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U.S. Department of Health and Human Services

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Enforcement Report for November 14, 2007

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.

rule

November 14, 2007
07-46

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II
___________________________________
PRODUCT
IPN Therapy, Intraperitoneal Nutrition Solution in dialysate bags, 1 to 3 liter volumes, Recall # D-039-2008
CODE
Prescriptions filled on or before 9/21/07.
RECALLING FIRM/MANUFACTURER
Pentec Health Inc, Boothwyn, PA, by telephone and fax between September 21, 2007 and September 28, 2007. Firm initiated recall is ongoing.
REASON
Increased incidence of fungal peritonitis..
VOLUME OF PRODUCT IN COMMERCE
27,000 bags
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III
___________________________________
PRODUCT
Cortisone Anti-Itch Cream (1.0% Hydrocortisone), Net Wt 1/2 oz tubes,  Also labeled as; Dr. Sheffield's Hydrocortisone Anti-Itch Maximum Strength, Net Wt 1/2 oz tubes, IvySoothe, Net Wt. 1 oz., LandeRx Hydrocortisone, Net Wt. 0.5 oz., Recall # D-021-2008
CODE
Lot Numbers: 005E1207 (Sheffield) 006E1207 (Sheffield) 01 1 E l 207 (Sheffield) 01 2E1207 (Sheffield) 079E02108 (Standard Homeopathic) 080E02/08 (Standard Homeopathic) 125E04108 (Lander) 128E04108 (Lander) 179E0508 (Sheffield) 180E0508 (Sheffield)
RECALLING FIRM/MANUFACTURER
Sheffield Laboratories, Division of Faria Limited LLC, New London, CT, by letter dated August 24, 2007. Firm initiated recall is ongoing.
REASON
Subpotent
VOLUME OF PRODUCT IN COMMERCE
293,322 tubes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Cefprozil for Oral Suspension USP, 250 mg/5 mL, Rx only, in 50 mL bottles (when mixed), 144 bottles/cases; NDC 0093-1076-76, Recall # D-038-2008
CODE
Lot number: 70532, exp 9/30/2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: TEVA Pharmaceuticals USA, Inc., Sellersville, PA, by letter on October 4, 2007.
Manufacturer: TEVA Pharmaceutical USA, Inc., Fairfield, NJ. Firm initiated recall is ongoing.
REASON
Subpotent. 9 month stability.
VOLUME OF PRODUCT IN COMMERCE
19,980 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0016-08;
b) Red Blood Cells, leukocytes reduced, Recall # B-0017-08;
c) Red Blood Cells, leukocytes reduced, irradiated, Recall # B-0018-08;
d) Red Blood Cells, leukocytes reduced, washed, Recall # B-0019-08;
e) Red Blood Cells, deglycerized, leukocytes reduced, Recall # B-0020-08;
f) Red Blood Cells (apheresis), Recall # B-0021-08;
g) Cryoprecipitated AHF, Recall # B-0022-08;
h) Cryoprecipitated AHF, pooled, Recall # B-0023-08;
i) Platelets, leukocytes reduced, Recall # B-0024-08;
j) Platelets, leukocytes reduced, irradiated, Recall # B-0025-08;
k) Source leukocytes, Recall # B-0026-08;
l) Fresh frozen plasma, Recall # B-0027-08;
m) Plasma, frozen, cryoprecipitate reduced, Recall # B-0028-08;
n) Recovered plasma, Recall # B-0029-08
CODE
a) Units: 18GC08953, 18GH91107;

