Safety
Enforcement Report for June 30, 2010
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
BAO DING SEA FOOD brand Boiled Horse Mackerel, Net Wt 450g -- PRODUCT OF CHINA -- UPC 6 937490 900081. The product is packaged in a vacuum packed plastic bag. Recall # F-2238-2010
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bao Ding Seafood Co., New York, NY, by press release on January 6, 2010.
Manufacturer: Fuzhou Dongshui Food Co, Ltd., Fuzhou, China. New York State Department of Agriculture & Markets initiated recall is complete
REASON
The imported processed fish was found to be uneviscerated based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
NY State
___________________________________
PRODUCT
Dean 7016 Chicken Flavor Soup Base, 30 lbs. pails. Recall # F-2239-2010
CODE
Lot Number: 0050
RECALLING FIRM/MANUFACTURER
Dean Distributors Inc, Vernon, CA, by e-mail on February 25, 2010. Firm initiated recall is complete.
REASON
The recall was initiated because the product was manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc., because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
129 pails
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Borenstein Savory Rub is packaged in a 50 lb. plastic bag and placed in a cardboard box, and label is attached to the outside of the box. Product labeled in part: Borenstein Savory Rub, Item #97401, DOM: 03/01/10, Net Wt. 50 lbs (22.7kg). Recall # F-2240-2010;
2) California Hamzyme Concentrate is packaged in a 50 lb. plastic bag and placed in a cardboard box, and label is attached to the outside of the box. Product labeled in part: California Hamzyme Concentrate, Item #44330, DOM: 03/01/10, Net Wt. 50 lbs (22.7kg). Recall # F-2241-2010
CODE
1) Lot #10029. 10 represent the year 2010 and 029 represent the Julian Date or January 29th;
2) Lot #10018. 10 represent the year 2010 and 018 represent the Julian Date or January 18th.
RECALLING FIRM/MANUFACTURER
Seasonings.net, LLC, Kent, WA, by telephone and e-mail on February 26, 2010 and letter via fax on March 1, 2010. Firm initiated recall is complete.
REASON
The product was manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1) 250 lbs; 2) 200 lbs
DISTRIBUTION
WA
___________________________________
PRODUCT
"VITA BREATH" dietary supplement (60, 500mg each) capsules packed in white non-flex plastic bottle, UPC: 89539120327. Recall # F-2248-2010
CODE
Lot Numbers: 1001, 1002, 1003 & 12.31.2010; Exp. Dates: 03/28/2011-12/31/2012
RECALLING FIRM/MANUFACTURER
American Herbal Laboratories, Inc., Rosemead, CA, by telephone on May 7, 2010 and by letters on May 13, 2010. Firm initiated recall is ongoing.
REASON
The recall was initiated after the firm was informed by FDA investigators that recent lab analysis show that the Vita Breath Dietary Supplement may contain elevated levels of Lead.
VOLUME OF PRODUCT IN COMMERCE
1,307 bottles
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I
___________________________________
PRODUCT
1) Zicam Cold Remedy Nasal Gel (Zincum Gluconium 2X) 0.50 fl oz bottle, packaged in single and Twin Pack boxes; UPC: 7322160121 and UPC: 7322160201208. Recall # D-611-2010;
2) Zicam Cold Remedy Gel Swabs, (Zincum Gluconium 2X) in boxes of 20 and 34 medicated swabs; UPC: 732216201017 and UPC: 732216300505. Recall # D-612-2010
CODE
All lots
RECALLING FIRM/MANUFACTURER
Matrixx Initiatives Inc., Scottsdale, AZ, by letters on June 23, 2009. Firm initiated recall is ongoing.
REASON
Reports of Adverse Events: use of product has been associated with anosmia (loss of smell) which is a long-term or permanent condition.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
STUD Capsule For Men, Herbal Supplement, packaged in blister packs containing 1 capsule, UPC 7 83259 00051 8 Supplement Facts Serving Size: 1 Capsule; Servings Per Container: 1. Rhodiola Rhizome Extract 65 mg, Lycium Fruit Extract 35 mg, Chinese Yam Rhizome Extract 40 mg, Cnidium Fruit Extract 20 mg, Poria Selerotium Extract 25 mg, Tienchi Ginseng Extract 5 mg, Cistanche 45 mg. Other Ingredients: Cassia Extract, Asian Ginseng Extract, Rice Flour and Gelatin. Made in The USA. Recall # D-614-2010
CODE
Lot # 060607-01 060108-01, Exp. 6/2013
RECALLING FIRM/MANUFACTURER
Kanec USA, Inc., Davie, FL, by letters, dated April 1, 2010, and by press release on April 2, 2010. Firm initiated recall is ongoing.
REASON
Marketed Without an NDA/ANDA: product contains sildenafil, the active ingredient in an FDA approved drug used in the treatment of erectile dysfunction, making the product an unapproved new drug.
VOLUME OF PRODUCT IN COMMERCE
150,000 capsules
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
MasXtreme Herbal Supplement for Men, Maximum Sexual Enhancement, Herbal Supplement for Men, 1 capsule per blister carton, 750 mg Proprietary Blend, UPC 0 94922 30080 5; Supplement Facts Serving Size: 1 Capsule Servings Per Container: 1 Amount per Capsule, Proprietary Blend: Chuchuhuasi (Bark), Maca (Root), Huanarpo Macho (Bark) (Jatropha macrantha), Catuaba (Bark), Evodia (Fruit) & Long Jack (Root) (Eurycoma longifolia) 750 mg. Recall # D-620-2010
CODE
Lot # 911035
RECALLING FIRM/MANUFACTURER
Recalling Firm: Natural Wellness, LLC, Deerfield Beach, FL, by e-mail and telephone beginning March 25, 2010, by e-mail and press release on March 30, 2010 and by e-mail on April 16, 2010.
