OCTOBER 2007
WEEK ENDING OCTOBER 6
PRODUCT Exacta-Mix
2400 OS v1.07, Model No. 8300-0073, Pharmacy Compounding System,
CODE
Version 1.07 of the EM2400 Operating
Software.
RECALLING FIRM/MANUFACTURER Baxa Corporation,
Englewood, CO,
REASON A software defect could allow
up to 50mL of extra volume being added to a TPN (Total Parenteral Nutrition)
solution.
VOLUME OF PRODUCT IN COMMERCE 30
units
DISTRIBUTION CA, CO, FL, DY, MI, NY, OH, OR, and
TX
PRODUCT
a)
Nuclear medicine systems: Gemini 16, Model 4535 679 28961. Gemini GXL,
Models # 4535 679 71891, #4535 679 75681, #4535 679
75691. Precedence,
Model #2169 -3000A, #2169-3001A,
#2169-3002A, and 2169-3003A. PET/CT
Computed tomography
systems,
b) Brilliance (a) CT 6 slice, Model #4535 670
73191. Brilliance(a) CT 10 Slice,
Model 4535 670 73181.
Brilliance 16 Slice, Model #4535 670 78851. Brilliance CT
16 Power, Model #4535 670 23331. Brilliance CT 40 Slice
Model #4550 110 04011.
Brilliance CT Big Bore, Model
#4535 670 88051. Computed tomography systems.
CODE
a) Serial #s: 4034-4100, 4102, 4103,
1041;
b) Serial #s: 30035; 40022; 5059, 50027, 50017; 6011, 6095, 6118,
60006; 9145, 9036,
9115, 9089, 9042, 90061, 90109, 90072,
90050, 90150, 7022
RECALLING FIRM/MANUFACTURER Philips
Medical Systems (Cleveland), Inc., Cleveland, OH,
REASON A
potential anomaly was identified on the CT subsystem, which could result in the
radiation dose being different than the calculated dose reported to the
operator.
VOLUME OF PRODUCT IN COMMERCE 90
devices
DISTRIBUTION Nationwide and
Internationally
PRODUCT Pyxis
Anesthesia System 3500, Model 3500,
CODE All serial numbers of the Pyxis
Anesthesia Station
RECALLING FIRM/MANUFACTURER Cardinal
Health 301 LLC DBA Cardinal Health Pyxis Products, San Diego, CA
REASON
System lock up; mini-drawers -under
certain circumstances during use, are not accessible, delaying the user from
accessing critical medications.
VOLUME OF PRODUCT IN
COMMERCE 369
units
DISTRIBUTION Nationwide
PRODUCT
a)
OEC 9900 Elite image-intensified fluoroscopic x-ray system,
b) OEC 9800 image-intensified fluoroscopic x-ray system,
c) OEC 8800 image-intensified fluoroscopic x-ray system,
07;
d) OEC 9900 Elite MD Motorized C-Arm System,
image-intensified
fluoroscopic x-ray system,
e) OEC FluoroTrak 9800 PLUS, image-intensified fluoroscopic
x-ray system,
f) OEC 9800
MD Motorized C-Arm System, image-intensified fluoroscopic
x-ray system,
g) OEC 9800 Plus (Flourotrak)
Image-intensified fluoroscopic x-ray system,
h) OEC 9900 Elite (NAV) Image-intensified fluoroscopic x-ray
system,
CODE
a) Serial Numbers: E2-0019, E2-0028,
E2-0064, E2-0142, E2-0156, E2-0170, E2-0180,
E2-0213,
E9-0008, E9-0040-G, E9-0103, E9-0029, ES-0060, ES-0088, ES-0096,
ES-0099, E9-0150, E9-0152, E9-0158;
b) Serial Numbers:
429 units within the range 8S-0007 thru 8S-7163,
455
units within the range 89-0014 thru 89-3520,
659 units
within the range 82-0010 thru 82-7138;
c) Serial Numbers: FIB-0020, FIB-0025,
FIB-0038, FIB-0050, FIB-0065, 2799PU5,
2832PU4, 3380PU3,
3589PU9, 4037PU8, 4816PU5, 4842PU1, 4860PU3,
5190PU4,
5204PU3, 5210PU0, 5270PU6;
d) Serial Numbers: E2-7075-MH, ES-0029-CH,
ES-0046-CH, ES-0066-CH, ES-0131-H;
e) Serial numbers: 89-1579-N, 89-2529-N,
82-2160-N, 8S-1932-N, 8S-2226-N;
f) Serial numbers: 82-7001-MH, 82-7004-MH,
82-7006-MH, 82-7009-MH, 82-7024-MH,
82-7034-MH,
82-7077-MH, 82-7086-MH, 82-7096-MH, 82-7098-MH, 82-7105-MH,
82-7110-MH, 82-7139-MH, 82-2061-C, 82-1094-C, 82-0619-M,
89-0483-C, 8S-7031-MH,
8S-7035-MH-RC, 8S-7047-MH,
8S-7075-CMH, 8S-7127-MH, 8S-7145-MH, 8S-7164-CMH,
8S-2791-C, 8S-2518-C, 8S-2519-C, 8S-2046-C, 8S-2054-C, 8S-1911-C,
8S-1772-C, 8S-1632-C,
8S-1490-C, 8S-1449-C, 8S-1224-C-RC,
8S-1212-C, 8S-1069-C, 8S-1065-C, 8S-1013-C,
8S-0849-C,
8S-0793-C, 8S-0790-C, 8S-0754-C, 8S-0744-C, 8S-0721-C, 8S-0717-C,
8S-0708-C, 8S-0678-C, 8S-0615-C, 8S-0559-C, 8S-0521-C,
8S-0510-C-RC, 8S-0421-C,
8S-0413-C, 8S-0405-C,
8S-0348-C-RC, 8S-0300-C, 8S-0192-C, 8S-0143-C, 8S-0144-C,
8S-0148-C, 8S-0140-C, 8S-0141-C, 8S-0093-C, 8S-0055-C, 8S-0011-C, 8S-0014-C,
8S-0016-C, 8S-0005-C, 8S-0006-C-RC;
g) Serial number
8S-2339-N;
h) Serial # ES-0152
RECALLING
FIRM/MANUFACTURER GE OEC Medical Systems, Inc., Salt Lake City, UT
REASON
During routine service, primary and/or
secondary collimators may not have been properly reinstalled.
VOLUME
OF PRODUCT IN COMMERCE 1,661
units
DISTRIBUTION Nationwide and
Germany
PRODUCT
a)
Practix 33 Mobile X-ray systems. The systems are used in general purpose
diagnostic imaging,
and are specifically used as mobile
X-ray systems for bedside radiological examinations,
b) Practix 160 Mobile X-ray systems. The systems are
used in general purpose diagnostic imaging,
and are
specifically used as mobile X-ray systems for bedside radiological examinations,
c) Practix 300 Mobile X-ray
systems. The systems are used in general purpose diagnostic imaging,
and are specifically used as mobile X-ray systems for
bedside radiological examinations,
CODE
a) Serial Numbers: P5-546; P5-370;
P5-547; P5-529; P5-371; P5-426; PS-686; P5-727,
and
P5-548;
b) Serial Numbers P3-449 and P3-443;
c) Serial numbers 4561206,
6561652, 6561768, 6561732, 6561728, 6561730,
6561767,
355142, and 06561731
RECALLING FIRM/MANUFACTURER Philips
Medical Systems North America Co. Phillips, Bothell, WA
REASON
X-ray systems lack product report
certification demonstrating compliance, and were illegally introduced into the
United States commerce.
