MARCH 2007

WEEK ENDING MARCH 3

PRODUCT
a) Sara Active Sling, patient lift - Narrow; item KKX053850.0 - models KA1230 (with safety) and KA1240,
b) Sara Active Sling, patient lift - Wide; item KKX00120.0 - models KA1231 (with safety) and KA1241,
c) Sara Active Sling, patient lift - Standard; item KK53210.0 - model KA1210 (with safety),
CODE
a) Item KKX053850.0 - models KA1230 (with safety) and KA1240, with production dates of September 2006 through December 2006. The tag on the sling will state the item number and have the year '06' hole-punched in the top line 'Y', and either the month '09', '10', '11' or '12' hole-punched in the third line 'M';
b) Item KKX00120.0 - models KA1231 (with safety) and KA1241, with production dates of September 2006 through December 2006. The tag on the sling will state the item number and have the year '06' hole-punched in the top line 'Y', and either the month '09', '10', '11' or '12' hole-punched in the third line 'M';
c) Item KK53210.0 - model KA1210 (with safety), with production dates of September 2006 through December 2006. The tag on the sling will state the item number and have the year '06' hole-punched in the top line 'Y', and either the month '09', '10', '11' or '12' hole-punched in the third line 'M'
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arjo, Inc., Roselle, IL, 
Manufacturer: Medibo N.V., Achel, Belgium. 
REASON There is the potential for the slings to come apart, potentially allowing injury to the patient.
VOLUME OF PRODUCT IN COMMERCE 95 slings
DISTRIBUTION Nationwide

PRODUCT O²Optix™ (lotrafilcon B) Soft Contact Lenses, Rx only, Ciba Vision. The product is distributed in 3 packs (3 lenses per package) and 6 packs (6 lenses per package), 
CODE All Lots starting with 6644001 through 6721262, with expiration dating of 2011/09 through 2011/11, and Lot numbers: 6626127, 6636101, 637017, 6637019, 6637103, 6640120, 6640124, 6642109, 6642119, 6642132 and 6643080, all with expiration dating of 2011/08
RECALLING FIRM/MANUFACTURER Ciba Vision Corporation, Duluth, GA, 
REASON Reduced lon Permeability
VOLUME OF PRODUCT IN COMMERCE 11.4 million lenses
DISTRIBUTION Nationwide and Internationally

PRODUCT Taut Intraducer Peritoneal Catheter, 12 Fr x 10 Fr x 20.3 cm; a sterile, Rx peritoneal catheter for single use, individually packaged in a Tyvek/clear pouch; the individually packaged, sterilized catheter was sold in two configurations: a) catalog number (REF) P.I.-128: 10 catheters per box, 10 boxes per case, and b) a sterile component of the convenience kit, catalog number (REF) 50000, System One Comprehensive Lap CBDE Kit,
CODE Lot number 04116, use by 2008-01, and lot number 05178, use by 2008-09 These two lots of catheters were sold individually and as sterile components of catalog number (REF) 50000, kit lot numbers KC05107, KC05186, KC06002, KC06025, KC06071, KC06060, KC06087, KC06116
RECALLING FIRM/MANUFACTURER Taut, Inc., Geneva, IL
REASON Taut, Inc. has become aware that some package seals are not intact, compromising the sterility of the catheters.
VOLUME OF PRODUCT IN COMMERCE 5,769 catheters
DISTRIBUTION Nationwide and Internationally

PRODUCT IMx Sirolimus Reagent Pack, in vitro diagnostic; list 5C91-21; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody Coated Microparticles, 1 bottle (9.7 mL) Sirolimus Alkaline Phosphatase Conjugate, and 1 bottle (10 mL) 4-Methylumbelliferyl Phosphate, 1.2 mM,
CODE Lots 053389, 053457, 063650, 063973, 064459, 064772, 064750, 065076
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories MPG, Abbott Park, IL, 
Manufacturer: Axis-Shield Diagnostics, Ltd., The Technology Park, Dundee, Scotland, UK. 
REASON The sirolimus values may shift higher after storage at 2-8°C or after one freeze/thaw cycle of specimens.
VOLUME OF PRODUCT IN COMMERCE 1,143 kits – U.S., 1,657 kits - Internationally
DISTRIBUTION Nationwide and Internationally

