Enforcement Report

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.

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August 27, 2008
08-34

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
Fresh cut cilantro, Villano U.S.A. Italia Bros. Farms Fresh Vegetables, Recall # F-525-8
CODE
No codes
RECALLING FIRM/MANUFACTURER
Villano Brothers Farms, Inc., Ft. Lupton, CO, by telephone on July 25, 2008. Firm initiated recall is complete.
REASON
Sample of cilantro collected during Salmonella St. Paul investigation tested positive for a different species of Salmonella.
VOLUME OF PRODUCT IN COMMERCE
550/60 count boxes
DISTRIBUTION
CO
___________________________________
PRODUCT
Legacy Farms ***Peppers Serrano Net Wt. 10 lbs. Produce of Mexico, Recall # F-526-8
CODE
N/A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Legacy Farms, Buena Park, CA, by e-mail on July 24, 2008.
Manufacturer: AgRoproductos LA Nacional S. DE R.L. DE C.V., Tijuana, Mexico. Firm initiated recall is complete.
REASON
Product contaminated with Salmonella Tucson.
VOLUME OF PRODUCT IN COMMERCE
70/10 lb cartons
DISTRIBUTION
CA, UT
___________________________________
PRODUCT
Jalapeno Peppers packed in 40 lb. boxes, Recall # F-527-8
CODE
Boxes reportedly no coded
RECALLING FIRM/MANUFACTURER
Recalling Firm: Caruso Produce, Inc., Tualatin, OR, by telephone on July 24, 2008.
Manufacturer: Neri, Martin, Tijuana, Mexico. Firm initiated recall is complete.
REASON
Jalapeno Peppers from Mexico contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
98 – 40 lb. cases
DISTRIBUTION
OR, WA
___________________________________
PRODUCT
Cilantro; the cilantro is sold fresh in bunches tied with a rubber-band, 60 bunches per wooden crate. There is no product labeling on the crate. Product of Mexico, Recall # F-528-8
CODE
Lot #: 5065, distributed between July 7, 2008 and July 9, 2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: La Galera Produce, Llc, Chicago, IL, by telephone on July 30, 2008.
Manufacturer: Vegetales Selectos DE Puebla SPR DE RL, San Salvador Huixcolotla, Mexico. Firm initiated recall is ongoing.
REASON
The cilantro was found to be contaminated with Salmonella Newport bacteria.
VOLUME OF PRODUCT IN COMMERCE
547 crates
DISTRIBUTION
IL, IN, IA, KY, MI, WI

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I
___________________________________
PRODUCT
a) ETHEX Morphine Sulfate Extended-Release Tablets (Morphine sulfate), 60 mg,
CII, packaged in 100-tablet bottles, RX, Recall # D-288-2008;
b) ETHEX Morphine Sulfate Extended-Release Tablets, (Morphine sulfate), 30 mg,
CII, packaged in 100-tablet bottles, Recall # D-289-2008;
c) MS Extended-Release Tablets, 30mg, or Further Manufacturing, Processing or
Repacking, Not For Sale in the United States (Export Only), RX Only;
Recall # D-290-2008
CODE
Lot #91762, Exp. 02/2010 (initially reported); 75091, Exp.7/2008;
75092, Exp. 7/2008; 77848, Exp. 7/2008; 77849, Exp. 10/2008;
77850, Exp. 10/2008; 77851, Exp. 10/2008; 82517, Exp. 11/2008;
82518, Exp. 11/2008; 83333, Exp. 10/2008; 83817, Exp. 11/2008;
83862, Exp. 10/2008; 84111, Exp. 10/2008; 84112, Exp. 11/2008;
84315, Exp. 11/2008; 84900, Exp. 12/2008; 85326, Exp. 11/2008;
85335, Exp. 11/2008; 85807, Exp. 11/2008; 86270, Exp. 11/2008;
86271, Exp. 12/2008; 86272, Exp. 4/2009; 86273, Exp. 4/2009;
86274, Exp. 6/2009; 86275, Exp. 6/2009; 86276, Exp. 8/2009;
87723, Exp. 8/2009; 87939, Exp. 9/2009; 88007, Exp. 10/2009;
89083, Exp. 12/2009; 89668, Exp. 10/2009; 89669, Exp. 9/2009;
89821, Exp. 12/2009; 90260, Exp. 1/2010; 90261, Exp. 1/2010;
90262, Exp. 1/2010; 90263, Exp. 1/2010; 90264, Exp. 1/2010;
90265, Exp. 1/2010; 90266, Exp. 1/2010; 90267, Exp. 1/2010;
90268, Exp. 2/2010; 90269, Exp. 2/2010; 90270, Exp. 2/2010;
90271, Exp. 2/2010; 90272, Exp. 2/2010; 91763, Exp. 1/2010;
91764, Exp. 1/2010; 91765, Exp. 2/2010;
b) Lots 75090, Exp. 6/2008; 77846, Exp. 9/2008; 77847, Exp. 11/2008;
80048, Exp. 7/2009; 83320, Exp. 7/2009; 89661, Exp. 11/2009;
89665, Exp. 7/2009; 90252, Exp. 11/2009; 90253, Exp. 1/2010;
90254, Exp. 1/2010; 90255, Exp. 1/2010; 90256, Exp. 1/2010;
90257, Exp. 1/2010; 90258, Exp. 4/2010; 93284, Exp. 4/2010;
c) Lot 84915, Repackage Contents By 12/13/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ethex Corp., Bridgeton, MO, by letters dated May 19, 2008, by press release on June 9, 2008 and press release and letters dated June 13, 2008.
Manufacturer: KV Pharmaceutical Co Westport, Saint Louis, MO. Firm initiated recall is ongoing.
REASON
Super-potent; over sized tablets
VOLUME OF PRODUCT IN COMMERCE
30-mg. - 181,496/100-ct. bottles and 734,392 bulk tablets; 60-mg. 282,603/100-ct. bottles
DISTRIBUTION
Canada
___________________________________
PRODUCT
a) Digitek (digoxin tablets, USP) 125 mcg (0.125 mg), an Rx oral cardiotonic –
a yellow, scored tablet imprinted with a "B" over "145"; single tablet unit dose
blister packs, packaged as: UD100 tablets (10X10), NDC 51079-945-20; UD 300
tablets (10X30), NDC 51079-945-57; PC300 tablets (10X30), NDC 51079-945-56;
and CP180 Patient Compliance Package (6X30), NDC 51079-945-66;
Recall # D-291-2008;
b) Digitek (digoxin tablets, USP) 250 mcg (0.25 mg); an Rx oral cardiotonic –
a white, scored tablet imprinted with a "B" over "146"; single tablet unit dose blister
packs, packaged as: UD100 tablets (10x10), NDC 51079-946-20 and CP180 Patient
Compliance Package, 180 tablets (6X30), NDC 51079-946-66; Recall # D-292-2008
CODE
a) Lot numbers: 7A666, exp. 7/08; 7F048, exp. 10/08; 7D352, exp. 12/08;
7P862, exp. 3/09; and 8C515, exp. 9/09; Lot number: 6S406, exp. 5/08;
Lot numbers: 7J541, exp. 1/09; 7M709, exp. 3/09; 7P965, exp. 4/09;
8A266, exp. 7/09; and 8C514, exp. 9/09; Lot numbers: 7P964, exp. 4/09 and
8B371, exp. 8/09;
b) Lot numbers: 6S379, exp. 5/08; 7C971, exp. 9/08; 7J525, exp. 1/09;
7V200, exp. 6/09; Lot numbers: 7P963, exp. 4/09 and 8A332, exp. 7/09
RECALLING FIRM/MANUFACTURER
UDL Laboratories, Inc., Rockford, IL, by letter on April 28, 2008. Firm initiated recall is ongoing.