b) Units: 18FE93718, 18FE93763, 18FE93814, 18FE93843, 18FE93862, 18FE93913, 18FE93921, 18FE93940, 18FE93951, 18FE93962, 18FE93976, 18FE94002, 18FE94128, 18FE94237, 18FE94293, 18FE94300, 18FE94384, 18FE94431, 18FE94446, 18FE94496, 18FE94651, 18FE94669, 18FE94699, 18FE94702, 18FE94766, 18FE94768, 18FE94856, 18FE94959, 18FE95013, 18FE95026, 18FE95043, 18FE95207, 18FE95252, 18FE95367, 18FE95508, 18FE95543, 18FE95579, 18FE95609, 18FE95873, 18FE95899, 18FE96074, 18FE96150, 18FE96170, 18FE96171, 18FE96192, 18FE96277, 18FE96281, 18FE96289, 18FE96316, 18FE96327, 18FE96344, 18FE96349, 18FE96466, 18FE96512, 18FE96606, 18FE96707, 18FE96788, 18FE97002, 18FE97006, 18FE97132, 18FE97255, 18FE97539, 18FE97601, 18FE97638, 18FE97655, 18FE97710, 18FE97716, 18FE97734, 18FE97737, 18FE97861, 18FE97896, 18FE98248, 18FE98256, 18FE98425, 18FE98450, 18FE98543, 18FE98699, 18FE98706, 18FE98768, 18FE99014, 18FE99076, 18FE99225, 18FE99585, 18FE99635, 18FE99807, 18FE99831, 18FE99841, 18FE99844, 18FF08811, 18FF08828, 18FF08920, 18FF09174, 18FJ59001, 18FJ59004, 18FJ59021, 18FJ59039, 18FJ59050, 18FJ59058, 18FJ59139, 18FJ59179, 18FJ59239, 18FJ59294, 18FJ59402, 18FJ59491, 18FJ59591, 18FJ59617, 18FJ59655, 18FJ59715, 18FJ59872, 18FJ59971, 18FJ60003, 18FJ60053, 18FJ60059, 18FJ60062, 18FJ60082, 18FJ60209, 18FJ60251, 18FJ60300, 18FJ60303, 18FJ60500, 18FJ60529, 18FJ60638, 18FJ60670, 18FJ60695, 18FJ60843, 18FJ60853, 18FJ60865, 18FJ60889, 18FJ61069, 18FJ61077, 18FJ61086, 18FJ61089, 18FJ61320, 18FJ61329, 18FJ61376, 18FJ61698, 18FJ61833, 18FJ61857, 18FJ61871, 18FJ62012, 18FJ62013, 18FJ62015, 18FJ62016, 18FJ62033, 18FJ62036, 18FJ62040, 18FJ62043, 18FJ62066, 18FJ62212, 18FJ62312, 18FJ62329, 18FJ62340, 18FJ62354, 18FJ62386, 18FJ62401, 18FJ62404, 18FJ62556, 18FJ62569, 18FJ62581, 18FJ62582, 18FJ62588, 18FJ62597, 18FJ62601, 18FJ62608, 18FJ62645, 18FJ62702, 18FJ62752, 18FJ62765, 18FJ62793, 18FJ63008, 18FJ63024, 18FJ63080, 18FJ63087, 18FJ63319, 18FJ63363, 18FJ63449, 18FJ63511, 18FJ63525, 18FJ63564, 18FJ63594, 18FJ63601, 18FJ63719, 18FJ63722, 18FJ63769, 18FJ63789, 18FJ63798, 18FJ63806, 18FJ63847, 18FJ63899, 18FJ64000, 18FJ64005, 18FJ64051, 18FJ64078, 18FJ64129, 18FJ64160, 18FJ64189, 18FJ64208, 18FJ64333, 18FJ64469, 18FJ64647, 18FJ64754, 18FJ64755, 18FJ64756, 18FJ64845, 18FJ64855, 18FJ64986, 18FJ65027, 18FJ65063, 18FJ65065, 18FJ65086, 18FJ65138, 18FJ65243, 18FJ65302, 18FJ65403, 18FJ65583, 18FJ65609, 18FJ65623, 18FJ65643, 18FJ65656, 18FJ65813, 18FJ65863, 18FJ65866, 18FJ65907, 18FJ65940, 18FK72271, 18FK72287, 18FK72354, 18FK72418, 18FK72434, 18FK72453, 18FK72455, 18FK72463, 18FK72576, 18FK72595, 18FK72596, 18FK72615, 18FK72681, 18FK72728, 18FK72885, 18FK72911, 18FK72918, 18FK72979, 18FK73228, 18FK73253, 18FK73333, 18FK73358, 18FK73402, 18FK73425, 18FK73513, 18FK73524, 18FK73554, 18FK73565, 18FK73597, 18FK73610, 18FK73612, 18FK73670, 18FK73712, 18FK73821, 18FK74022, 18FK74102, 18FK74144, 18FK74160, 18FK74171, 18FK74249, 18FK74273, 18FK74363, 18FK74367, 18FK74382, 18FK74385, 18FK74400, 18FK74402, 18FK74422, 18FK74440, 18FK74465, 18FK74498, 18FK74515, 18FK74521, 18FK74602, 18FK74641, 18FK74658, 18FK74715, 18FK74908, 18FK74962, 18FK75084, 18FK75085, 18FK75103, 18FK75113, 18FK75116, 18FK75129, 18FK75209, 18FK75217, 18FK75223, 18FK75224, 18FK75225, 18FK75264, 18FK75305, 18FK75368, 18FK75369, 18FK75383, 18FK75500, 18FK75535, 18FK75541, 18FK75723, 18FK75804, 18FK75814, 18FK75825, 18FK75830, 18FK75881, 18FK75882, 18FK75885, 18FK75940, 18FK75944, 18FK76000, 18FK76002, 18FK76014, 18FK76121, 18FK76151, 18FK76152, 18FK76154, 18FK76192, 18FK76330, 18FK76335, 18FK76356, 18FK76364, 18FK76366, 18FK76392, 18FK76417, 18FK76420, 18FK76422, 18FK76423, 18FK76431, 18FK76433, 18FK76444, 18FK76450, 18FK76459, 18FK76478, 18FK76550, 18FK76698, 18FK76733, 18FK76784, 18FK76800, 18FK76803, 18FK76807, 18FK76820, 18FK76867, 18FK77050, 18FK77062, 18FK77232, 18FK77338, 18FK77475, 18FK77533, 18FK77569, 18FK77784, 18FK77874, 18FK77935, 18FK77949, 18FK77964, 18FK77976, 18FK78135, 18FK78328, 18FK78333, 18FK78374, 18FK78376, 18FK78501, 18FK78514, 18FK78537, 18FK78544, 18FK78545, 18FK78559, 18FK78588, 18FK78592, 18FK78617, 18FK78652, 18FK78659, 18FK78673, 18FK78680, 18FK78692, 18FK78743, 18FK78755, 18FK78794, 18FK78864, 18FK78931, 18FK78994, 18FK79243, 18FK79254, 18FK79283, 18FK79396, 18FK79400, 18FK79510, 18FK79515, 18FK79567, 18FK79614, 18FK79718, 18FK79762, 18FK79809, 18FK79870, 18FK80019, 18FK80048, 18FK80249, 18FK80356, 18FK80427, 18FK80484, 18FK80606, 18FN09642, 18FN09681, 18FN09759, 18FN09768, 18FN10019, 18FN10195, 18FN10217, 18FQ84279, 18FQ84298, 18FQ84308, 18FQ84314, 18FQ84317, 18FQ84318, 18FQ84355, 18FQ84365, 18FQ84366, 18FQ84388, 18FQ84392, 18FQ84424, 18FQ84430, 18FQ84457, 18FQ84483, 18FQ84495, 18FQ84718, 18FQ84724, 18FQ84829, 18FQ84876, 18FQ84881, 18FQ85288, 18FQ85292, 18FQ85298, 18FQ85302, 18FQ85420, 18 FQ85448, 18FQ85458, 18FQ85468, 18FQ85527, 18FQ85593, 18FQ85627, 18FQ85642, 18FQ85646, 18FQ85691, 18FQ85729, 18FQ85733, 18FQ85797, 18FQ85833, 18FQ85849, 18FQ85851, 18FQ85859, 18FQ85865, 18FQ85905, 18FQ85935, 18FQ85953, 18FQ86166, 18FQ86260, 18FQ86286, 18FQ86305, 18FQ86401, 18FQ86419, 18FQ86432, 18FQ86499, 18FQ86819, 18FQ86822, 18FQ86894, 18FQ87031, 18FQ87032, 18FQ87090, 18FQ87114, 18FQ87119, 18FQ87159, 18FQ87198, 18FQ87299, 18FQ87408, 18FQ87675, 18FQ87735, 18FQ87874, 18FQ87878, 18FQ87915, 18FQ87960, 18FQ87972, 18FQ88062, 18FQ88089, 18FQ88102, 18FQ88193, 18FQ88314, 18FQ88438, 18FQ88469, 18FQ88540, 18FQ88561, 18FQ88612, 18FQ88877, 18FQ88919, 18FQ88958, 18FQ88982, 18FQ89104, 18FQ89482, 18FQ89809, 18FQ89953, 18FQ89957, 18FQ89958, 18FQ90039, 18FQ90061, 18FQ90062, 18FQ90063, 18FQ90064, 18FQ90065, 18FQ90066, 18FQ90077, 18FQ90309, 18FQ90337, 18FQ90338, 18FQ90362, 18FQ90370, 18FQ90377, 18FQ90430, 18FQ90452, 18FQ90454, 18FQ90476, 18FQ90573, 18FQ90596, 18FQ90657, 18FQ90666, 18FQ90686, 18FQ90706, 18FQ90750, 18FQ90757, 18FR77853, 18FR77859, 18FR77942, 18FR77957, 18FR77971, 18FR78013, 18FR78192, 18FR78218, 18FR78276, 18FR78339, 18FR78346, 18FR78390, 18FR78392, 18FR78416, 18FR78531, 18FR78709, 18FR78891, 18FR78904, 18FR79005, 18FR79009, 18FR79070, 18FR79119, 18FR79310, 18FR79311, 18FR79337, 18FR79364, 18FR79602, 18FR79838, 18FR79910, 18FR79932, 18FR79985, 18FR80016, 18FR80021, 18FR80025, 18FR80069, 18FR80110, 18FR80162, 18FR80171, 18FR80174, 18FR80204, 18FR80386, 18FR80415, 18FR80464, 18FR80492, 18FR80500, 18FR80534, 18FR80544, 18FR80667, 18FR80701, 18FR80704, 18FR80724, 18FR80923, 18FR81035, 18FR81052, 18FR81056, 18FR81211, 18FR81236, 18FR81290, 18FR81311, 18FR81563, 18FR81565, 18FR81579, 18FR81681, 18FR81696, 18FR81869, 18FR81872, 18FR81873, 18FR81890, 18FR82037, 18FR82052, 18FR82106, 18FR82150, 18FR82169, 18FR82213, 18FR82282, 18FR82290, 18FR82494, 18FR82501, 18FR82512, 18FR82514, 18FR82528, 18FR82539, 18FR82837, 18FR82840, 18FR82905, 18FR82962, 18FR83173, 18FR83216, 18FR83218, 18FR83242, 18FR83254, 18FR83313, 18FR83342, 18FR83345, 18FR83522, 18FR83595, 18FR83600, 18FR83703, 18FR83719, 18FR83771, 18FR84015, 18FR84016, 18FR84030, 18FR84060, 18FR84140, 18FR84234, 18FR84307, 18FR84331, 18FR84456, 18FR84490, 18FR84500, 18FR84507, 18FR84517, 18FR84761, 18FR84888, 18FR85005, 18FS68768, 18FS68956, 18FS69113, 18FS69295, 18FS69511, 18FS69522, 18FS69546, 18FS69564, 18FS69678, 18FS69680, 18FS69683, 18FS69731, 18FS69736, 18FS69802, 18FS69886, 18FS69891, 18FS69957, 18FS69965, 18FS70063, 18FS70064, 18FS70098, 18FS70144, 18FS70229, 18FS70230, 18FS70240, 18FS70253, 18FS70448, 18FS70533, 18FS70571, 18FS70574, 18FS70585, 18FS70625, 18FS70638, 18FS70726, 18FS70741, 18FS70751, 18FS70764, 18FS70991, 18FS71003, 18FS71081, 18FS71199, 18FS71492, 18FS71508, 18FS71509, 18FS71525, 18FS71669, 18FS71732, 18FS71761, 18FS71780, 18FS71828, 18FS71861, 18FS71894, 18FS71924, 18FS71934, 18FS71962, 18FS72107, 18FS72276, 18FS72280, 18FS72287, 18FS72352, 18FS72375, 18FS72434, 18FS72448, 18FS72461, 18FS72496, 18FS72507, 18FS72508, 18FS72531, 18FS72593, 18FS72614, 18FS72635, 18FS72643, 18FS72684, 18FS72749, 18FS72861, 18FS72983, 18FS73133, 18FS73140, 18FS73143, 18FS73224, 18FS73363, 18FS73380, 18FS73412, 18FS73430, 18FS73442, 18FS73447, 18FS73470, 18FS73491, 18FS73613, 18FS73645, 18FS73878, 18FS73934, 18FS73948, 18FS73950, 18FS74076, 18FS74177, 18FS74213, 18FS74266, 18FS74273, 18FS74382, 18FS74580, 18FS74636, 18FS74641, 18FS74708, 18FS74748, 18FS74764, 18FS74853, 18FS74900, 18FS74976, 18FS75000, 18FS75014, 18FS75022, 18FS75095, 18FS75109, 18FS75217, 18FS75227, 18FS75259, 18FS75276, 18FS75288, 18FS75391, 18FS75435, 18FS75473, 18FS75488, 18FS75494, 18FS77035, 18FS77059, 18FS77219, 18FS77267, 18FS77276, 18FS77280, 18FS77328, 18FS77358, 18FS77394, 18FS77524, 18FS77528, 18FS77585, 18FS77602, 18FS77672, 18FS77734, 18FS77773, 18FT68087, 18FT68197, 18FT68218, 18FT68219, 18FT68268, 18FT68271, 18FT68288, 18FT68358, 18FT68388, 18FT68411, 18FT68436, 18FT68439, 18FT68535, 18FT68639, 18FT68648, 18FT68709, 18FT68803, 18FT68846, 18FT68864, 18FT68965, 18FT68997, 18FT69016, 18FT69052, 18FT69086, 18FT69092, 18FT69093, 18FT69112, 18FT69151, 18FT69190, 18FT69217, 18FT69219, 18FT69238, 18FT69266, 18FT69276, 18FT69329, 18FT69371, 18FT69389, 18FT69550, 18FT69556, 18FT69572, 18FT69590, 18FT69628, 18FT69702, 18FT69921, 18FT69933, 18FT69944, 18FT70003, 18FT70026, 18FT70062, 18FT70098, 18FT70121, 18FT70172, 18FT70190, 18FT70236, 18FT70338, 18FT70339, 18FT70404, 18FT70491, 18FT70493, 18FT70506, 18FT70514, 18FT70637, 18FT70666, 18FT70748, 18FT70763, 18FT70787, 18FT70854, 18FT70888, 18FT70943, 18FT70944, 18FT70972, 18FT71037, 18FT71070, 18FT71091, 18FT71180, 18FT71374, 18FT71377, 18FT71419, 18FT71488, 18FT71515, 18FT71517, 18FT71525, 18FT71645, 18FT71693, 18FT71749, 18FT71773, 18FT71891, 18FT71892, 18FT71949, 18FT71984, 18FT72012, 18FT72022, 18FT72100, 18FT72148, 18FT72238, 18FT72258, 18FT72344, 18FT72347, 18FT72449, 18FT72518, 18FT72550, 18FT72603, 18FT72650, 18FT72738, 18FT72923, 18FT73006, 18FT73066, 18FT73114, 18FT73128, 18FT73138, 18FT73165, 18FT73179, 18FT73211, 18FT73251, 18FT73336, 18FT73400, 18FT73417, 18FT73438, 18FT73487, 18FT73543, 18FT73605, 18FT73611, 18FT73645, 18FT73681, 18FT73698, 18FT73713, 18FT73727, 18FT73754, 18FT73806, 18FT73808, 18FT73814, 18FT73935, 18FT73947, 18FT73963, 18FT73987, 18FT74028, 18FT74047, 18FT74097, 18FT74170, 18FT74281, 18FT74307, 18FT74526, 18FT74539, 18FT74557, 18FT74681, 18FT74705, 18FT74742, 18FT74927, 18FT74940, 18FT74978, 18FT74996, 18FT75285, 18FT75297, 18FT75326, 18FT75333, 18FT75346, 18FT75606, 18FT75629, 18FT75631, 18FT75653, 18FT75739, 18FT75740, 18FT75778, 18FT75840, 18FT75872, 18FT75893, 18FT75910, 18FT75915, 18FT76057, 18FT76145, 18FT76254, 18FT76267, 18FT76346, 18FT76359, 18FT76380, 18FT76492, 18FT76506, 18FT76516, 18FT76520, 18FT76541, 18FT76613, 18FT76629, 18FT76715, 18FT76719, 18FT76751, 18FT76762, 18FT76763, 18FT76831, 18FT76926, 18FT76985, 18FT77034, 18FT77036, 18FT77049, 18FT77139, 18FT77148, 18FT77193, 18FT77219, 18FT77299, 18FT77330, 18FT77359, 18FT77417, 18FT77512, 18FT77522, 18FT77573, 18FT77584, 18FT77589, 18FT77590, 18FT77592, 18FT77597, 18FT77604, 18FT77627, 18FT77693, 18FT77704, 18FT77716, 18FT77724, 18FT77751, 18FT77859, 18FT77894, 18FT78034, 18FT78050, 18FT78113, 18FT78132, 18FT78174, 18FT78183, 18FT78229, 18FT78354, 18FT78368, 18FT78412, 18FT78415, 18FT78445, 18FT78470, 18FT78475, 18FT78481, 18FT78507, 18FT78509, 18FT78511, 18FT78512, 18FT78531, 18FT78540, 18FT78607, 18FT78617, 18FT78681, 18FT78685, 18FT78700, 18FT78744, 18FT78750, 18FT78767, 18FT78779, 18FT78848, 18FT78849, 18FT78852, 18FT79018, 18FT79024, 18FT79080, 18FT79188, 18FT79213, 18FT79222, 18FT79231, 18FT79238, 18FT79385, 18FT79412, 18FT79490, 18FT79536, 18FT79539, 18FT79541, 18FT79555, 18FT79643, 18FT79762, 18FT79851, 18FT79860, 18FT79895, 18FT80085, 18FT80116, 18FT80200, 18FT80239, 18FT80249, 18FT80253, 18FT80301, 18FT80303, 18FT80415, 18FT80490, 18FT80512, 18FT80653, 18FT80683, 18FT80692, 18FT80768, 18FT80863, 18FV45854, 18FV45867, 18FV45874, 18FV45882, 18FV45935, 18FV45946, 18FV45997, 18FV46022, 18FV46054, 18FV46095, 18FV46098, 18FV46113, 18FV46116, 18FV46117, 18FV46122, 18FV46126, 18FV46139, 18FV46148, 18FV46153, 18FV46156, 18FV46174, 18FV46204, 18FV46276, 18FV46362, 18FV46375, 18FV46386, 18FV46391, 18FV46461, 18FV46467, 18FV46899, 18FV46959, 18FV46981, 18FV46990, 18FV47025, 18FV47149, 18FV47163, 18FV47183, 18FV47213, 18FV47216, 18FV47254, 18FV47292, 18FV47347, 18FV47350, 18FV47386, 18FV47434, 18FV47495, 18FV47545, 18FV47575, 18FV47687, 18FV47700, 18FV47751, 18FV47793, 18FV47797, 18FV47798, 18FV47821, 18FV47889, 18FV47898, 18FV47908, 18FV47921, 18FV48060, 18FV48119, 18FV48127, 18FV48198, 18FV48223, 18FV48287, 18FV48415, 18FV48421, 18FV48425, 18FV48444, 18FV48486, 18FV48557, 18FV48560, 18FV48621, 18FV48653, 18FV48762, 18FV48838, 18FV48849, 18FV49012, 18FV49042, 18FV49062, 18FV49143, 