JANUARY 2007

JANUARY 2007

WEEK ENDING JANUARY 6

PRODUCT
a) OneTouch Ultra- Blood Glucose test strips. For use with One Touch Brand Meters blood glucose meters,
b) OneTouch Basic/Profile Blood Glucose test strips. For use with One Touch Brand Meters blood glucose meters,
CODE
a) Lot # 2691191 and 2691261;
b) Lot # 272894A, 2619932, 2606340, and 2615211
RECALLING FIRM/MANUFACTURER
Recalling Firm: Royal Global Wholesale, Boynton Beach, FL,
Manufacturer: Unknown, Milpitas, CA.
REASON Counterfeit Glucose Test Strips
VOLUME OF PRODUCT IN COMMERCE 11,716 devices
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker),
50/60 Hz (20A power source required); Model 801763,
b) Terumo Advanced Perfusion System 1; 220V -240V; Model 801764
(sold outside of the U.S. only),
CODE
a) All units. Serial numbers 0011 through 0499;
b) Units 0006 through 0213.
RECALLING FIRM/MANUFACTURER: Terumo Cardiovascular Systems Corp., Ann Arbor, MI,
REASON Improperly adjusting the occlusion setting may result in a pump jam error and pump stoppage.
VOLUME OF PRODUCT IN COMMERCE 696 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Endologix Infrarenal Bifurcated Powerlink System with Visifiex
Delivery System (endovascular graft). Model Number 25-16-155BL,
b) Endologix Infrarenal Bifurcated Powerlink System with Visifiex
Delivery System (endovascular graft), Model Number 28-16-155BL,
CODE
a) Lot Numbers: W06-0333, W06-0392, W06-0500, W06-0553,
W06-0621, W06-1100 & W06-1152;
b) Lot Numbers: W06-0079, W06-0334, W06-0393, W06-0501,
W06-0658, W06-0773, W06-0988 & W06-1196
RECALLING FIRM/MANUFACTURER Endologix Inc., Irvine, CA
REASON Recall was initiated after a clinical incident involving separation of the front sheath, preventing deployment of the stent graft. This required the physician to convert the patient to conventional open repair.
VOLUME OF PRODUCT IN COMMERCE 30 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Solara Replacement Turbine, Autochuck End Cap, for dental handpiece, part number 064900,
CODE Lot numbers 1694789, 1697998, 1699566, and 1703516.0
RECALLING FIRM/MANUFACTURER Stardental Division, Lancaster PA
REASON End cap component can disassemble.
VOLUME OF PRODUCT IN COMMERCE 2756 end caps
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker),
50/60 Hz (20A power source required); Models 801763,
b) Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker),
50/60 Hz (10A power source required); Model 801764.
(Not distributed within the United States),
CODE
a) Serial numbers 0093 and 0104 through 0114;
b) Serial numbers 0040 through 0044
RECALLING FIRM/MANUFACTURER Terumo Cardiovascular Systems Corp., Ann Arbor, MI
REASON The gas system may fail calibration prior to use due to incorrect gas system flowmeter software.
VOLUME OF PRODUCT IN COMMERCE 17 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Posterior Acetabular Retractor-Left with Light Cord Bracket, Model #BIO-1-1050-A, and Posterior Acetabular Retractor-Right with Light Cord Bracket, Model #BIO-1-1051-A, packaged 1 retractor (left or right retractor) per plastic bag, CODE Lot #P0835-1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Whiteside Biomechanics, St. Louis, MO
Manufacturer: Friedrich Daniels, Solingen, Germany.
REASON The soft tissue pin in the retractor can break off and become embedded in the tissue.
VOLUME OF PRODUCT IN COMMERCE 10 retractors
DISTRIBUTION MD and MO

PRODUCT FC 500 MPL Flow Cytometry System with MXP Software Version 2.0 & 2.1, Part Number 626554 FC 500 MPL 733313 MPL Hardware Upgrade Kit, CODE System with MXP Software Version 2.0 & 2.1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA,
Manufacturer: Applied Cytometry, Sheffield, UK.
REASON The ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the Parameter Selection Dialog box is accessed. Issue limited only to protocols utilizing the Ratio parameter such as LeukoSure and DNA Cell Cycle.
VOLUME OF PRODUCT IN COMMERCE 37 in the US; 4 to Canada
DISTRIBUTION Nationwide and Canada

PRODUCT Histochemical PAS (Periodic Acid Schiff) Reaction Set. Class I medical device. Product size configuration: Set of 4 bottles including Schiff Reagent 225mL, Light Green SF Yellowish Stain 225mL, Sodium Carbonate Solution 225mL, and Periodic Acid Solution 225mL. Each kit provides reagents sufficient for a maximum of 100 tests, Item Number 64945/93,
CODE Lot # 5341, Exp. Date: May 31, 2007.
RECALLING FIRM/MANUFACTURER EMD Chemicals Inc., Gibbstown NJ, REASON Due to loose caps, the SO2 levels dropped significantly from release levels causing the product not to perform properly.
VOLUME OF PRODUCT IN COMMERCE 74 kits
DISTRIBUTION Nationwide

WEEK ENDING JANUARY 13

PRODUCT
a) One Touch Basic/Profile and
b) One Touch Ultra- Blood Glucose Test Strips,
CODE
a) Lot numbers: 2606340, 2619932, 272894A, 2615211;
b) One Touch Ultra Lot numbers: 2691191, 2691261
RECALLING FIRM/MANUFACTURER Core Care Technologies, Inc., Sewell NJ,
REASON Counterfeit product.
VOLUME OF PRODUCT IN COMMERCE 24,731 boxes
DISTRIBUTION Nationwide

PRODUCT
a) Allura X-per FD 10/10 x-ray, and fluoroscopy,
b) Allura Xper FD 20/10 x-ray, and fluoroscopy,
CODE
a) Units: 127, 113, 117, 112, 131, 128, 90, 17, 35, 137, 93, 51, 95,
27, 6, 47, 98, 22, 49, 39, 103, 120, 21, 40, 70, 101, 69, 94, 89,
23, 33, 31, 30, 29, 28, 32, 100, 63, 61 Additional units are identified
with site numbers: 533397, 531926, 104950, 104953, 103283,
103281, 530653, 104497;
b) Units: 82, 33, 73, 24, 36, 71, 34, 52, 18, 19, 56, 67, 32, 22, 23, 54, 74, 69, 38
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA
Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands.
REASON Potential for generator to lock-up. Fluoroscopy and x-ray is no longer possible, and system must be restarted to be able to continue.
VOLUME OF PRODUCT IN COMMERCE 66 devices
DISTRIBUTION Nationwide

PRODUCT
a) Terumo Advanced Perfusion System 1, 6 inch diameter
Roller Pump; Model 801041
b) Terumo Advanced Perfusion System 1, 4 inch diameter
Roller Pump; Model 801040,
CODE
a) Serial numbers: 0976 and 0979;
b) Serial number 3091 (correct) was labeled as serial number 0391 (incorrect).
RECALLING FIRM/MANUFACTURER Terumo Cardiovascular Systems Corp., Ann Arbor, MI,
REASON
a) Six inch roller pumps were mislabeled as 4 inch roller pumps;
b) An incorrect serial number was placed on one roller pump
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION Nationwide and Internationally

