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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September 27, 2006
06-39

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS III

______________________________
PRODUCT
a) Minute Maid Grape, 100% Juice, 10 FL oz (295 ml),
packed in PET bottles. UPC Code 250005322, Recall # F-321-6;
b) Minute Maid 100%, Juice Mixed Berry, 10 FL oz (295 ml),
packed in PET bottles. UPC# 250005687, Recall # F-322-6;
c) Minute Maid 100% Juice, Orange Juice,10 FL oz (295 ml),
packed in PET bottles. UPC #250005685, Recall # F-323-6;
d) Minute Maid 100% Juice, Apple Juice, 10 FL oz (295 ml),
packed in PET bottles. UPC #250005684, Recall # F-324-6
CODE
a) DEC 1806 AM A;
b) DEC 1806 AM A; DEC 1806 AM B, and DEC 1806 AM C;
c) DEC 1806 AM B; and DEC 1806 AM C;
d) DEC 1806 AM C; and DEC 1806 AM D
RECALLING FIRM/MANUFACTURER
Recalling Firm: The Coca Cola Company, Atlanta, GA, by telephone and letter on August 18, 2006.
Manufacturer: Coca Cola Foods, Auburndale, FL. Firm initiated recall is ongoing.
REASON
Some bottles have loose caps which may result in product spoilage.
VOLUME OF PRODUCT IN COMMERCE
55,311 cases
DISTRIBUTION
Nationwide and PR

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

______________________________
PRODUCT
a) Prosed EC tablets, each enteric coated tablet contains
Methenamine 81.6 mg, Phenyl Salicylate 36.2 mg,
Methylene Blue 10.8 mg, Benzoic Acid 9.0 mg, Atropine
Sulfate 0.06 mg, Hyoscyamine Sulfate 0.06 mg; Rx Only,
90 tablet bottles, NDC 15456-0909-90, Reall # D-365-6;
b) Prosed EC tablets, each enteric coated tablet contains
Methenamine 81.6 mg, Phenyl Salicylate 36.2 mg,
Methylene Blue 10.8 mg, Benzoic Acid 9.0 mg, Atropine
Sulfate 0.06 mg, Hyoscyamine Sulfate 0.06 mg; Rx Only,
Physician sample containing 12/ 2-tablet packets,
NDC 0076-0909-02, Recall # D-366-6;
c) Prosed/DS Tablets, each tablet contains Methenamine 81.6 mg,
Phenyl Salicylate 36.2 mg, Methylene Blue 10.8 mg, Benzoic
Acid 9.0 mg, Atropine Sulfate 0.06 mg, Hyoscyamine
Sulfate 0.06 mg; Rx Only, 100 tablet bottles, NDC 0076-0108-03,
Recall # D-367-6
CODE
a) Lots: 042253 exp. 7/31/06, 044512 exp. 1/31/07, 053615 exp. 3/31/08;
b) Lots: 043616 exp. 11/31/06, 044512 exp. 1/31/07;
c) Lot s: 043151 exp. 8/31/06, 043617 exp. 11/30/06, 044513 exp. 1/31/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Esprit Pharma, Inc., East Brunswick, NJ, by letters on July 31, 2006.
Manufacturer: Contract Pharmacal Corporation, Hauppauge, NY. Firm initiated recall is ongoing.
REASON
No testing was performed for hyoscyamine sulfate and atropine sulfate ingredients in these products to determine satisfactory conformance to specifications and to verify stability of these products over labeled shelf life.
VOLUME OF PRODUCT IN COMMERCE
44,124 bottles and physician samples
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

______________________________
PRODUCT
Source Plasma, Recall # B-1245-6
CODE
Units: 04LTXC0765, 04LTXC0160, 04LTXB9084, 04LTXB8169, 04LTXB7322, 04LTXB6359, 04LTXB5522, 04LTXB4666, 04LTXB3639, 04LTXB3085, 04LTXB1862, 04LTXB1398, 04LTXA6491, 04LTXA5251, 04LTXA4752, 04LTXA1575, 04LTXA0642, OD821102, OD820441, OD819205, OD817399, OD816901, OD815622, OD814928, OD812814, OD811735, OD809787, OD809220, OD805849, OD805347, OD803300, OD802668, OD801659, OD801012, OD799097, OD797625, OD796908, OD795784, OD795090, OD788373, OD787649, OD786576, OD785933, OD784633, OD784104
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Laredo, TX, by facsimile on July 19, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for high-risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
45 units
DISTRIBUTION
NC

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1436-6
CODE
Unit: LP00378
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on June 1, 2006. Firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with coagulase negative Staphylococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1440-6
CODE
Unit: LW13260
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on June 6, 2006. Firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with Streptococcus, Beta Hemolytic Group C, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1445-6;
b) Recovered Plasma, Recall # B-1446-6
CODE
a) and b) Units: 4715372, 4718070
RECALLING FIRM/MANUFACTURER
W. E. and Lela I. Stewart Blood Center, Tyler, TX, by facsimile on June 18, 2004 or June 22, 2004. Firm initiated recall is complete.
REASON
Blood products, which tested negative for antibody to Hepatitis C virus (anti-HCV), but were collected from a donor who previously tested positive for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
TX and Switzerland

______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1449-6
CODE
Unit: 5695494
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on January 9, 2006. Firm initiated recall is complete.
REASON
Blood product, in which the sample tubes for viral marker testing were not maintained at an appropriate temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

______________________________
PRODUCT
Source Plasma, Recall # B-1451-6
CODE
ST0871942 and ST0872000
RECALLING FIRM/MANUFACTURER
Stillwater Plasma Center LLC, Stillwater, OK, by facsimile on June 11, 2004. Firm initiated recall is complete.
REASON
Blood products, which were untested for viral markers by the nucleic acid test (NAT) method, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
UK

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1457-6;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-1458-6;
c) Red Blood Cells, Leukocytes Reduced, Irradiated,
Recall # B-1459-6;
d) Red Blood Cells, Leukocytes Reduced, Washed,
Recall # B-1460-6;
e) Red Blood Cells, (Apheresis) Leukocytes Reduced,
Irradiated, Recall # B-1461-6;
f) Platelets, Leukocytes Reduced, Recall # B-1462-6;
g) Fresh Frozen Plasma, Recall # 1463-6;
h) Plasma, Frozen, Recall # B-1464-6;
i) Plasma, Frozen, Cryoprecipitate Reduced,
Recall # B-1465-6;
j) Cryoprecipitated AHF, Recall # B-1466-6
CODE
a) Units: 11FH03559, 11FH03561, 11FH03565, 11FH03572, 11FH03575, 11FH03579, 11FJ11434, 11FL26181, 11FL27689, 11FL27978, 11FL27979, 11FL27982, 11FL27985, 11FL27997, 11FL27998, 11FM93213, 11FM93218, 11FM93221, 11FM95734, 11FS34518, 11FT13410, 11FT13412, 11FT13414, 11FT13699, 11FT13700, 11FT13701, 11FW21416, 11FW21418, 11FW21424, 11FW21426, 11FW21428, 11FW21429, 11FY25911, 11FY25920, 11FY25932, 11FY25934, 11FY25935, 11FY25938, 11GG34111, 11GG34112, 11GG34116, 11GG34117, 11GG34406, 11GG34408, 11GG34409, 11GG34412, 11GG37229, 11GG37233, 11GG37234, 11GG37234, 11GG37241, 11GG37244, 11GG37352, 11GG37353, 11GK76105, 11GK76440, 11GK76442, 11GK76443, 11GK76444, 11GK76455, 11GK76459, 11GK76460, 11GK76469, 11GK80795, 11GN77828, 11GQ66731, 11GQ66745, 11GQ66821, 11GQ66826, 11GQ66827, 11GQ66839, 11GQ68775, 11GQ68776, 11GR58794, 11GR58798, 11GR59456, 11GR59459, 11GR59478, 11GR59976, 11GR59977, 11GR59979, 11GR59995, 11GR59998, 11GR59999, 11GR60667, 11GR60673, 11GR60676, 11GR60707, 11GR60708, 11GR60709, 11GR60717, 11GR60721, 11GR60722, 11GR60728, 11GR60736, 11GR60740, 11GR60821, 11GR60823, 11GR60825, 11GR60828, 11GR60832, 11GR60834, 11GR60836, 11GR62620, 11GR62623, 11GR62631, 11GR62634, 11GR62635, 11GR62638, 11GR62640, 11GR62642, 11GY35605, 11GY35608, 11KF15681, 11KF15683, 11KF15690, 11KF15692, 11KF16418, 11KL06598, 11KL06687, 11KN02614, 11KN02615, 11KN02616, 11KN02617, 11KN02618, 11KN02621, 11KN02624, 11KN02625, 11KN02626, 11KN02630, 11KN02631, 11KN02631, 11KN02632, 11KN02635, 11KN02636, 11KN02644, 11LZ27474, 11LZ27776;

