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U.S. Department of Health and Human Services

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Enforcement Report for August 24, 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.

August 24, 2005
05-34

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS I

______________________________
PRODUCT
Pecan/caramel clusters under the following:
a) Catherine?s Finest Pecan Caramel Clusters sold in an
8 oz. box, in cases containing 36 boxes,
UPC 0 75655 00360 7;
b) Shwom?s Caramel Pecan Clusters sold in a 6 oz. box,
in cases containing 24 boxes, UPC 0 75655 00360 7.
The products were sold through fund raising organizations.
Recall # F-586-5.
CODE
UPC code only
RECALLING FIRM/MANUFACTURER
Barricini Candies, Moosic, PA, by telephone and letter on June 13, 2005, and by press release on June 20, 2005. Firm initiated recall is ongoing.
REASON
Product contains undeclared soy nuts.
VOLUME OF PRODUCT IN COMMERCE
26,808 boxes
DISTRIBUTION
CA, NM, NJ, and MD

_______________________________
PRODUCT
Preserved Apples. Product is packaged in a 12.35 oz. plastic tray. Recall # F-587-5
CODE
Best before 20.12.2005
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sino Best Food, Inc, Edison, NJ, by visit beginning on May 2, 2005.
Manufacturer: Beijin Hong Luo Foodstuff Group, Beijing, China. Firm initiated recall is complete.
REASON
Product contains undeclared sulfites based on the NY State Department of Agriculture and Markets? analysis.
VOLUME OF PRODUCT IN COMMERCE
99 cases, 30 packages per case
DISTRIBUTION
NJ and NYC

______________________________
PRODUCT
Cinnamon Almond Dark Chocolate Biscotti in bulk for sale as single service items that are displayed on shelves of restaurants and grocery stores without labeling. Recall # F-588-5
CODE
All product which does not list milk as an ingredient.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Feature Food, Inc., Cuyahoga Falls, OH, by letter dated June 28, 2005, and by press release dated June 30, 2005.
Manufacturer: M S Cotti, Walton Hills, OH. Firm initiated recall is ongoing.
REASON
The product contains milk, a known allergen, which is not listed as an ingredient on the product label.
VOLUME OF PRODUCT IN COMMERCE
Undetermined
DISTRIBUTION
IN, IL, MD, MI, OH, PA, and VA

______________________________
PRODUCT
Arnold Vending brand ?Sausage Gravy and Biscuit?, 8 ounce package, a single service item packaged in a black plastic bowl with a clear snap on-lid. Recall # F-590-5
CODE
Lot code ?07-19-05?
RECALLING FIRM/MANUFACTURER
Arnold Vending Company, Inc., Tiffin, OH, by visit on July 14, 2005. Firm initiated recall is ongoing.
REASON
Product contains undeclared eggs.
VOLUME OF PRODUCT IN COMMERCE
710/8 ounce packages
DISTRIBUTION
OH

______________________________
PRODUCT
Inglehoffer brand wasabi horseradish in clear plastic squeeze jar labeled inglehoffer Wasabi Horseradish Hot Creamy Freshly Graded Wasabi, Net Wt. 9.5 oz (269g), Recall # F-592-5
CODE
N172 where N = random designation for the year 2005 and 172 = julian date of production
RECALLING FIRM/MANUFACTURER
Beaverton Foods, Inc., Hillsboro, OR, by telephone and letter on July 15, 2005, and by press release and letter on July 19, 2005. Firm initiated recall is complete.
REASON
The product contains undeclared eggs, metabisulfites, and colors (FD&C Yellow #5 and FD&C Blue #1).
VOLUME OF PRODUCT IN COMMERCE
588 cases/6/9.5 oz
DISTRIBUTION
TX, GA, OR, and NJ

