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U.S. Department of Health and Human Services

Safety

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Enforcement Report for September 1, 2010

September 1, 2010                                                                                        10-34

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I
___________________________________
PRODUCT   
Soba Ramen 12 Pack/Net Wt 2.1 oz (60g). UPC 8-13551-00214-6. Recall # F-2795-2010
CODE
All current code dates.
RECALLING FIRM/MANUFACTURER
Blue Marble Brands, Providence, RI, by e-mail on August 5, 2010. Firm initiated recall is ongoing.
REASON
Soy allergen labeled as "Shoyu Powder" on package of Soba Ramen.
VOLUME OF PRODUCT IN COMMERCE
1518 master cases
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT   
Chocolate-covered blend of mixed tree nuts and dried fruit (cashews, almonds, pecans, Brazil nuts, tart cherries and blueberries) in 16-ounce gold foil zip top pouches.  Product Code 154, UPC code 4482300154. Recall # F-2796-2010
CODE
No lot code
RECALLING FIRM/MANUFACTURER
The South Bend Chocolate Company, Inc., South Bend, IN, by press release and by letter on August 6, 2010. FDA initiated recall is ongoing.
REASON
Product contains undeclared tree nuts: cashews, almonds, pecans, Brazil nuts.
VOLUME OF PRODUCT IN COMMERCE
174 1-pound packages
DISTRIBUTION
Nationwide
___________________________________
PRODUCT   
Whole Foods Market Old Fashioned White Bread. Lot # 2610, UPC 8461714035. Recall # F-2800-2010
CODE
Lot 2610
RECALLING FIRM/MANUFACTURER
Whole Foods Market Bakehouse, Plantation, FL, by letter beginning July 29, 2010. Firm initiated recall is complete.
REASON
The bread loaves have the potential to be contaminated with peanut butter.
VOLUME OF PRODUCT IN COMMERCE
240 loaves
DISTRIBUTION
FL

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II
___________________________________
PRODUCT   
Granulated Sugar marketed under the following brand names: Dixie Crystal Extra Fine; Imperial Sugar Extra Fine; Chef's Quality Extra Fine, Monarch Extra Fine, Market Pantry and Kroger brand. The product is packed in 2400, 2000, 50, 25, 10 and 5 pound sizes. Recall # F-2799-2010
CODE
Lot numbers: S194A, S195A, S196A, S197A, S198A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Imperial Sugar Co., Sugar Land, TX, by telephone and letter via fax and/or email on July 19, 2010.
Manufacturer: Imperial Sugar, Savannah, GA. Firm initiated recall is ongoing.
REASON
The product may contain plastic pieces.
VOLUME OF PRODUCT IN COMMERCE
30,384 packages (various sizes)
DISTRIBUTION
AR, FL, GA, IL, IN, KY, MO, NC, OK, SC, TN, VA and WI      
___________________________________
PRODUCT   
Folic Acid 1000 mcg - 1000 Tablets per bottle (UPC: 0 79854 51280 9), NDC # 54629-012800. Stock No. 1280. Recall # F-2801-2010
CODE
Lot number: 9KB31 EXP: 12/12
RECALLING FIRM/MANUFACTURER
National Vitamin Co Inc., Casa Grande, AZ, by letter on May 21, 2010. Firm initiated recall is ongoing.
REASON
The product may contain a foreign capsule.
VOLUME OF PRODUCT IN COMMERCE
3265 Bottles with 1000 tablets each
DISTRIBUTION
Nationwide    

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS I
___________________________________
PRODUCT   
Megatope (Iodinated I-131 Albumin Injection USP), solution for injection, 450 uCi/mL in 10mL vial, Rx only, NDC 50914-7731-4. Cat. # 7731. Recall # D-798-2010
CODE
Lot # M101104-156
RECALLING FIRM/MANUFACTURER
Iso-Tex Diagnostics, Inc., Friendswood, TX, by telephone on April 18, 2010 and by letter dated April 20, 2010. Firm initiated recall is complete.
REASON
Non-Sterility.
VOLUME OF PRODUCT IN COMMERCE
1 vial
DISTRIBUTION
TN

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II
___________________________________
PRODUCT   
Coumadin***(Warfarin Sodium Tablets, USP) Crystalline***1 mg***RX Only. 1) Item no. 0169-75 (Hospital Unit Dose Blister Pack of 100); 2) Item no. 16910 (Sample Blisters of 10). Recall # D-786-2010
CODE
1) Lot# 8F34006B, exp. 30-Jun-2011; lot# 8K44272A, exp. 31-Dec-2011; 8K46168A, exp. 31-Jan-2012; lot# 9F4437A, exp. 30-Jun-2012; 9K58012B, exp. 30-Nov-2012; 2) Lot# 9A48931A, exp. 31-Jan-2012; lot# 9A48931B, exp. 31-Jan-2012; lot# 9A48931C, exp. 31-Jan-2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bristol Myers Squibb, New Brunswick, NJ, by letter on June 22, 2010.
Manufacturer: Bristol Myers Squibb Holdings Pharma., Ltd., Manati, PR. Firm initiated recall is ongoing.
REASON
The recall is based upon the firm's determination that some tablets may not meet specification for isopropanol, which is required to maintain the active ingredient in a crystalline state. The firm's medical assessment indicates that the use of tablets with low isopropanol could, in some cases, potentially lead to patient-to-patient variation in bioavailability.
VOLUME OF PRODUCT IN COMMERCE
144,762 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT   
1) OXYGEN, COMPRESSED USP UN1072 medical gas in a high pressure size D, E, and H cylinders, Rx only, CAS: 7782-44-7. Recall # D-789-2010;

2) NITROGEN, COMPRESSED NF UN1066 medical gas in a high pressure size E, H, and T cylinders, Rx only, Airgas Puritan Medical, CAS 7727-37-9. Recall # D-790-2010;

3) AIR, COMPRESSED UN1002 (MEDICAL AIR, USP) medical gas in a high pressure size E, H, and T cylinders, Rx only, Airgas Puritan Medical, CAS: 132259-10-0. Recall # D-791-2010;

4) NITROUS OXIDE USP UN1070 medical gas in a high pressure size E and G cylinders, Rx only, Airgas Puritan Medical, CAS: 100224-97-2. Recall # D-792-2010;

5) CARBON DIOXIDE USP UN1013 medical gas in a high pressure size E and G cylinders, Rx only, Airgas Puritan Medical, CAS: 124-38-9. Recall # D-793-2010;

6) COMPRESSED GAS, OXIDIZING, N.O.S. (__% CARBON DIOXIDE, __% OXYGEN) UN3156 medical gas in a high pressure size E and H cylinders, Rx only, Airgas Puritan Medical, CAS: CARBON DIOXIDE 124-38-9 OXYGEN 7782-44-7. Recall # D-794-2010;

7) OXYGEN, COMPRESSED USP UN1072, Walk-O2-Bout, MEDICAL GAS, PRODUCED BY AIR LIQUEFACTION medical gas in a high pressure size E cylinder, Rx only, C.A.S. NO. 7782-44-7. Recall # D-795-2010;

