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U.S. Department of Health and Human Services

Safety

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Enforcement Report for August 24, 2011

 

August 24, 2011                                                                                        11-34
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
Cost Plus World Market Brand Tumeric Powder. Sold in a) 1.0 oz (42g), plastic packets. Non irradiated ; India Also packaged in 1 lb. individual ziplock pouches and 25 lb bulk containers; Item number P1645 for 1 pound and bulk bags. Recall # F-1625-2011
CODE
a) Lot numbers: CJI090244, VJI090244, CKI090244, VKI090244, VLI090244, CLI090244, VAJ090244, CBJ090244, CCJ090244, VBJ090244, CDJ090244, VDJ090244, VGJ090244, CHJ090244, VHJ090244, CHJ090244, VIJ090244, CJJ090244, VJJ090244, CKJ090244, VAK090244, CAK090244, VBK090244, CBK090244; b) Lot # 090244
RECALLING FIRM/MANUFACTURER
Recalling Firm: San Francisco Herb & Natural Food, Co., Fremont, CA, by letters on March 24, 2011.
Manufacturer: Starwest Botanicals Inc., Rancho Cordova, CA. California initiated recall is ongoing.
REASON
FDA samples were positive for lead in the amounts of 42.5 ppb and 48 ppb.
VOLUME OF PRODUCT IN COMMERCE
9,864 lbs
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
AZAR MOUNTAIN TRAIL MIX SWEET AND SALTY 9613896; Ingredients: Oil Roasted and Salted Peanuts (peanuts, cottonseed oil, salt); Cocoa Buttons (Sugar, partially hydrogenated vegetable oil (contains one or more of the following: palm kernel, cottonseed, soybean, coconut), cocoa, cocoa processed with alkali, calcium sulfate, corn syrup, dextrin, beeswax, carnuba wax, soy lecithin [an emulsifier], artificial flavor, artificial colors (includes Yellow #5, Yellow #5 Lake, Yellow #6, Yellow #6 Lake, Blue #1, Blue #1 Lake, Blue #2, Red #40 Lake)); Raisins, Oil Roasted and Salted Almonds (almonds, cottonseed oil, salt); Oil Roasted and Salted Cashews (cashews, cottonseed oil, salt). Net wt. 5 lbs (2270 grams) Recall # F-1627-2011
CODE
Date codes: 10256, 10284, 10313, 10320, 10342, 10357, 11017, 11031, 11066, 11089, 11109, 11123, 11138, and 11144
RECALLING FIRM/MANUFACTURER
Mount Franklin Foods LLC, El Paso, TX, by email on May 28, 2001 and press release on May 31, 2011. Firm initiated recall is ongoing.
REASON
Product contains undeclared milk.
VOLUME OF PRODUCT IN COMMERCE
2,788 cases
DISTRIBUTION
FL, IL, MT, CO, CA, MT, ID, OR, AR, TX
___________________________________
PRODUCT
1) XYMOGEN EXCLUSIVE PROFESSIONAL FORMULAS OrganiX Greens Organic Whole Food Bar GLUTEN FREE COLD PROCESSED DAIRY FREE SOY FREE PEANUT FREE GMO FREE 12 (50g) Bars Net wt. 21.16 oz (600g) Organic Whole Food Bar***Certified Organic Ingredients: Organic Cashew Butter, Organic Date Paste, Organic Premium Agave Nectar, Organic Brown Rice Protein, Organic Raisins, Organic Biosprouts Flax, Organic BioSprouts Quinoa, Organic Wheat Grass Juice Powder, Organic Barley Grass Juice Powder, Organic Sesame Seeds, Organic Spirulina, Organic Blueberries, Organic Raspberries, Organic Broccoli Sprouts, Organic Beet Juice and Organic Carrot Juice.***PREPARED IN A PEANUT FREE FACILITY.***Caution: May contain pieces of dates pits, stems, nut shells or seeds. Do not use if wrapper is tampered with or damaged. Prepared in a facility that uses tree nuts.***8 71149 00160 5. Recall # F-1628-2011;
 
2) XYMOGEN EXCLUSIVE PROFESSIONAL FORMULAS OrganiX Omega 3 Organic Whole Food Bar GLUTEN FREE COLD PROCESSED DAIRY FREE SOY FREE PEANUT FREE GMO FREE 12 -50 g Bars Net wt. 21.16 oz (600g)***Certified Organic Ingredients: Organic Cashew Butter, Organic Date Paste, Organic Premium Agave Nectar, Organic Biosprouts Flax, Organic BioSprouts Quinoa, Organic Raisins and Organic Sesame Seeds.***PREPARED IN A PEANUT FREE FACILITY.***Caution: May contain pieces of dates pits, stems, nut shells or seeds. Do not use if wrapper is tampered with or damaged. Prepared in a facility that uses tree nuts.***8 71149 00158 2. Recall # F-1629-2011;
 