______________________________
PRODUCT
Flavor Right (Parve) Whipped Topping in 7 oz aerosol cans. The product is shipped in cases containing 12 cans, Recall # F-593-5
CODE
PL3746 exp 7/22/05
RECALLING FIRM/MANUFACTURER
Recalling Firm: Flavor Right, Bethlehem, PA, by telephone and letter on May 26, 2005, and by press release on June 3, 2005.
Manufacturer: Alamance Foods, Inc., Burlington, NC. Firm initiated recall is ongoing.
REASON
The product contains undeclared milk ingredient.
VOLUME OF PRODUCT IN COMMERCE
664 cases
DISTRIBUTION
NY, NJ, and MD

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
a) Econopred plus (prednisolone acetate) Sterile Ophthalmic
Suspension, 1%, 5 ml tradesize, 5 ml sample, 10 ml
tradesize, and 10ml sample, Rx only, NDC 0098-0637-04,
Also under other label as Prednisolone Acetate Ophthalmic
Suspension1%, Recall # D-453-5;
b) Neomycin and Polymyxin B Sulfates and Dexamethasone
Ophthalmic Suspension, Each mL contains Neomycin
Sulfate equivalent to Neomycin 3.5mg, Polymyxin B
Sulfate 10,000 units, Dexamethasone 0.1%, Sterile,
5 ml tradesize, Rx only, Also sold in Saudia Arabia
as Maxitrol Sterile Ophthalmic Suspension,
Recall # D-454-5;
c) TobraDex (Tobramycin 0.3% (3mg) and Dexamethasone
0.1% (1mg)) Sterile Ophthalmic Suspension, 2.5ml sample,
5ml tradesize, 1 ml sample, 10ml tradesize, and 2.5ml
tradesize, Rx only, NDC 0065-0647-05, Recall # D-455-5;
d) Neomycin and Polymyxin B Sulfates and Hydrocortisone
Ophthalmic Suspension, USP, Each mL contains Neomycin
Sulfate (equivalent to 3.5mg neomycin sulfate base),
polymyxin B sulfate 10,000 units, hydrocortisone 10mg,
7.5ml tradesize, Rx only, NDC 61314-641-75,
Recall # D-456-5;
e) Ciprodex (ciprofloxacin 0.3% and dexamethasone 0.1%)
Sterile Otic Suspension, 7.5ml tradesize, 1.5ml sample,
and 7.5ml sample, Rx only, NDC 0065-8533-02.
Recall # D-457-5
CODE
a) Lot numbers: 70020F, 68154F, 71266F, and 71267F
(all 4 lots are samples); 72489F, and 82236F
(both lots are samples); 69081F; 71281F and 70591F;
Lot number 86060F distributed only in Botswana;
b) Lot 70565F and Lot 081663F distributed only in
Saudia Arabia;
c) Lot number: 72950F;
d) Lot number: 70029F;
e) Lot number 70739F; Lot number 72540F distributed
only in Canada
RECALLING FIRM/MANUFACTURER
Alcon Research, Ltd, Fort Worth, TX, by letter on July 20, 2005. Firm initiated recall is ongoing.
REASON
Lack of assurance of sterility; leak in the transfer hose of a Vaporous Hydrogen Peroxide (VHP) generator resulting in reduced amount of VHP used in decontamination cyle.
VOLUME OF PRODUCT IN COMMERCE
548,869 units
DISTRIBUTION
Nationwide, Botswana, Saudi Arabia, and Canada