8) OXYGEN, REFRIGERATED LIQUID USP UN1073 vertical gas liquid (VGL) cylinder (cryogenic), 180 liter dewar, Rx only, C.A.S. NO. 7782-44-7. Recall # D-796-2010;

9) NITROGEN, REFRIGERATED LIQUID NF UN1977 vertical gas liquid (VGL) cylinder (cryogenic), 180 liter dewar, Rx only, C.A.S. NO. 7727-37-9. Recall # D-797-2010
CODE
1), 2), 3), 4), 5), and 6) Products with expiration dates of July 13, 2010 through July 13, 2015 will be recalled since these cylinders have a five year expiration date;

7) Products with expiration dates of July 13, 2010 through July 13, 2012 will be recalled since these cylinders have a two year expiration date;

8) and 9) Products with expiration dates of July 13, 2010 through July 13, 2011 will be recalled since these cylinders have a one year expiration date.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Airgas South, Inc., Rome, GA, by press release and letter on July 23, 2010.
Manufacturer: Airgas South Inc., Chattanooga, TN. Firm initiated recall is ongoing.
REASON
CGMP Deviations: Products were manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices (cGMPs).
VOLUME OF PRODUCT IN COMMERCE
349,000 cylinders
DISTRIBUTION
GA, TN

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III
___________________________________
PRODUCT   
Acetaminophen Tablets, Acetaminophen 325 mg., 100 tablet bottles, OTC, sold under the following brand names: Good Neighbor Pharmacy Pain Relief, Good Neighbor Pharmacy,  NDC 24385-403-78; Care One Pain Relief Care One, NDC 41520-403-78; H.E.B. Pain Relief, H.E.B, NDC 37808-403-78; HyVee Pain Relief, NDC 42507-403-78; Leader Pain Reliever, NDC 37205-031-78; CVS Pain Relief, NDC 59779-403-78; Sunmark Pain reliever, NDC 49348-009-10; Hannaford Pain Reliever, NDC 41268-403-78; Equaline pain relief, NDC 41163-403-78; TopCare Pain Relief, NDC 36800-0403-78; Goodsense Pain Relief, NDC 0113-0403-78. Recall # D-768-2010
CODE
Lot numbers: 0BE2230, 0CE1359, 0CE1623, 0CE2533, 0DE1161, 0DE1610 and 0EE1594    
RECALLING FIRM/MANUFACTURER
L. Perrigo Co., Allegan, MI, by letter dated June 8, 2010. Firm initiated recall is ongoing.
REASON
The liver warning section of the product label warns that severe liver damage may occur if an adult takes more than 8 tablets in 24 hours. The warning should state that liver damage may occur if an adult takes more than 12 tablets in 24 hours.
VOLUME OF PRODUCT IN COMMERCE
60,594 bottles
DISTRIBUTION
Nationwide    

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT   
Red Blood Cells. Recall # B-1323-10
CODE
Unit: 17KV86747
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by fax on February 21, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria and leishmaniasis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN     
___________________________________
PRODUCT   
Source Plasma. Recall # B-1617-10
CODE
Unit: SQ052752
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank, Inc. of Wisconsin, Madison, WI, by fax on November 12, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was previously deferred for high risk behavior, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC     
___________________________________
PRODUCT   
Red Blood Cells. Recall # B-1853-10
CODE
Unit: 17GV55292
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by fax on February 27, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC
___________________________________
PRODUCT   
Source Plasma. Recall # B-1909-10
CODE
Units: 054714714, 0540714295, 0540712757, 0540712423, 0540710376, 0540709154, 0540708230, 0540704809, 0540696619, 0540696001, 0540693973
RECALLING FIRM/MANUFACTURER
CSL Plasma Inc., Louisville, KY, by email on April 15, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously permanently deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
IL, Switzerland, Germany     
___________________________________
PRODUCT   
Source Plasma. Recall # B-1913-10
CODE
Units: GA1043016, GA1055689, GA1056140, GA1056727, GA1057086, GA1059201, GA1059452, GA1060539, GA1061441, GA1064035, GA1064487, GA1076350
RECALLING FIRM/MANUFACTURER
DCI Biologicals LLC, Gallup, NM, by fax on September 19, 2009 and e-mail on December 31, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a body piercing within 12 months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
NY, UK
___________________________________
PRODUCT   
1) Red Blood Cells. Recall # B-2034-10;
2) Recovered Plasma. Recall # B-2035-10;
3) Red Blood Cells Leukocytes Reduced. Recall # B-2036-10;
4) Plasma Frozen within 24 hours (FP24). Recall # B-2037-10
CODE
1) Unit: W044409202317;
2) Units: W044410200600, W044409203203, W044409202317;
3) Units: W044410200600, W044409204563, W044409203203, W044409201066;
4) Units: W044409204563, W044409201066
RECALLING FIRM/MANUFACTURER
Northern Illinois Blood Bank dba Rock River Valley BC, Rockford, IL, by telephone and facsimile on April 13, 2010 and by letter dated April 19, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of exposure to Hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
Austria, NY, IL, WI
___________________________________
PRODUCT   
1) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-2038-10;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-2039-10
CODE
1) Units: 17FE36623, 17FE36611 (2 units), 17FE36627, 17FE36566;
2) Units: 17FE36601 (2 units),17FE36627 (2 units), 17FE36566
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region. Saint Paul, MN, by telephone on September 15, 2008 and by facsimile on September 26, 2008. Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but may have had an elevated white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
MN, WI