VOLUME OF PRODUCT IN COMMERCE 20
units
DISTRIBUTION PR
PRODUCT
a)
Philips Bucky Diagnost X-Ray System,
b) Philips
Digital Diagnost X-Ray system, ;
c) Philips Easy Diagnost
X-Ray System,
d) Philips Easy Diagnost Eleva,
e) Philips Omni Diagnost
Eleva,
f)
Philips Multi Diagnost Eleva,
CODE
a) Site numbers 5024, 5175, 6135, 6143,
6181, 6228, 6717, 6740, 6759, 6773, 6786, 6797, 6798, 6810, 6826, 6836, 6843,
6857, 6858, 6859, 6864, 6866, 6873, 6883, 6884, 6885, 6888, 6889, 6893, 6903,
6904, 6920, 6925, 6932, 6936, 6954, 6958, 6959, 6964, 6973, 6974, 6982, 6988,
6989, 6992, 10029, 10033, 10066, 10145, 10417, 10419, 10429, 10434, 10461,
10477, 10481, 10498, 10499, 13012, 13028, 13032, 13034, 13122, 13125, 13131,
13146, 13159, 13175, 13198, 13216, 13224, 13225, 13243, 13244, 13246, 13247,
13248, 13249, 13250, 13251, 13252, 13254, 13256, 13278, 13279, 13295, 13611,
13613, 13632, 13636, 13648, 13649, 13650, 13654, 13655, 13667, 13698, 13706,
13712, 13726, 13728, 13741, 13744, 13869, 13870, 13871, 13872, 13887, 13892,
13893, 13896, 13909, 13912, 13920, 13957, 13973, 13974, 13975, 14076, 14078,
14081, 14176, 16027, 16278, 16294, 16399, 16473, 16552, 16572, 16609, 17166,
17248, 17298, 17494, 17516, 17540, 17567, 17568, 17569, 17570, 17571, 17582,
17588, 17589, 17591, 17634, 17658, 17659, 17660, 17661, 17662, 17671, 17672,
17673, 19050, 19124, 19176, 19304, 19329, 19336, 25007, 25448, 25627, 25628,
25898, 26015, 26023, 26024, 26026, 26028, 26029, 26044, 26045, 26130, 26141,
26153, 26155, 26156, 26205, 26206, 26208, 26209, 26210, 26273, 26274, 26283,
28043, 28077, 28079, 28081, 28105, 28148, 28179, 28243, 31113, 34031, 34348,
34734, 35156, 35482, 35483, 35584, 35585, 35596, 37387, 37582, 37583, 37906,
37949, 37951, 37952, 37955, 37967, 37968, 37978, 37980, 37989, 37999, 38005,
38011, 38012, 38013, 38068, 38082, 38085, 38090, 38092, 38093, 38099, 38100,
38103, 38128, 38129, 38130, 38131, 38132, 38135, 38140, 38148, 38157, 38176,
38193, 38194, 38197, 38251, 38253, 38258, 38259, 38281, 38299, 38300, 38319,
38323, 38350, 38354, 38367, 38368, 38421, 38446, 38606, 38609, 38621, 38622,
38633, 38667, 38684, 38694, 38726, 38741, 38742, 38746, 38747, 38866, 38867,
38875, 38876, 38877, 38878, 38887, 38900, 38927, 38950, 38951, 38952, 38953,
38979, 38980, 38999, 40092, 40189, 40203, 40263, 40476, 40511, 40623, 40686,
40899, 40920, 40933, 40934, 40939, 40972, 41009, 41036, 41037, 41041, 41042,
41061, 41074, 41081, 41088, 41089, 41090, 41091, 41093, 41097, 41100, 41101,
41106, 41110, 41119, 41126, 41144, 41158, 41168, 41244, 41259, 41260, 41261,
41270, 41283, 41285, 41334, 41353, 41384, 41401, 41408, 41419, 41421, 41434,
41438, 41464, 41469, 41471, 41472, 41473, 43259, 43269, 43342, 43450, 43451,
43522, 43685, 43912, 44006, 44769, 44795, 44796, 44797, 44798, 44799, 44800,
44801, 44831, 44851, 44889, 44949, 44963, 45015, 45027, 45028, 45030, 45031,
45034, 45035, 45040, 45043, 45064, 45093, 46114, 46326, 46413, 46656, 46668,
46845, 46870, 46873, 46876, 46969, 46985, 47061, 47068, 47092, 47099, 47116,
47148, 47150, 47173, 47175, 47176, 47182, 47186, 47267, 49052, 49053, 49087,
49167, 49308, 50232, 50233, 50234, 50237, 50341, 50342, 50343, 50386, 52452,
52453, 52454, 52457, 52458, 52474, 52475, 52490, 58153, 58204, 58227, 58238,
58241, 58257, 58392, 58624, 58733, 58753, 58754, 58767, 58861, 58862, 58867,
58965, 58969, 58970, 58971, 59017, 59033, 59226, 59227, 59244, 59284, 59362,
59402, 59403, 59404, 59405, 59406, 59407, 59449, 59450, 59509, 59517, 59519,
59543, 59550, 59561, 59563, 59570, 59609, 59649, 59664, 59665, 59668, 59669,
61072, 61387, 61423, 61458, 61576, 61968, 62002, 62282, 62296, 62342, 62431,
62468, 62469, 62477, 62499, 62500, 62501, 62553, 62602, 62603, 62604, 62609,
62616, 62617, 62665, 62766, 62769, 62771, 62783, 62883, 62884, 62886, 62890,
62928, 62929, 62935, 62939, 62995, 64085, 64162, 64163, 64208, 64283, 64322,
64360, 64369, 64374, 64411, 64504, 64657, 65170, 67189, 67290, 67447, 67535,
73296, 73340, 73351, 74062, 74063, 74083, 76034, 76077, 76159, 76193, 76194,
76215, 76222, 76336, 76369, 76370, 76392, 76393, 76440, 76457, 76458, 76496,
76524, 76579, 76586, 76803, 76819, 76835, 76836, 76846, 76888, 76889, 76891,
76894, 76905, 76906, 76908, 76920, 76921, 76922, 76926, 76943, 76949, 76969,
76970, 76971, 76981, 76991, 76998, 80316, 80333, 82557, 82558, 82559, 82560,
82568, 82569, 82614, 82629, 82631, 82632, 82647, 82648, 82654, 82658, 82659,
82686, 82705, 82718, 82723, 82732, 82808, 82826, 82828, 82832, 82833, 82835,
82919, 82938, 83008, 83009, 83010, 83011, 83012, 83029, 83037, 83043, 83305,
83331, 83332, 83338, 83341, 83371, 83372, 83390, 83391, 83565, 83566, 83603,
83614, 83619, 83652, 83653, 83699, 83800, 83801, 83866, 83900, 83901, 83908,
83942, 83948, 83960, 83998, 84419, 84439, 84440, 84453, 84454, 84455, 84456,
84457, 84458, 84488, 84497, 84701, 84705, 84723, 84731, 84817, 84818, 84837,
84846, 84847, 84848, 84849, 84891, 84894, 84929, 84932, 84937, 84943, 84965,
84972, 85009, 85036, 85053, 85063, 85066, 85069, 85103, 85115, 85118, 85151,
85152, 85162, 85164, 85181, 85193, 85194, 85199, 85439, 85461, 85462, 85463,
85466, 85468, 85627, 85628, 85699, 85860, 86014, 86016, 86073, 86075, 86117,
86119, 86120, 86123, 86141, 86210, 86211, 86212, 86219, 86220, 86225, 86227,
86230, 86231, 86266, 86267, 86268, 86269, 86270, 86279, 86300, 86301, 86302,
86304, 86306, 86307, 86308, 86311, 86312, 86336, 86337, 86338, 86357, 86361,
86369, 86385, 86388, 86392, 86402, 86455, 86472, 86493, 86507, 86544, 86546,
86550, 86602, 86605, 86614, 86615, 86621, 86902, 86904, 86919, 86920, 86921,
86943, 86951, 86963, 86973, 86974, 87003, 87014, 87015, 87025, 87026, 87027,
87028, 87032, 87039, 87049, 87057, 87071, 87073, 87074, 87082, 87141, 87144,
87301, 87303, 87321, 87338, 87602, 87606, 87608, 100039, 100094, 100203, 100244,
100245, 100433, 100437, 100439, 100455, 100490, 100544, 100547, 100569, 100571,
100572, 100573, 100584, 100591, 100602, 100616, 100617, 100634, 100642, 100659,
100678, 100699, 100705, 100772, 100782, 100806, 100814, 100824, 100827, 100830,
100831, 100836, 100853, 100868, 100871, 100872, 100885, 100891, 100995, 100998,
101029, 101068, 101081, 101082, 101189, 101209, 101218, 101315, 101379, 101380,
101405, 101410, 101436, 101437, 101553, 101559, 101592, 101638, 101702, 101703,
101704, 101705, 101882, 101883, 101885, 101933, 101944, 101947, 101980, 101984,
101985, 101986, 101989, 101997, 102010, 102016, 102017, 102020, 102022, 102023,
102026, 102027, 102040, 102080, 102108, 102113, 102122, 102124, 102128, 102129,
102134, 102291, 102355, 102358, 102360, 102421, 102443, 102456, 102470, 102494,
102495, 102496, 102509, 102528, 102529, 102530, 102605, 102618, 102619, 102620,
102621, 102626, 102646, 102648, 102649, 102706, 102712, 102721, 102725, 102726,
102727, 102775, 102779, 102784, 102792, 102891, 102898, 102901, 102902, 102904,
102909, 102910, 102920, 102927, 102981, 102997, 102998, 103001, 103010, 103024,
103025, 103031, 103044, 103048, 103049, 103054, 103067, 103073, 103074, 103102,
103104, 103105, 103114, 103127, 103138, 103155, 103156, 103162, 103194, 103195,
103203, 103206, 103208, 103251, 103259, 103269, 103277, 103288, 103311, 103314,
103332, 103334, 103352, 103358, 103360, 103365, 103369, 103386, 103412, 103413,
103425, 103428, 103429, 103430, 103431, 103432, 103433, 103440, 103441, 103443,
103444, 103500, 103501, 103503, 103521, 103524, 103531, 103532, 103543, 103549,
103560, 103586, 103598, 103626, 103654, 103700, 103708, 103720, 103728, 103736,
103749, 103755, 103775, 103790, 103792, 103794, 103854, 103857, 103858, 103859,
103871, 103872, 103874, 103887, 103888, 103913, 103945, 103954, 103960, 103961,
103971, 103984, 104014, 104035, 104081, 104151, 104161, 104168, 104180, 104185,
104191, 104228, 104272, 104338, 104342, 104370, 104371, 104372, 104387, 104389,
104453, 104460, 104461, 104481, 104609, 104615, 104616, 104617, 104634, 104659,
104665, 104896, 104907, 105072, 105104, 105110, 105150, 105151, 105185, 105219,
105220, 105226, 105233, 105241, 105349, 105508, 105510, 105633, 105638, 105644,
105646, 105662, 105721, 105743, 105899, 105901, 105949, 105957, 250002, 250057,