REASON
Super-Potency; UDL repackaged lots of Digitek digoxin tablets that have been recalled by the manufacturer (Actavis) due to the tablets having a thickness approximately double that of their specification
VOLUME OF PRODUCT IN COMMERCE
65,242 cartons of 100, 4,624 cartons of 300, 86,489 cartons of 180
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
a) Alcohol-Free Mouthwash, a yellow liquid in a 2 fl. oz. plastic bottle, 96 bottles
per case, 4 fl. oz. (118 mL) plastic bottle, 24 bottles per case and 60 bottles
per case, and in a 16 fl. oz. plastic bottle, 12 bottles per case; the mouthwash was
distributed under the following labels, and in some cases may have been
repackaged into hospital admission kits: 1) Hydrox Fresh Moment Alcohol Free
Mouthwash, item #F0210 and I0210 (4 oz), and item D0212 (16 oz);
2) McKesson Medi-Pak Mouthwash, Reorder No. 23-I0210 (4 oz) and 23-D0212
(16 oz); 3) Cardinal Health Alcohol-Free Mouthwash, reorder AG-210 (4 oz)
and AG-219 (2 oz), Recall # D-293-2008;
b) Alcohol-Free Mouthwash, a blue liquid in a 4 fl. oz. (118 mL) plastic bottle,
60 bottles per case, and in a 32 fl. oz. plastic bottle, 12 bottles per case; the
mouthwash was distributed under the following labels, and in some cases may
have been repackaged into hospital admission kits: 1) Hydrox Fresh Moment
Alcohol Free Mouthwash, item #I0220 (4 oz) and D0224 (32 oz);
2) Careline Mouthwash Blue Alcohol Free, re-order 033-0040, UPC 6 90450 01029 4;
3) Freshscent Alcohol-Free Mouthwash, reorder #FMW2 (2 oz) and FMW4 (4 oz),
UPC 0 85317 00231 2;
4) DawnMist Alcohol Free Mouth Rinse, reorder #MR02 (2 oz) and MR3350 (4 oz);
5) GS Select Mouthwash, and Evoke Alcohol Free Mouthwash, both labels are
for 4 oz bottles with reorder #1958;
6) Bob Barker Alcohol-Free Mouthwash, 4 oz, part #AFM4;
7) Rensow Alcohol-Free Mouthwash, 4 oz., UPC 8 27912 06379 0, Re-Order
#601-510;
8) Medline Alcohol Free SparkleFresh Mouthwash, Reorder MDS095029
(2 oz) and MDS095030 (4 oz); Recall # D-294-2008;
c) Mouthwash with 2.5% Alcohol, a yellow liquid in a 4 oz. (118 mL) plastic bottle,
60 bottles per case; the mouthwash was distributed under the following labels:
1) Hydrox Fresh Moment Mouthwash and Gargle, item #I5200;
2) McKesson Medi-Pak Mouthwash, Reorder No. 23-I5200;
3) Medline SparkleFresh Mouthwash, REF MDS095040; Recall # D-295-2008
CODE
a) 1) All lots; 2) Lots 22862, 22864, 22979, 22995, 23053, 23056, 23267, 23272,
23418, 23481, 23488, 23558, 23581, 23754, 23763, 23829, 23837, 23916,
23918, 24047, 24096, 24194, 24212, 26265, 24279, 24268, 24350, 24476,
24566, 24637, 24702, 24715, 24847, 24875, 24921, 24950, 24989, 25075,
25103, 25233, 25286, 25339, 25548, 25552, 25554, 25616, 25642, 25793,
25936, 25966, 26005, 26045, 26048, 26049, 26174, 26214, 26223, 26240,
26488, 26507, 26511, 26512; Lots 22995, 23481, 24397, 24566, 24702,
25642, 26045, 26335, 26547;
3) Lots 22818, 22864, 22876, 22877, 22925, 22926, 22936, 22981, 22996, 23006,
23013, 23014, 23046, 23104, 23110, 23114, 23164, 23176, 23184, 23215, 23219,
23236, 23304, 23307, 23313, 23351, 23353, 23358, 23359, 23394, 23424, 23425,
23443, 23444, 23500, 23523, 23535, 23546, 23552, 23584, 23700, 23706, 23754,
23941, 23965, 23996, 24035, 24046, 24047, 24124, 24128, 24178, 24181, 24194,
24260, 24261, 24268, 24325, 24326, 24365, 24386, 24389, 24460, 24465, 24466,
24537, 24540, 24590, 24599, 24660, 24661, 24698, 24701, 24713, 24734, 24751,
24753, 24756, 24779, 24781, 24798, 24817, 24828, 24888, 24903, 24954, 24969,
25001, 25008, 25012, 25044, 25084, 25086, 25090, 25096, 25101, 25149, 25193,
25198, 25199, 25204, 25253, 25299, 25300, 25301, 25305, 25335, 25363, 25406,
25409, 25416, 25478, 25479, 25481, 25515, 25522, 25554, 25578, 25581, 25594,
25627, 25666, 25681, 25686, 25688, 25729, 25732, 25738, 25789, 25791, 25797,
25836, 25840, 25875, 25877, 25899, 25910, 25949, 25966, 25967, 25968, 25997,
26004, 26005, 26021, 26025, 26037, 26039, 26041, 26097, 26099, 26102, 26115,
26121, 26144, 26194, 26219, 26220, 26228, 26230, 26233, 26254, 26272, 26282,
26324, 26326, 26330, 26380, 26383, 26431, 26488, 26495, 26497, 26534, 26547,
26556; reorder AG-219 - lots 22818, 22936, 23176, 23394, 23500, 23700, 23965,
24072, 24602, 24954, 25090, 25301, 25457, 25666, 25797, 26160, 26324;
b) 1) All lots;
2) Lots 22871, 22873, 22985, 23068, 23145, 23158, 23246, 23315, 23342, 23380,
23453, 23530, 23780, 23824, 24150, 24230, 24299, 24302, 24369, 24378, 24398,
24435, 24648, 24742, 24803, 24882, 24885, 24918, 25140, 25356, 25372, 25455,
25465, 25773, 26148, 26150;
3) Lots 23621, 23846, 23973, 24790, 25713, 25939, 26451; Lots 23621, 23843,
24006, 24069, 24070, 24340, 24544, 24634, 24639, 24800, 24811, 25021, 25027,
25177, 25186, 25463, 25465, 25472, 25571, 25739, 25868, 25976, 25977, 26111,
26119, 26265, 26359, 26361, 26407,
4) Lots 23391, 23404, 23501, 23514, 23973, 24108, 24312, 24534, 24606, 24851,
24952, 25038, 25135, 25463, 25572, 25713, 25802, 25939, 26083, 26298, 26396,
Lots 22826, 22831, 22832, 23077, 23084, 23202, 23203, 23213, 23228, 23234,
23278, 23286, 23360, 23361, 23373, 23379, 23404, 23407, 23416, 23459, 23461,
23473, 23489, 23559, 23567, 23568, 23669, 23672, 23682, 23801, 23802, 23803,
23861, 23863, 23866, 23961, 23974, 23975, 23999, 24000, 24042, 24044, 24070,
24099, 24113, 24121, 24123, 24333, 24337, 24492, 24495, 24510, 24513, 24515,
24518, 24528, 24577, 24578, 24614, 24616, 24666, 24669, 24859, 24863, 24926,
24938, 24978, 24979, 24983, 24990, 24991, 25027, 25031, 25038, 25042, 25055,
25064, 25067, 25119, 25122, 25134, 25135, 25144, 25167, 25171, 25177, 25315,
25320, 25323, 25372, 25386, 25419, 25421, 25423, 25434, 25444, 25446, 25448,
25453, 25455, 25585, 25588, 25699, 25706, 25707, 25709, 25713, 25816, 25818,
25909, 25916, 25929, 25931, 25939, 25946, 25959, 25971, 25977, 25978, 25982,
25986, 25991, 26073, 26077, 26083, 26111, 26164, 26167, 26183, 26185, 26196,
26239, 26241, 26244, 26248, 26287, 26290, 26291, 26295, 26298, 26352, 26359,
26372, 26377, 26379, 26395, 26422, 26424, 26426, 26451, 26454, 26457, 26480,
26500;
5) Lots 23029, 23041, 23227, 23286, 23287, 23514, 23516, 23880, 23980, 24094,
24164, 24310, 24470, 24546, 24646, 24763, 24872, 24998, 25200, 25328, 25388,
25483, 25575, 25655, 25658, 25739, 25742, 25868, 25931, 25982, 25986, 26008,
26149, 26267, 26396, 26433;
6) Lots 24544, 26189, 26342, 26287, 24837, 24909, 25100, 25142, 25689, 26073,
26189, 26287, 26342;
7) Lots 25589, 25655, 25658, 25914;
8) Lots 23074, 23296, 23391, 23576, 23689, 23846, 23973, 24108, 24312, 24416,
24534, 24606, 24790, 24973, 25231, 25572, 25713, 26442, 26443, 26451, 26461,
26465, 26467, 26500, 26502, 26529, 26544; lots 22821, 22838, 22845, 22846,
22857, 22873, 22968, 22969, 22978, 22982, 23018, 23061, 23062, 23084, 23107,
23108, 23140, 23158, 23167, 23244, 23248, 23249, 23294, 23329, 23334, 23338,
23427, 23433, 23434, 23437, 23462, 23497, 23506, 23517, 23524, 23609, 23682,
23723, 23733, 23736, 23737, 23747, 23771, 23782, 23802, 23820, 23866, 23881,
23882, 23927, 23930, 23944, 23952, 23959, 24000, 24006, 24021, 24025, 24027,
24052, 24078, 24123, 24142, 24151, 24166, 24204, 24206, 24242, 24244, 24258,
24270, 24279, 24309, 24310, 24335, 24381, 24382, 24398, 24422, 24426, 24439,
24478, 24489, 24573, 24575, 24613, 24623, 24643, 24663, 24675, 24676, 24683,
24693, 24708, 24709, 24767, 24770, 24772, 24897, 24941, 25032, 25165, 25218,
25266, 25268, 25352, 25375, 25388, 25392, 25405, 25487, 25512, 25569, 25571,
25589, 25601, 25629, 25721, 25727, 24416, 26442, 26443, 26451, 26461, 26465,
26467, 26500, 26502, 26529, 26544;
c) 1) All lots; 2) Lots 22962, 23771, 23927, 24381, 24870, 25121, 25468, 25661,
26138, 26365; 3) - 22855, 22962, 24870, 25121, 25468
RECALLING FIRM/MANUFACTURER
Hydrox Chemical Co., Elgin, IL, by press release, e-mail and letter on May 23, 2008. Firm initiated recall is ongoing.
REASON
CGMP Deviations. The mouthwash was manufactured under conditions where by it may be contaminated with the bacteria Burkholderia cepacia.
VOLUME OF PRODUCT IN COMMERCE
60,000,000 bottles estimated
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1497-08
CODE
Unit: 12FZ66577
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Carolinas Blood Services Region, Charlotte, NC, by fax on September 21, 2007 and follow up letter on October 4, 2007.
Manufacturer: American Red Cross Blood Services Carolinas Region, Winston Salem, NC. 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
NC
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1747-08
CODE
Unit: 72E653904
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by telephone and fax on January 18, 2008. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1750-08
CODE
Unit: 1491085
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by telephone on September 28, 2006. Firm initiated recall is complete.