___________________________________
PRODUCT   
Plasma Frozen. Recall # B-2065-10
CODE
Unit: 240067081
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Rapid City, SD, by phone and fax on November 29, 2007. 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
NM    
___________________________________
PRODUCT   
Source Plasma. Recall # B-2120-10
CODE
Units: 6270836385, 6270835390, 6270834290, 6270833364, 6270831371, 6270817348, 6270800373, 6270799239, 6270796692, 6270795293, 6270794138, 6270792776, 6270790311, 6270789150, 6270787734, 6270786549, 6270785181, 6270784055, 6270782696, 6270781542, 6270780142, 6270778983, 6270775431, 6270774309, 6270773056, 6270771946, 6270768300, 6270767200, 6270766000, 6270764932, 6270763715, 6270762658, 6270761477, 6270760369, 6270759135, 6270756977, 6270755931, 6270754820, 6270753792, 6270752663, 6270751556, 6270750444, 6270749354, 6270748228, 6270747064, 6270745983, 6270744919, 6270740587, 6270739585, 6270738597, 6270737567, 6270736586, 6270735609, 6270733840, 6270732843, 6270731869, 6270730905, 6270729944, 6270644113, 6270643255, 6270642383, 6270641493, 6270635717, 6270634849, 6270633945, 6270633023, 6270622012, 6270616643, 6270615746, 6270614864, 6270613986, 6270613090, 6270612240, 6270611302, 6270610466, 6270609523, 6270608717, 6270607766, 6270606935, 6270606074, 6270605108, 6270604234, 6270603348, 6270602414, 6270601694, 6270600797, 6270599924, 6270599033, 6270598131, 6270597237, 6270596356, 6270595518, 6270594589, 6270593780, 6270592940, 6270592118, 6270591210, 6270590422, 6270589516, 6270588627, 6270587894, 6270587066, 6270586259, 6270585458, 6270584616, 6270583824, 6270582999, 6270582133, 6270581423, 6270580724, 6270579929, 6270579129, 6270578311, 6270577494, 6270576651, 6270575822, 6270574989, 6270574114, 6270573326, 6270572706, 6270571810, 6270571020, 6270570224, 6270569434, 6270568620, 6270567785, 6270566964, 6270566186, 6270565367, 6270564450, 6270563576, 6270560140, 6270559306, 6270558416, 6270557769, 6270556884, 6270556320, 6270555176, 6270554532, 6270553307, 6270552669, 6270551512, 6270550829, 6270549678, 6270548971, 6270548073, 6270547445, 6270546264, 6270545628, 6270544495, 6270543874, 6270542786, 6270542155, 6270541035, 6270540407, 6270539273, 6270538696, 6270537597, 6270537045, 6270535953, 6270535388, 6270534263, 6270533660, 6270532546, 6270531957, 6270530779, 6270530171, 6270529149, 6270528556, 6270527428, 6270526800, 6270525650, 6270525126, 6270523992, 6270523401, 6270522301, 6270521710, 6270520553, 6270502908, 6270501286, 6270500102, 6270499600, 6270498499, 6270497996, 6270496932, 6270496433, 6270495449, 6270494967, 6270493936, 6270493514, 6270492539, 6270492106, 6270491069, 6270490622, 6270489673, 6270489291, 6270487149, 6270486791, 6270485931, 6270485530, 6270484681, 6270484282, 6270483460, 6270483070, 6270482274, 6270481862, 6270481001, 6270480585, 6270479689, 6270479277, 6270478399, 6270477944, 6270477100, 6270476701, 6270473445, 6270472573, 6270472151, 6270471323, 6270470933, 6270470075, 6270469636, 6270468987, 6270468553, 6270467708, 6270467274, 6270466366, 6270465940, 6270465135, 6270464726, 6270463729, 6270463315, 6270462449, 6270462053, 6270461135, 6270460733, 6270459849, 6270459477, 6270458547, 6270458094, 6270457052, 6270456616, 6270455680, 6270455295, 6270454379, 6270454098, 6270453246, 6270452835, 6270452005, 6270451621, 6270450708, 6270450311, 6270449464, 6270449111, 6270448295, 6270447942, 6270431436, 6270431183, 6270430537, 6270430305, 6270429621, 6270429363, 6270428687, 6270428437, 6270427741, 6270427481, 6270426788, 6270426518, 6270425879, 6270425586, 6270424923, 6270424657, 6270423964, 6270423689, 6270423022, 6270422743, 6270422062, 6270421770, 6270421074, 6270420791, 6270420082, 6270419789, 6270419069, 6270410481, 6270410012, 6270409542, 6270408998, 6270408527, 6270408008, 6270407558, 6270406550, 6270406053, 6270405655, 6270405134, 6270404641, 6270404108, 6270403647, 6270403111, 6270402603, 6270402056, 6270401690, 6270401183, 6270400679, 6270400118, 6270399641, 6270399088, 6270398604, 6270398031, 6270397535, 6270397005, 6270396528, 6270395958, 6270395317, 6270394750, 6270394112, 6270393639, 6270393129, 6270392718, 6270392234, 6270391710, 6270391205, 6270390710, 6270390208, 6270389712, 6270389187, 6270388697, 6270388024, 6270387809, 6270387034, 6270386691, 6270385893, 6270385540, 6270384705, 6270384342, 6270383618, 6270383288, 6270382492, 6270382158, 6270381384, 6270381009, 6270380211, 6270379895, 6270379135, 6270378823, 6270378065, 6270377691, 6270376871, 6270376546, 6270375739, 6270375371, 6270374561, 6270374184, 6270373405, 6270373058, 6270372214, 6270371648, 6270371033, 6270370431, 6270369801, 6270368807, 6270368221, 6270367561, 6270366946, 6270366314, 6270365695, 6270364808, 6270364381, 6270363627, 6270363210, 6270362620, 6270362202, 6270361174, 6270360299, 6270359923, 6270359041, 6270358683, 6270357871, 6270357568, 6270356892, 6270356508, 6270355599, 6270355235, 6270354273, 6270353870, 6270352973, 6270352639, 6270351633, 6270351223, 6270350300, 6270349896, 6270348995, 6270348617, 6270347767, 6270347448, 6270346510, 6270346101, 6270345136, 6270344732, 6270343821, 6270343419, 6270342517, 6270342114, 6270341306, 6270340931, 6270340018, 6270339637, 6270338684, 6270338273, 6270337279, 6270336897, 6270336052, 6270335639, 6270334614, 6270334193, 6270333319, 6270332926, 6270331921, 6270331508, 6270330456, 6270330174, 6270329157, 6270328728, 6270327702, 6270327304, 6270326316, 6270325886, 6270324941, 6270324570, 6270323691, 6270323310, 6270322427, 6270322049, 6270321138, 6270320787, 6270319824, 6270319448, 6270318506, 6270318191, 6270317240, 6270316814, 6270315859, 6270315460, 6270314555, 6270314139, 6270313278, 6270312889, 6270312164, 6270311632, 6270310864, 6270309488, 6270308965, 6270307397, 6270306675, 6270418823, 6270418143, 6270418003, 6270417417, 6270416505, 6270415502, 6270415213, 6270414502, 6270414212, 6270413558, 6270413232, 6270412776, 6270412469, 6270361541, 6270305856, 6270305423, 6270304628, 6270300827, 6270300269, 6270299477, 6270298967, 6270298021, 6270296749, 6270296437, 6270295780, 6270294933, 6270294288, 6270293718, 6270293078, 6270292429, 6270291837, 6270291288, 6270290908, 6270290300, 6270289644, 6270289106, 6270288448, 6270287816, 6270287161, 6270286594, 6270285979, 6270285330, 6270284692, 6270284114, 6270283453, 6270282855, 6270282228, 6270281665, 6270281018, 6270280485, 6270279817, 6270279240, 6270278580, 6270277970, 6270277292, 6270276741, 6270276079, 6270275438, 6270274752, 6270274129, 6270273516, 6270272952, 6270272233, 6270271615, 6270270916, 6270270318, 6270269641, 6270268971, 6270268381, 6270267767, 6270267120, 6270266499, 6270265828, 6270265342, 6270264695, 6270264134, 6270263449, 6270262913, 6270262255, 6270261699, 6270261093, 6270260510, 6270259875, 6270259345, 6270258735, 6270258243, 6270257639, 6270257116, 6270256491, 6270255952, 6270255355, 6270254798, 6270254250, 6270253636, 6270253066, 6270252440, 6270252006, 6270251430, 6270250873, 6270250313, 6270249718, 6270249167, 6270248602, 6270248017, 6270247464, 6270246915, 6270246348, 6270245869, 6270245344, 6270244900, 6270244435, 6270244000, 6270243517, 6270243097, 6270242635, 6270242256, 6270241791, 6270662137, 6270661642, 6270659057, 6270658659, 6270656275, 6270655732, 6270654376, 6270648799, 6270648515, 6270645476, 6270642289, 6270641410, 6270640528, 6270638655, 6270637282, 6270628347, 6270627010, 6270626251, 6270402571, 6270402187, 6270401468, 6270401110, 6270400410, 6270400044, 6270397994, 6270397668, 6270396469, 6270394238, 6270393493, 6270390429, 6270387616, 6270371806, 6270370723, 6270366042, 6270365814, 6270364778, 6270364167, 6270363604, 6270362597, 6270362334, 6270360118, 6270359725, 6270358303, 6270357852, 6270357354, 6270356250, 6270355583, 6270354965, 6270353844, 6270353409, 6270351867, 6270351608, 6270350523, 6270350007, 6270427469, 6270425663, 6270419200, 6270415968, 6270415268, 6270414772, 6270502792, 6270501833, 6270501174, 6270500184, 6270264653, 6270264356    