250090, 250100, 250126, 250137, 250166, 250196, 250221, 250413, 250439, 250480,
250677, 250678, 250693, 250754, 250779, 250780, 250827, 250846, 251096, 395962,
500001, 500037, 500039, 500040, 504115, 504117, 504122, 504355, 504524, 504607,
504610, 504668, 504673, 504731, 504761, 504811, 504844, 504910, 504938, 505011,
505053, 505055, 505137, 505138, 505452, 505512, 505661, 505733, 505757, 505775,
505810, 505814, 505904, 505963, 505967, 505988, 506022, 506066, 506074, 506156,
506157, 506187, 506193, 506214, 506320, 506323, 506332, 506333, 506525, 506526,
506799, 506800, 506831, 506833, 506834, 506838, 506840, 519113, 519119, 519140,
519144, 519146, 519529, 519551, 519565, 519731, 519732, 519734, 519736, 519775,
519803, 519816, 519871, 520048, 520063, 520184, 520242, 520282, 520410, 520531,
520576, 520581, 520669, 520764, 520770, 520772, 520775, 520846, 521104, 521107,
521127, 521327, 521371, 521377, 521378, 521382, 521383, 521384, 521385, 521395,
521449, 521450, 521455, 521522, 521583, 521604, 521649, 521671, 521681, 521688,
521709, 521870, 521871, 521898, 521936, 521964, 521979, 521994, 521996, 522132,
522179, 522206, 522242, 522251, 522356, 522357, 522436, 522442, 522476, 530406,
530429, 530515, 530574, 530576, 530610, 530620, 531650, 531711, 531746, 531751,
531775, 531778, 531854, 531855, 531859, 531933, 532067, 532072, 532082, 532110,
532146, 532147, 532289, 532291, 532423, 532474, 532480, 532775, 532776, 532778,
532781, 532802, 532829, 532841, 532982, 533115, 533178, 533237, 533239, 533245,
533248, 533249, 533300, 533310, 533311, 533330, 533331, 533352, 533472, 533474,
533475, 533524, 533544, 533555, 533557, 533564, 533692, 533715, 533765, 533777,
533789, 533901, 533902, 533919, 534187, 534201, 534209, 534240, 534243, 534244,
534245, 534261, 534272, 534304, 534408, 534417, 534421, 534422, 534425, 534426,
534429, 534487, 534586, 534602, 534605, 534606, 534607, 534608, 534641, 534642,
534670, 534780, 534804, 534823, 534831, 534846, 534849, 534997, 535214, 535219,
535234, 535249, 535270, 535369, 535377, 535417, 535423, 535430, 535431, 535432,
535433, 535434, 535435, 535438, 535452, 535453, 535454, 535455, 535456, 535457,
535458, 535499, 535666, 535721, 535747, 535758, 535760, 535784, 535910, 535922,
535960, 536012, 536013, 536050, 536402, 536429, 536432, 536474, 536613, 536619,
536630, 536644, 536663, 536707, 536766, 536797, 536800, 536822, 536825, 536837,
536838, 536904, 536934, 536967, 536968, 536980, 537047, 537051, 537054, 537131,
537330, 537447, 537465, 537556, 537587, 537632, 537645, 537696, 537893, 537894,
537923, 537942, 537969, 538006, 538064, 538066, 538100, 538137, 538140, 538155,
538268, 538317, 538352, 538363, 538450, 538513, 538515, 538518, 538527, 538581,
538855, 538856, 538864, 538900, 538978, 539023, 539024, 539025, 539026, 539027,
539028, 539029, 539039, 539091, 539092, 539093, 539163, 539164, 539173, 539182,
539620, 539631, 539724, 539725, 539863, 539881, 540011, 540028, 540055, 540081,
540087, 540096, 540097, 540098, 540135, 540157, 540158, 540164, 540175, 540178,
540200, 540216, 540260, 540262, 540268, 540366, 540431, 540446, 540467, 540473,
540501, 540502, 540503, 540506, 540762, 540858, 540970, 541064, 541068, 541089,
541175, 541179, 541242, 541243, 541244, 541264, 541270, 541323, 541327, 541351,
541497, 541514, 541536, 541586, 541644, 541692, 541733, 541744, 541764, 541837,
541914, X0101, X0389, X0568, X0715, X0971, X0976, X1040, X1070, X1143, X1156,
X1157, X1182, X1183, X1195, X1196, X1200, X1208, X1209, X1211, X1212, X1217,
X1220, X1225, X1226, X1265, X1276, X1285, X1291, X1292, X1303, X1311, X1331,
X1332, X1334, X1336, X1337, X1359, X1360, X1361, X1400, X1406, X1415, X1416,
X1421, X1422, X1423, X1427, X1470, X1560, X1597, X1610, X1651, X1652, X1658,
X1660, X1667, X1682, X1701, X1702, X1727, X1728, X1748, X1754, X1773;
b) Site numbers 103982, 104073, 105158, 105629, 504343, 505773;
c) Site numbers: 6901, 6961, 6983, 6987, 10000, 10002, 10006, 10178, 10392, 10393, 10406, 10410, 10418, 10435, 10493, 13173, 13178, 13195, 13215, 13245, 13257, 13283, 13284, 13293, 13877, 13880, 13895, 13908, 13956, 13968, 13969, 13970, 13972, 13984, 13999, 14070, 14169, 14177, 26140, 26154, 26157, 26211, 26212, 26213, 26275, 38086, 38091, 38106, 38120, 38141, 38142, 38149, 38195, 38196, 38207, 38268, 38279, 38314, 38318, 38361, 38417, 38423, 38424, 38434, 38505, 38528, 38529, 38539, 38541, 38555, 38559, 38584, 38591, 38607, 38608, 38625, 38626, 38634, 38656, 38679, 38689, 38692, 38693, 38695, 38712, 38743, 38745, 38914, 38940, 38958, 38972, 38977, 38978, 38988, 40930, 40936, 40937, 40973, 41035, 41040, 41063, 41096, 41098, 41099, 41105, 41107, 41120, 41121, 41131, 41135, 41235, 41236, 41237, 41238, 41284, 41286, 41352, 41420, 41435, 41463, 41465, 41466, 41468, 44804, 44805, 44806, 44983, 45029, 45070, 45091, 45092, 50220, 50221, 50230, 50322, 50323, 50427, 50446, 50447, 52450, 52456, 52491, 59569, 59634, 59652, 59661, 59666, 62663, 62664, 62797, 62802, 62838, 62868, 62888, 62889, 62934, 62973, 62987, 62994, 62996, 62997, 73858, 76192, 76216, 76355, 76356, 76357, 76371, 76372, 76379, 76381, 76382, 76391, 76403, 76439, 76456, 76495, 76578, 76763, 76805, 76827, 76829, 76837, 76838, 76843, 76844, 76874, 76925, 76940, 76957, 76958, 76959, 76960, 76965, 76967, 76973, 76982, 80318, 80319, 80339, 82503, 82515, 82516, 82561, 82570, 82571, 82613, 82630, 82646, 82656, 82674, 82675, 82712, 82720, 82722, 82726, 82728, 82805, 82809, 82831, 82834, 82918, 82920, 82942, 82943, 82949, 82954, 83001, 83007, 83031, 83074, 83083, 83308, 83319, 83369, 83370, 83646, 83648, 83651, 83698, 83909, 83936, 83943, 83944, 83947, 84420, 84434, 84459, 84460, 84461, 84703, 84704, 84851, 84857, 84858, 84889, 84893, 84895, 84928, 84931, 84936, 84938, 84939, 84949, 84963, 84964, 85029, 85030, 85037, 85109, 85117, 85147, 85148, 85149, 85161, 85166, 85167, 85168, 85184, 85402, 85403, 85405, 85437, 85438, 85464, 85465, 85467, 85484, 85486, 85487, 85492, 85493, 85494, 85683, 86015, 86059, 86060, 86070, 86071, 86078, 86140, 86213, 86215, 86216, 86221, 86226, 86228, 86229, 86232, 86309, 86344, 86358, 86359, 86384, 86386, 86387, 86389, 86391, 86394, 86395, 86397, 86400, 86403, 86543, 86547, 86579, 86600, 86601, 86606, 86607, 86611, 86613, 86618, 86619, 86623, 86624, 86901, 86903, 86938, 86939, 86942, 86964, 86966, 86970, 86976, 86979, 86980, 87005, 87016, 87017, 87031, 87045, 87046, 87050, 87051, 87079, 87136, 87137, 87138, 87142, 87169, 87175, 87177, 87178, 87196, 87313, 87320, 87333, 87363, 87510, 87520, 87601, 87609, 87610, 100428, 100438, 100443, 100457, 100481, 100489, 100495, 100518, 100556, 100557, 100604, 100605, 100614, 100615, 100618, 100676, 100677, 100698, 100727, 100770, 100818, 100834, 100835, 100838, 100848, 100855, 100867, 100876, 100882, 100883, 100947, 100957, 101039, 101041, 101054, 101076, 101079, 101080, 101132, 101133, 101134, 101141, 101142, 101143, 101144, 101145, 101147, 101148, 101149, 101161, 101191, 101204, 101212, 101240, 101555, 101558, 101563, 101569, 101586, 101643, 101837, 101871, 101872, 101935, 101936, 101937, 101955, 101958, 101959, 101960, 102099, 102107, 102132, 102163, 102168, 102169, 102170, 102174, 102245, 102337, 102338, 102339, 102341, 102342, 102372, 102376, 102384, 102385, 102387, 102388, 102445, 102462, 102466, 102491, 102541, 102552, 102559, 102567, 102585, 102586, 102587, 102590, 102591, 102606, 102608, 102609, 102622, 102630, 102634, 102647, 102700, 102701, 102794, 102839, 102876, 102893, 102903, 102917, 102918, 102921, 102922, 102925, 103007, 103008, 103037, 103057, 103115, 103120, 103121, 103146, 103163, 103180, 103184, 103185, 103200, 103204, 103252, 103260, 103276, 103279, 103284, 103310, 103337, 103387, 103421, 103422, 103424, 103427, 103496, 103497, 103504, 103517, 103595, 103597, 103606, 103653, 103724, 103730, 103785, 103786, 103876, 103883, 103895, 103917, 103943, 103948, 103963, 103977, 104010, 104013, 104051, 104059, 104071, 104113, 104135, 104153, 104162, 104164, 104165, 104181, 104182, 104204, 104205, 104268, 104283, 104339, 104404, 104471, 104508, 104629, 104794, 104801, 104842, 104854, 104855, 104881, 104893, 104931, 105109, 105155, 105202, 105238, 105242, 105295, 105337, 105414, 105649, 105696, 105769, 250043, 250069, 250092, 250139, 250313, 250679, 500012, 504137, 504329, 504882, 505056, 505640, 506168, 506171, 519562, 519766, 519776, 519826, 520262, 520279, 520280, 521003, 530692, 532044, 534057, 534433, 534873, 535262, X1027, X1041, X1055, X1056, X1089, X1136, X1140, X1141, X1142, X1153, X1165, X1166, X1180, X1181, X1194, X1201, X1229, X1230, X1234, X1264, X1266, X1290, X1295, X1299, X1304, X1320, X1338, X1362, X1363, X1399, X1405, X1417, X1446, X1449, X1467, X1469, X1501, X1502, X1504, X1507, X1510, X1515, X1521, X1543, X1561, X1565, X1568, X1569, X1572, X1573, X1632, X1640, X1644, X1653, X1671, X1681, X1705, X1706, X1713, X1749, X1752, X1764, X1769;