REASON
Blood product, collected during instrument re-validation without QC being performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1775-08
CODE
Unit: 221020122
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Las Vegas, NV, by letter dated April 19, 2005. 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
NV
___________________________________
PRODUCT
Platelets, Recall # B-1781-08
CODE
Units: 2640884, 4799122, 4798951
RECALLING FIRM/MANUFACTURER
Our Lady Of The Lake Hospital, Inc., Baton Rouge, LA, by fax on December 1, 2005 and May 26, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had taken aspirin, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
LA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1784-08
CODE
Unit: 72E848848
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by telephone on February 5, 2008. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1785-08
CODE
Units: 0314326, 0648651
RECALLING FIRM/MANUFACTURER
West Tennessee Regional Blood Center, Inc., Jackson, TN, by facsimile on January 8, 2008. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1796-08;
b) Recovered Plasma, Recall # B-1797-08
CODE
a) and b) Unit: L99129
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by fax on November 17, 2005. 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
GA, Switzerland
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1800-08;
b) Fresh Frozen Plasma, Recall # B-1801-08;
c) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1802-08;
d) Red Blood Cells, Recall # B-1803-08;
e) Plasma Frozen, Recall # 1804-08
CODE
a) Units: 041FQ13689, 041FQ13693, 041FQ13701, 041FQ13703, 041LN13194, 041LN13196, 041LN13199, 041LN13200, 041LN13201, 041LN13202, 041LN13204, 041LN13206, 041LN13207, 041LN13210, 041LN13211, 041FT91907, 041FT91910, 041FT91912, 041FT91915, 041FT91917, 041FT91927, 041FT91941, 041FT91945, 041FT91948, 041FT91961, 041FT91966, 041FT91969, 041FN67656, 041FN67661, 041FN67662, 041FN67665, 041FN67666, 041FN67670, 041FN67673, 041FN67675, 041FN67679, 041FT92077, 041FT92081, 041FZ03566, 041FZ03568, 041FZ03570, 041FZ03572, 041FY51869, 041FY51876, 041FY51880, 041FY51885, 041FY51891, 041FY51909, 041FY51917, 041FY51923, 041FY51934, 041FY51939, 041GQ26733, 041GQ26734, 041GQ26736, 041GQ26741, 041GQ26743, 041GQ26745, 041GQ26746, 041GQ26750, 041FE27761, 041FE27762, 041FE27764, 041FE27765, 041FE27766, 041FE27767, 041FE27769, 041FE27771, 041FE27772, 041FE27774, 041FE27775, 041FE27777, 041FE27778, 041FV65615, 041FV65616, 041FV65617, 041FV65619, 041FV65620, 041FV65621, 041FY51940, 041FY51942, 041FY51945, 041FY51948, 041FY51956, 041FY51957, 041FY51959, 041FY51969, 041FY51977, 041FY51986, 041FY51991, 041FY51992, 041FY51994, 041FY51997, 041FY52000, 041FY52004, 041FY52005, 041FY52010, 041FY52017, 041FY52024, 041FY52026, 041FY52033, 041LS73280, 041LS73281, 041LS73282, 041LS73283, 041LS73284, 041LS73285, 041LS73286, 041LS73287, 041LS73288, 041LS73289, 041LS73290, 041LS73293, 041LS73294, 041LS73296, 041LS73297, 041LS73302, 041LS73303, 041LS73306, 041LS73308, 041LS73309, 041LS73310, 041LS73311, 041LX49941, 041LX49943, 041LX49944, 041LX49945, 041LX49949, 041LX49951, 041LS73329, 041LS73330, 041LS73331, 041LS73332, 041LS73333, 041LS73334, 041LS73335, 041LS73336, 041LS73338, 041LS73339, 041LS73341, 041LS73342, 041LS73344, 041LS73345, 041LS73347, 041LS73348, 041GF86135, 041GF86138, 041GF86139, 041GF86141, 041GF86144, 041GF86145, 041GF86148, 041GF86150, 041GF86157, 041GF86160, 041GF86163, 041GF86164, 041GF86166, 041GF86168, 041GF86170, 041GF86172, 041GF86176, 041GF86178, 041GF86181, 041LX49995, 041LX49997, 041LX49998, 041LX49999, 041LX50000, 041LX50001, 041LX50004, 041FV65830, 041FV65831, 041FV65832, 041FV65837, 041FV65838, 041FV65841, 041FV65843, 041FV65844, 041FV65847, 041FV65848, 041FE27944, 041FE27947, 041FE27948, 041FE27950, 041FE27953, 041FE27956, 041FE27965, 041FE27971, 041FE27972, 041FE27973, 041FE27979, 041FE27981, 041LN13637, 041LN13638, 041LN13640, 041LN13642, 041LN13643, 041LN13646, 041LN13648, 041LN13665, 041LN13666, 041LN13670, 041LN13685, 041LN13687, 041LN13689, 041LN13691, 041LN13692, 041LN13695, 041LN13696, 041LN13697, 041LN13701, 041LN13703, 041LN13707, 041LN13708, 041LN13711, 041LN13713, 041LN13716, 041LN13718, 041LN13720, 041LN13722, 041LN13724, 041FN68018, 041FN68023, 041FN68043, 041FN68046, 041FN68047, 041FN68053, 041FN68060, 041FN68064, 041FN68076, 041FN68083, 041FN68132, 041FN68134, 041FN68140, 041FN68141, 041FN68142, 041FN68144, 041FN68145, 041FN68146, 041FN68149, 041FN68151, 041FN68154, 041FN68162, 041FN68164, 041FN68165, 041FN68166, 041FN68173, 041FN68175, 041FN68177, 041FN68181, 041FN68185, 041FN68186, 041FN68192, 041FN68208, 041FN68212, 041FN68213, 041FN68218, 041FN68224, 041FN68225, 041FN68231, 041FN68234, 041FN68235, 041FN68237, 041FN68242, 041FN68245, 041FN68247, 041FN68248, 041FN68249, 041FN68251, 041FN68264, 041FN68265, 041FN68270, 041FN68273, 041FN68277, 041FN68283, 041FN68286, 041FN68287, 041FN68293, 041FN68298, 041FN68301, 041FN68304, 041LH56462, 041LH56463, 041LH56464, 041LH56465, 041LH56468, 041LH56470, 041LH56471, 041LH56474, 041LH56475, 041LH56478, 041LH56483, 041LH56484, 041LH56485, 041LH56486, 041LH56492, 041GQ27124, 041GQ27126, 041GQ27127, 041GQ27128, 041GQ27129, 041LN13853, 041LN13854, 041LN13855, 041LN13857, 041LN13858, 041LN13859, 041LN13860, 041LN13861, 041LN13862, 041LN13863, 041LN13864, 041LN13865, 041LN13866, 041LN13867, 041LN13868, 041LN13870, 041LN13871, 041LN13872, 041LN13878, 041LN13881, 041LN13882, 041LN13883, 041LN13884, 041LN13885, 041LN13887, 041LN13890, 041LN13891, 041LN13896, 041LN13899, 041LN13903, 041LN13906, 041LN13908, 041LX50149, 041LX50154, 041LX50156, 041LX50158, 041LX50159, 041LX50160, 041LX50162, 041LX50166, 041LX50168, 041LX50171, 041LX50174, 041FE28157, 041FE28159, 041FE28161, 041FE28162, 041FE28163, 041FE28165, 041FE28166, 041FE28168, 041FE28170, 041FE28171, 041FE28173, 041FE28176, 041FE28180, 041FE28181, 041FE28184, 041FE28185, 041FE28186, 041FE28187, 041FE28188, 041FE28189, 041FE28190, 041FE28191, 041FE28192, 041FE28194, 041FE28196, 041FE28197, 041FE28198, 041FE28200, 041FE28202, 041FE28203, 041FE28204, 041FE28205, 041FE28208, 041FE28209, 041FE28211, 041FV66148, 041FV66151, 041FV66154, 041FV66156, 041FV66157, 041FV66159, 041FV66165, 041FV66166, 041FV66188, 041FV66192, 041LN14026, 041LN14028, 041LN14029, 041LN14031, 041LN14032, 041LN14033, 041LN14035, 041LN14037, 041LN14039, 041LN14042, 041LN14046, 041LN14047, 041LN14052, 041LN14053, 041LN14055, 041LN14056, 041LN14059, 041LN14060, 041LN14061, 041LN14062, 041LN14063, 041LN14064, 041LN14066, 041LN14067, 041LN14070, 041LN14072, 041LN14073, 041LX50243, 041LX50244, 041LX50245, 041LX50246, 041LX50247, 041LX50248, 041LX50250, 041LX50252, 041LX50253, 041LX50254, 041LX50255, 041LX50257, 041LX50258, 041LX50259, 041LX50260, 041LX50261, 041LX50263, 041LX50264, 041LX50265, 041FY52777, 041FY52782, 041FY52785, 041FY52786, 041FY52787, 041FY52790, 041FY52792, 041FY52794, 04152797, 041FY52798, 041FY52800, 041FY52801, 041FY52802, 041FY52806, 041FY52807, 041FY52809, 041FY52810, 041FY52811, 041FY52816, 041FY52819, 041FN68549, 041FN68552, 041FN68553, 041FN68557, 041FN68562, 041FN68563, 041FN68565, 041FN68571, 041FN68572, 041FN68574, 041FN68576, 041FN68580, 041FN68581, 041FN68583, 041FN68585, 041FN68586, 041FE28323, 041FE28325, 041FE28326, 041FE28327, 041FE28328, 041FE28329, 041FE28330, 041FE28332, 041FE28333, 041FE28334, 041FE28336, 041LH56560, 041LH56564, 041LH56565, 041LH56567, 041LH56568, 041LH56583, 041LH56585, 041LH56588, 041FY52928, 041FY52930, 041FY52932, 041FY52934, 041FY52938, 041FY52944, 041FY52949, 041FY52954, 041FY52958, 041FY52961, 041FY52966, 041FY52967, 041FY52969, 041FY52976, 041FY52980, 041FY52985, 041FY52989, 041FY52992, 041FY52995, 041FY52996, 041FY52999, 041FY53002, 041FE28541, 041FE28543, 041FE28546, 041FE28553, 041FE28559, 041FE28560, 041FE28564, 041FE28565, 041FE28566, 041FE28569, 041FE28572, 041FE28573, 041FE28576, 041FE28577, 041GQ27615, 041GQ27616, 041GQ27618, 041GQ27621, 041GQ27623, 041GQ27627, 041GQ27629, 041GQ27631, 041GQ27633, 041GQ27635, 041GQ27637, 041GQ27638, 041GQ27639, 041GQ27641, 041GQ27645, 041GQ27647, 041GQ27651, 041GQ27655, 041GQ27657, 041GQ27659, 041GQ27660, 041GQ27661, 041LR96524, 041LR96526, 041LR96533, 041LR96543, 041LR96546, 041LR96553, 041LR96627, 041LR96662, 041LR96663, 041LR96708, 041LR96712, 041FE28605, 041FE28607, 041FE28608, 041FE28612, 041FE28613, 041FE28615, 041FE28617, 041FE28618, 041FE28622, 041FE28623, 041FE28624, 041FE28627, 041FE28632, 041FE28634, 041FE28635, 041FE28636, 041FE28637, 041FE28639, 041FN68620, 041FN68621, 041FN68622, 041FN68625, 041FN68628, 041FN68629, 041FN68631, 041FN68634, 041FN68636, 041FN68639, 041FN68642, 041FN68643, 041FN68646, 041FN68653, 041FN68662, 041FN68663, 041FE28705, 041FE28707, 041FE28708, 041FE28709, 041FE28710, 041FE28711, 041FE28712, 041FE28713, 041FE28714, 041FE28719, 041FE28720, 041FE28722, 041FE28724, 041FE28725, 041FE28726, 041FE28730, 041LN14458, 041LN14460, 041LN14469, 041LN14478, 041LN14481, 041LN14486, 041LN14488, 041LN14489, 041LN14490, 041LN14491, 041LN14493, 041LN14494, 041LN14495, 041LN14500, 041GQ27882, 041GQ27884, 041GQ27885, 041GQ27886, 041GQ27887, 041GQ27888, 041FE28772, 041FR59770, 041FR59778;

b) Units: 041FY51917, 041FY51923, 041FY51934, 041FY51939, 041FY52004, 041FY52005, 041FY52010, 041FY52017, 041FY52024, 041FY52026, 041FY52033, 041LN13722, 041LN13724, 041LR96526, 041LR96533, 041LR96543, 041LR96546, 041LR96553, 041LR96663;

c) Units: 041FQ13696, 041LS73298, 041FE28177, 041FY52940, 041GQ27649;

d) Units: 041GQ26738, 041GQ26747;

e) Units: 041FQ13689, 041FQ13693, 041LN13201, 041LN13202, 041FT91961, 041FT91969, 041FZ03570, 041FZ03572, 041GQ26733, 041GQ26741, 041LX49995, 041LX49996, 041LX50000, 041LX50002, 041FV65843, 041FE27944, 041FE27971, 041FE27973, 041FE27979, 041LN13707, 041LN13715, 041FN68140, 041FN68224, 041FN68237, 041LH56483, 041LH56486, 041GQ27129, 041LN13870, 041LX50170, 041FE28176, 041FE28177, 041FE28208, 041LN14028, 041LN14052, 041FN68552, 041FN68563, 041FE28329
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by telephone on February 1 and 2, 2006. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
696 units
DISTRIBUTION
AL, GA, MS, SC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1806-08
CODE
Unit: 6258253
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Jackson, MS, by fax on May 26, 2006. 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
CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1815-08
CODE
Unit: V49524
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by telephone and fax on January 8, 2007. Firm initiated recall is complete.