3) XYMOGEN EXCLUSIVE PROFESSIONAL FORMULAS OrganiX Spice Organic Whole Food Bar GLUTEN FREE COLD PROCESSED DAIRY FREE SOY FREE PEANUT FREE GMO FREE 12 (50g) Bars Net wt. 21.16 oz (600g)***Certified Organic Ingredients: Organic Cashew Butter, Organic Date Paste, Organic Premium Agave Nectar, Organic Brown Rice Protein, Organic Raisins, Organic Biosprouts Quinoa, Organic Bio Sprouts Flax and Organic Cinnamon. ***PREPARED IN A PEANUT FREE FACILITY.***Caution: May contain pieces of dates pits, stems, nut shells or seeds. Do not use if wrapper is tampered with or damaged. Prepared in a facility that uses tree nuts.***8 71149 00159 9*** Recall # F-1630-2011
CODE
1) Lot 4072110 and 5072110, Exp 21-Jul-11;
2) Lot 1083110 Exp. 31- Aug-11;
3) Lot 1072110 and 2072110, Exp 21-Jul-11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Atlantic Pro Nutrients, Inc. dba XYMOGEN, Orlando, FL, by letter on August 5, 2011 and press release on August 8, 2011.
Manufacturer: Living Ecology, Inc., Corona, CA. FDA initiated recall is ongoing.
REASON
The Xymogen Bars may contain undeclared peanut protein.
VOLUME OF PRODUCT IN COMMERCE
2,669 cartons
DISTRIBUTION
Nationwide, Canada and New Zealand
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
Harry and David Dark Chocolate Fleur De Sel Moose Munch Delirious Snacks. The product is 10oz size bag of caramel and dark chocolate coated popcorn with cashews and almonds. The bag is clear plastic and product can be seen clearly. Bar Code: "780994769205". Recall # F-1626-2011
CODE
"Best if Used By" date of 08/28/11
RECALLING FIRM/MANUFACTURER
Harry and David Operations, Inc., Medford, OR, by e-mail on August 1, 2011. Firm initiated recall is ongoing.
REASON
Product contains undeclared wheat.
VOLUME OF PRODUCT IN COMMERCE
7896 10 oz bags
DISTRIBUTION
Nationwide
__________________________________
PRODUCT
PENTREXYL FORTE NATURAL With Natural Antibiotic Properties Dietary Supplement Caja con 30 capsulas capsulas 500mg Helps to naturally fight common cold symptoms Ayuda de manera natural a combatir los sintomas del refriado mejorando el funcionamiento del sistema inmunologico Directions: One Pentrexil Forte Natural tablet twice daily DO NOT exceede more than 14 days at a time, or as recommended by your health care professional. Indicaciones: Tomar 1 capsula de Pentrexil Forte Natural 2 veces al dia. No exceder la dosis por mas de 14 dias, o siga las instrucciones de su medio. A paniculata is intended to support a normal, healthy respiratory tract and immune system. A Paniculata por sus propiedades antibioticas Ayuda a mantener sistema respiratorio e inmunologico sano protegiendolo contra afecciones del systema respiratorio. As a Dietary supplement Andrographis is used for prophylactic and symptomatic treatment of upper respiratory infections such as the common cold, as well as for uncomplicated sinusitis, pharyngotonsillitis, pneumonia, and bronchitis. Como suplemento dietetico Andrographis es usado para el tratamiento de afecciones respiratorias e infecciones como el resfriado comun y para sintomas de sinusitis simple. Recall # F-1631-2011
CODE
All lots distributed between October 19, 2010 and May 18, 2011.
RECALLING FIRM/MANUFACTURER
Phoenix Import & Dis, Spring, TX, by press releases on May 12 & 19, 2011. FDA initiated recall is ongoing.
REASON
The packaging is believed to be misleading, causing it to be confused with an antibiotic.
VOLUME OF PRODUCT IN COMMERCE
15,366 boxes
DISTRIBUTION
TX, GA
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
___________________________________
PRODUCT
Blue Runner(R) Shrimp Creole Sauce, Just Add Seafood, Net wt 25 oz (708 g), Product of U.S.A., UPC 070353502209. Recall # F-1632-2011
CODE
Lot #: GB0511SCRE1, GD1111SCRE1, GD1111SCRE2, GE1611SCRE1, GF111SCRE2
RECALLING FIRM/MANUFACTURER
Blue Runner Foods, Inc., Gonzales, LA, via email on August 1, 2011. FDA initiated recall is ongoing.
REASON
Misbranding. Product description includes shrimp which is not in the ingredient list or in the product.
VOLUME OF PRODUCT IN COMMERCE
2683 cases of 12 units
DISTRIBUTION
LA, FL, MS, AL
 
The FDA begins a pilot program seeking to expedite notifications of human drug product recalls to the public. The agency will modify the drug product section of the Enforcement Report17, published every Wednesday, to include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. Such recalls will be listed under the heading, “Recalls Pending Classification: DRUGS.” They will be reposted with their classification once that determination has been made. Send comments or suggestions to CDERRecallPilot@fda.hhs.gov.
 
RECALLS PENDING CLASSIFICATION: DRUGS
___________________________
PRODUCT
Avastin 0.1mL Syringes
CODE
All lots
RECALLING FIRM/MANUFACTURING FIRM
Walgreens Pharmacy dba Chroniscript, Miami FL
REASON FOR RECALL
Microbial contamination; Streptococcus oralis
___________________________
PRODUCT
Metformin Hydrochloride Tablets, 500 mg, 60 Tablets, NDC 0781-5050-61
CODE
204210
RECALLING FIRM/MANUFACTURING FIRM
Sandoz, Inc., 506 Carnegie Ctr Ste 400, Princeton New Jersey
REASON FOR RECALL
Presence of foreign matter
___________________________
PRODUCT
Benzalkonium Chloride Prep Pad, 0.13% Benzalkonium Chloride, w/v., 1-count pad per foil packet, packaged in 4,000 packets per case
CODE
8J123, Exp 09/11
RECALLING FIRM/MANUFACTURING FIRM
H & P Industries, Inc., 700 W North Shore Drive, Hartland, WI, 53029-8358
REASON FOR RECALL
Superpotency (Single Ingredient) Drug: This recall has been initiated as a result of out of specification results demonstrating high benzalkonium chloride
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I
___________________________________
PRODUCT
Regenerect Natural Male Erectile Stimulant Dietary Supplement Capsules, 625 mg proprietary blend, packaged in 1 count packets, Recall # D-828-2011
CODE
Lot Numbers: 100521 & 112850
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ethos Environmental Inc dba Regeneca International Inc., Irvine, CA, by press release on April 28, 2011 and by letter via e-mail beginning on May 2, 2011.
Manufacturer: Pinnacle Labs International, Inc., Upland, CA. Firm initiated recall is ongoing.
REASON
Marketed without an approved NDA/NADA; product found to contain sulfoaildenafil, an nnanalogue of sildenafil, the active ingredient used in an FDA approved product for the treatment of erectile dysfunction.
VOLUME OF PRODUCT IN COMMERCE
224,385 capsules
DISTRIBUTION
Nationwide and Puerto Rico
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
Pradaxa capsules, 75 mg (Dabigatran Etexilate), NDC#: 0597-0107-60, NDA#: 22-512. Recall # D-829-2011
CODE
Lot No. 002089, Exp. Date JAN 2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boehringer Ingelheim Roxane Inc., Columbus. OH, by letter on November 30, 2011. 
Manufacturer: Boehringer Ingelheim Pharma GMBH & Co. Ingelheim, Germany. Firm initiated recall is ongoing.
REASON
Wrong Bar Code; Incorrect bar code read on a Pradaxa 75 mg blister unit dose. When scanned, the blister bar code identified the NDC as Pradaxa 150 mg NDC.
VOLUME OF PRODUCT IN COMMERCE
1,143 boxes/10 blister cards/6/75 mg capsules
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Metronidazole Tablets USP, 250 mg, Rx olny, 100 count bottle; NDC 50111-333-01. Recall # D-832-2011;
 
