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U.S. Department of Health and Human Services

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Enforcement Report for April 1, 2009

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

 

April 1, 2009
09-13

 

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I 
___________________________________ 
PRODUCT 
Crown Point brand Sure-Pak 12 Meals Fully Prepared containing 1 oz. and 2 oz. squeeze packets of peanut butter. The packets are packed into meal kits which are cased 12 meals to a box. UPC: 613902921702, Recall # F-157-9
CODE 
Case Codes – 8261, 8278, 8285, 8287, 8294, 8320, 8322, 8330, 8350, 8357, 8358, 9003, and 9012
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Sopakco Packaging, Mullins ,  SC , by press release, letter, e-mail and fax on January 27, 2009.
Manufacturer: Boca Grande Foods / Modern Packaging, Duluth ,  GA. Firm initiated recall is ongoing.
REASON 
The product was manufactured using peanut paste recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella .
VOLUME OF PRODUCT IN COMMERCE 
21,551 cases
DISTRIBUTION 
Nationwide and countries of Ecuador , Trinidad , England and Panama
___________________________________ 
PRODUCT 
Classic Breaks Peanut Butter Frozen Cookie Dough, break apart cookies packaged in 32-oz. packages, UPC 745771005334, Recall # F-158-9
CODE 
Lot numbers: 26208, 26308, 29808, 33808, and 36508; added with expanded recall: 22507, 24007, 24707, 29707, 31007, 36207, 03008, 03908, 04608, 06708, 11308, 11408, 21908
RECALLING FIRM/MANUFACTURER 
Country Maid, Inc., West Bend , IA , by e-mail on January 19, 2009, by press release, telephone and on their website on January 20, 2009, and by press release and letter dated January 29, 2009. Firm initiated recall is ongoing.
REASON 
The product was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella .
VOLUME OF PRODUCT IN COMMERCE 
48,006 /2-lb. packages
DISTRIBUTION 
Nationwide
___________________________________ 
PRODUCT 
Lucky brand Peanut Butter in 3/4 (0.75) oz. and in 1.12 oz. individual serving pouches. Pouches do not bear a UPC code. This product was distributed in natural colored cardboard boxes with stenciling on the outside of the master carton with a product code of a) PB275 (200 ea 0.75 oz.), b) PB4001 (400 ea 1.12 oz.) or c) PB4002 (200 ea 1.12 oz.), Recall # F-159-9
CODE 
Bulk master cartons are coded 1067 through 3458. There are no codes on individual pouches.
RECALLING FIRM/MANUFACTURER 
Four In One Co., LLC, Chelmsford , MA , by letter dated January 20, 2009 and by press release and letter on February 20, 2009. Firm initiated recall is ongoing.
REASON 
Product was manufactured using peanut products recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella .
VOLUME OF PRODUCT IN COMMERCE 
a) 200 ea 0.75 oz.; b) 400 ea 1.12 oz.; c) 200 ea 1.12 oz.
DISTRIBUTION 
IL, NJ, NY, MI, MD, PA and NH
___________________________________ 
PRODUCT 
WOW Thai Peanut Wing Sauce and Dressing, Net 128 Fl. oz. (1 Gal) 3.78L. Packaged in a plastic jug. Bottles do not bear a UPC code, Recall # F-160-9
CODE 
Lot number: 07213
RECALLING FIRM/MANUFACTURER 
Allegro Fine Foods, Inc., Paris, TN, by press release on February 2, 2009 and by telephone, e-mail and fax on February 3, 2009. Firm initiated recall is ongoing.
REASON 
Product was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella .
VOLUME OF PRODUCT IN COMMERCE 
45 cases of 4-1 gallon jugs
DISTRIBUTION 
CA, LA, MT, CO, IL and Canada
___________________________________ 
PRODUCT 
a) Cambrooke Foods Cheddar Wizard Low Protein Imitation Cream Cheese, 8 oz jar, SKU 10310, Recall # F-161-9;
 
b) Cambrooke Foods Herb & Garlic Low Protein Imitation Cream Cheese, 8 oz jar, SKU 10308, Recall # F-162-9;
 
c) Cambrooke Foods Plain Low Protein Imitation Cream Cheese, 8 oz jar, SKU 10306, Recall # F-163-9
CODE 
All lot codes
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Cambrooke Foods, LLC, Framingham , MA , by e-mail, telephone and letter dated December 11, 2008.
Manufacturer: Cambrooke Foods, LLC, Randolph , MA . Firm initiated recall is complete.
REASON 
Products are contaminated with Listeria monocytogenes .
VOLUME OF PRODUCT IN COMMERCE 
4,740 units
DISTRIBUTION 
Nationwide and Canada
___________________________________ 
PRODUCT 
Peregrina Cheese brand QUESO FRESCO Fresh Cheese, Weight 14 Oz. (397g), UPC 8 17424 00024 6, Plant #36-8431, and Chipilo brand MEXICAN CHEESE QUESO FRESCO - Fresh Cheese, Net Wt. 15 oz. (425 g), UPC 8 17424 00028 4; Ingredients: Natural Pasteurized Milk, Rennet, Calcium Chloride, Salt Added. Contains Milk. The cheese is packed in a foil-wrapped package, Recall # F-164-9
CODE 
Code 4461
RECALLING FIRM/MANUFACTURER 
Peregrina Cheese Co., Brooklyn , NY , by telephone on February 4, 2009. Firm initiated recall is ongoing.
REASON 
The specific code of Peregrina Cheese brand QUESO FRESCO Fresh Cheese was sampled by New York State Department of Agriculture & Markets' Division of Milk Control and Dairy Services. New York State 's Food Laboratory analysis revealed the presence of Listeria monocytogenes , a pathogenic organism.
VOLUME OF PRODUCT IN COMMERCE 
55 units
DISTRIBUTION 
NY
___________________________________ 
PRODUCT 
a) Peregrina Cheese brand QUESO FRESCO Fresh Cheese, Weight 14 Oz. (397g) -- UPC 8 17424 00024 6 -- Ingredients: Natural Pasteurized Milk, Rennet, Calcium Chloride, Salt Added. Contains: Milk. --- Plant #36-8431 --- The cheese is packed in a foil-wrapped package. Recall # F-165-9;
 