PRODUCT HeartStart FR2+ Defibrillator
CODE Serial Numbers affected: 1204137082, 1204137014, 1204137016, 1204137022, 1204137126, 1204137128, 1204137132, 1204137136, 1204137146, 1204137018, 1204137020, 1204137124, 1204137130, 1204137134, 1204137138, 1204137028, 1204137030, 1204137032, 1204137036, 1204137038, 1204137040, 1204137042, 1204137044, 1204137046, 1204137048, 1204137050, 1204137064, 1204137070, 1204137072, 1204137074, 1204137076, 1204137078, 1204137080, 1204137084, 1204137086, 1204137088, 1204137090, 1204137092, 1204137094, 1204137140, 1204137162, 1204137164, 1204137166, 1204137168, 1204137196, 1204137198, 1204137200, 1204137202, 1204137204, 1204137206, 1204137208, 1204137034, 1204137144, 1204137142, 1204137228, 1204137396, 1204137054, 1204137056, 1204137058, 1204137060, 1204137062, 1204137066, 1204137068, 1204137096, 1204137100, 1204137102, 1204137104, 1204137106, 1204137108, 1204137110, 1204137112, 1204137114, 1204137116, 1204137118, 1204137226, 1204137230, 1204137238, 1204137266, 1204137268, 1204137270, 1204137272, 1204137286, 1204137290, 1204137294, 1204137120, 1204137122, 1204137224, 1204137232, 1204137234, 1204137236, 1204137274, 1204137276, 1204137280, 1204137282, 1204137284, 1204137288, 1204137292, 1204137296, 1204137298, 1204137300, 1204137304, 1204137306, 1204137308, 1204137312, 1204137316, 1204137318, 1204137322, 1204137324, 1204137330, 1204137354, 1204137388, 1204137394, 1204137572, 1204137352, 1204137386, 1204137382, 1204137384, 1204137472, 1204137483, 1204137381, 1204137302, 1204137310, 1204137314, 1204137334, 1204137336, 1204137338, 1204137340, 1204137342, 1204137344, 1204137346, 1204137356, 1204137358, 1204137360, 1204137362, 1204137364, 1204137374, 1204137376, 1204137379, 1204137389, 1204137390, 1204137392, 1204137398, 1204137400, 1204137402, 1204137403, 1204137404, 1204137406, 1204137408, 1204137409, 1204137410, 1204137411, 1204137412, 1204137414, 1204137416, 1204137418, 1204137420, 1204137421, 1204137424, 1204137427, 1204137429, 1204137433, 1204137435, 1204137438, 1204137442, 1204137448, 1204137450, 1204137454, 1204137456, 1204137458, 1204137460, 1204137464, 1204137468, 1204137477, 1204137481, 1204137485, 1204137487, 1204137489, 1204137320, 1204137326, 1204137332, 1204137348, 1204137350, 1204137366, 1204137368, 1204137370, 1204137372, 1204137378, 1204137383, 1204137385, 1204137387, 1204137391, 1204137395, 1204137397, 1204137399, 1204137401, 1204137405, 1204137413, 1204137415, 1204137417, 1204137419, 1204137422, 1204137423, 1204137431, 1204137436, 1204137437, 1204137439, 1204137440, 1204137446, 1204137452, 1204137462, 1204137466, 1204137470, 1204137474, 1204137476, 1204137478, 1204137479, 1204137480, 1204137482, 1204137484, 1204137486, 1204137488, 1204137491, 1204137493, 1204137495, 1204137497, 1204137499, 1204137501, 1204137503, 1204137505, 1204137507, 1204137509, 1204137511, 1204137524, 1204137526, 1204137528, 1204137530, 1204137532, 1204137534, 1204137536, 1204137538, 1204137564, 1204137568, 1204137570, 1204137576, 1204137578, 1204137580, 1204137582, 1204137380, 1204137425, 1204137697, 1204137540, 1204137637, 1204137680, 1204137610, 1204137659, 1204137800, 1204137702, 1204137634, 1204137513, 1204137515, 1204137517, 1204137519, 1204137521, 1204137523, 1204137542, 1204137544, 1204137546, 1204137560, 1204137562, 1204137563, 1204137565, 1204137566, 1204137567, 1204137569, 1204137571, 1204137573, 1204137574, 1204137575, 1204137581, 1204137583, 1204137584, 1204137587, 1204137588, 1204137589, 1204137590, 1204137591, 1204137592, 1204137593, 1204137594, 1204137595, 1204137597, 1204137598, 1204137599, 1204137600, 1204137602, 1204137603, 1204137604, 1204137605, 1204137606, 1204137607, 1204137608, 1204137609, 1204137611, 1204137612, 1204137613, 1204137614, 1204137616, 1204137618, 1204137624, 1204137626, 1204137628, 1204137630, 1204137632, 1204137636, 1204137638, 1204137640, 1204137641, 1204137642, 1204137644, 1204137645, 1204137646, 1204137647, 1204137648, 1204137649, 1204137650, 1204137652, 1204137654, 1204137655, 1204137656, 1204137658, 1204137660, 1204137661, 1204137662, 1204137664, 1204137668, 1204137671, 1204137681, 1204137683, 1204137685, 1204137687, 1204137689, 1204137691, 1204137692, 1204137693, 1204137705, 1204137706, 1204137707, 1204137708, 1204137709, 1204137710, 1204137712, 1204137714, 1204137548, 1204137552, 1204137554, 1204137556, 1204137558, 1204137577, 1204137579, 1204137585, 1204137615, 1204137619, 1204137620, 1204137621, 1204137622, 1204137623, 1204137635, 1204137639, 1204137643, 1204137663, 1204137667, 1204137669, 1204137670, 1204137672, 1204137673, 1204137674, 1204137675, 1204137676, 1204137677, 1204137678, 1204137679, 1204137682, 1204137684, 1204137686, 1204137688, 1204137690, 1204137695, 1204137698, 1204137699, 1204137700, 1204137701, 1204137703, 1204137704, 1204137711, 1204137713, 1204137722, 1204137725, 1204137727, 1204137729, 1204137731, 1204137737, 1204137768, 1204137770, 1204137772, 1204137774, 1204137776, 1204137778, 1204137780, 1204137782, 1204137784, 1204137790, 1204137792, 1204137794, 1204137796, 1204137798, 1204137802, 1204137804, 1204137806, 1204137808, 1204137810, 1204137812, 1204137814, 1204137816, 1204137818, 1204137820, 1204137822, 1204137824, 1204137828, 1204137830, 1204137832, 1204137842, 1204137852, 1204137854, 1204137788, 1204137617, 1204137665, 1204137596, 1204137786, 1204137840, 1204138056, 1204137954, 1204138004, 1204137865, 1204137911, 1204137831, 1204137787, 1204137825, 1204137861, 1204137863, 1204137875, 1204137877, 1204137879, 1204137883, 1204137887, 1204137889, 1204137891, 1204137897, 1204137901, 1204137905, 1204137907, 1204137909, 1204137913, 1204137915, 1204137917, 1204137919, 1204137937, 1204137939, 1204137943, 1204137950, 1204137952, 1204137956, 1204137957, 1204137968, 1204137976, 1204137984, 1204137986, 1204137992, 1204138000, 1204138002, 1204138006, 1204138008, 1204138010, 1204138012, 1204138016, 1204138048, 1204137757, 1204137766, 1204137827, 1204137867, 1204137881, 1204137885, 1204137893, 1204137899, 1204137903, 1204137925, 1204137940, 1204137947, 1204137949, 1204137953, 1204137959, 1204138014, 1204138018, 1204138030, 1204138052, 1204138054, 1204137393, 1204137735, 1204137741, 1204137743, 1204137745, 1204137747, 1204137749, 1204137751, 1204137753, 1204137755, 1204137758, 1204137759, 1204137760, 1204137761, 1204137762, 1204137763, 1204137764, 1204137765, 1204137767, 1204137771, 1204137773, 1204137777, 1204137789, 1204137793, 1204137795, 1204137797, 1204137799, 1204137801, 1204137803, 1204137807, 1204137809, 1204137811, 1204137813, 1204137815, 1204137817, 1204137819, 1204137821, 1204137823, 1204137826, 1204137833, 1204137834, 1204137835, 1204137836, 1204137837, 1204137838, 1204137839, 1204137841, 1204137844, 1204137845, 1204137846, 1204137848, 1204137850, 1204137851, 1204137857, 1204137858, 1204137862, 1204137864, 1204137866, 1204137868, 1204137870, 1204137871, 1204137872, 1204137874, 1204137876, 1204137882, 1204137884, 1204137886, 1204137888, 1204137890, 1204137892, 1204137894, 1204137898, 1204137900, 1204137902, 1204137906, 1204137908, 1204137912, 1204137914, 1204137916, 1204137918, 1204137920, 1204137922, 1204137924, 1204137928, 1204137930, 1204137932, 1204137934, 1204137936, 1204137938, 1204137942, 1204137944, 1204137946, 1204137960, 1204137964, 1204137966, 1204137970, 1204137052, 1204137407, 1204137601, 1204137805, 1204137829, 1204137843, 1204137847, 1204137849, 1204137859, 1204137869, 1204137873, 1204137878, 1204137896, 1204137904, 1204137910, 1204137926, 1204137948, 1204137958, 1204137962, 1204137972, 1204137974, 1204137978, 1204138022, 1204137791, 1204137856, 1204138020, 1204137769, 1204137969, 1204137980, 1204137982, 1204137991, 1204138032, 1204138036, 1204138046, 1204138049, 1204138058, 1204138064, 1204138084, 1204138007, 1204138034, 1204138051, 1204138028, 1204137993, 1204137995, 1204137997, 1204137999, 1204138072, 1204138178, 1204138180, 1204137941, 1204137961, 1204137963, 1204137965, 1204137967, 1204137973, 1204137975, 1204137977, 1204137983, 1204137985, 1204137987, 1204137989, 1204138001, 1204138005, 1204138009, 1204138024, 1204138026, 1204138060, 1204138062, 1204138066, 1204138068, 1204138076, 1204138078, 1204138080, 1204138182, 1204137981, 1204138003, 1204138082, 1204137929, 1204137931, 1204137933, 1204137935, 1204137945, 1204137971, 1204137994, 1204138059, 1204138067, 1204138069, 1204138071, 1204138073, 1204138075, 1204138081, 1204138085, 1204138087, 1204138089, 1204138093, 1204138097, 1204138103, 1204138105, 1204138107, 1204138109, 1204138113, 1204138115, 1204138117, 1204138119, 1204138123, 1204138125, 1204138127, 