18FV49175, 18FV49200, 18FV49205, 18FV49494, 18FV49544, 18FV49578, 18FV49628, 18FV49680, 18FV49764, 18FV49861, 18FV49873, 18FV50077, 18FV50256, 18FV50267, 18FV50269, 18FV50280, 18FV50361, 18FV50404, 18FV50521, 18FV50536, 18FV50571, 18FV50575, 18FV50594, 18FV50666, 18FV50686, 18FV50830, 18FV50831, 18FV50984, 18FV51002, 18FV51009, 18FV51019, 18FV51115, 18FV51121, 18FV51167, 18FV51264, 18FV51281, 18FV51290, 18FV51319, 18FV51323, 18FV51324, 18FV51326, 18FV51353, 18FV51362, 18FV51365, 18FV51403, 18FV51405, 18FV51411, 18FV51416, 18FV51425, 18FV51474, 18FV51482, 18FV51496, 18FV51623, 18FV51629, 18FV51651, 18FV51682, 18FV51696, 18FV51735, 18FV51757, 18FV51895, 18FV52007, 18FV52024, 18FV52067, 18FV52078, 18FV52099, 18FV52106, 18FV52115, 18FV52374, 18FV52380, 18FV52394, 18FV52426, 18FV52483, 18FV52644, 18FV52673, 18FV52721, 18FV52749, 18FV52778, 18FV52794, 18FV52834, 18FV52859, 18FV52894, 18FV52914, 18FV53018, 18FV53113, 18FV53163, 18FV53326, 18FV53362, 18FV53452, 18FV53485, 18FV53535, 18FV53573, 18FV53734, 18FV53959, 18FV53981, 18FW38726, 18FW38731, 18FW38748, 18FW38779, 18FW38909, 18FW38916, 18FW38921, 18FW38929, 18FW38932, 18FW38949, 18FW38959, 18FW38993, 18FW39007, 18FW39062, 18FW39104, 18FW39143, 18FW39178, 18FW39217, 18FW39236, 18FW39350, 18FW39372, 18FW39451, 18FW39566, 18FW39645, 18FW39659, 18FW39673, 18FW39792, 18FW39802, 18FW39811, 18FW39917, 18FW40008, 18FW40014, 18FW40076, 18FW40111, 18FW40134, 18FW40180, 18FW40278, 18FW40306, 18FW40309, 18FW40427, 18FW40448, 18FW40450, 18FW40472, 18FW40478, 18FW40483, 18FW40511, 18FW40570, 18FW40624, 18FW40646, 18FW40664, 18FW40699, 18FW40718, 18FW40739, 18FW40874, 18FW40968, 18FW41000, 18FW41046, 18FW41105, 18FW41117, 18FW41127, 18FW41278, 18FW41383, 18FW41463, 18FW41533, 18FW41601, 18FW41645, 18FW41653, 18FW41681, 18FW41812, 18FW41867, 18FW41930, 18FW42165, 18FW42300, 18FW42353, 18FW42369, 18FW42382, 18FW42523, 18FW42560, 18FW42571, 18FW42578, 18FW42725, 18FW42799, 18FW42813, 18FW42857, 18FW42874, 18FW42902, 18FW42931, 18FW42934, 18FW43159, 18FW43162, 18FW43171, 18FW43205, 18FW43218, 18FW43229, 18FW43256, 18FW43261, 18FW43394, 18FW43497, 18FW43660, 18FW43675, 18FW43811, 18FW43817, 18FW43942, 18FW43974, 18FW44043, 18FW44083, 18FW44101, 18FW44392, 18FW44421, 18FW44574, 18FW44606, 18FW44691, 18FW44755, 18FW45054, 18FW45068, 18FW45074, 18FW45087, 18FW45120, 18FW45264, 18FW45377, 18FW45390, 18FW45513, 18FW45573, 18FW45617, 18FW45627, 18FW45700, 18FW45727, 18FW45851, 18FW45890, 18FW45899, 18FW45905, 18FW46054, 18FW46080, 18FW46111, 18FW46154, 18FW46229, 18FW46277, 18FW46282, 18FW46288, 18FW46306, 18FW46448, 18FW46501, 18FW46564, 18FW46570, 18FW46618, 18FW46629, 18FW46630, 18FW46631, 18FW46651, 18FW46763, 18FW46933, 18FX46660, 18FX46677, 18FX46700, 18FX46762, 18FX46820, 18FX46840, 18FX46851, 18FX46866, 18FX46978, 18FX46981, 18FX47623, 18FX47722, 18FX47742, 18FX47791, 18FX47860, 18FX48026, 18FX48097, 18FX48112, 18FX48216, 18FX48257, 18FX48469, 18FX48546, 18FX48638, 18FX48777, 18FX48876, 18FX48886, 18FX48942, 18FX49099, 18FX49155, 18FX49209, 18FX49216, 18FX49238, 18FX49282, 18FX49284, 18FX49290, 18FX49313, 18FX49395, 18FX49419, 18FX49437, 18FX49523, 18FX49561, 18FX49620, 18FX49627, 18FX49659, 18FX50501, 18FX50586, 18FX50860, 18FX50896, 18FX50901, 18FX50975, 18FX50980, 18FX50988, 18FX51010, 18FX51048, 18FX51075, 18FX51101, 18FX51237, 18FX51310, 18FX51327, 18FX51382, 18FX51431, 18FX51479, 18FX51574, 18FX51631, 18FX51760, 18FX51873, 18FX52059, 18FX52148, 18FX52182, 18FX52193, 18FX52209, 18FX52284, 18FX52327, 18FX52437, 18FX52831, 18FX52835, 18FX52846, 18FX52861, 18FX52867, 18FX52889, 18FX52928, 18FX53093, 18FX53144, 18FX53173, 18FX53417, 18FX53430, 18FX53453, 18FX53466, 18FX53634, 18FX53720, 18FX53743, 18FX53833, 18FX53838, 18FX53879, 18FX53889, 18FX53917, 18FX54036, 18FX54038, 18FX54125, 18FX54148, 18FX54177, 18FX54419, 18FX54475, 18FX54482, 18FX54564, 18FX54618, 18FX54644, 18FX54717, 18FX54723, 18FX54888, 18FX54903, 18FX54911, 18FX54919, 18FX54922, 18FX54929, 18FX54995, 18FX55025, 18FY02851, 18FY02908, 18FY02921, 18FY02932, 18FY03090, 18FY03144, 18FY03162, 18FY03229, 18FY03259, 18FY03387, 18FY03392, 18FY03469, 18FY03496, 18FY03555, 18FY03604, 18FY03605, 18FY03724, 18FY03799, 18FY03802, 18FY03803, 18FY03804, 18FY03836, 18FY03893, 18FY03940, 18FY03943, 18FY04000, 18FY04038, 18FY04087, 18FY04092, 18FY04174, 18FY04219, 18FY04441, 18FY04464, 18FY04473, 18FY04598, 18FY04612, 18FY04613, 18FY04748, 18FY04753, 18FY04802, 18FY04859, 18FY04862, 18FY04891, 18FY04938, 18FY04968, 18FY04983, 18FY05001, 18FY05004, 18FY05052, 18FY05088, 18FY05149, 18FY05175, 18FY05182, 18FY05203, 18FY05216, 18FY05250, 18FY05273, 18FY05278, 18FY05282, 18FY05284, 18FY05403, 18FY05415, 18FY05416, 18FY05505, 18FY05509, 18FY05573, 18FY05690, 18FY05709, 18FY05718, 18FY05727, 18FY05735, 18FY05741, 18FY05988, 18FY06001, 18FY06030, 18FY06046, 18FY06076, 18FY06083, 18FY06109, 18FY06170, 18FY06192, 18FY06428, 18FY06462, 18FY06599, 18FY06624, 18FY06703, 18FY06717, 18FY06734, 18FY06882, 18FY06965, 18FY07047, 18FY07102, 18FY07106, 18FY07146, 18FY07158, 18FY07176, 18FY07334, 18FY07350, 18FY07421, 18FY07586, 18FY07600, 18FY07622, 18FY07722, 18FY07725, 18FY07741, 18FY07780, 18FY07849, 18FY08008, 18FY08309, 18FY08338, 18FY08540, 18FY08558, 18FY08563, 18FY08614, 18FY08640, 18FY08647, 18FY08649, 18FY08652, 18FY08659, 18FY08737, 18FY08772, 18FY08789, 18FY08807, 18FY08825, 18FY08835, 18FY08870, 18FY08886, 18FY08951, 18FY08953, 18FY09044, 18FY09071, 18FY09101, 18FY09118, 18FY09121, 18FY09135, 18FY09138, 18FY09260, 18FY09364, 18FY09483, 18FY09761, 18FY10000, 18FY10028, 18FY10079, 18FY10161, 18FY10166, 18FY10317, 18FY10331, 18FY10351, 18FY10401, 18FY10461, 18FY10593, 18FY10622, 18FY10681, 18FY10916, 18FY10961, 18FY10976, 18FY11108, 18FY11109, 18FY11127, 18FY11129, 18FY11185, 18FY11203, 18FY11285, 18FY11288, 18FY11295, 18FY11342, 18FY11375, 18FY11378, 18FY11379, 18FY11416, 18FY11439, 18FY11440, 18FY11563, 18FY11626, 18FY11719, 18FY11732, 18FY11736, 18FY11797, 18FY11850, 18FY11852, 18FY11868, 18FZ32964, 18FZ32997, 18FZ33030, 18FZ33048, 18FZ33062, 18FZ33070, 18FZ33076, 18FZ33146, 18FZ33282, 18FZ33347, 18FZ33644, 18FZ33679, 18FZ33692, 18FZ33743, 18FZ33796, 18FZ33829, 18FZ33966, 18FZ33967, 18FZ33968, 18FZ34077, 18FZ34131, 18FZ34153, 18FZ34267, 18FZ34318, 18FZ34330, 18FZ34366, 18FZ34427, 18FZ34476, 18FZ34490, 18FZ34494, 18FZ34513, 18FZ34543, 18FZ34581, 18FZ34588, 18FZ34609, 18FZ34610, 18FZ34619, 18FZ34679, 18FZ34728, 18FZ34770, 18FZ34814, 18FZ34839, 18FZ34851, 18FZ34852, 18FZ34922, 18FZ34963, 18FZ35083, 18FZ35135, 18FZ35185, 18FZ35227, 18FZ35283, 18FZ35303, 18FZ35306, 18FZ35312, 18FZ35362, 18FZ35548, 18FZ35549, 18FZ35570, 18FZ35644, 18FZ35680, 18FZ35703, 18FZ35729, 18FZ35748, 18FZ35816, 18FZ35934, 18FZ35938, 18FZ35981, 18FZ35984, 18FZ35990, 18FZ36168, 18FZ36192, 18FZ36243, 18FZ36285, 18FZ36296, 18FZ36297, 18FZ36299, 18FZ36326, 18FZ36341, 18FZ36391, 18FZ36407, 18FZ36408, 18FZ36437, 18FZ36689, 18FZ36768, 18FZ36795, 18FZ36808, 18FZ36885, 18FZ36933, 18FZ36955, 18FZ37223, 18FZ37225, 18FZ37231, 18FZ37233, 18FZ37237, 18FZ37238, 18FZ37239, 18FZ37242, 18FZ37258, 18FZ37310, 18FZ37331, 18FZ37395, 18FZ37470, 18FZ37485, 18FZ37528, 18FZ37622, 18FZ37704, 18FZ37742, 18FZ37831, 18FZ37866, 18FZ37907, 18FZ37908, 18FZ37944, 18FZ37955, 18FZ37959, 18FZ38009, 18FZ38054, 18FZ38157, 18FZ38283, 18FZ38330, 18FZ38392, 18FZ38457, 18FZ38526, 18FZ38539, 18FZ38548, 18FZ38564, 18FZ38594, 18FZ38605, 18FZ38644, 18FZ38649, 18FZ38679, 18FZ38729, 18FZ38749, 18FZ38862, 18FZ38873, 18FZ38887, 18FZ38899, 18FZ38907, 18FZ38912, 18FZ38920, 18FZ38942, 18FZ39040, 18FZ39081, 18FZ39085, 18FZ39164, 18FZ39202, 18FZ39241, 18FZ39330, 18FZ39349, 18FZ39421, 18FZ39450, 18FZ39525, 18FZ39539, 18FZ39676, 18FZ39773, 18FZ39862, 18FZ39892, 18FZ39908, 18FZ39921, 18FZ39926, 18FZ39930, 18FZ40043, 18GC05029, 18GC05060, 18GC05099, 18GC05116, 18GC05118, 18GC05164, 18GC05181, 18GC05203, 18GC05204, 18GC05378, 18GC05422, 18GC05433, 18GC05466, 18GC05486, 18GC05544, 18GC05731, 18GC05754, 18GC05784, 18GC05787, 18GC05817, 18GC05841, 18GC05976, 18GC05983, 18GC06164, 18GC06186, 18GC06234, 18GC06368, 18GC06706, 18GC06824, 18GC06830, 18GC06840, 18GC06845, 18GC06874, 18GC06878, 18GC06917, 18GC06939, 18GC06971, 18GC06973, 18GC07122, 18GC07222, 18GC07301, 18GC07345, 18GC07363, 18GC07371, 18GC07405, 18GC07416, 18GC07450, 18GC07468, 18GC07541, 18GC07607, 18GC07613, 18GC07657, 18GC07719, 18GC07720, 18GC07751, 18GC07926, 18GC08176, 18GC08357, 18GC08414, 18GC08581, 18GC08755, 18GC08913, 18GC08927, 18GC09011, 18GC09129, 18GC09146, 18GC09148, 18GC09169, 18GC09183, 18GC09251, 18GC09294, 18GC09298, 18GC09503, 18GC09528, 18GC09648, 18GC09688, 18GC09718, 18GC09720, 18GC09734, 18GC09735, 18GC09758, 18GC09823, 18GC09916, 18GC09933, 18GC09936, 18GC09937, 18GC10130, 18GC10131, 18GC10147, 18GC10497, 18GC10534, 18GC10540, 18GC10632, 18GC10671, 18GC10748, 18GC10754, 18GC10884, 18GC10931, 18GC10934, 18GC10951, 18GC10966, 18GC10971, 18GC11020, 18GC11056, 18GC11128, 18GC11140, 18GC11177, 18GC11255, 18GC11264, 18GC11283, 18GC11284, 18GC11412, 18GC11432, 18GC11441, 18GC11669, 18GC11691, 18GC11926, 18GC12011, 18GC12027, 18GC12102, 18GC12108, 18GC12110, 18GC12120, 18GC12135, 18GC12137, 18GC12166, 18GC12254, 18GC12314, 18GC12323, 18GC12353, 18GC12536, 18GC12553, 18GC12560, 18GC12562, 18GC12788, 18GC12839, 18GC12889, 18GC12890, 18GC12904, 18GC12948, 18GC12957, 18GC12976, 18GC13042, 18GC13104, 18GC13139, 18GC13181, 18GC13288, 18GC13289, 18GC13299, 18GC13305, 18GC13369, 18GC13440, 18GC13480, 18GC13564, 18GC13654, 18GC13849, 18GC13930, 18GH88170, 18GH88414, 18GH88449, 18GH88468, 18GH88573, 18GH88612, 18GH88635, 18GH88819, 18GH89164, 18GH89489, 18GH89491, 18GH89672, 18GH89865, 18GH89895, 18GH89919, 18GH90272, 18GH90448, 18GH90466, 18GH90469, 18GH90478, 18GH90484, 18GH90856, 18GH90911, 18GH90913, 18GH90921, 18GH91092, 18GH91099, 18GH91275, 18GH91321, 18GH91333, 18GH91344, 18GH91605, 18GH91656, 18GH91705, 18GH91848, 18GH91943, 18GH92017, 18GH92106, 18GH92263, 18GH92539, 18GH92645, 18GH92708, 18GH92872, 18GH92881, 18GH92935, 18GH93091, 18GH93301, 18GH93304, 18GH93341, 18GH93356, 18GH93365, 18GH93369, 18GH93409, 18GH93439, 18GH93533, 18GH93598, 18GH93790, 18GH93858, 18GH93931, 18GH94028, 18GM02067, 18GM02099, 18GM02102, 18GM02106, 18GM02131, 18GM02176, 18GM02278, 18GM02293, 18GM02420, 18GM02447, 18GM02475, 18GM02724, 18GM02759, 18GM02764, 18GM02819, 18GM02887, 18GM02956, 18GM02971, 18GM02973, 18GM02984, 18GM02990, 18GM02998, 18GM03021, 18GM03032, 18GM03056, 18GM03058, 18GM03059, 18GM03158, 18GM03171, 18GM05603, 18GN20606, 18GN20609, 18GN20613, 18GN20652, 18GN20795, 18GN20806, 18GN20900, 18GN20905, 18GN20951, 18GN20981, 18GN20992, 18GN21051, 18GN21056, 18GN21074, 18GN21089, 18GN21165, 18GN21225, 18GN21298, 18GN21385, 18GN21545, 18GN21556, 18GN21602, 18GN21641, 18GN21644, 18GN21650, 18GN21718, 18GN21745, 18GN21775, 18GN21779, 18GN21781, 18GN21784, 18GN21902, 18GN21908, 18GN21936, 18GN21990, 18GN22000, 18GN22020, 18GN22026, 18GN22027, 18GN22065, 18GN22067, 18GN22099, 18GN22101, 18GN22128, 18GN22189, 18GN22191, 18GN22335, 18GN22360, 18GN22394, 18GN22422, 18GN22506, 18GN22515, 18GN22520, 18GN22522, 18GN22523, 18GN22528, 18GN22555, 18GN22619, 18GN22821, 18GN22915, 18GN22944, 18GN23214, 18GN23268, 18GN23369, 18GN23450, 18GN23458, 18GN23499, 18GN23726, 18GN23913, 18GN23918, 18GN23946, 18GN24017, 18GN24023, 18GN24083, 18GN24118, 18GN24219, 18GN24288, 18GN24345, 18GN24353, 18GN24358, 18GN24359, 18GN24371, 18GN24408, 18GN24440, 18GN24594, 18GN24617, 18GN24618, 18GN24775, 18GN24879, 18GN24889, 18GN24917, 18GN24924, 18GN24940, 18GN24963, 18GN24965, 18GN24967, 18GN24969, 18GN25025, 18GN25059, 18GN25073, 18GN25087, 18GN25103, 18GN25113, 18GN25128, 18GN25354, 18GN25362, 18GN25364, 18GN25396, 18GN25414, 18GN25418, 18GN25423, 18GN25428, 18GN25463, 18GN25472, 18GN25498, 18GN25499, 18GN25502, 18GN25509, 18GN25516, 18GN25541, 18GN25544, 18GN25685, 18GN25691, 18GN25729, 18GN25812, 18GN25902, 18GN25907, 18GN25911, 18GN25930, 18GN26019, 18GN26141, 18GN26145, 18GN26218, 18GN26287, 18GN26304, 18GN26333, 18GN26336, 18GN26373, 18GN26378, 18GN26390, 18GN26434, 18GN26448, 18GN26514, 18GN26548, 18GN26734, 18GP14707, 18GP14720, 18GP14722, 18N84162, 18N84276, 18N84282, 18N84319, 18N84407, 18N84564, 18N84565, 18N84658, 18N84681, 18N84759, 18N84819, 18N84827, 18N84954, 18N85044, 18N85114, 18N85195, 18N85209, 18N85236, 18N85539, 18N85588, 18N85589, 18N85650, 18N85654, 18N85742, 18N85807, 18N85847, 18N85926, 18N86075, 18N86117, 18N86203, 18N86428, 18N86460, 18N86565, 18N86614, 18N86880, 18N86998, 18N87061, 18N87249, 18N87297, 18N87458, 18N87478, 18N87485, 18N87691, 18N87735, 18N87801, 18N87884, 18N88029, 18N88381, 18N88447, 18N88472, 18N88494, 18N88531, 18N88558, 18N88563, 18N88599, 18N88664, 18N88707, 18N88766, 18N88857, 18N88899;