d) Site numbers 102549, 102551, 103130, 103515, 103522, 103523, 103666, 104078, 104614, 104812, 105482, 105589, 105678, 105775, 105777, 500003, 500032, 504642, 504643, 504803, 504804, 504879, 504941, 504962, 504966, 505062, 505063, 505104, 505255, 505349, 505539, 505540, 505606, 505806, 505871, 505926, 506117, 506199, 506205, 506208, 506210, 506231, 506233, 506248, 506249, 506250, 506251, 506275, 506276, 506277, 506278, 506281, 506305, 506554, 506828, 506844, 506845, 519117, 519121, 519122, 519128, 519152, 519773, 519879, 519900, 520182, 520183, 520209, 520300, 520301, 520516, 520707, 520798, 520806, 521135, 521153, 521606, 521654, 521658, 521869, 521942, 522015, 522193, 522271, 522399, 522401, 522443, 522470, 522480, 530573, 530607, 530795, 530797, 530798, 531769, 531832, 531857, 531860, 532069, 532107, 532137, 532139, 532157, 532170, 532174, 532177, 532360, 532397, 532398, 532426, 532471, 532477, 532479, 532766, 532779, 532842, 532971, 532978, 533234, 533240, 533243, 533313, 533389, 533396, 533451, 533470, 533490, 533491, 533528, 533558, 533562, 533565, 533566, 533574, 533766, 533770, 533771, 533867, 533898, 533914, 533918, 533968, 534207, 534419, 534434, 534596, 534599, 534600, 534615, 534644, 534647, 534675, 534677, 534694, 534782, 534803, 534805, 534815, 534822, 534824, 534850, 534867, 534945, 535021, 535233, 535255, 535365, 535378, 535382, 535436, 535437, 535500, 535613, 535757, 535765, 535771, 535785, 535908, 535995, 536011, 536051, 536081, 536082, 536179, 536200, 536394, 536458, 536522, 536636, 536637, 536687, 536765, 536840, 536914, 536933, 536938, 536941, 536973, 536984, 536985, 536994, 537013, 537087, 537091, 537179, 537186, 537492, 537518, 537571, 537654, 537689, 537761, 537796, 537803, 537863, 537945, 537946, 537967, 537970, 537971, 538237, 538328, 538351, 538407, 538451, 538458, 538462, 538477, 538480, 538519, 538759, 538812, 538866, 538891, 538901, 539040, 539095, 539101, 539103, 539237, 539291, 539310, 539339, 539411, 539419, 539488, 539501, 539519, 539527, 539557, 539590, 539683, 539785, 540022, 540163, 540187, 540361, 540380, 540445, 540457, 540459, 540624, 540788, 540810, 541011, 541054, 541063, 541075, 541078, 541083, 541093, 541348, 541402, 541494, 541535, 541614, 541694, 541721, 541803, 541838, 541850, 541872, 541884;
e) Site numbers 520020, 521648, 522220, 533112, 533314, 533471, 533530, 535118, 535257, 535924, 539106, 540860, 541490;
f) Site numbers 102666, 104083, 104530, 105193, 105194, 105394, 504340,
504341, 505039, 505345, 505346, 506155, 506236, 506247, 519574, 532087, 532140,
532151, 532213, 532703, 533312, 533473, 533559, 534247, 535714, 535767, 536019,
536091, 536146, 536720, 536935, 537083, 537669, 537787, 538440, 539457, 539598,
539990, 540252, 541263, 541474
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North
America Co. Phillips, Bothell, WA
REASON Units
do not comply with the requirement to provide automatic beam limitation within
+/- 3 degrees of horizontal, vertical, and perpendicular to the plane of the
image receptor during radiographic procedures.
VOLUME OF PRODUCT IN
COMMERCE 2,583
units
DISTRIBUTION Nationwide
PRODUCT GE
Healthcare Proteus XR/a General Purpose Radiographic System, Models 2259973-4
and 2380179 containing Proteus Operator Console model# 2259976,
CODE
Lot #’s: 30920HL3, 30921HL1, 31931HL9,
3457OHL2, 34864HL9, 34911HL8, 35136HL1, 35191HL6, 35244HL3, 35936HL4, 36207HL9,
36361HL4, 36431HL5, 36521HL3, 36702HL9, 36704HL5, 37009HL8, 37261HL5, 37395HL1,
37396HL9, 37597HL2 & 993702WK0
RECALLING
FIRM/MANUFACTURER General Electric Medical Systems, LLC, Waukesha, WI
REASON
Labeling; failure to properly label per
21 CFR 1010.2 and 1010.3 -The Operator Console of the Proteus XR/a General
Purpose Radiographic Systems were not properly labeled.
VOLUME OF
PRODUCT IN COMMERCE 22 units
DISTRIBUTION WA,
KS, CO, NM, NC, FL, MT, AZ, TX, IL, NY, MD, GA
PRODUCT GE
Innova 2100-IQ Digital Fluoroscopic Imaging System, Versatile cardiac and
vascular imaging system.
CODE
Serial
numbers: 00000459256BU4, 00000459553BU4, 00000459554BU2, 00000459555BU9,
00000459556BU7, 00000459557BU5, 00000460056BU5, 00000460057BU3, 00000460058BU1,
00000460059BU9, 00000460060BU7, 00000460063BU1, 00000460065BU6, 00000460066BU4,
00000460067BU2, 00000461642BU1, 00000461643BU9, 00000461644BU7, 00000461645BU4,
00000462898BU8, 00000462899BU6, 00000462900BU2, 00000462901BU0, 00000462902BU8,
00000462903BU6, 00000462904BU4, 00000462905BU1, 00000462906BU9, 00000462907BU7,
00000463613BU2, 00000463630BU4, 00000463631BU2, 00000463632BU0, 00000463633BU8,
00000463634BU6, 00000463636BU1, 00000463637BU9, 00000463638BU7, 00000463639BU5,
00000463841BU7, 00000467440BU4, 00000467441BU2, 00000467442BU0, 00000467443BU8,
00000467444BU6, 00000467445BU3, 00000467446BU1, 00000467447BU9, 00000467448BU7,
00000467449BU5, 00000467451BU1, 00000469541BU7, 00000469542BU5, 00000469543BU3,
00000469544BU1, 00000469545BU6, 00000469546BU6, 00000469547BU4, 00000469548BU2,
00000469549BU0, 00000469550BU8, 00000470643BU8, 00000470644BU6, 00000470645BU3,
00000470646BU1, 00000470647BU9, 00000470648BU7, 00000470649BU5, 00000470650BU3,
00000470651BU1, 00000470652BU9, 00000471493BU7, 00000471494BU5, 00000471495BU2,
00000471496BU0, 00000471497BU8, 00000471498BU6, 00000471499BU4, 00000471500BU9,
00000471501BU7, 00000471502BU5, 00000472676BU6, 00000477489BU9, 00000477490BU7,
00000477491BU5, 00000477492BU3, 00000477493BU1, 00000477494BU9, 00000477495BU6,
00000477496BU4, 00000477497BU2, 00000477498BU0, 00000477893BU2, 00000479230BU5,
00000479231BU3, 00000479232BU1, 00000479233BU9, 00000479234BU7, 00000479235BU4,
00000479236BU2, 00000479237BU0, 00000479238BU8, 00000479239BU6, 00000479937BU5,
00000479945BU8, 00000479946BU6, 00000479947BU4, 00000479948BU2, 00000479949BU0,
00000479950BU8, 00000479951BU6, 00000479952BU4, 00000479953BU2, 00000479954BU0,
00000482511BU3, 00000482512BU1, 00000482513BU9, 00000482514BU7, 00000482515BU4,
00000482516BU2, 00000482517BU0, 00000482518BU8, 00000482519BU6, 00000482520BU4,
00000484054BU2, 00000485072BU3, 00000485074BU9, 00000485075BU6, 00000485076BU4,
00000485077BU2, 00000485078BU0, 00000485079BU8, 00000485080BU6, 00000485081BU4,
00000487465BU7, 00000487466BU5, 00000487469BU9, 00000487470BU7, 00000487471BU5,
00000487472BU3, 00000487473BU1, 00000487474BU9, 00000491019BU6, 00000491020BU4,
00000491021BU2, 00000491022BU0, 00000491023BU8, 00000491025BU3, 00000491027BU9,
00000491028BU7, 00000491032BU9, 00000492823BU0, 00000492824BU8, 00000492825BU5,
00000492827BU1, 00000492828BU9, 00000492830BU5, 00000492831BU3, 00000494960BU8,
00000504480BU5, 00000508755BU6, 00004600057BU3
RECALLING
FIRM/MANUFACTURER
Recalling Firm: General Electric Medical Systems,
LLC, Waukesha, WI,
Manufacturer: General
Electric Medical Systems, SCS, Buc Cedex, France.
REASON
The systems do not contain a
certification label on the C2 Cabinet (Beam-limiting control).
VOLUME OF PRODUCT IN COMMERCE 161
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a)
Laser Distance and Level Transmitters, Model No. LT4C,
b) Laser Level Transmitters, Model No. LM4C,
c)
LaserTrak, Model No. LT80,
d) Laser
Meter, Model No. LTM80,
e) Laser Distance and Level
Transmitters, Model No. LT200,
f) Laser Distance and
Level Transmitters, Model No. LM200,
g) Laser Distance
and Level Transmitters, Model No. LM02,
CODE
a) Model No. LT4C;
b) Model No.