1204138129, 1204138131, 1204138133, 1204138137, 1204138149, 1204138151, 1204138155, 1204138186, 1204138194, 1204138196, 1204138202, 1204138204, 1204138208, 1204138216, 1204138218, 1204138222, 1204137895, 1204137921, 1204137951, 1204137955, 1204137979, 1204137988, 1204137990, 1204137996, 1204137998, 1204138053, 1204138055, 1204138057, 1204138061, 1204138063, 1204138065, 1204138070, 1204138077, 1204138079, 1204138101, 1204138111, 1204138121, 1204138135, 1204138141, 1204138153, 1204138184, 1204138190, 1204138192, 1204138198, 1204138200, 1204138206, 1204138210, 1204138212, 1204138214, 1204138083, 1204138091, 1204138095, 1204138099, 1204138220, 1204137853, 1204138074, 1204137586, 1204137855, 1204137927, 1204138139, 1204137444, 1204137278, 1204137666, 1204137739, 1204137098, 1204137860, 1204138188, 0105138425, 0105138427, 0105138429, 0105138431, 0105138433, 0105138435, 0105138441, 0105138443, 0105138445, 0105138446, 0105138448, 0105138449, 0105138450, 0105138451, 0105138452, 0105138453, 0105138454, 0105138455, 0105138456, 0105138457, 0105138461, 0105138463, 0105138465, 0105138467, 0105138471, 0105138473, 0105138475, 0105138479, 0105138481, 0105138483, 0105138489, 0105138491, 0105138495, 0105138497, 0105138501, 0105138503, 0105138507, 0105138509, 0105138511, 0105138513, 0105138517, 0105138519, 0105138521, 0105138523, 0105138525, 0105138527, 0105138529, 0105138531, 0105138535, 0105138551, 0105138437, 0105138469, 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RECALLING FIRM/MANUFACTURER Phillips Medical Systems, Seattle, WA, REASON Potential for shock treatment to be delayed or prevented due to board contamination that causes intermittent switch operation.
VOLUME OF PRODUCT IN COMMERCE 2,000 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Terumo Advanced Perfusion System 1; 100V -120V, 15 A
(circuit breaker), 50/60 Hz (20A power source required) base;
Model 801763,
b) Terumo Advanced Perfusion System 1; 220V -240V, 7A
(circuit breaker), 50/60 Hz (10A power source required) base;
Model 801764. (Not distributed within the United States),
c) Terumo Advanced Perfusion System 1, 4 inch diameter
Roller Pump; Model 801040,
d) Terumo Advanced Perfusion System 1, 6 inch diameter
Roller Pump; Model 801041,
e) Terumo Advanced Perfusion System 1 Air Bubble
Detection Module; Catalog number 802110,
f) Terumo Advanced Perfusion System 1 Data Interface
CDI 100; Catalog number 802558,
g) Terumo Advanced Perfusion System 1 Data Interface
CDI 500; Catalog number 803479,
h) Terumo Advanced Perfusion System 1 Venous Occluder;
Catalog number 803480,
i) Terumo Advanced Perfusion System 1 Level Detection;
Catalog number 802111,
j) Terumo Advanced Perfusion System 1 Pressure Monitoring;
Catalog number 802112;
k) Terumo Advanced Perfusion System 1 Temperature Monitoring
System; Catalog number 802114;
l) Terumo Advanced Perfusion System 1 Flow Module;
Catalog number 802018,
m) Terumo Advanced Perfusion System 1 Data Interface RS 485;
Catalog number 803518,
n) Terumo Advanced Perfusion System 1 Control Unit;
Catalog number 801046,
o) Terumo Advanced Perfusion System 1 Electronic
Oxygen Blender/analyzer; Catalog number 801188,
p) Advanced Perfusion System 1 Central Control Monitor;
Catalog number 802100,
CODE
a) Serial numbers: 0013, 0017, 0019 through 0039, 1141 through 0163, 0165 through 0200 and 0203 through 0244;
b) Serial numbers 0006 through 0066, 0100 through 0116, 0118 and 0119;
c) Serial numbers: 0031, 0032, 0034 through 0041, 0045, 0047 through 0050, 0052, 0054, 0056 through 0059, 0064, 0067, 0071 through 0073, 0075 through 0080,
0082 through 0086, 0088 through 0095, 0097 through 0099, 0101 through 0105, 0107, 0108, 0110, 0111, 0113 through 0135, 0137 through 0140, 0142 through 0165, 0167 through 0180, 0182 through 0191, 0194, 0195, 0197 through 0204,
0206, 0207, 0209, 0211 through 0235, 0237 through 0250, 0252 through 0291, 0293 through 0437, 0440 through 0522, 0524 through 0527, 0700 through 0725, 0727, 0730 through 0858, 0860 through 0878, 0880, 0881, 0885 through 0903,
0906 through 0912, 0922 and 0924;
d) Serial numbers: 0033, 0034, 0036, 0038, 0041 through 0043, 0045, 0047 through 0049, 0052, 0054, 0055, 0057, 0058, 0061, 0063, 0064, 0069, 0072, 0075 through 0096, 0098, 0099, 0102 through 0116, 0118, 0124, 0127 through 0136,
0138 through 0146, 0148 through 0151, 0153 through 0163, 0165 through 0170, 0172, 0173, 0175, 0179, 0181 through 0187, 0189 through 0200, 0202 through 0231, 0233 through 0240, 0242 through 0278, 0281 through 0302, 0304 through 0481, 0483 through 0587, 0700 through 0753, 0757, 0758, 0760 through 0769, 0771 through 0787, 0789 through 0793, 0795 through 0866, 0868 through 0898, 0900 through 0921, 0923 through 0978, 0980 through 1001, 1004 through 1015,
1017, 1019 and 1024 through 1027;
e) Serial numbers: 00023 through 00026, 00034, 00041, 00051, 00060, 00063 through 00065, 00067 through 00069, 00071 through 00089, 00091 through 00139, 00141 through 00242, 00246 through 00280, 00282 through 00297, 00299 through
00323, 00325 through 00410 and 00419;
f) Serial numbers: 00008 through 00011, 00013, 00020 through 00030, 00032 through 00034, 00036 through 00059 and 00061 through 00078;
g) Serial numbers: 00009 through 00012, 00014 through 00017, 00019, 00023 through 00037, 00039 through 00049, 00051 through 00119, 00121, 00122 and 00124 through 00149;
h) Serial numbers: 00012 through 00019, 00021, 00025, 00027 through 00031, 00033 through 00053, 00055 through 00066, 00068 through 00075, 00078 through 00139, 00141 through 00147, 00149 through 00157 and 00159 through 00213;
i) Serial numbers: 00023, 00025 through 00027, 00055, 00061 through 00081, 00083 through 00099, 00101 through 00109, 00111 through 00183, 00185 through 00260, 00262 through 00269. 00271 through 00293, 00295 through 00307 and 00309 through 00357;
j) Serial numbers: 00017 through 00032, 00036, 00043, 00045 through 00057, 00059 through 00062, 00065 through 00071, 00073 through 00079, 00081 through 00099,
00102 through 00122, 00125 through 000251, 00253 through 00292, 00296 through 00309, 00311 through 00349, 00352 through 00479, 00484 and 00489;
k) Serial numbers: 00019 through 00034, 00036, 00037, 00046 through 00053, 00055 through 00069, 00073 through 00114, 00116 through 00128, 00131 through 00193, 00195 through 00203, 00205 through 00334, 00339 through 00355, 00357 through 00414, 00416 through 00431. 00434, 00435, 00439 through 00447, 00448
through 00466, 00468 through 00473, 00475 through 00477, 00479 through 00582, 00584 through 00590, 00592 through 00594 and 00606;
l) Serial numbers: 00017, 00020, 00023 through 00026, 00029 through 00031, 00033, 00034, 00036 through 00048, 00051 through 00055, 00057 through 00078, 00080 through 00120, 00122 through 00134, 00136, 00138 through 00155, 00158 through 00169, 00171 through 00210, 00212 through 00243 and 00248;
m) Serial numbers: 00007 through 00014, 00016 through 00024 and
00026 through 00031;
n) Serial numbers: 0020 through 0025, 0030 through 0036, 0038 through 0040, 0042, 0044, 0045, 0047 through 0081, 0083, 0084, 0086 through 0102, 0106 through 0110, 0112 through 0130, 0132 through 0137, 0139 through 0147, 0149 through 0154, 0157 through 0166, 0169 through 0175 and 0177 through 0189;
o) Serial numbers: 00010 through 00016, 00019, 00024 through 00027, 00030 through 00033, 00035, 00036, 00038 through 00040, 00042 through 00046, 00048 through 00050, 00052 through 00054, 00056 through 00059, 00061 through 00063, 00065, 00066, 00068, 00069, 00071 through 00073, 00075 through 00078, 00082, 00084, 00085, 00087, 00088, 00091, 00094, 00095, 00098 through 00103, 00105
through 00107, 00109 through 00111, 00113 through 00115, 00122, 00126 through 00129, 00133 through 00135, 00139, 00140, 00144, 00145, 00147, 00148, 00151, 00152, 00154 through 00157, 00163, 00167, 00168 through 00174, 00176 through 00182, 00184 through 00196, 00200, 00202 through 00206, 00210, 00211, 00213, 00214, 00216 through 00224, 00228 through 00231, 00237 through 00241,
00245 through 00250, 00300 through 00327 and 00330;
p) Serial numbers: 0047, 0049, 0052, 0054, 0055, 0065, 0066, 0069, 0071, 0072, 0074, 0076 through 0088, 0090 through 0111, 0113 through 0131, 0133 through 0276, 0278 through 0288, 0291 through 0293, 0295 through 0301 and 0303 through 0350
RECALLING FIRM/MANUFACTURER Terumo Cardiovascular Systems Corp., Ann Arbor, MI
REASON Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'X' being displayed on the monitor screen.
VOLUME OF PRODUCT IN COMMERCE 4,740 devices
DISTRIBUTION Nationwide and Internationally