REASON
Blood product, labeled as leukoreduced, but which did not meet the criteria for a leukoreduced product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1818-08
CODE
Units: V52774, V52807
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by fax on January 16, 2007. Firm initiated recall is complete.
REASON
Blood products, labeled leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1824-08
CODE
Unit: 72E110682
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc, Birmingham Region, Birmingham, AL, by fax on October 23, 2007. Firm initiated recall is complete.
REASON
Blood product, with insufficient plasma to support the platelet concentration, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1825-08
CODE
Unit: 0678409
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Jackson, MS, by fax on December 3, 2007. Firm initiated recall is complete.
REASON
Blood product, labeled leukoreduced which did not meet the requirements for a leukoreduced product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MS
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1829-08;
b) Platelets Leukocytes Reduced, Recall # B-1830-08;
c) Fresh Frozen Plasma, Recall # B-1831-08
CODE
a)Units: 19GH73271, 19GH73275, 19GH73280, 19GH73282, 19GH73284, 19GH73287, 19GH73288, 19GH73291, 19GH73292, 19GP23572, 19GP23573, 19GP23574, 19GP23577, 19GP23578, 19GP23579, 19GP23581, 19GP23582, 19GP23583, 19GP23585, 19GP23587, 19GP23588, 19GP23589, 19GP23591, 19GP23596, 19GP23598, 19GP23600, 19GP23601, 19GP23602, 19GP23603, 19GP23606, 19GP23607, 19GY40818, 19GY40819, 19GY40826, 19GY40827, 19GY40832, 19GY40839, 19GY40845, 19GY40849, 19GY40851, 19GY40860, 19GY40865, 19GY40869, 19GY40874, 19GY40887, 19GY40889, 19LF26427, 19LF26430, 19LF26446, 19LF26439, 19LF26442, 19LG24226, 19LG23956, 19LG23957, 19LG23960, 19LG23961, 19LG24228, 19LG24234, 19LH08639, 19LH08640, 19LH08641, 19LH08643, 19LH08645, 19LH08646, 19LH08648, 19LH08652, 19LH08653, 19LJ17865, 19LJ17866, 19LJ17871, 19LJ17872, 19LJ17875, 19LJ17876, 19LJ17877, 19LJ17879, 19LJ17880, 19LJ17883, 19LJ17889, 19LJ17896, 19LJ17899, 19LR09703, 19LR09705, 19LR09704, 19LR09706, 19LR09708, 19LR09709, 19LR09710, 19LR09711, 19LR09712, 19LR09713, 19LR09714, 19LR09715, 19LR09716, 19LT23203, 19LT23204, 19LT23206, 19LT23207, 19LT23212, 19LT23213, 19LT23219, 19LT23220, 19LT23221, 19LT23223, 19LT23408, 19LT23418, 19LT23422, 19LT23430, 19LT23432, 19LT23458, 19LT23460, 19LT23463, 19LT23468;

b) Units: 19GH73275, 19GH73279, 19GH73291, 19GP23572, 19GP23573, 19GP23574, 19GP23577, 19GP23578, 19GP23579, 19GP23581, 19GP23582, 19GP23583, 19GP23877, 19GP23884, 19GP23885, 19GP23886, 19GP23887, 19GP23895, 19GP23897, 19GP23901, 19GY40818, 19GY40819, 19GY40826, 19GY40827, 19GY40832, 19GY40844, 19GY40845, 19GY40849, 19GY40860, 19GY40865, 19GY40869, 19LF26428, 19LF26439, 19LF26442, 19LF26446, 19LT23204, 19LT23206, 19LT23209, 19LT23213, 19LT23219, 19LT23220, 19LT23408.

c) Units: 19GP23572, 19GP23573, 19GP23574, 19GP23577, 19GP23578, 19GP23579, 19GP23581, 19GP23582, 19GP23583, 19GP23877, 19GP23878, 19GP23879, 19GP23883, 19GP23884, 19GP23885, 19GP23886, 19GP23887, 19GP23888, 19GP23889, 19GP23897, 19LF26445, 19LT23219, 19LT23220, 19LT23408
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Tennessee Valley Region, Nashville, TN, by fax on August 26, 2005. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
178 units
DISTRIBUTION
TN, KY, IL, NC, OH, AL, PR, Virgin Islands
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1834-08
CODE
Unit: GP35046
RECALLING FIRM/MANUFACTURER
Blood Bank of San Bernardino and Riverside Counties, San Bernardino, CA, by telephone on May 9, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1836-08
CODE
Unit: 2320782
RECALLING FIRM/MANUFACTURER
Indiana Blood Center, Indianapolis, IN, by telephone on November 29, 2007 and by follow-up letter dated January 4, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with hemochromatosis and taking the drug Coumadin, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1844-08;
b) Fresh Frozen Plasma, Recall # B-1845-08
CODE
a) and b) Unit: 0683044
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Jackson, MS, by facsimile on December 7, 2007, January 25, 2008 and April 11, 2008. Firm initiated recall is complete.
REASON
Blood products, which was collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MS
___________________________________
PRODUCT
a) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-1853-08;
b) Platelets Pheresis Leukocytes Reduced, Recall # B-1854-08
CODE
a) Unit: 0695910A;
b) Unit: 0695910B
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Jackson, MS, by facsimile on November 2, 2007. Firm initiated recall is complete.
REASON
Blood products, which was possibly contaminated with Propionibacterium acnes, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MS
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1857-08;
b) Platelets; Recall # B-1858-08;
c) Fresh Frozen Plasma, Recall # B-1859-08
CODE
a) Unit: LM12831, LM00255, Q39763;
b) Unit: Q39763;
c) Unit: LM00255, Q39763
RECALLING FIRM/MANUFACTURER
Mid-South Regional Blood Center, Memphis, TN, by letter dated February 13, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the medication Tapazole, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
TN, GA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1860-08
CODE
Unit: 3635401
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on March 26, 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
LA
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1861-08;
b) Fresh Frozen Plasma, Recall # B-1862-08
CODE
a) and b) Unit: 3634611
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on February 19, 2008 and May 20, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1863-08
CODE
Unit: 72E875328
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc, Huntsville, AL, by facsimile on January 24, 2008. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1864-08
CODE
Units: 200441990 (2 units)
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc, Lafayette, LA, by telephone on February 6, 2008. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Propionibacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1865-08
CODE
Units: 72E111107 (2 units)
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc, Birmingham Region, Birmingham, AL, by facsimile on November 30, 2007 and January 10, 2008. Firm initiated recall is complete.
REASON
Blood products, with insufficient plasma volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL
___________________________________
PRODUCT
a) Recovered Plasma, Recall # B-1866-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-1867-08
CODE
a) and b) Units: 027FX11652
RECALLING FIRM/MANUFACTURER
ARC Greater Alleghenies, Johnstown, PA, by facsimile on April 21, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, WV
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1870-08;
b) Recovered Plasma, Recall # B-1871-08
CODE
a) and b) Unit: 054W27899
RECALLING FIRM/MANUFACTURER
American National Red Cross, Puerto Rico Region, Rio Piedras, PR, by electronic notification on May 3, 2007 or by letter dated May 7, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who engaged in high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PR, CA
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1873-08;
b) Platelet Pheresis Leukocytes Reduced, Recall # B-1874-08
CODE
a) Units: 54E20645, 54Z15665, 54L21398, 54V22343, 54L21853, 54C20280,
54X18576, 54X18587, 54L21727, 54V22414, 54X18577, 54X18018,
54V21975, 54E20449, 54KC65037, 53E21098, 54FM18915, 54KC67417,
54KM02116, 54X18405, 54X18443, 54Y29176, 54KC65733, 54C19815,
54C20040, 54Z14598, 54V21133, 54W20324, 54V21612, 54KC63700,
54KC64347, 54KC62493, 54KC62430, 54L19772, 54Y25731, 54Z13009,
54X17021, 54V20199, 54KC61989, 54KC62091, 54Y24894, 54KC60958,
54KC61059, 54V20612, 54KC62853, 54C19664, 54E18379, 54KC61105,
54KC67751, 54KC64736, 54KC67336;
b) Unit: 54E20645
RECALLING FIRM/MANUFACTURER
American National Red Cross, Puerto Rico Region, Rio Piedras, PR, by telephone on August 4, 2005 and by letter dated August 18, 2005 and follow-up letter on October 3, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from donors who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
52 units
DISTRIBUTION
PR
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-1882-08;
b) Recovered Plasma, Recall # B-1883-08
CODE
a) and b) Unit: 0336910
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone and facsimile on April 6, 2007. Firm initiated recall is complete.
REASON
Blood products, which was collected from a donor who may be at increased risk for HIV-1 Group O infection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MS, CA
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1884-08
CODE
Unit: 4424847
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Monroe, LA, by electronic mail on May 15, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1885-08
CODE
Unit: 4483859
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by letter and electronic mail on May 14, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for Leishmaniasis and Malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1886-08
CODE
Unit: 5763277
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on July 21, 2006. Firm initiated recall is complete.