b) Peregrina Cheese brand QUESO COTIJA MOLIDO, Net Wt. 15 oz. -- UPC barcode number 8 17424 00027 7 -- Made From Pasteurized Milk, Salt, Enzymes, Cultures, and Cellulose -- Plant # 36-1388. The cheese is packaged in 15 oz clear plastic bags that do not contain lot codes. Recall # F-166-9
CODE 
a) Codes: 4469, 4477, code 4483 (produced on 2/18/09);
b) No lot codes
RECALLING FIRM/MANUFACTURER 
Peregrina Cheese Corp., Brooklyn, NY, by letters and telephone on February 26-27, 2009, by press release on March 9, 2009 and telephone starting March 13, 2009. Firm initiated recall is ongoing.
REASON 
The products were found to be contaminated with Listeria monocytogenes based on FDA samplings and analyses.
VOLUME OF PRODUCT IN COMMERCE 
328 units
DISTRIBUTION 
NY, PA
___________________________________ 
PRODUCT 
Dillon's Gourmet Peanut Roll, 3 oz. size, UPC 017279040033. Product is wrapped in cellophane. Recall # F-167-9
CODE 
Lot Codes: 02907 through 35807, 00708 through 35708, and 00509 through 02209
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Dillon Candy, Co., Boston , GA , by press release and letters on February 3, 2009.
Manufacturer: Peanut Corporation of America , Blakely, GA. Firm initiated recall is ongoing.
REASON 
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella .
VOLUME OF PRODUCT IN COMMERCE 
119,337 single units
DISTRIBUTION 
Nationwide, Canada and Grand Cayman , B.W.I.
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I 
___________________________________ 
PRODUCT 
ALR Industries FAT LOSS & ENERGY SERIES Venom HYPERDRIVE 3.0, Fat Loss and Metabolism Support, Sustained Energy and Focus, Appetite Control Improved Performance, Dietary Supplement, 90 Capsules, packaged in bottles, UPC 094922 53474 3, Recall # D-213-2009
CODE 
All lot codes
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Applied Lifescience Research Industries, Inc., Oak View, CA, by their Website on December 24, 2008, by letter dated December 31, 2009 and by press release on January 27, 2009.
Manufacturer: Pinnacle Labs International, Inc., Upland , CA. Firm initiated recall is ongoing.
REASON 
FDA analysis revealed that the product contains the undeclared active pharmaceutical ingredient sibutramine.
VOLUME OF PRODUCT IN COMMERCE 
Approximately 190,000 bottles
DISTRIBUTION 
Nationwide, Canada , Poland , Sweden , Hungary , South Africa , the Netherlands , Australia , France and the United Kingdom
___________________________________ 
PRODUCT 
Isosorbide Mononitrate, 60 mg, Each tablet contains 60 mg Isosorbide Mononitrate, packaged in 30 tablet bottles, Rx only, Allscripts product #5341-0; NDC 58177-238-04, Recall # D-214-2009;
CODE 
Lot numbers: 6024159, 5347164 and 5342206;
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Allscripts LLC, Libertyville , IL , by letters dated November 13, 2008 and November 17, 2008.
KV Pharmaceutical Co. Westport , Saint Louis , MO. Firm initiated recall is ongoing.
REASON 
The products may contain oversized tablets.
VOLUME OF PRODUCT IN COMMERCE 
213,804 tablets (Includes Recall #'s D-215/220-2009)
DISTRIBUTION 
Nationwide
___________________________________ 
PRODUCT 
NIKKI HASKELL'S StarCaps Diet System Dietary Supplement Capsules, NATURAL EXTRACT PAPAYA & GARLIC, 550mg, 30 count bottles, Recall # D-221-2009
CODE 
Lot No.12/2011 - 84810; EXPANSION: Lot numbers: 12/2009 - 82866 and 12/2010 - 83801
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Balanced Health Products, Inc., New York , NY , by letters dated November 17, 2008, by press release on November 25, 2008, November 26, 2008, by letter dated December 5, 2008 and press release on December 8, 2008.
Manufacturer: Phoenix Labs Rising LLC, Farmingdale , NY . Firm initiated recall is ongoing.
REASON 
Unapproved new drug; the dietary supplement lots contain the undeclared drug ingredient Bumetanide, a prescription diuretic.
VOLUME OF PRODUCT IN COMMERCE 
67,312 bottles – 30 capsules per bottle (total for 3 lots)
DISTRIBUTION 
Nationwide, Canada , France and Bermuda
___________________________________ 
PRODUCT 
ETHEX Hydromorphone Hydrochloride Tablets, USP, CII, 2 mg, packaged in 100-tablet bottles, Rx only, Manufactured by KV Pharmaceutical Co for ETHEX Corporation, St. Louis, MO 63044, NDC 58177-620-04, Recall # D-222-2009
CODE 
Lot number: 90219, Exp. 3/2010
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Ethex Corp., Bridgeton , MO , by press release and letters on December 23, 2008.
Manufacturer: KV Pharmaceutical Co. Westport , Saint Louis , MO. Firm initiated recall is ongoing.
REASON 
The product may contain oversized tablets
VOLUME OF PRODUCT IN COMMERCE 
2,700 bottles (100 tablets/bottle)
DISTRIBUTION 
Nationwide
  
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II 
___________________________________ 
PRODUCT 
a) Guaifenesin DM, each tablet contains 600 mg guaifenesin and 30 mg dextromethorphan HBr, packaged in bottles of 14, 20, 28 and 40 sustained release tablets; Rx only, Allscripts a) product #4407-0 (28 tablets), b) 4407-1 (14 tablets), c) 4407-02 (20 tablets), d) 4407-3 (40 tablets); Rx only, NDC 58177-213-04, Recall # D-215-2009;
 
b) Guaifenesin/Pseudoephedrine 600 mg/120 mg, each extended-release tablet contains guaifenesin 600 mg, Pseudoephedrine 120 mg, packaged in bottles of 14, 20, 30 and 60 tablets; Allscripts product a) #3949-0 (20 tablets), b) 3949-1 (14 tablets), c) 3949-02 (30 tablets), d) 3949-3 (60 tablets); Rx only, NDC 58177-208-04, Recall # D-216-2009;
 
c) Doxazosin Mesylate, 2 mg, packaged in 30 tablet bottles; Allscripts product #5169-0, Rx only, NDC 58177-267-04, Recall # D-217-2009;
 
d) Doxazosin Mesylate, 4 mg, packaged in 30 tablet bottles; Allscripts product #5170-0, Rx only, NDC 58177-268-04, Recall # D-218-2009;
 
e) Doxazosin Mesylate, 8 mg, packaged in 30 tablet bottles; Allscripts product #5245-0, Rx only, NDC 58177-269-04, Recall # D-219-2009;
 
f) Hyoscyamine Sulfate, 0.125 mg, packaged in 20 tablet bottles, Allscripts product #3763-2, Rx only, NDC 58177-274-04, Recall # D-220-2009
CODE 
a) Lot numbers: 7275211 and 7276119; b) Lot numbers: 7281311, 7271047, 7261161 and 7229056; c) Lot numbers: 7310172, 7270038 and 7229057; Lot numbers: 7299121 and 7242044;
b) Lot numbers: 7305022, 7304178, 7296154, 7292080, 7290143, 7281238, 7278159, 7271079 and 7258173; b) Lot numbers: 7304175 and 7295202; c) Lot numbers: 7304176, 7296161, 7295203, 7290142, 7281237, 7271065 and 7270018; d) Lot numbers: 7304177, 7295200 and 7271078;
 
c) Lot number: 6222195;
 
d) Lot number: 6240238;
 
e) Lot numbers: 7026031, 7023181 and 6270227;
 
f) Lot numbers: 8044136 and 8038052
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Allscripts LLC, Libertyville , IL , by letters dated November 13, 2008 and November 17, 2008.
KV Pharmaceutical Co. Westport , Saint Louis , MO. Firm initiated recall is ongoing.
REASON 
The products may contain oversized tablets.
VOLUME OF PRODUCT IN COMMERCE 
213,804 tablets (Includes Recall # D-214-2009)
DISTRIBUTION 
Nationwide
___________________________________ 
PRODUCT 
a) Fleet Phospho-soda, Ginger-Lemon flavor, catalog # 105FBN, 1.5 fluid ounce (45 mL) bottles packaged in retail boxes, UPC 3-01320-10915-3, Recall # D-225-2009;
 