PRODUCT Quantum TTC Biliary Balloon Dilation Catheter, Order number QBD-10X3, 
CODE Lot number W2287708
RECALLING FIRM/MANUFACTURER Cook Endoscopy, Winston Salem, NC, 
REASON The graphic label is incorrect, it lists 6mm/ 18FR. The product label is correct, it lists 10mm/ 30FR.
VOLUME OF PRODUCT IN COMMERCE 12 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Skytron Infinity series (also called Astro series) minor surgery light, 3 bulbs in 1 - 19" diameter lighthead; Models IN19, IN19EL, IN19LH and IN19S,
b) Skytron Infinity Series (also called Astro series) minor surgery light with dual lightheads, 3 bulbs in each of 2 - 19" diameter lightheads, Made in Japan; Models IN1919 and IN1919EL and IN1919EL/PT, 
c) Skytron Infinity Series surgical light, 4 bulbs in 1 - 22" diameter lighthead, Made in Japan; Models IF54, IF54EL, IF54LH and IF54S,
d) Skytron Infinity Series surgical light with dual lightheads, 4 bulbs in each of 2 - 22" diameter lightheads, Made in Japan; Models IF5454 and IF5454EL, 
e) Skytron Infinity Series surgical light with triple lightheads, 4 bulbs in each of 3 - 22" diameter lightheads, Made in Japan; Models IF545454 and IF545454EL, 

f) Skytron Infinity Series surgical light, 5 bulbs in 1 - 22" diameter lighthead, Made in Japan; Models IF22, IF22B, IF22LH, IF22LHH-B, IF22M-S, IN22, IN22EL, IN22LH and IF22(EL),
g) Skytron Infinity Series surgical light with dual lightheads, 5 bulbs in each of 2 - 22" diameter lightheads, Made in Japan; Models IF2222, IF2222-B, IF2222B/PT, IF2222EL and IN2222EL,
h) Skytron Infinity Series surgical light with dual lightheads, 5 bulbs in 1 - 22" lighthead and 8 bulbs in 1 - 30" diameter lighthead. Made in Japan; Model IF3022B. (note only the 22' lighthead is affected.), 
i) Skytron Infinity Series surgical light with triple lightheads, 5 bulbs in each of 3 - 22" diameter lightheads, Made in Japan; Models IF222222-B, IF222222EL and IN222222EL,
j) Skytron Infinity Series surgical light with dual lightheads, 8 bulbs in 1 - 30" diameter lighthead and 5 bulbs in 1 - 22" diameter lighthead, Made in Japan; Models IN3022EL and IF3022EL. (note only the 22' lighthead is affected), 