_______________________________
PRODUCT
a) Paxil Tablets (paroxetine HCl) 10 mg, Bottles of 30,
Rx only, NDC 0029-3210-13 ----- Also labeled as
Paroxetine HCl Tablets, 10 mg, Bottles of 30,
Rx only, Recall # D-459-5;
b) Paxil Tablets (paroxetine HCl) 20 mg, Bottles of 100,
Rx only, NDC 0029-3211-20 ----- Also labeled as
ratio-Paroxetine Tablets, 20mg,Recall # D-460-5;
c) Paxil Tablets, (paroxetine HCl), 30 mg, Bottles of
30, Rx only, NDC 0029-3212-13, Recall # D-461-5;
d) Paxil Tablets (paroxetine HCl), 40 mg, Bottles of
30, Rx only, NDC 0029-3213-13, Recall # D-462-5
CODE
a) Lot # F61-5B10 expiration February 2008
Lot # 1-5Z76 expiration March 2008;
b) Lots # 203-5B11 & 202-5B11 expiration date 01-31-2008;
Lot # 1-5P22 expiration 03/31/07 (distributed only
in Canada);
c) Lots # 503-4B12, F503-4B12, 504-4B12, M504-4B12 &
I504-4B12 Expiration Date 12/31/2007;
d) Lots # 702-5B13 & 704-5B13 expiration date 03/31/2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smithkline Beecham Pharmaceuticals, Co., Cidra, PR, by letter dated July 11, 2005.
Manufacturer: Sb Pharmco Puerto Rico, Inc., Cidra, PR. Firm initiated recall is ongoing.
REASON
Superpotent
VOLUME OF PRODUCT IN COMMERCE
290,704 bottles
DISTRIBUTION
Nationwide, PR, HI, and Canada

_______________________________
PRODUCT
Toprol XL 50 mg tablets, 100 count bottles, Rx only, Recall # D-464-5
CODE
Lot # LF0012 exp 2/29/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Astra Zeneca, Wilmington, DE, by telephone on July 20, 2005 and by letter dated July 22, 2005.
Manufacturer: Astra Zeneca, Sodertalje, Sweden, Firm initiated recall is ongoing.
REASON
Mispackaging: bottles may also contain Toprol XL 100 mg tablets.
VOLUME OF PRODUCT IN COMMERCE
94,776 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_______________________________
PRODUCT
a) Mirtazapine Tablets, 30 mg, 10x10 blister cards
and 30 count bottles, Rx only, NDC 0054-8677-25,
Recall # D-465-5;
b) Mirtazapine Tablets, 45 mg, 30 count bottles,
Rx only, NDC 0054-4678-13, Recall # D-466-5
CODE
a) Lot 556066A, expiration date Feb. 07,
Lot 556066B, expiration date Feb. 07;
b) Lot 556247A, expiration date Apr. 07
RECALLING FIRM/MANUFACTURER
Boehringer Ingelheim Roxane, Inc., Columbus, OH, by letter dated July 26, 2005. Firm initiated recall is ongoing.
REASON
Dissolution Failure
VOLUME OF PRODUCT IN COMMERCE
69,913 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Platelets Pheresis Leukoreduced, Recall # B-1710-5
CODE
Unit number: 5229249
RECALLING FIRM/MANUFACTURER
Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, OK, by fax and telephone on February 8, 2005. Firm initiated recall is complete.
REASON
Blood product, contaminated with Staphylococcus epidermidis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

_______________________________
PRODUCT
Red Blood Cells, Recall # B-1737-5
CODE
Unit number: KH63089
RECALLING FIRM/MANUFACTURER
San Diego Blood Bank, San Diego, CA, by telephone on March 21, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported visiting an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

_______________________________
PRODUCT
Platelets Pheresis, Leukoreduced, Recall # B-1739-5
CODE
Unit number: 49GP20787 (distributed as two split products)
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southwest Region, Tulsa, OK, by telephone on October 11, 2004 and by letter on October 18, 2004. Firm initiated recall is complete.
REASON
Blood products, which did not have quality control testing performed but were collected during apheresis machine validation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1740-5;
b) Red Blood Cells (Apheresis), Leukocytes Reduced,
Recall # B-1741-5;
c) Platelets, Recall # B-1742-5
CODE
a) Unit number: 6924855;
b) Unit number: 2754204 (distributed as two split
products);
c) Unit number: 2754735
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSource, Glenview, IL, by telephone on April 9, and April 20, 2005.
Manufacturer: LifeSource, Arlington Heights, IL. Firm initiated recall is complete.
REASON
Blood products, which may have been collected using expired reagents, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
IL