Manufacturer: Florida Supplement Corp., Hollywood, FL. Firm initiated recall is ongoing.
REASON
Marketed Without an Approved NDA/ANDA: Product contains undeclared amounts of Aildenafil, an analog of Sildenafil. Sildenafil is the active pharmaceutical ingredient in an FDA-approved drug that is used to treat erectile dysfunction (ED). Product also contains the drug Phentolamine, which is used to expand blood vessels to increase blood flow.
VOLUME OF PRODUCT IN COMMERCE
202,176 capsules
DISTRIBUTION
Nationwide, Bahamas, Dominican Republic, and Barbados
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
Spectrum Kanamycin Sulfate, USP, (Kanamycin Monosulfate), Catalog #K1390, Sizes: 25g, 100g & 6 x 100g bottles. Recall # D-605-2010
CODE
Lots YI0763 (Mfr. Lot 90803) & YK0432 (Mfr. Lot 90803)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Spectrum Chemicals and Laboratory Products, Gardena, CA, by telephone and letter beginning on April 14, 2010.
Manufacturer: North China Pharm., Shijiazhuang, China. Firm initiated recall is ongoing.
REASON
Presence of foreign substance; trimethoprin detected.
VOLUME OF PRODUCT IN COMMERCE
10,000g
DISTRIBUTION
Nationwide and New Zealand
___________________________________
PRODUCT
1) PediaCare Children's Multi-Symptom Cold, Grape Flavor Liquid, 4 fl oz (118 mL), UPC 3 0045-0556-05 9, NDC 50580-556-04, OTC. Recall # D-616-2010;
2) PediaCare Children's Long-Acting Cough, Grape Flavor Liquid, 4 fl oz (118 mL), UPC 3 0045-0465-04 7, NDC 50580-465-04, OTC. Recall # D-617-2010;
3) PediaCare Children's Decongestant, Raspberry Flavor Liquid, 4 fl oz (118 mL), UPC 3 0045-0554-04 8, NDC 50580-554-04, OTC. Recall # D-618-2010;
4) PediaCare Children's Allergy & Cold, Grape Flavor Liquid, 4 fl oz (118 mL), UPC 3 0045-0552-04 4, NDC 50580-552-04, OTC. Recall # D-619-2010
CODE
All lots within expiry
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blacksmith Brands, Inc., Tarrytown, NY, by press release and letters dated May 28, 2010.
Manufacturer: McNeil Consumer Healthcare, Div of McNeil-PPC, Inc., Fort Washington, PA. Firm initiated recall is ongoing.
REASON
GMP deficiencies at manufacturing site.
VOLUME OF PRODUCT IN COMMERCE
2,328,984 units (total for 4 products)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Sertraline Hydrochloride Tablets, 100 mg, 1000 count bottles, Rx only, NDC 16714-613-06. Recall # D-621-2010
CODE
Lot #: SR1009068-A, Exp 7/2011
RECALLING FIRM/MANUFACTURER
Aurobindo Pharma Limited, Andhra Pradesh, India, by telephone on January 13, 2010 and by letters beginning on May 14, 2010, and June 16, 2010. Firm initiated recall is ongoing.
REASON
Adulterated Presence of Foreign Tablets: One foreign tablet of Zolpidem Tartrate Tablets, 10 mg, was found in a bottle of 100 count Sertraline HCL Tablets, 100 mg.
VOLUME OF PRODUCT IN COMMERCE
948 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Zolpidem Tartrate Tablets, 10 mg, CIV, 500 count bottle, Rx only, NDC 16714-622-02. Recall # D-622-2010
CODE
Lot #s: ZT1009034-A, Exp 7/2011; ZT1009036-A, Exp 7/2011
RECALLING FIRM/MANUFACTURER
Aurobindo Pharma Limited, Andhra Pradesh, India, by letters on May 14, 2010 and June 16, 2010. Firm initiated recall is ongoing.
REASON
Tablet Thickness: One oversize tablet was found in two lots of Zolpidem Tartrate Tablets, 10 mg, 500 count.
VOLUME OF PRODUCT IN COMMERCE
6,755 bottles
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
LITTLE TUMMYS Stimulant Laxative Drops (Sennosides 8.8mg/mL), 1 fl oz (30 mL) dropper bottle, OTC. UPC Code: 7 56184 12071 2; Product Code: 10756184123222. There are 24 packages in each case. Recall # D-615-2010
CODE
Lots: 08288 (exp. 07/28/10), 08518 (exp. 12/18/10), 09415 (exp. 10/16/11), 09478 (exp. 12/03/11)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtech Products, Inc., Irvington, NY, by e-mail, telephone or visit on April 19, 2010 and by letters on April 20, 2010.
Manufacturer: Altaire Pharmaceuticals, Inc., Aquebogue, NY. Firm initiated recall is ongoing.
REASON
Defective Container: seal breach on tamper evident foil seal.
VOLUME OF PRODUCT IN COMMERCE
193,992 bottles (8083 cases of 24 each)
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1276-10
CODE
Unit: 017GR52399
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Saint Paul, MN, by facsimile on March 24, 2006 and by letter on May 1, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
___________________________________
PRODUCT
Source Plasma for further manufacture. Recall # B-1343-10
CODE
Units: 2040055458, 2040053823, 2040052644
RECALLING FIRM/MANUFACTURER
PlasmaCare, Inc., Columbus, OH, by facsimile on October 29, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose scheduled physical exam was not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NC
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1441-10;
2) Plasma Frozen. Recall # B-1442-10
CODE
1) and 2) Unit: 35FX31325
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Roanoke, VA, by telephone on April 11, 2008 and followed up letter dated April 14, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WV, VA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1459-10
CODE
Unit: 72M912651
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on February 21, 2010. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
1) Platelets Leukocytes Reduced. Recall # B-1463-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1464-10
CODE
1) and 2) Unit: 16GW65754
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Columbus, OH, by telephone on December 13, 2007 and by letter on December 21, 2007. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1500-10
2) Platelets Leukocytes Reduced. Recall # B-1501-10
CODE
1) and 2) Unit: 42K03922
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Cleveland, OH, by telephone on July 28, 2008 and letter dated July 31, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to an area designated as endemic for malarial, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH
___________________________________
PRODUCT
Source Plasma. Recall # B-1518-10
CODE
Units: TA0009385, TA0009509, TA0009802, TA0009915, TA0010386, TA0010622, TA0009110
RECALLING FIRM/MANUFACTURER
Recalling Firm: DCI Biologicals Texarkana, LLC, Gallup, NM, by letters dated July 24, 2008 and July 28, 2008.