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Salt Lake City, UT, through online communication or facsimile transmission on February 10, 11 and 12, March 1st, and April 7th, 2010. Firm initiated recall is complete.
REASON
Source Plasma, collected from previously deferred donors, was distributed.
VOLUME OF PRODUCT IN COMMERCE
635 units
DISTRIBUTION
Switzerland, Germany, IL, NC
___________________________________
PRODUCT   
Source Plasma. Recall # B-2121-10
CODE
Units: 85958074, 85948433, 85946682, 85941830, 85939400, 85937666, 85933941, 85932166, 85919815, 85916890, 85914766, 85911451, 85908246, 85905832, 85903890, 85892569, 85879706, 85822597, 85821002, 85816176, 85813359, 85806276, 85802858, 85787285, 85786158, 85781726, 85780101, 85778221, 85770881, 85770263, 85765092, 85764378, 85758308, 85758179, 85753549, 85750630, 65188705, 65186343, 65181508, 65173756, 65142691, 65133224, 65131480, 65114513, 65105092, 65103586, 65098141, 65096345, 65092170, 65090329, 65084090, 65081013, 65069561, 65065501, 65039847, 65038048, 13510152, 13306052, 86086875, 86081740, 86079976, 86076746, 86075596, 86068451, 86068024, 86063067, 86062367, 86057301, 86051026, 86045315, 86043014, 86038812, 86036160, 86033176, 86029742, 86024013, 86017893, 86014151, 86011921, 86008181, 86002080, 86000543, 85994775, 85991408, 85989443, 85986305, 85984615, 85981539, 85980006, 85977235, 85972391, 85970571, 85967489, 85965553, 85962293, 85960688, 85957336, 85955820, 85952317, 85950443, 85947054, 85943124, 85939837, 85937925, 85935501, 85933170, 85929661, 85926271, 85754546, 65187227, 65184226, 65176603, 65173817, 65171165, 65167724, 65162934, 65161425, 65151341, 65148921, 65145807, 65137857, 65134405, 65120699, 65114018, 65109786, 65108383, 65103692, 65100882, 64967677, 64965390, 64961774, 64956138, 64952673, 64948553, 64947006, 64942384, 64939865, 64936413, 64934068, 64930336, 64928586, 6150193883, 6150190239, 8840005360, 8840000289, 6150158549, 6150154940, 6150151396, 6150151139, 6150149084, 6150148539, 6150147476, 6150146994, 6150144880, 6150144427, 6150137925, 6150136021
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Evans, CO, by facsimile transmissions dated January 4, February 5, and April 7, 2010. Firm initiated recall is complete.
REASON
Source Plasma, collected from previously deferred donors, was distributed.
VOLUME OF PRODUCT IN COMMERCE
157 units
DISTRIBUTION
CA, NC          
___________________________________
PRODUCT   
Source Plasma. Recall # B-2122-10
CODE
Units: 7020710329, 7020709018, 81 FQGHPF, 81 FQGHFL, 81 FQFMPC, 81 FQFMGT, 81 FQFLYF, 81 FQFLQZ, 81 FQFLJQ, 81 FQFKMB
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Aurora, CO, by email on February 10 and March 8, 2010. Firm initiated recall is complete.
REASON
Source Plasma, collected from previously deferred donors, was distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
Germany, Switzerland, IL     
___________________________________
PRODUCT   
Source Plasma. Recall # B-2123-10
CODE
Units: 6140233467, 6140232017, 6140230709, 6140105453, 6140104504, 6140103435, 6140101614, 6140101421, 6140099937
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Evansville, IN, electronically on February 10, 2010. Firm initiated recall is complete.
REASON
Source Plasma, collected from previously deferred donors, was distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
Switzerland, IL          
___________________________________
PRODUCT   
Source Plasma. Recall # B-2124-10
CODE
Units: 16370333, 16323940, 16319820, 16315792, 16311527, 16307957, 16303959, 98494361, 98490066, 98485796, 98481255, 98477166, 98473212, 98468539, 98465705, 98415854, 98410132, 98407071, 98399451, 98395378, 98391585, 98387090, 98383849, 98377527, 98370092, 98353163, 98279982, 98275762, 98271757, 98231508, 98188451, 98182572, 98179213, 98171255, 98135318, 98129102, 98036882, 98011513, 81866557, 81845576, 81835447, 81828340, 81803859, 81765058, 81756001, 81742929, 81724420, 81712632, 81699186, 81688029, 81685882, 81676545, 81652921, 81647965, 81628599, 81624256, 81620821, 81614837, 81612604, 81595952, 81581344, 81578375, 81573257, 81570218, 98364039, 98354849, 98349166, 98342969, 98339174, 98334179, 98327485, 98320011, 98316328, 98312856, 98309498, 98306343, 98302772, 98290628, 98287550, 98281930, 98278787, 98271900, 98269136, 98263660, 98260980, 6230026783, 6230026498, 98323531
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Pensacola, FL, by email on February 11, 2010. Firm initiated recall is complete.
REASON
Source Plasma, collected from previously deferred donors, was distributed.
VOLUME OF PRODUCT IN COMMERCE
88 units
DISTRIBUTION
CA     
___________________________________
PRODUCT   
Source Plasma. B-2125-10
CODE
Units: 0120346846, 0120346319, 0120346017
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Lawrence, KS, by facsimile transmission dated March 11, 2010. Firm initiated recall is complete.
REASON
Source Plasma, collected from previously deferred donors, was distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NC     
___________________________________
PRODUCT   
Source Plasma. B-2126-10
CODE
Units: 0520604583, 0520602930, 0520602141, 0520296690, 0520303291, 0520302900, 0520302567, 0520301693, 0520301652, 0520298875, 0520298666, 0520298359, 0520297935, 0520297530, 0520297344, 0520296937, 0520295978, 0520295423, 0520295225, 0520321501, 0520321111, 0520321012, 0520320268, 0520320116, 0520311440, 0520310494, 0520310159, 0520309945, 0520309719, 0520309362, 0520309130, 0520308496, 0520308327, 0520307398, 0520306726, 0520306495, 0520304877, 0520303446
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Memphis, TN, by email on March 11 and 12, 2010. Firm initiated recall is complete.
REASON
Source Plasma, collected from previously deferred donors, was distributed.
VOLUME OF PRODUCT IN COMMERCE
38 units
DISTRIBUTION
Germany, Switzerland, CA, NC
___________________________________
PRODUCT   
Source Plasma. Recall # B-2132-10
CODE
Units: 5090016615, 5090016284, 5090015389, 5090014235, 5090013958, 5090013519, 5090013245
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Minneapolis, MN, by fax on November 30, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a body piercing within 12 months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
NC     