b) Units: 11FJ11017, 11FJ11226, 11FJ11564, 11FJ11585, 11FJ11645, 11FJ11728, 11FJ11806, 11FL26137, 11FL26142, 11FL26144, 11FL26157, 11FL26162, 11FL26163, 11FL26165, 11FL26167, 11FL27690, 11FL27698, 11FL27700, 11FL27723, 11FL27724, 11FL27744, 11FL27748, 11FL27976, 11FL27977, 11FL27983, 11FL28000, 11FL28002, 11FL28151, 11FL28184, 11FL28207, 11FL28317, 11FL28803, 11FL28806, 11FL28814, 11FL28816, 11FL28818, 11FL28819, 11FL29279, 11FL29283, 11FL29304, 11FL29306, 11FL29308, 11FL29314, 11FL29341, 11FL29343, 11FL29345, 11FL29347, 11FM94663, 11FM94667, 11FM94674, 11FM95234, 11FM95237, 11FM95239, 11FM95241, 11FM95255, 11FM95257, 11FM95262, 11FM95265, 11FM95268, 11FM95274, 11FM95277, 11FM95278, 11FM95283, 11FM95285, 11FM95660, 11FM95669, 11FM95674, 11FM95679, 11FM95691, 11FM95692, 11FM95693, 11FM95700, 11FM95716, 11FM95717, 11FM95722, 11FM96874, 11FM96881, 11FS31164, 11FS31166, 11FS31168, 11FS31177, 11FS31183, 11FS31187, 11FS31190, 11FS32082, 11FS32088, 11FS32108, 11FS32111, 11FS32117, 11FS32839, 11FS32842, 11FS32845, 11FS32846, 11FS32850, 11FS32852, 11FS32854, 11FS32855, 11FS33116, 11FS33122, 11FS33125, 11FS33125, 11FS33135, 11FS33136, 11FS33137, 11FS33139, 11FS33147, 11FS33148, 11FS33150, 11FS34292, 11FS34293, 11FS34297, 11FS34318, 11FS34496, 11FS34499, 11FS34501, 11FS34513, 11FT12844, 11FT12846, 11FT12848, 11FT12854, 11FT12856, 11FT12860, 11FT12962, 11FT12973, 11FT12974, 11FT12975, 11FT12978, 11FT12992, 11FT12993, 11FT13249, 11FT13254, 11FT13256, 11FT13257, 11FT13867, 11FT13868, 11FW21411, 11FY25531, 11FY25533, 11FY25535, 11FY25536, 11FY25538, 11FY25542, 11FY25546, 11FY25627, 11FY25628, 11FY25645, 11FY25647, 11FY25648, 11FY25904, 11FY25912, 11FY25915, 11FY25917, 11FY26236, 11FY26239, 11FY26269, 11FY26272, 11FY26273, 11FY26274, 11FY26283, 11FY26284, 11FY26285, 11FY26288, 11FY26290, 11FY26291, 11FY26292, 11FY26407, 11FY26408, 11FY26409, 11FY26410, 11FY26412, 11FY26808, 11FY26809, 11FY26818, 11FY27254, 11FY27260, 11FY27262, 11FY27714, 11FY27715, 11FZ60443, 11FZ61930, 11FZ61936, 11FZ62010, 11FZ62017, 11FZ62020, 11FZ62024, 11FZ62026, 11FZ62027, 11FZ62031, 11FZ62039, 11FZ62040, 11FZ62288, 11FZ62290, 11FZ62291, 11FZ62292, 11FZ62295, 11FZ62302, 11FZ62303, 11GG34123, 11GG35097, 11GG35100, 11GG35106, 11GG35112, 11GG35113, 11GG35118, 11GG35120, 11GG35123, 11GG35200, 11GG35207, 11GG35430, 11GG35438, 11GG35440, 11GG35448, 11GG35462, 11GG35514, 11GG35516, 11GG35520, 11GG35525, 11GG35545, 11GG35800, 11GG35802, 11GG35803, 11GG35804, 11GG35807, 11GG35808, 11GG35810, 11GG35811, 11GG35812, 11GG35815, 11GG35816, 11GG35818, 11GG36783, 11GG37221, 11GG37222, 11GG37293, 11GG37301, 11GG37318, 11GG37335, 11GG37336, 11GG37340, 11GG37368, 11GG37369, 11GG37376, 11GG37389, 11GG37394, 11GG37397, 11GG37518, 11GG37531, 11GG37532, 11GG37582, 11GG37585, 11GG37586, 11GG37587, 11GG37593, 11GG37596, 11GH49974, 11GH49986, 11GH49989, 11GH49993, 11GH50014, 11GH50027, 11GH50035, 11GH50059, 11GH50189, 11GH50192, 11GH50193, 11GH50194, 11GH50195, 11GH50208, 11GH50211, 11GJ59992, 11GJ59996, 11GJ60000, 11GJ61857, 11GJ61894, 11GJ61898, 11GJ61902, 11GJ61908, 11GJ61913, 11GJ61929, 11GJ61930, 11GJ61935, 11GJ61940, 11GJ61945, 11GJ61952, 11GJ63374, 11GJ63378, 11GK76103, 11GK76118, 11GK76120, 11GK76122, 11GK77201, 11GK77203, 11GK77213, 11GK77216, 11GK77460, 11GK77461, 11GK77463, 11GK77464, 11GK77490, 11GK77495, 11GK77498, 11GK77499, 11GK77515, 11GK77548, 11GK77556, 11GK77560, 11GK78807, 11GK78809, 11GK78810, 11GK78842, 11GK78859, 11GK79502, 11GK79503, 11GK79504, 11GK79517, 11GK79519, 11GK79520, 11GK79523, 11GK79525, 11GK79526, 11GM82454, 11GM82456, 11GN74564, 11GN74571, 11GN74600, 11GN74603, 11GN74608, 11GN74611, 11GN74621, 11GN74623, 11GN74637, 11GN74658, 11GN74681, 11GN74701, 11GN74795, 11GN74813, 11GN74819, 11GN75296, 11GN75305, 11GN75308, 11GN75327, 11GN75329, 11GN75333, 11GN75344, 11GN77517, 11GN77518, 11GN77594, 11GN77595, 11GN77599, 11GN77600, 11GN77618, 11GN77624, 11GN77625, 11GN77817, 11GN77818, 11GN77827, 11GN77830, 11GN77897, 11GN77907, 11GN77908, 11GN77919, 11GN77923, 11GN77924, 11GN77932, 11GN77934, 11GN77944, 11GN77948, 11GN77958, 11GN77959, 11GN77961, 11GN77966, 11GN77968, 11GN77974, 11GN77976, 11GN78730, 11GN78732, 11GN78735, 11GN78737, 11GN78743, 11GN78745, 11GN78757, 11GN78762, 11GN78763, 11GN78764, 11GN78766, 11GQ 66781, 11GQ65398, 11GQ65399, 11GQ65408, 11GQ65410, 11GQ65417, 11GQ65432, 11GQ65439, 11GQ65441, 11GQ65451, 11GQ65457, 11GQ65462, 11GQ66646, 11GQ66654, 11GQ66746, 11GQ66774, 11GQ66776, 11GQ66787, 11GQ67220, 11GQ67222, 11GQ67418, 11GQ67419, 11GQ67423, 11GQ67424, 11GQ67437, 11GQ67438, 11GQ67439, 11GQ67440, 11GQ67450, 11GQ67451, 11GQ67834, 11GQ67836, 11GQ67843, 11GQ67846, 11GQ67871, 11GQ67872, 11GQ67873, 11GQ67876, 11GQ67877, 11GQ68503, 11GQ68509, 11GQ68511, 11GQ68518, 11GQ68519, 11GQ68522, 11GQ68755, 11GQ68764, 11GQ68766, 11GQ69137, 11GQ69138, 11GQ69165, 11GQ69167, 11GQ69168, 11GQ69556, 11GQ69557, 11GQ69560, 11GQ69562, 11GQ69579, 11GQ69581, 11GQ69586, 11GQ69608, 11GQ69610, 11GQ69612, 11GQ69615, 11GQ69618, 11GQ69621, 11GQ69642, 11GQ69648, 11GQ69650, 11GQ69654, 11GQ69656, 11GQ69663, 11GQ69665, 11GQ69668, 11GQ69988, 11GQ69993, 11GQ69996, 11GQ69998, 11GQ70002, 11GQ70003, 11GQ70029, 11GQ70033, 11GQ70036, 11GQ70042, 11GQ70045, 11GQ70046, 11GQ70049, 11GQ70052, 11GQ70457, 11GQ70469, 11GQ70509, 11GQ70512, 11GQ70541, 11GQ70544, 11GQ70545, 11GQ70594, 11GQ70596, 11GQ70597, 11GQ70603, 11GQ70604, 11GQ70609, 11GQ70615, 11GQ70616, 11GQ70618, 11GQ70681, 11GQ70682, 11GQ70687, 11GQ70713, 11GQ70714, 11GR58502, 11GR58687, 11GR58710, 11GR58766, 11GR58770, 11GR58780, 11GR58781, 11GR59131, 11GR59132, 11GR59145, 11GR59150, 11GR59162, 11GR59470, 11GR59471, 11GR59477, 11GR60655, 11GR60699, 11GR60713, 11GR60846, 11GR60848, 11GR60853, 11GR60863, 11GR60866, 11GR60982, 11GR60984, 11GR60988, 11GR61008, 11GR61014, 11GR61018, 11GR61022, 11GR61027, 11GR61032, 11GR61035, 11GR61037, 11GR61039, 11GR61041, 11GR61045, 11GR61053, 11GR61299, 11GR61300, 11GR61301, 11GR61308, 11GR61310, 11GR61311, 11GR61314, 11GR61316, 11GR61610, 11GR61615, 11GR61617, 11GR61620, 11GR61624, 11GR61626, 11GR61634, 11GR62438, 11GR62471, 11GR62476, 11GR62477, 11GR62506, 11GR62508, 11GR62527, 11GR62568, 11GR62570, 11GR62572, 11GR62573, 11GR62593, 11GR62598, 11GR62599, 11GR62605, 11GR62606, 11GR62613, 11GR62647, 11GR64558, 11GR64594, 11GR64610, 11GR64614, 11GR64636, 11GS80246, 11GS80267, 11GS80268, 11GS80269, 11GS80274, 11GS80281, 11GS80294, 11GS80420, 11GS80422, 11GS80425, 11GS80900, 11GS80902, 11GS80905, 11GS80909, 11GS80909, 11GS80910, 11GS80916, 11GS80917, 11GS80918, 11GS80919, 11GS80948, 11GS81057, 11GS81063, 11GS81066, 11GS81074, 11GS81075, 11GS81078, 11GS82454, 11GS82461, 11GS82463, 11GS82467, 11GS82470, 11GS82749, 11GV63599, 11GV63602, 11GV63603, 11GV63608, 11GV63632, 11GV63635, 11GY35620, 11GY35622, 11GY35625, 11GY35633, 11GY35663, 11GY35668, 11GY35669, 11GY35670, 11GY35673, 11GY35676, 11GY36769, 11GY36778, 11GY36779, 11GY36782, 11GY36783, 11KF16416, 11KF16428, 11KF16430, 11KF16432, 11KL06699, 11KL06900, 11KL07387, 11KL07428, 11KN02611, 11KN02640, 11KN02643, 11KN03210, 11KN03211, 11KN03225, 11KN03228, 11KN03230, 11KN03231, 11KN03233, 11KN03248, 11KX06143, 11KX06206, 11KX06263, 11KX06281, 11KX06331, 11KX06761, 11LE20024, 11LE20026, 11LE20027, 11LE20034, 11LE20036, 11LZ27845, 11LZ27860;