b) Fleet Phospho-soda, Unflavored, catalog # 105BN, 1.5 fluid ounce (45 mL) bottles packaged in retail boxes, UPC 3-01320-10815-6, Recall # D-226-2009;
 
c) Fleet Phospho-soda, Ginger-Lemon flavor, catalog # 805FPPK, 1.5 fluid ounce (45 mL) bottles packaged in boxes, For Use By Health Professionals Only, Not For Retail Sale, UPC 3-01320 10702-9, Recall # D-227-2009;
 
d) Fleet Phospho-soda, Unflavored, catalog # 805PPK, 1.5 fluid ounce (45 mL) bottles packaged in boxes, For Use By Health Professionals Only, Not For Retail Sale, UPC 3-01320 10701-2, Recall # D-228-2009;
e) Fleet Phospho-soda EZ-Prep Bowel Cleansing System, catalog #102, containing 2 bottles of unflavored Phospho-soda 45 mL (1.5 fluid ounces and 1.0 fluid ounces); 2 lemonade flavor packets (0.07 ounces); one-12 fluid ounce mixing cup and patient information sheets, packaged in a papercard box, 3-01320-00102-0, Recall # D-229-2009
CODE 
a) All lots are being recalled and are identified as follows: 060060032L 060090009L 060090008L 060090010L 060130015L 060270039L 060310010L 060310011L 060530047L 060530048L 060590001L 060550017L 060730020L 060740041L 0608000031 0608100028 0608200038 060270038L 0610100019 0610200022 0610400001 0611100038 0611400039 0611500039 0611600018 0611700026 0612300031 0612500033 0612600002 0613800026 0613900036 0613900035 0614200031 0615300062 0615700015 0615700016 0615800030 0615900032 0616000002 0616000003 0616400023 0616600021 0616600023 0617100003 0617800019 0619500045 0619900007 0619800007 0620300005 0621200035 0621200036 0621300047 0621400011 0622100005 0622200033 0622300055 0622800006 0624200007 0624800020 0624900021 0625000032 0626300023 0626500003 0626800017 0626900037 0627800008 0628200007 0628400002 0629300042 0629900006 0611100037 0611500030 0624000017 0630600015 0631200020 0631700005 0631800016 0631900005 0632000009 0633100001 0634109L 0634110L 0634518L 0634807L 0634625L 0700207L 0700312L 0700434L 0700529L 0700530L 0700800020 0700800021 0701100009 0701200007 0701500008 0703200008 0703800009 0704600044 0704700011 0705300018 0705700004 0706800047 0707200005 0707400027 0707500017 0708500006 0708700018 0708800040 0709200008 0711700008 0711700006 0712000017 0712100021 0712700001 0713600016 0713700021 0713800024 0713800025 0715700008 0715800008 0715900006 0717000031 0703200007 0716900006 0717700004 0717700005 0717800017 0717800018 0719000008 0719200008 0719300006 0720700005 0720800009 0722500004 0722700008 0723500006 0723500007 0724800007 0722800006 0726200008 0726300001 0726300009 0726700007 0726800008 0727000012 0727400009 0727800024 0728300017 0728200009 0729500010 0729600006 0729700009 0730500006 0730600004 0730900004 0733700020 0733700044 0733800019 0733900015 0734000010 0801100013 0801400011 0801500007 0801500008 0801700006 0802800008 0802900006 0803700003 0804500009 0805700004 0805800004 0806700005 0807000008 0808800010 0809300010 0809800001 0810700010 0812000005 0812100021 0812600014 0813000005 0813300007 0813300012 0813400001 0814000009 0814100029 0814200004 0816500005 0817800018 0818900012 0819000002 0819000008 0819600012 0819800004 0819900005 0821100009 0821200007 0821900005 0813500020 0823300008 0823400007 0823800007 0824000005 0824600007 0825600006 0825900008 0826100004 0826300005 0826600008 0828100007 0829400012 0829800005 0831700005 0832600012;
 
b) All lots are recalled and identified as follows: 053480009L 060170020L 060160019L 060380021L 060370024L 060600020L 060600021L 609000040 608900009 611000024 611000025 613100022 613200013 615000003 615200012 615200015 619500043 620600030 620700022 622900032 623000007 625600005 627600019 627600020 631200021 0633805L 0633806L 636000003 636200025 701800010 702200006 705800004 709300006 709400028 712400013 715200015 715500005 715600009 719700021 719700022 722100008 725700009 726100007 728800036 731000004 731100007 800300013 800400007 803800005 803900007 804200001 804200013 808500009 808700004 813500007 813600006 814000008 822100007 822400012 824900007 826900006 827000006 828900009 834500031 834600003;
 
c) All lots are recalled and identified as follows: 0610300054 0612300029 0614300024 0617300007 0620800008 0616300021 0706700017 0707100001 0711400016 0711500003 0711700007 0717200024 0717200025 0723500005 0728500007 0729500006 0734600008 0736100052 0802100006 0814200005 0810500005 0824700005 0827700007 0828000010;
 
d) All lots are recalled and identified as follows: 0610900010 0613000050 0614500012 0619400007 0705900017 0706400035 0710200010 0719400009 0725600014 0725700008 0726000019 0726100024 0731900011 0732000011 0732300002 0808000003 0813700005 0813700006 0822500021 0827300013;
 
e) Lot numbers: 619900001 620200036 620600031 620900055 621600036 621900034 622700009 622800021 620800010 0620955L 0622709L 0621934L 0622821L 0620810L 700400023 701100031 630300003 702000001 702500014 0620631L 0622821L 703100003 703600009 705100014 705400024 705700001 705800012 706100002 706400021 706700018 707300024 707900027 708200014 709300001 710000027 710800002 711300001 711600001 713100002 716200004 714400008 717300011 718700011 721500029 720400010 722000006 722600017 724100008 727000013 728200011 729100011 729500014 729900026 730500009 731200003 731800009 733000012 734500023 800200015 800800005 801100014 802100009 803700010 804400010 807300008 807900009 808500035 809500007 810800010 812300003 812800008 813500009 814100011 815000010 815600007 816400006 817800021 819200003 820700009 821900025 822800007 824000031 824700007 825300009 826300008 827000010 827600009 831200012 831800027 832500029 833900006 834500030
RECALLING FIRM/MANUFACTURER 
C B Fleet Co. Inc., Lynchburg , VA , by press release on December 11, 2008 and by letters on December 12 and December 15, 2008. Firm initiated recall is ongoing.
REASON 
Over the counter (OTC) laxative products available to consumers are labeled as intended for “professional use only”. The products contain oral sodium phosphate solutions.
VOLUME OF PRODUCT IN COMMERCE 
656,067 cases total
DISTRIBUTION 
Nationwide
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III 
___________________________________ 
PRODUCT 
a) Mometasone Furoate Cream, USP 0.1%, 15 g Tube (NDC 68462-192-17) and 45 g Tube, NDC 68462-192-55. For dermatologic use only. Not for ophthalmic use, Rx only, Recall # D-223-2009;
 