Manufacturer: DCI Biologicals Texarkana, LLC, Texarkana, AR. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
NC, Austria
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-1519-10;
2) Fresh Frozen Plasma. Recall # B-1520-10
CODE
1) and 2) Unit: 2410916
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by letter dated April 17, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking the medication Avodart, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH
___________________________________
PRODUCT
Source Plasma. Recall # B-1551-10
CODE
Units: TA2027243; TA2027466; TA2027967; TA2028589; TA2029646; TA2034008; TA2034254
RECALLING FIRM/MANUFACTURER
DCI Biologicals Texarkana, LLC, Texarkana, AR, by fax, letter and e-mail on October14, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who failed to answer questions regarding risk for vCJD, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma. Recall # B-1552-10
CODE
Units: 392024241, 392024888, 392024736, 392024460, 392023913, 392023630, 392022516, 392022315, 392021477, 392019895, 392019018, 392018776, 392017949, 392017800, 392016873, 392015873, 392015695, 392021266, 392014979, 392014796, 392014513, 392014318, 392014004, 392013315, 392011484, 392011296, 392010995, 392010791, 392011918, 392011746, 392010035, 392009822, 392009567, 392009386, 392009013, 392008696, 392007424, 392007190, 392006837, 392006655, 392003751, 392003669, I56018212, I56018076, I56017991, I56016744, I56016629, I56016549, I56016464, I56016382, I56016060, I56015712, I56015693, I56015156, I56015051, I56014305, I56014146, I56013685, I56013373, I56013201, I56012705, I56012233, I56008497 and I56008467
RECALLING FIRM/MANUFACTURER
Recalling Firm: Talecris Plasma Resources Inc., Research Triangle Park, NC, by fax on August 21, 2008.
Manufacturer: Talecris Plasma Resources, Inc., Rockford, IL. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously permanently deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
64 units
DISTRIBUTION
NC, Austria
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1554-10
CODE
Unit: 4164109
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by fax on August 9, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1555-10
CODE
Units: 53LK15606; 53LK15607; 53LK15607; 53LK15606
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore, MD, by telephone on August 22, 2007 and follow up letter dated January 17, 2008. Firm initiated recall is complete.
REASON
Blood products, not tested for hemoglobin content as part of the collection equipment validation process, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
MD
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1557-10
CODE
Unit: 8037059
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by telephone on September 9, 2007. Firm initiated recall is complete.
REASON
Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1568-10
CODE
Units: 8206247 Part 1; 8206247 Part 2; 8205841 Part 1; 8205841 Part 2; 8205513 Part 1; 8205513 Part 2
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH, by letter on October 30, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
OH
___________________________________
PRODUCT
1) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1572-10;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-1573-10
CODE
1) Unit: 8115549;
2) Units: 8115549; 8115907; 8116095
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH, by letter dated October 24, 2006. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
OH
___________________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1576-10
CODE
Unit: W010407004016
RECALLING FIRM/MANUFACTURER
Department of the Army, Brooke Army Medical Center, Fort Sam, Houston, TX, by fax on October 26, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose risk for variant Creutzfeldt-Jakob Disease (vCJD) was undetermined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1581-10
CODE
Unit: 12C84554
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Carolinas Region, Charlotte, NC, by facsimile on January 11, 2010 and by letter dated April 9, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC, AL
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1582-10
CODE
Unit: W121609542219
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Piedmont, SC, by telephone on January 19, 2010 and by facsimile on January 20, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1585-10
CODE
Unit: W0415100010056
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Lubbock Center, Lubbock, TX, by telephone on February 17, 2010.
Manufacturer: Blood Systems, Inc., San Angelo, TX. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1586-10
CODE
Units: W041009231481L, W0410100184536
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., dba United Blood Services, Scottsdale, AZ, by telephone and facsimile on March 24, 2010.
Manufacturer: Blood Systems, Inc., dba United Blood Services, Chandler, AZ. Firm initiated recall is complete.
REASON
Blood products, for which quality control testing was not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1587-10
CODE
Unit: 72N220724
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on March 29, 2010. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1588-10
CODE
Unit: 72N333896
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by facsimile on March 19, 2010. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1589-10
CODE
Unit: 72N093024
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Mobile, AL, by facsimile on March 31, 2010. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-1590-10;
2) Red Blood Cells. Recall # B-1591-10
3) Platelets. Recall # B-1593-10
CODE
1) Unit: 1030796;
2) and 3) Unit: 1030796, 0914211;
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by electronic notification on March 22, 2010 and by letter dated March 29, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
VA, MN
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1595-10;
2) Recovered Plasma. Recall # B-1596-10
CODE
1) and 2) Unit: W035209185910Z
RECALLING FIRM/MANUFACTURER
Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc., Tyler, TX, by letter dated March 2, 2010 and by e-mail on March 2, 2010 and March 10, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a blood transfusion within a year of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
1) Platelets Pooled Leukocytes Reduced Irradiated. Recall # B-1597-10;
2) Fresh Frozen Plasma. Recall # B-1598-10;
3) Red Blood Cells. Recall # B-1599-10
CODE
1) Unit: W120609383914;
2) and 3) Unit: W120609207864
RECALLING FIRM/MANUFACTURER
Michigan Blood, Saginaw, MI, by facsimile on February 12, 2010 and February 16, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of exposure to and treatment for rabies, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MI
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1600-10;
2) Red Blood Cells. Recall # B-1601-10;
3) Platelets Pooled Leukocytes Reduced. Recall # B-1602-10
CODE
1) Unit: W120609270227;
2) Unit: W120609202742;
3) Units: W120609380204, W120609381649
RECALLING FIRM/MANUFACTURER
Michigan Blood, Saginaw, MI, by facsimile on February 23, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who resided in an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
MI
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-1603-10;
2) Fresh Frozen Plasma. Recall # B-1604-10;
3) Recovered Plasma. Recall # B-1605-10
CODE
1) and 2) Unit: W035409010150;
3) Unit: 3167933
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by telephone and facsimile on February l, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Austria, OH
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1606-10
CODE
Unit: W117010154265 (2 units)
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific – Irwin Center, San Francisco, CA, by telephone on February 10, 2010 and by letter dated February 12, 2010. Firm initiated recall is complete.