2) Metronidazole Tablets USP, 500 mg, Rx only, 100 count bottle; NDC 50111-334-01. Recall # D-833-2011
CODE
1) Lot number: 313336, Exp. date: 8/2012; Lot number: 316770, Exp. date: 2/2013;
2) Lot number: 317021, Exp 5/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on April 1, 2011.
Manufacturer: Pliva Krakow S.A., Krakow, Poland. Firm initiated recall is ongoing.
REASON
Low Tablet Weight: Some tablets may not conform to weight specifications.
VOLUME OF PRODUCT IN COMMERCE
46,4s63 Units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
0.9% Sodium Chloride Injection, USP 1000 mL VisIV Container NDC 0409-7983-48, Rx only. Recall # D-834-2011
CODE
Lot Code: 96-094-JT
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake Forest IL, by letter on April 6, 2011.
Manufacturer Hospira, Inc., Austin, TX. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility; Potential for the solution to leak from the port seal and sterility to be compromised.
VOLUME OF PRODUCT IN COMMERCE
124,428
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Gabapentin Tablets USP, 600 mg, 500 count bottle, NDC # 0093-4443-05. Recall # D-835-2011
CODE
Lot # 24G431, exp 5/2012
RECALLING FIRM/MANUFACTURER
Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on June 13, 2011. Firm initiated recall is ongoing.
REASON
Presence of Foreign Substance: Potential for small glass particles.
VOLUME OF PRODUCT IN COMMERCE
1,973 bottles
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
Levetiracetam Oral Solution 100 mg/mL, Rx Only, 16 fl oz bottle, NDC: 351991-651-16. Recall # D-836-2011
CODE
Lot number: M10111A; Lot number: M10115A, and Lot number: M10114A. All with expiration dates of 11/12
RECALLING FIRM/MANUFACTURER
Tris Pharma Inc., Monmouth Junction, NJ, by letter on April 5, 2011. Firm initiated recall is ongoing.
REASON
Microbial Contamination of Non-Sterile Products: Out of specification results were observed in stability sample testing for microbiological limits in three lots of Levetiracetam Oral Solution, 100 mg/ml.
VOLUME OF PRODUCT IN COMMERCE
11,508 bottles
DISTRIBUTION
CT
___________________________________
PRODUCT
1) Cramer Blister Kit, Stock #761201, UPC # 311960743020. Recall # D-841-2011;
 
2) Cramer Coach's Team First Aid Kit, Stock #761206, UPC # 311960743075. Recall # D-842-2011;
 
3) Unlabeled Fanny Pack Equipped, Stock #111005, containing 2 individually-wrapped Triad Sterile Alcohol Prep Pads, Cat. No. 10-3101. The fanny pack contains other components. Recall # D-843-2011;
 
4) Cramer Personal First Aid Kit, For Sports, Home, Travel, and Camping, Stock #761203, UPC # 311960743099. Recall # D-844-2011;
 
5) Cramer First Aid Kit, Stock #112000, 111 pieces of comprehensive first aid supplies, Cat. No. 10-3101, UPC # 311960507301. Recall # D-845-2011;
 
6) Riddell First Aid Kit, a) Stock #907281, b) Stock #361206, packaged in an unlabeled bag, containing 6 individually-wrapped Triad Sterile Alcohol Prep Pads, Cat. No. 10-3101. The bag contains other components. Recall # D-846-2011
CODE
1) Lot #: LTK479, LTK482, LUL497;
 
2) Lot #: LUI415, LUI427, LUI429, LUJ437, LVF227, LVF249, LVG254, LVG266, LVG279, LVJ370, LVJ371, LVJ372, LWA008;
 
3) Lot #: LUG333, LVH317;
 
4) Lot #: LUB037, LUL495, LUL496, LUL500, LVF209
 
5) Lot #: LUB037, LUL495, LUL496, LUL500, LVF209;
 
6) Lot #: LVG255
RECALLING FIRM/MANUFACTURER
Cramer Products Inc., Gardner, KS, by letter dated February 3, 2011. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility: These kits are being recalled because they contain individually wrapped Triad alcohol pads which were recalled under the Triad Group recall because of potential contamination with the bacteria, Bacillus cereus.
VOLUME OF PRODUCT IN COMMERCE
10,492 kits
DISTRIBUTION
Nationwide, Canada, Mexico, and Bermuda
___________________________________
PRODUCT
1) Thyro-Tab 0.50 mg. in bulk drums intended for repackaging, RX. Recall # D-849-2011;
 
2) Levothroid (levothyroxine sodium tablets, USP), 50 mcg, packaged in 100-tablet bottles, Rx only, NDC 0456-1321-01. Recall # D-850-2011
CODE
1) Lots HA19010 and HB19010, Exp. date July, 2011;
2) Lots 1079114 and 1079115, Exp. date July, 2011
RECALLING FIRM/MANUFACTURER
Lloyd Inc Of Iowa, Shenandoah, IA, by letters dated November 30, 2010 and December 9, 2010. Firm initiated recall is complete.
REASON
Subpotent; 3 month stability
VOLUME OF PRODUCT IN COMMERCE
Thyro-Tab - 3,817,963 tablets; Levothroid - 37,280/100-ct. bottles
DISTRIBUTION
Nationwide and PR
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
Diflorasone Diacetate Cream USP, 0.05%, a) 15 g tube, NDC 51672-1296-1, UPC 3 51672 12961 3; b) 30 g tube, NDC 51672-1296-2, UPC 3 51672 12962 0; and c) 60 g tube, NDC 51672-1296-3, UPC 3 51672 12963 7; Rx only. Recall # D-831-2011
CODE
Lot #: a) B0042, Exp 02/12; b) H9046, Exp 08/11; B0042, Exp 02/12; c) H9046, Exp 08/11; B0041, B0042, Exp 02/12; E0117, E0118, Exp 05/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY, by letters dated August 12, 2011.
Manufacturer: Taro Pharmaceuticals, Inc., Brampton, Canada. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: Out-of-specification results for Diflorasone Diacetate Cream USP, 0.05% were obtained for known and total degradants.
VOLUME OF PRODUCT IN COMMERCE
27,557 tubes
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
1) Glimepride Tablets USP, 1 mg, Rx only, 100 tablets, NDC 0781-5045-01. Recall # D-837-2011;
 
2) Glimepride Tablets USP, 2 mg, Rx only, 100 tablets, NDC 0781-5046-01. Recall # D-838-2011;
 
3) Glimepride Tablets USP, 4 mg, Rx only, 100 tablets, NDC 0781-5047-01. Recall # D-839-2011
CODE
1) Lot #: 100652 Exp 4/2011 101233 5/2011; 101885 8/2011; 101886 8/2011; 102530 10/2011; 102532 10/2011; 102533 10/2011; 103010 11/2011; 103847 2/2012; 104131 3/2012; 104132 3/2012; 104287 4/2012; 104336, 4/2012;
 