_______________________________
PRODUCT
Red Blood Cells, Leukoreduced, Recall # B-1814-05
CODE
Unit number: 4635908
RECALLING FIRM/MANUFACTURER
Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, OK, by fax and letter on May 28, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1849-5
CODE
Unit numbers: 10741-6737 (split unit)
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc, dba United Blood Services, Scottsdale, AZ, by telephone on December 17, 2002, and by letter dated March 4, 2003. Firm initiated recall is complete.
REASON
Platelets, collected from a donor in which donor suitability was not adequately evaluated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ

_______________________________
PRODUCT
a) Red Blood Cells (Apheresis), Leukoreduced,
Recall # B-1883-5;
b) Red Blood Cells, Leukoreduced, Recall # B-1884-5
CODE
a) Unit numbers: 4866607 (1), 4866607 (2), 4729645;
b) Unit number: 4793024
RECALLING FIRM/MANUFACTURER
Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, OK, by fax on December 30, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the medication Sulfasalazine, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
OK and Switzerland

_______________________________
PRODUCT
Source Plasma, Recall # B-1930-5
CODE
Unit numbers: 04FINB3069, 04FINB3465, 04FINB3706, 04FINB4229, 04FINB4566
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Fort Wayne, IN, by facsimile dated April 29, 2005. Firm initiated recall is complete.
REASON
Source Plasma, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
CA

_______________________________
PRODUCT
Source Plasma, Recall # B-1932-5
CODE
Unit numbers: G-74950-020, G-75250-020
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, McAllen, TX, by facsimile dated October 15, 2003. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor that subsequently reported risk factors for infection with human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Switzerland

_______________________________
PRODUCT
a) Red Blood Cells Leukoreduced, Recall # B-1933-5;
b) Recovered Plasma, Recall # B-1934-5
CODE
a) and b) Unit number: 4885230
RECALLING FIRM/MANUFACTURER
Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, OK, by fax on June 20, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of Multiple Sclerosis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK and Switzerland

_______________________________
PRODUCT
Source Plasma, Recall # B-1940-5
CODE
Unit numbers: F-00461-020, F-00696-020, F-01359-020, F-01688-020, F-03857-020, F-04500-020, F-07316-020, F-07722-020, F-26531-020, F-26766-020, F-27114-020, F-27348-020, F-27749-020, F-27997-020, F-28391-020, and F-28599-020
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, McAllen, TX, by facsimile on October 30, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on an unexplained weight loss, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
NC, and Spain

_______________________________
PRODUCT
Red Blood Cells, Recall # B-1950-5
CODE
Unit number: 0684848
RECALLING FIRM/MANUFACTURER
The Blood connection, Inc., Greenville, SC, by letter dated November 22, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who should have been deferred due to use of the medication Azulfidine, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1953-5
CODE
Unit number 12KP82113
RECALLING FIRM/MANUFACTURER
American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on March 8, 2004 and by letter dated March 17, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

_______________________________
PRODUCT
Red Blood Cells, Recall # B-1955-5
CODE
Unit number F149707
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program, Seattle, WA, by letter on August 13, 2003. 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
WA.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced Irradiated, Recall # B-1956-5
CODE
Unit number: H204562 (distributed as two split units)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by letter on June 25, 2003.
Manufacturer: Puget Sound Blood Center and Program, Silverdale, WA. 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
2 units
DISTRIBUTION
WA

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1957-5;
b) Platelets, Pooled, Recall # B-1958-5
CODE
a) Unit numbers: P136795 and P135463;
b) Unit number: P136795
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program, Seattle, WA, by letter on September 5, 2003. 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
3 units
DISTRIBUTION
WA.