c) Units: 11FM95698, 11FM95723, 11FT13248, 11FY26268, 11GG37365, 11GG37370, 11GQ67214, 11GQ69584, 11GQ70462, 11GQ70471, 11GS82465;

d) Units: 11GQ65428, 11GQ65436;

e) Unit: 11GR62459;

f) Units: 11FM95674, 11FM95677, 11FM96881, 11FY25535, 11FY25536, 11FY25541, 11FZ61936, 11GG35097, 11GG35100, 11GG35112, 11GG35113, 11GJ59992, 11GJ59996, 11GM82456, 11GN74637, 11GN74658, 11GN74681, 11GN78743, 11GN78757, 11GN78763, 11GQ65399, 11GQ65408, 11GQ65432, 11GQ65436, 11GQ65439, 11GQ67423, 11GQ68503, 11GQ68509, 11GQ68511, 11GQ68518, 11GQ68519, 11GQ68522, 11GQ69137, 11GQ69138, 11GQ69167, 11GQ69168, 11GQ69608, 11GQ69612, 11GQ69615, 11GQ69621, 11GQ69642, 11GQ69650, 11GQ69654, 11GQ69656, 11GQ70512, 11GQ70535, 11GQ70541, 11GQ70544, 11GR62438, 11GR62459, 11GR62471, 11GR62476, 11GR62477, 11GR62477, 11GR62506, 11GR62527, 11GS80422, 11GS80425;

g) Units: 11FH03559, 11FH03561, 11FH03565, 11FH03572, 11FH03575, 11FH03579, 11FL27976, 11FL27978, 11FL27979, 11FL27982, 11FL28814, 11FL28818, 11FL29304, 11FL29306, 11FL29308, 11FL29314, 11FL29341, 11FL29343, 11FL29345, 11FM93213, 11FM93218, 11FM93221, 11FM95674, 11FM95677, 11FM96874, 11FM96881, 11FS33117, 11FS33122, 11FS33125, 11FS33135, 11FS33136, 11FS33137, 11FS33139, 11FS33147, 11FS33148, 11FS33150, 11FS34293, 11FS34297, 11FS34318, 11FS34499, 11FT12856, 11FT12860, 11FT13414, 11FT13699, 11FT13700, 11FT13701, 11FW21411, 11FW21416, 11FW21418, 11FW21428, 11FW21429, 11FY25546, 11FZ61936, 11FZ62020, 11FZ62566, 11FZ62567, 11FZ62575, 11FZ62577, 11GG34112, 11GG34116, 11GG34117, 11GG37293, 11GG37301, 11GG37365, 11GG37369, 11GG37370, 11GG37394, 11GG37397, 11GJ59992, 11GJ59996, 11GJ60000, 11GK76440, 11GK76442, 11GK76443, 11GK76444, 11GK76455, 11GK76460, 11GK76469, 11GK77203, 11GK77213, 11GK77216, 11GK78807, 11GK78809, 11GK78810, 11GK78842, 11GK78859, 11GK79517, 11GK79519, 11GK79520, 11GK79521, 11GK79525, 11GK79526, 11GK80791, 11GK80795, 11GM82454, 11GM82456, 11GN74637, 11GN74658, 11GN74681, 11GN74795, 11GN74819, 11GN77822, 11GN77824, 11GN77827, 11GN77830, 11GN78735, 11GN78766, 11GQ65398, 11GQ65399, 11GQ65410, 11GQ65417, 11GQ65432, 11GQ65436, 11GQ65441, 11GQ65457, 11GQ67437, 11GQ67438, 11GQ67439, 11GQ67871, 11GQ67872, 11GQ67873, 11GQ68509, 11GQ68511, 11GQ68518, 11GQ68755, 11GQ68764, 11GQ68766, 11GQ68769, 11GQ68775, 11GQ68776, 11GQ69642, 11GQ69648, 11GQ69663, 11GQ69665, 11GQ69668, 11GQ70049, 11GQ70456, 11GQ70457, 11GQ70462, 11GQ70464, 11GQ70465, 11GQ70469, 11GQ70471, 11GQ70588, 11GQ70596, 11GQ70597, 11GQ70603, 11GQ70604, 11GQ70609, 11GQ70610, 11GQ70616, 11GR58502, 11GR58770, 11GR58780, 11GR58781, 11GR58794, 11GR59976, 11GR59977, 11GR59979, 11GR59995, 11GR59998, 11GR59999, 11GR60832, 11GR60834, 11GR60835, 11GR60836, 11GR60863, 11GR60982, 11GR60984, 11GR61009, 11GR61615, 11GR61617, 11GR61620, 11GR61621, 11GR61626, 11GR61634, 11GR62459, 11GR62471, 11GR62476, 11GR62477, 11GR62506, 11GR62508, 11GR62527, 11GR62598, 11GR62599, 11GR62606, 11GR62613, 11GR62647, 11GS80246, 11GS80267, 11GS80268, 11GS80420, 11GS80422, 11GS80425, 11GS82749, 11GY35633, 11GY36773, 11KF15681, 11KF15683, 11KF16430, 11KN03211, 11KN03225, 11KN03228, 11KN03231;

h) Units: 11FL26181, 11FM95660, 11FM95691, 11FM95692, 11FM95698, 11FY25531, 11FY25533, 11FY25535, 11FY25538, 11FY25541, 11FY25542, 11FZ62031, 11GG35097, 11GG35106, 11GG35113, 11GG35120, 11GG35123, 11GG35517, 11GG37352, 11GJ61894, 11GK79503, 11GN74701, 11GN78745, 11GN78762, 11GQ67419, 11GQ67423, 11GQ69138, 11GQ69168, 11GQ69610, 11GQ69612, 11GQ69615, 11GQ69618, 11GQ69621, 11GQ69656, 11GQ70509, 11GQ70544, 11GR60821, 11GR60823, 11GR60825, 11GR60828, 11GR64556, 11KN02640, 11KN02643, 11KN02644

i) Units: 11FL26137, 11FL26144, 11FL26157, 11FL28184, 11FM95239, 11FM95257, 11FM95278, 11FM95285, 11FM95716, 11FM95722, 11FS32839, 11FS32840,
11FS32842, 11FS32845, 11FS32850, 11FS32855, 11FT13867, 11FY26269, 11GG35804, 11GG36783, 11GG37593, 11GK76103, 11GK76105, 11GK76118, 11GK76120, 11GK76122, 11GN77517, 11GN77518, 11GP16284, 11GQ69581, 11GQ70003, 11GQ70029, 11GR59145, 11GR59459, 11GR61299, 11GR61311, 11GS80281, 11GS80294, 11GS80900, 11GS80902, 11GS80905, 11GS80909, 11GS80910, 11GS80919, 11GS81078, 11GY35608, 11GY35620, 11GY35622, 11GY35668, 11GY35673, 11KN02624, 11KN02626, 11KN02630;

j) Units: 11FL26137, 11FL26144, 11FL26157, 11FL26162, 11FL26163, 11FL26167, 11FL28184, 11FL28207, 11FL28317, 11FM94667, 11FM94674, 11FM95234, 11FM95239, 11FM95257, 11FM95262, 11FM95265, 11FM95268, 11FM95277, 11FM95278, 11FM95285, 11FM95717, 11FM95722, 11FM95723, 11FM95734, 11FS31164, 11FS31166, 11FS31168, 11FS31177, 11FS31183, 11FS31187, 11FS32082, 11FS32088, 11FS32111, 11FS32117, 11FS32840, 11FS32842, 11FS32845, 11FS32854, 11FS32855, 11FT13248, 11FT13249, 11FT13254, 11FT13256, 11FT13257, 11FY25627, 11FY25628, 11FY25645, 11FY25648, 11FY26239, 11FY26269, 11FY26270, 11FY26272, 11FY26273, 11FY26274, 11FY26283, 11FY26284, 11FY26285, 11FY26288, 11FY26407, 11FY26408, 11FY26409, 11FY26410, 11FY26412, 11FY26808, 11FY26809, 11FY26818, 11FY27260, 11FY27261, 11FY27262, 11FZ62039, 11GG35200, 11GG35203, 11GG35207, 11GG35800, 11GG35802, 11GG35803, 11GG35804, 11GG35807, 11GG35808, 11GG35810, 11GG35811, 11GG35812, 11GG35815, 11GG35816, 11GG35818, 11GG36783, 11GG37518, 11GG37531, 11GG37532, 11GG37582, 11GG37585, 11GG37593, 11GG37596, 11GJ61929, 11GJ61935, 11GJ61940, 11GJ61945, 11GK76103, 11GK76105, 11GK76118, 11GK76120, 11GK76122, 11GN74603, 11GN77517, 11GN77518, 11GN77594, 11GN77599, 11GN77600, 11GN77618, 11GN77625, 11GN77626, 11GP16284, 11GQ67220, 11GQ67222, 11GQ69556, 11GQ69557, 11GQ69560, 11GQ69562, 11GQ69581, 11GQ69988, 11GQ69993, 11GQ70002, 11GQ70029, 11GQ70042, 11GQ70046, 11GQ70052, 11GQ70713, 11GR59145, 11GR59150, 11GR59162, 11GR59456, 11GR59459, 11GR59470, 11GR59478, 11GR61299, 11GR61300, 11GR61308, 11GR61311, 11GR61316, 11GS80281, 11GS80294, 11GS80900, 11GS80902, 11GS80905, 11GS80916, 11GS80917, 11GS80918, 11GS80919, 11GS81063, 11GS81064, 11GS81074, 11GS81075, 11GS81078, 11GS82454, 11GS82463, 11GS82467, 11GS82469, 11GY35605, 11GY35620, 11GY35622, 11GY35668, 11GY35673, 11GY35676, 11KN02611, 11KN02614, 11KN02615, 11KN02616, 11KN02617, 11KN02621, 11KN02625, 11KN02632, 11KN02635
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Missouri-Illinois Region, St. Louis, MO, by telephone on or about February 3, 2005, and letters dated on or about February 18, 2005. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may compromise the sterility of the products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1,340 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Platelets, Recall # B-1501-6
CODE
Units: T21647, T21648, T21649, T21652, T21655, T21656, T21657, T21707, T21713, T21715, T56914, T56915, T56919, T56921, T56923, T56928, T56930, T56937, T72558, T72560, T72562, T72567, T72570, T72574
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Traverse City, MI, by fax and telephone on February 13, 2006. Firm initiated recall is complete.
REASON
Blood products, with QC results below the firm’s acceptable standard for platelet yield, were distributed.
VOLUME OF PRODUCT IN COMMERCE
24 units
DISTRIBUTION
MI

