firm initiated recall is ongoing.
REASON
Under recovery of diluted samples by as much as 20%.
VOLUME OF PRODUCT IN COMMERCE
Not specified
DISTRIBUTION
Nationwide, Germany, Sweden, Italy, Japan and Spain

_______________________________
PRODUCT
Nichols Advantage TSH -- Third Generation. Recall # Z-0874-05.
CODE
Lots 62-400791 and 62-400796
RECALLING FIRM
Nichols Institute Diagnostics, San Clement, CA, by letter on April 28, 2005. Firm initiated recall is ongoing.
REASON
Does not meet performance claims in the labeling for analytical and functional sensitivity.
VOLUME OF PRODUCT IN COMMERCE
1,072
DISTRIBUTION
Nationwide, Germany, Greece and Spain

_______________________________
PRODUCT
a) UNO 102 EM/EE/ES Patient Lift. Recall # Z-0875-05;
b) UNO 100 EM/EE Patient Lift. Recall # Z-0876-05;
c) Sabina I and II EM/EE Patient Lift. Recall # Z-0877-05.
CODE
a) Serial Numbers: Range 33590-42291;
b) Serial Numbers: Range 7090602-7093161;
c) Serial Number: Range 401205-41442
RECALLING FIRM/MANUFACTURER
Recalling Firm: Liko, Inc, Franklin, MA, by letter dated September 29, 2004.
Manufacturer: Liko Ab, Lulea, Sweden. Firm Initiated recall is ongoing.
REASON
Incorrect length support screws may cause patient lift failure.
VOLUME OF PRODUCT IN COMMERCE
950 units
DISTRIBUTION
Canada

_______________________________
PRODUCT
Servo-I Ventilator. Recall # Z-0878-05.
CODE
All Servo-i units with serial numbers below 17617
RECALLING FIRM
Recalling Firm: Maquet Inc, Bridgewater, NJ, by letter on March 31, 2005.
Manufacturer: Maquet Critical Care AB, Solna, Sweden. Firm initiated recall is ongoing.
REASON
Complaints about batteries indicating a satisfying remaining time but after a short time suddenly shut off without giving alarms to indicate short remaining battery back-up time. (Power off alarm will be given).
VOLUME OF PRODUCT IN COMMERCE
4379 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Perkin ELmer Life and Analytical Sciences - NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit. Recall # Z-0879-05.
CODE
Catalog Number: MS-8970 Lot numbers: 252208, 257031, 258928, 258937, 259588, 263097, 267166, 267628, 268256, 268258, 268403, 268404, 268675
RECALLING FIRM/MANUFACTURER
Recalling Firm: Perkin Elmer Life and Analytical, North Billerica, MA, by letter on March 11, 2005 and May 5, 2005.
Manufacturer: Perkin Elmer Life Sciences, Turku, Finland. Firm initiated recall is ongoing.
REASON
Pump failure may affect data integrity.
VOLUME OF PRODUCT IN COMMERCE
622 kits
DISTRIBUTION
AL, CA, CT, FL, IN, LA, GA, MI, MO, NJ, OR, SC

_______________________________
PRODUCT
SC-AcuFix Thinline Low-Profile Anterior Cervical Plate System. Recall # Z-0880-05.
CODE
All devices lot number 10RY and earlier of the following part numbers were removed from the market in 2002: 407-1020; 407-1022; 407-1024; 407-1026; 407-1028; 407-1030; 407-1032; 407-1034; 407-2236; 407-2238; 407-2240; 407-2242; 407-2244; 407-2246; 407-2248; 407-2250; 407-2252; 407-2254
RECALLING FIRM
Spinal Concepts, Inc, An Abbott Laboratories Company, Austin, TX, by telephone around August 2002. Firm initiated recall is complete.
REASON
Complaints were received where swivels came out of plate and where the screw went through the plate.
VOLUME OF PRODUCT IN COMMERCE
28 Parts (total of 10 Systems)
DISTRIBUTION
CA, IL, IN, NC, MS, PA, NY and VA

_______________________________
PRODUCT
a) Roche brand AccuData GTS Plus System; Catalog number
3000249, material number 03000249001. Recall # Z-0881-
05;
b) Roche brand AccuData GTS System; Catalog number 404,
material number 03136833001. Recall # Z-0882-05;
c) Roche brand AccuData GTS/GTS Plus System Replacement
Base/Module; Catalog number 3426050, material number
03426050001. Recall # Z-0883-5.
CODE
All units
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated April 18, 2005.
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany. Firm initiated recall is ongoing.
REASON
If foil wrapped packages or other metallic objects are lodged behind the supply drawer, an electrical short may result and high heat generated; this could result in plastic melting and battery leakage for customers using 'C' cell batteries to power their base and could render the system inoperable (system won't turn on) for customers using the A/C adaptor without batteries.
VOLUME OF PRODUCT IN COMMERCE
39000 units
DISTRIBUTION
Nationwide and Guam

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
IRISpec CA/ IRISpec CB Two-Part Urine Chemistry Control Twin Set, part no. 800-0074. Recall # Z-0884-05.
CODE
Lot No. 103-05
RECALLING FIRM/MANUFACTURER
International Remote Imaging Systems Inc, Chatsworth, CA, by telephone on April 29, 2005. Firm initiated recall is ongoing.
REASON
Nonconformance to performance specifications. The instrument failed to report a positive result for nitrite which was expected for a conforming part B control.
VOLUME OF PRODUCT IN COMMERCE
107 units
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR JUNE 15, 2005

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