PRODUCT Product Description: Edwards Lifesciences-Swan-Ganz,Thermodilution Venous Infusion Port (VIP) Catheter with AMC Thromboshield (An Antimicrobial*Heparin Coating), REF:831HF75, Model Number: 831FH75,
CODE Lot number: 246HC197 Expiration Date: Feb. 2008
RECALLING FIRM/MANUFACTURER Edwards LifeSciences Technology SAEL, Anasco, PR
REASON Misbranding-One lot of Swan-Ganz Thermodilution VIP Catheters, Model 831HF75, lot 246HC197 was labeled with different model information (831F75) on the edge label . The edge label states the model is 831F75 which incorrectly indicates that product does NOT contain an antimicrobial heparin coating. (The tray lid label correctly states the model is 831HF75, containing the heparin coating).
VOLUME OF PRODUCT IN COMMERCE 1,110 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Bivona Adult Tracheostomy Tube, I.D. 8.5 mm, O.D 11.0 mm, Length 88 mm, TTS 11.8 mm, Mfrd by Smiths Medical Critical Care; Product code 670185, CODE Lot numbers 1008187, 1023402 and 1012767
RECALLING FIRM/MANUFACTURER Smiths Medical ASD, Inc., Gary, IN, REASON Mislabeled- The outer diameter (OD) of the shaft is labeled as 11.0 m on the inner, outer and tray label in error. The OD is actually 11.8 mm.
VOLUME OF PRODUCT IN COMMERCE 197 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) TruFit CB Plug Size Code Red, 7mm; quantity 1;
Part #605-001-03; product labeled as sterile;
b)TruFit CB Plug Size Code Blue, 9mm; quantity 1;
Part #605-001-05; product labeled as sterile;
c) TruFit BGS Plug Size Code Red, 7mm; quantity 1;
Part #600-001-03; product labeled as sterile;
d) TruFit BGS Plug Size Code Blue, 9mm; quantity 1;
Part #600-001-05; product labeled as sterile;
CODE 051024-14 and 011-051024-14
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith & Nephew, Inc., Endoscopy Division, Andover, MA,
Manufacturer: OsteoBiologics, Inc., San Antonio, TX.
REASON Mis-packaging. Product in the package may be a different size than indicated on the labeling.
VOLUME OF PRODUCT IN COMMERCE 119 units
DISTRIBUTION Nationwide

PRODUCT Puritan Bennett KnightStar 330 Bi-Level Ventilator, Catalogue Numbers: Y-KS330-NA, Y-KS330-SD, DSY-KS330-NA, DSY-K5330-SD, DLY-KS330-NA & DLY-KS330-SD,
CODE All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puritan Bennett Corporation, Carlsbad, CA
Manufacturer: Nellcor Puritan Bennett Ireland, Galway, Ireland.
REASON Directions for Use-Puritan Bennett has determined that a service interval should be defined for the device. The firm has also determined that an exhalation filter should be employed when the device is in use.
VOLUME OF PRODUCT IN COMMERCE 7,754 devices
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Bayer Advia 70 Hematology Analyzer,
b) Drew Excell 22 Hematology Analyzer,
CODE All lots
RECALLING FIRM/MANUFACTURER Drew Scientific, Inc., Oxford, CT.
REASON Flags and alerts on the user interface will not automatically transfer to the LIS.
VOLUME OF PRODUCT IN COMMERCE 844 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Bayer Advia 70 Hematology Analyzer,
b) Drew Excell 22 Hematology Analyzer,
CODE All lots.
RECALLING FIRM/MANUFACTURER Drew Scientific, Inc., Oxford, CT.
REASON System has given inaccurate readings when running samples that trigger an extra rinse due to very high WBC, RBC or Platelet counts.
VOLUME OF PRODUCT IN COMMERCE 844 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) LifeScan brand One Touch Sure Step-Blood Glucose Monitoring
System Test Strips, 50 strips per package, part number: 020-052-01,
b) LifeScan brand One Touch Sure Step Pro-Blood Glucose Monitoring
System Test Strips, 50 strips per package, part number: 010-797-02,
CODE
a) Lot number: 2627353;
b) Lot number: 2634187008
RECALLING FIRM/MANUFACTURER LifeScan, Inc., Milpitas, CA
REASON Inaccurage test results: testing may lead to no test results, error message or inaccurately low test results.
VOLUME OF PRODUCT IN COMMERCE 26,398 units
DISTRIBUTION Nationwide