REASON
Blood product, for which physical examination was undocumented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1890-08;
b) Cryoprecipitated AHF, Recall # B-1891-08
CODE
a) and b) Unit: 7046817
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by letter on August 16, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who lived in an area at risk for vCJD, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA, TX
___________________________________
PRODUCT
a) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-1901-08;
b) Platelets Pheresis Leukocytes Reduced, Recall # B-1902-08
CODE
a) and b) Unit: 71X282563
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Montgomery Region, Montgomery, AL, by facsimile on June 5, 2006. Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but was not tested to verify the White Blood Cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1906-08
CODE
Units: 4436768A, 4436768B
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Monroe, LA, by telephone and facsimile on January 24, 2007. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AR
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1916-08
CODE
Unit: 54W13853
RECALLING FIRM/MANUFACTURER
American National Red Cross, Puerto Rico Region, Rio Piedras, PR, by electronic notification on August 23, 2007 or by letter dated August 28, 2007. 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
PR
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1917-08
CODE
Unit: 54V28464
RECALLING FIRM/MANUFACTURER
American National Red Cross, Puerto Rico Region, Rio Piedras, PR, by electronic notification on July 25, 2007. 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
a) Fresh Frozen Plasma, Recall # B-1918-08;
b) Red Blood Cells, Recall # 1919-08
CODE
a) and b) Unit: 54KG72768
RECALLING FIRM/MANUFACTURER
American National Red Cross, Puerto Rico Region, Rio Piedras, PR, by telephone on September 1, 2006 and by letter dated September 18, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PR
___________________________________
PRODUCT
a) Red Blood Cells Frozen, Recall # 1925-08;
b) Platelets, Recall # B-1926-08
CODE
a) and b) Units: 054KF64285
RECALLING FIRM/MANUFACTURER
American National Red Cross, Puerto Rico Region, Rio Piedras, PR, by telephone on April 21, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who previously tested positive for anti-HTLV-1, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PR

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1532-08
CODE
Unit: 17FM15192
RECALLING FIRM/MANUFACTURER
The American National Red Cross, North Central Region, Saint Paul, MN, by letter dated November 17, 2005. Firm initiated recall is complete.
REASON
Blood product, positive for the Jka antigen but labeled Jka negative, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-1748-08;
b) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1749-08
CODE
a) Unit: 0789140;
b) Unit: 1395169
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter dated November 8, 2006 and follow-up letter dated December 27, 2006. Firm initiated recall is complete.
REASON
Blood product, positive for Jka antigen but labeled Jka negative, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MN
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1772-08
CODE
Unit: KW06254
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on February 19, 2008. Firm initiated recall is complete.
REASON
Blood product, prepared from a unit of Whole Blood which may have exceeded the acceptable collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WV
___________________________________
PRODUCT
Red Blood Cells, Recall # B-1798-08
CODE
Unit: 4804166
RECALLING FIRM/MANUFACTURER
Our Lady of the Lake Hospital, Inc, Baton Rouge, LA, by fax on December 18, 2005. 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
LA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1799-08
CODE
Unit: 4803790
RECALLING FIRM/MANUFACTURER
Our Lady of the Lake Hospital, Inc, Baton Rouge, LA, by fax on December 20, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with hemochromatosis and an elevated blood pressure, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
Cryoprecipitated AHF, Recall # B-1827-08
CODE
Unit: Q44355
RECALLING FIRM/MANUFACTURER
Mid-South Regional Blood Center, Memphis, TN, by letter on January 17, 2007. Firm initiated recall is complete.
REASON
Blood product, prepared from a whole blood unit with a possible extended collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Source Plasma, Recall # B-1828-08
CODE
Unit: 380059065
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources Inc., Monroe, LA, by fax on June 1, 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
NC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1835-08
CODE
Units: GM56424, GN12404
RECALLING FIRM/MANUFACTURER
Blood Bank of San Bernardino and Riverside Counties, San Bernardino, CA, by letter dated June 7, 2006. Firm initiated recall is complete.
REASON
Blood products, incorrectly identified as negative for the C antigen, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
a) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-1841-08;
b) Platelets Pheresis Leukocytes Reduced, Recall # B-1842-08
CODE
a) and b) Unit: 38FX22944
RECALLING FIRM/MANUFACTURER
American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by letter dated March 27, 2008. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specification, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IN
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1846-08;
b) Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated, Recall # B-1847-08
CODE
a) Units: 221025653, 221026912, 221026921, 221026924, 221025647, 221025223,
221025231, 221025235, 221025241, 221025245, 221025247, 221025249,
221025252, 221025253;
b) Units: 221026918, 221025228
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc, Las Vegas, NV, by letters dated May 16, 2005. Firm initiated recall is complete.
REASON
Blood products, documented as being out of controlled storage for more than 30 minutes, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
NV, FL, AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1868-08
CODE
Unit: LM23407
RECALLING FIRM/MANUFACTURER
Mid-South Regional Blood Center, Memphis, TN, by facsimile on December 14, 2007. Firm initiated recall is complete.
REASON
Blood product, manufactured from a unit of Whole Blood which was not maintained at appropriate temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1869-08
CODE
Unit: 22FM00876
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by facsimile on April 25, 2008. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly labeled as negative for K antigen, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1872-08
CODE
Units: 11KP06794, 54E14586, 54FM17153, 54FM17531, 54KC50316, 54KC50328, 54KC50595, 54KW16304, 54KW17055, 54L15449, 54L15543, 54L15553, 54L15918, 54V16693, 54W15989, 54X13941, 54Y17679, 54Y17763, 54Y17782, 54Y18990, 54Z09020
RECALLING FIRM/MANUFACTURER
American National Red Cross, Puerto Rico Region, Rio Piedras, PR, by telephone on November 16, 2005 and by letter dated December 29, 2005. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly tested for red blood cell antigens, were distributed.
VOLUME OF PRODUCT IN COMMERCE
21 units
DISTRIBUTION
PR
___________________________________
PRODUCT
Source Plasma, Recall # B-1880-08
CODE
Unit: KZ020722
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Memphis, TN, by facsimile on May 30, 2007. 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
Austria
___________________________________
PRODUCT
Source Plasma, Recall # B-1881-08
CODE
Unit: KZ01410
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Memphis, TN, by facsimile on May 24, 2007. 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
Austria
___________________________________
PRODUCT
Red Blood Cells, Irradiated, Recall # B-1903-08
CODE
Units: 71S076506; 71S07652X; 71S079613
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Montgomery Region, Montgomery, AL, by facsimile on June 21, 2006. Firm initiated recall is complete.
REASON
Blood products, which were labeled with an incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells Irradiated, Recall # B-1904-08
CODE
Units: 71S043721, 71S273655
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Montgomery Region, Montgomery, AL, by telephone on May 13, 2006. Firm initiated recall is complete.
REASON
Blood products, which were labeled with an incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1905-08
CODE
Units: 71R990197 Part 1; 71R990197 Part 2; 71R984492 Part 1; 71R984492 Part 2
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Montgomery Region, Montgomery, AL, by facsimile on June 3, 2005. Firm initiated recall is complete.
REASON
Blood products, which did not meet the acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
AL
___________________________________
PRODUCT
a) Fresh Frozen Plasma (Apheresis), Recall # B-1907-08;
b) Fresh Frozen Plasma, Recall # B-1908-08
CODE
a) Units: 200400175, 208476824, 208478875A, 208478875B, 208478936,
208478990A, 208478990B, 208478645, 206636967, 206636988, 208439960,
208475130;
b) Units: 203161178A, 203161178B, 203161178C, 206636309A, 206636309B, 206636309C, 208475702A, 208475702B, 208475702C, 208476362A, 208476362B, 208476362C, 208477535A 208477535B, 208477535C, 208477690A, 208477690B, 208477690C, 206634338, 206636455, 208477478, 200400043, 00400098, 200400099, 200400130, 200400139, 200400155, 200400175, 200400195, 200400227, 200400604, 200400616, 200400715, 200401004, 200401068, 200401074, 200401076, 200401085, 200401403, 200401424, 200402048, 200402410, 200403211, 200403227, 200403229, 200403257, 203161126, 203161156, 206634709, 206635367, 206635882, 206635910, 206635948, 206635949, 206635952, 206636189, 206636299, 206636471, 206636671, 206636736, 206636767, 206636769, 206636909, 206636928, 206636945, 206636960, 206638550, 206638937, 206638956, 206638982, 208458358, 208460394, 208460745, 208464895, 208468180, 208468192, 208471897, 208473467, 208473506, 208473513, 208473781, 208473800, 208473903, 208473906, 208473918, 208473924, 208474129, 208474365, 208474531, 208474663, 208475329, 208475438, 208475478, 208475508, 208475677, 208475708, 208475712, 208475915, 208475962, 208475970, 208475983, 208475993, 208476116, 208476497, 208476592, 208476720, 208476762, 208476795, 208476844, 208476872, 208476920, 208476944, 208476950, 208476971, 208476974, 208476975, 208477280, 208477377, 208477381, 208477392, 208477509, 208477592, 208477642, 208477715, 208477773, 208477802, 208477803, 208477819, 208477900, 208477917, 208477968, 208477975, 208477995, 208478217, 208478247, 208478280, 208478298, 208478317, 208478362, 208478466, 208478471, 208478618, 208478963, 208479061, 208479085, 208479090, 208479116, 208479123, 208479236, 208479239, 208479366, 208479432, 208479452, 208479521, 208479522, 208479552, 208479567, 208479635, 208479655, 208479694, 208479850, 208479875, 208479879, 208479884, 208479916
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lafayette, LA, by telephone on August 22, 2007. Firm initiated recall is complete.
REASON
Blood products, which may have reached an unacceptable temperature during storage, were distributed.
VOLUME OF PRODUCT IN COMMERCE
177 units
DISTRIBUTION
LA, AZ, TX, NM, NV
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1915-08
CODE
Unit: 54W13853
RECALLING FIRM/MANUFACTURER
American National Red Cross, Puerto Rico Region, Rio Piedras, PR, by electronic notification on August 23, 2007 or by letter dated August 28, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1920-08;
b) Platelets, Recall # B-1921-08;
c) Recovered Plasma, Recall # B-1922-08
CODE
a), b), and c) Unit: 54KF99592
RECALLING FIRM/MANUFACTURER
American National Red Cross, Puerto Rico Region, Rio Piedras, PR, by telephone on September 21, 2006 and letter dated October 16, 2006 or by electronic notification on September 22, 2006. 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
3 units
DISTRIBUTION
PR, CA

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
Access Power Supply Assembly Sled Part Number: A48196/6845C; Component of: Access and Access 2 Immunoassay Systems, SYNCHRON LXi 725 System, and UniCel DxC 600i System. Instrument part numbers 81600 and 81600N; Recall # Z-1183-2008
CODE
Part numbers only
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on October 17, 2007.