______________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1509-6
CODE
Units: 003G34864, 003KF22885 (split product), 003KF22896 (slit product)
003KF22897
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southern Region, Atlanta, GA, by telephone on December 22, 2005 and January 6, 2006 and follow-up letters on January 9, 2006 and February 28, 2006. Firm initiated recall is complete.
REASON
Blood products, which did not meet the monthly quality control testing requirements, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
GA

______________________________
PRODUCT
Human Cornea for Transplantation, Recall # B-1706-6
CODE
2005-10-2124
RECALLING FIRM/MANUFACTURER
Lions Eye Bank of Nebraska, Inc., Omaha, NE, by telephone on February 28, 2006, and by letter dated March 8, 2006. Firm initiated recall is complete.
REASON
Human tissue, incorrectly tested for HCV, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 tissue
DISTRIBUTION
KS

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1707-6
CODE
Units: 53FY23896 (parts 1 and 2)
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake and Potomac Regions, Baltimore, MD, by telephone on June 2, 2005 and by letter dated June 7, 2005. Firm initiated recall is complete.
REASON
Platelets, inappropriately prepared by splitting the product into two storage bags instead of one, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MD

______________________________
PRODUCT
Source Plasma, Recall # B-1722-6
CODE
Unit: NG0070429
RECALLING FIRM/MANUFACTURER
DCI Biologicals Nacogdoches, LLC, Nacogdoches, TX, by telephone and facsimile on September 3, 2003. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor who had sexual contact with an individual who tested positive for human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1732-6
CODE
Unit: 9006657
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile transmission dated January 7, 2005. Firm initiated recall is complete.
REASON
Platelets, were distributed in one bag instead of two.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

______________________________
PRODUCT
Human Corneal Tissue, Recall # B-1733-6
CODE
06-0541 OS
RECALLING FIRM/MANUFACTURER
Northwest Lions Eye Bank, Seattle, WA, by letter dated May 22,2006, e-mail dated May 23, 2006, and facsimile transmission dated June 14, 2006. Firm initiated recall is complete.
REASON
Human tissue for transplantation, that subsequent to distribution tested reactive for HCV by PCR testing.
VOLUME OF PRODUCT IN COMMERCE
1 tissue
DISTRIBUTION
Saudi Arabia

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1734-6
CODE
Unit: 9023166
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile transmission dated June 22, 2005. Firm initiated recall is complete.
REASON
Red Cells, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1735-6;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-1736-6;
c) Platelets Pheresis, Leukocytes Reduced,
Recall # B-1737-6;
d) Platelets Pheresis, Leukocytes Reduced,
Irradiated, Recall # B-1738-6
CODE
a) Unit: 6597839;
b) Units: 9023987, 9021530;
c) and d) Unit: 9026921
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile transmission dated June 27, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
AL, CO, and UT

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1739-6
CODE
Unit: 6707920
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile transmission dated June 30, 2005. Firm initiated recall is complete.
REASON
Red Cells, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1740-6
CODE
Unit: 9025673
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile transmission dated July 27, 2005. Firm initiated recall is complete.
REASON
Red Cells, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1741-6
CODE
Units: 6904019, 6902224, 6898834, 6896359
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile transmission dated August 15, 2005. Firm initiated recall is complete.
REASON
Red Cells, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CO and FL

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1742-6;
b) Recovered Plasma, Recall # B-1743-6
CODE
a) and b) Unit: 2530363
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by facsimile transmission dated October 27, 2004. Firm initiated recall is complete.
REASON
Red Cells, collected from a donor who was at increased risk for variant Creutzfeldt - Jakob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX and Switzerland

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1744-6
CODE
Units: 4728786, 4728787, 4728788
RECALLING FIRM/MANUFACTURER
W. E. & Lela I. Stewart Blood Center, Inc., Tyler, TX, by telephone on April 14, 2004, and by letter dated April 19, 2004. Firm initiated recall is complete.
REASON
Blood products, mislabeled as leukoreduced, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1759-6
CODE
Units: 4756576
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile transmission dated April 30, 2005. Firm initiated recall is complete.
REASON
Platelets, with a low platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX

______________________________
PRODUCT
Red Blood Cells, Recall # B-1771-6
CODE
Unit: C39150
RECALLING FIRM/MANUFACTURER
HCSC-Blood Center, Bethlehem, PA, by telephone on May 24, 2006 and follow-up letter on June 23, 2006. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may have compromised its sterility, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1774-6
CODE
Unit: 4724065
RECALLING FIRM/MANUFACTURER
W. E. & Lela I. Stewart Blood Center, Inc., Tyler, TX, by telephone on January 15, 2004. Firm initiated recall is complete.
REASON
Blood product, with an elevated ALT, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1775-6
CODE
Unit: 6725909
RECALLING FIRM/MANUFACTURER
W. E. & Lela I. Stewart Blood Center, Inc., Tyler, TX, by telephone on March 24, 2004. Firm initiated recall is complete.
REASON
Blood product, with an elevated ALT, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

______________________________
PRODUCT
Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-1805-6
CODE
Units: 003FK48138, 003FK48196, 003FK48197 (2 units), 003FK48204, 003FK48215, 003FK48219, 003FK48220, 003FK48222 (2 units)
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern Region, Atlanta, GA, by telephone on February 13, 2006 and by letter dated February 14, 2006. Firm initiated recall is complete.
REASON
Blood products, collected using automated equipment that was not validated for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
GA and SC

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1834-6;
b) Platelets, Recall # B-1835-6;
c) Recovered Plasma, Recall # B-1836-6
CODE
a), b), and c) Unit: GV63542
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on December 28, 2004 or December 29, 2004. Firm initiated recall is ongoing.
REASON
Blood products, which tested negative for hepatitis, but were collected from a donor who was subsequently determined to have been deferred for testing positive for Hepatitis C, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
PA and RI

______________________________
PRODUCT
Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-1837-6
CODE
Units: 2112098 2109877 2109873 2108729 2108720 2106714 2108708 2108703 2109924 2112683 2109815 2109870 2109876 2112244 2112248 2108738 2108693 2108699 2109914 2108722 2108716 2108721 2108715 2110132 2108692 2108726 2108707 2108702 2108736 2108725 2108727 2108741 2108681 2108712 2108710 2108717 2109912 2109868 2108732 2108719
RECALLING FIRM/MANUFACTURER
Bergen Community Regional Blood Center, Paramus, NJ, by letter dated January 14, 2005. Firm initiated recall is complete.
REASON
Blood products, mislabeled as leukocyte reduced, were distributed.
VOLUME OF PRODUCT IN COMMERCE
40 units
DISTRIBUTION
NY and NJ

______________________________
PRODUCT
Source Plasma, Recall # B-1841-6
CODE
Units: BR016851, BR016703, BR016557, BR016394, 91600851, 91155412, 92927285, 92922617, 92809833, 92805521, 92801639, 92687349, 92684928, 92569874, 92567368, 92563698, 92498938, 92496242, 93969624, 93966504, 93961684, 93949163, 93944540, 93941693, 93986359, 93983853, 91486462, 91482433, 91278272, 91271358, 91187871, 91184436, 91152336, 90755941, 90752582, 91036896, 91034090, 90827563, 91130112, 91127877, 91121950, 90689093, 90682346, 90330421, 90321535, 78248311, 77868565, 77860637, 77857620, 77852410, 76958588, 76952999, 76860072, 76853388, 76717932, 76713569, 76668388, 76660870, 76535987, 76530531, 78925410, 78920682, 76456473, 76451270, 77617705, 78882485, 78877368, 77493378, 76337741, 76330834, 76304873, 76209420, 76203336, 76200625
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Birmingham, AL, by facsimile on December 8, 2003. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from an ineligible donor due to a history of testing positive for hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE
74 units
DISTRIBUTION
CA and KY

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

______________________________
PRODUCT
Fresh Frozen Plasma Pheresis, Recall # B-1448-6
CODE
Unit: 5624923
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on October 19, 2005. Firm initiated recall is complete.
REASON
Blood product, which lacked assurance of proper shipping temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

______________________________
PRODUCT
Source Plasma, Recall # B-1508-6
CODE
Units: TA0008694, TA0008837
RECALLING FIRM/MANUFACTURER
DCI Biologicals L.L.C, Texarkana, AR, by fax on January 17, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of idiopathic thrombocytopenia purpura (ITP), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria

______________________________
PRODUCT
Fresh Frozen Plasma Pheresis, Recall # B-1724-6
CODE
Unit: 027GE19597
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by telephone on December 13, 2005 and by letter dated December 22, 2005. Firm initiated recall is complete.
REASON
Blood product, collected using automated equipment that was not validated for use, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WV

______________________________
PRODUCT
Red Blood Cells, Recall # B-1797-6
CODE
Unit: 1471750
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, Inc, New York, NY, by telephone on May 7, 2001.
Manufacturer: New York Blood Center, Inc, Westbury, NY. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly labeled as being negative for unexpected antibodies, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY

______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1800-6
CODE
Unit: 5717497
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on January 18, 2006. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined after receiving information regarding a post-donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