c) Units: 18FE98536, 18FE99216, 18FJ64245, 18FK72402, 18FK73972, 18FK75026, 18FK78853, 18FR81665, 18FT68325, 18FT70956, 18FT71138, 18FT72978, 18FT73015, 18FT73820, 18FT76087, 18FT76108, 18FT80525, 18FV46099, 18FV47785, 18FX48408, 18FX53325, 18FY04577, 18FY04623, 18FY05395, 18FY05441, 18FY08808, 18FY11839, 18FZ33133, 18FZ36328, 18FZ38500, 18GH93351, 18GN25173, 18N86835;

d) Units: 18FS70637, 18GN22019;

e) Unit: 18FT80393;

f) Units: 18FT75857, 18FT76477 (2 units), 18FT76676 (2 units), 18FT78166 (2      units),   18FT79639 (2 units);

g) Units: 18FE94300, 18FE94329, 18FE94496, 18FE94702, 18FE94766, 18FE94768, 18FE95508, 18FE95899, 18FE96171, 18FE96277, 18FE96316, 18FE96344, 18FE96466, 18FE96512, 18FE97255, 18FE97716, 18FE97861, 18FE97896, 18FE98248, 18FE98256, 18FE99635, 18FF08811, 18FJ59179, 18FJ59185, 18FJ59971, 18FJ60053, 18FJ60062, 18FJ60529, 18FJ60841, 18FJ61069, 18FJ61077, 18FJ61086, 18FJ61320, 18FJ62033, 18FJ62036, 18FJ62556, 18FJ62569, 18FJ62597, 18FJ62702, 18FJ63087, 18FJ63448, 18FJ63594, 18FJ63899, 18FJ64051, 18FJ64755, 18FJ64756, 18FK72514, 18FK72576, 18FK72596, 18FK72728, 18FK72757, 18FK73228, 18FK73513, 18FK73565, 18FK73597, 18FK73670, 18FK73972, 18FK74022, 18FK74144, 18FK74160, 18FK74363, 18FK74382, 18FK74402, 18FK74465, 18FK74908, 18FK74962, 18FK75084, 18FK75085, 18FK75103, 18FK75113, 18FK75129, 18FK75209, 18FK75217, 18FK75223, 18FK75224, 18FK75225, 18FK75305, 18FK75368, 18FK75369, 18FK75881, 18FK76000, 18FK76330, 18FK76364, 18FK76366, 18FK77232, 18FK77935, 18FK78374, 18FK78376, 18FK78501, 18FK78692, 18FK78794, 18FK79243, 18FQ84355, 18FQ84366, 18FQ84388, 18FQ84424, 18FQ84457, 18FQ84483, 18FQ85642, 18FQ85646, 18FQ85691, 18FQ85729, 18FQ85851, 18FQ85859, 18FQ85865, 18FQ86819, 18FQ87198, 18FQ87915, 18FQ88877, 18FQ88919, 18FQ90430, 18FQ90454, 18FR78218, 18FR79070, 18FR79279, 18FR79838, 18FR79932, 18FR80069, 18FR80204, 18FR80492, 18FR81563, 18FR81681, 18FR81696, 18FR82494, 18FR82962, 18FR83173, 18FR83313, 18FR83522, 18FR83600, 18FR84331, 18FS69295, 18FS69678, 18FS70448, 18FS70574, 18FS70585, 18FS70625, 18FS70637, 18FS70741, 18FS71081, 18FS71199, 18FS71436, 18FS71732, 18FS71761, 18FS71861, 18FS71924, 18FS71934, 18FS71962, 18FS72593, 18FS72614, 18FS72684, 18FS72749, 18FS74076, 18FS74177, 18FS74382, 18FS74976, 18FS75435, 18FS75473, 18FS75488, 18FT68358, 18FT68846, 18FT69190, 18FT69550, 18FT69556, 18FT69572, 18FT69628, 18FT69944, 18FT70121, 18FT70236, 18FT70404, 18FT70491, 18FT70506, 18FT70514, 18FT70613, 18FT70637, 18FT70666, 18FT70748, 18FT70787, 18FT70956, 18FT70972, 18FT71070, 18FT71091, 18FT71138, 18FT71419, 18FT71517, 18FT71525, 18FT71645, 18FT72238, 18FT72344, 18FT72650, 18FT73114, 18FT73128, 18FT73438, 18FT74281, 18FT75285, 18FT77512, 18FT77522, 18FT77589, 18FT77590, 18FT77592, 18FT77597, 18FT77604, 18FT77693, 18FT77704, 18FT77716, 18FT78050, 18FT78132, 18FT78229, 18FT78685, 18FT78779, 18FT79024, 18FT79213, 18FT79222, 18FT79643, 18FV46022, 18FV46174, 18FV46362, 18FV46375, 18FV46386, 18FV46467, 18FV46990, 18FV47213, 18FV47386, 18FV47785, 18FV47793, 18FV47797, 18FV47798, 18FV47819, 18FV48060, 18FV48119, 18FV48127, 18FV48223, 18FV48415, 18FV48421, 18FV48425, 18FV48486, 18FV48762, 18FV49042, 18FV49676, 18FV49861, 18FV50571, 18FV51002, 18FV51319, 18FV51324, 18FV51425, 18FV51651, 18FV52024, 18FV52043, 18FV52099, 18FV52115, 18FV52749, 18FW38748, 18FW38779, 18FW39062, 18FW39104, 18FW39217, 18FW39645, 18FW39802, 18FW40014, 18FW40309, 18FW41046, 18FW41105, 18FW41117, 18FW41645, 18FW42523, 18FW42560, 18FW42578, 18FW42725, 18FW42799, 18FW42804, 18FW42813, 18FW42874, 18FW42902, 18FW43205, 18FW44043, 18FW44083, 18FW44101, 18FW44691, 18FW45054, 18FW45074, 18FW45087, 18FW45390, 18FX46677, 18FX46700, 18FX47623, 18FX47791, 18FX48204, 18FX48408, 18FX49209, 18FX49290, 18FX49313, 18FX49561, 18FX49822, 18FX51010, 18FX51237, 18FX51310, 18FX52284, 18FX53048, 18FX53325, 18FX53417, 18FX53430, 18FX53453, 18FX53634, 18FX53917, 18FX54419, 18FY02851, 18FY03259, 18FY03555, 18FY04038, 18FY04441, 18FY04473, 18FY04623, 18FY04748, 18FY04753, 18FY04891, 18FY04961, 18FY04968, 18FY04983, 18FY05415, 18FY05416, 18FY05441, 18FY05514, 18FY05690, 18FY05709, 18FY05727, 18FY05988, 18FY06001, 18FY06083, 18FY06170, 18FY06599, 18FY06722, 18FY06734, 18FY07600, 18FY07622, 18FY07640, 18FY08268, 18FY08772, 18FY08825, 18FY08835, 18FY09071, 18FY09101, 18FY09121, 18FY09529, 18FY11127, 18FY11129, 18FY11439, 18FZ32964, 18FZ33070, 18FZ33205, 18FZ33644, 18FZ33679, 18FZ33692, 18FZ34427, 18FZ34610, 18FZ34770, 18FZ34963, 18FZ35135, 18FZ35185, 18FZ35227, 18FZ35341, 18FZ35549, 18FZ35981, 18FZ35984, 18FZ35990, 18FZ36243, 18FZ36285, 18FZ36328, 18FZ36341, 18FZ36437, 18FZ36808, 18FZ36955, 18FZ37573, 18FZ37622, 18FZ37866, 18FZ37908, 18FZ38054, 18FZ38283, 18FZ38330, 18FZ38526, 18FZ38548, 18FZ38594, 18FZ38605, 18FZ38649, 18FZ39040, 18FZ39862, 18GC05060, 18GC05164, 18GC05181, 18GC05204, 18GC05422, 18GC05433, 18GC05544, 18GC06234, 18GC07122, 18GC07301, 18GC07345, 18GC07348, 18GC07363, 18GC07468, 18GC08176, 18GC08927, 18GC08953, 18GC09183, 18GC09213, 18GC09688, 18GC09933, 18GC09936, 18GC10534, 18GC10931, 18GC11056, 18GC11283, 18GC11412, 18GC11691, 18GC11926, 18GC12904, 18GH89865, 18GH90913, 18GH91705, 18GH92708, 18GM02099, 18GM02102, 18GM02420, 18GM02764, 18GN21165, 18GN21298, 18GN21556, 18GN21602, 18GN21644, 18GN21650, 18GN21902, 18GN22335, 18GN22360, 18GN22394, 18GN22422, 18GN23913, 18GN24023, 18GN24358, 18GN24371, 18GN24594, 18GN24617, 18GN25103, 18GN25414, 18GN25418, 18GN25423, 18GN25509, 18GN25541, 18GN26218, 18N84819, 18N84827, 18N85114, 18N87061, 18N87478;

h) Units: 18FE96170, 18FE97638, 18FJ63080, 18FJ63449, 18FJ63769, 18FJ65138, 18FJ65403, 18FK74715, 18FK75723, 18FK75882, 18FK75885, 18FK76800, 18FK76803, 18FK76867, 18FK77338, 18FQ89809, 18FQ90077, 18FR82052, 18FR82106, 18FS71052, 18FS72643, 18FS73447, 18FS74213, 18FS74900, 18FT71374, 18FT71377, 18FT71892, 18FT71949, 18FT72518, 18FT73251, 18FT77724, 18FT77859, 18FT78113, 18FT78183, 18FT79555, 18FV47025, 18FV47495, 18FV48560, 18FV49544, 18FV50256, 18FV50267, 18FV50269, 18FV52007, 18FV52374, 18FW40306, 18FW41653, 18FW42297, 18FW43229, 18FW43675, 18FW44392, 18FW45264, 18FX50975, 18FX51873, 18FX52182, 18FX52193, 18FX52209, 18FX53715, 18FX54177, 18FY05403, 18FY05505, 18FY07722, 18FY07741, 18FY07754, 18FY09135, 18FY09138, 18FY10166, 18FZ35283, 18FZ36296, 18FZ36297, 18FZ36299, 18FZ36454, 18FZ37395, 18FZ37955, 18FZ39892, 18GC06029, 18GC06706, 18GC09675, 18GC10540, 18GC11264, 18GC13356, 18GH90466, 18GH91275, 18GN22189, 18GN23268, 18GN24017, 18GN25025, 18GN25087, 18GN25472, 18GN26390;

i) Units: 18FE94699, 18FE94702, 18FE95543, 18FE95609, 18FE96466, 18FJ59591, 18FJ59872, 18FJ60003, 18FJ60638, 18FJ60695, 18FJ61089, 18FK72918, 18FK73821, 18FK73972, 18FK74022, 18FK74962, 18FK75103, 18FK75113, 18FK75116, 18FK78994, 18FQ84424, 18FQ84430, 18FQ84495, 18FQ85691, 18FQ90309, 18FR77942, 18FR77971, 18FR78192, 18FR78392, 18FR78531, 18FR81035, 18FR81052, 18FS69511, 18FS69957, 18FS70253, 18FS75217, 18FS77734, 18FT68218, 18FT68219, 18FT68288, 18FT68535, 18FT68648, 18FT68846, 18FT68965, 18FT69052, 18FT69086, 18FT69092, 18FT69112, 18FT69151, 18FT69190, 18FT69217, 18FT69238, 18FT69389, 18FT69702, 18FT69921, 18FT69944, 18FT70026, 18FT70098, 18FT70121, 18FT70172, 18FT70190, 18FT70236, 18FT70491, 18FT70493, 18FT70613, 18FT70854, 18FT71037, 18FT71419, 18FT71515, 18FT71773, 18FT71949, 18FT72022, 18FT72100, 18FT72238, 18FT72344, 18FT72449, 18FT72603, 18FT72650, 18FT72923, 18FT73006, 18FT73015, 18FT73114, 18FT73165, 18FT73814, 18FT73987, 18FT74028, 18FT74281, 18FT76541, 18FT77049, 18FT77573, 18FT77584, 18FT77589, 18FT77590, 18FT77597, 18FT77604, 18FT77627, 18FT77693, 18FT77704, 18FT78050, 18FT78183, 18FT78412, 18FT78470, 18FT78531, 18FT78700, 18FT78732, 18FT78744, 18FT78849, 18FT79222, 18FT79238, 18FT79860, 18FT80085, 18FT80239, 18FT80253, 18FT80393, 18FT80415, 18FT80469, 18FT80714, 18FT80768, 18FV45874, 18FV45935, 18FV45946, 18FV46095, 18FV46156, 18FV47350, 18FV47687, 18FV47700, 18FV47785, 18FV47793, 18FV47797, 18FV47816, 18FV48223, 18FV48486, 18FV48557, 18FV48560, 18FW38726, 18FW38909, 18FW38932, 18FW38949, 18FW38959, 18FW39372, 18FW39645, 18FW39917, 18FW40450, 18FW40664, 18FW41278, 18FW45573, 18FW45578, 18FW45617, 18FW45627, 18FW46618, 18FW46630, 18FX48097, 18FX48112, 18FX49209, 18FX49238, 18FX54177, 18FY02932, 18FY03604, 18FY03724, 18FY03799, 18FY03802, 18FY03803, 18FY04038, 18FY05395, 18FY05505, 18FY05509, 18FY11868, 18FZ33030, 18FZ33829, 18FZ34366, 18FZ34427, 18FZ34581, 18FZ34610, 18FZ35303, 18FZ38887, 18FZ38899, 18GC05118, 18GC07657, 18GC11412, 18GH93356, 18GN21385, 18GN21775, 18GN21779, 18N84819, 18N84827;

j) Units: 18FS69886, 18FS75227, 18FT68803, 18FT72258, 18FY05573, 18FY10593, 18GN21089;

k) Units: 18FT73251, 18FT75285, 18FT79555;

l) Units: 18FE93763, 18FE93814, 18FE95026, 18FE95043, 18FE95207, 18FE95367, 18FE95543, 18FE95579, 18FE95609, 18FE95873, 18FE96606, 18FE97601, 18FE97737, 18FE98450, 18FE98699, 18FE99014, 18FE99807, 18FF08920, 18FJ59402, 18FJ59591, 18FJ59617, 18FJ59872, 18FJ60003, 18FJ60059, 18FJ60082, 18FJ60300, 18FJ60695, 18FJ61698, 18FJ62386, 18FJ62404, 18FJ63008, 18FJ63024, 18FJ63564, 18FJ64000, 18FJ64208, 18FJ64647, 18FJ64986, 18FJ65609, 18FK72287, 18FK72418, 18FK72615, 18FK73301, 18FK73402, 18FK73554, 18FK73712, 18FK74102, 18FK74171, 18FK74658, 18FK75541, 18FK76121, 18FK76151, 18FK76152, 18FK76154, 18FK76192, 18FK76391, 18FK76392, 18FK76417, 18FK76420, 18FK76421, 18FK76423, 18FK76433, 18FK76444, 18FK76450, 18FK76459, 18FK76698, 18FK76733, 18FK77533, 18FK77874, 18FK78544, 18FK78545, 18FK78559, 18FK78592, 18FK78652, 18FK78673, 18FK78680, 18FK78931, 18FK78994, 18FK79718, 18FK79870, 18FK80343, 18FK80606, 18FQ85302, 18FQ85468, 18FQ85733, 18FQ85797, 18FQ85833, 18FQ85905, 18FQ86286, 18FQ86499, 18FQ87735, 18FQ87960, 18FQ88062, 18FQ88469, 18FQ90309, 18FQ90337, 18FQ90338, 18FR77942, 18FR77971, 18FR78339, 18FR79310, 18FR79311, 18FR79552, 18FR80162, 18FR80171, 18FR80174, 18FR80386, 18FR80415, 18FR80464, 18FR80923, 18FR81211, 18FR81665, 18FR81869, 18FR81872, 18FR83242, 18FR83254, 18FR83298, 18FR83342, 18FR84016, 18FR84030, 18FR84060, 18FS69113, 18FS69886, 18FS69891, 18FS69957, 18FS69965, 18FS70064, 18FS70229, 18FS70230, 18FS70240, 18FS70253, 18FS70533, 18FS70571, 18FS71492, 18FS71780, 18FS71828, 18FS72496, 18FS72507, 18FS72531, 18FS72983, 18FS73224, 18FS73363, 18FS73491, 18FS73934, 18FS73948, 18FS74641, 18FS75227, 18FS77328, 18FS77358, 18FT68197, 18FT68218, 18FT68219, 18FT68268, 18FT68709, 18FT69086, 18FT69092, 18FT69151, 18FT69238, 18FT69329, 18FT69389, 18FT69702, 18FT69921, 18FT69933, 18FT70026, 18FT70062, 18FT70172, 18FT70190, 18FT70338, 18FT70854, 18FT71037, 18FT71488, 18FT71749, 18FT71773, 18FT71984, 18FT72012, 18FT72100, 18FT72148, 18FT72923, 18FT73006, 18FT73015, 18FT73066, 18FT73170, 18FT73224, 18FT73224, 18FT73224, 18FT73336, 18FT73487, 18FT73571, 18FT73645, 18FT73681, 18FT73698, 18FT73727, 18FT73802, 18FT73806, 18FT73808, 18FT73814, 18FT73935, 18FT73947, 18FT73963, 18FT73987, 18FT74028, 18FT74097, 18FT74526, 18FT74539, 18FT74557, 18FT74705, 18FT74742, 18FT75297, 18FT75346, 18FT75631, 18FT76254, 18FT76346, 18FT76492, 18FT76506, 18FT76516, 18FT76520, 18FT76613, 18FT76715, 18FT76719, 18FT76751, 18FT76762, 18FT76831, 18FT76985, 18FT77049, 18FT77299, 18FT77359, 18FT77536, 18FT77536, 18FT78354, 18FT78412, 18FT78445, 18FT78445, 18FT78445, 18FT78470, 18FT78531, 18FT78540, 18FT78681, 18FT78744, 18FT78767, 18FT79860, 18FT80085, 18FT80200, 18FT80239, 18FT80253, 18FT80301, 18FT80303, 18FT80393, 18FT80415, 18FT80512, 18FT80535, 18FT80683, 18FT80692, 18FT80971, 18FV45854, 18FV45867, 18FV45997, 18FV46899, 18FV46959, 18FV46981, 18FV47149, 18FV47216, 18FV47292, 18FV47350, 18FV47366, 18FV47609, 18FV47700, 18FV48150, 18FV48444, 18FV48557, 18FV48849, 18FV49062, 18FV49175, 18FV49764, 18FV50077, 18FV51009, 18FV51019, 18FV51264, 18FV51405, 18FV51474, 18FV51482, 18FV51496, 18FV51735, 18FV52721, 18FV52834, 18FV53362, 18FV53485, 18FV53734, 18FW38959, 18FW39811, 18FW39917, 18FW40008, 18FW40076, 18FW40134, 18FW40278, 18FW40427, 18FW40448, 18FW40450, 18FW40511, 18FW40570, 18FW40646, 18FW40664, 18FW40699, 18FW40718, 18FW40739, 18FW41000, 18FW41127, 18FW41278, 18FW41383, 18FW41930, 18FW43817, 18FW43974, 18FW44606, 18FW45573, 18FW45578, 18FW45617, 18FW45627, 18FW45700, 18FW45727, 18FW46288, 18FW46618, 18FW46629, 18FW46631, 18FX46791, 18FX48097, 18FX48112, 18FX48216, 18FX48226, 18FX48546, 18FX48777, 18FX49284, 18FX49620, 18FX51760, 18FX52861, 18FX52867, 18FX53583, 18FX53743, 18FX53833, 18FX53840, 18FX53879, 18FX53889, 18FX54148, 18FY02921, 18FY03604, 18FY03724, 18FY04087, 18FY04598, 18FY06109, 18FY06462, 18FY06703, 18FY07047, 18FY07106, 18FY07146, 18FY08309, 18FY08640, 18FY08870, 18FY08886, 18FY08951, 18FY08953, 18FY09044, 18FY09260, 18FY10028, 18FY10079, 18FY10681, 18FY11852, 18FY11868, 18FZ33030, 18FZ33782, 18FZ34069, 18FZ34077, 18FZ34153, 18FZ34267, 18FZ34366, 18FZ34476, 18FZ34513, 18FZ34619, 18FZ35083, 18FZ35312, 18FZ35703, 18FZ35729, 18FZ35934, 18FZ35938, 18FZ36168, 18FZ36391, 18FZ36407, 18FZ36408, 18FZ36795, 18FZ37035, 18FZ37310, 18FZ37485, 18FZ38009, 18FZ38873, 18FZ38887, 18FZ38899, 18FZ38912, 18FZ38942, 18FZ39081, 18FZ39085, 18FZ39539, 18GC05817, 18GC05976, 18GC05983, 18GC06164, 18GC06917, 18GC06939, 18GC07222, 18GC07450, 18GC07926, 18GC09011, 18GC09251, 18GC09823, 18GC09916, 18GC10497, 18GC10951, 18GC10966, 18GC10971, 18GC10982, 18GC11284, 18GC13104, 18GH93356, 18GM02887, 18GM02892, 18GM02956, 18GM02973, 18GM05603, 18GM05705, 18GN21385, 18GN21775, 18GN21779, 18GN21781, 18GN21784, 18GN21990, 18GN22128, 18GN22506, 18GN22515, 18GN22520, 18GN22523, 18GN22528, 18GN22619, 18GN24118, 18GN24353, 18GN24618, 18GN24879, 18GN24940, 18GN24965, 18GN24969, 18GN25354, 18GN25362, 18GN25691, 18GN26145, 18N85044, 18N85539, 18N86614, 18N87249, 18N87485, 18N88558, 18N88563, 18N88664;