LM4C;
c) Model No. LT80;
d) Model No. LM80;
e) Model
No. LT200;
f) Model No. LM200;
g) Model No. LM02
RECALLING
FIRM/MANUFACTURER K Tex, Galvez, LA,
REASON Failure
to comply with Federal Laser Product Performance Standards (21 CFR 1040.10,
1040.11, 1002.10-improper classification, incomplete labeling, incomplete user
information and failure to submit required product reports)
VOLUME OF
PRODUCT IN COMMERCE 1,008
units
DISTRIBUTION Nationwide
PRODUCT The
Pinnacle3 Radiation Therapy Planning (RTP) system and its associated software;
composed of several modules including the core Pinnacle3 functionality, Syntegra
(TM), P3IMRT, P3MD and AcQSim3 (TM). The Pinnacle3 RTP system is composed of a
Sun UNIX workstation (or UNIX-complaint computer) running the Solaris operating
system and software, and a UNIX terminal emulation package on a personal
computer, which allows the user to enter patient data into the system, use that
data to construct a plan for radiation therapy, and evaluate the plan- Philips
Medical Systems-Model #9200-0652A-ENG, 9200-0700A-ENG, 9200-0700B-ENG,
9200-0700C-ENG (with software versions 7.6C, 8.0d and 8.0h),
CODE
Pinnacle3 Version 7.6c Software Kit
Model #9200-0652A-ENG Pinnacle3 Version 8.0d Software Kit Model #9200-0700A-ENG
Pinnacle3 Version 8.0d p 1 Software Kit Model #9200-0700B-ENG Pinnacle3 Version
8.0h Software Kit Model #9200-0700C-ENG
RECALLING
FIRM/MANUFACTURER Philips Nuclear Medicine, Inc., Fitchburg, WI,
REASON
Incorrect Absolute Marking Coordinates
when used with PQ-Series scanners due to a software
malfunction.
VOLUME OF PRODUCT IN COMMERCE 1,407
units
DISTRIBUTION Nationwide and
Canada
PRODUCT
Triathlon
X3 Total Stabilizer + Tibial Insert For use with Triathlon Universal Baseplates,
knee prosthesis. #5 13mm Stryker Orthopaedics. Product numbers: 5537-G-109,
5537-G-111, 5537-G-113, 5537-G-116, 5537-G-119, 5537-G-122, 5537-G-125,
5537-G-128, 5537-G-131, 5537-G-209, 5537-G-211, 5537-G-213, 5537-G-216,
5537-G-219, 5537-G-222, 5537-G-225, 5537-G-228, 5537-G-231, 5537-G-309,
5537-G-311, 5537-G-313, 5537-G-316, 5537-G-319, 5537-G-322, 5537-G-325,
5537-G-328, 5537-G-331, 5537-G-409, 5537-G-411, 5537-G-413, 5537-G-416,
5537-G-419, 5537-G-422, 5537-G-425, 5537-G-428, 5537-G-431, 5537-G-509,
5537-G-511, 5537-G-513, 5537-G-516, 5537-G-519, 5537-G-522, 5537-G-525,
5537-G-528, 5537-G-531, 5537-G-609, 5537-G-611, 5537-G-613, 5537-G-616,
5537-G-619, 5537-G-622, 5537-G-625, 5537-G-628, 5537-G-631, 5537-G-709,
5537-G-711, 5537-G-713, 5537-G-716, 5537-G-719, 5537-G-722, 5537-G-725,
5537-G-728, 5537-G-731, 5537-G-809, 5537-G-811, 5537-G-813, 5537-G-816,
5537-G-819, 5537-G-822, 5537-G-825, 5537-G-828, 5537-G-831,
CODE
All lot codes
RECALLING
FIRM/MANUFACTURER Stryker Howmedica Osteonics, Corp., Mahwah, NJ
REASON
Stabilizer posts, packaged with the
Triathlon TS Plus Tibial inserts have a specification anomaly related to length,
resulting in a potential for the post to slightly protrude above the top surface
of the plastic post.
VOLUME OF PRODUCT IN COMMERCE 14
units
DISTRIBUTION GA, OH, MN and
TX
PRODUCT
a)
Normal Saline 3ml in 12ml Syringe. The product is shipped 120 units per carton,
b) Normal Saline 10ml in 12ml
Syringe. The product is shipped in 120 units per carton,
CODE
a) Item number 531584. Lot
number 070606SFR exp 6/09;
b) Item number 531587. Lot numbers 070507SFR exp
5/09, 070523SFR exp 5/09
070529SFR exp 6/09, 070601SFR
exp 6/09, 070605SFR exp 6/09, 070608SFR exp 6/09,
070613SFR exp 6/09, 070618SFR exp 6/09, 070620SFR exp 6/09, and 070625SFR exp
6/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: B. Braun
Medical, Inc., Allentown, PA,
Manufacturer: AM2PAT, Angier, NC.
REASON
Particulate matter in
product.
VOLUME OF PRODUCT IN COMMERCE 1,325,760
units
DISTRIBUTION Nationwide
PRODUCT Cerner
Millennium RadNet Auto Launch Study and Auto Launch Report software
functionalities
CODE Radiology 2007
Cumulative Production Package 25143.
RECALLING
FIRM/MANUFACTURER Cerner Corp., Kansas City, MO
REASON
Defects in the Auto
Launch functionality make it possible for a mismatch of patient
data.
VOLUME OF PRODUCT IN COMMERCE 9
units
DISTRIBUTION Nationwide
PRODUCT Endoscopic
Instrument Control System (da Vinci Surgical System) Model IS1200, A4.3 SW
level,
CODE Systems manufactured or
upgraded to Model IS1200 hardware/software level in this time frame: 2/17/2000 -
3/27/2007
RECALLING FIRM/MANUFACTURER Intuitive Surgical,
Inc., Sunnyvale, CA,
REASON Under certain circumstances,
the product's software may crash and require a manual override or restart before
functioning again. In addition, there is an unrelated addendum to the User
Manual to clarify an icon not described in the previous User
Manual.
VOLUME OF PRODUCT IN COMMERCE 405
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT daVinci
S Surgical system, patient side cart Auxiliary power board (APB) (printed
circuit board assembly), endoscopic instrument control system. Model number
IS2000, part number 351040-04,
CODE System numbers SG002, SG004, SG010 ,
SG032, SG060, SG061, SG064, SG065, SG066, SG067, SG068, SG069, SG070, SG071,
SG072, SG073, SG074, SG075, SG076, SG077, SG078, SG079, SG080, SG081, SG082,
SG083, SG084, SG086, SG090, SG116, SG117, SG118, SG120, SG121, SG126, SG174,
SG175, SG184
RECALLING FIRM/MANUFACTURER Intuitive
Surgical, Inc., Sunnyvale, CA,
REASON Product may
malfunction and fail to start up on AC power.
VOLUME OF PRODUCT IN
COMMERCE 38 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Trident
PSL Acetabular Shell; Arc Deposited; Hydroxylapatite Coated; Cluster Screw
Holes; Hip prosthesis component.
CODE
Catalog number/ lot code: 540-11-56F
36906101 540-11-58G 37048901 540-11-58G 37122001 542-11-46D 34977701 542-11-46D
35105901 542-11-46D 35382701 542-11-46D 35483101 542-11-46D 35525001 542-11-46D
35584201 542-11-46D 37497001 542-11-46D 37830601 542-11-46D 37884701 542-11-46D
38034101 542-11-46D 38124501 542-11-48D 35028401 542-11-48D 35332701 542-11-48D
35406002 542-11-48D 35406003 542-11-48D 35687701 542-11-48D 35726401 542-11-48D
35834801 542-11-48D 37790101 542-11-48D 37891501 542-11-48D 38025001 542-11-48D
38025002 542-11-48D 38160501 542-11-50E 35032701 542-11-50E 35207301 542-11-50E
35385903 542-11-50E 35428901 542-11-50E 35428903 542-11-50E 35481501 542-11-50E
35481502 542-11-50E 35481502 542-11-50E 35515802 542-11-50E 35827902 542-11-50E
36966303 542-11-50E 37344301 542-11-50E 37515302 542-11-50E 37695201 542-11-50E
37888201 542-11-50E 37920201 542-11-50E 38245801 542-11-50E 38274303 542-11-52E
32886803 542-11-52E 35018402 542-11-52E 35018403 542-11-52E 35018404 542-11-52E
35085001 542-11-52E 35199201 542-11-52E 35199202 542-11-52E 35199204 542-11-52E
35325401 542-11-52E 35325403 542-11-52E 35373402 542-11-52E 35373403 542-11-52E
35419904 542-11-52E 35726002 542-11-52E 35866302 542-11-52E 35866304 542-11-52E
37057001 542-11-52E 37096702 542-11-52E 37368002 542-11-52E 37886202 542-11-52E
37886204 542-11-52E 37886206 542-11-52E 37925602 542-11-52E 37995901 542-11-52E
37995902 542-11-54F 35091602 542-11-54F 35186502 542-11-54F 35732703 542-11-54F
35868801 542-11-54F 35965101 542-11-54F 37443401 542-11-54F 37443403 542-11-54F
37789201 542-11-54F 37916502 542-11-54F 38095601 542-11-54F 38223203 542-11-56F
35081001 542-11-56F 35225301 542-11-56F 35225302 542-11-56F 35225303 542-11-56F
35290801 542-11-56F 35335101 542-11-56F 35524501 542-11-56F 35535102 542-11-56F
35831001 542-11-56F 36330001 542-11-56F 36542101 542-11-56F 36542102 542-11-56F
36768001 542-11-56F 36907201 542-11-56F 37050902 542-11-56F 37461501 542-11-56F
37743301 542-11-56F 38099001 542-11-58G 35638002 542-11-58G 35959701 542-11-58G
35959702 542-11-58G 36052801 542-11-58G 36137301 542-11-58G 36195501 542-11-58G
36195502 542-11-58G 36332802 542-11-58G 36372301 542-11-58G 36412601 542-11-58G
36430601 542-11-58G 36489601 542-11-58G 36489602 542-11-58G 36553001 542-11-58G
36583801 542-11-58G 36633201 542-11-58G 36758901 542-11-58G 36758902 542-11-58G
36898201 542-11-58G 37049101 542-11-58G 37049102 542-11-58G 37049103 542-11-58G
37122401 542-11-58G 37122402 542-11-58G 37122403 542-11-58G 37173201 542-11-58G
37242901 542-11-58G 37242902 542-11-58G 37279901 542-11-58G 37332301 542-11-58G
37500801 542-11-58G 37500801 542-11-58G 37500803 542-11-58G 37826804 542-11-60G
34806101 542-11-60G 34907101 542-11-60G 35666901 542-11-60G 35946101 542-11-60G
36002201 542-11-60G 36406701 542-11-60G 36435401 542-11-60G 36765101 542-11-60G
37119701 542-11-60G 37119702 542-11-60G 37273901 542-11-60G 37402101 542-11-62G
37358901 542-11-62H 34930801 542-11-62H 35272101 542-11-62H 35508901 542-11-62H
36270401 542-11-62H 36842101 542-11-64H 36406301 542-11-64H 37082601 542-11-64H
37358801 542-11-64H 37859901
RECALLING
FIRM/MANUFACTURER Stryker Howmedica Osteonics Corp. Mahwah, NJ
REASON
Dimensional anomaly.