___________________________________
PRODUCT   
Source Plasma. Recall # B-2133-10
CODE
Units: 3330018341, 3330027393, 3330031807, 3330031195, 3330018623, 3330027863, 3330029429, 3330031273, 3330031001, 3330028801, 3330027665, 3330026912, 3330029555, 3330028898, 3330030302
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., El Paso TX, by fax on August 12, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose scheduled physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
NC     
___________________________________
PRODUCT   
Source Plasma. Recall # B-2134-10
CODE
Units: 3910020431, 3910019695, 3910018715, 3910018227, 3910017100, 3910016675, 3910015596, 3910015120, 3910014175, 3910013575, 3910012934, 3910012281, 3910010102, 3910009899, 3910007715, 3910007430
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., N Las Vegas, NV, by fax on July 17, 2009. 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
16 units
DISTRIBUTION
NC     
___________________________________
PRODUCT   
Source Plasma. Recall # B-2135-10
CODE
Unit: 365077251
RECALLING FIRM/MANUFACTURER
Telecris Plasma Resources, Inc., Roanoke, VA, by fax on June 24, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose scheduled physical exam was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT   
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-2136-10
CODE
Unit: 42GX05287 (part 1 and 2)
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Cleveland, OH, by letter on December 05, 2007.
Manufacturer: American Red Cross Blood Services, Cleveland, OH. Firm initiated recall is complete.
REASON
Blood product, labeled leukoreduced without the assurance that it met the criteria for a leukoreduced product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH     
___________________________________
PRODUCT   
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-2137-10
CODE
Unit: 42GY03688
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Cleveland, OH, by telephone on December 09, 2007.
Manufacturer: American Red Cross Blood Services, Cleveland, OH. Firm initiated recall is complete.
REASON
Blood product, labeled leukoreduced without the assurance that it met the criteria for a leukoreduced product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH     
___________________________________
PRODUCT   
Source Plasma. Recall # B-2149-10
CODE
Units: 5110035715, 5110034874, 5110034591, 5110034356, 5110034026, 5110033751, 5110033277, 5110031968, 5110030931, 5110028870, 5110028325, 5110028089, 5110032264
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Pensacola , FL, by fax on April 8, 2010. 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
13 units
DISTRIBUTION
NC     
___________________________________
PRODUCT   
Source Plasma.  Recall # B-2150-10
CODE
Unit: 3910068870
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., N Las Vegas, NV, by fax on December 30, 2009. 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
NC
___________________________________
PRODUCT   
Source Plasma. Recall # B-2151-10
CODE
Units: 3750053955, 3750054264, 3750054644, 3750055082, 3750052323, 3750052871, 3750053992, 3750051398, 3750051658, 3750052488, 3750052245
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources Inc., Killeen, TX, by fax on April 05, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who may have received a body piercing/tattoo within 12 months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
NC     
___________________________________
PRODUCT   
COBE Spectra Apheresis System Disposable Tubing Sets: WBC Set, Spectra 70600 and Functionally Closed WBC Set, Spectra 70620. Recall # B-2164-10
CODE
Lot Numbers 01S15238 and 01S15239
RECALLING FIRM/MANUFACTURER
Caridian BCT, Inc., Lakewood, CO, by letter on July 12 and 13, 2010. Firm initiated recall is ongoing.
REASON
Cobe Spectra Apheresis Disposable Tubing Sets, with an increased number of reports of leaks, were distributed.
VOLUME OF PRODUCT IN COMMERCE
30 cases (US), 328 cases (International)
DISTRIBUTION
AZ, CA, IL, MI, NY, PA, TX. Foreign distribution to Australia, Belgium, Canada, Costa Rica, Japan, Taiwan   
___________________________________
PRODUCT   
Cryoprecipitated AHF. Recall # B-2178-10
CODE
Units: KC24828, KX23273, KC24843, KC24847, KX06475, LC97291, LL95069, LM15878, LM17070, LM17286, LM17555, LW89291, LW89300, LW89302, KC24863, LC97310, LL95099, LM15898, LM17107, LM17108, LM17110, LM17113, LC97210, LC97212, LW89126, LW89129, KX23135, LW89143, LW89144, LW89145, LC97228, LC97230, LM16708, KC24753, KC24757, LC97237, LM17508, LM17510, LM15072, LM16670, LM16673, KC24717, KX23114, LM14998, LW89124, LM11393, LM12152, LW88618, LW89156, LC97226, KC24754, KX23164, LC97235, LM17512, LL95056, LM15220, LM16130, KC24827, LW89229, LM16170, LM17354, KX23213, LM11388, LL94832, LC97193, LC97227, KX22612, LM10487, LM11389, LM11392, LW88623
RECALLING FIRM/MANUFACTURER
Mid-South Regional Blood Center, Memphis, TN, by letters starting on September 26, 2007. Firm initiated recall is complete.
REASON
Blood products, which failed monthly QC testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
71 units
DISTRIBUTION
TN
___________________________________
PRODUCT   
1) Red Blood Cells Leukocytes Reduced. Recall # B-2179-10;
2) Plasma Frozen. Recall # B-2180-10
CODE
1) and 2) Unit: 17GW07355
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Saint Paul, MN, by letter dated May 7, 2008.
Manufacturer: The American National Red Cross - North Central Region, Saint Paul, MN. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MN    
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-2182-10
CODE
Unit: 17FJ91757
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Saint Paul, MN, by fax and letter on June 27, 2008.
Manufacturer: The American National Red Cross - North Central Region, Saint Paul, MN. 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
WI, IL
___________________________________
PRODUCT   
1) Red Blood Cells. Recall # B-2215-10;
2) Fresh Frozen Plasma. Recall # B-2216-10
CODE
1) and 2) Unit: 0951592
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter on November 5, 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
2 units
DISTRIBUTION
MN     
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-2221-10
CODE
Unit: 1454833
RECALLING FIRM/MANUFACTURER
Recalling Firm: Memorial Blood Centers, Saint Paul, MN, by letter on September 30, 2008. 
Manufacturer: Memorial Blood Centers Duluth. Duluth, MN. 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
MN, PA