Manufacturer: Beckman Coulter, Inc., Chaska, MN. Firm initiated recall is ongoing.
REASON
Electrical grounding failure: During manufacturing, internal testing found one instrument with an intermittent failure of the electrical grounding. The source of the problem was traced to inadequate soldering.
VOLUME OF PRODUCT IN COMMERCE
3,247 Instruments
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
a) Biomet brand Modular Microplasty Cup Inserter, 3/8" thread; Model 31-400600
assembled with a 3/8" threaded insert; Model 31-400603. Instrument for hip
prosthesis acetabular cup component; Recall # Z-1185-2008;
b) Biomet brand Modular Microplasty Cup Impactor, 3/8" - 24 Thread Insert;
Model 31-400603. Instrument for hip prosthesis acetabular cup component;
Recall # Z-1186-2008;
c) Biomet Microplasty Cup Impactor, 1/4" -28 Thread Insert; Model 31-400605.
Instrument for hip prosthesis acetabular cup component; Recall # Z-1187-2008
CODE
a) Lots: 095116, 095117, 096758, 0967822 and 096824;
b) Lot 095207;
c) Lots: 095209, 095210, 096830, 096857 and 096858
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biomet, Inc., Warsaw, IN, by letter dated January 16, 2008 and by email and letter on January 17, 2008.
Manufacturer: C & A Tool Engineering Inc., Churubusco, IN. Firm initiated recall is ongoing.
REASON
The weld at the lock location may fracture during impaction.
VOLUME OF PRODUCT IN COMMERCE
458 Instruments
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Bio-Rad MONOLISA Anti-HBc EIA, Catalog Number 26186. In vitro diagnostic; Recall # Z-1189-2008
CODE
Lot Number 232BGG
RECALLING FIRM/MANUFACTURER
Bio-Rad Laboratories, Redmond, WA, by letter on January 7-8, 2008. Firm initiated recall is complete.
REASON
Incorrect result: Elevated reactivity with a kit lot 232BGG. Patient samples that are negative for antibodies to anti-HBc could be assigned a positive result.
VOLUME OF PRODUCT IN COMMERCE
31 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Implantable Cardioverter Defibrillator EPIC VR Tiered-therapy
Cardioverter/Defibrillator, Model V-197, Recall # Z-1320-2008;
b) Implantable Cardioverter Defibrillator EPIC DR Tiered-therapy
Cardioverter/Defibrillator, Model V-235; Recall # Z-1321-2008;
c) Implantable Cardioverter Defibrillator EPIC HF Tiered-therapy
Cardioverter/defibrillator with biventricular stimulation, Model
V-337; Recall # Z-1322-2008;
d) Implantable Cardioverter Defibrillator EPIC HF Tiered-therapy
Cardioverter/Defibrillator with Biventricular Stimulation, Model
V-338; Recall # Z-1323-2008;
e) Implantable Cardioverter Defibrillator EPIC HF Tiered-therapy
Cardioverter/defibrillator with biventricular stimulation, Model
V-339; Recall # Z-1324-2008;
f) Implantable Cardioverter Defibrillator EPIC + VR Tiered-therapy
Cardioverter/defibrillator, Model V-196; Recall # Z-1325-2008;
g) Implantable Cardioverter Defibrillator EPIC DR Tiered-therapy
Cardioverter/defibrillator, Model V-233; Recall # Z-1326-2008;
h) Implantable Cardioverter Defibrillator EPIC + DR Tiered-therapy
Cardioverter/defibrillator, Model V-236; Recall # Z-1327-2008;
i) Implantable Cardioverter Defibrillator EPIC + DR Tiered-therapy
Cardioverter/defibrillator, Model V-239; Recall # Z-1328-2008;
j) Implantable Cardioverter Defibrillator EPIC + HF Tiered-therapy
Cardioverter/defibrillator with biventricular stimulation, Model
V-350; Recall # Z-1329-2008;
k) Implantable Cardioverter Defibrillator EPIC II VR Tiered-therapy
Cardioverter/defibrillator, Model V-158; Recall # Z-1330-2008;
l) Implantable Cardioverter Defibrillator EPIC II DR Tiered-therapy
Cardioverter/defibrillator, Model V-255; Recall # Z-1331-2008;
m) Implantable Cardioverter Defibrillator EPIC II+ DR Tiered-therapy
Cardioverter/defibrillator, Model V-258; Recall # Z-1332-2008;
n) Implantable Cardioverter Defibrillator EPIC II HF Tiered-therapy
Cardioverter/defibrillator with Biventricular Stimulation, Model V-355;
Recall # Z-1333-2008;
o) Implantable Cardioverter Defibrillator EPIC II+ HF Tiered-therapy
Cardioverter/defibrillator with Biventricular Stimlation, Model V-357;
Recall # Z-1334-2008;
p) Implantable Cardioverter Defibrillator EPIC II+ HF Tiered-therapy
Cardioverter/defibrillator with Biventricular Stimulation, Model V-356;
Recall # Z-1335-2008;
q) Implantable Cardioverter Defibrillator ATLAS + VR Tiered-therapy
Cardioverter/defibrillator, Model V-193; Recall # Z-1336-2008;
r) Implantable Cardioverter Defibrillator ATLAS DR Tiered-therapy
Cardioverter/defibrillator, Model V-242; Recall # Z-1337-2008;
s) Implantable Cardioverter Defibrillator ATLAS + DR Tiered-therapy
Cardioverter/defibrillator, Model V-243; Recall # Z-1338-2008;
t) Implantable Cardioverter Defibrillator ATLAS + HF Tiered-therapy
Cardioverter/defibrillator with biventricular stimulation, Model V-341;
Recall # Z-1339-2008;
u) Implantable Cardioverter Defibrillator ATLAS + HF Tiered-therapy
Cardioverter/defibrillator with biventricular stimulation, Model V-340;
Recall # Z-1340-2008;
v) Implantable Cardioverter Defibrillator ATLAS + HF Tiered-therapy
Cardioverter/defibrillator with biventricular stimulation, Model V-343;
Recall # Z-1341-2008;
w) Implantable Cardioverter Defibrillator ATLAS II VR Tiered-therapy
Cardioverter/defibrillator, Model V-168; Recall # Z-1342-2008;
x) Implantable Cardioverter Defibrillator ATLAS II DR Tiered-therapy
Cardioverter/defibrillator, Model V-265; Recall # Z-1343-2008;
y) Implantable Cardioverter Defibrillator ATLAS II+ DR Tiered-therapy
Cardioverter/defibrillator, Model V-268; Recall # Z-1344-2008;
z) Implantable Cardioverter Defibrillator ATLAS II HF Tiered-therapy
Cardioverter/defibrillator with biventricular stimulation, Model V-365;
Recall # Z-1345-2008;
aa) Implantable Cardioverter Defibrillator ATLAS II+ HF Tiered-therapy
Cardioverter/defibrillator with biventricular stimulation, Model V-366;
Recall # Z-1346-2008;
bb) Implantable Cardioverter Defibrillator ATLAS II+ HF Tiered-therapy
Cardioverter/defibrillator with biventricular stimulation, Model V-367;
Recall # Z-1347-2008;
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
St Jude Medical CRMD, Sylmar, CA, by letter on January 16, 2008 and press release on January 18, 2008. Firm initiated recall is ongoing.
REASON
A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of implantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an arrhythmia. If an arrhythmia occurred and the device was unable to detect it, then a patient would not receive potentially life saving therapy.
VOLUME OF PRODUCT IN COMMERCE
Over 143,000 defibrillators
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Exacta-Mix 2400, Pharmacy Compounding System is used in the pharmacy to
compound multiple source ingredients into on final solution based on user-specified
sequences and volumes. Models 2400-D, 2400-M, 2400-L; Recall # Z-1370-2008;
b) Exacta-Mix 600 Pharmacy Compounding System is used in the pharmacy to
compound multiple source ingredients into on final solution based on
user-specified sequences and volumes. Model 071B-RS232; Recall # Z-1371-2008
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Baxa Corporation, Englewood, CO, by letter on February 11, 2008. Firm initiated recall is ongoing.
REASON
Flush solution from TPN compounder may be added to patient's TPN bag.
VOLUME OF PRODUCT IN COMMERCE
1,221 systems
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Radius Rod Persuader is a non-sterile instrument for use with other devices in
spinal surgery. Catalog number: 486619190; Recall # Z-1377-2008;
b) Radius Capsin is a non-sterile instrument for use with other devices in spinal
surgery. Catalog number: 486619210; Recall # Z-1378-2008
CODE
a) Lot numbers: 067805, 067806, 067807, 06D694;
b) Lot numbers: 06A277, 06A279, 06D632
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Spine, Allendale, NJ, by FedEx on February 19, 2008.
Manufacturer: Stryker Spine, Cestas, Aquitane, France. Firm initiated recall is ongoing.
REASON
a) The t-bar of the Radius Rod Persuader devices froze due to a loosening screw
causing the device to fail;
b) The Radius Capsin has separation of the tip from the inserter.
VOLUME OF PRODUCT IN COMMERCE
a) 65 Persuaders; b) 52 Capsins
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Given® Diagnostic System with PillCam® SB Capsule - Gastrointestinal capsule imaging system. The device is an ingestible telemetric gastrointestinal capsule imaging system is used for visualization of the small bowel mucosa as an adjunctive tool in the detection of abnormalities of the small bowel. The device captures images of the small bowel with a wireless camera contained in a capsule. This device includes an ingestible capsule (containing a light source, camera, transmitter, and battery), an antenna array, a receiving/recording unit, a data storage device, computer software to process the images, and accessories; Recall # Z-1447-2008;
CODE
GMB-0253-01-GLR Card-Proposed Diagnostic Algorithm for Suspected Crohn's Disease.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Given Imaging Inc., Duluth, GA, by letter on December 13, 2007.
Manufacturer: Given Imaging Ltd., Yokneam, Israel. Firm initiated recall is ongoing.