VOLUME
OF PRODUCT IN COMMERCE 1,220
units
DISTRIBUTION Nationwide, Romania, Chile and
Brazil
PRODUCT
Merit
Medical Surgical Convenience Kits, Custom and SPPT,. Part numbers: K05-01767A,
K05-01769, K05-01769A, K09-03843M, K09-03951M, K09-05894F, K09-08610,
K10-00033Q, K10-00382M, K10-00685K, K10-00984F, K10-01531F, K10-01826D,
K10-01826F, K10-02902B, K10-03080D, K10-03378C, K10-03397B, K10-03590A,
K10-03590B, K10-03659D, K10-03659F, K10-03659G, K10-03689, K10-03907B,
K12-01342D, K12-01444B, K12-01468, K12-01484A, K12-01487, K12-01490A, K12-01593,
K12-01638, K12-01661, K12-01667, K12-01667A, K12-01964, K12-01968, K12-02098,
SPPT-100/C, SPPT-5F-10C, SPPT-5F-10L/A, SPPT-5F-7/C, SPPT-5F-7L/A,
CODE
Merit Lot Numbers: A339685, A342805,
A343855, A344934, A348869, A350784, A350904, A353811, A355556, A357384, A357617,
A358608, A360773, A361301, A364800,A365752, A366125, A366523, A367651, A371190,
A372815, A374857, A375138, A375848, A376973, A377976, A381997, A384786, A387975,
F390117, F399800, F406192, F434870, F440785, F440789, F440801, F440803, F442051,
F449479, F449481, F449482, F449483, F453020, F453170, F455150, F456553, F465539,
F465540, F470421, F471056, F471659, F473566, F474320, F476314, F476367, F476543,
F476597, F477729, F480127, F480129, F480131, F480140, F482129, F482853, F488460,
F488709, F488858, F489432, F491275, F491462, F491656, F491659, F492220, F492223,
F494547, F495828, F496118, F496939, F502345, F504184, F505776, F505782, F505785,
F505786, F505790, F505794, F505799, F508595, F509197, F511015, F513651, F514433,
F514954, F514957, F515853, F517537, F517708, F518306, F520504, F523595, F526626,
F528413, F534059, F536871, F537731, F538716, F548977,
F548978
RECALLING FIRM/MANUFACTURER Merit Medical
Systems, Inc, South Jordan, UT
REASON Expiration
Dating; Some Convenience Kits contain medications and/or skin preparations that
may expire before the expiration date on the outer package
label.
VOLUME OF PRODUCT IN COMMERCE 16,633
units
DISTRIBUTION Nationwide
PRODUCT Altaire
Shoulder Coil, an accessory to the Altaire MRI system. The shoulder coil is a
two-channel, receive only coil that functions at 29.641 MHz band. It consists of
a cable and a coil (imaging) body. A portion of the cable is referred to as the
balun assembly or balun trap. The shoulder coil assembly is packaged in a
cardboard box with foam inserts.
CODE
Serial Numbers: 203, 303, 305, 307, 308,
309, 310, 311, 312, 313, 314, 315, 316, 317, 318, 319, 320, 321, 323, 325, 326,
327, 328, 329, 330, 332, 333, 335, 336, 337, 338, 339, 340, 341, 342, 343, 344,
345, 346, 347, 348, 349, 350, 351, 352, 353, 354, 355, 356, 357, 359, 360, 361,
362, 363, 364, 365, 366, 367, 368, 369, 370, 371, 372, 373, 374, 375, 377, 378,
379, 380, 381, 382, 383, 384, 385, 386, 387, 388, 389, 390,, 391, 392, 393, 394,
395, 396, 397, 398, 399, 400, 401, 402,, 403, 404, 405, 406, 407, 408, 410, 411,
412, 413, 414, 415 416, 417, 418, 419, 420, 421, 422, 424, 425, 426, 427, 429,
430, 431, 432, 434, 435, 436, 437, 438, 439, 440, 441, 442, 443, 445, 446, 447,
449, 450, 451, 452, 453, 454, 456, 457, 458, 460, 461, 462, 463, 464, 465, 466,
467, 468, 469, 470, 472, 473, 474, 475, 476, 477, 478, 479, 480, 481, 482, 483,
485, 486, 487, 488, 489, 491, 492, 493, 494, 495, 496, 497 499, 501, 502, 503,
504, 505, 509, 510, 512, 513, 514, 515 516, 517, 518, 519, 520, 521, 522, 523,
524, 527, 528, 529 530, 531, 532, 533, 534, 535, 536, 537, 538, 539, 540, 541,
542, 543, 544, 545, 546, 547, 548, 549, 550, 551, 552, 553, 554, 555, 556, 557,
559, 560, 561, 562, 563, 564, 565, 566, 567, 568, 570, 571, 572, 573, 574, 575,
576, 577, 578, 579, 580, 581, 582, 583, 584, 585, 586, 587, 588, 589, 590, 591,
592, 593, 594, 595, 596, 597, 598, 599, 600, 601, 602, 603
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Hitachi Medical Systems America
Inc, Twinsburg, OH,
Manufacturer: Hitachi
Medical Corporation, Tokyo, Japan.
REASON Overheating; A portion (balun assembly) of the
cable that connects the shoulder coil to the actual MRI unit may malfunction and
result in overheating of the balun assembly. The overheating of the balun
assembly could result in injury to the patient or operator if either came into
contact with the assembly.
VOLUME OF PRODUCT IN
COMMERCE 273
units
DISTRIBUTION Nationwide
PRODUCT
a)
Spectrum Designs Medical-Nasal Dorsal Columella Implant, Catalog Number:
S400-314S,
b) Spectrum
Designs Medical Anatomical Chin Implant; Catalog Number 250-134S;
CODE
a) Lot
#31053; Serial Numbers: BAG612 ,BAG6I3, BAG6I4, BAG652, BAG654 and BAG655;
b)
Lot # 31140; Serial Numbers BAHO45 through BAH144
RECALLING
FIRM/MANUFACTURER Spectrum Designs, Inc., Carpinteria, CA,
REASON
Mispackaging/Mislabeling: a portion of
packaged Nasal LOT 31053 contained chin implants instead of the nasal
implant.
VOLUME OF PRODUCT IN COMMERCE 230
units
DISTRIBUTION CA and
China
PRODUCT
a)
Davol Salute Fixation Reusable Handle Item Code: 0113024-Product
Code 9113024 (Refurbished),
b)
Davol Salut Fixation Reusable 38cm Shaft (Laparoscopic) Item
Numbers: 0113036-Product Code 9113036-(Refurbished),
c) Davol Salute Reusable 18cm
Shaft (Short/Open) Item Numbers: 0113037-
Product Code:
9113037(Refurbished),
d) Davol Salute Laparoscopic
38cm Sterile Implant Cartridge, Sterile- 10 Q-ring;
5/Box,
Item Number: 0113058,
e) Davol Salute
Laparoscopic 38cm Sterile Implant Cartridge, Sterile- 30
Q-ring;
5/Box, Item Number: 0113035,
f) Davol Salute Laparoscopic 38cm Sterile Implant Cartridge 60
Q-ring;5/Box,
Item Number: 0113059,
g) Davol Salute Short 18cm Sterile Implant Cartridge - 10
Q-ring;5/Box,
Item Number: 0113043m,
h) Davol Salute Short 18cm Sterile Implant Cartridge - 30
Q-ring;5/Box,
Item Number: 0113061,
CODE
All serial numbers
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Davol, Inc., Sub. C. R. Bard,
Inc., Cranston, RI,
Manufacturer: BARD SHANNON LIMITED, Humacao, PR.
REASON
Malformed constructs (straight
shots) may form causing injury to user/patient. Abdominal mesh attachment system
component, for use in hernia repair.
VOLUME OF PRODUCT IN
COMMERCE 2,400
handles
DISTRIBUTION Nationwide and Internationally
PRODUCT Abbott Aeroset/Architect Clinical Chemistry, AST Activated
(ASTA), List Number:
8D37-30,
CODE Lot
#46059HW00
RECALLING FIRM/MANUFACTURER Abbott
Laboratories Inc., South Pasadena, CA,
REASON Mislabeling: The
empty cartridges supplied with Clinical Chemistry ASTA, lot number 46059HW00,
have an incorrect top label. The top label on the cartridge incorrectly
indicates ALTA instead of ASTA.
VOLUME OF PRODUCT IN
COMMERCE 15 in the US and 680 units
Internationally
DISTRIBUTION IL, TX, Dominican Republic,
El Salvador, Germany, Panama, and Jamaica
WEEK ENDING OCTOBER 13
PRODUCT BreathTek
Urea Hydrolysis Rate Calculation CD, Version 1.3.5 - January 1,'03, in vitro
diagnostic,
CODE Version 1.3.5 -
January 1, '03
RECALLING FIRM/MANUFACTURER Meretek
Diagnostics, Inc., Lafayette, CO.