PRODUCT Phenobarbital- Reagent-Clinical Chemistry--List number: 1E08-20-Abbott Diagnostics Division,
CODE
Lot number: 39074HW00 (exp. 9/30/06),
Lot number: 41008HW00 (exp. 10/31/06),
Lot number: 42063HW00 (exp. 12/31/06)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Inc., South Pasadena, CA,
Manufacturer: Dade Behring, Inc., Cupertino, CA.
REASON Erratic elevated results and or the inability to calibrate due to imprecision.
VOLUME OF PRODUCT IN COMMERCE 448 kits
DISTRIBUTION Nationwide and Internationally

PRODUCT BOLD/INI-CLIP 2.2mm Drill Bit with AO Attachment. Model/Catalog number: 159004ND,
CODE Lot Numbers: D2CJ/; D2CJ/1; D2PS; E0X4; E14K; E14L; E14M; E14N; E1KM; E1KN; E1X2; E24S; E2JS; E2LP
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integra LifeSciences, Corp., Plainsboro, NJ,
Manufacturer: NewDeal SA, Lyon, France.
REASON Incorrect drill length-Cannulated drill bits were manufactured to incorrect specifications (shorter length) resulting in inadequate preparation of bone prior to insertion of the UNI-CLIP Staple.
VOLUME OF PRODUCT IN COMMERCE 107 units
DISTRIBUTION Nationwide

PRODUCT Expo32 ADC Software Version 1.1C, Part Number 6418337-New Users Software Kit, and Part Number 175454 Upgrade Software Kit used with the Coulter EPICS XL Flow Cytometers,
CODE Version 1.1C
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA,
Manufacturer: Applied Cytometry, Sheffied, UK.
REASON The firm has confirmed that the ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the Parameter Selection Dialog box is accessed. This issue is limited to only protocols utilizing the Ratio parameter.
VOLUME OF PRODUCT IN COMMERCE28 units
DISTRIBUTION Nationwide

PRODUCT
a) RYM-5000 InVision-Plus® Neutral Displacement I.V. Connector,
packaged 200 units per box, 5 boxes per case (1000 units/case);
labeled as Sterile-Nonpyrogenic; assembled in Mexico,
b) RYM-5000 InVision-Plus® NEUTRAL™ I.V. Connector,
packaged 200 units per box, 5 boxes per case (1000 units/case);
abeled as Sterile-Nonpyrogenic; assembled in Mexico,
c) RYM-5001 InVision-Plus® Neutral Displacement I.V. Connector,
packaged 100 units per box, 5 boxes per case (500 units/case);
labeled as Sterile-Nonpyrogenic; assembled in Mexico,
CODE
a) Lot numbers: 400, 401, and 402;
b) Lot number: 405;
c) Lot numbers: 500, 502, 503, 504, and 505
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rymed Technologies, Inc., Austin, TX,
Manufacturer: Accelent Juarez, Juarez, Mexico.
REASON Weld failures on IV connector (area of female luer and spike body).
VOLUME OF PRODUCT IN COMMERCE 79,328 units
DISTRIBUTION Nationwide

PRODUCT
a) Confirm Clearly Smart Pregnancy Test (Confirm Clearly Starter Kits, UPC Code 3-02340-30136-7, Product Code 30136; Confirm Clearly Starter Kits: When sold in the U.S., the product consists of a reader and two disposable test sticks; when sold in Canada, the product consists of a reader and one disposable test stick;
b) Confirm Clearly Refills Kits, UPC Code 3-02340-30138-1, Product Code 30138) Note: Confirm Clearly Refills Kits: The refill consists of three disposable test sticks;
c) Special Pack Deal (6 Starter Kits & 6 Refill Kits),
CODE
a) Lot numbers : LE612, LE613, LF601, LF606, LF612, LG604, LG609, LG616, LH601, LH607, LH610, LH615, LH621, LJ607, LK605 & LK611;
b) Lot numbers : LE611, LF603, LF611, LG602, LG605, LG613, LG614, LH602, LH603, LH611, LH612, LH614, LH619, LJ606, LK602 & LK610;
c) Lot number; LH608
RECALLING FIRM/MANUFACTURER Mizuho USA, Inc., Poway, CA
REASON False positives-the firm has received a higher than expected rate of complaints regarding false-positive results.
VOLUME OF PRODUCT IN COMMERCE 241,200 Starter Kits and 232,800 Refill Kits
DISTRIBUTION Nationwide and Internationally

WEEK ENDING JANUARY 20

PRODUCT
a) One Touch Basic/Profile and
b) One Touch Ultra- Blood Glucose Test Strips,
CODE
a) Lot #'s 2606340, 2619932, 272894A, 2615211;
b) Lot #'s 2691191, 2691261
RECALLING FIRM/MANUFACTURER Core Care Technologies, Inc., Swell, NJ
REASON Counterfeit product.
VOLUME OF PRODUCT IN COMMERCE 24731 boxes
DISTRIBUTION Nationwide

PRODUCT Advanced Bionics Precision Linear Leads, part of the Precision Spinal Cord Stimulation System. Model Numbers: SC-2138-30, SC-2138-50, SC-2138-50T and SC-2138-70,
CODE Serial Numbers: 111744, 112122, 112141, 112224, 112233, 114114, 116547, 116553, 117860, 117907, 110490, 100600, 110625, 110809, 113745, 113780, 112055 and 118943
RECALLING FIRM/MANUFACTURER Advanced Bionics Corp., Sylmar, CA, REASON A small number of unimplanted Precision Linear Leads may have been assembled with incorrect electrode material. At high stimulation levels, the metal may corrode and dissolved metals may enter the patient.
VOLUME OF PRODUCT IN COMMERCE 18
DISTRIBUTION Nationwide and Internationally

PRODUCT Edwards Lifesciences VANTEX Central Venous Catheter Set with OLIGON-Model A2720S,
CODE Lot numbers: 946DC131, 946DC239 and 946FC460
RECALLING FIRM/MANUFACTURER Edwards LifeSciences Corp., of Puerto Rico, Anasco, PR,
REASON Lack of Assurance of Sterility-Device packaging was manufactured with an incorrect lid that could compromise the sterility of the product.
VOLUME OF PRODUCT IN COMMERCE 135 units (3 lots)
DISTRIBUTION Nationwide and Italy

PRODUCT SPS Blue Line Tube Clamp Adapters, Product number BL120M, CODE Devices purchased between August 29 and September 20, 2006.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Southern Prosthetic Supply Co., Alpharetta, GA,
Manufacturer: Medi Bayreuth, Bayreuth, Bavaria, Germany.
REASON Device Fracturing: recent design and process changes leave the device susceptible to fracturing, which could cause the prosthesis to fail.
VOLUME OF PRODUCT IN COMMERCE 943 units
DISTRIBUTION Nationwide

PRODUCT
a) REMstar Heated Humidifier (Respiratory Gas Humidifier)
Model numbers: 1005792, U1005792, R1005792, SC1005792,
AC1005792, and 1007861,
b) REMstar Heated Humidifer Main PCA Repair Kit,
Part number 1006265,
CODE
a) Serial numbers H045582 through H239662;
b) Lot number 020613, 020614, 020801, 020823, 020926, 021121, 021226, 030130, 030303, 030320, 303401, 303417, 030423, 030514, and 030611
RECALLING FIRM/MANUFACTURER Respironics, Inc., Murrysville, PA,
REASON AC inlet connector failure that can result in thermal damage to the humidifier enclosure and/or ignition of materials external to the device.
VOLUME OF PRODUCT IN COMMERCE 172,000 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray,
cemented, Left Medial/Right Lateral, Size 1, sterile; Part number 1498-24-001,
b) Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray,
cemented, Right Medial/Left Lateral, Size 1, sterile; Part number 1498-23-001
c) Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray,
cemented, Left Medial/Right Lateral, Size 2, sterile; Part number 1498-24-002,
d) Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray,
cemented, Right Medial/Left Lateral, Size 2, sterile; Part number 1498-23-002
e) Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Left Medial/Right Lateral, Size 3, sterile; Part number 1498-24-003
f) Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Right Medial/Left Lateral, Size 3, sterile; Part number 1498-23-003,
g) Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Left Medial/Right Lateral, Size 4, sterile; Part number 1498-24-004,
h) Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Right Medial/Left Lateral, Size 4, sterile; Part number 1498-23-004,
i) Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Left Medial/Right Lateral, Size 5, sterile; Part number 1498-24-005,
j) Depuy Preservation Uni-Compartmental Knee Fixed Tibial Tray, cemented, Right Medial/left Lateral, Size 5, sterile; Part number 1498-23-005,
CODE All Lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Depuy Orthopaedics, Inc., Warsaw, IN,
Manufacturer Firm: DePuy Ireland Ltd., Cork, Ireland.
REASON Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.
VOLUME OF PRODUCT IN COMMERCE 558
DISTRIBUTION Nationwide and Internationally

PRODUCT Simplex P with Tobramycin. Antibiotic PMMA Bone Cement,
CODE Lot Code MBN003, catalog no. 6197-9-010 (10 pk) Lot Code MBN003, catalog no. 6197-9-001 (1 pk) Lot Code MBN004; catalog no. 6197-9-010 (10 pk) Lot code MBN004; catalog no. 6197-9-001 (1 pk) Lot Code MBN003 and MBN004 - powder ''use by'' date 12/2007 Lot Code MBN003 and MBN004 - liquid ''use by'' date 9/2006 Product ''Use By'' Date: September 2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics Corp., MahwahNJ.,
Manufacturer: Stryker, Limerick, Ireland.
REASON The expiration date on the external label is incorrect in that it does not identify the earliest expiration date of the subcomponents. The External label provides for an incorrect longer expiration date than the actual subcomponents will support. The expiration date on the external package states December 2007 and the expiration date of the liquid monomer is September 2006.
VOLUME OF PRODUCT IN COMMERCE 813 units
DISTRIBUTION Nationwide