___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-2238-10
CODE
Unit: 17FN13105
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Saint Paul, MN, by fax on June 23, 2008.
Manufacturer: The American National Red Cross - North Central Region, Saint Paul, MN. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN     

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT   
Source Plasma. Recall # B-2127-10
CODE
Unit: 3850072972
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Oklahoma City, OK, by fax on August 28, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose scheduled physical exam was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC     
___________________________________
PRODUCT   
Source Plasma. Recall # B-2128-10
CODE
Units: 3770006919, 3770006738, 3770006235, 3770006019, 3770005427, 3770005212, 3770004607, 3770004374, 3770003846, 3770003638, 3770002754, 3770001930, 3770001675, 3770001215, 3770000985, 3770000509, 3770000300
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Anderson, IN, by fax on October 27 and 28, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose scheduled physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
NC     
___________________________________
PRODUCT   
Source Plasma. Recall # B-2129-10
CODE
Units: 5090010866, 5090011329, 5090011786, 5090013004, 5090013283, 5090013753, 5090014019, 5090018576
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Minneapolis, MN, by fax on November 2, 2009. 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
NC     
___________________________________
PRODUCT   
Source Plasma. Recall # B-2130-10
CODE
Unit: 3390028930
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources Inc., Toledo, OH, by fax on November 12, 2009. 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
NC
___________________________________
PRODUCT   
Source Plasma. Recall # B-2131-10
CODE
Unit: 3830057089
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Milwaukee, WI, by fax on November 23, 2009. 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
NC     
___________________________________
PRODUCT   
Source Plasma. Recall # B-2147-10
CODE
Unit: 3930076625
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Charlotte, NC, by fax on October 13, 2009. Firm initiated recall is complete.
REASON
Blood product, not tested for HIV and HCV NAT, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC     
___________________________________
PRODUCT   
Source Plasma. Recall # B-2148-10
CODE
Units: 3910049082, 3910048591, 3910047918, 3910046427, 3910045980, 3910045224, 3910044810, 3910043943, 3910043786    
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., N Las Vegas, NV, by fax on May 22 and 26, 2009. 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
9 units
DISTRIBUTION
NC     
___________________________________
PRODUCT   
Recovered Plasma. Recall # B-2181-10
CODE
Unit: 17FJ91757
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Saint Paul, MN, by fax and letter on June 27, 2008.
Manufacturer: The American National Red Cross - North Central Region, Saint Paul, MN. 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
WI, IL
___________________________________
PRODUCT   
Recovered Plasma. Recall # B-2217-10
CODE
Unit: 0951592
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter on November 5, 2008. 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
MN
___________________________________
PRODUCT   
1) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-2218-10;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-2219-10
CODE
1) W036708601857 Part 1, W036710101687 Part 1, W036710101687 Part 2, W036710101726, W036710103903 Part 2, W036710103935, W036710103921 Part 2, W036710103921 Part 3, W036710101702, W036710101703, W036709102270, W036709102286 Part 2, W036709110590 Part 1, W036709110648 Part 1, W036709110648 Part 2;

2) W036708601906 Part 2 W036708601768 Part 1, W036708402270, W036708402272 Part 1, W036708402272 Part 2, W036709102279, W036709102286 Part 1, W036709102298, W036709300581, W036709102253, W036709110590 Part 2, W036709110669, W036709110677 Part 1, W036709110578, W036709110626
RECALLING FIRM/MANUFACTURER
Central Illinois Community Blood Center, Springfield, IL, by fax on February 10, 2010 and letter March 24, 2010. Firm Initiated recall is complete.
REASON
Blood products, for which the quality control testing was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
30 units
DISTRIBUTION
IL
___________________________________
PRODUCT   
Recovered Plasma. Recall # B-2222-10
CODE
Unit: 1454833
RECALLING FIRM/MANUFACTURER
Recalling Firm: Memorial Blood Centers, Saint Paul, MN, by letter on September 30, 2008. 
Manufacturer: Memorial Blood Centers Duluth. Duluth, MN. 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
MN, PA
___________________________________
PRODUCT   
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-2223-10
CODE
Units: 9927862 Part 1; 9927155 Part 1
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by letter on September 23, 2008. Firm initiated recall is complete.
REASON
Blood products, lacking assurance of having been maintained at an acceptable temperature during shipping, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL      

___________________________________
PRODUCT   
Source Plasma. Recall # B-2240-10
CODE
Unit: FZ073043
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank Inc. of Wisconsin, Milwaukee, WI, by fax on July 25, 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
Austria           
___________________________________
PRODUCT   
Source Plasma. Recall # B-2241-10
CODE
Unit: FZ073912
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank Inc. of Wisconsin, Milwaukee, WI, by fax on June 30, 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
Austria

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II
___________________________________
PRODUCT   
1) Fresenius 2008H Dialysate Delivery Machine, Catalog numbers 501228, R190188 (Refurbished), R501228, RTLR501228 (Refurbished). Recall # Z-2224-2010;

2) Fresenius 2008K, 2008K2 and 2008 K2@home Hemodialysis Machines, Catalog numbers: 2008K: 190300, 190303, 190305, 190336, 190371, 190372, 190373, 190517, R190305 (Refurbished), R190371 (Refurbished), RTL190371, RTL190373, RTLR190305 (Refurbished), RTLR190371 (Refurbished), RTLR190373 (Refurbished). 
Recall # Z-2225-2010;

3) Fresenius Granuflo 1 Mixer Dissolution Unit - Tested, and Granuflo Dissolution Tank, Model Numbers G047-80101 and RTLG047-80101, Catalog Numbers G047-80101 and RTLG047-80101. Recall # Z-2226-2010;