2) Lot #: 100857 4/2011; 102364 9/2011; 103009 11/2011; 104073 3/2012; 104616 5/2012;
 
3) Lot #: 101732, 7/2011; 102557 10/2011; 103846 2/2012; 104617 5/2012
RECALLING FIRM/MANUFACTURER
Corepharma LLC, Middlesex, NJ, by letters on March 4, 2011. Firm initiated recall is ongoing.
REASON
Labeling: Incorrect or Missing package insert: Product was packaged with an incorrect package insert/outsert.
VOLUME OF PRODUCT IN COMMERCE
158,987 bottles
DISTRIBUTION
CO
___________________________________
PRODUCT
Clindamycin Phosphate, Topical Solution USP, 1% (Pledgets). Recall # D-840-2011
CODE
Lot 045NL, Exp. 6/12/2011; Lot 046NL, Exp. 6/12/2011; Lot 047NL, Exp. 6/12/2011; Lot 033NS, Exp. 9/12/2011; Lot 034NS, Exp. 9/12/2011; Lot 035NS, Exp. 9/12/2011; Lot 038PA, Exp 12/12/2011; Lot 039PA, Exp 12/12/2011; Lot 040PA, Exp 12/12/2011; Lot 041PA, Exp 12/12/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: VersaPharm, Inc., Warminster, PA, by letters on May 26, 2011.
Manufacturer: Pharma Pac, LLC, De Kalb, MI. Firm initiated recall is complete.
REASON
Impurities/Degradation Products: Out-of-specification result or trending toward out-of-specification result for a degradation impurity.
VOLUME OF PRODUCT IN COMMERCE
71,110
DISTRIBUTION
Nationwide and PR
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced. Recall # B-1604-11;
2) Red Blood Cells. Recall # B-1605-11;
3) Red Blood Cells Leukocytes Reduced. Recall # B-1606-11;
4) Fresh Frozen Plasma. Recall # B-1607-11;
5) Cryoprecipitated AHF. Recall # B-1608-11;
6) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1609-11;
7) Fresh Frozen Plasma (APheresis). Recall # B-1610-11
CODE
1) Units: 8002985, 1280873;
 
2) Units: 1281426, 1279935;
 
3) Units: 8249831,8225797, 8226031, 8229024, 8234263, 8237998, 8240635, 8210490, 8212845, 8212946, 8216038, 8219309, 8220816, 8222159, 8202193, 8205055, 8008975, 8009132, 8011988, 8013740, 8014672, 8015148, 8015195, 8016500, 8019285, 8020311, 8022747, 8005154, 8007701, 8004292, 8003332, 1281937, 2771583, 8507147, 8525410, 8503838, 8501043, 8502068, 8502713, 8502812;
 
4) Units: 8222159, 8205055, 8022747, 8007701, 8003332, 1279935, 8503838, 8502812, 8249831;
 
5) Unit: 8004292;
 
6) Unit: 8246610;
 