k) Skytron Infinity Series surgical light with triple lightheads, 8 bulbs in 1 - 30" diameter lighthead and 5 bulbs in each of 2 - 22" diameter lightheads, Model IN302222EL, IF302222-B, IN30AR2222EL and IN30TV2222EL. (note only the 22' lightheads are affected),
CODE
a) Each lighthead bears a unique serial number. For units with model numbers beginning with IN 19, all seven digit serial numbers with the following numbers in the third and fourth positions of the numerical series: 95, 96, 97, 98 or 99 (example: xx95xxx) plus all eight serial numbers with a 0 in the fifth position (example: xxxx0xxx);
b) Code Information: Each lighthead bears a unique serial number. For units with model numbers beginning with IN 19, all seven digit serial numbers with the following numbers in the third and fourth positions of the numerical series: 95, 96, 97, 98 or 99 (example: xx95xxx) plus all eight serial numbers with a 0 in the fifth position (example: xxxx0xxx);
c) Each lighthead bears a unique serial number. For units with model numbers beginning in IF54, all serial numbers with the following numbers in the third and fourth positions of the numerical series: 95, 96, 97, 98, 99, 00 or 01 (example: xx98xxx);
d) Each lighthead bears a unique serial number. For units with model numbers beginning in IF54, all serial numbers with the following numbers in the third and fourth positions of the numerical series: 95, 96, 97, 98, 99, 00 or 01 (example: xx98xxx);
e) Code Information: Each lighthead bears a unique serial number. For units with model numbers beginning in IF54, all serial numbers with the following numbers in the third and fourth positions of the numerical series: 95, 96, 97, 98, 99, 00 or 01 (example: xx98xxx);
f) Each lighthead bears a unique serial number. For units with model numbers beginning with IF22, all serial numbers with the following numbers in the third and fourth position of the numerical series: 95, 96, 97, 98, 99 or 00 (examples: xx97xxxx or xx00xxxB). For units with model numbers beginning with IN22 , all serial numbers with the following numbers in the third and fourth positions of the numerical series: 92, 93 or 94 (example: xx93xxxx);
g) Each lighthead bears a unique serial number. For units with model numbers beginning with IF22, all serial numbers with the following numbers in the third and fourth position of the numerical series: 95, 96, 97, 98, 99 or 00 (examples: xx97xxxx or xx00xxxB). For units with model numbers beginning with IN22 , all serial numbers with the following numbers in the third and fourth positions of the numerical series: 92, 93 or 94 (example: xx93xxxx);
h) Each lighthead bears a unique serial number. For units with model numbers containing IF and 22, all serial numbers with the following numbers in the third and fourth position of the numerical series: 95, 96, 97, 98, 99 or 00 (examples: xx97xxxx or xx00xxxB);
i) Code Information: Each lighthead bears a unique serial number. For units with model numbers beginning with IF22, all serial numbers with the following numbers in the third and fourth position of the numerical series: 95, 96, 97, 98, 99 or 00
(examples: xx97xxxx or xx00xxxB). For units with model numbers beginning with IN22, all serial numbers with the following numbers in the third and fourth positions of the numerical series: 92, 93 or 94 (example: xx93xxxx);
j) Each lighthead bears a unique serial number. For units with model numbers containing IF and 22, all serial numbers with the following numbers in the third and fourth position of the numerical series: 95, 96, 97, 98, 99 or 00 (examples: xx97xxxx or xx00xxxB). For units with model numbers containing IN and 22 , all serial numbers with the following numbers in the third and fourth positions of the numerical series: 92, 93 or 94 (example: xx93xxxx);
k) Each lighthead bears a unique serial number. For units with model numbers containing IF and 22, all serial numbers with the following numbers in the third and fourth position of the numerical series: 95, 96, 97, 98, 99 or 00 (examples: xx97xxxx or xx00xxxB). For units with model numbers containing IN and 22 , all serial numbers with the following numbers in the third and fourth positions of the numerical series: 92, 93 or 94 (example: xx93xxxx)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Skytron, Div. The KMW Group, Inc, Grand Rapids, MI,  
Manufacturer: Dai-Ichi Shomei Co., Ltd. Tokyo, Japan. 
REASON If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
VOLUME OF PRODUCT IN COMMERCE Approximately 5,000 units
DISTRIBUTION Nationwide and Canada

PRODUCT
a) Symbia S Series SPECT (Single-Photon Emission Computed Tomography)
System with a Pinhole Collimator; part number 08717741,
b) Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography
and Computed Tomography) System with a Pinhole Collimator, 
CODE
a) All systems with pinhole collimators and e.soft software versions 5.5 or earlier:
Serial numbers 01006, 01008, 01009, 01019, 01021, 01022, 01024, 01032,
01033, 01034, 01038, 01044, 01045, 01049, 01051, 01052;
b) All systems with pinhole collimators and e.soft software versions 5.5 or earlier:
Serial numbers 01015, 01032, 01037, 01045, 01061, 01065, 01068, 01072, 01074, 01076, 01077
RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Hoffman Estates, IL,
REASON Symbia systems, running on e.soft version 5.5 or earlier, could allow a fully-extended patient pallet to come into contact with the pinhole collimator, resulting in system damage.
VOLUME OF PRODUCT IN COMMERCE 27 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Cmax Surgical Table, Model No. 2182625, 
CODE Serial Numbers: C429106030 through C436306020
RECALLING FIRM/MANUFACTURER Steris Corporation, Montgomery, AL, 
REASON A variation in suppliers welding processes, at the inner section of the hydraulic lift column, of the surgical table, may result in the table top becoming unstable, which could result in injury to patients or staff.
VOLUME OF PRODUCT IN COMMERCE 46 units
DISTRIBUTION Nationwide and Canada