PRODUCT Re-Flex VSP and Low Profile Re-Flex VSP external prosthetic foot modules with integrated shock absorber, Model numbers RFXS0002, RFXS0003, RFLS0006 and RFL50007,
CODE Inner tube serial numbers beginning with 1472 through 1677 are suspect. This number is not traceable to the customer. The recall will be based on shipments made during the period that these numbers were in use.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ossur, Reykjavik, Iceland,
Manufacturer: Ossur North America Inc., Aliso Viejo, CA.
REASON Inner Tube Breakage: distributed low quality units can lead to breakage of the inner tube, resulting in an abrupt rotation of the shock module, compromising function and stability of the prosthetic foot.
VOLUME OF PRODUCT IN COMMERCE 138 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Howmedica Hip Fracture Stem System, Product Number: 6942-0-10,
No. 1 Femoral Component, Fenestrated Sterile Made in Ireland,
b) Howmedica Hip Fracture Stem System No. 2 Femoral Component Fenestrated Sterile REF Catalogue #6942-0-020 Made in Ireland,
c) Howmedica Hip Fracture Stem System No. 3 Femoral Component Fenestrated Sterile REF Catalogue #6942-0-030 Made in Ireland,
d) Howmedica Hip Fracture Stem System No. 3.5 Femoral Component Uses No. 3 Fenestrated Plus Sterile REF Catalogue #6942-0-035 Made in Ireland,
e) Howmedica Hip Fracture Stem System No. 4 Femoral Component Fenestrated Sterile REF Catalogue #6942-0-040 Made in Ireland,
CODE
a) Lot codes: 6499601, 6660201, 6660202, 6660203, 6660204, 6660205, 7237401, 7237402, 7237403, 7237404, 7237405, 7934101, 7934102, 7934103, 7934104, 7934105, 8345801, 8345802, 8345803, 8345804, 9714001, 9911901, 9911902, 10420701, 10420702, 10756001, 11319201, 11369101, 11369102,
11369103, 11605201, 11605202, 13093201, 13093301, 13093302, 13093401, 13093501, 13562501, 13562502, 13782001, 15550502,16060001, 16060002, 16840301, 17289301, 17289302, 18448101, 18448102, 18448103, 18593901, 14413201R, P4FEA;
b) Lot Codes: 7237501, 7237502, 7237503, 7237505, 7600201, 7600202, 7662301, 7662302, 7662303, 7662304, 7692401, 7692402, 7692403, 7692406, 7805601, 7805602, 7805603, 7805604, 7934901, 7934902, 7944903, 7934904, 7999101, 7999102, 7999103, 7999104, 8152001, 8152002, 8152003, 8152004, 8152005, 8152006, 8152101, 8152102, 8152103, 8152104, 8241701, 8241702, 8241703, 8241704, 8241705, 8241706, 8345701, 8345702, 8345703, 8345704, 8478101, 8478102, 8478103, 8478104, 8569601, 8569602, 8632901, 8632902, 8633001, 8633101, 8633201, 8791103, 8791104, 8971301, 8993501, 8994801, 8995001, 8995601, 8995701, 9004401, 9004402, 9243601, 9243602, 9243603, 9400701, 9400702, 9400703, 9400704, 9400705, 9400706, 9475901, 9714101, 9714102, 9714104, 9911701, 9911702, 9911703, 9911705, 9911706, 9967201, 9967202, 9967203, 10353602, 10362901, 10420901, 10421001, 10585002, 10585003, 10585004, 10585005, 10585006, 10673301, 10673302, 10673303, 11064601, 11064602, 11064603, 11089903, 11089904, 11369301, 11369302,
11369303, 11436901, 11436902, 11605301, 11604302, 11791901, 11791902, 11791903, 11920901, 11920902, 11920903, 12084501, 12084502, 12084503, 12084505, 12406801, 12406802, 12406803, 12406901, 12947501, 12947502, 12947503, 12947504, 13184201, 13184202, 13184203, 13184204, 13184301, 13412201, 13412202, 13412203, 13782102, 13782104, 13793501, 13973502, 13984701, 13984702, 13984703, 14108402, 14196701, 14196702, 14274601,
14368101, 14368102, 14368103, 15485101, 15485102, 15485103, 15485104, 15485105, 15668701, 15668702, 15953601, 15953602, 15953603, 15953604, 15953605, 15953606, 16059801, 16059802, 16059803, 16165601, 16203701, 16203702, 16499401, 16499402, 16499403, 16499404, 16937901, 16937902, 16937904, 17220101, 17220102, 17220103, 17220104, 17307801, 17307802, 17307804, 17658001, 17658002, 17658003, 17745201, 17745202, 17745203,
17969401, 17969402, 18320601, 18320602, 18448602, 18594101, 18594102, 18594601, 19246901, 19247001, 19247101, 19329001, 19329002, 19532501, 19532504, 19577101, 19577102,19826201, 19826203, 15953604R, 19329001R, 7805601R;
c) Lot codes: 7238602, 7238603, 7238604, 7353002, 7353003, 7600501, 7600502, 7692501, 7692503, 7692504, 7692505, 7292506, 7935101, 7935102, 7935103, 7999701, 7999702, 7999703, 7999801, 7999803, 8152201, 8152203, 8152204, 8152205, 8152206, 8152207, 8152208, 8241801, 8241802, 8242101, 8252102, 8242103, 8345503, 8345504, 8531601,8531901, 8532001, 8532301, 8532401, 8532501, 8532601, 8643301, 8643302, 8643303, 8643304, 8643305, 8850801, 8850802, 8850901, 8850902, 8850903, 9011101, 9044301, 9044302, 9044303, 9044304, 9090101, 9124401, 9400801, 9400802, 9400803, 9503202, 9574801, 9911802, 9911803, 9948101, 9948102, 10164601, 10164602, 10212501, 10317501, 10353702, 10353703, 10917801, 10917802, 10917803,
10917804, 10917806, 11064501, 11064503, 11092701, 11092702, 11092703, 11092704, 11092705, 11369401, 11369402, 11605501, 11607801, 12407001, 12407003, 12407005, 12407006, 12870602, 12870603, 12870604, 12947201, 12947202, 12947203, 13294601, 13294602,13294603, 13294604, 13294605, 13294606, 13412101, 13412102, 13412103, 13412104, 13782202, 13782203,
13782204, 13782205, 14377903, 14412801, 14412804, 14412805, 14682701, 14682702, 14738901, 15236201, 15550301, 15550302, 15550303, 16059701, 16059703, 16059704, 16059705, 16059706, 16165503, 16499502, 16750801, 16937801, 16937802, 16937803, 16937804, 16937805, 16937806, 17540401, , 17540402, 17657902, 17657903, 17745101, 17842801, 17842802, 17842803,18062101, 18062202, 18131401, 18131402, 18131403,
18448701, 18448702, 18594201, 18594202, 18594203, 18946901, 18946902, 19428801, 19673002, 19673003, 19673004, 19726201, 20304601, 20304602, 20304604, 20304607, 7023401R;
d) Lot codes: 7566701, 7819401, 7819402, 7819403, 7819405, 7869001,
7869002, 7869003, 7869004, 7869005, 7935701, 7935702, 7935704, 7999901, 7999902, 8152301, 8152302, 8152303, 8242501, 8850401, 8850402, 8850403, 8850404, 9503301, 9844801, 9844802, 9948201, 9948203, 10546201, 10546202, 10673501, 11090201, 11319301, 11319302, 11319303, 11369601, 11605702, 16033902, 16033903, 16165902, 16166001, 16840401, 16840402, 17289401, 17289402, 18448001, 18448002, 19131601, 10131602, 19490903, 19490904,
19834301;
e) Lot codes: 7567401, 7799201, 7868901, 7868902, 7868903, 7936001, 7936002, 8243001, 8243002, 9401001, 9948301, 9948302, 9948304, 14342101, 17596001, 17596002, 17810901, 17969201, 18062501, 18062502, 18062503, 8243003R, MPRTA.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ
Manufacturer: Stryker Ireland, Ltd., Orthopaedics, Carrigtohill, Ireland.
REASON Lack of assurance of Sterility (package integrity): Anomalies in seal width and strength that may affect the integrity of the sterile barrier.
VOLUME OF PRODUCT IN COMMERCE 1,657 units
DISTRIBUTION Nationwide

PRODUCT Minstrel Patient Lift with SR weighing scale; a non-AC-powered patient lift; model number HMB002-US,
CODE All serial numbers manufactured prior to June 2004. The production date can be determined by the serial number on the mast of the lift. Serial numbers start with MPLA or MPLAT, followed by the last two digits of the year and two digits for the month of production, i.e. MPLA0103 = March 2001.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arjo, Inc., Roselle, IL, .
Manufacturer: Arjo Med. AB, Gloucester, UK.
REASON The hanger bar assembly may detach from the lift during use due to fatigue failure of the bolt.
VOLUME OF PRODUCT IN COMMERCE 76 units
DISTRIBUTION Nationwide

PRODUCT BHM Kwiktrak Fixed Gate component of the Kwiktrak rail system used with the Maxi Sky 600 Ceiling Patient Lift. The fixed gate, part #700.11550, was sold in two kits: a) Part #700.11500 Kwiktrak Gate Kit composed of the fixed gate and a 3-contact interface kit part #700.15515, and b) Part #700-11505 Double Gate Kit composed of two fixed gates and 3-contact interface kits,
CODE All fixed gate components.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arjo, Inc., Roselle, IL
Manufacturer: B. H. M. Medical, Inc., Magog Quebec, Canada
REASON The Kwiktrak Gate stopper may fail and allow the ceiling lift to pass through to the end of the track and fail to the floor.
VOLUME OF PRODUCT IN COMMERCE 3 gate systems
DISTRIBUTION MI, OH, and IL

PRODUCT
a) Viasys V.I.P. Bird Gold pediatric ventilator, Catalog Number 15653,
b) Viasys V.I.P. Bird Sterling pediatric ventilator, Catalog Number 15654,
CODE
a) Serial numbers: AAM01001 to AMM01590 + KJI001178 and AAMO1648 to AEM01298;
b) Serial numbers: AAM01128 to ABMO1015 and AAM1119 to ACMO1142
RECALLING FIRM/MANUFACTURER Viasys Respiratory Care, Inc., Palm Springs, CA
REASON The correction is due to a repeat “failure to cycle” event.
VOLUME OF PRODUCT IN COMMERCE 2,017 units
DISTRIBUTION Nationwide and Internationally

PRODUCT BHM Reacher for Portable Ceiling Lifts; a portable ceiling lift accessory used to connect the lift to the BHM Track or KwikTrak Trolley. The reacher comes in two models: part #700.08310 - 24' handle length, and part #700.08320 - 36' handle length,
CODE Part #700.08310 - 24'' handle length, and part #700.08320 - 36'' handle length, all reachers shipped between November 2003 through November 6, 2006.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arjo, Inc., Roselle, IL,
Manufacturer: B. H. M. Medical, Inc., Magog Quebec, Canada.
REASON The carabineer may not be correctly attached to the reacher and the portable patient lift may drop.
VOLUME OF PRODUCT IN COMMERCE 886 reachers
DISTRIBUTION Nationwide