7) Unit: 8246610
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakersfield, CA, by fax on November 3, 2005. Firm initiated recall is complete.  
REASON
Blood products, collected from an ineligible donor due to improper HIV re-entry, were distributed.
VOLUME OF PRODUCT IN COMMERCE
56 units
DISTRIBUTION
CA, NJ
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1773-11
CODE
Unit: 018FN35887
RECALLING FIRM/MANUFACTURER
American National Red Cross, Great Lakes Region, Lansing, MI, by fax beginning on August 13, 2009. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1835-11
CODE
Unit: W088411520582
RECALLING FIRM/MANUFACTURER
Blood Bank Of Hawaii, Honolulu, HI, by fax on May 10, 2011. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may have compromised its sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
HI
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated. Recall # B-1837-11
CODE
Units: W117010107638; W117010107638
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific - Irwin Center, San Francisco, CA, by telephone on June 2, 2011.
Manufacturer: Blood Centers of the Pacific- Peninsula Center, Millbrae, CA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1838-11;
2) Red Blood Cells Frozen. Recall # B-1839-11;
3) Platelets Leukocytes Reduced. Recall # B-1840-11;
4) Platelets Pooled Leukocytes Reduced. Recall # B-1841-11;
5) Red Blood Cells. Recall # B-1842-11
CODE
1) Unit: 2018600;
2) Unit: 2196281;
3) Unit: 2196281;
4) Unit: 2905419;
5) Units: 2048231; 2048231; 2196281; 2226047; 2253014; 2390832; 2390832
RECALLING FIRM/MANUFACTURER
Community Blood Centers/S Florida, Inc., Lauderhill, FL, by fax on May 23, 2011 and follow up letter on May 24, 2011. 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
11 units
DISTRIBUTION
NY, FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1847-11
CODE
Unit: 06LR63126
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by facsimile, letter and electronic mail dated May 11, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA  
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1849-11
CODE
Unit: 06GV37035
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by fax on January 29, 2011. 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
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1859-11
CODE
Unit: W036810004251
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Inc., Miami, FL, by telephone and letter on June 30, 2011. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland and FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1879-11
CODE
Unit: 12GE19182
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Charlotte, NC, by fax and letter on May 9, 2011.
Manufacturer: American Red Cross Blood Services, Wilmington, NC. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, NC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1885-11
CODE
Units: W045111225706; W045110168511; W045110179967
RECALLING FIRM/MANUFACTURER
Community Blood Center of the Ozarks, Springfield, MO, by e-mail and letter on June 20, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Austria, MO, NC, AR
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1901-11
CODE
Unit: W042311002786V
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Billings, MT, via the internet on June 3, 2011.
Manufacturer: Blood Systems, Inc., Cheyenne, WY. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1902-11
CODE
Unit: W038609893679
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Inc., Sarasota, FL, by e-mail on June 2, 2011 and fax on June 9, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1903-11
CODE
Units: W047011122574A; W047011122574B
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., Long Island City, by letter dated June 28, 2011. Firm initiated recall is complete.
REASON
Blood products, labeled leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ, NY
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1904-11
CODE
Units: W041611021971O; W041611021969C; W041611021969C; W041611021971O; W041611021970Q; W041611021970Q; W041611021959G; W041611021959G
RECALLING FIRM/MANUFACTURER
Blood Systems Inc/dba United Blood Services, Meridian, MS, by fax on May 27, 2011 and letter dated July 8, 2011. 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
8 units
DISTRIBUTION
AZ, TN, MS
___________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced. Recall # B-1922-11;
2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall #B-1923-11
CODE
1) Units: 017FE68497; 017FE68541; 017FE68553;
2) Units: 017FE68485; 017FE68514; 017FE68514; 017FE68485
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by telephone on May 26, 2011. Firm initiated recall is complete.
REASON
Blood products, labeled leukoreduced which did not meet the requirements for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
MN
___________________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1924-11
CODE
Unit: W044211235379
RECALLING FIRM/MANUFACTURER
San Diego Blood Bank, San Diego, CA, by telephone on May 18, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-1926-11;
2) Cryoprecipitated AHF, Pooled. Recall # B-1927-11;
3) Recovered Plasma. Recall # B-1928-11
CODE
1) Unit: W038111035872;
2) Unit: W038111980473;
3) Unit: W038111035872
RECALLING FIRM/MANUFACTURER
Recalling Firm:Florida's Blood Centers - Lake Park, Palm Beach Gardens, FL, by telephone on June 9, 2011 and facsimile letter on June 10, 2011.
Manufacturer: Florida's Blood Centers, Inc. - Port St. Lucie, FL. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1929-11
CODE
Unit: W229811502379
RECALLING FIRM/MANUFACTURER
Blood Center of Northcentral Wisconsin, Inc., Wausau, WI, by facsimile on June 28, 2011. Firm initiated recall is complete.
REASON
Blood products, which was collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY, CO
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1930-11;
2) Plasma Frozen. Recall # B-1931-11
CODE
1) and 2) Units: W117010197336; W117010123376
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific - Irwin Center, San Francisco, CA, by telephone dated May 31, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of Hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall #B-1940-11
CODE
Unit: W127811200915
RECALLING FIRM/MANUFACTURER
Tacoma Pierce County Blood Bank, Tacoma, WA, by telephone and letter on May 31, 2011 and a follow-up letter on June 29, 2011. Firm initiated recall is complete.
REASON
Blood product, collected using a method that had not been validated, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
1) Plasma Frozen. Recall # B-1942-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1943-11
CODE
1) and 2) Unit: W042211033473L
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Las Vegas, NV, by telephone on June 3, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NV
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall #B-1944-11
CODE