______________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B-1806-6;
b) Fresh Frozen Plasma Pheresis, Recall # B-1807-6;
c) Cryoprecipitated AHF, Recall # BB-1808-6;
d) Recovered Plasma, Recall # B-1809-6
CODE
a) Units: 923632, 923636, 923672, 923692, 952708, 952711, 952712, 955440, 955454, 955471, 955546, 955548, 971266, 971290, 971342, 986073, 986083, 986193, 988385, 2103276, 2103624, 2103630, 2103635, 2103637, 2103638, 2103709, 2103785, 2103794, 2104107, 2104456, 2104560, 2105354, 2105362, 2105379, 2105387, 2105398, 2105399, 2105400, 2105758, 2105989, 2106378, 2106389, 2106748, 2106756, 2106764, 2106776, 2106780, 2106792, 2106820, 2106961, 2106969, 2107250, 2107253, 2107256, 2107257, 2107258, 2107287, 2107297, 2107305, 2107318, 2107329, 2107358, 2107376, 2107797, 2107816, 2107822, 2107830, 2107843, 2107849, 2107860, 2107861, 2107863, 2107865, 2107874, 2107876, 2107880, 2107881, 2107883, 2107892, 2107914, 2107922, 2107931, 2107945, 2107991, 2108000, 2108204, 2108210, 2108213, 2108227, 2108228, 2108229, 2108234, 2108236, 2108244, 2108247, 2108250, 2108287, 2108288, 2108298, 2108299, 2108304, 2108308, 2108311, 2108319, 2108325, 2108326, 2108339, 2108351, 2108355, 2108357, 2108361, 2108371, 2108376, 2108389, 2108395, 2108396, 2108658, 2108693, 2108699, 2108710, 2108716, 2108722, 2108744, 2108745, 2108747, 2108758, 2108774, 2108775, 2108778, 2108780, 2108814, 2108817, 2108821, 2108834, 2108862, 2108868, 2108873, 2108880, 2108881, 2108886, 2108892, 2108899, 2108903, 2108906, 2108926, 2108938, 2108942, 2108952, 2108953, 2108958, 2109118, 2109211, 2109221, 2109228, 2109231, 2109239, 2109261, 2109267, 2109270, 2109277, 2109297, 2109316, 2109321, 2109322, 2109347, 2109356, 2109363, 2109385, 2109387, 2109391, 2109808, 2109809, 2109811, 2109829, 2109833, 2109834, 2109842, 2109847, 2109851, 2109858, 2109861, 2109862, 2109865, 2109870, 2109872, 2109881, 2109883, 2109886, 2109890, 2109905, 2109970, 2110001, 2110004, 2110008, 2110018, 2110032, 2110044, 2110052, 2110059, 2110062, 2110119, 2110157, 2110183, 2110212, 2110264, 2110265, 2110273, 2110290, 2110331, 2110381, 2110384, 2110410, 2110427, 2110437, 2110450, 2110575, 2110762, 2110819, 2110826, 2110829, 2110830, 2110837, 2110918, 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2113209, 2113219, 2113226, 2113227, 2113232, 2113241, 2113243, 2113254, 2113401, 2113435, 2113437, 2113448, 2113495, 2114004, 2114023, 2114040, 2114078, 2114127, 2114138, 2114145, 2114197, 2114221, 2114252, 2114309, 2114378, 2114386, 2114421, 2114435, 2114566, 2114741, 2114760, 2114787, 2114794, 2114836, 2114849, 2114851, 2114855, 2114882, 2114927, 2115204, 2115210, 2115495, 2115498, 2115499, 2115502, 2115505, 2115520, 2115528, 2115534, 2115536, 2115552, 2115554, 2116009, 2116022, 2116032, 2116045, 2116048, 2116050, 2116054, 2116059, 2116062, 2116067, 2116073, 2116075, 2116076, 2116098, 2116103, 2116125, 2116127, 2116130, 2116140, 2116141, 2116146, 2116162, 2116165, 2116172, 2116191, 2116227, 2116355, 2116403, 2116575, 2116625, 2116747, 2116751, 2116752, 2116781, 2116785, 2116840, 2117009, 2117072, 2117330, 2117331, 2117349, 2117361, 2117362, 2117366, 2117368, 2117369, 2117374, 2117383, 2117384, 2117385, 2117387, 2117391, 2117400, 2117443, 2117517, 2117534, 2117574, 2117595, 2117600, 2117604, 2117655, 2117659, 2117739, 2117799, 2117827, 2117893, 2117946, 2117955, 2117984, 2118019, 2118211, 2118332, 2118353, 2118544, 2118585, 2118591, 2118756, 2118904, 2119393, 2119394, 2119464, 2119959, 2120032, 2120050, 2120170, 2120209, 2120217, 2120219, 2120220, 2120225, 2120227, 2120229, 2120235, 2120237, 2120244, 2120248, 2120249, 2120281, 2120286, 2120296, 2120312, 2120313, 2120339, 2120348, 2120379, 2120380, 2120381, 2120387, 2120388, 2120390, 2120391, 2120396, 2120545, 2120547, 2120591, 2120595, 2120596, 2120639, 2120893, 2120905, 2121126, 2121218, 2121224, 2121229, 2121234, 2121240, 2121249, 2121251, 2121253, 2121257, 2121270, 2121276, 2121285, 2121288, 2121290, 2121300, 2121309, 2121321, 2121500, 2121509, 2121532, 2121558, 2121561, 2121587, 2121597, 2121610, 2121632, 2121652, 2121659, 2121663, 2121664, 2121672, 2121680, 2121693, 2121697, 2121698, 2121702, 2121723, 2121731, 2121732, 2121734, 2121741, 2121746, 2121755, 2121761, 2121772, 2121778, 2121787, 2121795, 2121800, 2121820, 2121839, 2121846, 2121855, 2121856, 2121868, 2121875, 2121878, 2121880, 2121881, 2121883, 2121899, 2121908, 2121915, 2121916, 2121919, 2121927, 2121931, 2121936, 2121946, 2121956, 2121958, 2121962, 2121963, 2121982, 2121985, 2121986, 2122052, 2122056, 2122064, 2122066, 2122069, 2122079, 2122090, 2122122, 2122125, 2122146, 2122168, 2122171, 2122181, 2122202, 2122207, 2122217, 2122251, 2122322, 2122339, 2122347, 2122410, 2122419, 2122421, 2122428, 2122435, 2122441, 2122459, 2122466, 2122474, 2122479, 2122486, 2122487, 2122501, 2122504, 2122511, 2122516, 2122519, 2122521, 2122523, 2122524, 2122526, 2122531, 2122534, 2122535, 2122538, 2122541, 2122548, 2122553, 2122554, 2122556, 2122562, 2122563, 2122565, 2122569, 2122577, 2122583, 2122589, 2122598, 2122601, 2122690, 2122726, 2122736, 2122747, 2122748, 2122749, 2122759, 2122760, 2122761, 2122763, 2122764, 2122768, 2122774, 2122775, 2122780, 2122800, 2122811, 2122816, 2122818, 2122832, 2122839, 2122844, 2122845, 2122877, 2122880, 2122886, 2122888, 2122896, 2122897, 2122899, 2122901, 2122904, 2122908, 2122909, 2122910, 2122924, 2122947, 2122951, 2122955, 2122961, 2122973, 2122975, 2122977, 2122984, 2122994, 2122998, 2123169, 2123174, 2123188, 2123326, 2123338, 2123349, 2123398, 2123399, 2123402, 2123403, 2123410, 2123412, 2123427, 2123428, 2123437, 2123438, 2123441, 2123449, 2123450, 2123476, 2123487, 2123511, 2123524, 2123547, 2123577, 2123582, 2123585, 2123596, 2123598, 2123601, 2123602, 2123613, 2123628, 2123643, 2123656, 2123658, 2123664, 2123675, 2123683, 2123691, 2123708, 2123710, 2123750, 2123756, 2123765, 2123771, 2123788, 2123790, 2123792, 2123798, 2123800, 2123818, 2123838, 2123853, 2123871, 2123875, 2123891, 2123915, 2123925, 2123966, 2123967, 2123969, 2124043, 2124202, 2124213, 2124214, 2124216, 2124221, 2124227, 2124229, 2124235, 2124280, 2124298, 2124305, 2124311, 2124312, 2124322, 2124324, 2124325, 2124326, 2124328, 2124329, 2124330, 2124340, 2124347, 2124351, 2124356, 2124359, 2124364, 2124367, 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2125731, 2125765, 2125771, 2125778, 2125797, 2125798, 2125801, 2125822, 2125836, 2125837, 2125842, 2125849, 2125851, 2125856, 2125858, 2125862, 2125866, 2125867, 2125871, 2125896, 2125903, 2125904, 2125909, 2125912, 2125915, 2125916, 2125921, 2125931, 2125932, 2125936, 2125951, 2125952, 2125953, 2125958, 2125961, 2125967, 2125978, 2125983, 2125985, 2126010, 2126029, 2126040, 2126050, 2126053, 2126057, 2126079, 2126087, 2126095, 2126097, 2126131, 2126134, 2126138, 2126184, 2126208, 2126211, 2126227, 2126242, 2126246, 2126287, 2126299, 2126303, 2126306, 2126307, 2126308, 2126310, 2126312, 2126320, 2126330, 2126333, 2126334, 2126336, 2126343, 2126344, 2126349, 2126351, 2126353, 2126354, 2126357, 2126360, 2126362, 2126363, 2126365, 2126370, 2126373, 2126380, 2126384, 2126385, 2126386, 2126390, 2126392, 2126393, 2126603, 2126617, 2126620, 2126632, 2126633, 2126635, 2126639, 2126648, 2126666, 2126671, 2127017, 2127020, 2127022, 2127030, 2127038, 2127040, 2127042, 2127049, 2127053, 2127054, 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b) Units: 2103212, 2103239, 2103249, 2103256, 2103258, 2103286, 2103290, 2103336, 2103612, 2103621, 2103646, 2103659, 2104545, 2104564, 2122965, 0952714, 2103770, 2103789, 2101088, 2102048, 2102239, 2103217, 2103228, 2104544;

c) Units: 988336, 2109089, 2109559, 2118216, 2118697, 2118698, 2118776, 2120749, 2124246, 2124251, 2124268, 2124275, 2125603, 2125604, 2125606, 2125623, 2125627, 2125629, 2125636, 2127411, 4896912, 4947858, 5511066, 5511322, 5512133, 5512158, 5512225, 5512478, 5513256, 5513261, 5514218, 5514831, 5514855, 5514860, 5514862, 5518095, 5518127, 5528500, 5530047, 5531245, 5531782, 5531794, 5554727, 5555780, 5557831, 5557855, 5562618, 5566982, 5568771, 5568875, 5572840, 5574398, 5576628, 5593818, 5602704, 5602723, 5605421, 5621161, 5621229, 5621235, 5621907, 5623647, 5623653, 5624476;