PRODUCT
a) Baxter Colleague Single Channel Volumetric Infusion Pumps; Made in Singapore; product codes 2M8151, 2M8151R, 2M8161, 2M8161R, ;
b) Baxter Colleague Triple Channel Volumetric Infusion Pumps; Made in Singapore; product codes 2M8153, 2M8153R, 2M8163, 2M8163R,
CODE All serial numbers used in or near linear accelerator suites
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL,
Manufacturer: Baxter Healthcare Corp., Singapore, Singapore.
REASON Baxter has identified the potential for a corruption of the memory chip in the pump to occur due to linear accelerator radiation exposure. If corruption occurs, it could result in an interruption of therapy with an audible and visual alarm notification to the user.
VOLUME OF PRODUCT IN COMMERCE 344,074 pumps
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) GammaMed 12i radionuclide applicator systems,
b) GammaMed 12it radionuclide applicator system,
CODE
a) H630701 H630703 H630704 H630705 H630706 H630708
H630710 H630711 H630712 H630713 H630714 H630715
H630716 H630718 H630719 H630720 H630721 H630722
H630723 H630724 H630725 H630727 H630728 H630729
H630730 H630732 H630733 H630735 H630736 H630737
H630739;
b) H630202
RECALLING FIRM/MANUFACTURER
Recalling Firm: Varian Medical Systems, Charlottesville, VA
Manufacturer: Varian Medical Systems Haan, Haan, Federal Republic of Germany.
REASON Medical device for patient treatment does not meet electrical safety standards.
VOLUME OF PRODUCT IN COMMERCE 44 devices
DISTRIBUTION Nationwide and Internationally

PRODUCT ARCHITECT LH Reagent, each kit contains bottles of Anti-Beta LH coated Microparticles and bottles of Anti-Alpha LH acridinium-labeled Conjugate; list numbers 6C25-22 (4 x 100 tests), 6C25-27(1 x 100 tests), and 6C25-30 (4 x 500 tests),
CODE Lot numbers 33198M200 and 41861M100, 33198M201, and 33871M100. All lots expire 6/16/2007.
RECALLING FIRM/MANUFACTURER Abbott Laboratories MPG, Abbott Park, IL,
REASON The lots of ARCHITECT LH Reagent List 6C25-22, have the potential to generate patient specimen results that are elevated. Correlation studies have demonstrated an upward shift in slope for patient results of approximately 13% on average when compared to other currently available reagent lots and an average bias from patient specimens of 13% to 17% has been observed.
VOLUME OF PRODUCT IN COMMERCE 2, 960 kits
DISTRIBUTION Nationwide and Internationally

PRODUCT International Technidyne Corporation (ITC) ProTime Microcoagulation System Instrument-Catalogue Number-Protimeint & Protimepro, Protimeintrf & Protimeprorf, Protimeintl & Protimeprol,
CODE
Serial Number's V50000 V50002 V50004 V50005 V50006 V50007 V50008 V50009 V50010 V50012 V50013 V50014 V50018 V50021 V50022 V50024 V50026 V50028 V50030 V50032 V50033 V50034 V50037 V50041 V50043 V50046 V50048 V50049 V50054 V50055 V50056 V50058 V50063 V50064 V50066 V50067 V50069 V50070 V50072 V50073 V50074 V50075 V50076 V50077 V50078 V50079 V50080 V50083 V50086 V50087 V50088 V50091 V50093 V50096 V50098 V50099 V50101 V50102 V50103 V50104 V50105 V50106 V50107 V50109 V50111 V50112 V50114 V50115 V50116 V50117 V50119 V50121 V50122 V50123 V50124 V50125 V50130 V50131 V50132 V50134 V50135 V50136 V50137 V50140 V50141 V50143 V50144 V50145 V50146 V50148 V50150 V50151 V50153 V50156 V50157 V50158 V50159 V50160 V50164 V50165 V50166 V50168 V50170 V50174 V50175 V50176 V50177 V50178 V50180 V50181 V50183 V50185 V50186 V50187 V50188 V50190 V50191 V50194 V50196 V50198 V50199 V50200 V50202 V50203 V50205 V50206 V50207 V50208 V50210 V50211 V50212 V50213 V50214 V50215 V50218 V50219 V50222 V50227 V50228 V50229 V50230 V50231 V50232 V50233 V50235 V50236 V50239 V50241 V50244 V50245 V50246 V50247 V50248 V50249 V50251 V50252 V50253 V50257 V50260 V50262 V50264 V50266 V50267 V50268 V50271 V50273 V50274 V50276 V50277 V50278 V50279 V50280 V50283 V50291 V50294 V50295 V50296 V50297 V50298 V50299 V50300 V50301 V50302 V50304 V50305 V50307 V50310 V50312 V50315 V50319 V50320 V50322 V50323 V50325 V50326 V50327 V50328 V50329 V50335 V50336 V50337 V50338 V50339 V50341 V50343 V50347 V50348 V50352 V50353 V50354 V50357 V50359 V50361 V50366 V50367 V50368 V50370 V50371 V50372 V50375 V50377 V50378 V50380 V50382 V50385 V50387 V50388 V50389 V50392 V50393 V50394 V50395 V50398 V50400 V50402 V50403 V50404 V50406 V50408 V50409 V50410 V50411 V50413 V50414 V50415 V50416 V50417 V50422 V50423 V50424 V50425 V50427 V50428 V50429 V50430 V50432 V50435 V50436 V50437 V50438 V50439 V50440 V50442 V50444 V50446 V50447 V50453 V50454 V50459 V50461 V50463 V50464 V50467 V50470 V50471 V50473 V50475 V50477 V50478 V50480 V50483 V50485 V50486 V50487 V50491 V50492 V50493 V50498 V50501 V50502 V50503 V50504 V50505 V50506 V50507 V50508 V50509 V50510 V50511 V50513 V50514 V50515 V50516 V50517 V50518 V50519 V50520 V50521 V50522 V50523 V50524 V50526 V50527 V50529 V50531 V50533 V50534 V50536 V50539 V50540 V50541 V50542 V50543 V50544 V50545 V50546 V50547 V50549 V50551 V50552 V50555 V50556 V50557 V50558 V50559 V50560 V50562 V50565 V50566 V50568 V50569 V50570 V50571 V50572 V50574 V50575 V50576 V50577 V50578 V50579 V50580 V50582 V50583 V50584 V50586 V50587 V50588 V50589 V50590 V50591 V50592 V50593 V50594 V50595 V50596 V50597 V50598 V50599 V50601 V50602 V50603 V50604 V50605 V50606 V50607 V50608 V50609 V50612 V50613 V50614 V50615 V50616 V50619 V50620 V50621 V50623 V50625 V50626 V50628 V50630 V50634 V50635 V50636 V50637 V50640 V50641 V50642 V50645 V50647 V50650 V50652 V50653 V50655 V50656 V50657 V50658 V50659 V50661 V50662 V50663 V50664 V50665 V50666 V50667 V50669 V50670 V50671 V50672 V50673 V50676 V50679 V50680 V50682 V50683 V50685 V50686 V50687 V50688 V50689 V50690 V50691 V50692 V50693 V50694 V50697 V50700 V50701 V50703 V50704 V50705 V50707 V50708 V50709 V50710 V50712 V50713 V50714 V50715 V50716 V50717 V50719 V50720 V50722 V50723 V50724 V50725 V50727 V50728 V50729 V50732 V50733 V50734 V50735 V50736 V50737 V50738 V50739 V50743 V50744 V50746 V50748 V50749 V50750 V50752 V50754 V50756 V50757 V50758 V50759 V50761 V50762 V50763 V50764 V50765 V50766 V50768 V50770 V50771 V50772 V50773 V50774 V50775 V50776 V50777 V50778 V50780 V50783 V50784 V50785 V50786 V50787 V50788 V50792 V50793 V50794 V50795 V50796 V50797 V50798 V50800 V50801 V50802 V50803 V50804 V50805 V50807 V50808 V50809 V50810 V50811 V50812 V50814 V50815 V50816 V50817 V50818 V50820 V50821 V50822 V50823 V50824 V50825 V50826 V50827 V50828 V50829 V50830 V50831 V50833 V50834 V50836 V50837 V50838 V50839 V50840 V50841 V50842 V50843 V50844 V50845 V50847 V50849 V50850 V50851 V50852 V50854 V50856 V50857 V50859 V50860 V50861 V50862 V50863 V50864 V50865 V50867 V50868 V50869 V50870 V50871 V50872 V50873 V50874 V50875 V50876 V50878 V50879 V50880 V50881 V50882 V50883 V50884 V50885 V50887 V50888 V50889 V50890 V50891 V50892 V50893 V50895 V50896 V50897 V50898 V50899 V50900 V50901 V50903 V50904 V50906 V50907 V50908 V50910 V50911 V50912 V50913 V50914 V50917 V50918 V50919 V50921 V50922 V50923 V50925 V50926 V50927 V50929 V50930 V50932 V50933 V50934 V50935 V50936 V50938 V50939 V50940 V50941 V50942 V50943 V50944 V50945 V50946 V50947 V50949 V50950 V50951 V50954 V50956 V50957 V50958 V50959 V50960 V50961 V50962 V50963 V50964 V50967 V50968 V50970 V50972 V50974 V50975 V50976 V50978 V50981 V50982 V50983 V50984 V50985 V50986 V50991 V50992 V50994 V50995 V50996 V50997 V50998 V50999 V51000 V51001 V51003 V51004 V51005 V51006 V51008 V51009 V51010 V51011 V51012 V51013 V51014 V51015 V51016 V51017 V51018 V51019 V51020 V51021 V51022 V51023 V51024 V51027 V51029 V51030 V51031 V51032 V51034 V51036 V51037 V51038 V51039 V51040 V51043 V51044 V51045 V51046 V51047 V51048 V51049 V51050 V51051 V51052 V51053 V51054 V51055 V51056 V51058 V51059 V51060 V51062 V51063 V51064 V51065 V51067 V51068 V51069 V51070 V51071 V51073 V51074 V51075 V51076 V51077 V51079 V51080 V51081 V51082 V51083 V51084 V51085 V51086 V51088 V51089 V51090 V51091 V51092 V51093 V51094 V51095 V51096 V51097 V51100 V51101 V51102 V51103 V51105 V51106 V51107 V51108 V51110 V51111 V51112 V51113 V51114 V51115 V51116 V51118 V51119 V51120 V51121 V51122 V51123 V51125 V51126 V51127 V51128 V51129 V51130 V51131 V51132 V51134 V51135 V51137 V51138 V51139 V51140 V51141 V51142 V51143 V51145 V51146 V51148 V51149 V51150 V51152 V51154 V51155 V51157 V51158 V51159 V51160 V51161 V51162 V51163 V51164 V51166 V51167 V51168 V51170 V51171 V51173 V51176 V51177 V51180 V51182 V51184 V51195 V51199 V51202 V51204 V51209 V51212 V51214 V51215 V51217 V51219 V51222 V51223 V51224 V51225 V51226 V51227 V51228 V51230 V51231 V51232 V51233 V51234 V51236 V51237 V51238 V51239 V51240 V51242 V51244 V51246 V51247 V51248 V51249 V51250 V51251 V51256 V51260 V51261 V51270 V51271 V51274 V51280 V51281 V51282 V51285 V51288 V51289 V51290 V51296 V51297 V51300 V51301 V51303 V51304 V51305 V51306 V51307 V51308 V51309 V51310 V51311 V51312 V51313 V51314 V51315 V51316 V51317 V51320 V51322 V51323 V51324 V51325 V51326 V51334 V51337 V51338 V51339 V51340 V51342 V51343 V51344 V51346 V51349 V51350 V51354 V51356 V51357 V51358 V51359 V51360 V51361 V51362 V51363 V51364 V51365 V51367 V51368 V51369 V51370 V51372 V51373 V51375 V51376 V51377 V51378 V51380 V51381 V51382 V51383 V51384 V51385 V51387 V51392 V51396 V51398 V51399 V51400 V51404 V51405 V51407 V51411 V51412 V51413 V51415 V51416 V51422 V51424 V51426 V51428 V51429 V51430 V51431 V51432 V51433 V51435 V51436 V51440 V51441 V51443 V51444 V51445 V51446 V51447 V51448 V51450 V51451 V51452 V51453 V51454 V51455 V51458 V51459 V51460 V51461 V51462 V51463 V51464 V51466 V51467 V51468 V51469 V51471 V51473 V51474 V51475 V51476 V51477 V51478 V51480 V51481 V51484 V51485 V51487 V51490 V51491 V51493 V51494 V51495 V51497 V51751 V51752 V51753 V51754 V51755 V51756 V51759 V51760 V51762 V51764 V51766 V51767 V51768 V51771 V51772 V51774 V51775 V51777 V51778 V51779 V51782 V51783 V51785 V51786 V51788 V51794 V51795 V51796 V51797 V51800 V51801 V51802 V51803 V51804 V51805 V51806 V51807 V51808 V51809 V51810 V51811 V51812 V51815 V51816 V51817 V51818 V51819 V51820 V51822 V51823 V51824 V51826 V51827 V51829 V51830 V51831 V51832 V51833 V51835 V51839 V51842 V51845 V51847 V51849 V51850 V51851 V51852 V51854 V51856 V51857 V51858 V51859 V51861 V51862 V51863 V51864 V51865 V51867 V51868 V51870 V51872 V51874 V51875 V51876 V51877 V51879 V51880 V51881 V51883 V51884 V51886 V51891 V51893 V51894 V51895 V51896 V51897 V51901 V51902 V51903 V51904 V51905 V51906 V51907 V51909 V51910 V51911 V51912 V51914 V51915 V51916 V51917 V51918 V51919 V51921 V51923 V51925 V51926 V51927 V51928 V51929 V51931 V51932 V51933 V51934 V51935 V51936 V51938 V51939 V51940 V51942 V51943 V51944 V51948 V51952 V51953 V51958 V51961 V51963 V51973 V51974 V51978 V51985 V51986 V51987 V51988 V51991 V51994 V51995 V51997 V51999 V52000 V52002 V52003 V52004 V52005 V52006 V52007 V52008 V52009 V52011 V52012 V52015 V52016 V52018 V52019 V52021 V52022 V52025 V52026 V52027 V52030 V52032 V52033 V52035 V52037 V52038 V52039 V52041 V52042 V52045 V52046 V52047 V52048 V52051 V52053 V52054 V52056 V52057 V52058 V52059 V52060 V52061 V52062 V52064 V52066 V52067 V52068 V52069 V52072 V52073 V52074 V52075 V52076 V52080 V52081 V52082 V52083 V52084 V52085 V52089 V52090 V52092 V52095 V52098 V52100 V52101 V52103 V52104 V52105 V52106 V52110 V52111 V52112 V52113 V52114 V52115 V52116 V52117 V52118 V52119 V52121 V52122 V52123 V52124 V52125 V52131 V52133 V52135 V52137 V52138 V52139 V52143 V52144 V52145 V52147 V52148 V52149 V52151 V52153 V52154 V52155 V52157 V52159 V52161 V52162 V52163 V52165 V52166 V52169 V52171 V52172 V52174 V52175 V52178 V52182 V52184 V52186 V52187 V52190 V52191 V52195 V52196 V52197 V52201 V52202 V52203 V52206 V52212 V52213 V52214 V52218 V52220 V52222 V52224 V52228 V52229 V52230 V52231 V52232 V52233 V52234 V52236 V52238 V52241 V52242 V52243 V52244 V52247 V52249 V52250 V52251 V52252 V52253 V52256 V52259 V52260 V52261 V52262 V52266 V52267 V52268 V52270 V52271 V52273 V52275 V52276 V52279 V52280 V52281 V52283 V52284 V52285 V52288 V52291 V52292 V52293 V52295 V52296 V52297 V52299 V52301 V52302 V52303 V52304 V52305 V52306 V52307 V52308 V52309 V52312 V52313 V52314 V52316 V52318 V52319 V52320 V52321 V52322 V52323 V52324 V52325 V52327 V52328 V52333 V52334 V52335 V52338 V52340 V52341 V52342 V52343 V52344 V52347 V52348 V52349 V52350 V52353 V52356 V52357 V52358 V52359 V52360 V52361 V52362 V52364 V52365 V52366 V52367 V52368 V52369 V52370 V52371 V52373 V52375 V52376 V52377 V52378 V52379 V52381 V52382 V52383 V52384 V52385 V52388 V52389 V52390 V52391 V52393 V52394 V52395 V52397 V52398 V52399 V52401 V52403 V52404 V52406 V52407 V52408 V52409 V52411 V52412 V52413 V52415 V52417 V52418 V52419 V52420 V52421 V52422 V52423 V52424 V52426 V52427 V52428 V52429 V52430 V52431 V52432 V52433 V52434 V52435 V52437 V52438 V52439 V52440 V52441 V52442 V52443 V52444 V52445 V52446 V52447 V52448 V52450 V52452 V52453 V52454 V52455 V52456 V52457 V52458 V52460 V52461 V52462 V52463 V52464 V52466 V52467 V52468 V52469 V52470 V52472 V52473 V52474 V52475 V52476 V52477 V52478 V52479 V52480 V52481 V52482 V52483 V52484 V52486 V52487 V52488 V52490 V52491 V52492 V52502 V52506 V52533 V52534 V52547 V52548 V52550 V52551 V52554 V52556 V52557 V52558 V52559 V52562 V52569 V52570 V52575 V52576 V52577 V52578 V52579 V52587 V52588 V52590 V52591 V52592 V52594 V52597 V52603 V52604 V52607 V52619 V52620 V52621 V52632 V52635 V52637 V52640 V52646 V52791 V52795 V52797 V52798 V52799 V52800 V52802 V52806 V52807 V52808 V52814 V52818 V52823 V52824 V52825 V52826 V52827 V52832 V52833 V52836 V52837 V52838
RECALLING FIRM/MANUFACTURER International Technidyne Corp., Edison, NJ,
REASON Incorrect Test Results-ProTime ITC's Microcoagulation System: Professional Instrument may report incorrect test results when more than 50 tests are in the memory and the technician uses the AUTO Send or PRINT RESULTS feature.
VOLUME OF PRODUCT IN COMMERCE 1,538 units
DISTRIBUTION Nationwide