REASON
Blood products, which were not quarantined after receiving post donation information concerning an illness following donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-1607-10
CODE
Unit: 08NWVB4925
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Clarksburg, WV, by facsimile on March 19, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-1608-10
CODE
Unit: 09DIAM6213
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Dubuque, IA, by facsimile on March 22, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not have a complete physical exam prior to donating, was distributed.
VOLUME OF PRODUCT IN COMMERCE
CA
DISTRIBUTION
1 unit
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1609-10
CODE
Unit: W117009140843
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific – Irwin Center, San Francisco, CA, by telephone on February 22, 2010 and by letter dated February 22, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelet Pheresis Leukocytes Reduced. Recall # B-1610-10
CODE
Unit: W035410004669 (7 units)
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by telephone on February 18, 2010. Firm initiated recall is complete.
REASON
Blood products, labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
OH
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-1611-10;
2) Fresh Frozen Plasma. Recall # B-1612-10
CODE
1) and 2) Unit: 72M447306
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by facsimile on March 17, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for receiving a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1613-10;
2) Cryoprecipitated AHF, Pooled. Recall # B-1614-10
CODE
1) Unit: W038110054274;
2) Unit: W038110982894
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers – Lake Park, Lake Park, FL, by telephone on February 17, 2010 and March 12, 2010 and by letters dated February 24, 2010 and March 15, 2010. Firm initiated recall is complete.
REASON
Blood products, manufactured from units of Whole Blood that were overweight, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1615-10
CODE
Units: W038109032908, 7375108
RECALLING FIRM/MANUFACTURER
Recalling Firm: Florida’s Blood Centers, Inc., Melbourne, FL by telephone on March 22, 2010 and by letter dated March 22, 2010.
Manufacturer: Florida’s Blood Centers, Inc., Rockledge, FL. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1621-10;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-1622-10
CODE
1) Unit: LC87524;
2) Unit: LC88580
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc., Milwaukee, WI, by facsimile on November 16, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1624-10
CODE
Unit: W036309160505
RECALLING FIRM/MANUFACTURER
Recalling Firm: BloodCenter of Wisconsin, Inc., Milwaukee, WI, by facsimile on January 21, 2010.
Manufacturer: BloodCenter of Wisconsin, Inc., Racine, WI. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who took aspirin within 48 hours of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1625-10
CODE
Unit: 29KF48780
RECALLING FIRM/MANUFACTURER
American National Red Cross, Mid Atlantic Region, Norfolk, VA, by facsimile and electronic notification on February 19, 2010 and by letter dated February 19, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
___________________________________
PRODUCT
1) Platelets. Recall # B-1627-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1628-10
CODE
1) and 2) Unit: 2495919
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letter dated March 23, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
KY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1629-10
CODE
Units: 2466096, 2393080B, 2393080A, 2466096A
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letter dated March 26, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
KY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1630-10
CODE
Unit: W045010026325
RECALLING FIRM/MANUFACTURER
Community Blood Center of Greater Kansas City, Kansas City, MO, by telephone on March18, 2010 and by letter dated March 30, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KS
___________________________________
PRODUCT
1) Platelets. Recall # B-1631-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1632-10
CODE
1) Units: 2435190, 2534284;
2) Units: 2435190, 2495268, 2534284
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letter dated March 31, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
KY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1633-10
CODE
Unit: W041609045435R
RECALLING FIRM/MANUFACTURER
Blood Systems Inc,/dba United Blood Services, Meridian, MS, by telephone and facsimile on March 15, 2010 and by letter dated April 7, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MS
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1635-10
CODE
Unit: 003GL94680
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southern Region, Douglasville, GA, by facsimile on November 22, 2009 and by letters dated November 22, 2009 and December 21, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1636-10
CODE
Unit: 72N569412
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., East Alabama Region, Opelika, AL, by facsimile on April 9, 2010. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1637-10
CODE
Unit: 72N430021
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Dunwoody, GA, by facsimile on April 12, 2010. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1638-10;
2) Platelets Pooled Leukocytes Reduced. Recall # B-1639-10
CODE
1) Unit: 0824440;
2) Unit: 1016908
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH, by letter dated April 7, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1640-10
CODE
Unit: W036209625278
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by telephone on February 17, 2010. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly labeled as negative for the K red cell antigen, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1641-10
CODE
Unit: 03LE51675
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA, by facsimile on December 19, 2009 and by letter dated March 23, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1499-10
CODE
Unit: GL01133
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc, Milwaukee, WI, by facsimile on November 16, 2006. 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
WI
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1556-10
CODE
Unit: 2880059
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center University of Cincinnati Medical Center, Cincinnati, OH, by letter dated June 11, 2007. Firm initiated recall is complete.