REASON
The cards included in the product's education kit (proposing a clinical algorithm for capsule endoscopy in patients with suspected Crohn's disease), were printed incorrectly.
VOLUME OF PRODUCT IN COMMERCE
1,392 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Allen Medical C-Flex, Polar Head Positioner. Catalog Number: A-70700-A1. Product is a medical device used to maintain the position of an anesthetized patient during surgery; Recall # Z-1478-2008
CODE
Serial Numbers: A111211, A116292
RECALLING FIRM/MANUFACTURER
Allen Medical Systems, Inc., Acton, MA, by telephone on November 8, 2007 and the Sales Representative. Firm initiated recall is complete.
REASON
Handle jamming in the open position, preventing the device from adequately supporting the head during spinal surgery. Possible delay in surgery, or injury.
VOLUME OF PRODUCT IN COMMERCE
2 devices
DISTRIBUTION
MA, MS
___________________________________
PRODUCT
a) VITALITY DR+ Implantable Cardioverter Defibrillator (ICD), model 1872;
Recall # Z-1513-2008;
b) VITALITY EL, models T127, T167, T177 Implantable Cardioverter Defibrillator
(ICD), pulse-generator, dual Chamber; Recall # Z-1514-2008
CODE
Devices that are implanted subpectorally with the serial number facing the ribs.
RECALLING FIRM/MANUFACTURER
Boston Scientific CRM Corporation, Saint Paul, MN, by letter dated January 4, 2008. Firm initiated recall is ongoing.
REASON
Repetitive mechanical stress applied to the titanium case can induce component damage and device malfunction in certain ICD and CRT-D devices implanted subpectorally with the serial number facing the ribs. Devices implanted subcutaneously or in a subpectoral position with the serial number facing away from the ribs are not included in this advisory. This update identifies additional VITALITY ICD models that are also subject to this failure mechanism if implanted in a susceptible orientation. Consequence includes: Loss of shock therapy, loss of pacing therapy (intermittent or permanent), or loss of telemetry communications.
VOLUME OF PRODUCT IN COMMERCE
25,000
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
3DKNEE Tibial Insert Trial, Size 2, 13mm Right; Part #801-01-640; Used in surgery to determine the correct size of 3DKnee component to implant that would allow for the best range of motion and joint stability; Z-1539-2008
CODE
Lot #53906407
RECALLING FIRM/MANUFACTURER
Encore Medical, Lp, Austin, TX, by telephone on February 20, 2008. Firm initiated recall is complete.
REASON
Tibial insert trial incorrectly marked for thickness; device thickness marked correctly as 13mm on the underside of the trial, but is incorrectly marked as 15mm on the side.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
Germany
___________________________________
PRODUCT
The OptiVantage DH Injection System is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with computed tomography equipment. The J-Bow component is used to connect the powerhead to a suspension system. Catalog #V8400, Part No. 241078 & Catalog #V8402, Part #241079; Recall # Z-1694-2008
CODE
Part numbers only
RECALLING FIRM/MANUFACTURER
Mallinckrodt, Inc., Cincinnati, OH, by letter on April 18, 2008. Firm initiated recall is ongoing.
REASON
Screws can begin to loosen and shear off to the point of the J-Bow falling from the suspension system. This may cause injury to patients or hospital staff.
VOLUME OF PRODUCT IN COMMERCE
783 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Excimer Laser System; WaveScan WaveFront System, Software Version 3.65, for use with the VISX STAR S4 and STAR S4 IR Excimer Laser Systems. System is a diagnostic instrument intended for the automated measurement; analysis and recording of refractive errors and wavefront aberrations to the target shape and then generates the commands for the VISX STAR laser to create the target shape on the cones. Part Numbers 0070-0150, 0070-0150R, 0070-1006, 0070-1006R, and 0070-1478; Recall # Z-1695-2008
CODE
All systems with software version 3.65 and earlier
RECALLING FIRM/MANUFACTURER
Visx Incorporated, a subsidiary of AMO, Inc., Santa Clara, CA, by letter on November 27, 2006. Firm initiated recall is complete.
REASON
Firm became aware of a significant overcorrection in one eye of a patient who had received a wavefront-guided LASIK treatment at a facility in Germany. The probability of a recurrence of this error was determine to be extremely remote, however to prevent re-occurrence of this type of incident a software update was developed.
VOLUME OF PRODUCT IN COMMERCE
1,310 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Omnifit EON Surgical Protocol; Recall # Z-1750-2008
CODE
Literatur Number LSP48 4/04
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics, Corporation, Mahwah, NJ, by letter on May 17, 2007. Firm initiated recall is complete.
REASON
The Table 2 Broach and Neck Trial Sizing (Literature # LSP48 04/04) on page 3 is incorrect, reading 5mm less than what it should be for certain sizes.
VOLUME OF PRODUCT IN COMMERCE
2,501 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
HerpeSelect 1 and 2 Immunoblot IgG Kit, IB0900G Intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 and HSV-2 in human sera; Recall # Z-1764-2008
CODE
Lot Codes 063169 (Expires December 2007), 063354 (Expires October 2007), 063355 (Expires July 2007)
RECALLING FIRM/MANUFACTURER
Focus Diagnostics, Inc., Cypress, CA, by letter starting on July 6, 2007. Firm initiated recall is ongoing.
REASON
A small percentage of samples tested in specific lots, the HSV common antigen band appears lighter (less reactive) than the reading control band. Reduced reactivity of the common antigen band may lead to inaccurate interpretation of a sample as negative.
VOLUME OF PRODUCT IN COMMERCE
187 kits
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Medical charged-particle radiation therapy system. Siemens Linear Medical Accelerators equipped with COHERENCE Therapist R2.0 and Oncologist R2.0. Product update, TH 030//07/S. The COHERENCE Therapist R2.0 software numbers are: 7358299, 7360857, and 8141835 and applies only to those parts used with the following devices: Coherence AG Therapist; Coherence Therapist System; Coherence Impression Therapist; PRIMEVIEW 3i; AG Therapist 3rd party V&R; Coherence Therapist 2.0 and PRIMEVIEW 3i 2.0; Recall # Z-1769-2008
CODE
Software Numbers 7358299, 7360857, and 8141835
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Concord, CA, by letter on October 3, 2007. Firm initiated recall is ongoing.
REASON
A image issue: a complaint that images viewed in the device may shift, which could result in mistreatment.
VOLUME OF PRODUCT IN COMMERCE
359 systems
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Bariatric Wheelchair, 24" Wide and 19" Deep Seat, 600 lb. Weight Capacity;
Item #MDS809600 comes with Removable Desk-Length Arms, Swing-Away
Detachable Footrests, Fixed Height. item #MDS809650 comes with Removable
Desk-Length Arms, Swing-Away Detachable Elevating Legrests, Fixed Height;
Recall # Z-1770-2008;
b) Bariatric Wheelchair, 26" Wide and 20" Deep Seat, 700 lb. Weight Capacity;
Item #MDS809700 comes with Removable Full-Length Arms, Swing-Away
Detachable Footrests, Hemi-Height Adjustable. item #MDS809750 comes with
Removable Full-Length Arms, Swing-Away Detachable Elevating Legrests, Hemi-
Height Adjustable; Recall # Z-1771-2008;
c) Bariatric Wheelchair, 28" Wide and 20" Deep Seat, 700 lb. Weight Capacity; Item
#MDS809800 comes with Removable Desk-Length Arms, Swing-Away Detachable
Footrests, Hemi-Height Adjustable. item #MDS809850 comes with Removable Desk-
Length Arms, Swing-Away Detachable Elevating Legrests, Hemi-Height Adjustable;
Recall # Z-1772-2008
CODE
All wheelchairs purchased between 12/01/2005 and 08/31/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medline Industries Inc., Mundelein, IL, by letter dated March 31, 2008. Firm initiated recall is ongoing.
Manufacturer: Taiwan An I Co., Ltd., Shi-koou Shiang, Chia-yi Hsien, Taiwan. Firm initiated recall is ongoing.
REASON
Fingers can get injured. There is a potential for users to pinch their fingers between the seat bars when opening the wheelchairs. Injuries can be severe from fractures to severing.
VOLUME OF PRODUCT IN COMMERCE
1,138 wheelchairs
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Infusion System. EKOS EndoWave Infusion System. EKOS EndoWave Infusion System Drug Delivery Catheter with Ultrasound Core. Labeled as Sterile, Single Use Only. Connector clip is CIC Connector Clip; Part Number: 700-4000. The infusion system is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytes, into the peripheral vasculature; Recall # Z-1773-2008
CODE
CIC Connector Clip; Lot numbers: 080324024, 080324025, 080324026, 080324027, 080325002, 080325003;
EndoWave System Control Unit S/N: PT3B-001, PT3B-002, PT3B-004, PT3B-006, PT3B-007, PT3B-008, PT3B-009, PT3B-010, PT3B-011, PT3B-012, PT3B-013, PT3B-014, PT3B-017, PT3B-018, PT3B-020, PT3B-021, PT3B-022, PT3B-024, PT3B-025, PT3B-027, PT3B-029, PT3B-030, PT3B-031, PT3B-032, PT3B-033, PT3B-034, PT3B-035, PT3B-037, PT3B-038, PT3B-040, PT3B-041, PT3B-042, PT3B-043, PT3B-044, PT3B-045, PT3B-046, PT3B-047, PT3B-049, PT3B-050, PT3B-051, PT3B-052, PT3B-057, PT3B-058, PT3B-059, PT3B-060, PT3B-062, PT3B-063, PT3B-064, PT3B-065, PT3B-066, PT3B-067, PT3B-068, PT3B-070, PT3B-071, PT3B-072, PT3B-073, PT3B-074, PT3B-075, PT3B-076, PT3B-078, PT3B-079, PT3B-080, PT3B-082, PT3B-084, PT3B-085, PT3B-087, PT3B-088, PT3B-089, PT3B-090, PT3B-091, PT3B-093, PT3B-094, PT3B-095, PT3B-096, PT3B-097, PT3B-098, PT3B-099, PT3B-100, PT3B-102, PT3B-103, PT3B-104, PT3B-108, PT3B-109, PT3B-110, PT3B-111, PT3B-112, PT3B-113, PT3B-114, PT3B-115, PT3B-118, PT3B-119, PT3B-121, PT3B-123, PT3B-124, PT3B-127, PT3B-128, PT3B-130, PT3B-131, PT3B-132, PT3B-133, PT3B-135, PT3B-137, PT3B-138, PT3B-139, PT3B-140, PT3B-141, PT3B-143, PT3B-145, PT3B-146, PT3B-147, PT3B-148, PT3B-150, PT3B-151, PT3B-152, PT3B-153, PT3B-154, PT3B-155, PT3B-156, PT3B-157, PT3B-158, PT3B-159, PT3B-163, PT3B-164, PT3B-165, PT3B-168, PT3B-169, PT3B-172, PT3B-173, PT3B-174, PT3B-175, PT3B-176, PT3B-177, PT3B-178, PT3B-180, PT3B-181, PT3B-183, PT3B-186, PT3B-188, PT3B-192, PT3B-193, PT3B-195, PT3B-196, PT3B-197, PT3B-199, PT3B-201, PT3B-202, PT3B-204, PT3B-205, PT3B-206, PT3B-207, PT3B-208, PT3B-210, PT3B-211, PT3B-212, PT3B-214, PT3B-215, PT3B-217, PT3B-218, PT3B-219, PT3B-221, PT3B-253, PT3B-254, PT3B-255, PT3B-256, PT3B-257, PT3B-258, PT3B-259, PT3B-260, PT3B-261, PT3B-262, PT3B-263, PT3B-264, PT3B-265, PT3B-266, PT3B-267, PT3B-268, PT3B-269, PT3B-270, PT3B-271, PT3B-273, PT3B-274, PT3B-275, PT3B-276, PT3B-280, PT3B-285, PT3B-286, PT3B-287, PT3B-288, PT3B-289, PT3B-291, PT3B-292, PT3B-294, PT3B-295, PT3B-297, PT3B-298, PT3B-308, PT3B-310, PT3B-311, PT3B-312, PT3B-313, PT3B-314, PT3B-315, PT3B-316, PT3B-319, PT3B-320, PT3B-321, PT3B-323, PT3B-326, PT3B-328, PT3B-329, PT3B-332, PT3B-333, PT3B-334, PT3B-335, PT3B-337, PT3B-338, PT3B-339, and PT3B-344
RECALLING FIRM/MANUFACTURER
EKOS Corporation, Bothell, WA, by visit beginning April 1, 2008. Firm initiated recall is ongoing.