d) Units: 955528, 955534, 955535, 955537, 955538, 955539, 955540, 955541, 955542, 955543, 955545, 955547, 988336, 988357, 993047, 993229, 2106812, 2107521, 2108803, 2108804, 2108807, 2108808, 2108809, 2108811, 2108813, 2108815, 2108820, 2108829, 2108830, 2108831, 2108842, 2108844, 2108846, 2108848, 2108849, 2108850, 2108853, 2108857, 2108858, 2108861, 2108863, 2108864, 2108866, 2108872, 2108876, 2108883, 2108885, 2108889, 2108894, 2108897, 2108900, 2108902, 2108904, 2108908, 2108915, 2108917, 2108918, 2108920, 2108921, 2108922, 2108924, 2108930, 2108931, 2108933, 2108934, 2108936, 2108939, 2108940, 2108941, 2108944, 2108948, 2108949, 2108954, 2108955, 2108956, 2108957, 2108959, 2108960, 2108961, 2109084, 2109089, 2109559, 2117569, 2117573, 2117576, 2117577, 2117579, 2117581, 2117587, 2117591, 2117594, 2117599, 2117731, 2118216, 2118217, 2118312, 2118315, 2118359, 2118572, 2118573, 2118574, 2118578, 2118579, 2118580, 2118582, 2118583, 2118587, 2118589, 2118590, 2118595, 2118596, 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2122483, 2122484, 2122489, 2122492, 2122494, 2122496, 2122498, 2122499, 2122503, 2122506, 2122508, 2122513, 2122522, 2122539, 2122543, 2122544, 2122546, 2122550, 2122555, 2122557, 2122560, 2122566, 2122567, 2122568, 2122572, 2122574, 2122575, 2122579, 2122581, 2122582, 2122584, 2122588, 2122590, 2122592, 2122593, 2122594, 2122600, 2122803, 2122804, 2122806, 2122808, 2122812, 2122813, 2122815, 2122822, 2122833, 2122835, 2122837, 2122838, 2122841, 2122842, 2122843, 2122848, 2122849, 2122850, 2122851, 2122852, 2122860, 2122861, 2122862, 2122863, 2122864, 2122865, 2122866, 2122867, 2122870, 2122872, 2122874, 2122875, 2122876, 2122878, 2122881, 2122882, 2122885, 2122891, 2122893, 2122895, 2122898, 2122900, 2122907, 2122912, 2122913, 2122921, 2122922, 2122923, 2122925, 2122931, 2122932, 2122934, 2122937, 2122938, 2122939, 2122940, 2122942, 2122943, 2122944, 2122945, 2122946, 2122948, 2122949, 2122953, 2122954, 2122956, 2122958, 2122959, 2122960, 2122962, 2122964, 2122966, 2122971, 2122974, 2122978, 2122979, 2122980, 2122981, 2122983, 2122987, 2122988, 2122991, 2122992, 2122995, 2122996, 2123179, 2123182, 2123183, 2123184, 2123186, 2123187, 2123189, 2123190, 2123191, 2123192, 2123194, 2123196, 2123197, 2123200, 2123360, 2123370, 2123371, 2123379, 2123380, 2123381, 2123383, 2123384, 2123385, 2123389, 2123390, 2123393, 2123394, 2123549, 2123595, 2123597, 2123599, 2123600, 2123603, 2123604, 2123605, 2123606, 2123607, 2123608, 2123609, 2123610, 2123611, 2123612, 2123614, 2123618, 2123619, 2123620, 2123621, 2123626, 2123630, 2123635, 2123636, 2123640, 2123645, 2123649, 2123650, 2123653, 2123662, 2123663, 2123665, 2123666, 2123673, 2123676, 2123677, 2123680, 2123682, 2123687, 2123688, 2123695, 2123697, 2123701, 2123702, 2123703, 2123707, 2123709, 2123711, 2123713, 2123715, 2123718, 2123723, 2123729, 2123731, 2123732, 2123733, 2123739, 2123740, 2123741, 2123744, 2123747, 2123749, 2123752, 2123754, 2123755, 2123766, 2123774, 2123777, 2123778, 2123779, 2123780, 2123784, 2123786, 2123787, 2123789, 2123799, 2123870, 2123929, 2123930, 2123932, 2123933, 2123937, 2123938, 2123942, 2123943, 2123944, 2123945, 2123946, 2123949, 2123950, 2123952, 2123953, 2123954, 2123965, 2123968, 2123971, 2123973, 2123975, 2123977, 2123979, 2123984, 2123985, 2123986, 2123987, 2123989, 2123991, 2123992, 2123993, 2123995, 2124203, 2124209, 2124211, 2124215, 2124217, 2124218, 2124220, 2124222, 2124224, 2124226, 2124228, 2124231, 2124232, 2124237, 2124239, 2124241, 2124246, 2124261, 2124268, 2124275, 2124282, 2124288, 2124289, 2124291, 2124293, 2124300, 2124303, 2124308, 2124310, 2124313, 2124315, 2124316, 2124317, 2124327, 2124331, 2124338, 2124349, 2124350, 2124355, 2124361, 2124365, 2124369, 2124371, 2124378, 2124381, 2124382, 2124383, 2124386, 2124390, 2124393, 2124394, 2124400, 2124601, 2124602, 2124603, 2124604, 2124606, 2124609, 2124611, 2124613, 2124616, 2124617, 2124619, 2124621, 2124623, 2124627, 2124628, 2124630, 2124631, 2124632, 2124634, 2124636, 2124639, 2124641, 2124643, 2124649, 2124801, 2124804, 2124805, 2124807, 2124809, 2124816, 2124818, 2124819, 2124820, 2124821, 2124822, 2124825, 2124827, 2124829, 2124830, 2124831, 2124832, 2124833, 2124835, 2124837, 2124839, 2124841, 2124842, 2124843, 2124844, 2124845, 2124846, 2124848, 2124849, 2124850, 2124852, 2124853, 2124855, 2124856, 2124859, 2124869, 2124872, 2124873, 2124874, 2124875, 2124878, 2124880, 2124882, 2124884, 2124886, 2124887, 2124888, 2124889, 2124892, 2124893, 2124896, 2124897, 2124898, 2124899, 2124900, 2124901, 2124903, 2124905, 2124906, 2124908, 2124909, 2124911, 2124912, 2124913, 2124914, 2124915, 2124916, 2124917, 2124918, 2124919, 2124920, 2124921, 2124923, 2124924, 2124928, 2124930, 2124932, 2124933, 2124934, 2124935, 2124936, 2124938, 2124939, 2124944, 2124946, 2124951, 2124954, 2124956, 2124957, 2124960, 2124961, 2124962, 2124963, 2124965, 2124966, 2124967, 2124968, 2124969, 2124970, 2124971, 2124972, 2124973, 2124974, 2124975, 2124976, 2124977, 2124978, 2124979, 2124980, 2124981, 2124982, 2124983, 2125001, 2125004, 2125008, 2125011, 2125022, 2125025, 2125026, 2125029, 2125032, 2125035, 2125040, 2125046, 2125047, 2125048, 2125050, 2125054, 2125056, 2125057, 2125060, 2125063, 2125065, 2125066, 2125068, 2125070, 2125073, 2125079, 2125083, 2125084, 2125086, 2125087, 2125088, 2125091, 2125093, 2125097, 2125103, 2125104, 2125118, 2125123, 2125125, 2125129, 2125139, 2125148, 2125153, 2125154, 2125161, 2125164, 2125167, 2125168, 2125169, 2125170, 2125172, 2125173, 2125176, 2125177, 2125182, 2125184, 2125185, 2125187, 2125188, 2125190, 2125403, 2125404, 2125405, 2125411, 2125412, 2125414, 2125415, 2125416, 2125421, 2125422, 2125427, 2125428, 2125430, 2125434, 2125435, 2125438, 2125439, 2125441, 2125442, 2125443, 2125446, 2125447, 2125448, 2125449, 2125450, 2125451, 2125453, 2125455, 2125456, 2125457, 2125458, 2125459, 2125460, 2125462, 2125463, 2125465, 2125470, 2125476, 2125477, 2125478, 2125482, 2125483, 2125484, 2125485, 2125486, 2125487, 2125491, 2125493, 2125496, 2125498, 2125503, 2125505, 2125507, 2125509, 2125513, 2125514, 2125517, 2125518, 2125520, 2125526, 2125529, 2125531, 2125603, 2125604, 2125605, 2125606, 2125607, 2125608, 2125609, 2125611, 2125612, 2125613, 2125616, 2125619, 2125620, 2125622, 2125623, 2125624, 2125627, 2125629, 2125630, 2125631, 2125632, 2125634, 2125635, 2125636, 2125637, 2125640, 2125643, 2125645, 2125647, 2125649, 2125650, 2125653, 2125656, 2125657, 2125660, 2125661, 2125663, 2125665, 2125670, 2125673, 2125678, 2125695, 2125698, 2125700, 2125702, 2125704, 2125705, 2125707, 2125709, 2125711, 2125712, 2125714, 2125715, 2125716, 2125717, 2125718, 2125719, 2125725, 2125727, 2125730, 2125734, 2125741, 2125743, 2125744, 2125747, 2125748, 2125750, 2125751, 2125753, 2125754, 2125756, 2125760, 2125761, 2125762, 2125766, 2125769, 2125774, 2125775, 2125784, 2125785, 2125790, 2125792, 2125800, 2125802, 2125803, 2125805, 2125808, 2125824, 2125825, 2125826, 2125827, 2125828, 2125829, 2125830, 2125831, 2125834, 2125835, 2125838, 2125841, 2125843, 2125844, 2125848, 2125850, 2125852, 2125853, 2125854, 2125861, 2125863, 2125864, 2125872, 2125873, 2125876, 2125878, 2125879, 2125881, 2125885, 2125889, 2125890, 2125892, 2125900, 2125901, 2125902, 2125907, 2125910, 2125914, 2125920, 2125922, 2125925, 2125928, 2125929, 2125937, 2125940, 2125941, 2125943, 2125944, 2125945, 2125946, 2125947, 2125948, 2125954, 2125956, 2125962, 2125964, 2125972, 2125975, 2125976, 2125977, 2125979, 2125980, 2125981, 2125984, 2125987, 2125988, 2125989, 2125993, 2125996, 2125999, 2126018, 2126154, 2126180, 2126197, 2126200, 2126202, 2126204, 2126205, 2126207, 2126209, 2126210, 2126212, 2126213, 2126214, 2126216, 2126217, 2126218, 2126219, 2126221, 2126224, 2126226, 2126228, 2126229, 2126230, 2126231, 2126232, 2126233, 2126235, 2126236, 2126239, 2126240, 2126241, 2126243, 2126244, 2126245, 2126247, 2126248, 2126249, 2126250, 2126251, 2126252, 2126253, 2126254, 2126259, 2126260, 2126261, 2126262, 2126263, 2126265, 2126266, 2126267, 2126268, 2126270, 2126271, 2126272, 2126273, 2126274, 2126276, 2126279, 2126280, 2126281, 2126282, 2126283, 2126284, 2126285, 2126286, 2126288, 2126290, 2126291, 2126292, 2126293, 2126294, 2126295, 2126296, 2126298, 2126300, 2126302, 2126309, 2126321, 2126322, 2126323, 2126324, 2126325, 2126326, 2126327, 2126328, 2126331, 2126332, 2126335, 2126338, 2126340, 2126341, 2126342, 2126345, 2126346, 2126350, 2126355, 2126356, 2126368, 2126369, 2126375, 2126377, 2126378, 2126381, 2126387, 2126388, 2126397, 2126398, 2126400, 2126601, 2126604, 2126608, 2126609, 2126611, 2126612, 2126618, 2126625, 2126626, 2126631, 2126634, 2126636, 2126637, 2126638, 2126640, 2126641, 2126642, 2126643, 2126646, 2126647, 2126649, 2126650, 2126651, 2126652, 2126653, 2126654, 2126655, 2126656, 2126657, 2126658, 2126659, 2126661, 2126663, 2126664, 2126665, 2126667, 2127001, 2127003, 2127004, 2127005, 2127006, 2127008, 2127009, 2127011, 2127012, 2127013, 2127014, 2127018, 2127021, 2127025, 2127029, 2127032, 2127034, 2127036, 2127039, 2127044, 2127047, 2127050, 2127052, 2127055, 2127057, 2127058, 2127059, 2127061, 2127063, 2127065, 2127066, 2127069, 2127074, 2127076, 2127079, 2127081, 2127083, 2127091, 2127094, 2127095, 2127097, 2127098, 2127099, 2127100, 2127101, 2127102, 2127104, 2127105, 2127107, 2127109, 2127112, 2127113, 2127117, 2127118, 2127122, 2127124, 2127125, 2127127, 2127129, 2127131, 2127134, 2127136, 2127138, 2127143, 2127144, 2127146, 2127147, 2127150, 2127152, 2127153, 2127154, 2127155, 2127156, 2127157, 2127158, 2127159, 2127160, 2127162, 2127165, 2127167, 2127168, 2127172, 2127174, 2127178, 2127179, 2127182, 2127184, 2127202, 2127205, 2127206, 2127211, 2127213, 2127219, 2127222, 2127225, 2127227, 2127231, 2127234, 2127238, 2127241, 2127242, 2127243, 2127603, 2127609, 2127610, 2127611, 2127612, 2127613, 2127614, 2127615, 2127616, 2127617, 2127618, 2127619, 2127620, 2127624, 2127626, 2127628, 2127630, 2127631, 2127632, 2127633, 2127634, 2127635, 2127636, 2127638, 2127642, 2127644, 2127650, 2127653, 2127660, 2127661, 2127667, 2127668, 2127670, 2127681, 2127684, 2127689, 2127690, 2127692, 2127695, 2127697, 2127699, 2127705, 2127706, 2127713, 2127715, 2127722, 2127724, 2127725, 2127726, 2127730, 2127733, 2127735, 2127736, 2127738, 2127739, 2127741, 2127742, 2127743, 2127746, 2127748, 2127758, 2127759, 2127761, 2127766, 2127768, 2127770, 2127772, 2127773, 2127776, 2127780, 2127783, 2127784, 2127788, 2127790, 2127791, 2127792, 2127793, 2127797, 2127798, 2127799, 2128002, 2128006, 2128007, 2128009, 2128013, 2128014, 2128015, 2128017, 2128025, 2128027, 2128028, 2128030, 2128032, 2128033, 2128034, 2128036, 2128038, 2128046, 2128047, 2128048, 2128056, 2128057, 2128058, 2128059, 2128062, 2128067, 2128070, 2128071, 2128073, 2128075, 2128083, 2128096, 2128097, 2128201, 2128203, 2128207, 2128209, 2128210, 2128215, 2128216, 2128217, 2128230, 2128235, 2128237, 2128243, 2128244, 2128245, 2128250, 2128254, 2128257, 2128258, 2128259, 2128265, 2128272, 2128273, 2128274, 2128276, 2128277, 2128279, 2128281, 2128286, 2128287, 2128290, 2128293, 2128300, 2128303, 2128304, 2128307, 2128308, 2128311, 2128313, 2128314, 2128318, 2128320, 2128321, 2128323, 2128324, 2128325, 2128326, 2128329, 2128331, 2128334, 2128338, 2128339, 2128340, 2128341, 2128343, 2128344, 2128345, 2128348, 2128355, 2128357, 2128360, 2128361, 2128364, 2128365, 2128366, 2128369, 2128371, 2128372, 2128374, 2128378, 2128379, 2128380, 2128381, 2128382, 2128384, 2128387, 2128388, 2128390, 2128391, 2128394, 2128396, 2128397, 2128402, 2128404, 2128405, 2128409, 2128410, 2128412, 2128413, 2128414, 2128415, 2128418, 2128420, 2128421, 2128422, 2128423, 2128424, 2128425, 2128426, 2128428, 2128439, 2128441, 2128605, 2128611, 2128622, 2128625, 2128627, 2128635, 2128641, 2128643, 2128647, 2128648, 2128654, 2128658, 2128659, 2128660, 2128661, 2128667, 2128676, 2128679, 2128686, 2128691, 2128695, 2128697, 2128699, 2128700, 2128701, 2128702, 2128721, 2128722, 2128724, 2128728, 2128729, 2128731, 2128735, 2128736, 2128737, 2128741, 2128744, 2128748, 2128749, 2128750, 2128751, 2128753, 2128754, 2128756, 2128759, 2128762, 2128764, 2128770, 2128771, 2128777, 2128778, 2128780, 2128787, 2128792, 3238077
RECALLING FIRM/MANUFACTURER
Bergen Community Regional Blood Center, Paramus, NJ, by facsimile or letter from August 3, 2005 to August 5, 2005. Firm initiated recall is complete.
REASON
Blood products, which were exposed to unacceptable storage temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2,967 units
DISTRIBUTION
NJ and NY