PRODUCT NicoletOne version 5.20 software (also known as NicoletOne Version 5.2 Software) used with the NicoletOne LTM, Sleep, nEEG, vEEG and ICU monitoring Systems, 
CODE NicoletOne Version 5.20 software released and installed after August 07, 2006.
RECALLING FIRM/MANUFACTURER Nicolet Biomedical, Div of Viasys Healthcare, Madison, WI,
REASON A software anomaly exists in the 5.20.1038 NicoletOne LTM, Sleep, nEEG, vEEG and ICU Monitor systems using the M, and/or C series amplifiers. If this anomaly occurs, the system will display the data for channel one in all channels on NicoletOne LTM, Sleep, nEEG, vEEG or ICU Monitor systems.
VOLUME OF PRODUCT IN COMMERCE 75 systems
DISTRIBUTION Nationwide and Internationally

PRODUCT OsSatura TCP (pure tricalcium phosphate) 3mm granules packaged in glass jars, Part Numbers: 05-6010-050 5cc, 05-6010-100 10cc, 05-6010-150 15cc & 05-6010-300 30cc, 
CODE Batch numbers shipped to US: 82/0415, 82/04474, 82/05062, 82A/05454, 82/04172, 82/04264, 82/04274, 82/04472, 82/04511, 82/05052, 82A/0526, 82A/05404, 82A/0619, 82/04182, 82/04204, 82/04252, 82A/05452, 82A/06014, 82A/0620, 82/04194, 82/04242, 82/04492 & 82A/06024
RECALLING FIRM/MANUFACTURER Teknimed SA, L, France.
REASON The firm has determined an incorrect Instructions for Use (IFU) was packaged within the product box.
VOLUME OF PRODUCT IN COMMERCE 3,366 units
DISTRIBUTION Nationwide

PRODUCT
a) Anaerotest for microbiology, in vitro diagnostic. Specification: Performance Test Anerobic: white within 4-6 hours; aerobic: blue with 20 minutes Item # 1.19034.0002 17.08.06 1 unit UPC 4 022536 667928, 
b) Anaerotest, in vitro diagnostic; Microbiology, 50 test strips Item # 1.15112.001. Store dry and tightly closed. Store at + 15 C to +25C, 
CODE a) and b) Lot # OC553145
RECALLING FIRM/MANUFACTURER
Recalling Firm: EMD Chemicals Inc, Gibbstown, NJ, 
Manufacturer: Merck KGaA, Darmstadt, Germany. 
REASON Lot # OC553145 of Anaerotest failed to remain in specification. QC indicator shows an anaerobic environment even if oxygen is present.
VOLUME OF PRODUCT IN COMMERCE 8 rolls item #1.19034.002; 800 packages of 50 strips of item #1.15112.001
DISTRIBUTION Nationwide including PR

WEEK ENDING MARCH 10

PRODUCT One Touch Basic/Profile and One Touch Ultra-Blood Glucose Test strips- 50-count, 
CODE One Touch Ultra Test Strips: Lot #’s: 2691191, 2691261. One Touch Ultra Basic/Profile Test Strips- Lot #''s 272894A, 2619932, 2606340, 2651211
RECALLING FIRM/MANUFACTURER Safety & Supplies Co, Inc, East Brunswick, NJ,
REASON Counterfeit product (manufacturer unknown)
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Nationwide

PRODUCT Stryker Tom Tessier Osseous Microtome: Plug for Bone Mill Systems (Parts 01-15400 and 01-15401); Part 01-15407,
CODE Lots: G4C00F72HN, G5H00F72HN, G7T00F72HN, G8W00F72HN and G9700F72HN
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Leibinger USA, Portage MI, 
Manufacturer: Stryker Leibinger Gmbh, Freiburg, Germany. 
REASON Metal shavings come off of the plug as a result of friction between the plug and the cutting cylinder, and may be mixed with the milled bone chips.
VOLUME OF PRODUCT IN COMMERCE 26 units
DISTRIBUTION Nationwide

PRODUCT Polyethylene tibial posterior stabilized components. Optetrak All Poly Tibial PS Component, Knee prosthesis. Catalog number: 204-11-13, CODE Serial numbers: 0900529-0900532
RECALLING FIRM/MANUFACTURER Exactech, Inc., Gainesville, FL, REASON The outside profile on this manufactured lot of devices is oversized and does not meet specifications.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION NY