m) Units: 18FE94329, 18FE94496, 18FE96349, 18FE98248, 18FJ59179, 18FJ59185, 18FJ60053, 18FJ60062, 18FJ63449, 18FJ63594, 18FJ64755, 18FK73228, 18FK73513, 18FK73670, 18FK73821, 18FK74273, 18FK74465, 18FK74908, 18FK75036, 18FK75116, 18FK76330, 18FK76366, 18FK77964, 18FK79254, 18FK79762, 18FQ85646, 18FQ85691, 18FQ88877, 18FR79070, 18FR80534, 18FR82494, 18FS69678, 18FS70625, 18FS71761, 18FS72614, 18FS72684, 18FT69550, 18FT69556, 18FT69572, 18FT69628, 18FT69944, 18FT70748, 18FT71070, 18FT71091, 18FT71892, 18FT72603, 18FT72650, 18FT73114, 18FT77602, 18FT77894, 18FT78132, 18FT78229, 18FT78732, 18FT80116, 18FV46362, 18FV46375, 18FV46386, 18FV47025, 18FV47816, 18FV48223, 18FV52024, 18FV52043, 18FW39372, 18FW39645, 18FW40309, 18FW41046, 18FW42165, 18FW42813, 18FX46677, 18FX48204, 18FX48408, 18FX49290, 18FX52059, 18FX53917, 18FY03555, 18FY04961, 18FY04968, 18FY05415, 18FY05514, 18FY05709, 18FY05741, 18FY06192, 18FY06734, 18FY09101, 18FY09529, 18FY10166, 18FY11129, 18FY11440, 18FZ33205, 18FZ33692, 18FZ34770, 18FZ36243, 18FZ37528, 18FZ38283, 18GC05164, 18GC05433, 18GC05544, 18GC06029, 18GC07348, 18GC08913, 18GC09213, 18GC09475, 18GC10671, 18GC11056, 18GC11283, 18GC11535, 18GC11647, 18GC12890, 18GC13214, 18GH92708, 18GM02759, 18GN21298, 18GN21902, 18GN22360, 18GN25509;

n) Units: 18FE94329, 18FE94890, 18FE96302, 18FE96972, 18FE99831, 18FE99841, 18FE99844, 18FE99983, 18FF09174, 18FJ59418, 18FJ62602, 18FJ63448, 18FJ64469, 18FJ64754, 18FJ64855, 18FJ65027, 18FJ65063, 18FJ65065, 18FJ65086, 18FJ65138, 18FJ65243, 18FJ65302, 18FJ65403, 18FJ65623, 18FJ65643, 18FJ65656, 18FJ65813, 18FJ65863, 18FJ65940, 18FK72757, 18FK75036, 18FK76391, 18FK76421, 18FK78514, 18FK78588, 18FK78617, 18FK78743, 18FK78853, 18FK78864, 18FK79283, 18FK79396, 18FK79400, 18FK79614, 18FK79809, 18FK80048, 18FK80249, 18FK80356, 18FK80427, 18FK80484, 18FQ85862, 18FQ89080, 18FQ89953, 18FQ89957, 18FQ89958, 18FQ90039, 18FQ90362, 18FQ90370, 18FQ90377, 18FQ90430, 18FQ90452, 18FQ90454, 18FQ90573, 18FQ90596, 18FQ90657, 18FQ90666, 18FR79374, 18FR79552, 18FR79682, 18FR81880, 18FR81892, 18FR81900, 18FR83402, 18FR84140, 18FR84234, 18FR84307, 18FR84456, 18FR84490, 18FR84500, 18FR84507, 18FR84517, 18FR84888, 18FR85005, 18FR85101, 18FS71658, 18FS71819, 18FS73019, 18FS75000, 18FS75014, 18FS75022, 18FS75095, 18FS75109, 18FS75276, 18FS77035, 18FS77059, 18FS77219, 18FS77267, 18FS77276, 18FS77280, 18FS77394, 18FS77524, 18FS77528, 18FS77585, 18FS77602, 18FS77672, 18FS77734, 18FT73170, 18FT73571, 18FT75136, 18FT75191, 18FT77536, 18FT77602, 18FT78174, 18FT78368, 18FT78607, 18FT78617, 18FT78848, 18FT78849, 18FT78852, 18FT79018, 18FT79188, 18FT79555, 18FT79643, 18FT79762, 18FT80249, 18FT80469, 18FT80490, 18FT80653, 18FV47609, 18FV47816, 18FV47819, 18FV48150, 18FV49618, 18FV49676, 18FV51396, 18FV52043, 18FV52067, 18FV52078, 18FV52380, 18FV52394, 18FV52426, 18FV52644, 18FV52673, 18FV52778, 18FV52794, 18FV52859, 18FV52914, 18FV53018, 18FV53113, 18FV53163, 18FV53535, 18FV53573, 18FV53897, 18FV53981, 18FW39458, 18FW42297, 18FW45068, 18FW45851, 18FW45890, 18FW45899, 18FW45905, 18FW46054, 18FW46080, 18FW46111, 18FW46154, 18FW46277, 18FW46282, 18FW46448, 18FW46501, 18FW46564, 18FW46763, 18FX48204, 18FX48226, 18FX50503, 18FX53048, 18FX53528, 18FX53720, 18FX53838, 18FX53903, 18FX54036, 18FX54125, 18FX54419, 18FX54445, 18FX54475, 18FX54564, 18FX54618, 18FX54644, 18FX54717, 18FX54723, 18FX54888, 18FX54903, 18FX54911, 18FX54919, 18FX54922, 18FX54929, 18FX54995, 18FX55025, 18FY04824, 18FY05810, 18FY05827, 18FY07134, 18FY07754, 18FY07933, 18FY09529, 18FY10000, 18FY10161, 18FY10317, 18FY10331, 18FY10351, 18FY10401, 18FY10461, 18FY10506, 18FY10916, 18FY10976, 18FY11109, 18FY11127, 18FY11185, 18FY11203, 18FY11285, 18FY11288, 18FY11295, 18FY11342, 18FY11375, 18FY11378, 18FY11379, 18FY11416, 18FY11439, 18FY11563, 18FY11626, 18FY11719, 18FY11724, 18FZ33205, 18FZ34069, 18FZ35341, 18FZ36454, 18FZ36907, 18FZ37035, 18FZ37573, 18FZ37618, 18FZ38907, 18FZ39065, 18FZ39202, 18FZ39241, 18FZ39330, 18FZ39349, 18FZ39450, 18FZ39525, 18FZ39676, 18FZ39773, 18FZ39862, 18FZ39892, 18FZ39921, 18FZ39926, 18GC06029, 18GC07326, 18GC07348, 18GC09151, 18GC09213, 18GC09475, 18GC09675, 18GC11432, 18GC11441, 18GC11647, 18GC11669, 18GC12011, 18GC12027, 18GC12102, 18GC12108, 18GC12120, 18GC12135, 18GC12137, 18GC12254, 18GC12314, 18GC12323, 18GC12353, 18GC12536, 18GC12553, 18GC12560, 18GC12562, 18GC12788, 18GC12839, 18GC12889, 18GC12904, 18GC12948, 18GC12957, 18GC12976, 18GC13042, 18GC13139, 18GC13181, 18GC13288, 18GC13289, 18GC13299, 18GC13305, 18GC13356, 18GC13369, 18GC13564, 18GH09866, 18GH92645, 18GH92872, 18GH92935, 18GH93091, 18GH93301, 18GH93304, 18GH93341, 18GH93351, 18GH93365, 18GH93369, 18GH93533, 18GH93598, 18GH93790, 18GH93858, 18GH93934, 18GM02106, 18GM02131, 18GM02176, 18GM02278, 18GM02447, 18GM02475, 18GM02724, 18GM02764, 18GM02819, 18GM02971, 18GM02984, 18GM02990, 18GM02998, 18GM03021, 18GM03032, 18GM03056, 18GM03058, 18GM03059, 18GM03171, 18GN23282, 18GN24332, 18GN25396, 18GN25461 (2 units), 18GN25463, 18GN25498, 18GN25499, 18GN25502, 18GN25685, 18GN25714, 18GN25714, 18GN25729, 18GN25902, 18GN25907, 18GN25911, 18GN25930, 18GN26140, 18GN26141, 18GN26218, 18GN26287, 18GN26304, 18GN26373, 18GN26413, 18GN26434, 18GN26448, 18N86685, 18N87735, 18N87799 (2 units), 18N87801, 18N87884, 18N88381, 18N88447, 18N88472, 18N88494, 18N88531, 18N88599, 18N88707, 18N88766, 18N88857, 18N88899, 18FR82587, 18FS75288, 18FT78475, 18FT78481, 18FV53326, 18FW45377, 18FX54482, 18FY11736, 18GN26378, 18GN26576, 18N87691
RECALLING FIRM/MANUFACTURER

American National Red Cross, Great Lakes Region, Lansing, MI, by letters dated between October 2, 2003 and January 12, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose health history screening for risk factors for Creutzfeldt-Jakob Disease (CJD) and variant Creutzfeldt-Jakob Disease )vCJD) was done with an obsolete questionnaire, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4,048 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Plasma Cryoprecipitate Reduced Recall # B-0116-08;
b) Red Blood Cells Leukocytes Reduced (Apheresis), Recall # B-0117-08;
c) Red Blood Cells Leukocytes Reduced, Recall # B-0118-08;
d) Fresh Frozen Plasma (Apheresis), Recall # B-0119-08;
e) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0120-08;
f) Plasma Frozen, Recall # B-0121-08;
g) Red Blood Cells Leukocytes Reduced Washed, Recall # : B-0122-08;
h) Platelets Pheresis Leukocytes Reduced, Recall # : B-0123-08
CODE
a) Lot #’s: 30743-7345, 30743-7348, 30743-7554, and 30743-7565;
b) Lot #’s: 30743-7356 (split product), 30743-7546 (split product), 30743-8082
    (split product), 30743-8093 (split product), 30743-8099 (split product), 30743-8119
    (split product), 30743-8145 (split product), 30743-8161 (split product), 30744-0221
    (split product), 30744-0225 (split product), 30744-1941 (split product), 30744-1973
    (split product), 30744-2483 (split product), 30744-2849, 30744-2854 (split product),
     30744-2863 (split product), 30744-2867 (split product), and 30744-3066 (split
    product);
c) Units: 30743-7184, 30743-7189, 30743-7195, 30743-7340, 30743-7345,
    30743-7352, 30743-7355, 30743-7360, 30743-7554, 30743-7561, 30743-7565,
    30743-7568, 30743-8079, 30743-8089, 30743-8096, 30743-8113, 30743-8115,
    30743-8138, 30743-8148, 30743-8150, 30743-8152, 30743-8155, 30743-8167,
    30743-9813, 30743-9816, 30743-9856, 30743-9859, 30743-9863, 30743-9865,
    30744-0214, 30744-0229, 30744-0233, 30744-0240, 30744-0605, 30744-0610,
    30744-0615, 30744-0620, 30744-0661, 30744-0665, 30744-0668, 30744-0671,
    30744-0675, 30744-0684, 30744-0687, 30744-0690, 30744-0707, 30744-0722,
    30744-0769, 30744-0779, 30744-0782, 30744-0797, 30744-1486, 30744-1488,
    30744-1492, 30744-1510, 30744-1516, 30744-1518, 30744-1521, 30744-1575,
    30744-1588, 30744-1591, 30744-1597, 30744-1652, 30744-1656, 30744-1657,
    30744-1670, 30744-1682, 30744-1704, 30744-1937, 30744-1946, 30744-1948,
    30744-1984, 30744-1988, 30744-1998, 30744-2000, 30744-2001, 30744-2011,
    30744-2014, 30744-2017, 30744-2020, 30744-2023, 30744-2025, 30744-2062,
    30744-2073, 30744-2200, 30744-2202, 30744-2489, 30744-2520, 30744-2526,
    30744-2528, 30744-2534, 30744-2535, 30744-2802, 30744-2804, 30744-2812,
    30744-2846, 30744-2858, 30744-2860, 30744-2903, 30744-3043, 30744-3047,
    30744-3049, 30744-3056, 30744-3059, 30744-3498, 30744-3500, 30744-3512,
    30744-3516, 30744-3522, 30744-3525, 30744-4200, 30744-4217, and 30744-4236;
d) Unit: 30744-1678;
e) Unit: 30744-1685;
f) Units: 30743-8086, 30743-8108, 30744-0229, 30744-0235, 30744-0237,
    30744-0240, 30744-0610, 30744-0615, 30744-0620, 30744-0661, 30744-0665,
    30744-0668, 30744-0671, 30744-0675, 30744-0690, 30744-0707, 30744-0722,
    30744-1516, 30744-1518, and 30744-1521;
g) Unit: 30744-0237;
h) Units: 30743-7549, 30743-7578, 30744-1650, 30744-1676, 30744-1678,
    30744-2485 (split product), 30744-2524, 30744-3494 (split product), 30744-3503
    (split product), and 30744-3518 (split product)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale, AZ, by letter and telephone on November 22, December 2 and 6, 2004 and January 24, 2005. 
Manufacturer: Blood Systems, Inc., Fargo ND. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
189 units
DISTRIBUTION
AZ, SD, CA, MN, ND, MT, RI, Switzerland
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall B-0128-08
CODE
Unit: 7098503 (split unit)
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by facsimile on October 10, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor who had traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 components
DISTRIBUTION
TX
___________________________________
PRODUCT
a) Platelets, Recall # B-0131-08;
b) Fresh Frozen Plasma, Recall # B-0132-08
CODE
a) Units: FV16572, FV16665, and LV2839;
b) Units: FV16572, FV16665
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburg, PA, by facsimile dated February 16, 2007. Firm initiated recall is complete.
REASON
Blood product’s which were manufactured from whole blood units in which associated blood components contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
PA
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0169-08;
b) Cryoprecipitated AHF, Recall # B-0170-08;
c) Recovered Plasma, Recall # B-0171-08
CODE
a) and b) Unit: 7149539;
c) Units: 7149539 (1); and 7149539(2)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Oklahoma Blood Institute - Sylvan N Goldman Center, Oklahoma City, OK, by email and facsimile on January 22, 2007.
Manufacturer: Oklahoma Blood Institute, Enid, OK. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 components
DISTRIBUTION
OK, CA, and Switzerland
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0172-08
CODE
Unit: LC68658
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on August 8, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT
Plasma Cryoprecipitate Reduced, Recall # B-0173-08
CODE
Unit: 71S930021
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by telephone and facsimile on November 8, 2006 and November 16, 2006. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which an associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL, AL, and GA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0188-08
CODE
Unit: LZ17139
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on August 2, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malarial, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0191-08
CODE
Unit: 9407214
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on November 22, 2006.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells Pheresis Leukocytes Reduced, Recall # B-0206-08
CODE
Units: 2237647 (Parts A & B), 2534911 (Parts A & B)
RECALLING FIRM/MANUFACTURER
Medic Inc, Knoxville, TN, by facsimile on June 22, 2006. Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
TN
___________________________________
PRODUCT
Cryoprecipitated AHF, Recall # B-0211-08
CODE
Unit: 2616158
RECALLING FIRM/MANUFACTURER
Medic Inc., Knoxville, TN, by telephone on November 8, 2005 and by facsimile on November 9, 2005. Firm initiated recall is complete.
REASON
Blood product, manufactured from an overweight unit of Whole Blood, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0213-08
CODE
Unit: 2346743
RECALLING FIRM/MANUFACTURER
Medic Inc., Knoxville, TN, by facsimile on October 6, 2006. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly tested for the antibody to hepatitis B core antigen (anti-HBc), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0214-08
CODE
Unit: 2080412 (Part B)
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by facsimile on July 12, 2006. Firm initiated recall is complete.
REASON
Blood product, associated with a unit that was found to contain a leak, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0216-08
CODE
Unit: 9611012 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on July 7, 2006. Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but exceeded the acceptable limit for white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0217-08
CODE
Unit: 123776100
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc, Scottsdale AZ, by telephone on August 6, 2007.
Manufacturer: Blood Systems, Inc., Albuquerque, NM. Firm initiated recall is complete.
REASON
Blood product, with a platelet count that exceeded the firm’s specification, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NM
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0218-08
CODE
Unit: 9309998
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on July 21, 2006. Firm initiated recall is complete.
REASON
Blood product, which was inappropriately labeled as a single platelet product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0219-08
CODE
Unit: 2067926
RECALLING FIRM/MANUFACTURER
Medic Inc., Knoxville, TN, by telephone on October 12, 2005 and by facsimile on October 28, 2005. Firm initiated recall is complete.
REASON
Blood product, with a low platelet yield, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0221-08
CODE
Unit: 55Y30696
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR, by letter and electronic mail on January 12, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AR and CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0223-08
CODE
Unit: 72C41278X
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by telephone and facsimile on July 23, 2007. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Plasma Cryoprecipitate Reduced, Recall # B-0224-08
CODE
Unit: 71T609859
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by letter dated February 15, 2007. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which an associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0225-08;
b) Platelets, Recall # B-0226-08;
c) Fresh Frozen Plasma, Recall # B-0227-08;
d) Red Blood Cells (Apheresis), Recall # B-0228-08
CODE
a), b), and c) Units: LR94961 and LR94967;
d) Units: GR70512, LR94958 (double unit), LR94954 (double unit), GR70507
    (double unit)
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on March 8, 2007. Firm initiated recall is complete.
REASON
Blood products, which were improperly tested for the antibody to the human immunodeficiency virus (anti-HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
PA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0229-08
CODE
Unit: 1116451
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by telephone on December 16, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had medical history of hepatitis B, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0232-08
CODE
Unit: 5114307
RECALLING FIRM/MANUFACTURER
Lifesource, Glenview, IL, by telephone on May 18, 2007. 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
IL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0235-08
CODE
Units: 0700015, part A and 0700015, part B
RECALLING FIRM/MANUFACTURER
Lifesource, Glenview, IL, by telephone on March 12, 2007. Firm initiated recall is complete.
REASON
Blood products, which did not meet the acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0124-08
CODE
Lot #’s: 30743-7184, 30743-7189, 30743-7195, 30743-7352, 30743-7355, 30743-7360, 30743-7561, 30743-7568, 30743-8079, 30743-8113, 30743-8115, 30743-8134, 30743-8138, 30743-8140, 30743-8148, 30743-8150, 30743-8152, 30743-8155, 30743-8167, 30743-9813, 30743-9816, 30743-9832, 30743-9837, 30743-9856, 30743-9859, 30743-9863, 30743-9865, 30744-0214, 30744-0233, 30744-0605, 30744-0684, 30744-0687, 30744-1575, 30744-1588, 30744-1591, 30744-1597, 30744-1656, 30744-1670, 30744-1998, 30744-2000, 30744-2001, 30744-2025, 30744-2073, 30744-2200, 30744-2202, 30744-2211, 30744-2520, 30744-2526, 30744-2528, 30744-2535, 30744-2846, 30744-2858, 30744-2860, 30744-2881, 30744-2903, 30744-3043, 30744-3047, 30744-3049, 30744-3056, 30744-3059, 30744-3070, 30744-3500, 30744-3508, 30744-3512, 30744-3516, 30744-3522, 30744-3525, and 30744-4050
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale, AZ, by letter and telephone on November 22, December 2 and 6, 2004 and January 24, 2005. 
Manufacturer: Blood Systems, Inc., Fargo ND. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
68 units
DISTRIBUTION
AZ, SD, CA, MN, ND, MT, RI, Switzerland
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0149-08
CODE
Unit: 71S939457
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by facsimile dated September 25, 2006. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which an associated blood component contained fibrin strands or clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0150-08
CODE
Unit: 71T302825
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by facsimile dated September 25, 2006. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which an associated blood component contained fibrin strands or clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0151-08
CODE
Unit: 71T29748X
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by facsimile on October 30,  2006. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which an associated blood component contained fibrin strands or clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0174-08
CODE
Unit: 71S930021
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by telephone and facsimile on November 8, 2006 and November 16, 2006. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which an associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL, AL, and GA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0175-08
CODE
Units: 71T310407 and 71T319101
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by telephone and facsimile on October 19, 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
GA
___________________________________
PRODUCT
a) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0203-08;
b) Platelets Pheresis Leukocytes Reduced, Recall # B-0204-08
CODE
a) Unit: 7178157;
b) Units: 7165952, 7165949, 7151572, 7168330, 7178159, 7165954 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N Goldman Center, Oklahoma City, OK, by telephone and facsimile on December 13, 2006. Firm initiated recall is complete.
REASON
Blood products, for which the quality control testing was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
OK, NY, TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0205-08
CODE
Unit: 2619788
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone on July 26, 2006 and by facsimile on July 27, 2006. Firm initiated recall is complete.
REASON
Blood product, which failed to meet the minimum requirement for red blood cell recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0208-08
CODE
Unit 2441807
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone on July 14, 2006 and by facsimile on July 20, 2006. Firm initiated recall is complete.
REASON
Blood product, which was out of controlled storage for more than 30 minutes during irradiation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0209-08
CODE
Unit: 9611325
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on August 3, 2006. Firm initiated recall is complete.
REASON
Blood product, manufactured without the entire quantity of additive solution, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0210-08
CODE
Unit: 6795467
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on September 27, 2006. Firm initiated recall is complete.
REASON
Blood product, manufactured without the entire quantity of additive solution, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0212-08
CODE
Unit: 2084869

RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on October 10, 2006. 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
CO
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0215-08
CODE
Unit: 2537846
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by facsimile on September 29, 1006. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly labeled as to an unexpected antibodies, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0220-08
CODE
Units: KZ89526; LR97688; FR63790; KM54447; LC47307; LC46528; FR69637; FW86523; LV06679
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on December 21, 2004. Firm initiated recall is complete.
REASON
Blood products, leukodepleted greater than five days after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
WI
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0222-08
CODE
Unit: 55Y30696
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR, by letter and electronic mail on January 12, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AR and CA

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS I
___________________________________
PRODUCT
Welch Allyn AED 10, Automated External Defibrillator, a portable 12V internal battery powered defibrillator; Model AED10; Part Numbers: 970302E,970308E,970309E, 970310E and 970311E; Recall # Z-0129-2008
CODE
Serial numbers of units affected: NA036960, NA036970, NA037000, NA037004, NA037005, NA037009, NA037010, NA037012, NA037014, NA037015, NA037020, NA037022, NA037025, NA037027, NA037029, NA037030, NA037030, NA037031, NA037032, NA037034, NA037035, NA037036, NA037044, NA037045, NA037046, NA037048, NA037050, NA037051, NA037052, NA037053, NA037056, NA037057, NA037058, NA037088, NA037090, NA037091, NA037092, NA037093, NA037094, NA037095, NA037097, NA037098, NA037108, NA037110, NA037111, NA037112, NA037114, NA037115, NA037116, NA037118, NA037119, NA037120, NA037121, NA037122, NA037123, NA037124, NA037125, NA037126, NA037127, NA037128, NA037129, NA037132, NA037134, NA037139, NA037140, NA037143, NA037145, NA037146, NA037147, NA037148, NA037149, NA037150, NA037154, NA037155, NA037157, NA037158, NA037159, NA037160, NA037161, NA037162, NA037163, NA037164, NA037166, NA037167, NA037168, NA037169, NA037170, NA037171, NA037172, NA037173, NA037174, NA037175, NA037177, NA037179, NA037180, NA037182, NA037183, NA037184, NA037185, NA037186, NA037187, NA037188, NA037189, NA037190, NA037193, NA037194, NA037203, NA037206, NA037207, NA037209, NA037210, NA037213, NA037217, NA037219, NA037220, NA037221, NA037223, NA037225, NA037228, NA037234, NA037256, NA037354, NA037499, NA037511, NA037512, NA037513, NA037515, NA037516, NA037517, NA037518, NA037519, NA037523, NA037524, NA037525, NA037532, NA037533, NA037534, NA037535, NA037536, NA037538, NA037539, NA037540, NA037541, NA037542, NA037543, NA037544, NA037545, NA037546, NA037547, NA037548, NA037549, NA037550, NA037551, NA037552, NA037553, NA037554, NA037555, NA037556, NA037557, NA037558, NA037559, NA037560, NA037561, NA037562, NA037563, NA037564, NA037565, NA037566, NA037567, NA037568, NA037569, NA037570, NA037571, NA037572, NA037573, NA037574, NA037575, NA037576, NA037577, NA037578, NA037579, NA037580, NA037581, NA037582, NA037583, NA037584, NA037585, NA037586, NA037587, NA037588, NA037589, NA037590, NA037591, NA037592, NA037593, NA037594, NA037595, NA037596, NA037597, NA037598, NA037599, NA037600, NA037601, NA037602, NA037603, NA037604, NA037605, NA037606, NA037607, NA037608, NA037609, NA037610, NA037614, NA037615, NA037616, NA037617, NA037619, NA037620, NA037621, NA037622, NA037624, NA037625, NA037626, NA037627, NA037628, NA037629, NA037630, NA037631, NA037632, NA037633, NA037634, NA037635, NA037636, NA037637, NA037638, NA037639, NA037640, NA037641, NA037643, NA037644, NA037645, NA037646, NA037647, NA037648, NA037649, NA037650, NA037651, NA037652, NA037653, NA037654, NA037655, NA037656, NA037658, NA037659, NA037660, NA037661, NA037662, NA037663, NA037664, NA037665, NA037666, NA037667, NA037668, NA037669, NA037670, NA037671, NA037672, NA037673, NA037674, NA037675, NA037676, NA037677, NA037678, NA037679, NA037680, NA037681, NA037682, NA037683, NA037684, NA037685, NA037686, NA037688, NA037691, NA037696, NA037699, NA037700, NA037702, NA037704, NA037705, NA037706, NA037707, NA037708, NA037712, NA037713, NA037716, NA037717, NA037719, NA037720, NA037723, NA037724, NA037725, NA037729, NA037730, NA037731, NA037732, NA037738, NA037742, NA037743, NA037745, NA037746, NA037747, NA037749, NA037750, NA037751, NA037752, NA037757, NA037761, NA037762, NA037765, NA037766, NA037768, NA037769, NA037770, NA037773, NA037775, NA037779, NA037780, NA037781, NA037782, NA037784, NA037785, NA037786, NA037787, NA037788, NA037789, NA037790, NA037794, NA037795, NA037796, NA037797, NA037798, NA037800, NA037801, NA037802, NA037803, NA037804, NA037805, NA037806, NA037808, NA037809, NA037810, NA037811, NA037814, NA037816, NA037817, NA037818, NA037819, NA037821, NA037822, NA037823, NA037824, NA037825, NA037826, NA037828, NA037829, NA037831, NA037832, NA037834, NA037835, NA037836, NA037837, NA037838, NA037839, NA037840, NA037841, NA037842, NA037843, NA037844, NA037845, NA037846, NA037847, NA037848, NA037849, NA037850, NA037851, NA037852, NA037853, NA037854, NA037855, NA037856, NA037857, NA037858, NA037859, NA037860, NA037861, NA037862, NA037863, NA037864, NA037866, NA037867, NA037869, NA037870, NA037871, NA037872, NA037873, NA037874, NA037875, NA037876, NA037877, NA037878, NA037879, NA037880, NA037881, NA037882, NA037883, NA037884, NA037885, NA037886, NA037887, NA037888, NA037889, NA037890, NA037891, NA037892, NA037893, NA037894, NA037895, NA037896, NA037897, NA037898, NA037899, NA037900, NA037901, NA037902, NA037903, NA037904, NA037905, NA037906, NA037907, NA037908, NA037909, NA037911, NA037912, NA037913, NA037915, NA037918, NA037919, NA037920, NA037922, NA037923, NA037924, NA037926, NA037927, NA037928, NA037929, NA037930, NA037931, NA037932, NA037933, NA037934, NA037935, NA037936, NA037937, NA037939, NA037940, NA037942, NA037943, NA037944, NA037946, NA037947, NA037948, NA037950, NA037952, NA037954, NA037959, NA037960, NA037963, NA037969, NA037971, NA037972, NA037973, NA037975, NA037977, NA037978, NA037979, NA037980, NA038000, NA038004, NA038005, NA038012, NA038027, NA038028, NA038029, NA038030, NA038031, NA038032, NA038033, NA038035, NA038036, NA038037, NA038038, NA038039, NA038040, NA038041, NA038042, NA038043, NA038044, NA038045, NA038046, NA038047, NA038048, NA038049, NA038050, NA038051, NA038052, NA038053, NA038054, NA038056, NA038057, NA038058, NA038059, NA038060, NA038061, NA038062, NA038063, NA038064, NA038065, NA038066, NA038067, NA038068, NA038069, NA038070, NA038072, NA038073, NA038074, NA038075, NA038076, NA038077, NA038078, NA038080, NA038081, NA038082, NA038083, NA038084, NA038085, NA038086, NA038087, NA038088, NA038089, NA038090, NA038091, NA038092, NA038093, NA038094, NA038095, NA038096, NA038097, NA038098, NA038099, NA038100, NA038101, NA038102, NA038103, NA038104, NA038105, NA038106, NA038107, NA038108, NA038109, NA038110, NA038111, NA038112, NA038113, NA038114, NA038116, NA038117, NA038118, NA038119, NA038120, NA038121, NA038122, NA038123, NA038124, NA038125, NA038126, NA038127, NA038128, NA038129, NA038130, NA038131, NA038132, NA038133, NA038134, NA038135, NA038136, NA038137, NA038138, NA038139, NA038140, NA038141, NA038142, NA038143, NA038144, NA038145, NA038146, NA038147, NA038148, NA038149, NA038150, NA038151, NA038152, NA038153, NA038154, NA038155, NA038156, NA038157, NA038158, NA038159, NA038160, NA038161, NA038162, NA038163, NA038164, NA038165, NA038166, NA038167, NA038168, NA038169, NA038170, NA038171, NA038172, NA038174, NA038175, NA038176, NA038177, NA038178, NA038179, NA038180, NA038181, NA038182, NA038183, NA038184, NA038185, NA038186, NA038187, NA038188, NA038189, NA038190, NA038191, NA038193, NA038194, NA038195, NA038196, NA038197, NA038198, NA038199, NA038200, NA038201, NA038202, NA038203, NA038204, NA038205, NA038206, NA038207, NA038208, NA038209, NA038210, NA038211, NA038213, NA038214, NA038215, NA038216, NA038217, NA038218, NA038219, NA038220, NA038221, NA038222, NA038223, NA038224, NA038225, NA038226, NA038227, NA038228, NA038229, NA038230, NA038231, NA038232, NA038233, NA038234, NA038235, NA038236, NA038237, NA038238, NA038239, NA038240, NA038241, NA038242, NA038243, NA038244, NA038245, NA038246, NA038247, NA038249, NA038250, NA038251, NA038252, NA038253, NA038254, NA038255, NA038256, NA038257, NA038258, NA038259, NA038260, NA038261, NA038262, NA038263, NA038264, NA038265, NA038266, NA038267, NA038268, NA038269, NA038270, NA038271, NA038272, NA038273, NA038274, NA038275, NA038276, NA038277, NA038278, NA038279, NA038280, NA038281, NA038282, NA038283, NA038284, NA038285, NA038286, NA038287, NA038288, NA038289, NA038290, NA038291, NA038292, NA038293, NA038294, NA038295, NA038296, NA038297, NA038298, NA038299, NA038300, NA038301, NA038302, NA038303, NA038304, NA038305, NA038306, NA038307, NA038308, NA038309, NA038310, NA038311, NA038312, NA038313, NA038314, NA038315, NA038316, NA038317, NA038318, NA038319, NA038320, NA038321, NA038322, NA038323, NA038324, NA038325, NA038326, NA038327, NA038328, NA038329, NA038330, NA038331, NA038332, NA038333, NA038334, NA038335, NA038336, NA038337, NA038338, NA038339, NA038340, NA038341, NA038342, NA038343, NA038344, NA038345, NA038346, NA038347, NA038348, NA038349, NA038350, NA038351, NA038352, NA038353, NA038354, NA038355, NA038356, NA038357, NA038358, NA038359, NA038360, NA038361, NA038362, NA038363, NA038364, NA038365, NA038366, NA038367, NA038368, NA038369, NA038370, NA038371, NA038372, NA038373, NA038374, NA038375, NA038376, NA038377, NA038378, NA038379, NA038380, NA038381, NA038382, NA038383, NA038384, NA038385, NA038388, NA038389, NA038390, NA038392, NA038393, NA038396, NA038397, NA038398, NA038399, NA038400, NA038403, NA038404, NA038406, NA038407, NA038409, NA038410, NA038412, NA038413, NA038414, NA038415, NA038416, NA038417, NA038420, NA038421, NA038422, NA038423, NA038425, NA038427, NA038428, NA038429, NA038430, NA038432, NA038434, NA038435, NA038436, NA038437, NA038438, NA038439, NA038440, NA038441, NA038442, NA038443, NA038447, NA038448, NA038449, NA038450, NA038452, NA038453, NA038454, NA038455, NA038456, NA038457, NA038458, NA038459, NA038465, NA038467, NA038468, NA038471, NA038472, NA038473, NA038475, NA038476, NA038477, NA038478, NA038479, NA038483, NA038484, NA038485, NA038486, NA038489, NA038490, NA038492, NA038493, NA038494, NA038496, NA038498, NA038499, NA038500, NA038501, NA038502, NA038503, NA038504, NA038505, NA038506, NA038507, NA038508, NA038509, NA038510, NA038511, NA038512, NA038513, NA038514, NA038515, NA038516, NA038517, NA038518, NA038519, NA038520, NA038521, NA038522, NA038523, NA038524, NA038526, NA038527, NA038528, NA038529, NA038531, NA038532, NA038533, NA038536, NA038538, NA038539, NA038541, NA038542, NA038543, NA038544, NA038545, NA038547, NA038549, NA038550, NA038551, NA038552, NA038554, NA038555, NA038556, NA038557, NA038558, NA038559, NA038560, NA038561, NA038562, NA038564, NA038565, NA038566, NA038567, NA038568, NA038569, NA038570, NA038571, NA038572, NA038573, NA038574, NA038575, NA038576, NA038577, NA038578, NA038579, NA038580, NA038581, NA038582, NA038583, NA038585, NA038586, NA038587, NA038589, NA038590, NA038591, NA038592, NA038593, NA038594, NA038595, NA038596, NA038597, NA038598, NA038599, NA038600, NA038601, NA038602, NA038603, NA038604, NA038605, NA038607, NA038608, NA038609, NA038610, NA038612, NA038613, NA038614, NA038616, NA038618, NA038619, NA038624, NA038625, NA038626, NA038627, NA038628, NA038629, NA038630, NA038632, NA038634, NA038635, NA038636, NA038637, NA038638, NA038639, NA038640, NA038641, NA038642, NA038643, NA038644, NA038645, NA038646, NA038648, NA038649, NA038650, NA038651, NA038652, NA038653, NA038654, NA038658, NA038659, NA038662, NA038665, NA038666, NA038667, NA038668, NA038669, NA038671, NA038672, NA038673, NA038674, NA038675, NA038676, NA038677, NA038678, NA038679, NA038680, NA038683, NA038684, NA038685, NA038686, NA038687, NA038688, NA038690, NA038691, NA038692, NA038693, NA038694, NA038696, NA038697, NA038699, NA038700, NA038702, NA038704, NA038705, NA038706, NA038707, NA038709, NA038711, NA038712, NA038713, NA038714, NA038715, NA038716, NA038717, NA038718, NA038719, NA038720, NA038721, NA038722, NA038723, NA038725, NA038726, NA038727, NA038728, NA038729, NA038730, NA038731, NA038732, NA038733, NA038734, NA038735, NA038736, NA038737, NA038738, NA038739, NA038740, NA038741, NA038742, NA038743, NA038744, NA038745, NA038746, NA038747, NA038748, NA038749, NA038750, NA038751, NA038752, NA038753, NA038754, NA038755, NA038756, NA038757, NA038758, NA038759, NA038760, NA038761, NA038762, NA038763, NA038764, NA038765, NA038766, NA038767, NA038768, NA038769, NA038770, NA038771, NA038772, NA038773, NA038774, NA038775, NA038776, NA038777, NA038778, NA038779, NA038780, NA038781, NA038782, NA038783, NA038784, NA038785, NA038786, NA038787, NA038788, NA038789, NA038791, NA038792, NA038793, NA038794, NA038795, NA038796, NA038797, NA038798, NA038799, NA038800, NA038801, NA038802, NA038803, NA038804, NA038805, NA038806, NA038807, NA038808, NA038809, NA038810, NA038811, NA038814, NA038815, NA038816, NA038817, NA038818, NA038819, NA038820, NA038821, NA038822, NA038823, NA038824, NA038825, NA038826, NA038827, NA038828, NA038829, NA038831, NA038832, NA038833, NA038834, NA038835, NA038836, NA038837, NA038838, NA038839, NA038840, NA038841, NA038842, NA038843, NA038845, NA038846, NA038847, NA038848, NA038849, NA038850, NA038851, NA038852, NA038853, NA038854, NA038855, NA038856, NA038857, NA038858, NA038859, NA038860, NA038861, NA038862, NA038863, NA038864, NA038865, NA038867, NA038868, NA038869, NA038870, NA038871, NA038872, NA038873, NA038874, NA038875, NA038876, NA038877, NA038878, NA038879, NA038880, NA038881, NA038882, NA038883, NA038884, NA038885, NA038886, NA038887, NA038888, NA038889, NA038890, NA038892, NA038894, NA038896, NA038897, NA038898, NA038899, NA038900, NA038901, NA038902, NA038903, NA038904, NA038905, NA038906, NA038907, NA038908, NA038909, NA038911, NA038912, NA038913, NA038914, NA038915, NA038916, NA038917, NA038918, NA038919, NA038920, NA038921, NA038922, NA038923, NA038924, NA038925, NA038926, NA038927, NA038928, NA038929, NA038930, NA038931, NA038932, NA038933, NA038934, NA038935, NA038936, NA038937, NA038938, NA038939, NA038940, NA038942, NA038943, NA038944, NA038945, NA038946, NA038947, NA038951, NA038952, NA038953, NA038956, NA038957, NA038958, NA038959, NA038960, NA038961, NA038963, NA038964, NA038965, NA038966, NA038969, NA038970, NA038971, NA038973, NA038975, NA038979, NA038980, NA038981, NA038982, NA038983, NA038985, NA038986, NA038988, NA038989, NA038991, NA038993, NA038994, NA038995, NA038996, NA038997, NA039004, NA039005, NA039006, NA039007, NA039008, NA039009, NA039010, NA039011, NA039012, NA039014, NA039015, NA039016, NA039017, NA039018, NA039019, NA039020, NA039021, NA039022, NA039025, NA039026, NA039027, NA039028, NA039029, NA039030, NA039031, NA039032, NA039033, NA039034, NA039035, NA039036, NA039037, NA039038, NA039039, NA039040, NA039041, NA039042, NA039047, NA039048, NA039049, NA039050, NA039051, NA039052, NA039053, NA039054, NA039055, NA039056, NA039057, NA039058, NA039059, NA039060, NA039061, NA039062, NA039063, NA039064, NA039065, NA039066, NA039067, NA039068, NA039069, NA039070, NA039071, NA039072, NA039073, NA039074, NA039075, NA039076, NA039077, NA039078, NA039079, NA039080, NA039081, NA039083, NA039084, NA039085, NA039086, NA039087, NA039088, NA039089, NA039090, NA039091, NA039092, NA039093, NA039094, NA039095, NA039096, NA039097, NA039098, NA039099, NA039100, NA039101, NA039102, NA039103, NA039104, NA039105, NA039106, NA039107, NA039108, NA039109, NA039110, NA039111, NA039112, NA039113, NA039114, NA039115, NA039116, NA039117, NA039118, NA039119, NA039120, NA039121, NA039122, NA039123, NA039124, NA039125, NA039126, NA039127, NA039128, NA039129, NA039130, NA039131, NA039132, NA039133, NA039134, NA039135, NA039136, NA039137, NA039138, NA039139, NA039140, NA039141, NA039142, NA039143, NA039144, NA039145, NA039146, NA039147, NA039148, NA039149, NA039150, NA039151, NA039152, NA039153, NA039154, NA039155, NA039156, NA039157, NA039158, NA039159, NA039160, NA039161, NA039162, NA039163, NA039164, NA039165, NA039166, NA039167, NA039168, NA039169, NA039170, NA039171, NA039172, NA039173, NA039174, NA039175, NA039176, NA039177, NA039178, NA039179, NA039180, NA039181, NA039182, NA039183, NA039184, NA039185, NA039186, NA039187, NA039188, NA039189, NA039190, NA039191, NA039192, NA039193, NA039194, NA039195, NA039196, NA039197, NA039198, NA039200, NA039201, NA039202, NA039203, NA039204, NA039205, NA039206, NA039207, NA039208, NA039209, NA039210, NA039211, NA039212, NA039213, NA039214, NA039215, NA039216, NA039217, NA039218, NA039219, NA039220, NA039221, NA039222, NA039223, NA039224, NA039225, NA039226, NA039227, NA039228, NA039229, NA039230, NA039231, NA039232, NA039233, NA039234, NA039235, NA039236, NA039237, NA039238, NA039239, NA039240, NA039241, NA039242, NA039243, NA039244, NA039245, NA039246, NA039247, NA039248, NA039249, NA039250, NA039251, NA039252, NA039253, NA039254, NA039255, NA039256, NA039257, NA039258, NA039259, NA039260, NA039261, NA039262, NA039263, NA039264, NA039265, NA039266, NA039267, NA039268, NA039269, NA039270, NA039271, NA039272, NA039273, NA039274, NA039275, NA039276, NA039277, NA039278, NA039279, NA039280, NA039281, NA039282, NA039283, NA039284, NA039285, NA039286, NA039287, NA039288, NA039289, NA039290, NA039291, NA039292, NA039293, NA039294, NA039295, NA039296, NA039297, NA039298, NA039299, NA039300, NA039301, NA039302, NA039303, NA039304, NA039305, NA039306, NA039307, NA039308, NA039309, NA039310, NA039311, NA039312, NA039313, NA039314, NA039315, NA039316, NA039317, NA039318, NA039319, NA039320, NA039321, NA039322, NA039324, NA039327, NA039328, NA039329, NA039330, NA039331, NA039332, NA039334, NA039335, NA039336, NA039337, NA039340, NA039341, NA039342, NA039343, NA039344, NA039345, NA039346, NA039347, NA039349, NA039350, NA039351, NA039352, NA039353, NA039354, NA039355, NA039356, NA039357, NA039358, NA039359, NA039360, NA039361, NA039362, NA039363, NA039364, NA039366, NA039367, NA039368, NA039369, NA039370, NA039371, NA039372, NA039373, NA039374, NA039375, NA039376, NA039377, NA039378, NA039379, NA039380, NA039381, NA039382, NA039383, NA039385, NA039386, NA039387, NA039388, NA039389, NA039390, NA039391, NA039392, NA039393, NA039394, NA039395, NA039396, NA039397, NA039398, NA039399, NA039400, NA039401, NA039402, NA039403, NA039404, NA039405, NA039406, NA039407, NA039408, NA039409, NA039410, NA039411, NA039412, NA039413, NA039414, NA039415, NA039416, NA039417, NA039418, NA039419, NA039420, NA039421, NA039422, NA039423, NA039424, NA039425, NA039426, NA039427, NA039428, NA039429, NA039430, NA039431, NA039432, NA039433, NA039434, NA039435, NA039436, NA039437, NA039438, NA039439, NA039440, NA039441, NA039442, NA039443, NA039444, NA039445, NA039446, NA039447, NA039448, NA039449, NA039450, NA039451, NA039452, NA039453, NA039454, NA039455, NA039456, NA039457, NA039458, NA039459, NA039460, NA039461, NA039462, NA039463, NA039464, NA039465, NA039466, NA039467, NA039468, NA039469, NA039470, NA039471, NA039472, NA039473, NA039474, NA039475, NA039476, NA039477, NA039478, NA039479, NA039480, NA039481, NA039482, NA039483, NA039484, NA039485, NA039486, NA039487, NA039488, NA039489, NA039490, NA039491, NA039492, NA039493, NA039494, NA039495, NA039497, NA039498, NA039499, NA039500, NA039501, NA039502, NA039503, NA039504, NA039505, NA039506, NA039507, NA039508, NA039510, NA039511, NA039512, NA039514, NA039515, NA039516, NA039517, NA039518, NA039519, NA039520, NA039521, NA039522, NA039523, NA039524, NA039525, NA039526, NA039527, NA039528, NA039529, NA039530, NA039531, NA039532, NA039533, NA039534, NA039535, NA039536, NA039537, NA039538, NA039539, NA039540, NA039541, NA039542, NA039543, NA039544, NA039545, NA039546, NA039547, NA039548, NA039549, NA039550, NA039551, NA039552, NA039553, NA039554, NA039555, NA039556, NA039558, NA039560, NA039561, NA039562, NA039563, NA039564, NA039565, NA039566, NA039567, NA039568, NA039569, NA039570, NA039571, NA039572, NA039573, NA039574, NA039575, NA039577, NA039578, NA039579, NA039581, NA039582, NA039584, NA039585, NA039586, NA039588, NA039589, NA039591, NA039592, NA039593, NA039595, NA039598, NA039599, NA039600, NA039601, NA039603, NA039604, NA039605, NA039607, NA039608, NA039609, NA039612, NA039616, NA039618, NA039619, NA039620, NA039621, NA039623, NA039624, NA039629, NA039630, NA039632, NA039633, NA039639, NA039644, NA039645, NA039650, NA039655, NA039664, NA039674, NA039692, NA039701, NA039702, NA039703, NA039711, NA039715, NA039719, NA039720, NA039722, NA039723, NA039724, NA039726, NA039728, NA039729, NA039730, NA039732, NA039733, NA039734, NA039735, NA039736, NA039737, NA039741, NA039742, NA039743, NA039744, NA039747, NA039748, NA039750, NA039751, NA039753, NA039754, NA039755, NA039756, NA039757, NA039758, NA039759, NA039760, NA039761, NA039762, NA039763, NA039764, NA039766, NA039767, NA039771, NA039772, NA039773, NA039774, NA039776, NA039778, NA039780, NA039781, NA039782, NA039784, NA039785, NA039786, NA039787, NA039790, NA039793, NA039795, NA039796, NA039797, NA039798, NA039799, NA039800, NA039802, NA039803, NA039804, NA039805, NA039806, NA039808, NA039809, NA039810, NA039814, NA039828, NA039839, NA039842, NA039843, NA039844, NA039846, NA039847, NA039848, NA039849, NA039850, NA039851, NA039852, NA039853, NA039854, NA039855, NA039856, NA039857, NA039858, NA039859, NA039860, NA039865, NA039866, NA039868, NA039871, NA039876, NA039877, NA039878
RECALLING FIRM/MANUFACTURER
Welch Allyn Protocol, Inc, Beaverton, OR, by letter dated October 26, 2007, and by press release on October 30, 2007. Firm initiated recall is ongoing.
REASON
Failure to Deliver Shock; a defective capacitor may cause the delay or non-delivery of the defibrillating shock which may result in failure to resuscitate the patient.
VOLUME OF PRODUCT IN COMMERCE
1,795 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II
___________________________________
PRODUCT
Abbott Diagnostic International, Ltd.-- AxSYM Digoxin III Reagent Pack, List (6L07-20), For In Vitro Diagnostic use. This reagent system is composed of one bottle of Digoxin-Alkaline Phosphates Conjugate, one bottle of Anti-Digoxin (Rabbit) Coated microparticles, one bottle of MEIA buffer, and one bottle of Digoxin Probe wash solution., Recall # Z-0064-2008
CODE
Lot # 46181Q100 Exp. Date 08/10/07, Lot # 50267Q100 Exp.Date 12/16/07
RECALLING FIRM/MANUFACTURER
Abbott Diagnostic International, Ltd., Barceloneta, PR, by letter on July 20, 2007. Firm initiated recall is ongoing.
REASON
Incorrect Results -- Error codes 1062, 1063, 1113, and 1118 observed when running patient samples on the AxSYM Digoxin III assay, rather than a concentration, is reported for the patient sample.
VOLUME OF PRODUCT IN COMMERCE
3,104 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Sunisa Flexi-DT S0014115 Digital Table Flexi-DT, 115-240 V // Internal Battery 24V, 4-2A Internal Battery 8A, 50-60Hz. Model Numbers 51335678, 2269647, 2242088-2, 5141609-2, 5115763, and 5128145, Recall # Z-0075-2008
CODE