Unit: W037711122440
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center UC Medical Center, Cincinnati, OH, by telephone on May 2, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which hematocrit was not appropriately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
1) Anti-Jka Bioclone 1x3ml; Product number 721105. Recall # B-1519-11;
2) Anti-Fya 1x3ml; Product #715130. Recall # B-1520-11;
3) Anti-P1 1x3mL; Product number 715530. Recall # B-1521-11;
4) Anti-IGG 1x10 mL; Product number 716360; Anti-IGG GRN 1x10 ml; Product number 716760. Recall # B-1522-11;
5) Anti-SM S 1x3mL, Product #721830. Recall # B-1523-11;
6) Anti-B Bioclone 3x10 mL, Product #711328. Recall # B-1524-11;
7) Anti-SM k Cellano 1x3mL, Product number 721030. Recall # B-1525-11;
8) Anti-SM E Bioclone 1x5 mL, Product 714180. Recall # B-1526-11;
9) Anti-Leb Bio 2.0, Product #715380. Recall # B-1527-11;
10) Hepatitis B Virus Core Antigen(EIA, Recombinant), Product number 933245. Recall # B-1528-11;
11) Anti-E Bioclone 1 x 5 mL, Product number 713180. Recall # B-1529-11;
12) Anti-A,B Bioclone 3 x 10 mL, Product number 711528. Recall # B-1530-11;
13) Anti-Lea Bio 2.0 - , Product number 715280. Recall # B-1531-11;
14) Anti-A Bioclone 3x10 mL, Product number 711228. Recall # B-1532-11;
15) Anti-c Bioclone 1 x 5 mL ; Product number 713080. Recall # B-1533-11;
16) Anti-M - 1 x 5 mL, Product number 715850; Recall # B-1534-11
CODE 
1) Lot #JAB385AX; Expiry Date 11/25/2011;
2) Lot #FA220B; Expiry date 3/15/2012;
3) Lot #PG162A; Expiry date 1/18/2012;
4) Lot #IG163B; Expiry date 1/14/2012; Lot #IGG163C; Expiry Date 2/04/2012;
5) Lot #LS162A, Expiry date 2/23/2012;
6) Lot #BBB776AX; Expiry date 3/11/2012;
7) Lot #LK178A, Expiry date 9/04/2011;
8) Lot #SEB370A, Expiry Date 2/23/2012;
9) Lot #LBB238A, Expiry date 3/22/2012;
10) Lot number CHK536, Expiry Date 7/29/10;
11) Lot #EB310A, Expiry Date, 11/02/2011;
12) Lot number ABB692AXM, Expiry Date 3/18/2012;
13) Lot number LAB148A, Expiry Date 11/15/2010;
14) Lot number BAA584AX, Expiry date 2/12/2012;
15) Lot # CB292A, Expiry Date 1/4/2012;
16) Lot number: MM 574A, Expiry date 1/27/2012
RECALLING FIRM/MANUFACTURER
Ortho Clinical Diagnostics Inc., Raritan, NJ, by telephone on July 2, 2010, and letter on July 5, 2010. Firm initiated recall is ongoing.
REASON
Ortho-Clinical Diagnostics and Micro-typing Systems Licensed Products, with a short-term temperature excursion, were distributed.
VOLUME OF PRODUCT IN COMMERCE
17 lots
DISTRIBUTION
Canada  
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1752-11
CODE
Unit: 22GP41417
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by fax on April 18, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-1753-11
CODE
Unit: 3910125380
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., N Las Vegas, NV, by fax on June 11, 2011. Firm initiated recall is complete.
 REASON
Blood product, collected from donors whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma. Recall # B-1836-11
CODE
Units: 41200198041; 41200188610; 41200164570; 41200135710; 41200111250; 41201586919; 41200073679; 41200059375
RECALLING FIRM/MANUFACTURER
Csl Plasma, Inc., Indianapolis, IN, via the internet on May 24, 2011. Firm initiated recall is complete.
REASON
Blood products, collected using an abbreviated screening process, for which the donors were not eligible, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
Germany; IL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1843-11
CODE
Units: W117011310695; W117011310695; W117011310695; W117011310690; W117011310690; W117011310696
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific - Irwin Center, San Francisco, CA, by telephone on May 11, 2011 and follow-up letter dated May 26, 2011.
Manufacturer: Blood Centers Of The Pacific - North Bay Center, Fairfield, CA. Firm initiated recall is complete.
REASON
Blood products, possible exposed to unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1845-11
CODE
Unit: W115111135783E
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on May 12, 2011. Firm initiated recall is complete.
REASON
Blood products, leukoreduced greater than five days after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Source Plasma. Recall # B-1846-11
CODE
Units: 05501216022; 05501134537; 05501168171; 05500773388
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Portland, OR, by a shared data base on May 24, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
Switzerland; Germany, and IL
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1848-11
CODE
Unit: 06LR63126
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by facsimile, letter and electronic mail dated May 11, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1858-11
CODE
Unit: W036810004251
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Inc., Miami, FL, by telephone and letter on June 30, 2011. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland and FL
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1880-11
CODE
Unit: 12GE19182
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Charlotte, NC, by fax and letter on May 9, 2011.
Manufacturer: American Red Cross Blood Services, Wilmington, NC. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, NC
___________________________________
PRODUCT
Recovered Plasma: Recall # B-1886-11
CODE
Units: W045111225706; W045109102273; W045110168511; W045110179967
RECALLING FIRM/MANUFACTURER
Community Blood Center of the Ozarks, Springfield, MO, by e-mail and letter on June 20, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
Austria, MO, NC, AR
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1898-11
CODE
Unit: 06LW08609
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, electronically via the Logic system on May 19, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated.Recall # B-1899-11
CODE
Units: W071211017743; W071211017873
RECALLING FIRM/MANUFACTURER
Medic Inc., Knoxville, TN, by telephone on May 18, 2011 and follow up letter dated May 19, 2011. Firm initiated recall is complete.
REASON
Blood products, labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Irradiated. Recall # B-1900-11
CODE
Unit: W0423110143675
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Billings, MT, by telephone and fax on June 21, 2011.
Manufacturer: Blood Systems, Inc., Cheyenne, WY. Firm initiated recall is complete.
REASON
Blood product, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WY
___________________________________
PRODUCT
Red Blood Cells, Recall # B-1941-11
CODE
Unit: W020411001343
RECALLING FIRM/MANUFACTURER
Naval Hospital, Camp LeJune, NC, by facsimile and telephone on April 22, 2011. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I
___________________________________
PRODUCT
1) Terumo Coronary Ostia cannula, 10 Fr, 10 (25 cm) long. Part Number 804115. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment. Recall # Z-2554-2011;
 