REASON Diagnostic test kit
for Helicobacter pylori was distributed for adult and pediatric use, but was not
approved for pediatric use.
VOLUME OF PRODUCT IN
COMMERCE 92
units
DISTRIBUTION Nationwide
PRODUCT CVI
OZ Palm Injector, used to perfuse contrast media into vessels for angiographic
procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC),
CODE
Lot Numbers: XX-02-X; XXX-03-X;
XXX-04-X; XXX-05-X; 356-05; 356-06; 360-06; 361-06; 024-07; 044-07; 045-07;
046-07, where X is any number.
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Lemaitre Vascular, Inc.,
Burlington, MA,
Manufacturer: Cardiovascular Innovations, Athens, TX.
REASON
Sterility of device
may be compromised due to breach in sterile barrier.
VOLUME OF
PRODUCT IN COMMERCE 7,860
units
DISTRIBUTION Nationwide, Canada, Netherlands, and
Germany
PRODUCT
a)
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization
system,
Part Number 1156-50,
b)
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization
system,
Part Number 1156-60,
CODE
Lot number 44QR
RECALLING
FIRM/MANUFACTURER Abbott Spine, Austin , TX
REASON Tip of PathFinder surgical instrument broke
during procedure.
VOLUME OF PRODUCT IN COMMERCE 22
units
DISTRIBUTION Nationwide
PRODUCT GE
Disposable Multi Absorber Canister used with EZchange Module for the Aisys,
Avance, Aespire Anesthesia systems. The EZchange Module is an optional accessory
for these anesthesia systems,
CODE EZchange Manifold with part number
1407-7021-000, 1407-7027-000, M1053007, M1053008
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Datex - Ohmeda, Inc.,
Madison, WI,
Manufacturer: Molecular
Products, Ltd., Dunmow, United Kingdom.
REASON Elevated inspired CO2 levels related to the use
of the Datex-Ohmeda GE Healthcare Disposable Multi Absorber Canister with the
EZchange Module.
VOLUME OF PRODUCT IN COMMERCE 389,070
units
DISTRIBUTION Nationwide and Internationally
PRODUCT 4
glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials
of Calibration Verification Material. BetaHCG Calibration Verification Test Set,
in vitro diagnostic. Catalog # 020661,
CODE Lot #G803536 Exp. Date August
2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tosoh
Bioscience Inc., Grove City, OH,
Manufacturer: Tosoh Corporation, Minato-Ku, Japan.
REASON
Firm discovered that a
deterioration value of approximately 20% was found when the product of this lot
was measured. Tosoh AIA confirmed that deterioration of the product occurred
over time and resulted in a deviation from the assigned value.
VOLUME
OF PRODUCT IN COMMERCE 47
boxes
DISTRIBUTION Nationwide
PRODUCT
a)
Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit
Package:
Contents of unopened or undamaged package
guaranteed sterile; After use place
product in a puncture
resistant container and dispose properly. Reorder number
371111,
b) Shelf Pack: Bard-Parker Rib-Back Stainless
Steel no.11, surgical blade. Unit Package:
Contents of
unopened or undamaged package guaranteed sterile; After use place
Product in a puncture resistant container and dispose
properly. Reorder number
371211,
CODE
a) Lot 0207321;
b) Lot Number
02028051, and Lot Number 02028090
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Company,
Franklin Lakes, NJ,
Manufacturer: Becton
Dickinson Medical Systems, Hancock, NY.
REASON Complaints received of rust on the blades of BD
Bard-Parker Surgical blades.
VOLUME OF PRODUCT IN
COMMERCE 4026 units of lot 02027321; 39,000 units of lot 02028051;
17700 units of lot 02028090
DISTRIBUTION Nationwide
PRODUCT Ammonia
Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro
diagnostic,
CODE Lot numbers FL029
exp 8/30/07, GB059 exp 11/30/07, GD005 exp 12/30/07, GE093 exp 1/30/08, GH034
exp 4/30/08, GJ039 exp 7/30/08, HB064 exp 11/30/08, and HD035 exp
1/30/09
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Thermo Fisher Scientific, Pittsburgh, PA,
Manufacturer: Thermo Fisher Scientific, Victoria, Australia.
REASON
Method is
susceptible to positive interference from endogenous ALT in patient
samples.
VOLUME OF PRODUCT IN COMMERCE 6,882
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT APhL®
HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic,
CODE
Lot #060425. Lot number on the outer
packaging of the received kits was 060308.
RECALLING
FIRM/MANUFACTURER Louisville Apl Diagnostics, Inc., Seabrook, TX,
REASON
Product mislabeled. Outer container
labeled with incorrect lot number.
VOLUME OF PRODUCT IN
COMMERCE 3 test
kits
DISTRIBUTION Canada
PRODUCT
a)
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component
adhesive, contents: 4 ml, dental bonding agent; Reorder
No. 66001710,
b) Heraeus Kulzer
GLUMA Comfort Bond + Desensitizer light curing one component
adhesive, Assortment Value Pack 3 x 4 ml, dental bonding
agent; Reorder No.
6018222,
CODE
a) and b) Lot 010065; exp.
02/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Heraeus Kulzer Inc., Dental Products Division, South Bend, IN,
Manufacturer: Heraeus Kulzer Gmbh
& Co. KG (Medical Division), Wehrheim 1, Federal Republic of Germany.
REASON
The material may
solidify in the bottle, and thus be rendered unusable.
VOLUME OF
PRODUCT IN COMMERCE 1,972
units
DISTRIBUTION Nationwide and Canada
WEEK ENDING OCTOBER 20
PRODUCT
a) EPIK® KNEE SYSTEM Angled Insert Impactor
LM/RL; Catalog #801-03-051
Rev. A; non-sterile; knee prosthesis instrument,
b)
EPIK® KNEE SYSTEM Angled Insert Impactor RM/LL; Part
#801-03-052
Rev. A; non-sterile; knee prosthesis
instrument,
CODE All
lots
RECALLING FIRM/MANUFACTURER Encore Medical, Lp,
Austin, TX
REASON Angled Insert Impactor may scratch Tibial
Insert on the articulating surface, causing increased wear at the damaged
site.
VOLUME OF PRODUCT IN COMMERCE 10
units
DISTRIBUTION CA, FL, and
MD
PRODUCT Brain
Heart Infusion Agar (BHIA) + Vancomycin 6 MCG/ML Microbiological media plates.
PML's catalog #P1174,
CODE LOT
CODES: 75707-1, 75975-1, 76285-1, 235823-1, 236361-1, 236916-1, 237354-1,
237378-1, 237917-1
RECALLING FIRM/MANUFACTURER Pml
Microbiologicals, Inc., Wilsonville, OR,
REASON Marketed a
regulated product without a 510(k).
VOLUME OF PRODUCT IN
COMMERCE 2,245
plates
DISTRIBUTION Nationwide, PR, and
Canada
PRODUCT Brain
Heart Infusion Agar labeled BHIA + Vancomycin 6 MCG/ML for screening for
Vancomycin Resistant Enterococc, Catalog #P1174, CODE Lots: 229957-1 and
229958-1
RECALLING FIRM/MANUFACTURER Pml Microbiologicals, Inc., Wilsonville,
OR
REASON Plates
manufactured without vancomycin. Possibility for false resistant
results.
VOLUME OF PRODUCT IN COMMERCE 640
plates
DISTRIBUTION Nationwide and
Canada
PRODUCT Medtronic
InterStim II INS Model 3058 with N'Vision InterStim-B Software supplied on the
Model 8870 Version MMB_01/NNB_01 N'Vision with a Clinican Programmer Model 8840.
Implantable Neurostimulator for Urinary Control. Catalog # 8870MM01 &
8870NNB01,
CODE All serial numbers
within above catalog/model numbers
RECALLING
FIRM/MANUFACTURER Medtronic Neurological, Minneapolis, MN, by letter
beginning on July 11, 2007. F
REASON A software issue may cause a lower than
expected battery capacity estimate when evaluating an InterStim II Implantable
Neurostimulator (model 3058) with an N'Vision Clinician Programmer(Model 8840)
before implant .
VOLUME OF PRODUCT IN COMMERCE 1,885
units
DISTRIBUTION Nationwide and the
Netherlands
PRODUCT Pump
waste tube for blood gas analysis kit. One yellowish/white rubber tube per
plastic bag. Used on ABL800 Flex Series blood gas analyzers
CODE
Serial #905-671,
902-754
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Radiometer America Inc., Westlake, OH,
Manufacturer: Radiometer
Medical ApS, Bronshoj, Denmark.
REASON Tube may break. The firm discovered that the
yellowish/white tubes used in their blood gas analyzers (ABL800 Flex Series)
were manufactured incorrectly. These tubes have the potential to break off at
the black plastic connectors. The breakage may occur during the installation of
the tubes or after a short time in use.
VOLUME OF PRODUCT IN
COMMERCE 189 pieces
DISTRIBUTION Nationwide
and
Canada
PRODUCT STA
Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic,
CODE
BT7 7016065; BT7 7016067; BT7 7016068;
BT7 7016072; BT7 7016074; BT7 7016075; BT8 7016076; BT7 7016078; BT7 7017080;
BT7 7016090; BT7 7016091; BT8 7026119; BT8 7026126; BT8 7026127; BT8 7026128;
BT8 7026130; BT7 7026134; BT7 7026135; BT7 7026140; BT8 7026146; BT8 7026147;
BT8 7026148; BT8 7026149; BT8 7026150; BT7 7026151; BT7 7026152; BT7 7026153;
BT7 7026154; BT7 7026155; BT7 7026156; BT7 7026157; BT7 7036164; BT7 7036166;
BT7 7036167; BT7 7036168; BT7 7036177; BT7 7036192
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Diagnostica Stago, Inc.,
Parsippany, NJ,
Manufacturer: Diagnostica
Stago - Taverny Site, Taverny, France.
REASON Incorrect results. Internal investigation
determined the presence of a defective measurement head which can impact the
results of clotting tests by either yielding no result or rendering an error
message.