Model # 2269647 / Serial # 00001001025WK4 00001001930WK5 00001002256WK4 00001002566WK6 00001002571WK6 00001003965WK9 00001004156WK4 00001004469WK1 00001007157WK9 Model # 5115763 / Serial# 00000994502WK3 00000997066WK6 00000997612WK7 00000997613WK5 00001000007WK3 00001002479WK2 00001002828WK0 00001003563WK2 00001003571WK5 Model #5128145 / Serial # 00000002041M32 00000002051M31 00001004319WK8 00001005661WK2 Model#5135678 / Serial # 00001004505WK2 00001004507WK8 00001004763WK7 00001004764WK5 00001004771WK0 00001005019WK3 00001005032WK6 00001005033WK4 00001005182WK9 00001005184WK5 00001005260WK3 00001005702WK4 00001005705WK7 00001005707WK3 00001005755WK2 00001005760WK2 00001005762WK8 00001005763WK6 00001005764WK4 00001005911WK1 00001005912WK9 00001006042WK4 00001006179WK4 00001006471WK5 00001006475WK6 00001006478WK0 00001006635WK5 00001006822WK9 00001006873WK2 00001006875WK7 00001006878WK1 00001006880WK7 00001007163WK7 00001007169WK4 00001007191WK8 00001007405WK2 00001007409WK4 00001007478WK9 00001007499WK5 00001007516WK6 00001007528WK1 00001007534WK9 00001007535WK6 00001007649WK5 00001007650WK3 00001007713WK9 00001007717WK0 00001007719WK6 00001007780WK8 00001007782WK4 00001007784WK0 00001007906WK9 00001007910WK1 00001008307WK9 00001008312WK9 00001008682WK5 00001008809WK4 00001008810WK2 00001008835WK9 00001008837WK5 00001008843WK3 00001009057WK9 00001009061WK1 00001009062WK9 00001009063WK7 00001009217WK9 00001009536WK2 00001009604WK8 00001009609WK7 00001009707WK9 00001009817WK6 00001010430WK5 Model #2242088-2 / Serial # 00000001709M35 Model #5141608-2 / Serial # 00000114134VE0
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by visit on August 2007. 
Manufacturer: Suinsa, Madrid, Spain. Firm initiated recall is ongoing.
REASON
Suinsa Flex-DT Table - Reports of several problems including: 1) Hot Brake (Longitudinal Overheating) potential risk of burns 2) Brake Locks and Sudden Releases 3) Emergency Stop Circuit Button; open instead of closed 4) Longitudinal Brakes Release does not engage properly 5) Tilting Movement causing tabletop to slide; may cause risk of pinched fingers to patient and/or operator 6) Lodging Pins on floor Uncovered; may cause potential risk of falling to patient and/or operator.
VOLUME OF PRODUCT IN COMMERCE
96 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Foundation® Hip System Bipolar Modular, Size 40mm OD; Cat. #412-01-040;
    Sterile; assembly required by physician prior to implant; Recall # Z-0082-2008;
b) Foundation® Hip System Bipolar Modular, Size 41mm OD; Cat. #412-01-041;
     Sterile; assembly required by physician prior to implant; Recall # Z-0083-2008;
c) Foundation® Hip System Bipolar Modular, Size 42mm OD; Cat. #412-01-042;
    Sterile; assembly required by physician prior to implant; Recall Z-0084-2008;
d) Foundation® Hip System Bipolar Modular, Size 43mm OD; Cat. #412-01-043;
     Sterile; assembly required by physician prior to implant; Recall # Z-0085-2008;
e) Foundation® Hip System Bipolar Modular, Size 44mm OD; Cat. #412-01-044;
    Sterile; assembly required by physician prior to implant; Recall # Z-0086-2008;
f) Foundation® Hip System Bipolar Modular, Size 45mm OD; Cat. #412-01-045;
    Sterile; assembly required by physician prior to implant; Recall # Z-0087-2008;
g) Foundation® Hip System Bipolar Modular, Size 46mm OD; Cat. #412-01-046;
    Sterile; assembly required by physician prior to implant; Recall # Z-0088-2008;
h) Foundation® Hip System Bipolar Modular, Size 47mm OD; Cat. #412-01-047;
    Sterile; assembly required by physician prior to implant; Recall # Z-0089-2008;
i)  Foundation® Hip System Bipolar Modular, Size 48mm OD; Cat. #412-01-048;
    Sterile; assembly required by physician prior to implant; Recall # Z-0090-2008;
j) Foundation® Hip System Bipolar Modular, Size 49mm OD; Cat. #412-01-049;
    Sterile; assembly required by physician prior to implant; Recall # Z-0091-2008;
k) Foundation® Hip System Bipolar Modular, Size 50mm OD; Cat. #412-01-050;
    Sterile; assembly required by physician prior to implant; Recall # Z-0092-2008;
l) Foundation® Hip System Bipolar Modular, Size 51mm OD; Cat. #412-01-051;
    Sterile; assembly required by physician prior to implant; Recall # Z-0093-2008;
m) Foundation® Hip System Bipolar Modular, Size 52mm OD; Cat. #412-01-052;   
     sterile; assembly required by physician prior to implant; Recall # Z-0094-2008;
n)  Foundation® Hip System Bipolar Modular, Size 53mm OD; Cat. #412-01-053;
    Sterile; assembly required by physician prior to implant; Recall # Z-0095-2008;
o) Foundation® Hip System Bipolar Modular, Size 54mm OD; Cat. #412-01-054;
    Sterile; assembly required by physician prior to implant; Recall # Z-0096-2008;
p) Foundation® Hip System Bipolar Modular, Size 56mm OD; Cat. #412-01-056;
    Sterile; assembly required by physician prior to implant; Recall # Z-0097-2008;
q) Foundation® Hip System Bipolar Modular, Size 58mm OD; Cat. #412-01-058;
    Sterile; assembly required by physician prior to implant; Recall # Z-0098-2008;
r) Foundation® Hip System Bipolar Modular, Size 60mm OD; Cat. #412-01-060;
    Sterile; assembly required by physician prior to implant; Recall # Z-0099-2008
CODE
a) Lot #: 633811, 633851, 738381, 738391, 770021, 777371, 792441, 817581,
     831031, 878311, 905531, 905541, 907051, 944231, and 949371;
b) Lot #: 602661, 691241, 633821, 633861, 738401, 770031, 777381, 792451,
    797031, 811141, 831041, 836151, 845221, 848651, 857671, 878321, 905551,
    932691, 949381, 958921 and 964161;
c) Lot #: 644021, 648331, 672341, 675901, 678461, 678471, 678481, 678491, 678501,
    678511, 678521, 693251, 694501, 697771, 732831, 733871, 736411, 736741,
    738071, 738081, 738411, 738421, 770041, 774781, 774791, 777391, 779571,
    779581, 783901, 783911, 788351, 794371, 794381, 811151, 811161, 835501,
    835511, 836161, 844591, 845951, 848661, 854461, 854471, 854481, 854491,
    857681, 874941, 874951, 882561, 882571, 882581, 893551, 893561, 893571,
    903121, 903131, 933751, 944241, 944251, 949391, 949401, 964171, 964181,
    964191 and 964201;
d) Lot #: 679631, 678531, 678541, 678551, 678561, 678571, 691661, 692771, 692761,
    694351, 694401, 694411, 694421, 698261, 695131, 695911, 697781, 730131,
    731451, 731461, 731471, 205452, 736421, 770051, 770061, 770071, 770181,
    780151, 783921, 788361, 792671, 794391, 811171, 811181, 811191, 811201,
    811291, 832281, 832291, 835521, 842301, 842311, 848671, 854501, 854511
    54981, 874961, 874971, 874981, 882591, 882601, 893581, 893591, 893601,
    893611, 903141, 903151, 905561, 925731, 925741, 925751, 927231, 932711,
    932721, 933761, 933771, 933781, 944261, 944271, 949411, 949421, 964211,
     964221, 964231 and 964241;
e) Lot #: 640791, 640801, 640811, 677101, 677111, 678581, 678591, 678601, 678611,
    678621, 679611, 679621, 693841, 693851, 693861, 695121, 695861, 697851,
    697861, 698771, 730141, 730221, 731481, 003612, 003622, 003632, 003642,
    208672, 735781, 736431, 736441, 736451, 736461, 736751, 737391, 738431,
    738891, 738911, 770081, 770191, 772371, 776721, 778421, 780161, 783931,
    788381, 788391, 794401, 795481, 795491, 812181, 812191, 812201, 812211,
    813511, 817551, 817561, 833181, 833191, 834981, 834991, 837691, 837791,
    842321, 842331, 847351, 847361, 847391, 847401, 854341, 854381, 854391,
    854401, 854411, 857691, 857701, 874991, 875001, 878331, 878351, 878531,
    878541, 882611, 882621, 882631, 891271, 891281, 891301, 893631, 893641,
    905571, 905581, 907081, 907091, 907101, 907111, 925761, 925771, 932731,
    932741, 938211, 938221, 949431, 949441, 951081, 964251, 964261, 964271,
    964281, 964291, 964301, 964311 and 421494A;
f) Lot #: 629071, 677121, 677131, 678651, 678661, 678671, 678681, 679641,
    691251, 691261, 691271, 693871, 693881, 694511, 694521, 694531, 695111,
    697791, 698971, 698981, 730201, 731491, 733951, 734531, 736471, 736481,
    736761, 738091, 738101, 738901, 770091, 772351, 772361, 777411, 780171,
    783941, 788411, 788421, 795501, 795511, 812221, 813521, 813531, 814301,
    814311, 817571, 834021, 834031, 835551, 836171, 842341, 842351, 845961,
    847381, 854351, 854421, 854431, 854441, 855871, 855881, 857721, 875011,
    875021, 878341, 878361, 878551, 878561, 891291, 891311, 893621, 894391,
    894401, 905591, 905601, 907061, 907071, 925781, 925791, 932751, 938231,
    938241, 938251, 949451, 949461, 951091, 959761, 959771, 964321, 964331,
    964341 and 964351;
g) Lot #: 644031, 672331, 677061, 677981, 677991, 678691, 678701, 678711,
    678721, 679651, 679661, 697671, 691281, 691291, 693261, 699171, 730241,
    735791, 736491, 736501, 736511, 736771, 737811, 738441, 738451, 738461,
    770101, 770111, 770221, 773281, 777421, 778431, 782551, 788441, 788451,
    810911, 811211, 813501, 830751, 830761, 830911, 830921, 835531, 835541,
    842361, 842371, 847411, 848681, 848691, 853541, 857731, 857741, 857751,
    875571, 875581, 878371, 878381, 878391, 885381, 885401, 892331, 894241,
    894251, 905611, 907121, 907131, 907141, 907211, 925801, 925811, 927241,
    927251, 927261, 932761, 949471, 949491, 949851, 951101, 951111, 951121,
    958941, 966131, 966141 and 982721;
h) Lot #: 602731, 677071, 677081, 677091, 678001, 678011, 678731, 678741,
    678751, 678761, 693891, 693901, 695101, 697801, 699141, 699151, 732841,
    208522, 208532, 208542, 208552, 733961, 734521, 735721, 736521, 739121,
    770121, 777431, 780391, 783951, 788491, 796481, 797041, 797341, 814321,
    814331, 830931, 830941, 835561, 836181, 842381, 844601, 848701, 853551,
    855191, 855201, 857761, 857771, 875591, 875601, 878401, 878411, 878421,
    878431, 885391, 892341, 907151, 907161, 907171, 907181, 907191, 907201,
    925821, 933801, 933811, 933821, 933831, 949501, 949511, 964361, 964371,
    982731 and 421511A;
i) Lot #: 546541, 675911, 677601, 678771, 678781, 693911, 693921, 695081,
    697091, 697811, 699931, 730251, 732541, 732851, 735731, 736531, 736781,
    739441, 770131, 777441, 777451, 781061, 783961, 788501, 788511, 794411,
    794421, 797051, 830291, 830301, 830951, 835571, 835581, 842391, 842401,
    844611, 854991, 857781, 872031, 872041, 872051, 872061, 878571, 878581,
    885411, 885421, 892351, 892361, 892371, 892381, 905621, 905881, 907221,
    933841, 933851, 933861, 938261, 939751, 944281, 944291, 964381, 964391,
    964401, 982741 and 421521A;
j) Lot #: 624391, 675921, 678791, 678801, 678811, 678821, 679691, 691671,
    693931, 693941, 695061, 695921, 696971, 697101, 699941, 208562, 208582,
    732861, 733821, 733841, 734401, 735741, 736541, 770141, 773291, 773301,
    777461, 779901, 783971, 788521, 794431, 797061, 830311, 831511, 835591,
    835601, 842411, 842421, 857791, 872071, 882641, 892391, 892401, 905891,
    905901, 907231, 933871, 938271, 958951, 964411, 964421 and 421531A;
k) Lot #: 624401, 676821, 677141, 677611, 678831, 678841, 678851, 678861,
    678871, 695171, 633831, 733831, 734561, 738471, 738481, 738491, 770151,
    777471, 778441, 778451, 788531, 788541, 814371, 830961, 840341, 840351,
    840361, 844621, 854641, 854651, 855001, 857801, 894261, 894271, 905631,
    905641, 905651, 907241, 933881, 933891, 949521, 949531, 958961, 964431,
    964441 and 964451;
l) Lot #: 542491, 624411, 676831, 678881, 678891, 679701, 690791, 695161,
    695931, 735751, 770161, 777481, 777491, 788551, 794441, 814361, 830971,
    844631, 844641, 847421, 850801, 854661, 854671, 875521, 875531, 878441,
    882651, 882661, 894281, 894291, 905661, 907251, 933901, 949551 and 964471;
m) Lot #: 624421, 676851, 676861, 677151, 678901, 678911, 678921, 693271,
    695151, 738501, 739461, 770171, 777501, 777511, 781071, 788561, 794451,
    814351, 830981, 830991, 855011, 875541, 878451, 894301, 894311, 894321,
    907261, 933911, 949561 and 949571;
n) Lot #: 676841, 678931, 678941, 679711, 690801, 695141, 695941, 777521,
    781081, 788571, 814341, 831001, 844641, 854681, 855021, 878591, 894331,
    894341, 894351, 907271, 933921, 933931, 949581, 949591, 964481, 964491
    and 519861A;
o) Lot #: 608031, 648321, 675931, 678951, 678961, 678971, 695091, 695851,
    780401, 788581, 788591, 788601, 794461, 831021, 840371, 844651, 848711,
     855031, 857811, 875551, 894361, 894371, 907281, 933941, 949601, 964501
    and 964511;
p) Lot #: 627751, 629111, 678981, 678991, 679001, 690231, 210192, 695841,
    855041, 875561, 882671, 894381, 905671, 9072291, 939741, 949611 and 964521;
q) Lot #: 546711, 546721, 546731, 679011, 679021, 379031, 679041, 679051,
    695071, 695871 and 989981;
r) Lot #: 677621, 679061, 679071, 679081, 679091, 633841, 695881, 899041 and  
    989991
RECALLING FIRM/MANUFACTURER
Encore Medical, Lp, Austin, TX, by telephone, e-mail and letters beginning on August 2, 2007. Firm initiated recall is ongoing.
REASON
Device mislabeled. Hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
VOLUME OF PRODUCT IN COMMERCE
5,191 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Portex perfit Percutaneous Tracheostomy Tube Replacement Kit, Sterile Ref: 536090, Recall # Z-0100-2008
CODE
Lot: 1155185
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smiths Medical ASD, Inc., Keene, NH, by letter on September 18, 2007.
Manufacturer: Smiths Medical, Kent, UK. Firm initiated recall is ongoing.
REASON
Mislabeled. The product is labeled as a size 9.0 mm tracheostomy tube, but the package contains a 7.0 mm tracheostomy tube.
VOLUME OF PRODUCT IN COMMERCE
40 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
GE Healthcare Voluson E8 ultrasound scanner with Software version 6.2.0 and 6.2.1 and DICOM stations with these software versions; Recall # Z-0113-2008
CODE
Serial Numbers: D00210, D00223, D00225, D00239, D00241, D00293, D00326, D00347, D00415, D00425, D00435, D00445, D00455, D00456, D00459, D00460, D00465, D00467, D00468, D00469, D00480, D00481, D00484, D00485, D00487, D00490, D00491, D00493, D00495, D00502, D00503, D00505, D00512, D00516, D00517, D00523, D00525, D00531, D00532, D00537, D00539, D00541, D00542, D00543, D00546, D00548, D00550, D00551, D00552, D00554, D00558, D00560, D00561, D00562, D00563, D00564, D00565, D00566, D00567, D00568, D00569, D00570, D00571, D00572, D00573, D00574, D00575, D00576, D00577, D00579, D00580, D00581, D00582, D00625, D00627, D00628, D00632, D00633, D00636, D00638, D00639, D00640, D00649, D00652, D00653, D00655, D00665, D00666, D00668, D00108, D00123, D00134, D00139, D00168, D00173, D00176, D00178, D00182, D00185, D00186, D00187, D00189, D00192, D00193, D00194, D00195, D00198, D00199, D00200, D00203, D00209, D00214, D00220, D00224, D00226, D00227, D00228, D00230, D00231, D00232, D00233, D00236, D00242, D00243, D00244, D00246, D00249, D00252, D00254, D00258, D00282, D00291, D00292, D00295, D00296, D00297, D00299, D00300, D00302, D00303, D00304, D00305, D00306, D00307, D00310, D00312, D00314, D00316, D00317, D00318, D00319, D00327, D00330, D00335, D00336, D00337, D00339, D00340, D00343, D00344, D00346, D00349, D00350, D00351, D00352, D00354, D00355, D00356, D00359, D00361, D00362, D00364, D00366, D00367, D00372, D00374, D00375, D00388, D00391, D00392, D00393, D00395, D00396, D00397, D00398, D00399, D00402, D00403, D00404, D00405, D00406, D00411, D00413, D00418, D00420, D00421, D00422, D00423, D00426, D00451, D00180, D00379, D00387, D00430, D00433, D00444, D00454, D00464, D00470, D00476, D00497, D00509, D00513, D00522, D00526, D00540, D00544, D00545, D00547, D00549, D00553, D00555, D00556, D00557, D00559, D00585, D00586, D00103, D00155, D00166, D00250, D00251, D00255, D00325, D00331, D00595, D00584, D00280, D00342, D00369, D00148, D00213, D00301, D00428, D00601, D00602, D00603, D00604, D00324, D00151, D00471, D00519, D00593, D00466, D00494, D00659, D00432, D00473, D00321, D00591, D00599, D00153, D00217, D00222, D00248, D00437, D00514, D00322, D00449, D00474, D00475, D00478, D00504, D00507, D00508, D00521, D00528, D00529, D00533, D00534, D00583, D00634, D00635, D00641, D00644, D00645, D00663, D00126, D00128, D00240, D00272, D00277, D00279, D00332, D00341, D00407, D00419, D00486, D00424, D00499, D00288, D00308, D00394, D00483, D00143, D00117, D00138, D00150, D00165, D00167, D00183, D00218, D00245, D00253, D00259, D00261, D00264, D00315, D00328, D00378, D00383, D00385, D00431, D00462, D00613, D00618, D00121, D00141, D00154, D00170, D00171, D00190, D00234, D00256, D00267, D00311, D00313, D00461, D00145, D00146, D00196, D00201, D00205, D00206, D00207, D00257, D00263, D00266, D00268, D00410, D00438, D00439, D00458, D00479, D00488, D00489, D00496, D00511, D00518, D00520, D00527, D00538, D00594, D00596, D00598, D00600, D00605, D00621, D00660, D00661, D00179, D00202, D00204, D00208, D00215, D00219, D00221, D00237, D00260, D00265, D00271, D00275, D00276, D00281, D00285, D00286, D00287, D00353, D00358, D00360, D00365, D00429, D00309, D00334, D00368, D00477, D00482, D00149, D00152, D00289, D00290, D00323, D00401, D00211, D00144, D00181, D00191, D00269, D00472, D00588, D00589, D00161, D00162, D00164, D00229, D00329, D00370, D00371, D00390, D00427, D00160, D00212, D00283, D00320, D00122, D00137, D00156, D00377, D00409, D00434, D00446, D00447, D00450, D00452, D00453, D00463, D00492, D00506, D00510, D00515, D00524, D00530, D00535, D00578, D00587, D00590, D00592, D00597, D00606, D00607, D00608, D00609, D00610, D00611, D00612, D00614, D00615, D00616, D00617, D00619, D00620, D00622, D00623, D00624, D00626, D00629, D00630, D00631, D00642, D00643, D00647, D00650, D00651, D00654, D00656, D00658, D00662, D00664, D00667, D00669, D00670, D00672, D00101, D00105, D00107, D00113, D00125, D00127, D00131, D00132, D00135, D00136, D00158, D00163, D00175, D00188, D00278, D00294, D00333, D00357, D00373, D00376, D00381, D00382, D00384, D00386, D00389, D00400, D00408, D00412, D00414, D00416, D00417, D00436, D00440, D00441, D00442, D00443, D00498, D00500, D00501. Version 6.2.0 was distributed 3/24/07 and version 6.2.1: 4/10/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Wauwatosa, WI, by letters on July 15, 2007.
Manufacturer: GE Medical Systems, Kretztechnik GmbH & Co. OHG, Zipf, Austria. Firm initiated recall is ongoing.
REASON
When a spectrum of a Pulsed Wave Doppler shows an angle correction unequal to 0 is reloaded from the archive or the image is sent to a DICOM station, this angle correction is mistakenly disregarded resulting in an underestimation of the flow velocities.
VOLUME OF PRODUCT IN COMMERCE
521 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Medtronic Sofamor Danek METRx ™ System Bayonet Electrosurgical Pencil, sterile; REF (P/N) 9560575; Recall # Z-0114-2008
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Warsaw Orthopedic, Inc. dba Medtronic Sofamor Danek, Warsaw, IN, by letter dated September 4, 2007.
Manufacturer: Zinnanti Surgical Design LLC, Hershey, PA. Firm initiated recall is ongoing.
REASON
Packaging weakness may compromise sterility and instructions for use are inadequate.
VOLUME OF PRODUCT IN COMMERCE
Approximately 22,632 pencils
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
The Brilliance CT Big Bore is a whole body computed tomography X-Ray system. The malfunctioning software application is the Tumor Localization (Tumor LOC) application.
All Brilliance CT Big Bore Scanners with Tumor Localization software versions v2.2.1, v2.2.2, & v2.2.5. This software version is included on Brilliance CT Big Bore Scanners, Model Number 728243; Recall #  Z-0121-2008
CODE
Serial Numbers 7001 - 7215
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letters on October 1, 2007. Firm initiated recall is ongoing.
REASON
The maximum intensity projection (MIP) images produced from respiratory gated images by the Tumor Localization (Tumor LOC) software application on Brilliance Big Bore CT scanners will be labeled incorrectly for certain patient orientations and view conventions when saved for later viewing.
VOLUME OF PRODUCT IN COMMERCE
206 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Storz Equipment, Fluid Management Stand, for Fluid Management Systems, Product number: 26601EQ-KT, Recall # Z-0144-2008 
CODE
Product has no lot or serial numbers.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Karl Storz Endoscopy America, Inc., Culver City, CA, by letter on September 10, 2007.
Manufacturer: Mpe, Inc., Milwaukee, WI. Firm initiated recall is ongoing.
REASON
Outflow Difference. The accuracy of the equipment displayed value could be influenced by external factors of the cart/stand and may result in a fluctuating or inaccurate reading.
VOLUME OF PRODUCT IN COMMERCE
287 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Mevatron KD2,Medical charge-particle radiation therapy system (Medical Digital
    Linear Accelerator), Model Number: 1940753; Recall # Z-0155-2008;
b) Mevatron KD-2,Medical charge-particle radiation therapy system (Medical Digital
    Linear Accelerator), Model Numbers: 8515520 and 9822685; Recall # Z-0156-2008;
c) Mevatron KDS,Medical charge-particle radiation therapy system (Medical Digital   
    Linear Accelerator), Model Number: 9401522; Recall # Z-0157-2008;
d) Mevatron KDS-2,Medical charge-particle radiation therapy system (Medical
    Digital Linear Accelerator), Model Numbers: 9411588 and 9822693;
    Recall # Z-0158-2008;
e) Mevatron-2 6300, Medical charge-particle radiation therapy system (Medical Digital
    Linear Accelerator), Model Number: 9401316;  Recall # Z-0159-2008;
f) Mevatron M-2 6700,Medical charge-particle radiation therapy system (Medical
    Digital Linear Accelerator), Model Number: 9401407; Recall # Z-0160-2008;
g) Mevatron M-2 6740, Medical charge-particle radiation therapy system (Medical
    Digital Linear Accelerator), Model Number: 9401506; Recall # Z-0161-2008;
h) Mevatron MD-2, Medical charge-particle radiation therapy system (Medical
    Digital Linear Accelerator), Model Number: 9401654; Recall # Z-0162-2008;
i) Mevatron MDX-2, Medical charge-particle radiation therapy system (Medical
    Digital Linear Accelerator), Model Number: 9401746; Recall # Z-0163-2008;
j) Oncor Avant Garde, Medical charge-particle radiation therapy system (Medical
    Digital Linear Accelerator), Model Number: 5863472; Recall # Z-0164-2008;
k) Oncor Expression,Medical charge-particle radiation therapy system (Medical
    Digital Linear Accelerator), Model Numbers: 7360204 and 7360717;
    Recall # Z-0165-2008;
l) Oncor Impression Plus,Medical charge-particle radiation therapy system (Medical
    Digital Linear Accelerator),Model Number: 5857912; Recall # Z-0166-2008;
m) Oncor Impression, Medical charge-particle radiation therapy system (Medical
     Digital Linear Accelerator), Model Number: 5857920; Recall # Z-0167-2008;
n) Mevatron M2/Primus Mid, Medical charge-particle radiation therapy system
    (Medical Digital Linear Accelerator), Model Number 1940035,; Recall #  Z-0168-
    2008;
o) Primus Plus, Medical charge-particle radiation therapy system (Medical Digital
    Linear Accelerator), Model Number: 4504200; Recall # Z-0169-2008
CODE
a) Serial numbers 2509, 2568, 2698, 2168, 2459, 2589, 2616, 2667, 1985, 2145,
    2213, 2216, 2218, 2297, 2571, 2582, 2602, 2612, 2636, 2776, 2038, 2448, 2451,
    2452, 2466, 2505, 2525, 2531, 2547, 2567, 2575, 2578, 2681, 2686, 2751, 2769,
    2777, 2781, 2229, 2726, 2111, 2245, 2561, 1798, 2414, 2542, 2585, 2607, 2631,
    2724, 2731, 2739, 2824, 2826, 2858, 2859, 2864, 2877, 2951, 2952, 3021, 3029,
    3035, 3041, 2394, 2648, 2663, 2801, 2729, 2587, 2592, 02574A, 2498, 2621,
    2704, 2494, 2601, 2807, 2327, 2405, 2569, 2353, 2754;
b) Serial Numbers: 1633, 1772, 1874, 1901, 1938, 1941, 1944, 1987, 2014, 2076,
    2082, 2088, 2135, 2154, 2173, 2175, 2179, 2228, 2246, 2273, 2315, 2329, 2348,
    2383, 2508, 2562, 2568, 2579, 2586, 2598, 2614, 2634, 2645, 2646, 2656, 2676,
    2679, 2713, 2743, 2756, 2202, 2462, 2436, 2472, 2474, 2652, 2133, 2224, 2319,
    2099, 4, 5, 1894, 1928, 1948, 2043, 2074, 2128, 2131, 2376, 2431, 2437, 2441,
    2444, 2496, 2584, 2595, 2687, 2711, 2721, 2757, 2774, 2558, 2726, 2111, 2115,
    2457, 2714, 2065, 2413, 2414, 2542, 2577, 2585, 2606, 2623, 2631, 2724, 2725,
    2727, 2732, 2739, 2775, 2786, 2824, 2826, 2858, 2859, 2864, 2481, 2563, 2609,
    2617, 2638, 2639, 2643, 2649, 2659, 2672, 2697, 2734, 2742, 2771, 2811, 2837,
    2885, 2561, 2715, 2718, 02587A, 02592A, 2498, 2621, 2537, 2601, 2422, 2483,
    2541, 2624, 2123, 2282, 2327, 2405, 2405, 1953, 2662, 2479, 2569, 2127, 2345,
    2754;