b) Mometasone Furoate Ointment, USP 0.1%; 15 grams (NDC 68462-225-17 and 45 grams, NDC 68462-225-55. For dermatologic use only, not for ophthalmic use, Rx only, Recall # D-224-2009
CODE 
a) Batch numbers: BD15058001, BD15058002, BD15058003, BD15058004, BD15058005, BD15058007; BD15058008, BD15058009 and BD15058010. Expiration May 2010;
 
b) Batch numbers: BD15068001, BD15068002, BD15068003 and BD15068004. Expiration Date May 2010
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Glenmark Pharmaceuticals, Inc., USA , Mahwah , NJ , by telephone on October 15, 2008 and by letters the week of December 22, 2008.
Manufacturer: Glenmark Pharmaceuticals Limited, Himachal Pradesh State , India . Firm initiated recall is ongoing.
REASON 
Measured value for relates substances unknown impurity and total impurities have exceeded specification at 3 month stability timepoint.
VOLUME OF PRODUCT IN COMMERCE 
23,304 tubes of ointment; 71,568 tubes of cream
DISTRIBUTION 
IN, FL, RI, TN, NC, and MO
  
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II 
___________________________________ 
PRODUCT 
Source Plasma, Recall # B-0419-09
CODE 
Units: GZ058579, GZ058265, GZ057836, GZ057674, GZ057102, GZ056889, GZ056492, GZ055913, GZ054841 and GZ053767
RECALLING FIRM/MANUFACTURER 
Bio-Blood Components, Inc., Gary , IN , by fax on June 17, 2008. Firm initiated recall is complete.
REASON 
Blood products, collected from a donor whose physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
10 units
DISTRIBUTION 
Austria
___________________________________ 
PRODUCT 
Platelets, Recall # B-0486-09
CODE 
Unit: Y54278
RECALLING FIRM/MANUFACTURER 
Virginia Blood Service, Inc., Richmond , VA , by letter dated February 11, 2008. 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 
VA
___________________________________ 
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0487-09
CODE 
Unit: 53FL50346
RECALLING FIRM/MANUFACTURER 
American National Red Cross-Greater Chesapeake and Potomac Region, Baltimore , MD , by telephone on August 21, 2008 followed by a letter dated August 27, 2008. 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 
MD
___________________________________ 
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0582-09
CODE 
Unit: 53FL58806
RECALLING FIRM/MANUFACTURER 
American National Red Cross-Greater Chesapeake and Potomac Region, Baltimore , MD , by telephone on January 3, 2008 followed by a letter dated January 4, 2008. Firm initiated recall is complete.
REASON 
Blood product, which was labeled as JK(b-), but was collected from a donor who subsequently tested JK(b+), was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
MD
___________________________________ 
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0583-09
CODE 
Unit: 53FC70564
RECALLING FIRM/MANUFACTURER 
American National Red Cross-Greater Chesapeake and Potomac Region, Baltimore , MD , by telephone on March 14, 2008 followed by a letter dated March 21, 2008. Firm initiated recall is complete.
REASON 
Blood product, which was labeled as negative for the Fyb antigen, but was collected from a donor who subsequently tested positive for Fyb antigen, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
MD
___________________________________ 
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0617-09
CODE 
Unit: 13FV95107 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER 
American Red Cross Southeastern Michigan Region, Detroit , MI , by telephone on July 14, 2008. Firm initiated recall is complete.
REASON 
Blood products, which did not have quality control testing performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
2 units
DISTRIBUTION 
MI
___________________________________ 
PRODUCT 
a) Cryoprecipitated AHF, Recall # B-0620-09;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0621-09;
c) Platelets Pheresis Leukocytes Reduced, Recall # B-0622-09;
d) Recovered Plasma, Recall # B-0623-09
CODE 
a), b), d) Unit:  FQ90481 ;
c) FQ89249, FQ87227, FQ86353
RECALLING FIRM/MANUFACTURER 
Blood Center of Wisconsin, Inc., Milwaukee , WI , by facsimile or electronic notification on April 10, 2006. Firm initiated recall is complete.
REASON 
Blood products, collected from a donor with a history of sexual contact with an individual who lived in or immigrated from an HIV Group O risk area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
6 units
DISTRIBUTION 
WI, TX, Switzerland
___________________________________ 
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0627-09
CODE 
Unit: 6045864
RECALLING FIRM/MANUFACTURER 
Blood Bank of Delmarva, Inc., Newark , DE , by letter dated August 18, 2008. Firm initiated recall is complete.
REASON 
Blood product, collected from a donor who was previously deferred for testing positive for the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
MD
___________________________________ 
PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-0628-09
b) Recovered Plasma, Recall # B-0629-09;
c) Fresh Frozen Plasma, Recall # B-0630-09
CODE 
a) Units: 3202233, 3123605, 1857983, 1857985, 1857986, 1857981, 2318524, 3875140, 2321331, 4374545, 4372495, 4375557, 4763990;
 
b) Units: 1857986, 1857983, 1857981, 2318524, 3875140, 2321331, 4374545, 4763990, 3202233;
 