4) Main Power Supply Assembly (50 and 60 Hz) and AC Power cord assembly for hemodialysis machines and Granuflo 1 mixers. Catalog Numbers 190011 (60 Hz main power supply), 190092 (50 Hz main power supply), 150425 (AC power cord assembly -hemodialysis machine) and 160089 (AC power cord assembly, Granuflo 1 mixers). Recall # Z-2227-2010
CODE
No lot numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fresenius Medical Care North America, Waltham, MA, by letter on June 28, 2010.
Manufacturer: Fresenius USA, Inc., Walnut Creek, CA. Firm initiated recall is ongoing.
REASON
Power cords may fail if the prongs crack or fail at the plug, and may become a fire/burn/shock hazard or delay/interrupt therapy.
VOLUME OF PRODUCT IN COMMERCE
72,142 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT   
AXIOM Artis MP/Artis dMP and Artis zee Multipurpose. Angiographic x-ray system. Model numbers: 10094139, 5904466, 7555365. Recall # Z-2233-2010
CODE
Serial numbers: 20136, 157435, 20205, 57089, 20334, 20114, 57077, 157458, 20052, 20303, 20343, 20016, 157136, 20208, 20238, 20242, 157436, 57144, 57189, 20322, 20295, 20081, 157448, 20209, 157165, 20254, 20170, 20282, 20076, 157168, 20050, 157213, 20363, 20179, 57035, 157164, 157156, 20202, 20338, 57188, 20348, 20172, 20183, 57073, 20264, 57016, 20325, 20143, 20367, 20258, 57009, 20182, 20175, 157169, 20056, 57004, 20082, 20037, 20053, 157139, 57187, 58702, 20250, 20313, 20100, 20207, 20230, 157146, 20157, 157476, 20249, 57204, 20140, 57111, 20181, 20281, 57171, 20033, 20074, 20165, 57113, 20243, 20178, 57193, 20188, 20339, 57117, 20141, 57041, 57072, 57008, 157414, 20321, 157215, 57198, 57054, 57155, 20097, 20003, 20015, 20233, 20220, 20265, 57098, 57124, 57116, 57045, 157184, 20185, 57156, 57076, 57105, 58701, 20086, 20087, 20217, 157409, 20102, 57012, 57201, 20180, 20294, 157466, 157442, 20129, 157449, 20171, 57024, 57183, 157438, 157440    
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on July 13, 2010.
Manufacturer: Siemens AG, Medical Solution, Forchheim, Germany. Firm initiated recall is ongoing.
REASON
The Axiom Artis MP, Artis dMP or Artis zee Multipurpose C-arm gearbox can become damaged. If the gearbox is damaged, the C-arm may tilt away when being repositioned and collide with nearby objects in its range of motion.
VOLUME OF PRODUCT IN COMMERCE
131 units
DISTRIBUTION
Nationwide
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PRODUCT   
3DKnee Baseplates, Size 8, Left, Part # 333-01-108. Size 8, Left, Part # 333-01-108. Recall # Z-2244-2010
CODE
Lot number: A1000003
RECALLING FIRM/MANUFACTURER
Encore Medical, LP, Austin, TX, by letter on June 28, 2010. Firm initiated recall is ongoing.
REASON
One lot of product has an incorrect color label. The color label is a secondary visual indicator of sizing.
VOLUME OF PRODUCT IN COMMERCE
18 units
DISTRIBUTION
FL, MO, and Italy
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PRODUCT   
1) Medtronic Everest 20 Disposable Inflation Device, AC2200. Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon. Recall # Z-2271-2010;

2) Medtronic Everest 30 Disposable Inflation Device, AC3200. Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon. Recall # Z-2272-2010;

3) Medtronic Everest 30 Disposable Inflation Device, AC3205P. Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon. Recall # Z-2273-2010
CODE
1) Lot numbers: 50517330, 50517331,50517332, 50517333, 50517334, 50519716, 50519717, 50519718, and 50519679;

2) Lot numbers: 50517324;

3) Lot numbers: 50517336, 50517337, and 50517339
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic, Inc., Danvers, MA, by letter on July 15, 2010.
Manufacturer: Availmed S.A. de CV, Tijuana, Mexico. Firm initiated recall is ongoing.
REASON
Product sterility may be compromised due to breach of package seal integrity.
VOLUME OF PRODUCT IN COMMERCE
4,897 units
DISTRIBUTION
Nationwide and the countries of Austria, Belgium, Czech Republic, Finland, France, Germany, Greece, Ireland, Israel, Italy, Lithuania, Pakistan, Poland, Portugal, Slovakia, Spain, Sweden, Switzerland, Ukraine, United Arab Emirates, and United Kingdom
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PRODUCT   
Arrow Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 Fr. Catheters; Catalog number AJ-09801. Recall # Z-2274-2010
CODE
Lot numbers: RF0018145, RF0021641, RF9044164, RF9069739, RF9070837, RF9100262
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arrow International Inc., Reading, PA, by letter on June 7, 2010.
Manufacturer: Arrow International Inc., Asheboro, NC. Firm initiated recall is ongoing.
REASON
Sterility not assured. The stopcock handle position was inadvertently changed from an open to a closed position, which prevents sterilization of the closed portion of the device. Sterility of the affected product cannot be guaranteed.
VOLUME OF PRODUCT IN COMMERCE
3,000 kits
DISTRIBUTION
Japan
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PRODUCT   
Carescape Monitor B850 Usage: The Carescape TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. Recall # Z-2275-2010
CODE
Parent Serial Number SED10102064GA SED10102074GA SED10102077GA SED10102078GA SED10102087GA SED10102088GA SED10102089GA SED10102094GA SED09441082GA SED10021717GA SED10021718GA SED10021722GA SED10031770GA SED10031772GA SED10031776GA SED09451341GA SED09471459GA SED09471460GA SED09471461GA SED09471463GA SED09471464GA SED09471467GA SED09471468GA SED09471469GA SED09471470GA SED09471472GA SED09471474GA SED09471476GA SED09471480GA SED09471481GA SED09471486GA SED09471488GA SED09471491GA SED09471493GA SED09471496GA SED09471478GA SED09491583GA SED09491587GA SED09491595GA SED09491596GA SED09491597GA SED09491599GA SED09511674GA SED09511676GA SED10021713GA SED09451339GA SED09451340GA SED10061886GA SED09400941GA SED09400945GA SED09400948GA SED10021730GA SED10031735GA SED10031744GA SED10031749GA SED10071894GA SED10071896GA SED10071901GA SED10071902GA SED10071903GA SED10071904GA SED10071907GA SED10071913GA SED10071914GA SED10071916GA SED10071920GA SED10071921GA SED10071931GA SED10071937GA SED10081947GA 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RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by letter dated July 12, 2010.
Manufacturer: General Electric Medical Systems Information Technology,
Milwaukee, WI. Firm initiated recall is ongoing.
REASON
GE Healthcare has become aware of four potential safety issues associated with the CARESCAPE" Monitor B850: 1. Loss of user input when using certain displays or the USB remote control. 2. Potential for a delay in treatment or missed alarm when the alarm light is used as a primary alarm source and audible alarms are turned down or off. 3. The CARESCAPE Monitor B850 will not use user entered hemoglobin values when calculating SvO2 values, which could result in incorrect treatment of a patient. 4. When CARESCAPE B850 is used in conjunction with Tram, the HR Alarm Limits may revert back to default settings, which could result in a missed alarm. There were no reported patient injuries or illnesses.
VOLUME OF PRODUCT IN COMMERCE
875 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT   
ABC Bend-A-Beam Handpiece REF 134003 Handcontrol Malleable Handpiece, 3" (7.6 cm) qty: 1 Sterile (pouch label) ABC Bend-A-Beam Handpiece REF 134003 Handcontrol Malleable Handpiece, 3" (7.6 cm) qty: 10 Sterile (case label) Usage: Electrosurgical handpiece for use as monopolar electrosurgical accessory in conjunction with CONMED electrosurgical units equipped with argon beam coagulation. Recall # Z-2276-2010;

2) ABC Bend-A-Beam Handpiece REF 134006 Handcontrol Malleable Handpiece, 6" (15.2 cm) qty: 1 Sterile, (Pouch label); ABC Bend-A-Beam Handpiece REF 134006 Handcontrol Malleable Handpiece, 6" (15.2 cm) qty: 10 Sterile, (case label) Usage: Electrosurgical handpiece for use as monopolar electrosurgical accessory in conjunction with Conmed electrosurgical units equipped with argon beam coagulation. Recall # Z-2277-2010;