c) Serial Numbers:  1917, 1988, 2019, 2232, 2104, 2069, 2193, 2194, 2221, 2159;
d) Serial Numbers: 2055, 2097, 2106, 2108, 2122, 2183, 2208, 2222, 2242, 2244, 2251, 2263, 2269, 2272, 2276, 2284, 2289, 2324, 2335, 2336, 2339, 2357, 2358, 2372, 2513, 2514, 2518, 2665, 2691, 2108A, 2023, 2158, 2168, 2398, 2398BIS, 2264, 2084, 2447, 2453, 2553, AB4220323T, 2229, 2111, 2485, 2402, 2394, 2115, 2245, 2304, 2519, 2327, 2196, 2353;
e) Serial Numbers: 2489, 2594, 2635, 2703, 2407, 24581968;
f) Serial Numbers: 1966, 2029, 2223, 2488, 2787, 2408, 2651, 2752, 2239, 2429, 2861, 2849, 2219, 2432, 2464, 2664, 2418, 2428, 2708, 2779, 2619, 2704, 2802, 2749;
g)   Serial Numbers: 2011, 2093, 2156, 2161, 2171, 2177, 2186, 2211, 2227, 2247, 2254, 2271, 2325, 2338, 2343, 2349, 2355, 2367, 2369, 2523, 2526, 2758, 2767, 2435, 2591, 2164, 2267, 1969, 2484, 2389, 2301, 2417, 2442, 2581, 2608, 2629, 2632, 2633, 2693, 2741, 2821, 2331, 2723, 2456, 2468, 2533, 2766, 2841, 2889, 2907, 2939, 2943, 2654, 2684, 2503;
h)  Serial Numbers: 1949, 1991, 1996, 2045, 2053, 2067, 2113, 2117, 2139, 2152, 2189, 2192, 2199, 2231, 2233, 2234, 2235, 2238, 2241, 2252, 2261, 2281, 2316, 2328, 2374, 2397, M2166, 2283, 2305, 2346, 2427, 2487, 2605, 2674, 2682, 2683, 2856, 2539, 2445, 2588, 2661, 2812, 2937, 2163, 2478, 2205, 2884, 2362, 2392, 2425, 2426, 2454, 2502, 2535, 2546, 2599, 2615, 2637, 2657, 2685, 2691, 2461, 2262, 2423, 2528, 2641, 2694, 2716, 2761, 2813, 2819, 2825, 2874, 2714, 2217, 2249, 2544, 2118, 2439, 2709;
i)  Serial Numbers: 2125, 2137, 2538, 2499.
j)  Serial Numbers: 3738,  3817,  3904,  3905,  3926,  3934,  3938,  3987,  3988,  4016,  4079,  4082,  4095,  70-4077,  70-4113,  70-4188,  70-4197,  70-4283,  70-4368,  3852,  70-4168,  70-4169,  3737,  3739,  3758,  3806,  3856,  3884,  3891,  3912,  3929,  3937,  3941,  3944,  70-4163,  70-4291,  70-4325,  3895,  3896,  4049,  70-4201,  70-4297,  70-4314,  70-4184,  70-4213,  70-4223,  5012,  70-4311,  3881,  70-4324,  70-4217,  3932;
k) Serial Numbers: 5029, 5037, 5042, 5094;
l)  Serial Numbers: 3753, 3754, 3755, 3761, 3764, 3769, 3778, 3783, 3791, 3793, 3801, 3802, 3803, 3804, 3815, 3846, 3855, 3877, 3888, 3901, 3907, 3945, 3948, 3953, 3955, 3957, 3964, 3975, 3981, 3989, 3998, 4015, 4019, 4035, 4065, 4067, 4072, 4091, 5033, 5060, 5088, 5093, 5096, 70-4119, 70-4122, 70-4129, 70-4135, 70-4142, 70-4144, 70-4145, 70-4157, 70-4159, 70-4161, 70-4166, 70-4172, 70-4174, 70-4175, 70-4177, 70-4183, 70-4222, 70-4262, 70-4306, 70-4317, 70-4343, 70-4345, 70-4349, 70-4354, 70-4356, 70-4362, 70-4378, 70-4379, 3956, 4011, 70-4136, 70-4154, 70-4334, 4024, 3796, 3799, 3865, 70-4361, 3795, 4074, 5002, 5034, 5057, 3739, 3808, 4017, 4022, 4068, 4081, 4084, 4096, 5001, 5011, 5032, 5053, 5058, 5086, 5087, 5095, 70-4107, 70-4132, 70-4147, 70-4149, 70-4153, 70-4171, 70-4189, 70-4288, 70-4312, 70-4331, 70-4333, 70-4366, 5031, 70-4158, 3983, 3823, 3965, 5061, 5091, 70-4124, 70-4137, 70-4329, 70-4348, 5068, 5085, 70-4215, 70-4253, 70-4272, 70-4305, 70-4335, 70-4338, 70-4123, 70-4176, 70-4209, 3816, 4012, 4053, 5023, 70-4186, 70-4241, 70-4244, 3776, 3848, 3858, 3963, 4002, 4027, 70-4097, 70-4346, 70-4384, 4071, 3836, 3827, 4005, 5039, 5040, 70-4231, 5030, 70-4328, 70-4365, 4026, 70-4258, 70-4301, 4009, 3916, 70-4278, 3925, 3954, 5027, 5044, 5069, 70-4224, 70-4295, 70-4299, 5004, 704093, 3968, 4037, 70-4193, 70-4292, 70-4127, 3841, 3863, 4008, 4062, 4064;
m)  Serial Numbers: 3878, 4021, 4078, 70-4143, 70-4207, 70-4235, 70-4257, 70-4344, 70-4296, 3974, 70-4165, 70-4167, 3729, 5022, 5035, 5074, 3811, 3845, 3962, 3973, 70-4152, 5015, 70-4238, 70-4374, 70-4386, 5024, 704083, 3894, 4048, 70-4276, 70-4277, 70-4281, 3883, 70-4083;
n)  Serial Numbers: 1966,  2011,  2029,  2046,  2156,  2171,  2177,  2186,  2247,  2261,  2506,  2507,  2512,  2515,  2516,  2517,  2521,  2522,  2524,  2526,  2527,  2532,  2572,  2573,  2593,  2596,  2611,  2613,  2622,  2626,  2644,  2647,  2669,  2678,  2689,  2692,  2695,  2696,  2699,  2702,  2705,  2722,  2735,  2738,  2745,  2758,  2765,  2767,  2784,  2791,  2792,  2794,  2806,  2814,  2816,  2817,  2818,  2834,  2845,  2847,  2855,  2857,  2875,  2898,  2901,  2906,  2913,  2921,  2929,  2955,  2959,  2961,  2962,  2965,  2968,  2974,  2988,  2995,  3009,  3013,  3016,  3018,  3045,  3055,  3057,  3061,  3071,  3078,  3082,  3084,  3089,  3101,  3103,  3116,  3118,  3126,  3133,  3136,  3138,  3147,  3156,  3162,  3192,  3207,  3208,  3228,  3232,  3243,  3258,  3274,  3285,  3287,  3294,  3296,  3298,  3303,  3304,  3316,  3353,  3364,  3383,  3397,  3409,  3425,  3433,  3434,  3435,  3439,  3448,  3458,  3482,  3495,  3503,  3512,  3517,  3541,  3557,  3576,  3591,  3604,  3605,  3616,  3617,  3618,  3623,  3624,  3629,  3631,  3639,  3644,  3664,  3673,  3678,  3692,  3699,  3702,  3736,  3748,  3756,  3774,  3788,  3798,  3805,  3826,  3842,  3859,  3873,  3931,  3939,  3986,  4018,  5092,  5500371,  70-4146,  70-4178, 
      70-4287,  70-4316,  70-4323,  70-4347,  70-4363,  M2855,  3647,  4031,  59130,  3175,  3204,  3205,  3206,  3012,  3246,  3251,  3491,  3648,  2435,  70-4134,  2998,  3108,  3313,  2747,  2752,  2809,  2879,  2946,  3054,  3221,  3229,  3554,  3559,  3581,  3585,  3588,  3589,  3655,  3787,  3857,  3889,  3903,  3906,  3911,  3913,  3927,  5065,  70-4118,  70-4203,  70-4246,  2469,  2473,  2475,  2476,  2559,  2618,  3235,  3236,  3376,  4063,  70-4111,  2744,  3065,  3152,  3337,  2803,  2804,  2915,  3393,  3683,  4182,  4233,  1940035,  70-4182,  2861,  2603,  2969,  3301,  3575,  3625,  3627,  3676,  3882,  70-4202,  2086,  2257,  2295,  2352,  2401,  2438,  2576,  2604,  2707,  2759,  2778,  2835,  3051,  3063,  3169,  3321,  3394,  3914,  3923,  4092,  5048,  70-4284,  2005,  2057,  2443,  2465,  2543,  2545,  2552,  2597,  2625,  2642,  2653,  2673,  2675,  2688,  2706,  2719,  2737,  2748,  2795,  2822,  2831,  2876,  2881,  2926,  2932,  2935,  2947,  2953,  2971,  2984,  3001,  3015,  3056,  3059,  3062,  3086,  3088,  3096,  3099,  3141,  3197,  3253,  3314,  3328,  3363,  3415,  3652,  3792,  3885,  2949,  3358,  3385,  2868,  3449,  3451,  2566,  3712,  3847,  3946,  3951,  5016,  5025,  5082,  70-4269,  70-4319,  70-4339,  70-4369,  3609,  3789,  4248,  70-4248,  2698,  3775,  3777,  3779,  3784,  3807,  2583,  2677,  2799,  2852,  2981,  3281,  3355,  3432,  3478,  3537,  3538,  3555,  3593,  3633,  3643,  3705,  3726,  3733,  3743,  3785,  3869,  3898,  3928,  70-4151,  70-4273,  ZTVL00009,  ZTVX00003,  2299,  2362,  2392,  2402,  2425,  2426,  2454,  2455,  2471,  2495,  2497,  2529,  2535,  2546,  2599,  2637,  2657,  2685,  2691,  2712,  2728,  2736,  2772,  2843,  2853,  2873,  2925,  2999,  3035,  3038,  3073,  3083,  3166,  3167,  3178,  3185,  3195,  3196,  3198,  3252,  3275,  3282,  3325,  3335,  3338,  3341,  3344,  3357,  3379,  3429,  3442,  3472,  3476,  3508,  3523,  3527,  3528,  3532,  3535,  3548,  3563,  3637,  3674,  3685,  3694,  3723,  3741,  3747,  3821,  3838,  3854,  3871,  3874,  3875,  3886,  3892,  3933,  3971,  3982,  4007,  4014,  4023,  4025,  4038,  4073,  5009,  5018,  5019,  5051,  5054,  5055,  5070,  70-4104,  70-4106,  70-4108,  70-4114,  70-4115,  70-4138,  70-4191,  70-4261,  70-4375,  70-5005,  2255,  3834,  2886,  3194,  3052,  2534,  2789,  2982,  2983,  3368,  3388,  3463,  4087,  3006,  3132,  3139,  3164,  3173,  3188,  3263,  3266,  3277,  3293,  3306,  3331,  3352,  3404,  3419,  3437,  3446,  3447,  3473,  3505,  3509,  3546,  3596,  3607,  3613,  3615,  3635,  3656,  3658,  3665,  3671,  3681,  3687,  3697,  3715,  3716,  3771,  3809,  3843,  3849,  3851,  3864,  3866,  3879,  3908,  3918,  3921,  3935,  3966,  3992,  3997,  4003,  4034,  4041,  4044,  4046,  4052,  4058,  4066,  4069,  4094,  4236,  5071,  5072,  5078,  5080,  6100,  704088,  704098,  70-4121,  70-4128,  70-4155,  70-4164,  70-4196,  70-4199,  70-4211,  70-4214,  70-4216,  70-4228,  70-4242,  70-4243,  70-4245,  70-4259,  70-4263,  70-4265,  70-4274,  70-4286,  70-4293,  70-4294,  70-4298,  70-4303,  70-4307,  70-4321,  70-4332,  70-4337,  70-4342,  70-4352,  70-4353,  70-4355,  70-4358,  70-4371,  70-4372,  70-4377,  70-4381,  70-4382,  70-4383,  70-4385,  3309,  3682,  340563,  722348,  70-4268,  3381,  2382,  3812,  2549,  2554,  2717,  2888,  70-4229,  3659,  70-4289,  2499,  2619,  2684,  2704,  2802,  3247;
o)  Serial Numbers:  2701,  2733,  2762,  2768,  2823,  2827,  2828,  2836,  2839,  2842,  2846,  2848,  2863,  2867,  2887,  2893,  2894,  2896,  2899,  2911,  2912,  2914,  2931,  2933,  2934,  2936,  2941,  2954,  2958,  2972,  2991,  2996,  2997,  3004,  3014,  3019,  3025,  3027,  3039,  3049,  3053,  3066,  3068,  3069,  3075,  3076,  3077,  3079,  3087,  3092,  3097,  3102,  3105,  3109,  3111,  3112,  3114,  3125,  3131,  3134,  3137,  3142,  3153,  3154,  3161,  3165,  3168,  3174,  3179,  3181,  3186,  3203,  3209,  3211,  3212,  3213,  3214,  3215,  3223,  3224,  3225,  3239,  3241,  3244,  3245,  3254,  3255,  3257,  3261,  3264,  3267,  3272,  3286,  3292,  3297,  3302,  3305,  3318,  3319,  3323,  3324,  3342,  3349,  3354,  3361,  3365,  3367,  3377,  3392,  3402,  3403,  3413,  3414,  3417,  3418,  3422,  3423,  3424,  3426,  3427,  3443,  3452,  3453,  3456,  3461,  3471,  3474,  3477,  3479,  3484,  3501,  3504,  3514,  3515,  3516,  3519,  3524,  3533,  3534,  3542,  3547,  3564,  3565,  3568,  3569,  3572,  3574,  3583,  3595,  3597,  3601,  3602,  3622,  3634,  3651,  3657,  3666,  3667,  3672,  3675,  3679,  3695,  3696,  3701,  3709,  3711,  3731,  3745,  3751,  3773,  3781,  3825,  3829,  3832,  3835,  3862,  3899,  3922,  3924,  3942,  3949,  3978,  3979,  4001,  4036,  4059,  5008,  50941,  2933A,  70-4117,  70-4185,  3744,  3749,  340258,  340262,  2956,  2963,  3579,  3582,  3587,  3592,  3663,  2773,  2815,  2964,  3046,  3217,  3308,  3334,  3724,  3917,  3598,  3752,  3373,  3561,  104744,  3042,  3158,  3191,  3284,  3291,  3295,  3356,  3378,  3382,  3406,  3407,  3469,  3619,  3638,  3641,  3645,  3742,  3919,  70-4173,  3612,  3824,  3995,  3732,  2869,  3219,  3343,  3502,  3861,  2871,  3268,  70-4126,  2753,  2808,  2928,  2987,  3026,  3032,  3037,  3047,  3117,  3201,  3234,  3346,  3398,  3431,  3522,  3545,  3599,  3649,  3703,  3704,  3767,  3814,  5063,  2782,  2783,  2796,  2829,  2832,  2833,  2851,  2854,  2866,  2891,  2938,  2942,  2944,  2945,  2948,  2967,  2973,  2989,  2994,  3031,  3033,  3034,  3044,  3072,  3081,  3091,  3093,  3094,  3098,  3106,  3127,  3128,  3129,  3144,  3145,  3155,  3182,  3199,  3231,  3259,  3332,  3333,  3348,  3351,  3362,  3387,  3399,  3438,  3467,  3539,  3549,  3552,  3578,  3614,  3686,  3693,  3763,  4013,  2957,  3307,  3395,  3444,  3936,  2862,  2976,  3642,  3833,  4099,  4131,  4232,  70-4131,  70-4308,  2793,  2805,  2918,  3202,  3499,  3571,  3577,  3684,  3714,  3718,  3725,  3768,  3786,  3794,  3958,  3972,  3977,  3999,  4042,  4075,  5073,  98943,  102842,  340274,  70-4264,  70-4194,  3311,  3369,  3401,  2785,  2992,  3107,  3135,  3183,  3326,  3372,  3396,  3408,  3416,  3421,  3475,  3689,  3961,  4039,  5036,  70-4133,  70-4271,  ZTVK00010,  104,  2844,  2908,  3022,  3058,  3143,  3148,  3157,  3184,  3187,  3189,  3193,  3233,  3237,  3256,  3262,  3278,  3315,  3327,  3336,  3359,  3366,  3436,  3488,  3513,  3518,  3521,  3526,  3529,  3531,  3536,  3668,  3677,  3717,  3813,  3819,  3822,  3839,  3844,  3867,  3868,  3872,  3876,  3902,  3943,  3984,  3985,  3991,  4033,  4043,  4047,  4055,  4057,  4085,  4105,  5007,  5010,  5021,  5050,  5066,  5079,  5090,  70-4101,  70-4102,  70-4187,  70-4204,  70-4206,  70-4219,  70-4225,  70-4227,  70-4247,  70-4252,  70-4266,  70-4275,  70-4351,  70-4357,  70-4364,  3250,  4103,  70-4103,  3288,  2975,  3227,  3339,  3347,  3386,  3389,  3994,  4045,  70-4373,  3028,  3722,  4061,  70-4195,  344125,  2985,  3011,  3483,  3506,  3562,  3698,  3412,  3002,  3273,  3276,  3489,  3492,  2916,  2917,  2922,  2978,  2979,  3005,  3007,  3067,  3085,  3115,  3119,  3149,  3176,  3248,  3265,  3299,  3455,  3459,  3462,  3464,  3468,  3511,  3558,  3573,  3586,  3632,  3646,  3669,  3762,  3766,  3782,  3818,  3831,  3853,  3915,  3947,  3959,  3976,  3993,  4051,  4076,  4239,  5047,  340203,  70-4116,  70-4156,  70-4162,  70-4198,  70-4205,  70-4208,  70-4212,  70-4237,  70-4255,  70-4279,  70-4315,  70-4318,  70-4322,  70-4326,  70-4341,  70-4376,  3043,  3594,  340180,  3746,  340263,  3384,  3146,  3283,  70-4282,  2897,  2902,  2904,  2993,  3249,  3626,  3628,  3893,  4004,  3727,  3728,  3441,  70-4327,  2905,  3121,  3123,  3177,  3216,  3584,  3757,  3828,  3312,  3317,  2882,  3279,  3734,  4218,  70-4218,  2924,  3024,  3606,  3608,  3909,  70-4139,  70-4141,  70-4251,  2797,  2883,  2903,  2919,  2923,  2986,  3036,  3095,  3122,  3159,  3172,  3242,  3391,  3454,  3466,  3543,  3553,  3556,  3621,  3636,  3653,  3654,  3661,  3662,  3713,  3772,  3967,  3969,  4006,  4028,  4109,  5045,  5046,  70-4112,  70-4192,  70-4285,  2878,  3017,  3329,  2872,  2966,  3064,  3797,  3897,  5013,  2892,  3008,  3074,  3218,  3226,  3375,  3486,  3567,  3493,  3003,  3507,  3735,  3759,  4086,  5003,  340264,  70-4256,  3113,  3238,  3405,  3465,  3481,  3691,  3706,  3708,  3719,  3721,  340251,  298700097,  302600003,  303200005,  303700007,  304700009,  311700023,  334600031,  3411,  3887,  3525,  3544,  70-4302.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Concord, CA, by letter on March 26, 2007. Firm initiated recall is ongoing.
REASON
Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of future treatment plans. A second reason is an unplanned Dosimetry calibration data set can be erroneously copied during "Service Mode."
VOLUME OF PRODUCT IN COMMERCE
2.123 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Signa MFO/I Magnetic Resonance System, Model Numbers : 2210339, 2262700, 2276937, 2282853, 2282860, 2282880, 2352129, 2388781, 5105123, 5113339, 2138300-32, 2189500-3, 2198999-4, 2259620-4, 2262700-2, 2269512-2, 2286849-2, 2352129-2, 2377062-5, 2377062-8; Recall # Z-0170-2008
CODE
Units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
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Waukesha WI,  by field service visits in December 2006.
Manufacturer: GE Hangwei Medical Systems Co., LTD, Beijing PR, China. Firm initiated recall is complete.
REASON
Incorrect patient positioning; when moving the patient into the bore may lead to wrist and hand injury.
VOLUME OF PRODUCT IN COMMERCE
163 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Ximatron Digital Imaging (Ximavision), V 7.5.51 with Service Pack (SP), Oncology Information System, Varian Medical Systems, Recall # Z-0213-2008
CODE
Serial numbers H720441, H720637, H720672, H720702, H720781, H720791, H720804, H720865, H720873, H720894, H720895, H720916, H720932, H720973
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc., Palo Alto, CA, by letter on June 25, 2007. Firm initiated recall is ongoing.
REASON
Unexpected loss of Treatment Field Add-Ons (Wedges, Blocks, etc) during Ximatron simulation. If an unapproved treatment field is created without an MLC, but with an add-on, the add on will be deleted without warning. If this is not detected and corrected, incorrect dose delivery will occur.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
MO, NY and Internationally
___________________________________
PRODUCT
Texium Closed Male Luer (CML), Model Number: 10012241, Recall # Z-0218-2008
CODE
No serial numbers. Model number only.
RECALLING FIRM/MANUFACTURER
 Recalling Firm: Cardinal Health 303 Inc., dba Alaris Products, San Diego, CA, by letters on August 30, 2007.
Manufacturer: Cardinal Health 303, Inc., Creedmoor, NC. Firm initiated recall is ongoing.
REASON
Leaks. There is a risk of leakage at the female end of the Texium closed male luer (CML) when attached to a spin luer. (NOTE: users who connect the female portion of the Texium closed male luer to fixed (one-piece) male luers on tubing or on syringes are not affected by this issue).
VOLUME OF PRODUCT IN COMMERCE
76,300 units
DISTRIBUTION
Nationwide, Australia, Canada, Japan and Switzerland
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PRODUCT
OPTI® LION E-Plus Cassettes, Model BP7507, (25 per box), In Vitro Diagnostic, Recall # Z-0119-2008
CODE
Lot numbers 701800, 706800, 710801, 711800, 711801, 712800, 713800, 714800, 714801, 714802, and 718800
RECALLING FIRM/MANUFACTURER
OPTI Medical Systems, Inc., Roswell, GA, by e-mail and fax on/about July 18, 2007. Firm initiated recall is ongoing.
REASON
Incorrect results/stability failure; Actual device stability studies show sodium and chloride sensors age differently than anticipated when stored at the high end of labeled storage, therefore subsequent measurements give results outside the allowed error allowance before the 6 month expiration date shown on the device.
VOLUME OF PRODUCT IN COMMERCE
289 boxes pf 25 cassettes
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
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PRODUCT
Medtronic Paceart System, 2006 Edition, The Paceart System can act as a Practice Management software application and is intended for use by facilities that provide services such as event monitoring, trans-telephonic pacemaker evaluation, and in-office evaluation of implanted cardiac devices; Recall # Recall Number : Z-0081-2008
CODE
2006 First Edition (Get Connected Edition)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Inc. Cardiac Rhythm Management, Minneapolis, MN, by letter on August 27, 2007.
Manufacturer: Medtronic Paceart, Arden Hills, MN. Firm initiated recall is ongoing.
REASON
An issue with the Paceart System - 2006 First Edition (Get Connected Edition) exists. Under certain circumstances, Paceart System Generic ICD reports may not accurately reflect patient VT/VF, SVT/NST and Mode Switch/AT/AF episode detection data. When episode detection data is imported into the Paceart System from certain sources, the Paceart System Generic ICD reports display a zero, suggesting no episodes have occurred, instead of indicating that no data is available.
VOLUME OF PRODUCT IN COMMERCE
721 units
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR NOVEMBER 14, 2007

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