REASON
Catheter disconnection. There is a potential for the catheter to disconnect from the Catheter Interface Cable (CIC) pod which connects to the Control Unit.
VOLUME OF PRODUCT IN COMMERCE
218 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
CELL-DYN Sapphire Hematology Analyzer, List number 08H00-01, LIS/ Middleware Interface Specification. For in vitro diagnostic use in counting and characterizing blood cells; Recall # Z-2139-2008
CODE
Revision B
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Santa Clara, CA, by letter on April 1l, 2008. Firm initiated recall is ongoing.
REASON
Table in LIS Specification depicting the association between Record ID and Numerical Result Label is incorrect. If a record ID is used to configure the system for mapping, results will come out nonsensical.
VOLUME OF PRODUCT IN COMMERCE
15 spec sheets
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Osteo-Clage Cable System Package Assembly (01-0001-S). Product labeled in part, "2.0mm x 850 mm CoCr Cable / Sleeve... REF 01-0001-S; Recall # Z-2140-2008
CODE
Lot: W59192 (W=work order, ###=sequential number); Expiration date: 2015-01 (Year/Month)
RECALLING FIRM/MANUFACTURER
Acumed LLC, Hillsboro, OR, by letter on March 28, 2008. Firm initiated recall is ongoing.
REASON
Cables of incorrect diameter were used in product assembly, resulting in the sleeve not being able to bind to the cable after crimping.
VOLUME OF PRODUCT IN COMMERCE
50 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
StatSampler 200 uL, Li Heparin (micro blood collector); Ref: SS2H. Packed in Catalog Numbers: SS2H (I vial), SS2H-06 (6 kits/case), CH2C-I0 (I0 vials/kit). Intended for collection and processing of capillary blood to prepare plasma/serum; Recall # Z-2234-2008
CODE
Lot number: 7296 Expiration Date: 12/09; Lot 8031 Expiration Date: 3/10
RECALLING FIRM/MANUFACTURER
Recalling Firm: StatSpin, Inc., dba Iris Sample Processing, Westwood MA, by telephone and letter dated June 19, 2008.
Manufacturer: Drummond Scientific Co., Broomall PA. Firm initiated recall is ongoing.
REASON
EDTA inadvertently mixed with lithium heparin solution contained in capillary tubes.
VOLUME OF PRODUCT IN COMMERCE
171 vials
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
___________________________________
PRODUCT
a) Equal Diagnostics Lipase Color Reagent Kit Part Number: 905-B For In Vitro
Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number
80-2005-01, Reagent lot Number 491686; Recall # Z-2148-2008;
b) Equal Diagnostics Lipase Color Reagent Kit Part Number: 905-C For In Vitro
Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 2005-01,
Reagent lot Number 491686; Recall # Z-2149-2008;
c) Equal Diagnostics Lipase Color Reagent Kit Part Number: 905-D For In Vitro
Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 2005-01,
Reagent lot Number 491686; Recall # Z-2150-2008;
d) Equal Diagnostics Lipase Color Reagent Kit Part Number: 905-E For In Vitro
Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 2005-01,
Reagent lot Number 491686; Recall # Z-2151-2008
CODE
a) Lot # 7EPM30 exp 01/15/09;
b) Lot # 7EPN32 Exp 01/15/09;
c) Lot # 7EP027 exp 01/15/09;
d) Lot # 7EPP31 exp 01/15/09
RECALLING FIRM/MANUFACTURER
Genzyme Corporation, Cambridge, MA, by letter on April 14, 2008. Firm initiated recall is complete.
REASON
Calibration and Quality Control outside of established range resulting from an increase in initial OD readings with the reagent contained within the kits.
VOLUME OF PRODUCT IN COMMERCE
3,443 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II
___________________________________
PRODUCT
1) COUNTRY ACRES ALL-STOCK 14% TEXTURED, Formula 56AT,
Item No. 0049098, packaged in 50 lbs. bags; Recall # V-225-2008;
2) COUNTRY ACRES ALL-STOCK 16% TEXTURED, Formula 56AZ,
Item No. 0051858, packaged in 50 lbs. bags; Recall # V-226-2008;
3) COUNTRY ACRES HORSE COMPLETE 14, Formula 35EX,
Item No. 0048193, packaged in 50 lbs. bags; Recall # V-227-2008;
4) COUNTRY ACRES HORSE PELLET 10, Formula 35DR, Item No. 0041941,
packaged in 50 lbs. bags; Recall # V-228-2008;
5) COUNTRY ACRES HORSE PELLET 12, Formula 35DS, Item No. 0041940,
packaged in 50 lbs. bags; Recall # V-229-2008;
6) COUNTRY ACRES HORSE SWEET 10, Formula 35DN, Item No. 0041937,
packaged in 50 lbs. bags; Recall # V-230-2008;
7) COUNTRY ACRES HORSE SWEET 12, Formula 35DP, Item No. 0041943,
packaged in 50 lbs. bags; Recall # V-231-2008;
8) COUNTRY ACRES LAYER 16%, Formula 6514, Item No. 0009876, packaged
in 50 lbs. bags; Recall # V-232-2008;
9) PURINA Complete Advantage Horse Feed, Formula 3505, Item No. 0034202,
packaged in 50 lbs. bags; Recall # V-233-2008;
10) PURINA EQUINE JUNIOR HORSE FEED, Formula 35G9, Item No. 0001206,
packaged in 50 lbs. bags; Recall # V-234-2008;
11) PURINA EQUINE SENIOR HORSE FEED, Formula 35J9, Item No. 0001209,
packaged in 50 lbs. bags; Recall # V-235-2008;
12) PURINA GOAT CHOW GOAT FEED, Formula 5501, Item No. 0001403,
packaged in 50 lbs. bags; Recall # V-236-2008;
13) PURINA Horse Chow 100 Horse Feed, Formula 3531, Item No. 0004984,
packaged in 50 lbs. bags; Recall # V-237-2008;
14) PURINA Horseman's EDGE 10:10 TXT HF, Formula 35CZ, Item No. 0054628,
packaged in 50 lbs. bags; Recall # V-238-2008;
15) PURINA Horseman's EDGE COMPLETE 14, Formula 35TK, Item No. 0065331,
packaged in 50 lbs. bags; Recall # V-239-2008;
16) PURINA Horseman's EDGE PELLET 10:6, Formula 35Y5, Item No. 0010610,
packaged in 50 lbs. bags; Recall # V-240-2008;
17) PURINA Horseman's EDGE PELLET 12:6 + LYSINE, Formula 35TG, Item No.
0065244, packaged in 50 lbs. bags; Recall # V-241-2008;
18) PURINA Horseman's EDGE SWEET 14:6, Formula 35TP, Item No. 0065356,
packaged in 50 lbs. bags; Recall # V-242-2008;
19) PURINA Horseman's EDGE SWEET 12:6 + LYSINE, Formula 35TM, Item No.
0065354, packaged in 50 lbs. bags; Recall # V-243-2008;
20) PURINA PURE PRIDE 100, Formula 3516, Item No. 0001187, packaged in 50 lbs.
bags; Recall # V-244-2008;
21) PURINA SOW & PIG BUILDER OTC 50, Formula 26WK, Item No. 0047869,
packaged in 50 lbs. bags; Recall # V-245-2008;
22) PURINA MILLS START & GROW SUNFRESH RECIPE, Formula 61S3,
Item No. 0057259, packaged in 50 lbs. bags; Recall # V-246-2008;
CODE
Lots 8JAN01GD1 to 8MAR10GD1 (manufactured on January 1, 2008 to March 10, 2008). The lot numbers are printed on the sewing strip of each bag
RECALLING FIRM/MANUFACTURER
Recalling Firm: Land O Lakes Purina LLC, Shoreview, MN, by telephone and fax on April 21-22, 2008.
Manufacturer: Land O’Lakes Purina Feed, LLC, Guilderland Center, NY. Firm initiated recall is ongoing.
REASON
Finished products were manufactured with peanut hulls. The peanut hulls were found to contain aflatoxin above acceptable levels.
VOLUME OF PRODUCT IN COMMERCE
113,348/50 lb. bags
DISTRIBUTION
NY, CT, MA, NH, VT, RI, ME

END OF ENFORCEMENT REPORT FOR AUGUST 27, 2008

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