3) ABC Bend-A-Beam Handpiece REF 134009 Handcontrol Malleable Handpiece, 9" (22.8 cm) qty: 1 Sterile, (Pouch label); ABC Bend-A-Beam Handpiece REF 134006 Handcontrol Malleable Handpiece, 9" (22.8 cm) qty: 10 Sterile (Case label) Usage: Electrosurgical handpiece for use as monopolar electrosurgical accessory in conjunction with Conmed electrosurgical units equipped with argon beam coagulation. Recall # Z-2278-2010;

4) ABC Probe REF 160656 5 mm Handswitching Probe, 28 cm qty: 1 Sterile; ABC Probe REF 160656 5 mm Handswitching Probe, 28 cm qty: 10 Sterile. Usage: Electrosurgical handpiece for use as monopolar electrosurgical accessory in conjunction with Conmed electrosurgical units equipped with argon beam coagulation. Recall # Z-2279-2010;

5) ABC Probe REF 160636 5 mm Handswitching Probe, 36 cm qty: 1 Sterile; ABC Probe REF 160636 5 mm Handswitching Probe, 36 cm qty: 10 Sterile Usage: Electrosurgical handpiece for use as monopolar electrosurgical accessory in conjunction with Conmed electrosurgical units equipped with argon beam coagulation.
Recall # Z-2280-2010;

6) ABC Probe REF 160644 5 mm Handswitching Probe, 44 cm Qty: 1 Sterile, ABC Probe REF 160636 5 mm Handswitching Probe, 44 cm, qty: 10 Sterile, Usage: Electrosurgical handpiece for use as monopolar electrosurgical accessory in conjunction with Conmed electrosurgical units equipped with argon beam coagulation. Recall # Z-2281-2010;

7) ABC PROBE REF 160655 5 mm Footswitching Probe, QTY: 1 STERILE ABC PROBE REF 160655 5 mm Footswitching Probe, QTY: 10 STERILE; Usage: Electrosurgical handpiece for use as monopolar electrosurgical accessory in conjunction with CONMED electrosurgical units equipped with argon beam coagulation. Recall # Z-2282-2010
CODE
Lot: 0306021 through 0806021
RECALLING FIRM/MANUFACTURER
Recalling Firm: ConMed Electrosurgery, Centennial, CO, by letter on December 18, 2008.
Manufacturer: Seisa Medical, Chih, Mexico. Firm initiated recall is ongoing.
REASON
The internal electrode can protrude in front of ceramic insulator at the tip of the ABC Handpiece used with Conmed Electrosurgical units.
VOLUME OF PRODUCT IN COMMERCE
Domestic 5527 cases; International 5497 cases
DISTRIBUTION
Nationwide and International
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PRODUCT   
Genzyme Biosurgery Essentials Kit, Item Number 82004. Recall # Z-2310-2010
CODE
Lot Numbers Affected: RM00654 RM00664 RM00672 RM00687 RM00690 RM00698 RM00700 RM00711 RM00714 RM00727 RM00732 RM00741 RM00748 RM00757 RM00773 RM00781 RM00791 RM00802 RM00820 RM00835
RECALLING FIRM/MANUFACTURER
Genzyme Corp., Cambridge, MA, letter on July 13, 2010. Firm initiated recall is ongoing.
REASON
Revised Labeling of Carticel Essentials Kit clarifies the non-sterile packaging of the outer clear plastic tray which should not be opened in the sterile field.
VOLUME OF PRODUCT IN COMMERCE
3,132 kits
DISTRIBUTION
Nationwide
___________________________________
PRODUCT   
E.faecalis/OE PNA FISH Intended Use: E. faecalis/OE PNA FISH" (Cat. No. KT003) is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Enterococcus faecalis and selected other enterococci (OE) from blood cultures. E. faecalis/OE PNA FISH provides rapid identification of E. faecalis and selected other enterococci (OE) on smears made from positive blood cultures and is compatible with all major blood culture media. Recall # Z-2315-2010
CODE
None
RECALLING FIRM/MANUFACTURER
AdvanDx, Inc., Woburn, MA, by letter dated June 8, 2010, and email notification on June 11, 2010. Firm initiated recall is ongoing.
REASON
Some strains of streptococcus anginosus cross-reach with E. faecalis/OE PNA FISH to produce a false positive green signal.
VOLUME OF PRODUCT IN COMMERCE
547 units
DISTRIBUTION
Nationwide, Denmark, Finland and Sverige (European)

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS III
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PRODUCT   
Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer. Recall # Z-2292-2010
CODE
Lot# 528020R - Serial Numbers: 55839, 60778, 60848, 60957, 61391, 170021, 185765, 185766, 185768, 185769, 185946, 190014, 190015, 190018, 2004053, 2004578, 209584, 209585, 209586, 209587, 209611, 209627, 209628, 209629, 209631, 170022, 170023, 190019, 190021, 190025, 220048, 222535, 53049, 62327, 223207, 240031, 240032, 240039, 240040, 240048
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integrated Orbital Implants Inc., San Diego, CA, by telephone and email beginning June 7, 2010.
Manufacturer: Interpore Cross International LLC, Irvine, CA. Firm initiated recall is ongoing.
REASON
Integrated Orbital Implants, Inc. has initiated a recall of its Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer due to a labeling issue in which the expiration date of the product was omitted.
VOLUME OF PRODUCT IN COMMERCE
25 units
DISTRIBUTION
MT, AL, IN, IA, NY, KY, IL, MI, FL, Canada, Germany, and Turkey

RECALLS AND FIELD CORRECTIONS:  VETERINARY - CLASS I
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PRODUCT   
Natural Balance Sweet Potato & Chicken Dry Dog Food; Best By date of June 17, 2011; 5-lb. Bag, UPC Code: 7-23633-99000-4, and 28-lb. Bag, UPC Code: 7-23633-99002-8. Recall # V-193-2010
CODE
Best By date of June 17, 2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Natural Balance Pet Food Inc., Pacoima, CA, via telephone on June 17, 2010, press release on June 18, 2010, and letters beginning on June 18, 2010.
Manufacturer: Diamond Pet Foods, Lathrop, CA. Firm initiated recall is ongoing.
REASON
Product has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
28 lb units (2,576 bags), 5 lb units (504 cases/3,024 bags)
DISTRIBUTION
Nationwide

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PRODUCT   
Merrick Delicious BEEF FILET SQUARES Dog Treats 10 oz (283g). UPC 022808600169. Recall # V-194-2010
CODE
Lot # 10084TL7 Best By Mar 24, 2012
RECALLING FIRM/MANUFACTURER
Tejas Industries Inc., Hereford, TX, by press release, telephone and letters on July 2, 2010. Firm initiated recall is ongoing.
REASON
Pet treats may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
82 cases
DISTRIBUTION
CA, MD, IL, MA, FL, and Canada  

END OF ENFORCEMENT REPORT FOR SEPTEMBER 1, 2010

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