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1959-5;
b) Platelets, Pooled, Recall # B-1960-5;
c) Platelets, Pooled Irradiated, Recall # B-1961-5
CODE
a) Unit numbers: Z111561 and P133425;
b) Unit number: Z111561;
c) Unit number: P133425
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program, Seattle, WA, by letter on August 7, 2003. 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
4 units
DISTRIBUTION
WA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1965-5
CODE
Unit number: 36263-6295
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Ventura, CA, by telephone on February 2, 2002. Firm initiated recall is complete.
REASON
Blood product, that tested out of specification for red blood cell volume, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

_______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1966-5
CODE
Unit number: GN22768
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on May 17, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a whole blood unit in which the associated Red Blood Cells component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1967-5
CODE
Unit number: 04GK65744
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Dedham, MA, by facsimile and by letter dated May 5, 2005. 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
NY

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1968-5;
b) Recovered Plasma, Recall # B-1969-5
CODE
a) and b) Unit number: 04GK72340
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Dedham, MA, by telephone and by letter dated April 14, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had received a tattoo within twelve months of the donation and who has engaged in a high risk behavior activity, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA and MA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Platelets, Recall # B-1634-5
CODE
Unit number: 3464384
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., Tampa, FL, by telephone on September 4, 1997. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who received MMR vaccine prior to donating, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1685-5
CODE
Unit numbers: 49GN32010, 49GN32011, 9GN32013, 49GN32014, 49GN32033, 49GN32034, 49GN32040
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southwest Region, Tulsa, OK, by telephone on June 17, 2004. Firm initiated recall is complete.
REASON
Red Cells, manufactured in an unvalidated centrifuge, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
OK

_______________________________
PRODUCT
Recovered Plasma, Recall # B-1885-5
CODE
Unit numbers: 4793024, 4729645     
RECALLING FIRM/MANUFACTURER
Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, OK, by fax on December 30, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the medication Sulfasalazine, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK and Switzerland

_______________________________
PRODUCT
Platelets Pheresis Leukoreduced, Recall # B-1931-5
CODE
Unit number: 4866268
RECALLING FIRM/MANUFACTURER
Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, OK, by fax and telephone on April 19, 2005. Firm initiated recall is complete.
REASON
Blood product, possible contaminated with coagulase-negative staphylococcus, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK

_______________________________
PRODUCT
Red Blood Cells, Recall # B-1939-5
CODE
Unit number LV56708
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on April 27, 2005. Firm initiated recall is complete.
REASON
Blood product that was out of controlled storage for more than 30 minutes was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

_______________________________
PRODUCT
Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-1949-5
CODE
Units: 12KY19834 (Parts 1 and 2)
RECALLING FIRM/MANUFACTURER
American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on March 8, 2004 and by letter dated March 19, 2004. 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
NC

_______________________________
PRODUCT
Recovered Plasma, Recall # B-1951-5
CODE
Unit number: 0684848
RECALLING FIRM/MANUFACTURER
The Blood connection, Inc., Greenville, SC, by facsimile on November 22, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who should have been deferred due to use of the medication Azulfidine, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY

_______________________________
PRODUCT
Source Plasma, Recall # B-1962-5
CODE
Unit number: VA-132567
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, Van Nuys, CA, by facsimile on December 15, 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
Austria

_______________________________
PRODUCT
Source Plasma, Recall # B-1963-5
CODE
Unit number: VA-182031
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, Van Nuys, CA, by facsimile on September 5, 2002. 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
Austria

_______________________________
PRODUCT
Source Plasma, Recall # B-1964-5
CODE
Unit number: VA-113171
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, Van Nuys, CA, by facsimile on August 20, 2002. 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
Austria