VOLUME OF PRODUCT IN COMMERCE 41
units
DISTRIBUTION Nationwide
PRODUCT Medtronic
InterStim INS (Model 3023) with N’Vision Inter Stim-B software supplied on the
Model 8870 Version MMB_01/NNB_01 with N’Vision Clinician Programmer Model 8840
or InterStim iCon Patient Programmer Model 3037. Implantable Neurostimulator for
Urinary Control,
CODE All serial
numbers within above catalog/model numbers
RECALLING
FIRM/MANUFACTURER Medtronic Neurological, Minneapolis, MN
REASON
Software issue may cause false low
battery alert to be displayed when interrogating an Interstim Implantable
Neurostimulator (Model 3023) with an N’Vision Clinician Programmer (Model 8840),
or with an Inter Stim iCon Patient Programmer (Model 3037).
VOLUME OF
PRODUCT IN
COMMERCE 1,885
DISTRIBUTION Nationwide and
the
Netherlands
PRODUCT Precision
Implantable Pulse Generator (IPG), Model Number SC-110,
CODE
Serial Number
161767
RECALLING FIRM/MANUFACTURER Advanced Bionics
Corp., Sylmar, CA,
REASON Mislabeled. Product labeled with the
incorrect shelf-life information.
VOLUME OF PRODUCT IN
COMMERCE 1
device
DISTRIBUTION MD
PRODUCT Angiomat
Illumena Injector with Auxiliary Console,
CODE Lot #’s: 902040; 904045; and
902045Cl
RECALLING FIRM/MANUFACTURER Mallinckrodt Inc.,
Cincinnati, OH,
REASON Synchronization problems. Units that have
both a main programmable console and an auxiliary programmable console, when
simultaneously, injection parameters are programmed into the unit’s main console
and the unit’s auxiliary consoles, mis-synchronization could occur resulting in
a variance between the intended injection parameters (those programmed) and the
actual parameters of the injection delivered to the patient.
VOLUME
OF PRODUCT IN COMMERCE 176
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT ON-Q
PainBuster with OnDemand (270 ml, 2 ml/hr + 5 ml bolus /60 min refill), Model
PMB01, anesthetic/ narcotic medication pump.
CODE 6A4171 (exp. MAR 2009), 694133 (exp. FEB
2009), 654920 (exp. OCT 2008), 5A4732 (exp. MAR 2008), 584699 (exp. JAN
2008)
RECALLING FIRM/MANUFACTURER I-Flow Corporation,
Lake Forest, CA,
REASON Misassembly: The ON-Q PainBuster PMB01
package may contain a Soaker catheter instead of a Non-Soaker catheter. As a
result, the bolus button may remain latched in the down position which may cause
the the device to deliver continuously at 7 ml/hr instead of 2
ml/hr.
VOLUME OF PRODUCT IN COMMERCE 2,582
units
DISTRIBUTION Nationwide and Internationally
PRODUCT PEMView
Software used with Naviscan PEM Flex Solo I and PEM Flex Solo II PET Scanner,
for nuclear medicine imaging,
CODE Serial numbers: C3, P1, P2, P3, P4, P5,
P6, P7, P8, P10, P11, P12, P14, P002-B-070119-01, P002-B-070316-01,
P002-B-070423-01, P002-B-070531-01, P002-B-070629-01,
P002-B-070712-01
RECALLING FIRM/MANUFACTURER Naviscan PET
Systems, San Diego, CA,
REASON Naviscan has identified a potential safety issue
with all versions of PEM View Software commonly used for analyzing patient
images acquired on the PEMFIex product line. 1. The Positron Emission
Mammography Standardized Uptake Value (PEMSUV) and distance measurements for the
product mentioned above may be inaccurate if a zoomed image has been opened,
measurement tools are used, and the applet remains open while subsequent
measurements are being made on another applet (12 slice view). This software
defect results in unreliable andlor inconsistent readings in the size, distance
between lesions and mass measurement, which could result in the physician
selecting inaccurate margins for surgery. 2. In addition, under these same
circumstances the Region of Interest (ROI) numbering might not be sequential or
multiple regions within the same image might have the same number. Duplicative
numbering could result in confusion in definition of the region of interest. 3.
When images, user defined as "Other," are acquired, the thumbnail image is
mislabeled as "LCC" (Left Craniocaudal) while the caption contains the correct
user-defined labeling. This thumbnail mislabeling could result in reader
confusion in the body part being displayed.
VOLUME OF PRODUCT IN
COMMERCE 19 units
DISTRIBUTION Nationwide
Statement on Medtronic's Market Suspension of Their Sprint Fidelis Defibrillator Leads
Statement by Daniel Schultz, M.D., director of the Center for Devices and Radiological Health:
Medtronic's decision to remove its Sprint Fidelis defibrillation leads from the market is in the best interest of patient safety.
These electronic wires are prone to fracture in a small number of patients which can cause the defibrillator to deliver unnecessary shocks or not operate at all. Based on our initial review of reported adverse events, some deaths and major complications have occurred after the leads have fractured.
Defibrillators are life-saving products for patients with a heart rhythm abnormality. We know it can be frightening for a patient to learn that a product they rely on so much might have a serious defect. However, patients can be assured that the likelihood of fracture is very low and FDA is committed to ensuring that the risk to patients is minimized.
Background:
Today, Medtronic announced it was suspending distribution of its Sprint Fidelis defibrillation leads because a small number of fractures have been detected. As a result of Medtronic's action, no more Sprint Fidelis leads will be sold or manufactured and any remaining product should be pulled from inventory and returned to the company. Patients who are implanted with this lead are encouraged to contact their physicians for further information.
Medtronic first notified physicians in March about the fracture rate at that time and the proper method for implantation. Additional data on adverse events accumulated since then has prompted today's action.
Implantable cardioverter defibrillators (ICDs) and Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds) are used to treat abnormal heart rhythms that can cause the heart to stop suddenly. ICDs and CRT-Ds shock the heart back into normal rhythm by sending a pulse of energy through an electronic wire or lead that is connected to the heart.
When a defibrillator lead is slightly more prone to fracture, it doesn't mean that every lead will break. Most leads will function well, as is the case with Sprint Fidelis. In the infrequent circumstance where a lead actually breaks, or "fractures," the lead may send false signals that cause inappropriate defibrillator shocks, or therapies such as pacing or shocks may not be delivered.
Current adverse event information indicates that fractures have occurred in less than 1 percent of the approximately 268,000 of these leads implanted worldwide. We don't know if this rate of adverse events will remain constant or increase over the life of these leads.
Patients should recognize that a small number of Sprint Fidelis leads are used with defibrillators made by manufacturers other than Medtronic. If patients have reason to believe that they have a Sprint Fidelis lead or if they do not know the model of their lead, they should contact their health care professional.
WEEK ENDING OCTOBER 27
PRODUCT FP1000
Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for
in vitro diagnostic use.
CODE Software versions 1.1 &
1.2
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman
Coulter Inc., Brea, CA
Manufacturer: Beckman Coulter, Inc., Miami, FL.
REASON
Pressure (from recapped tubes) or
vacuum (from under-filled short-draw tubes) will cause inaccurate results if not
properly vented.
VOLUME OF PRODUCT IN COMMERCE 10
units
DISTRIBUTION Nationwide and
Canada
PRODUCT
a)
Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4
mm Blade Length; 1.0mm Blade Width; Becton Dickinson
Vacutainer Systems. Catalog Number 366356, Recall #
Z-0044-2008;
b) Microtainer Safety Flow Lancets; Yellow Sterile Use once and
discard; 2.2mm Blade Length; 1.0mm blade width; Becton
Dickinson Vacutainer System. Catalog number 365759,
c) Microtainer Safety Flow Lancets; Blue Sterile Use once and
Discard; 1.9mm Blade Length; 1.0 mm Blade Width; Becton
Dickinson Vacutainer Systems, Catalog number 366357,
CODE
a) Lot numbers: 2340296,
2353789, 3007400, 3043001, 3073415, 3100407, 3198493;
b) Lot numbers:
2340323, 3017522, 3049342, 3069725, 3136072, 3149410, 3220675, 3213535, 2319394;
c) Lot numbers: 2228742; 3022532;
3037536; 3055877; 3062548; 3079392; 3086096; 3135003;
3142723; 3199645; 3225646; 3240751; 3248047; 3268651; 2323030; 2330450
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Company,
Franklin Lakes, NJ
Manufacturer: Becton Dickinson Caribe Ltd, San Lorenzo, PR.
REASON
Potential for the
blade and holder assembly to become loose and then separate from the main body
of the lancet during the process of disposal.
VOLUME OF PRODUCT IN
COMMERCE 7,833,000
units
DISTRIBUTION Nationwide and Canada
PRODUCT
a)
ESA LeadCare II Blood Test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-6762,
b) ESA LeadCare II Blood Test Kit, 6 test Kit containing Level 1
and Level 2 Control Vials with lot number: 0704A Catalog
Number: 70-7142,
CODE a) and b) Lot number:
0704A
RECALLING FIRM/MANUFACTURER Esa Biosciences, Inc.,
Chelmsford, MA,
REASON Level 1 and Level 2 Control
values were incorrectly assigned.
VOLUME OF PRODUCT IN
COMMERCE 367 kits
DISTRIBUTION Nationwide and
UK
PRODUCT Battery
Pack portion of the LifeVest device. The LifeVest is a wearable cardioverter
defibrillator worn by a patient at risk for sudden cardiac arrest (SCA). Product
number 10A0894-A01.
CODE Serial
numbers 71000101 through 71003176
RECALLING
FIRM/MANUFACTURER Zoll Lifecor Corporation, Pittsburgh, PA
REASON
Possible malfunction of the battery pack.
A significant electrostatic discharge (ESD) can cause the battery pack to
malfunction. The malfunction causes the battery pack to discharge more rapidly
and prevents the pack from recharging.
VOLUME OF PRODUCT IN
COMMERCE 2,006 packs
DISTRIBUTION Nationwide
and Internationally