c) Unit: 1857985
RECALLING FIRM/MANUFACTURER 
Indiana Blood Center , Indianapolis , IN , by telephone on July 30, 2008 or electronic notification on September 2, 2008. Firm initiated recall is complete.
REASON 
Blood products, which were incorrectly tested for viral markers, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
23 units
DISTRIBUTION 
IN
___________________________________ 
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0642-09
CODE 
Unit: 18GT16173 Part 1 and Part 2
RECALLING FIRM/MANUFACTURER 
American National Red Cross-Great Lakes Region, Lansing, MI, by telephone on January 30, 2008 and letter on February 6, 2008. 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 
2 units
DISTRIBUTION 
MI
___________________________________ 
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0644-09
CODE 
Units: 18FV72186, 18GM31584, 18FG22053, 18GR27491 and 18GR23452
RECALLING FIRM/MANUFACTURER 
American National Red Cross-Great Lakes Region, Lansing, MI, by telephone/electronic mail on April 4, 2008 and letter on April 16, 2008. 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 
MA, MI, PA
___________________________________ 
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0646-09 
CODE 
Unit: 18GM31314
RECALLING FIRM/MANUFACTURER 
American National Red Cross-Great Lakes Region, Lansing, MI, by telephone on April 3, 2008 and letter on April 10, 2008. 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 
Red Blood Cells Leukocytes Reduced, Recall # B-0647-09
CODE 
Unit: 18FJ86440
RECALLING FIRM/MANUFACTURER 
American National Red Cross-Great Lakes Region, Lansing, MI, by telephone on June 24, 2008 and letter on July 7, 2008. 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 
MI
___________________________________ 
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0650-09
CODE 
Unit: 13FP54357
RECALLING FIRM/MANUFACTURER 
American Red Cross Southeastern Michigan Region, Detroit , MI , by telephone on August 1, 2008 and follow-up letter on August 25, 2008. Firm initiated recall is complete.
REASON 
Blood product, for which Quality Control was not performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
MI
___________________________________ 
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0653-09
CODE 
Unit: 53FM98690
RECALLING FIRM/MANUFACTURER 
American National Red Cross-Greater Chesapeake and Potomac Region, Baltimore , MD , by telephone on May 1, 2008 and follow-up letter dated May 2, 2008. 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 
D.C.
___________________________________ 
PRODUCT 
Source Plasma, Recall # B-0654-09
CODE 
Units: GP124502, GP124366, GP124309, GP124286, GP124271, GP124239, GP124224, GP124186, GP124161, GP124150, GP124124, GZ055201, GZ053075, GZ052909, GZ056035, GZ055749, GZ055613, GZ054764, GZ054278, GZ053877, GZ053601, GZ052461, GZ052239, GZ051960, GZ051134 and GZ054586
RECALLING FIRM/MANUFACTURER 
Bio-Blood Components, Inc., Gary , IN , by fax on June 13, 2008. Firm initiated recall is complete.
REASON 
Blood products, collected from a donor whose physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
26 units
DISTRIBUTION 
CA, Austria and Germany
___________________________________ 
PRODUCT 
Source Plasma, Recall # B-0655-09
CODE 
Unit: 08FINB1972
RECALLING FIRM/MANUFACTURER 
BioLife Plasma Services, L.P., Fort Wayne , IN , by fax on June 9, 2008. Firm initiated recall is complete.
REASON 
Blood product, collected from a donor whose physical exam was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
CA
___________________________________ 
PRODUCT 
a) Red Blood Cells, Recall # B-0656-09;
b) Platelets, Recall # B-0657-09
CODE 
a) and b) Unit: LM10569
RECALLING FIRM/MANUFACTURER 
Mid-South Regional Blood Center , Memphis , TN , by letters dated June 18, 2008 and September 6, 2008. 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 
TN
___________________________________ 
PRODUCT 
a) Red Blood Cells, Recall # B-0659-09;
b) Fresh Frozen Plasma, Recall # B-0660-09;
c) Platelets, Recall # B-0661-09
CODE 
a) and b) Units: KX07877; KX05639;
c) KX05639
RECALLING FIRM/MANUFACTURER 
Mid-South Regional Blood Center , Memphis , TN , by letter beginning July 10, 2008. Firm initiated recall is complete.
REASON 
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 
5 units
DISTRIBUTION 
TN
___________________________________ 
PRODUCT 
Platelets Pheresis, Leukocytes Reduced, Recall # B-0662-09
CODE 
Units: 2803868 and 4151735
RECALLING FIRM/MANUFACTURER 
Indiana Blood Center , Indianapolis , IN , by telephone on September 3, 2008. Firm initiated recall is complete.
REASON 
Blood products, with unacceptably high platelet concentrations, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
2 units
DISTRIBUTION 
IN
___________________________________ 
PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-0663-09;
b) Platelets, Recall # B-0664-09
CODE 
a) and b) Unit: F54891
RECALLING FIRM/MANUFACTURER 
Michigan Community Blood Centers , Grand Rapids , MI , by fax on July 28, 2008. Firm initiated recall is complete.
REASON 
Blood products, collected from a donor who may have visited a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
2 units
DISTRIBUTION 
MI
___________________________________ 
PRODUCT 
Source Plasma, Recall # B-0667-09
CODE 
Unit: 2010134478
RECALLING FIRM/MANUFACTURER 
Plasma Care, Inc. dba Marion Blood Plasma, Inc., Indianapolis , IN , by fax on March 26, 2008. Firm initiated recall is complete.
REASON 
Source Plasma, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
NC
___________________________________ 
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0683-09
CODE 
Unit: 6215788
RECALLING FIRM/MANUFACTURER 
South Texas Blood and Tissue Center , San Antonio , TX , by fax on December 17, 2008 and January 12, 2009. Firm initiated recall is complete.
REASON 
Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
TX
___________________________________ 
PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-0684-09;
b) Recovered Plasma, Recall # B-0685-09
CODE 
a) and b) Units: 6165539, 6184317
RECALLING FIRM/MANUFACTURER 
South Texas Blood and Tissue Center , San Antonio , TX , by fax and e-mail on November 25, 2008 and as follow-up by fax on February 5, 2009. Firm initiated recall is complete.
REASON 
Blood products, collected from a donor with risk factors for vCJD, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
4 units
DISTRIBUTION 
TX, Austria
___________________________________ 
PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-0686-09;
b) Cryoprecipitated AHF, Recall # B-0687-09
CODE 
a) and b) Unit: 6176273
RECALLING FIRM/MANUFACTURER 
South Texas Blood and Tissue Center , San Antonio , TX , by fax on November 24, 2008 and December 2, 2008. Firm initiated recall is complete.
REASON 
Blood products, collected from a donor who disclosed taking Evista, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
2 units
DISTRIBUTION 
TX
  