2) Terumo Coronary Ostia cannula, 12 Fr, 10 (25 cm) long; Part Number 804117. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment. Recall # Z-2555-2011;
 
3) Terumo Coronary Ostia cannula, 14 Fr, 10 (25 cm) long; Part Number 804159. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment. Recall # Z-2556-2011
CODE
1) Lot #’s: lot 0520497, 0528973, 0569610, 0606841;
2) Lot #’s: 0520484, 0528974, 0555870, 0565140, 0569078, 0584967, 0613859, 0618949, 0621707, 0626263, 0633299;
3) Lot #’s: 0520498, 0528975, 0567050, 0582503, 0617088, 0624866
RECALLING FIRM/MANUFACTURER
Recalling Firm: Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter dated May 16, 2011.
Manufacturer: California Medical Laboratories Inc., Costa Mesa, CA. Firm initiated recall is ongoing.
REASON
The presence of adhesive and/or skiving of plastic material observed inside the distal tip of the cannula, which could lead to particulate and/or decrease in the internal diameter. The plastic skiving may detach and enter the patient, embolizing the coronary vasculature. The potential risk due to decrease in the internal tip diameter is inadequate delivery of cardioplegia and/or prolonged procedure due to lower flows.
VOLUME OF PRODUCT IN COMMERCE
6,400 units
DISTRIBUTION
Nationwide and Internationally
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
Accolade TMZF Plus Hip Stem: a) Catalog # 3020-0537 Accolate d TMZF Hip Stem # 5; b) Catalog #6020-3535 Accolade 132 Size 3.5; c)  Catalog # 6021-0230 Accolade Plus TMZF Hip Stem #2; d) Catalog # 6021-0335 Accolade Plus TMZF Hip Stem #3; e) Catalog #3021-0435 Accolade TMZF Hip Stem #4; f) Catalog # 6021-0435 Accolade Plus TMZF Hip Stem #4; g) Catalog #6021-2530 Accolade (127 deg) Size 2.5 Accolade (127 deg) Size 2.5; h) Catalog # 6021-4535 Accolade (127 DEG) Size 4.5 K994366; k023105; K032300. The subject hip stem is a single-use device intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty. Recall # Z-2557-2011
CODE
a) Lot #31390203; b) Lot #31446602R; c) Lot #31515703; d) Lot 31586402; e) Lot # 31597205; f) Lot #31597206;  g) Lot #31486505; h) Lot #31850001
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics Corp. Mahwah, NJ, by letter dated March 1, 2011.
Manufacturer: Stryker Ireland, Ltd., Orthopaedics, Carrigtohill, County Cork, Ireland. Firm initiated recall is ongoing.
REASON
Accolade TMZF Plus Hip Stems are being recalled due to grit blast media which was observed in the drive hole.
VOLUME OF PRODUCT IN COMMERCE
44 units (a) 8 units; b) 0 units; c) 10 units; d) 10 units; e) 1 unit; f) 4 units; g) 10 units; h) 1 unit)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Focal Radiation Treatment Planning Workstation. Focal Release 4.51.00 and above. Allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data form a Windows-based PC and transfer the information back to the RTP system. It is intended for use in radiation treatment planning using generally accepted contouring methods. Recall # Z-2562-2011
CODE
Release 4.51.00 and higher
RECALLING FIRM/MANUFACTURER
Computerized Medical Systems Inc., Maryland Heights, MO, by letter dated November 5, 2010. Firm initiated recall is ongoing.
REASON
Focal: If a plan involving Dynamic MLC Delivery is sent from XiO to Focal and called up there in Plan Review, the angle of the gantry is set to zero for all beams. If this plan is then sent from Focal to the R&V System, the gantry angles all remain at zero which could lead to patient mistreatment.
VOLUME OF PRODUCT IN COMMERCE
155 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Monaco Radiation Treatment Planning Workstation. Monaco Release 2.04.00 and above. Used to create treatment plans for any cancer patient for who external beam intensity modulated radiation therapy (IMRT) has been prescribed. Recall # Z-2569-2011
CODE
Release 2.04 and higher
RECALLING FIRM/MANUFACTURER
Computerized Medical Systems Inc., Maryland Heights, MO, by letter on October 27, 2010. FDA initiated recall is ongoing.
REASON
Monaco: In XiO IMRT (Dynamic MLC Delivery) software, the radiation beam angle is set to zero. If different beam angles are selected via Monaco software, the beam angles will remain at zero.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
Nationwide and the Netherlands
___________________________________
PRODUCT
XiO Radiation Treatment Planning System. XiO Release 4.50.00 and above Used to create treatment plans for any cancer patient for who external beam radiation therapy of brachytherapy has been prescribed. Recall # Z-2582-2011
CODE
Release 4.50 and higher
RECALLING FIRM/MANUFACTURER
Computerized Medical Systems Inc., Maryland Heights, MO, by letter in November 2010. Firm initiated recall is ongoing.
REASON
XiO: When a new electron beam is added to a plan, the calculation Algorithm is set to Pencil Beam, and an Aperture is added to the beam, the user can select Port-Port Properties and edit the Material Thickness values. If the algorithm is then changed to Monte Carlo, the calculation will proceed and the user is not warned the Material/Thickness values just entered are not used in the dose calculation. Further, when XiO prints out the BEV of the ports, the Material/Thickness values printed on the plot are the values entered on the Port Properties page, not the values actually used in the dose calculation.
VOLUME OF PRODUCT IN COMMERCE
556 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Focal Radiation Treatment Planning System, Focal Release 4.50.00 and above for use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data from a Windows-based PC and transfer the information back to the RTP system. Recall # Z-2592-2011
CODE
Focal Release 4.50.00 and above
RECALLING FIRM/MANUFACTURER
Computerized Medical Systems Inc., Maryland Heights, MO, by letter beginning on May 21, 2010. Firm initiated recall is ongoing.
REASON
Focal: for XiO plans calculated in relative dose mode, the Focal Plan Review application will display the DVH and maximum dose correctly. However, the isodose display is not scaled correctly. If the user evaluated the plan based only on the isodose display, they might misinterpret the actual dose delivered to the patient.
VOLUME OF PRODUCT IN COMMERCE
308 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
XiO Radiation Treatment Planning System, XiO Release 2.1.0 and above Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed. Recall # Z-2593-2011
CODE
XiO Release 2.1.0 and above
RECALLING FIRM/MANUFACTURER
Computerized Medical Systems Inc., Maryland Heights, MO, by letter beginning on May 27, 2010. Firm initiated recall is ongoing.
REASON
XiO Software: The Patient Scan position is being confused with the treatment orientation of the patient. The Patient Scan position is determined from the data entered in PFM. Subsequently, when a New Teletherapy Plan is created for a patient in Teletherapy, the user is prompted with Head/Foot Gantry on the text page. This prompt is asking for the orientation of the patient when they are treated. The Setup Reference Definition index in XiO displays only the Patient Scan position.
VOLUME OF PRODUCT IN COMMERCE
1,400 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
XiO Radiation Treatment Planning System, XiO Release 4.0.2 and above Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed. Recall # Z-2595-2011
CODE
XiO Release 4.0.2 and above
RECALLING FIRM/MANUFACTURER
Computerized Medical Systems Inc., Maryland Heights, MO, by letter beginning on May 28, 2010. Firm initiated recall is ongoing.
REASON
XiO Software: when Digitally Reconstructed Radiographs (DRRs) are generated in XiO, and DICOM is used to export the DRRs (File-Print-DRR), the exported images are associated with the Beams, but NOT the Plan. The Plan association had always been done manually by the user. This is functionality that has never been provided on XiO. The problem occurs because XiO is not storing a persistent DICOM identifier with the Plan that the DRRs can reference when exporting.
VOLUME OF PRODUCT IN COMMERCE
1,288 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Focal Radiation Treatment Planning System, Focal Release 4.3.0 through 4.34.01 For use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data from a Windows-based PC and transfer the information back to the RTP system. Recall # Z-2596-2011
CODE
Focal Release 4.3.0 through 4.34.01 
RECALLING FIRM/MANUFACTURER
Computerized Medical Systems Inc., Maryland Heights, MO, by letter beginning on May 28, 2010. Firm initiated recall is ongoing.      
REASON
Focal: when a plan is sent to Focal from XiO and the structure properties are edited in Focal CT Sim activity, these changes result in changes to the MLC or field size for the plan when they should not. XiO will recalculate dose when modified plan is returned to XiO however the user may not notice that it has changed form the plant they had approved earlier. Editing the structure properties (color, rendering) in Focal can cause the MLC to discard individual leaf edits that do not match the MLC contour. Editing the structure properties in Focal can also cause the collimators to also change under certain circumstances.
VOLUME OF PRODUCT IN COMMERCE
233 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Monaco Radiation Treatment Planning Workstation, Monaco Release 2.03.00 and above To create treatment plans for any cancer patient for whom external beam intensity modulated radiation therapy (IMRT) has been prescribed. Recall # Z-2598-2011
CODE
Monaco Release 2.03.00and above
RECALLING FIRM/MANUFACTURER
Computerized Medical Systems Inc., Maryland Heights, MO, by letter on January 13, 2011. Firm initiated recall is ongoing.     
REASON
Monaco: When the isocenter location is edited in the IMRT Activity screen, the shift coordinates are not updated in the IMRT Plan report.
VOLUME OF PRODUCT IN COMMERCE
137 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
1) Encompass Hip Stem, Plasma Spray, 12/14 Taper, Standard, REF 108-XXXX, Sterile R. Intended for use in total hip arthroscopy. Device fixation is achieved by an optimal, press-fit in the medullary canal, which maximizes contact between the stem and the bone. REF Number 108- 1017, 1019, 1217, 1219, 1221, 1223, 1419, 1421, 1423, 1425, 1623, 1625, 1627, 1825, 1827. Recall # Z-2602-2011;
 