PRODUCT Ultraview SL Command Module with Masimo Sp02 Option, a multiparameter patient monitor
CODE Serial numbers: 1496-004112, 1496-005720, 1496-004094, 1496-004088, 1496-004089, 1496-004090, 1496-004091, 1496-004092, 1496-004093, 1496-004110, 1496-011601, 1496-004111, 1496-010974, 1496-010975, 1496-010977, 1496-011021, 1496-004174, 1496-004175, 1496-004177, 1496-004178, 1496-004179, 1496-004180, 1496-004165, 1496-004166, 1496-009201, 1496-006236, 1496-006432, 1496-006434, 1496-008163, 1496-008164, 1496-005413, 1496-011026, 1496-006435, 1496-006436, 1496-006829, 1496-006830, 1496-006831, 1496-006832, 1496-006895, 1496-006912, 1496-006913, 1496-006914, 1496-009137, 1496-009138, 1496-004108, 1496-004109, 1496-005761, 1496-008497, 1496-008498, 1496-008499, 1496-008500, 1496-008501, 1496-010056, 1496-010057, 1496-005369, 1496-005388, 1496-005412, 1496-010607, 1496-010053, 1496-005254, 1496-005255, 1496-005256, 1496-005257, 1496-005258, 1496-005326, 1496-005327, 1496-005328, 1496-005329, 1496-004075, 1496-004076, 1496-004077, 1496-004078, 1496-004079, 1496-004080, 1496-004081, 1496-004082, 1496-004083, 1496-004084, 1496-004085, 1496-004095, 1496-004096, 1496-004097, 1496-004098, 1496-004099, 1496-004100, 1496-004101, 1496-004102, 1496-004103, 1496-004104, 1496-005340, 1496-005361, 1496-005363, 1496-005364, 1496-005365, 1496-010479, 1496-010480, 1496-010482, 1496-010483, 1496-010485, 1496-010486, 1496-010487, 1496-010488, 1496-010489, 1496-010592, 1496-010595, 1496-010602, 1496-010603, 1496-010604, 1496-010605, 1496-010606, 1496-010608, 1496-010609, 1496-010620, 1496-010621, 1496-010623, 1496-010624, 1496-010625, 1496-010627, 1496-010628, 1496-010778, 1496-010819, 1496-010821, 1496-010822, 1496-010823, 1496-010824, 1496-010825, 1496-010826, 1496-010827, 1496-010828, 1496-010829, 1496-010830, 1496-010831, 1496-010832, 1496-010833, 1496-010835, 1496-010836, 1496-010837, 1496-010838, 1496-010839, 1496-010840, 1496-010841, 1496-010842, 1496-010843, 1496-010844, 1496-010845, 1496-010870, 1496-010871, 1496-010872, 1496-010874, 1496-010876, 1496-010877, 1496-010879, 1496-010834, 1496-010846, 1496-010847, 1496-010848, 1496-010849, 1496-010850, 1496-010851, 1496-010852, 1496-010853, 1496-010854, 1496-010855, 1496-010856, 1496-010857, 1496-010858, 1496-010859, 1496-010860, 1496-010861, 1496-010862, 1496-010863, 1496-010864, 1496-010865, 1496-010866, 1496-010867, 1496-010868, 1496-010869, 1496-010094, 1496-010095, 1496-010120, 1496-010121, 1496-010122, 1496-010123, 1496-010124, 1496-010125, 1496-010126, 1496-010127, 1496-010128, 1496-010129, 1496-010130, 1496-010131, 1496-010132, 1496-010133, 1496-010134, 1496-010135, 1496-010136, 1496-010137, 1496-010138, 1496-010466, 1496-010467, 1496-010468, 1496-009114, 1496-009115, 1496-009116, 1496-009117, 1496-009118, 1496-009119, 1496-009120, 1496-009121, 1496-009122, 1496-009123, 1496-009124, 1496-009125, 1496-009126, 1496-009127, 1496-009128, 1496-009129, 1496-009130, 1496-009131, 1496-009132, 1496-009133, 1496-009134, 1496-009143, 1496-009144, 1496-009145, 1496-009146, 1496-009147, 1496-009148, 1496-009149, 1496-009150, 1496-009151, 1496-009152, 1496-009153, 1496-009154, 1496-009155, 1496-009156, 1496-009157, 1496-009158, 1496-009159, 1496-009160, 