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III 
___________________________________ 
PRODUCT 
Fresh Frozen Plasma, Recall # B-0375-09
CODE 
Unit: Q44150
RECALLING FIRM/MANUFACTURER 
Mid-South Regional Blood Center , Memphis , TN , by letter dated August 6, 2007. Firm initiated recall is complete.
REASON 
Blood product, prepared from a whole blood unit that was collected without a documented bleed time, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
TN
___________________________________ 
PRODUCT 
Recovered Plasma, Recall # B-0488-09
CODE 
Unit: 53FL50346
RECALLING FIRM/MANUFACTURER 
American National Red Cross-Greater Chesapeake and Potomac Region, Baltimore , MD , notified electronically on August 21, 2008. 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 
The Operator's Manual for the Fenwal Amicus Separator Apheresis Device, Recall # B-0541-09
CODE 
Amicus Separator Operator's Manual, Version 2.1
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Fenwal, Inc., Lake Zurich , IL , by letter dated November 26, 2008 and e-mail on November 26, 2008.
Manufacturer: Delphi Medical Systems Colorado Corp., Longmont , CO. Firm initiated recall is ongoing.
REASON 
Operator's Manuals for the Fenwal Amicus Separator's Apheresis System, containing instructions which may lead to an increased potential for a donor citrate reaction, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
258 manuals
DISTRIBUTION 
Nationwide, Europe, the Middle East, Africa and Latin America
___________________________________ 
PRODUCT 
Recovered Plasma, Recall # B-0631-09
CODE 
Units: 4375557, 3123605
RECALLING FIRM/MANUFACTURER 
Indiana Blood Center , Indianapolis , IN , by telephone on July 30, 2008 or electronic notification on September 2, 2008. Firm initiated recall is complete.
REASON 
Blood products, which were incorrectly tested for viral markers, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
2 units
DISTRIBUTION 
Austria
___________________________________ 
PRODUCT 
Recovered Plasma, Recall # B-0643-09
CODE 
Units: 18GR23452, 18GM31584, 18FG22053, 18FV72186, and 18GR27491
RECALLING FIRM/MANUFACTURER 
American National Red Cross-Great Lakes Region, Lansing, MI, by telephone/electronic mail on April 4, 2008 and letter on April 16, 2008. 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 
CA
___________________________________ 
PRODUCT 
Recovered Plasma, Recall # B-0645-09
CODE 
Unit: 18GM31314
RECALLING FIRM/MANUFACTURER 
American National Red Cross-Great Lakes Region, Lansing, MI, by telephone on April 3, 2008 and letter on April 10, 2008. 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-0648-09
CODE 
Unit: 18FJ86440
RECALLING FIRM/MANUFACTURER 
American National Red Cross-Great Lakes Region, Lansing, MI, by telephone on June 24, 2008 and letter on July 7, 2008. 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 
Red Blood Cells Leukocytes Reduced, Recall # B-0649-09
CODE 
Unit: 13FV95143
RECALLING FIRM/MANUFACTURER 
American Red Cross Southeastern Michigan Region, Detroit , MI , by telephone on August 13, 2008 and by follow-up letter on August 27, 2008. Firm initiated recall is complete.
REASON 
Blood product, which failed to meet the minimum specification for red blood cell percent recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
MI
___________________________________ 
PRODUCT 
Red Blood Cells Leukocytes Reduced, Washed, Recall # B-0651-09
CODE 
Units: Q64761, Y13712, F25713 and F70974
RECALLING FIRM/MANUFACTURER 
Michigan Community Blood Centers , Grand Rapids , MI , by fax on August 11, 2008 or September 8, 2008. Firm initiated recall is complete.
REASON 
Washed red cells, manufactured with an incorrect saline solution, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
4 units
DISTRIBUTION 
MI
___________________________________ 
PRODUCT 
Recovered Plasma, Recall # B-0652-09
CODE 
Unit: 53FM98690
RECALLING FIRM/MANUFACTURER 
American National Red Cross-Greater Chesapeake and Potomac Region, Baltimore , MD , by e-mail on May 1, 2008. 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 
Recovered Plasma, Recall # B-0658-09
CODE 
Unit: KC39330
RECALLING FIRM/MANUFACTURER 
Mid-South Regional Blood Center , Memphis , TN , by letters dated April 23, 2008, July 30, 2008 and August 13, 2008. 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 
NY
___________________________________ 
PRODUCT 
Recovered Plasma, Recall # B-0688-09
CODE 
Unit: 6176273
RECALLING FIRM/MANUFACTURER 
South Texas Blood and Tissue Center , San Antonio , TX , by fax on November 24, 2008 and December 2, 2008. Firm initiated recall is complete.
REASON 
Blood product, collected from a donor who disclosed taking Evista, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
FL
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I 
___________________________________ 
PRODUCT 
1) Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782L. Sizes: 3 CM in length, REF (240) 27782L. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized. Recall # Z-1124-2009;
  
2) Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782K. Sizes: 5.5CM in length, REF (240) 27782K. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1125-2009;
 
3) Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782J. Sizes: 4.5 CM in length, REF (240) 27782J. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall Z-1126-2009;
  
4) Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782H. Sizes: 11 CM in length, REF (240) 27782H. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1127-2009;
 
5) Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782G. Sizes 10cm in length, REF (240) 27782G. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1128-2009;
 
6) Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782F. Sizes: 9 CM in length, REF (240) 27782F. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1129-2009;
 
7) Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782E. Sizes: 8 CM in length, REF (240) 27782E. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1130-2009;
 
8) Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782D. Sizes: 7 CM in length, REF (240) 27782D. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1131-2209;
 
9) Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782C. Sizes: 6 CM in length, REF (240) 27782C. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1132-2009;
 
10) Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782B. Sizes: 5 CM in length, REF (240) 27782B. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1133-2009;
 
11) Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782A. Sizes: 4 CM in length, REF (240) 27782 a. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1134-2009;
 
12) Snap Shunt Ventricular Catheter, Standard, with BioGlide, 4 CM, Ref 27708A. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1135-2009;
 
13) Snap Shunt Ventricular Catheter, Standard, with BioGlide, 5 CM, Ref 27708B. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1136-2009;
 
14) Snap Shunt Ventricular Catheter, Standard, with BioGlide, 6 CM, Ref 27708C. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1137-2009;
 
15) Snap Shunt Ventricular Catheter, Standard, with BioGlide, 7 CM, Ref 27708D. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z1138-2009;
 
16) Snap Shunt Ventricular Catheter, Standard, with BioGlide, 8 CM, Ref 27708E. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1139-2009;
 
17) Snap Shunt Ventricular Catheter, Standard, with BioGlide, 3 CM, Ref 27708F. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1140-2009;
 
18) Snap Shunt Ventricular Catheter, Standard, with BioGlide, 9CM, Ref 27708G. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1141-2009;
 
19) Snap Shunt Ventricular Catheter, Standard, with BioGlide, 10 CM, Ref 27708H. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1142-2009;
 
20) Snap Shunt Ventricular Catheter, Standard, with BioGlide, 11 CM, Ref 27708J Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1143-2009;
 
21) Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 3 CM, Ref 27802A. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1144-2009;
 
22) Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 4 CM, Ref 27802B. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1145-2009;
 
23) Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 5 CM, Ref 27802C. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1146-2009;
 
24) Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 6 CM, Ref 27802D. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1147-2009;
 
25) Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 7 CM, Ref 27802E. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1148-2009;
 
26) Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 8 CM, Ref 27802F. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1149-2009;
 
27) Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 9 CM, Ref 27802G. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1150-2009;
 
28) Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 10 CM, Ref 27802H. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1151-2009;
 
29) Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 11 CM, Ref 27802J. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1152-2009
CODE 
All lots
RECALLING FIRM/MANUFACTURER 
Medtronic Neurosurgery, Goleta , CA , by letter on February 13, 2009. Firm initiated recall is ongoing.
REASON 
The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
VOLUME OF PRODUCT IN COMMERCE 
3,048 units
DISTRIBUTION 
Nationwide, Ireland and Australia
___________________________________ 
PRODUCT 
a) Tri-State Centurion Chest Tube Insertion Tray, sterile, 6 per case; Reorder CHT620, Recall # Z-1157-2009;
 
b) Tri-State Centurion Chest Tube Insertion Tray (Dentry/Bardmoor), sterile, 6 per case; Reorder CHT505, Recall # Z-1158-2009;
 
c) Tri-State Centurion PICC Line Tray, sterile, 10 per case; Reorder CVI2370, Recall # Z-1159-2009;
 
d) Tri-State Centurion PICC Insertion Tray, sterile, 15 per case; Reorder CVI2415A, Recall # Z-1160-2009;
 
e) Tri-State Centurion PICC/CVC Insertion Tray, sterile, 15 per case, Reorder CVI2490, Recall # Z-1161-2009;
 
f) Lee Medical Neonatal/Ped PICC Insertion Tray, sterile, 15 per case; Reorder CVI1025, Recall # Z-1162-2009;
 
g) Tri-State Centurion Port Access Kit, sterile, 20 per case; Reorder KNV35, Recall # Z-1163-2009;
 
h) Tri-State Centurion Port Access Tray, sterile, 20 per case; Reorder DT4825, Recall # Z-1164-2009;
 
i) Tri-State Centurion Port Access Tray, sterile, 20 per case; Reorder DT5245, Recall # Z-1165-2009;
 
j) Tri-State Centurion Port Access Tray, sterile, 20 per case; Reorder KNV75, Recall # Z-1166-2009;
 