______________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1813-6
CODE
Unit: 003FG43251
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southern Region, Atlanta, GA, by telephone and follow-up letter on December 15, 2005. Firm initiated recall is complete.
REASON
Blood product, mislabeled as Jk(b-), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

______________________________
PRODUCT
Source Plasma, Recall # B-1838-6
CODE
Units: OD772864, OD788657, OD787923, O4LTXB0540
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Laredo, TX, by facsimile on July 28, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NC

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

______________________________
PRODUCT
GE Precision 500D Radiographic and Fluoroscopic Imaging System, Stationary X-ray System consisting of an X-ray generator; angulating table with x-ray Tube, collimator and image intensifier; wall stand; Overhead tube suspension; operator console and digital archive system, Recall # Z-1304-06
CODE
All serial numbers affected
RECALLING FIRM/MANUFACTURER
General Electric Med Systems LLC, WaukeshaWI, by letter, dated November 24, 2005 was hand delivered to all customers beginning May 15, 2006. Firm initiated recall is ongoing.
REASON
Systems are non-compliant with Federal Performance Standard Title 21, Code of Federal Regulation (CFR), 1020.32(a)(1) in that the systems allow the production of x-rays when the primary protective barrier is not in position to intercept the entire cross section of the useful beam
VOLUME OF PRODUCT IN COMMERCE
1,289 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Hil-Rom Affinity Three Birthing Bed, Model P3700, Recall # Z-1503-06
CODE
All units distributed after October 2000 and equipped with the 12VAC accessory outlet option.
RECALLING FIRM/MANUFACTURER
Hill-Rom, Inc., Batesville, IN, letter dated August 18, 2006. Firm initiated recall is ongoing.
REASON
The cable on the auxiliary outlet may become pinched, which may result in an electrical short with melting of the plastic transformer and the emission of smoke.
VOLUME OF PRODUCT IN COMMERCE
9,324 beds
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Therakos Photopheresis Procedural Kit for use with the UVAR XTS Instrument, Catalog number XT125, Recall # Z-1504-06
CODE
Lot numbers: U706, U707, U708, U709, U710, U711, and U712
RECALLING FIRM/MANUFACTURER
Recalling Firm: Therakos, Inc., Exton, PA, by letter dated July 18, 2006.
Manufacturer: Harmac Medical Products, Inc., Buffalo, NY. Firm initiated recall is ongoing.
REASON
Centrifuge Bowl may leak.
VOLUME OF PRODUCT IN COMMERCE
1,315 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
BD™ BBL™ Staphyloslide Latex Test Kit, Catalog # 240952 (100 tests/kit) and Catalog # 240953 (500 tests/kit), packaged in a kit configuration with test reagents and labware, Recall # Z-1505-06
CODE
Lot Number / Exp. Date 16629910 April 30, 2007 16562410 April 30, 2007 16629920 April 30, 2007 16562420 April 30, 2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Co, SparksMD, by e-mail, faxed letters, and certified courier on August 17, 2006
Manufacturer: Oxoid, Ltd, Basingstoke, UK. Firm initiated recall is ongoing.
REASON
False Negative Staphylococcus aureus results which could prevent infected patients from receiving antimicrobial treatment; due to the failure of the Positive Control to react within 20 seconds. The failure is due to reduced reactivity of the latex component.
VOLUME OF PRODUCT IN COMMERCE
1,572 kits
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) Conmed System 2500 Electrosurgical Unit,
REF 60-8011-SYS, Recall # Z-1507-06;
b) Conmed System 5000 Electrosurgical unit,
REF 60-8005-SYS, 60-8015-SYS, 60-8018-SYS,
60-8005-001, 60-8005-003, Recall Z-1508-06
CODE
a) Serial numbers: 06GGN 001 thru 009,
06FGN 001 thru 010;
b) Serial Numbers: 06GGP 004, 06GGP 005, 06GGP 009,
06GGP 011, 06GGP 012, 06GGP 024, 06GGP 027 thru 030,
06GGP 057 thru 059, 06GGP 090 thru 092, 06GGP 131 thru
140, 06GGP 141 thru 144, 06FGP 022, 06FGP 023,
06FGP 029 thru 046, 06FGP 048 thru 056, 06FGP 062
thru 071, 06FGP 073 thru 079, 06FGP 090, 06FGP 106,
06FGP 107, 06FGP 110 thru 112
RECALLING FIRM/MANUFACTURER
Conmed Electrosurgery, Centennial,CO, by letter on September 1, 2006 and September 7, 2006. Firm initiated recall is ongoing.
REASON
Wrong size capacitor installed in electrosurgical generator could malfunction, causing muscle stimulation or delay in therapy.
VOLUME OF PRODUCT IN COMMERCE
103 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) Solara 2G manual wheelchair, Recall # Z-1509-06;
b) Solara Spree GT manual wheelchair, Recall # Z-1510-06;
c) Solara Spree XT (SPRXT) manual wheelchair, Recall # Z-1511-06
CODE
a) 06EE008858, 06EE010422, 06EE010432, 06EE010434,
06EE010442, 06EE010453, 06EE010454, 06EE010745,
06EE010747, 06EE010749, 06EE010758, 06EE010799,
06EE010804, 06EE010810, 06EE011357, 06EE011378,
06EE011379, 06FE000048, 06FE000050, 06FE000054,
06FE000055, 06FE000057, 06FE000985, 06FE001000,
06FE001012, 06FE001604, 06FE001612, 06FE001625,
06FE006654, 06FE006661, 06FE007243, 06FE008820,
06FE008829, 06FE008832, 06FE009212, 06FE010083;
b) 06EE011382, 06FE000065, 06FE001632, 06FE001635,
06FE006693, 06FE007246;
c) 06FE009232
RECALLING FIRM/MANUFACTURER
Invacare Corp., Elyria, OH, by telephone on June 23, 2006 and by letter dated June 26, 2006. Firm initiated recall is ongoing.
REASON
The wheelchairs with the Travel Ready Option (TRRO) may contain incorrectly finished oval tie down brackets. The inner edge of the bracket may cause the tie-down straps (used to tie down the chairs during transport) to fray or be cut.
VOLUME OF PRODUCT IN COMMERCE
43 wheelchairs
DISTRIBUTION
Nationwide and Canada