REASON
Blood product, which did not have a platelet count performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
___________________________________
PRODUCT
1) Platelets Pooled Leukocytes Reduced. Recall # B-1574-10
2) Red Blood Cells. Recall # B-1575-10
CODE
1) Unit: 1010007;
2) Unit: 6748176
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH, by letter on July 25, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for leishmaniasis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1580-10
CODE
Unit: 12C84554
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Carolinas Region, Charlotte, NC, by facsimile on January 11, 2010 and by letter dated April 9, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC, AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1583-10
CODE
Unit: W149509205472
RECALLING FIRM/MANUFACTURER
Northern California Community Blood Bank, Eureka, CA, by facsimile on January 22, 2010. Firm initiated recall is complete.
REASON
Blood product, manufactured without the additive solution, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1592-10
CODE
Unit: 0914211
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by electronic notification on March 22, 2010 and by letter dated March 29, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1626-10
CODE
Unit: 29KF48780
RECALLING FIRM/MANUFACTURER
American National Red Cross, Mid Atlantic Region, Norfolk, VA, by facsimile and electronic notification on February 19, 2010 and by letter dated February 19, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1634-10
CODE
Unit: W041609045435R
RECALLING FIRM/MANUFACTURER
Blood Systems Inc,/dba United Blood Services, Meridian, MS, by telephone and facsimile on March 15, 2010 and by letter dated April 7, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
Medtronic Orthopedic Dovetail Clamp, REF 9730289. In combination with a tera-tracker reference frame, is used by an Orthopedic surgeon to navigate the location of an acetabular cup positioner/impactor during hip replacement surgery. Recall # Z-0923-2010
CODE
All lot numbers
RECALLING FIRM/MANUFACTURER
Medtronic Navigation, Inc., Louisville, CO, by letter on November 3, 2009. Firm initiated recall is ongoing.
REASON
Orthopedic clamp may slip if used with non-indicated system, resulting in possible inaccurate navigation information being displayed.
VOLUME OF PRODUCT IN COMMERCE
244 units
DISTRIBUTION
VA, IA, MN and OK and countries of Australia, Austria, Belarus, Belgium, Brazil, Canada, China, Croatia, Czech Republic, Denmark, France, Germany, Hong Kong, Iceland, India, Israel, Italy, Japan, Korea, Lebanon, Malta, Mexico, Netherlands, Poland, Russian Federation, Saudi Arabia, South Africa, Switzerland, Turkey, United Arab Emirates, and UK
___________________________________
PRODUCT
1) Pointe Scientific Creatinine Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # C7539-150, C7539-625, C7539-625-S, C7539-1250, HC939-756, HC939-1340, 12-C7539-98, 8-C7539-R1-120, 8-C7539-R1-500, 8-C7539-R1-1000, 7-C7539-R1-120, 7-C7539-R1-1000, and 7-C7539-R1-500. For the quantitative determination of creatinine in serum. For in-vitro diagnostic use only. Recall # Z-1035-2010;
2) Pointe Scientific Creatinine Reagent R2; Catalog 3-C7539-L, 7-C7539-R2-30, 7-C7539-R2-125, 7-C7539-R2-250, 8-C7539-R2-30, 8-C7539-R2-125 and 8-7539-R2-250. For the quantitative determination of creatinine in serum. For in-vitro diagnostic use only. Recall # Z-1036-2010
CODE
All lots numbers containing the numbers 923202; exp. 2011-08.
RECALLING FIRM/MANUFACTURER
Pointe Scientific, Inc., Canton, MI, by letter, dated December 1, 2009. Firm initiated recall is ongoing.
REASON
An additional 10% picric acid was added to the R2 component during production.
VOLUME OF PRODUCT IN COMMERCE
892 kits plus 625 vials and 40.4L.
DISTRIBUTION
Nationwide, Bolivia, Greece, Guyana, India, Indonesia, Israel, Kenya, Korea, Malaysia, Mexico, Pakistan, Philippines, Russia, Serbia, Sri Lanka, Tanzania, Trinidad and Ukraine
___________________________________
PRODUCT
FHC micro Targeting Guideline 4000 version 1.4 (GL4K) Software, Catalog # MT-GL4K. Int. This version of software was released in August 2009. Recall # Z-1143-2010
CODE
Serial Numbers: 19454, 14423, 17349, 19215, 15573, 19424, 17583, 17589, 17588, and 17581.
RECALLING FIRM/MANUFACTURER
FHC, Inc., Bowdoinham, ME, by telephone and by email, dated December 2009, beginning December 28th. Firm initiated recall is complete.
REASON
The raster tab for the GL4K version 1.4 software may assign incorrect depths for waveform recordings and if used to identify the implantation target for the DBS lead, the implant may be placed in the wrong location.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
GA, MA, NC, NJ, OH, RI, TN, TX, and WV and Bucharest, Romania
___________________________________
PRODUCT
LM Aculight Corporation Perseus Pulsed Fiber Laser, Model number: ML36L-1541. Additional Model numbers with non-defective type"A" fiber: M22L-1540, M27L-1541, M281-1540, M30PL-1541, & M33L-1541. Pulsed laser energy generator intended for use as an OEM component for the LiDAR/Rangefinding, Surveillance, Mapping, and Sensing. Part Number: 35-001466-032. Recall # Z-1170-2010
CODE
Serial Numbers: 00001, 00002, and 00003
RECALLING FIRM/MANUFACTURER
Lockheed-Martin Aculight, Bothell, WA, by letter on May 1, 2009. Firm initiated recall is ongoing.
REASON
Defect of optical fiber - The Perseus device with type "B" fiber has been found to emit potentially hazardous laser radiation.