k) Tri-State Centurion Implanted Access Port Tray, sterile, 16 per case; Reorder DT7105, Recall # Z-1167-2009;
 
l) Tri-State Centurion Sutureless Multi-Lumen CVC Insertion Kit, sterile, 5 per case, Reorder ECVC175, Recall # Z-1168-2009;
 
m) Tri-State Centurion Umbilical Vessel Tray without catheter, sterile, 5 per tray; reorder UVT 170, Recall # Z-1169-2009
CODE 
a) Lot 2008111350;
b) Lot 2008111350;
c) Lot 2008111050;
d) Lot 2008111150;
e) Lot 2008111850;
f) Lot 2008111750;
g) Lot 2008111150;
h) Lot 2008110250;
i) Lot 2008111250;
j) Lot 2008111450;
k) Lot 2008111650;
l) Lot 2008111250;
m) Lot 2008111050
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Tri-State Hospital Supply Corp., Howell , MI , by letter dated January 14, 2009.
Tri-State Hospital Supply Corp., Salisbury , NC . Firm initiated recall is ongoing.
REASON 
Lack of assurance of sterility, as the package seals may be inadequate.
VOLUME OF PRODUCT IN COMMERCE 
1,736 devices
DISTRIBUTION 
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II 
___________________________________ 
PRODUCT 
Roche COBAS c 111 Analyzer with ISE module option, GMMI No. 04777433001; Is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein electrolyte tests. Analytes are measured photometrically or turbidimetrically. The analyzer also has an optional ISE module for measuring sodium, potassium and chloride, R ecall # Z-1009-2009
CODE 
Serial numbers: 50654, 50694, 50541, 50634, 50251, 50506, 50453, 50688, 50244, 50475, 50597, 50656, 50598, 50635, 50632, 50586, 50320, 50246, 50693, 50692, 50562, 50547, 50624, 50690, 50687, 50680, 50560, 50247, 50538, 50633, 50201, 50612, 50576, 50689, 50681, 50424, 50651, 50661, 50452, 50450, 50290, 50630, 50319, 50250, 50549, 50682, 50683, 50685, 50660, 50545, 50463, 50655, 50539, 50653, 50249, 50563, 50561, 50686, 50649, 50470, 50657, 50448, 50644, 50595, 50575, and 50679
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Roche Diagnostics Corp., Indianapolis ,  IN , by letter dated November 17, 2008.
Manufacturer: Roche Instrument Center AG, Rotkreuz , Switzerland
REASON 
Due to a manufacturing error at the supplier, not all cobas c 111 pinch valve caps are properly glued to the correct position on the pinch valve shaft. Without the glue, the cap can become loose or misaligned. The effect of these faulty valves is that they may not open or close properly which can disturb the fluid transportation within the ISE module resulting in problems with ISE calibration, controls and/or sample results. Inaccurate and unflagged results may be generated and a wrong diagnosis due to incorrect results cannot be excluded.
VOLUME OF PRODUCT IN COMMERCE 
66 devices
DISTRIBUTION 
Nationwide
___________________________________ 
PRODUCT 
QCA and iQCA software, a video microscopy software system for quantitative estrogen receptor immunohistochemistry; Cell Analysis Inc., Evanston, IL 60201 or Highland Park, IL 60035. Intended to measure and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed, paraffin-embedded tissue specimens immunohistochemically stained for estrogen receptors. Indicated for use as an aid in the management, prognosis and prediction of therapy outcomes of breast cancer when used with reagents validated for those indications, Recall # Z-1040-2009
CODE 
All software versions 3.7 and above.
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Leica Microsystems, Inc., Bannockburn , IL , by letters dated November 6, 2008.
Manufacturer: Vision Biosystems, Mount Waverley , Australia . Firm initiated recall is ongoing.
REASON 
A change in the software to open up the software architecture to include other analytes other than Estrogen Receptor was made without FDA review and approval.
VOLUME OF PRODUCT IN COMMERCE 
5 units
DISTRIBUTION 
Nationwide
___________________________________ 
PRODUCT 
Bio-Rad Variant II TURBO Hemoglobin Testing System with CDM v 4.0, model number 270-2600. Provides an integrated method for sample preparation, separation and the percent determination of percent hemoglobin A 1 c in EDTA human whole blood. This device only tests for A 1 c, Recall # Z-1041-2009
CODE 
Version 4.0 software
RECALLING FIRM/MANUFACTURER 
Bio-Rad Laboratories, Inc., Hercules, CA, by letter, fax and telephone on October 17, 2008. Firm initiated recall is ongoing.
REASON 
Sample results may be assigned to the wrong barcode number and tube position numbers, leading to discrepant sample results.
VOLUME OF PRODUCT IN COMMERCE 
92 devices
DISTRIBUTION 
Nationwide and countries of Argentina, Australia, Brazil, Canada, Chile, China, Colombia, France, Germany, Hong Kong, Hungary, India, Italy, Mexico, New Zealand, Singapore, South Korea, Sweden, Taiwan and the UK
___________________________________ 
PRODUCT 
DiaSorin LIAISON (R) Chemiluminescence Analyzer Model # 15970. Colorimeter, Photometer, Spectrophotometer for clinical use, Recall # Z-1042-2009
CODE 
Serial numbers: 2229000828, 2229000829, 2229000839, 2229000857, 2229000859, 2229000926, 2229000972, 2229001196, and 2229001230
RECALLING FIRM/MANUFACTURER 
Recalling Firm: DiaSorin, Inc., Stillwater , MN , by visit on/about January 5, 2009.
Manufacturer: Stratec Biomedical Systems AG, Birkenfeld , Germany . Firm initiated recall is ongoing.
REASON 
DiaSorin determined that there was a potential for a short to occur in a residual starter pump electrical cable in the LIAISON ® Analyzer.
VOLUME OF PRODUCT IN COMMERCE 
9 units
DISTRIBUTION 
Nationwide and Canada
___________________________________ 
PRODUCT 
Stryker Impaction Bur Guard REF 2296-301, 2296-300, 0260-901-300, & 5400-300; Intended to be used with impaction Drill. Drill is used for surgical procedures involving precision drilling and cutting of bone and hard tissue. The bur guard covers the nose of the handpiece and the shaft of the cutting accessory to prevent exposure to heat and moving parts, as well as minimize bur whip and handpiece vibration. Recall # Z-1052-20098
CODE 
Any hand pieces repaired and returned from 9/18/08 to 10/10/08 may have the recalled bur guards. Serial Numbers: 0414100533, 0414100563, 0509100113, 0509100153, 0723404443, 0719104803, 98030843, 0318200043, 0727604043, 0729800243, 98061133, 0329401103, 97060133, 0424700493, 95022553, 0225501513, 0326900083, 99020483, 0330800593, 96010273, 0318200013, 97010813, 0324102133, 96050103, 0225501563, 99050023, 94091003, 97060223, 97060243, 97060613, 97080253, 98080163, 98050533, 98020403, 0533401073, 97050523, 0428800503, 0713801143, 0633303273, 96070353, 0311401713, 00120423, 99050053, 01020103, 02010803, 96120423, 99090353, 0233004783, 98061203, 99090293, 99110863, 0428202963, 0624803663, 0719000333, 94121523, 99100013, 94080453, 97050833, 96090533, 97120983, 97120993, 99111173, 0726300403, 0726300413, 01070163, 01070173, 0409604363, 0418005013, 0528001463, 99010543, 0511800053, 0511800083, 0709208133, 98050813, 00020373, 97020173, 99100123, 97050823, 01040533, 0228902373, 0231700673, 99070473, 0313302433, 99010903, 0819605873, 95040843, 94120653, 0715001683, 95021513, 95021523, 98010663, 0230100243, 98100133, 99100073, 0713123243, 0415500963, 95011113, 0726708833, 95030323, 0230100233, 99090493, 00080073, 95100103, 95100113, 0230200313, 97040563, 99070123, 0316200853, 94090983, 00110113, 94111083, 99010683, 97110023, 98120993, 00030153, 0512301433, 94100163, 94121103, 94121113, 98010673, 96110383, 97110453, 0330700333, 97121623, 98100863, 0414900263, 0232500443, 95022133, 0414100543, 0414100553, 0414100613, 0509100133, 0723404483, 98111233, 95100203, 0734700603, 00080083, 98050053, 00120433, 99040403, 99100113, 0309902613, 0808801833, 0233801463, 0721406933, 94121903, 99080283, 0731614433, 0608304673, 0609004613, 0611506303, 0611506313, 0613003513, 0613003533, 0525500823, 96120233, 95110333, 0417601883, 0618101713, 0624205473, 94090153, 98120473, 97100113, 0233900963, 00100793, 00030163, 0225600983, 0231000193, 96020173, 95030143, 01090313, 0606604453, 0334600733, 98050113, 0231800503, 94120733, 94050013, 0715001663, 94122153, 95030993, 95120103, 94110683, 0635406433, 98081583, 99020373, 94070313, 99111033, 0315500203, 96070313, 0535500863, 0632200223, 0417601873, 0400500163, 0631003513, 97080383, 0621206363, 02010793, 0401402363, 0336400963, 0330901153, 0229100103, 0508201013, 0634605013, 0635406413, 95100603, 00060133, 0530602873, 98011083, 98021223, 97111273, 98120113, 97030263, 97050393, 97020163, 99100253, 97090053, 00040293, 0703902843, 0707903723, 97050563, and 97090943
RECALLING FIRM/MANUFACTURER 
Stryker Instruments, Div. of Stryker Corp., Portage , MI , by letter dated January 27, 2009. Firm initiated recall is ongoing.
REASON 
Bur guards were distributed without an expiration date, and if they are used after they have expired it could result in the patient or operating room staff experiencing a burn or laceration.
VOLUME OF PRODUCT IN COMMERCE 
70 units
DISTRIBUTION 
Nationwide
 
RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS I 
___________________________________ 
PRODUCT 
a) Special Kitty Gourmet Blend Premium Cat Food in 3.5 lb bags; UPC number 81131 17546, Recall # V-111-2009;
 
b) Special Kitty Gourmet Blend Premium Cat Food in 7 lb bags; UPC number 81131 17547, Recall # V-112-2009;
 
c) Special Kitty Gourmet Blend Premium Cat Food in 18 lb bags; UPC number 81131 17548, Recall # V-113-2009;
 
d) Special Kitty Original Premium Cat Food in 3.5 lb bags, UPC number 81131 17557, Recall # V-114-2009;
 
e) Special Kitty Original Premium Cat Food in 7 lb bags; UPC number 81131 17562, Recall # V-115-2009;
 
f) Special Kitty Original Premium Cat Food in 18 lb bags; UPC number 81131 17559, Recall # V-116-2009;
 
g) Special Kitty Kitten Premium Cat Food in 3.5 lb bags, UPC number 81131 17553, Recall # V-117-2009;
 
h) Special Kitty Kitten Premium Cat Food in 7 lb bags; UPC number 81131 17554, Recall # V-118-2009;
 
i) Berkle y & Jensen Bistro Blend Premium Cat Food in 21.6 lb bags; UPC number 00000 20052, Recall # V-119-2009;
j) Berkley & Jensen Small Bites & Bones Dog Food in 52 lb bags; UPC number 00000 14958, Recall # V-120-2009;
 
k) Shop Rite Crunchy Bites, Bones and Healthy Squares Dog Food in 20 lb bags; UPC number 41190 04521, Recall # V-121-2009;
 
l) Ol' Roy Puppy Complete Premium Dog Food in 4 lb bags; UPC number 81131 79078, Recall # V-122-2009;
 
m) Ol' Roy Puppy Complete Premium Dog Food in 20 lb bags; UPC number 81131 79080, Recall # V-123-2009;
 
n) Ol' Roy Complete Nutrition Premium Dog Food in 4 lb bags; UPC number 81131 17550, Recall # V-124-2009;
 
o) Ol' Roy Complete Nutrition Premium Dog Food in 4.4 lb bags; UPC number 81131 69377, Recall # V-125-2009;
 
p) Ol' Roy Complete Nutrition Premium Dog Food in 8 lb bags; UPC number 05388 67144, Recall # V-126-2009;
 
q) Ol' Roy Complete Nutrition Premium Dog Food in 20 lb bags, UPC number 81131 17549, Recall # V-127-2009;
 
r) Ol' Roy Complete Nutrition Premium Dog Food in 22 lb bags; UPC number 05388 60342, R ecall # V-128-2009;
 
s) Ol' Roy Complete Nutrition Premium Dog Food in 44.1 lb bags; UPC number 81131 17551, Recall # V-129-2009;
 
t) Ol' Roy Complete Nutrition Premium Dog Food in 50 lb bags; UPC number 78742 01022, Recall # V-130-2009;
 
u) Ol' Roy High Performance Premium Dog Food in 20 lb bags; UPC number 05388 60345, Recall # V-131-2009;
 
v) Ol' Roy High Performance Premium Dog Food in 50 lb bags, UPC number 78742 05815, Recall # V-132-2009;
 
w) Ol' Roy Meaty Chunks & Gravy Premium Dog Food in 22 lb bags; UPC number 81131 69630, Recall # V-133-2009;
 
Ox) l' Roy Meaty Chunks & Gravy Premium Dog Food in 50 lb bags, UPC number 81131 69631, Recall # V-134-2009
CODE 
Best Used By Dates Between AUG 11 09 and OCT 3 09. Under the best use by date consumers should look for 50 as the first two digits of the second line. This number (50) indicates the PA manufacturing plant.
RECALLING FIRM/MANUFACTURER 
Recalling Firm: MARS Petcare US, Inc., Franklin ,  TN , by press release on October 27, 2008 and November 25, 2008.
Manufacturer: Mars Petcare, Allentown ,  PA. Firm initiated recall is ongoing.
REASON 
Finished product is positive for Salmonella. 
VOLUME OF PRODUCT IN COMMERCE 
152,400 pounds
DISTRIBUTION 
CT, DE, MA, MD, NC, NH, NJ, NY, OH, PA, RI, VA, VT, and WV
 
END OF ENFORCEMENT REPORT FOR APRIL 1, 2009

 

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