1496-009161, 1496-009162, 1496-009163, 1496-009164, 1496-009165, 1496-009166, 1496-009167, 1496-009168, 1496-009169, 1496-009170, 1496-009171, 1496-009172, 1496-009173, 1496-009174, 1496-009175, 1496-009176, 1496-009177, 1496-009178, 1496-009179, 1496-009180, 1496-009181, 1496-009182, 1496-009183, 1496-009184, 1496-009186, 1496-009187, 1496-009188, 1496-009189, 1496-009190, 1496-009191, 1496-009192, 1496-009193, 1496-009194, 1496-009195, 1496-009196, 1496-009197, 1496-009198, 1496-009199, 1496-009200, 1496-009207, 1496-009208, 1496-009209, 1496-009210, 1496-009211, 1496-009212, 1496-009213, 1496-009214, 1496-009215, 1496-009216, 1496-009217, 1496-009218, 1496-009219, 1496-009220, 1496-009221, 1496-009222, 1496-009223, 1496-009224, 1496-009225, 1496-009226, 1496-009227, 1496-009228, 1496-009229, 1496-009230, 1496-009231, 1496-009232, 1496-009233, 1496-009234, 1496-009235, 1496-009236, 1496-009237, 1496-009238, 1496-009239, 1496-009240, 1496-009241, 1496-009242, 1496-009243, 1496-009244, 1496-009245, 1496-009246, 1496-009247, 1496-009248, 1496-009249, 1496-009250, 1496-009251, 1496-009252, 1496-009253, 1496-009254, 1496-009255, 1496-009256, 1496-009257, 1496-009258, 1496-009260, 1496-009261, 1496-009262, 1496-009263, 1496-009264, 1496-009908, 1496-009909, 1496-010054, 1496-010055, 1496-010484, 1496-010610, 1496-010611, 1496-010622, 1496-010878, 1496-010880, 1496-010881, 1496-010882, 1496-010883, 1496-010884, 1496-010885, 1496-010886, 1496-010887, 1496-010888, 1496-010889, 1496-010890, 1496-010912, 1496-010970, 1496-010976, 1496-011027, 1496-011440, 1496-011452, 1496-011455, 1496-011459, 1496-011464, 1496-011469, 1496-011470, 1496-011471, 1496-011472, 1496-011473, 1496-011474, 1496-011475, 1496-011476, 1496-011477, 1496-011478, 1496-011479, 1496-011602, 1496-011603, 1496-011604, 1496-011605, 1496-011606, 1496-011607, 1496-011608, 1496-011609, 1496-011610, 1496-011611, 1496-011612, 1496-011613, 1496-011614, 1496-011615, 1496-011616, 1496-011626, 1496-011627, 1496-011628, 1496-011629, 1496-011630, 1496-011631, 1496-011632, 1496-011633, 1496-011634, 1496-011636, 1496-011637, 1496-011638, 1496-011639, 1496-011640, 1496-011641, 1496-009204, 1496-009205, 1496-009206, 1496-007416, 1496-010469, 1496-010470, 1496-010471, 1496-010472, 1496-010473, 1496-010474, 1496-010475, 1496-010476, 1496-010477, 1496-010478, 1496-004807, 1496-004808, 1496-006833, 1496-006896, 1496-006910, 1496-006911, 1496-006915, 1496-006916, 1496-007279, 1496-007280, 1496-007308, 1496-007309, 1496-007310, 1496-007311, 1496-007312, 1496-007313, 1496-007648, 1496-007767, 1496-007768, 1496-007769, 1496-007770, 1496-007771, 1496-007772, 1496-007779, 1496-007780, 1496-007781, 1496-009891, 1496-009892, 1496-009893, 1496-009894, 1496-009895, 1496-009898, 1496-009899, 1496-009900, 1496-005366, 1496-005367, 1496-005368, 1496-005370, 1496-005371, 1496-005372, 1496-005373, 1496-005374, 1496-005375, 1496-005376, 1496-005377, 1496-005378, 1496-005379, 1496-005380, 1496-005381, 1496-005382, 1496-005383, 1496-005384, 1496-005385, 1496-005386, 1496-005387, 1496-006957, 1496-006958, 1496-006967, 1496-006968, 1496-006969, 1496-006970, 1496-006971, 1496-006972, 1496-006973, 1496-006981, 1496-007630, 1496-007631, 1496-007632, 1496-007633, 1496-007744, 