VOLUME OF PRODUCT IN COMMERCE
21 units
DISTRIBUTION
PA, FL, MD, CO, Austria and Canada
___________________________________
PRODUCT
ev3 Protg EverFlex Self-Expanding Biliary Stent System, Sterile EO, (REF: PRB35-06-150-080, REF PRB35-06-120-120 and PRB35-06-150-120), 4.5 - 5.5mm, Expiration: 2011-10-01, Rx only. Intended as a palliative treatment of malignant neoplasms in the biliary tree. Recall # Z-1598-2010
CODE
Lot Numbers: 7857377, 7856788 and 7858698
RECALLING FIRM/MANUFACTURER
Ev3, Inc., Plymouth, MN, by letter dated March 31, 2010. Firm initiated recall is ongoing.
REASON
A lot of 120mm Protg EverFlex" Biliary Stent system may contain a 150mm length Self-Expanding stent and two lots o 150mm Protg EverFlex" Biliary Stent System may contain a 120 mm length Self-Expanding stent.
VOLUME OF PRODUCT IN COMMERCE
19 units
DISTRIBUTION
CA, FL, IL, LA, MA, MI, NH, PA, TN, TX, UT, VA and WA
___________________________________
PRODUCT
Eon Mini Implantable Pulse Generator (IPG). Indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain. Recall # Z-1599-2010
CODE
Device Code: 65-3788-01, Serial Numbers: 703271, 703287, 703050, 703051, 704169, 704476 and 704520
RECALLING FIRM/MANUFACTURER
Advanced Neuromodulation Systems, Inc., Plano, TX, by letter dated April 2010. Firm initiated recall is ongoing.
REASON
Due to a missed inspection step during manufacturing, a small number of devices may experience a gradual or sudden loss of charging capability.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Disposable Skin Stapler - 35 Wide; Surgical Skin Stapler; Rx, sterile, single use skin stapler, individually packaged in a thermo-formed tray with a Tyvek lid, 5 trays per box; Made in China; catalog number FS-35W. Designed to close incisions during a surgical procedure. Recall # Z-1610-2010
CODE
Lot Numbers: 090203-SH and 091008-SH
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cardinal Health, Mc Gaw Park, IL, by letter dated April 1, 2010.
Manufacturer: Ningbo Advan Electrical Co. Ltd., Cixi City, China. Firm initiated recall is ongoing.
REASON
The sterility of the staplers is questionable.
VOLUME OF PRODUCT IN COMMERCE
1,638 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) 4.5MM Bone Tap, Modular; Intended to create a screw thread in a hole drilled into bone to facilitate placement of a bone screw. Part Number 52-1024. Recall # Z-1611-2010;
2) 5.5MM Bone Tap, Modular; Intended to create a screw thread in a hole drilled into bone to facilitate placement of a bone screw. Part Number 52-1025. Recall # Z-1612-2010;
3) 6.5MM Bone Tap, Modular ; Intended to create a screw thread in a hole drilled into bone to facilitate placement of a bone screw. Part Number 52-1026. Recall # Z-1613-2010;
4) 7.5MM Bone Tap, Modular; Intended to create a screw thread in a hole drilled into bone to facilitate placement of a bone screw. Part Number 52-1027. Recall # Z-1614-2010;
5) 8.5MM Bone Tap, Modular. Intended to create a screw thread in a hole drilled into bone to facilitate placement of a bone screw. Part Number 52-1028. Recall # Z-1615-2010
CODE
1); 2); 3); 4) and 5) Lot numbers: 16380-xxxx and 17162-xxxx
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blackstone Medical, Inc., Wayne, NJ, by letter dated April 21, 2010.
Manufacturer: Orthofix, Inc., McKinney, TX. Firm initiated recall is ongoing.
REASON
Certain lots of the non-cannulated Modular Bone Taps used with the Firebird Spinal Fixation Systems may contain a manufacturing non conformance resulting in the taps creating a single lead screw thread rather than the required dual lead screw thread.
VOLUME OF PRODUCT IN COMMERCE
465 total bone taps
DISTRIBUTION
Nationwide, Australia and Spain
___________________________________
PRODUCT
1) Advance Duramer Tibial Insert, REF: Kimp-312L, Size 3 Left Medial Pivot, Thickness 12MM, 1 each, Sterile EO. Indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients. Recall # Z-1636-2010;
2) Advance Duramer Tibial Insert, REF: Kimp-312R Size 3 Right Medial Pivot, Thickness 12MM, 1 each, Sterile EO. Indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients. Recall # Z-1637-2010
CODE
1) Lot Number: 679391;
2) Lot Number: 681644
RECALLING FIRM/MANUFACTURER
Wright Medical Technology, Inc., Arlington, TN, by letter dated November 24, 2009. Firm initiated recall is complete.
REASON
The left medial pivot and right medial pivot inserts were co-mingled.
VOLUME OF PRODUCT IN COMMERCE
70 units
DISTRIBUTION
Nationwide, The Netherlands, Italy, Republic of Korea and Japan
___________________________________
PRODUCT
BD Beaver Arthro-Lok Pointed Tip 4mm Blade, REF 376780. Intended for use in arthroscopic procedures. Recall # Z-1638-2010
CODE
Lot Number: 7291713, Expiration Date: 2012-10
RECALLING FIRM/MANUFACTURER
Becton Dickinson and Co., Waltham, MA, by telephone, fax and e-mail beginning June 12, 2009. Firm initiated recall is complete.
REASON
Mislabeled: Arthro-Lok Pointed Tip 4mm Blade curving right instead of left.
VOLUME OF PRODUCT IN COMMERCE
354 units
DISTRIBUTION
Nationwide, Japan and Belgium
___________________________________
PRODUCT
Churchill Medical Systems Bag Access Device w/Smartsite Needleless Injection Site, Sterile, Non pyrogenic, Latex Free Product Code: KSA-140. Intravascular administration set. Recall # Z-1639-2010
CODE
Lot Numbers: 903005, 904057, 904060, 904061, 904062, 904063, 905089, 905090, 905091, 906199, 907005, 907006, 907007, 909014, 909015, 909016, 909017, 909018, 909026, 909031, 909032, 909033, 909034, 909035, 909036 and 909037
RECALLING FIRM/MANUFACTURER
Churchill Medical Systems, Inc., Dover, NH, by letter dated October 20, 2009. Firm initiated recall is complete.