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

_______________________________
PRODUCT
a) Baxter Colleague Single Channel Volumetric Infusion
Pumps; Made in Singapore; product codes 2M8151,
2M8151R, 2M8161, 2M8161R, Recall # Z-1059-05;
b) Baxter Colleague Triple Channel Volumetric Infusion
Pumps; Made in Singapore; product codes 2M8153,
2M8153R, 2M8163, 2M8163R, Recall # Z-1060-05
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare, Corp., Round Lake IL, by letter on July 20, 2005.
Manufacturer: Baxter Healthcare, Corp., Singapore, Singapore. Firm initiated recall is ongoing.
REASON
A hardware problem can cause internal communications errors, which halt therapies, generate alarms and communication failure codes.
VOLUME OF PRODUCT IN COMMERCE
344,074 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
a) VENTAK PRIZM AVT model no. 1900, Atrial and
Ventricular Therapies. Sterilized using gaseous
ethylene oxide. Recall # Z-1107-05;
b) VITALITY AVT, model A135 and A155. Implantable
Cardioverter Defibrillator. Atrial and Ventricular
Therapies. Sterilized using gaseous ethylene oxide.
Recall # Z-1108-05
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Guidant Corp., Saint Paul, MN, by letter dated July 22, 2005.
Manufacturer: Guidant-Ireland, Clomel, Ireland, Firm initiated recall is ongoing.
REASON
Guidant is revising its original recommendations set forth in the 06/17/05 physician letter because new information indicates that one of the original recommendations can increase the risk of a latching event, which may limit available therapy.
VOLUME OF PRODUCT IN COMMERCE
20,905 (approximately 17,000 devices remain implanted in US)
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
a) Medtronic Neurosurgery C/N 3805-014 Peelaway
Introducer Sheath, Disposable 14 F,
Recall # Z-1110-05;
b) Medtronic Neurosurgery C/N 3805-015 Peelaway
Introducer Sheath, Disposable 15 F,
Recall # Z-1111-05
CODE
a) Lots: A46413, A6414, A48711, A49692, A53066,
A53867, A55500, A55753, A57046, A58460, A60519,
A61343, A67224;
b) Lots: A55754, A59282, A62361, A64132
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Neurosurgery, Goleta, CA, by letters on July 5, 2005.
Manufacturer: B. Braun Medical, Inc., Allentown, PA, Firm initiated recall is ongoing.
REASON
Cracked hubs/handles and/or improper peeling of the sheath during use.
VOLUME OF PRODUCT IN COMMERCE
448 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
PASV Central Venous Catheter, 7F, Cat. # CVC702IK, Model # M0001CVC702IK. The 7Fr PASV Central Venous Catheter is a packaged configuration comprised of a silicone Central Venous Catheter with PASV Valve, Guidewire, Syringe, Needle, Tunneler, Scalpel, Sheath/Dilator, and caps, Recall # Z-1112-05
CODE
934445 exp. 2/28/2007; 942510 exp. 1/31/2007; 938122 exp. 3/31/2007; 935225 exp. 2/28/2007; 933703 exp 1/21/2007; 931401 exp. 12/31/2006; 929657 exp. 12/31/2006; 929435 exp. 12/31/2006
RECALLING FIRM
Recalling Firm: Boston Scientific Corp., Natick, MA, by letters dated May 25, 2004.
Manufacturer: Boston Scientific Corp., Glens Fall, NY, Firm initiated recall is complete.
REASON
Kits labeled to contain 0.028? guidewire contain 0.038? guidewire.
VOLUME OF PRODUCT IN COMMERCE
290 units
DISTRIBUTION
Nationwide and UK

_______________________________
PRODUCT
Tri-Plex Adapter, single unit (MD-04000) or box of 25 (MD-04001) or case of 100 (MD-04002). Adaptor that is coupled between an endotracheal tube and a ventilator. Device allows practitioner to access the airway without having to disconnect the circuit. Sterile, Single Use, Recall # Z-1371-05
CODE
Lot number: 2005001
RECALLING FIRM/MANUFACTURER
Medical Device Group Inc., Poway, CA, by telephone on June 8, 2005, and by letters on June 10, 2005. Firm initiated recall is ongoing.
REASON
Device separation presenting a choking hazard. The plunger seal separated from the plunger.
VOLUME OF PRODUCT IN COMMERCE
2,282 units
DISTRIBUTION
Nationwide, Brazil and Canada

_______________________________
PRODUCT
Syndeo PCA Syringe Pump, product codes 2L3113 and 2L3113R; Made in Singapore, Recall # Z-1373-05
CODE
All serial numbers
RECALLING FIRM
Recalling Firm: Baxter Healthcare, Corp., Round Lake IL, by letters dated July 6, 2005.
Manufacturer: Baxter Healthcare, Corp., Singapore, Singapore. Firm initiated recall is ongoing.
REASON
During an infusion in the 'Basal + PCA' or 'PCA only' modes, the SYNDEO pump may generate false Service Code 919 or Service Code 920, which will cause the pump to stop the infusion. Also, while attempting to turn on the device by pressing the On/Off key, the pump may not power up properly.
VOLUME OF PRODUCT IN COMMERCE
4,392 units
DISTRIBUTION
Nationwide and Canada