WEEK ENDING JANUARY 27

PRODUCT
a) RYM-5000 InVision-Plus® Neutral Displacement I.V. Connector, packaged
200 units per box, 5 boxes per case (1000 units/case); labeled as
Sterile-Nonpyrogenic; assembled in Mexico,
b) RYM-5000 InVision-Plus® NEUTRAL™ I.V. Connector, packaged 200 units
per box, 5 boxes per case (1000 units/case); labeled as Sterile-Nonpyrogenic;
assembled in Mexico,
c) RYM-5001 InVision-Plus® Neutral Displacement I.V. Connector,
packaged 100 units per box, 5 boxes per case (500 units/case); labeled as
Sterile-Nonpyrogenic; assembled in Mexico,
CODE
a) Lots #400, 401, and 402;
b) Lot #405;
c) Lots #500, 502, 503, 504 and 505
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rymed Technologies, Inc., Austin TX
Manufacturer: Accelent Juarez, Juarez, Mexico.
REASON Weld failures on IV connector (area of female luer and spike body)
VOLUME OF PRODUCT IN COMMERCE 79,328 units
DISTRIBUTION Nationwide

PRODUCT Welch Allyn PIC 50 Portable Intensive Care System, Multi-Parameter Monitor/Defibrillator; a portable 12V internal battery powered defibrillator; Part Numbers-971081, 971082, 971083, 971084,
CODE Serial numbers 80052, 80141, 80190, 80191, 80425, 80426, 80430, 80431, 80432, 80435, 80436, 80587, 80826, 80915, 80916, 80918, 80920, 80921, 80923, 80924, 80925, 80926, 80927, 80928, 80929, 80930, 80932, 80934, 80960, 80962, 80963, 80967, 80969, 80971, 80972, 80973, 80974, 80975, 80976, 80981, 80983, 80987, 80989, 80990, 80991, 80992, 80993, 81003, 81004, 81005, 81006, 81007, 81008, 81009, 81010, 81011, 81012, 81013, 81014, 81015, 81016, 81017, 81018, 81019, 81020, 81022, 81023, 81024, 81025, 81026, 81027, 81028, 81029, 81030, 81031, 81032, 81033, 81034, 81035, 81036, 81037, 81038, 81044, 81045, 81046, 81047, 81049, 81070, 81094, 81102, 81103, 81104, 81105, 81109, 81110, 81111, 81112, 81113, 81165, 81167, 81178, 81179, 81181, 81184, 81187, 81188, 81192, 81194, 81197, 81258, 81297, 81499, 81627, 81765, 81767, 81769, 81770, 81773, 81803, 81804, 81823, 81827, 81828, 81829, 81832, 81833, 81834, 81835, 81837, 81838, 81839, 81840, 81841, 81842, 81843, 81844, 81845, 81846, 81853, 81855, 81857, 81858, 81860, 81861, 81862, 81863, 81864, 81865, 81866, 81867, 81868, 81869, 81884, 81885, 81886, 81920, 81921, 81922, 81923, 81924, 81925, 81926, 81927, 81928, 81929, 81930, 81931, 81932, 81933, 81934, 81935, 81936, 81937, 81938, 81939, 81940, 81941, 81942, 81943, 81944, 81945, 81946, 81949, 81957, 81983, 81984, 81985, 81986, 81987, 81988, 81989, 81990, 81996, 81997, 81998, 81999, 82000, 82001, 82003, 82004, 82005, 82016, 82017, 82019, 82021, 82022, 82023, 82024, 82025, 82027, 82028, 82034, 82035, 82036, 82037, 82038, 82039, 82043, 82061, 82062, 82063, 82064, 82065, 82066, 82067, 82068, 82069, 82070, 82071, 82072, 82073, 82074, 82075, 82076, 82077, 82078, 82079, 82080, 82098, 82099, 82100, 82101, 82102, 82103, 82104, 82105, 82106, 82107, 82108, 82109, 82111, 82122, 82123, 82124, 82126, 82127, 82128, 82160, 82161, 82162, 82163, 82164, 82165, 82169, 82172, 82173, 82174, 82175, 82176, 82177, 82178, 82179, 82180, 82181, 82182, 82183, 82184, 82185, 82186, 82192, 82193, 82194, 82195, 82196, 82198, 82199, 82200, 82201, 82202, 82204, 82252, 82253, 82254, 82255, 82256, 82257, 82258, 82259, 82260, 82261, 82262, 82263, 82264, 82265, 82266, 82267, 82268, 82270, 82271, 82272, 82273, 82284, 82285, 82286, 82317, 82318, 82319, 82321, 82322, 82323, 82324, 82325, 82326, 82327, 82328, 82329, 82330, 82342, 82343, 82344, 82346, 82347, 82348, 82349, 82408, 82409, 82411, 82412, 82413, 82414, 82415, 82416, 82417, 82418, 82419, 82421, 82424, 82426, 82430, 82461, 82462, 82463, 82464, 82465, 82466, 82467, 82468, 82469, 82470, 82471, 82472, 82473, 82474, 82475, 82517, 82518, 82519, 82520, 82521, 82522, 82528, 82529, 82530, 82531, 82532, 82533, 82536, 82537, 82538, 82550, 82552, 82553, 82555, 82556, 82557, 82559, 82560, 82561, 82562, 82563, 82564, 82565, 82569, 82570, 82612, 82613, 82614, 82615, 82616, 82617, 82618, 82619, 82621, 82623, 82624, 82625, 82626, 82627, 82628, 82629, 82630, 82631, 82655, 82656, 82657, 82658, 82659, 82660, 82661, 82662, 82663, 82664, 82665, 82666, 82667, 82668, 82669, 82670, 82671, 82672, 82689, 82690, 82773, 82774, 82775, 82776, 82777, 82778, 82779, 82780, 82781, 82782, 82783, 82784, 82785, 82786, 82787, 82788, 82789, 82790, 82791, 82792, 82793, 82794, 82795, 82796, 82797, 82798, 82799, 82800, 82801, 82802, 82803, 82804, 82805, 82806, 82807, 82808, 82809, 82810, 82811, 82812, 82813, 82827, 82828, 82829, 82830, 82852, 82857, 82858, 82859, 82962, 82965, 82966, 82967, 82975, 82986, 82989, 82991, 82998, 83010, 83011, 83012, 83013, 83060, 83061, 83062, 83063, 83064, 83065, 83066, 83067, 83084, 83088, 83089, 83090, 83142, 83144, 83145, 83147
RECALLING FIRM/MANUFACTURER MRL, Inc., A Welch Allyn Co., Buffalo Grove, IL
REASON Shock Delay:The monitor-debrillator may display an 'ECG Comm' error message on the display during use,which may prevent or cause an unacceptable delay the delivery of a defibrillation shock. This delay could result in failure to resuscitate the patient.
VOLUME OF PRODUCT IN COMMERCE 510 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) ADVIA 1200 Chemistry System, Automated Clinical Chemistry Analyzer –
human serum, plasma and urine tests. The following are the measured
parameters that are within the scope of this 'field correction': Affected assay:
Valproic Acid. Affecting assays: Digoxin; Phenytoin; Gentamicin; Theophylline,
b) ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer –
human serum, plasma and urine tests. The following are the measured
parameters that are within the scope of this 'field correction': Affected assay:
Valproic Acid. Affecting assays: Digoxin; Phenytoin; Gentamicin; Theophylline,
c) ADVIA 2400 Chemistry System, Automated Clinical Chemistry Analyzer –
human serum, plasma and urine tests. The following are the measured
parameters that are within the scope of this 'field correction': Affected assay:
Valproic Acid. Affecting assays: Digoxin; Phenytoin; Gentamicin; Theophylline,
CODE
a) All ADVIA 1200 Chemistry Systems are involved as well as all existing assay lots for Valproic Acid (VPA), Phenytoin (PHNY), Gentamicin (GENT), Digoxin (DIG), and Theophylline (THEO). ADVIA 1200 Part # 094-A001, VPA Part # B01-4784-01, PHNY Part # B01-4775-01, DIG Part # B01-4769-01, GENT Part # B01-4787-01, THEO Part # B01-4772-01;
b) All ADVIA 1650 Chemistry Systems are involved as well as all existing assay lots for Valproic Acid (VPA), Phenytoin (PHNY), Gentamicin (GENT), Digoxin (DIG), and Theophylline (THEO). ADVIA 1650 Part # 073-A001, VPA Part # B01-4784-01, PHNY Part # B01-4775-01, DIG Part # B01-4769-01, GENT Part # B01-4787-01, THEO Part # B01-4772-01;
c) All ADVIA 2400 Chemistry Systems are involved as well as all existing assay lots for Valproic Acid (VPA), Phenytoin (PHNY), Gentamicin (GENT), Digoxin (DIG), and Theophylline (THEO). ADVIA 2400 Part # 073-A010, VPA Part # B01-4784-01, PHNY Part # B01-4775-01, DIG Part # B01-4769-01, GENT Part # B01-4787-01, THEO Part # B01-4772-01
RECALLING FIRM/MANUFACTURER Bayer Healthcare, LLC (Diagnostics Division), Tarrytown, NY
REASON Bayer received a customer complaint where the Valproic Acid Quality control material recovered lower than target when it was run in a panel of other Therapeutic Drug (TDM) assays. The under recovery observed by the customer was approximately -25%.
VOLUME OF PRODUCT IN COMMERCE 1,184 instruments
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) TraXis Fixed Trial in sizes: 7mm, 9mm, 11mm, 13mm and 15mm;
part of TraXis vertebral body replacement system,
Part #2665-1-07 (7mm), 2665-1-09 (9mm), 2665-1-11 (11mm),
2665-1-13 (13mm), 2665-1-15 (15mm),
b) TraXis Fixed Rasp in sizes: 7mm, 9mm, 11mm, 13mm and 15mm;
for use with TraXis vertebral body replacement system
Part #2664-1-07 (7mm), 2664-1-09 (9mm), 2664-1-11 (11mm),
2664-1-13 (13mm), 2664-1-15 (15mm),
CODE
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RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Spine, Austin, TX,
Manufacturer: Phillips Precision, Inc., Elmwood Park, NJ.
REASON Tip of devices may dislodge while in use during surgery.
VOLUME OF PRODUCT IN COMMERCE 142 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Roche IGGT COBAS INTEGRA Immunoglobulin G (Turbidimetric); Catalog no. 20766631322. in vitro diagnostic,
CODE
Lots: 66160001; exp. 12/31/06; 66395101, exp. 2/28/07; 67306401, exp. 1/31/08; 66954901, exp. 5/31/07; 67589901, exp. 4/30/08 and 68049501, exp. 10/31/08.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN,
Manufacturer: Roche Diagnostics Gmbh, Mannheim, Germany.
REASON Falsely elevated IGGT results may be reported because the R2 reagent of the Tina-quant Gen.2 albumin assay has a carryover effect on the Immunoglobulin G (turbidimetric) assay when used on the COBAS INTEGRA 700 and 800 analyzers.
VOLUME OF PRODUCT IN COMMERCE 18,905 units
DISTRIBUTION Nationwide

PRODUCT Fibrin Analysis Catheter Testing System includes the component BD Vacutainer Luer-Lok Access Device; Catalogue #364902 as a finished sterile device, Non Pyrogenic in unopened undamaged package, Disposable/ Single use/ Do Not Reuse; for use with multi lumen; (4 Venous Catheter sizes) 20 cm. 12 fr. Central; 16 cm. 7-7.5-8 fr. Central; 20 cm 7.7.5-8 fr Central; 16cm 12 fr. Central, CODE 6071115, 607054, 607123, 607055, 607124, 607116, 607053
RECALLING FIRM/MANUFACTURER Continental Medical Labs,Inc., Waterford, WI,
REASON Fibrin Analysis Catheter Testing System contains the ''Luer Lok Access Device'' that fails to lock securely to certain catheter devices because the male luer taper surface is not within the specification of the taper.
VOLUME OF PRODUCT IN COMMERCE 840 kits
DISTRIBUTION WI

PRODUCT I-Flow ON-Q PainBuster (100 ml, 2 mI/hr) Pump, PM012,
CODE Lot numbers: 662449 & 662742
RECALLING FIRM/MANUFACTURER I-Flow Corp., Lake Forest, CA,
REASON The pump flow rate labeling may not match the package labeling. The label on filter may not match the label on the top of the pump or the package labeling.
VOLUME OF PRODUCT IN COMMERCE 3,475 units
DISTRIBUTION Nationwide

PRODUCT HiZel, Trayless-sterile hydrogel wound dressing. Sizes 2.4 x 2.4', 2.4 x 4.7', & 4.7 x 4.7'. Product is a transparent, flexible sheet. Packaged in a peelable pouch,
CODE All product from shipment dated March 28, 2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Embeem, Inc., N. Brunswick, NJ,
Manufacturer: ABS Medicare Pvt. Ltd, Gujarat, India.
REASON Foreign material- this device, a sterile wound care product, was found to be contaminated with clumps of brown/black foreign material
VOLUME OF PRODUCT IN COMMERCE 1,258 pieces
DISTRIBUTION Nationwide

PRODUCT DRLock Volar Plate Screw System, Model #DVR-900. The product is a kit contained in an aluminum tray case that contains the following: IMPLANTS: 6 stainless steel plates (2-lefts, 2-rights, and 1-right long and 1-right left), 48 distal locking-screws (ranging from 10-24mm), 32 distal locking pegs, 36 proximal locking screws, 24 proximal non-locking screws. INSTRUMENTS: 2 Bending Pliers*, 1 Bone Reduction Forcep*, 2 Hohmann Retractors *, 1 Ratchet Handle*, 1 Periosteal Elevator*, 1 Dingman Elevator *, 1 K & K Elevator *, four Driver tips *, five drill guides*, 2-1.6 Drill Bits *, 2-2.3 Drill Bits *, 1 Plate Holder Verbruge *, 2 Depth Gages *, 6 K wires,
CODE Tray kit (case) set number: 'BAA', 'BAB', 'BAC', 'BAD', 'BAE', 'BAF', 'BAH', and 'BAJ'. (The distal locking-screws contained in the kit are identified with lot numbers S104 and S200)
RECALLING FIRM/MANUFACTURER
Recalling Firm: OrthoHelix Surgical Designs, Inc., Akron, OH
Manufacturer: Specialized Medical Devices, Lancaster, PA.
REASON The 48 distal locking-screws (ranging from 10-24mm) contained in the kit are not within established specifications, specifically the minor diameter of the screws are undersized.
VOLUME OF PRODUCT IN COMMERCE 180 units
DISTRIBUTION SC, TX, CO, and OH