REASON
Bond between the spike and needle may leak, break or detach resulting in leakage or spillage of chemotherapeutic agents.
VOLUME OF PRODUCT IN COMMERCE
283,900 each
DISTRIBUTION
FL
___________________________________
PRODUCT
UniCel DxH 800 Coulter Cellular Analysis System, Part Number 629029. Quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. Recall # Z-1656-2010
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter dated March 10, 2010.
Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.
REASON
Issue 1: The Diagnostic procedure, Simulate-CDNR Cycle, is not functioning properly. Impact: There is a potential for inadequate sample preparation of samples following the use of this Diagnostic function impacting WBC, Differential, Reticulocyte and/or NRBC results. Issue 2: Use of the Auto Prune function causes the deletion of Quality Control files. Impact: If the last run for a control lot is older than the number of days set in Auto Prune (default, 30 days), all the QC runs of that control file will be deleted.
VOLUME OF PRODUCT IN COMMERCE
63 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
1) Mallory Head Calcar Provisional, 34 mm replacement stem, 11 mm x 220 mm left, Sterile, REF 104773. Implant device intended for use in femoral revision surgery. Recall # Z-1665-2010;
2) Mallory Head Calcar Provisional, 45 mm replacement stem, 13.0 x 220 mm left, Sterile, REF 104986. Implant device intended for use in femoral revision surgery. Recall # Z-1666-2010;
3) Mallory Head Calcar Femoral, 34 mm resection/porous coated, 9mm x 170 mm stem, Sterile, REF 11-104902. Implant device intended for use in femoral revision surgery. Recall # Z-1667-2010;
4) Mallory Head Calcar Femoral, 34 mm resection/porous coated, 13.0 x 170 mm,, Sterile, REF 11-104904. Implant device intended for use in femoral revision surgery. Recall # Z-1668-2010;
5) Mallory Head Calcar Femoral, 34 mm resection/porous coated, 15.0 mm x 170 mm stem, Sterile, REF 11-104905. Implant device intended for use in femoral revision surgery. Recall # Z-1669-2010;
6) Mallory Head Calcar Provisional, 55 mm resection/porous coated, 17.0 mm x 260 mm left, Sterile, REF 11-104939. Implant device intended for use in femoral revision surgery. Recall # Z-1670-2010;
7) Mallory Head Calcar Femoral, 34 mm resection/porous coated, 9.0 mm x 220 mm right stem, Sterile, REF 11-104947. Implant device intended for use in femoral revision surgery.
Recall # Z-1671-2010;
8) Mallory Head Calcar Femoral, 34 mm resection/porous coated, 15.0 mm x 220 mm right stem, Sterile, REF 11-104953. Implant device intended for use in femoral revision surgery.
Recall # Z-1672-2010;
9) Mallory Head Calcar Femoral, 34 mm resection/porous coated, 15.0 mm x 220 mm left stem, Sterile, REF 11-104954. Implant device intended for use in femoral revision surgery.
Recall # Z-1673-2010;
10) Mallory Head Calcar Femoral, 55 mm resection/porous coated, 15.0 mm x 220 mm right stem, Sterile, REF 11-104971. Implant device intended for use in femoral revision surgery. Recall # Z-1674-2010;
11) Mallory Head Calcar Femoral 55 mm resection/porous coated 15.0 mm x 220 mm left stem, Sterile, REF 11-104972. Implant device intended for use in femoral revision surgery. Recall # Z-1675-2010;
12) 17 mm Mallory Head Calcar 45 mm repl. femoral/100% porous 18.5 mm minimum ream dia x 260 mm rt., Sterile, REF CP154591. Implant device intended for use in femoral revision surgery. Recall # Z-1676-2010;
13) 17 mm Mallory Head Calcar 55 mm repl. femoral/100% porous 18.5 mm minimum ream dia. x 220 mm rt., Sterile, REF CP154593. Implant device intended for use in femoral revision surgery. Recall # Z-1677-2010;
14) 19 mm Mallory Head Calcar 45 mm repl. femoral/100% porous 20.5 mm minimum ream dia. x 260 mm rt., Sterile, REF CP154599. Implant device intended for use in femoral revision surgery. Recall # Z-1678-2010;
15) 19 mm Mallory Head Calcar 55 mm repl. femoral/100% porous 20.5 mm minimum ream dia. x 260 mm lt.., Sterile, REF CP154604. Implant device intended for use in femoral revision surgery. Recall # Z-1679-2010
CODE
1) Lot Number: M997990;
2) Lot Number: M553140;
3) Lot Numbers: M650320, M298660;
4) Lot Number: M479250;
5) Lot Numbers: M205110, M205120, M562570, M565210, M427660, M110390;
6) Lot Number: M059030;
7) Lot Numbers: M420820, M826280;
8) Lot Number: M562580;
9) Lot Number: M597090;
10) Lot Number: M647810;
11) Lot Number: M472000;
12) Lot Numbers: M609130 and M083500;
13) Lot Number: M609120;
14) Lot Number: M609070;
15) Lot Number: M920160
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by letter dated March 10, 2010. Firm initiated recall is ongoing.
REASON
The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep.
VOLUME OF PRODUCT IN COMMERCE
41 units
DISTRIBUTION
OH, IN, FL, KY, NV, CA, Mexico, Chile, China, Japan and The Netherlands
___________________________________
PRODUCT
UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029. Quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. Recall # Z-1680-2010
CODE
All Serial Numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter dated December 8, 2009.
Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.
REASON
The Corrective Action was initiated after Beckman Coulter confirmed three issues related to host transmissions with the UniCel DxH 800. This information only affects instruments interfaced to a host system.