______________________________
PRODUCT
Boston Scientific Cutting Balloon Ultra2 Monorail Device, Recall # Z-1512-06
CODE
Material Number (UPN) / Catalog Number / Lot/Batch #: H749CBM200060 / CBM20006 / EG0438 & EG0499; H749CBM200100 / CBM20010 / EG0427; H749CBM225060 / CBM22506 / EG0448 & EG0471; H749CBM225100 / CBM22510 / EG0444 & EG0502; H749CBM250060 / CBM25006 / EG0439 & EG0472; H749CBM250100 / CBM25010 / EGO425, EG0440, EG0474 & EG0475; H749CBM250150 / CBM25015 / EG0466; H749CBM275060 / CBM27506 / EG0420 & EG0487; H749CBM275100 / CBM27510 / EG0419 & EG0456; H749CBM275150 / CBM27515 / EG0424; H749CBM300060 / CBM30006 / EG0423, EG0473 & EG0497; H749CBM300100 / CBM30010 / EG0426, EG0441, EG0465, EG0485; H749CBM300150 / CBM30015 /EG0443 & EG0418; H749CBM325060 / CBM32506 / EG0500; H749CBM325100 / CBM32510 / EG0422 & EG0501; H749CBM325150 / CBM32515 / EG0467; H749CBM350060 / CBM35006 / EG0437; H749CBM350100 / CBM35010 / EG0349, EG0428, EG0468; H749CBM350150 / CBM35015 / EG0421 & EG0486; H749CBM375060 / CBM37506 / EG0503; H749CBM375100 / CBM37510 / EG0457; H749CBM375150 / CBM37515 / EG0455; H749CBM400060 / CBM40006 / EG0504; H749CBM400100 / CBM40010 / EG0442 & EG0498; H749CBM400150 / CBM40015 / EG0476
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific, Maple Grove,MN, by letters dated July 21, 2006.
Manufacturer: Boston Scientific Corporation, etterkenny, Ireland. Firm initiated recall is ongoing.
REASON
Lack of assurance of sterility (pre-sterilization bioburden limits exceeded)
VOLUME OF PRODUCT IN COMMERCE
1,000 devices
DISTRIBUTION
Nationwide

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PRODUCT
Stryker Power-Pro Powered Ambulance Cot, Model 6500, Recall # Z-1513-06
CODE
All units with a serial number lower than 060739380
RECALLING FIRM/MANUFACTURER
Styker Medical Division of Styker Corp., Portage, MI, by letter dated August 29, 2006. Firm initiated recall is ongoing.
REASON
The head section wheel assembly may flex outward from the cot because the head section wheel bolts, which hold the assembly upright, may back out.
VOLUME OF PRODUCT IN COMMERCE
2,033 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
ADVIA Centaur CP System, Automated Immunoassay Analyzer, Part/Catalogue Number 086-A001, Recall # Z-1516-06
CODE
All ADVIA Centaur CP systems using software versions 3.1 and 3.2.
RECALLING FIRM/MANUFACTURER
Bayer Healthcare, LLC (Diagnostics Division), Tarrytown, NY, by e-mail on August 4, 2006. Firm initiated recall is ongoing.
REASON
Sample/Patient mis-identification (software defect) the system can associate a test result and sample identification (SID) with an incorrect patient name when the Patient Demographics feature is used and the Patient Identification (PID) field is left blank.
VOLUME OF PRODUCT IN COMMERCE
254 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
UniCel Dxl 800 Access Immunoassay Systems Wash Buffer, Part Number 8547197 Wash Buffer, Recall # Z-1518-06
CODE
221208F (exp 6/9/07), 221209F(exp 6/9/07), 221210F (exp 6/10/07), 221211F (exp 6/10/07), 221212F (exp 6/12/07), 221213F (exp 6/12/07), 221214F (exp 6/13/07), 221215F (exp 6/13/07), 221216F (exp 6/14/07), 221217F (exp 6/14/07), 221218F (exp 6/15/07), 221219F (exp 6/15/07), 221220F (exp 6/16/07), 221221F (exp 6/16/07), 221222F (exp 6/17/07), 221223F (exp 6/17/07), 221224F (exp 6/19/07), 221225F (exp 6/19/07), 221226F (exp 6/20/07), 221227F (exp 6/20/07), 221228F (exp 6/21/07), 221229F (exp 6/21/07); All software versions
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc, BreaCA, by letter was sent on July 28, 2006.
Manufacturer: Beckman Coulter Inc, Florence, KY. Firm initiated recall is ongoing.
REASON
The neck of the wash buffer cube can be extended higher than intended possibly causing the system to aspirate air instead of buffer before the buffer container is empty without the system immediately indicating that the supply is empty. This may lead to incorrect assay results.
VOLUME OF PRODUCT IN COMMERCE
12,947 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
OptiBond Solo Plus Self-Etch Adhesive System, Part Number 31966, Recall # Z-1521-06
CODE
Lot numbers: 448798, 449556 and 451706
RECALLING FIRM/MANUFACTURER
Kerr Corp, Orange, CA, by letter on August 29, 2006. Firm initiated recall is ongoing.
REASON
Mis-pack/mis-label: The OptiBond Self Etch Primer and OptiBond Solo Plus Adhesive in the chambers were mis-packaged/mis-labeled in reverse order. Application of these products in reverse order may result in compromised bond strength.
VOLUME OF PRODUCT IN COMMERCE
247 kits (50 unidose pouches/kit)
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

______________________________
PRODUCT
Ruggles(tm) Leyla Ball Joint Clamp, MODEL/CATALOG #: R2383. The Leyla Ball Joint Clamp is part of the Table Mounting Hardware that is used with the Leyla Retractor System. The Leyla Table Mounting Hardware consists of the Ball Joint Clamp, the Rigid Holding Rod, the Coupling Head, and the Coupling Head Turn Table. The Ball Joint Clamp is available individually or as part of the Table Mount Set. The Table Mounting Hardware are attachments to operating room surgical tables. The product is supplied non-sterile and may be packaged individually or as part of the Table Mount Set, Recall # Z-1506-06
CODE
143 601736
RECALLING FIRM/MANUFACTURER
Recalling Firm: J. Jamner Surgical Instruments, Inc., Hawthorne, NY, by letter dated April 24, 2006.
Manufacturer: Rebstock, Durbheim, Germany. Firm initiated recall is ongoing.
REASON
The Ruggles(tm) Leyla Ball Joint Clamp may not properly tighten onto the Rigid Holding Rod. Although this condition can be observed during assembly, if the device were to be used during surgery, any attachments to the Rigid Holding Rod could move.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
MS, IL, WI, and TX

______________________________
PRODUCT
Porex Nostril Retainers, Catalog #7241, Size 4, Recall # Z-1515-06
CODE
Lot number: B002E05N
RECALLING FIRM/MANUFACTURER
Recalling Firm: Porex Surgical, Inc., Newnan, GA, by telephone, on July 11, 2006 and follow-up letter on July 12, 2006.
Manufacturer: G. E. Silicones, Lic, Waterford, NY. Firm initiated recall is ongoing.
REASON
Device contains a trace amount of amine via introduction through an intermediate supplied by a third party raw material.
VOLUME OF PRODUCT IN COMMERCE
27 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Anti-CD45 Cocktail antibody in 6 ml vials; Cat. No. AM371-5M, Recall # Z-1519-06
CODE
Lot number AM3710606, Expiration date June 2008.
RECALLING FIRM/MANUFACTURER
Biogenex Laboratories, San RamonCA, by letter on September 5, 2006. Firm initiated recall is ongoing.
REASON
Mislabeling: Anti-CD45 cocktail antibody mislabeled as Ki-67.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
OASIS® Medical SOFT PLUG® Extended Duration Plug, Reference 6403, Recall # Z-1520-06
CODE
Lot: LA1105E
RECALLING FIRM/MANUFACTURER
Oasis Medical, Inc., Glendora, CA, by fax and certified mail on July 5, 2006. Firm initiated recall is ongoing.
REASON
Labeled with an incorrect diameter.
VOLUME OF PRODUCT IN COMMERCE
1,212 pouches
DISTRIBUTION
Nationwide and Internationally

END OF ENFORCEMENT REPORT FOR SEPTEMBER 27, 2006

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