_______________________________
PRODUCT
Newport HT50 All Purpose Ventilator, Recall # Z-1375-05
CODE
All serial numbers. Products are identified by serial numbers on back of ventilators. Manufacturer states serial numbers of ventilators involved in field correction may be obtained through shipping records.
RECALLING FIRM/MANUFACTURER
Newport Medical Instruments, Inc., Costa Mesa, CA, by letter dated October 29, 2004 and December 20, 2004. Firm initiated recall is ongoing.
REASON
Lack of alarm prior to shutdown.
VOLUME OF PRODUCT IN COMMERCE
3,654 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
UltraLite Vehicles powered by Rascal Motorized Vehicles, Recall # Z-1376-05
CODE
All units distributed under Model Number UL370.
RECALLING FIRM/MANUFACTURER
Electric Mobility Corp., Sewell, NJ, by letters on April 20, 2005. Firm initiated recall is ongoing.
REASON
The engager set screw may become loose. This problem may cause the potentiometer to become off-center thus affecting the end users stopping capabilities.
VOLUME OF PRODUCT IN COMMERCE
788 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Cytomics FC500 MPL with MXP Software, Recall # Z-1377-05
CODE
Versions 1.1 and 2.0
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letters on July 13, 2005.
Manufacturer: Applied Cytometry Systems, Dinnington, UK. Firm initiated recall is ongoing.
REASON
Software anomaly. If the laser is shutdown or fluctuates outside of the specification limits, the software continues to run and will not indicate a laser failure, and could therefore cause erroneous results.
VOLUME OF PRODUCT IN COMMERCE
36 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler, Recall # Z-1378-05
CODE
All units with software code version numbers: PN950-0101, Rev 1.7 and PN950-0108, Rev 1.7a
RECALLING FIRM/MANUFACTURER
Cepheid, Sunnyvale, CA, by letters on July 22, 2005. Firm initiated recall is ongoing.
REASON
A problem in the software has the potential to be associated with the incorrect reporting of sample results.
VOLUME OF PRODUCT IN COMMERCE
163 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
Regius-IM, The Regius Image Manager for Centralized workflow and improved image quality software, Recall # Z-1391-05
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Konica Medical Imaging, Inc, Wayne, NJ, by telephone, visit, and letter, beginning on April 7, 2005. Firm initiated recall is ongoing.
REASON
One feature of the software on some of the devices which permits assembling three digital images into one image has occasionally had problems aligning the three images exactly.      
VOLUME OF PRODUCT IN COMMERCE
60 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
DL2000 Data Manager, Recall # Z-1372-05
CODE
Not Applicable but refers to software version 6.4.109f
RECALLING FIRM
Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letters during the week of June 20, 2005.
Manufacturer: Normand Informatique, Cedex, France. Firm initiated recall is ongoing.
REASON
Version v6.4.109f, any result designated as ?calculated chemistry? at DL2000 may upload to the LIS with an incorrect or blank sample ID.
VOLUME OF PRODUCT IN COMMERCE
287 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Coagulation Factor VIII Deficient Plasma (OTXW). Factor Deficiency Test, Recall # Z-1374-05
CODE
Lot numbers: 503845A, 503846A, and 503847D
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dade Behring, Inc., Newark DE, by letters on July 13, 2005.
Manufacturer: Aventis Behring Gmbh, Marburg, Germany. Firm initiated recall is ongoing.
REASON
Sample may exhibit falsely high results.
VOLUME OF PRODUCT IN COMMERCE
3,255 packs
DISTRIBUTION
Nationwide and Internationally

END OF ENFORCEMENT REPORT FOR AUGUST 24, 2005

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