VOLUME OF PRODUCT IN COMMERCE
42 units
DISTRIBUTION
Nationwide and Canada
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
___________________________________
PRODUCT
1) Vycon Nutrisafe 2 syringe 5 ml, For Oral use only with Nutrisafe 2 Product Code: 1015.062M Vycon/Churchill Medical System. Recall # Z-1203-2010;
2) Vycon Nutrisafe 2 syringe 10 ml, Syringe for connection to Nutrisafe 2. For oral use only Product Code: 1015.122M Vycon/Churchill Medical System. Recall # Z-1204-2010
CODE
1) Lot Numbers: 910118 Exp: 2014/10;
2) Lot Numbers: 910107, Exp: 2014/11 911165, Exp. 2014/12
RECALLING FIRM/MANUFACTURER
Churchill Medical Systems, Inc., Dover, NH, by letter on January 29, 2010. Firm initiated recall is ongoing.
REASON
Mislabeled feeding syringes : 12 ml syringe mislabeled as 10 ml.
VOLUME OF PRODUCT IN COMMERCE
33,700 units
DISTRIBUTION
CA, NM, NJ, NY, PA, VA, and TX
___________________________________
PRODUCT
Euflexxa (1% sodium hyaluronate). Pre-filled syringe, Rx only, 3 syringes per carton; Indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics. Recall # Z-1635-2010
CODE
Lot Numbers: RC0101A, Exp. 5/2010; RC0102A, Exp. 5/2010; RC0107A, Exp 5/2010; RC0114A, Exp 5/2010; RC0118A, Exp 6/2010; RC0122A, Exp 6/2010; RC0123A, Exp 6/2010; RC0127A, Exp 6/2010; and RC0131A, Exp 6/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ferring Pharmaceuticals Inc., Parsippany, NJ, by letter dated April 16, 2010.
Manufacturer: Bio-Technology General (Israel), Ltd., Kiryat Malchi, Beer Tuvia, Israel. Firm initiated recall is ongoing.
REASON
Out of Specification results for molecular weight or viscosity through the established expiration date.
VOLUME OF PRODUCT IN COMMERCE
29,376 cartons of 3 syringes per carton
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Cepheid Xpert Flu A Panel (GXFLUPANEL-10). Indicated as an automated multiplex real-time RT-PCR assay for use in laboratories for the in vitro qualitative detection and differentiation of 2009 H1N1 influenza viral RNA. Recall # Z-1651-2010
2) Cepheid Xpert Flu A Panel (GXFLUPANEL-CE-10). Indicated as an automated multiplex real-time RT-PCR assay for use in laboratories for the in vitro qualitative detection and differentiation of 2009 H1N1 influenza viral RNA. Recall # Z-1652-2010
CODE
1) Lot Numbers: 00401, 00502, 00701, 00702 (Expires 2010 07 11 for lot 00401 and 2010 09 05 for the rest);
2) Lot Number: 00501 (Expires 2010 08 08)
RECALLING FIRM/MANUFACTURER
Cepheid, Sunnyvale, CA, by letter beginning February 19, 2010. Firm initiated recall is ongoing.
REASON
Firm has had an increasing number of customer complaints regarding higher than expected Indeterminate Test Results due to "Invalid" test reports from our system when they have been conducting their own internal validation studies using banked frozen repository specimens.
VOLUME OF PRODUCT IN COMMERCE
2,747 kits
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Coulter LH 500 Series System. Quantitative, automated hematology analyzer and leukocyte differential cell counter for in vitro diagnostic use in clinical laboratories. Product LH500 100V Part number 178832; Product LH500 120V Part number 178833; Product LH500 240V Part Number 178834. Recall # Z-1657-2010;
2) Unicel DxH 800 Coulter Cellular Analysis System. Quantitative, automated hematology analyzer and for in vitro diagnostic use in screening patient populations found in clinical laboratories. Part number: 629029. Recall # Z-1658-2010
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter dated February 12, 2010.
Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.
REASON
Issue 1: The system will substitute or omit the characters # @ [\] ' {I) when the system is configured in a language other than English or Chinese. Example: Using the character @, a substitution in the string '123@456' would result in '123#456' and an omission would result in '123456' Issue 2: The system will omit the character ~ regardless of language. Impact: There is a potential for Specimen or Patient misidentification to occur.
VOLUME OF PRODUCT IN COMMERCE
1,576 units
DISTRIBUTION
Nationwide and Canada
RECALLS AND FIELD CORRECTIONS: VETERINARY – CLASS II
___________________________________
PRODUCT
Gentamicin Sulfate Solution, 100 mg/ml, each mL contains gentamicin sulfate veterinary equivalent to 100 mg gentamicin base, packaged in sterile multi-dose 100-ml bottles, 12/case, RX, ANDA 200-395, under the following brand names and labels: (1) VEDCO GentaVed 100, NDC 50989-040-12; (2) AgriLabs LEGACY, NDC 57561-336-04; (3) Phoenix Pharmaceutical, Inc. GentaMax 100, NDC 57319-520-05; (4) RXV Gentamicin Sulfate Solution; (5) VetTek Gentamicin Sulfate Solution, NDC 60270-338-10; and (6) Butler GENTAFUSE, NDC 11695-4146-1. Recall # V-188-2010
CODE
Lot 091239, Exp. 01/2012
RECALLING FIRM/MANUFACTURER
Sparhawk Laboratories Inc., Lenexa, KS, by telephone on June 8, 2010, and by letters dated June 11, 2010. Firm initiated recall is ongoing.
REASON
A water leak occurred in the fill room outside the filling line.
VOLUME OF PRODUCT IN COMMERCE
14,677/100-ml. bottles
DISTRIBUTION
MO, TN, and OH
END OF ENFORCEMENT REPORT FOR JUNE 30, 2010
#