2) Encompass Hip Stem, Plasma Spray, 12/14 Taper, Extended, REF 109-XXXX, Sterile R. Intended for use in total hip arthroscopy. Device fixation is achieved by an optimal, press-fit in the medullary canal, which maximizes contact between the stem and the bone. REF Number 109-1019, 1217, 1219, 1223, 1419, 1421, 1423, 1425, 1623, 1625, 1627, 1825, 1827. Recall # Z-2603-2011
CODE t
All lot numbers
RECALLING FIRM/MANUFACTURER
Ortho Development Corp, Draper, UT, by letter on May 11, 2011. Firm initiated recall is ongoing.      
REASON
Tests on PVC packaging material resulted in alert levels for cytotoxicity.
VOLUME OF PRODUCT IN COMMERCE
226 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
syngo Dynamics Picture Archiving Communication System. The software is a picture archiving and communication system intended for acceptance, transfer, display, storage, archive, and manipulation of digital medical images including quantification and report generation. Recall # Z-2762-2011
CODE
Serial numbers: 10091602 and 10091604
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions, USA, Inc., Ann Arbor, MI, by letter on May 10, 2011. Firm initiated recall is ongoing.
REASON
For systems upgraded to syngo Dynamics version 9.0, if a legacy report generated by version 3.x or earlier is opened in the version 9.0 portals, the legacy report may be deleted and replaced with a new report from the version 9.0 reporting system or a blank report.
VOLUME OF PRODUCT IN COMMERCE
38 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Philips Diagnost 94, Diagnost 96, Diagnost 97 Universal X-Ray System The Diagnost is a multifunctional, universal X~ray system with remote controlled facilities. Routine examinations that can be performed with the Diagnost include: Gastro-Intestinal examination, Urograpy, Bronchography, Arthrography, Hysterography, Myelography, Lymphography, Skeletal radiography, Tomography and Venography/phlebography. Special procedures that require subtracted and non subtracted digital imaging include: Angiography, Peripheral angiography (bolus chasing) and Vascular and non~vascular interventional procedures. Recall # Z-2765-2011
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Healthcare Inc., Andover, MA, by letter on April 18, 2011. 
Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.
REASON
Updated Instructions For Use: During an examination where the patient is positioned on a -rotatable- chair with knees pointed to the rear of the system, the patients lower legs or ankles may be injured/broken.
VOLUME OF PRODUCT IN COMMERCE
52 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Endopledge Sinus Catheter Kit, REF: EP, 9 Fr x 18.9", Sterile EO, Sterile R, Device is a three-lumen, 9 Fr catheter with an elastomeric balloon near its tip for occluding the coronary sinus in order to retrograde perfuse the coronary circulation. An 11 Fr catheter introducer sheath, which is compatible with the catheter contamination guard, is packaged with these catheters. Recall # Z-2776-2011;
 
2) Steerable Coronary Sinus Catheter, Model SCS01, 9 Fr x 20.4", Sterile R, Edwards Lifesciences Port Access Systems. Device is a three-lumen, 9 Fr catheter with an elastomeric balloon near its tip for occluding the coronary sinus in order to retrograde perfuse the coronary circulation. An 11 Fr catheter introducer sheath, which is compatible with the catheter contamination guard, is packaged with these catheters. Recall # Z-2777-2011
CODE
1) Lot numbers: 751029B, 751036B, 751041B, 755814AB, 763115B, 763119B, 763123B, 763125B, 763127B, 763128B, 763129B, 774333B, 774334B, 774336B, 774337, 774337B, 784527B, 794302B, 794303, 794586, 798587, 818578, 818581, 821595, 831328, 833441, 841434, 848624, 848628, 848632, 856438, 856502, 856509, 856510, 856513;
 
2) Lot numbers: 678238B, 751043B, 755821B, 763122B
RECALLING FIRM/MANUFACTURER
Edwards Lifesciences, LLC, Draper, UT, by letter dated June 15, 2011. Firm initiated recall is ongoing.
REASON
Possibility of separation of the introducer sheath from the hub on Coronary Sinus Catheters.
VOLUME OF PRODUCT IN COMMERCE
2,895 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) BD Vacutainer Push Button Blood Collection Set; a) REF 367324 Rx only, 23 G x 3/4" x 12 " (0.6 x 19 mm x 305 mm); BD Vacutainer Push Button Blood Collection Set without Multiple Sample Luer Adaptor, Sterile, Rx only, 21 G x 3/4 x 12" 0.8 x 19 mm x 305 mm Blood collection system. Recall # Z-3028-2011
 
2) BD Bactec Blood Culture Procedural Tray, Cat. Number 442805. Used in conjunction with the blood collection system. Recall # Z-3029-2011
CODE
1) Lot #0315173, 0316102, 0323342, 0327441; Lot #0309244, 0309286, 0312571; Lot #0334101, 0336557, 0347425, 0354635, and 10131090
2) Lot # 1035325, 1053472, and 1066162
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letter dated April 22, 2011. 
Manufacturer: Becton Dickinson Medical Systems, Sandy, UT. Firm initiated recall is ongoing.
REASON
BD Vacutainer Push Button Blood Collection Set can potentially undergo cannula separation from the hub.
VOLUME OF PRODUCT IN COMMERCE
1,778,960
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
___________________________________
PRODUCT
Hemoglobin F & A2 Calibrator, 0.2 mL, 4 brown glass vials/box. Hemoglobin F & A2 Calibrator is used as in-vitro calibration material for Beta-thalassemia testing on the Tosoh G7. Part Number 020019. Recall # Z-3030-2011
CODE
Lot # BCAL05R. Used By Date 2011-10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tosoh Bioscience Inc., Grove City, OH, by letter dated July, 25, 2011.
Manufacturers: Tosoh Corp., Minato-Ku, Japan;
Diesse Diagnostica Senese Srl, Monteriggioni Si, Italy. Firm initiated recall is ongoing.
REASON
The value after reconstitution appeared to be lower than the assigned value on the label. The measured value for Lot BCAL05R was 5.3%, whereas the value on the label is 5.7%. The criteria of the value is +/- 0.3%.
VOLUME OF PRODUCT IN COMMERCE
6 boxes/4/2 mL bottles
DISTRIBUTION
Nationwide and Canada
 
RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS I
___________________________________
PRODUCT
Pig ears labeled as follows: (1) Prime Time Premium Dog Treats, Premium Natural Pig Ears, packaged in 2-ct. bags (UPC 7-48976-18316-6), 5-ct. bags (UPC 7-48976-09040-2 with a $5.99 retail price), and 5-ct. bags (UPC 7-48976-19040-9 with a $6.99 retail price). Premium Pig Ears, packaged in 20-ct. mesh bags, UPC 7-48976-09065-5. Recall # V-392-2011
CODE
No code
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blackman Industries Inc., Kansas City, KS, by letters dated May 3, May 6, and May 17, 2011, and by press release on May 17, 2011.
Manufacturers: Blackman Industries Inc., Kansas City, KS; Keys Manufacturing Company, Inc., Paris, IL. Firm initiated recall is ongoing.
REASON
The product is potentially contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
809/2-pks., 251/5-pks, and 12/20-pks
DISTRIBUTION
MO, KS, IA, and SD
___________________________________
PRODUCT
OSU Swine Vitamin Premix NB-6522B, Vitamin Source for Swine Feeds, packaged in 50-lb. bags. Recall # V-391-2011
CODE
Lot # 1123014
RECALLING FIRM/MANUFACTURER
Nutra Blend LLC, Neosho, MO, by telephone on May 9, 2011. Firm initiated recall is complete.
REASON
The premix is deficient in Vitamin D.
VOLUME OF PRODUCT IN COMMERCE
40/50-lb. bags
DISTRIBUTION
OK
 
END OF ENFORCEMENT REPORT FOR AUGUST 24, 2011
 
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