1496-007745, 1496-007746, 1496-007747, 1496-007748, 1496-007749, 1496-007750, 1496-007751, 1496-007752, 1496-007753, 1496-007754, 1496-007755, 1496-007756, 1496-007757, 1496-008503, 1496-008504, 1496-008580, 1496-008581, 1496-008582, 1496-008583, 1496-008584, 1496-008585, 1496-008586, 1496-008587, 1496-009847, 1496-009854, 1496-009855, 1496-009856, 1496-009857, 1496-009858, 1496-009859, 1496-009860, 1496-009861, 1496-009862, 1496-009863, 1496-009864, 1496-009865, 1496-009866, 1496-009867, 1496-009868, 1496-009869, 1496-009870, 1496-009871, 1496-009872, 1496-009873, 1496-009874, 1496-009875, 1496-009877, 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1496-006531, 1496-006532, 1496-006533, 1496-006534, 1496-006535, 1496-006536, 1496-006537, 1496-006538, 1496-006539, 1496-006540, 1496-006541, 1496-006542, 1496-007867, 1496-007868, 1496-009925, 1496-009951, 1496-009952, 1496-010046, 1496-010047, 1496-010048, 1496-010481, 1496-011185, 1496-011186, 1496-011187, 1496-011600, 1496-006116, 1496-006909, 1496-006924, 1496-006925, 1496-006929, 1496-006930, 1496-006931, 1496-006932, 1496-006933, 1496-006934, 1496-006935, 1496-006936, 1496-006937, 1496-006938, 1496-006939, 1496-006940, 1496-006941, 1496-006942, 1496-006943, 1496-006944, 1496-006945, 1496-006946, 1496-006947, 1496-006948, 1496-006949, 1496-006950, 1496-006952, 1496-006953, 1496-006954, 1496-006955, 1496-006956, 1496-009923, 1496-009924
RECALLING FIRM/MANUFACTURER Spacelabs Healthcare, Incorporated, Issaquah, WA
REASON Potential for modules to reset, alarms returning to default settings, invasive pressure losing its labels and zero calibration and Sp02 alarm limits being frozen. This can result in delay in treatment.
VOLUME OF PRODUCT IN COMMERCE 1,261 devices
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Biosense Webster PREFACE Guiding Sheath, Multipurpose Short,
for the introduction of intravascular electrophysiology catheters into any
cardiac chamber. Catalog Number 301803MS,
b) Biosense Webster PREFACE Guiding Sheath, Multipurpose 62cm,
for the introduction of intravascular electrophysiology catheters into any
cardiac chamber. Catalog Number 301803M, 
c) Biosense Webster PREFACE Guiding Sheath, Multipurpose 77cm,
for the introduction of intravascular electrophysiology catheters into any
cardiac chamber. Catalog Number 301805M, 
d) Biosense Webster PREFACE Guiding Sheath, Anterior, for the introduction
of intravascular electrophysiology catheters into any cardiac chamber.
Catalog Number 301803A, 
e) Biosense Webster PREFACE Guiding Sheath, Posterior, for the introduction
of intravascular electrophysiology catheters into any cardiac chamber.
Catalog Number 301803P, 
CODE
a) Lot numbers: 13070991, 13073870, 13073873, 13080117, 13082797,
13090941, 13099292, 13103566, 13109369, L0103032, L0103066,
L0103069, L0103295, L0105007, L0106017, L0106161, L0106271,
L0203066, L0206045, L0206152, L0206235, L0206249, L0304237,
L0306029, L0306084, L0306161, L0306209, L0404116, L0502384,
L0502568, L0504042, L0602226, L0604089, L0704070, L0804173,
L0902370, L0902618, L0904056, L0904071, L0904089, L0904134,
L0904150, L1002219, L1004025, L1004057, L1004259, L1102088,
L1102219, L1205135 & L1205189;
b) Lot numbers: 13070988, 13070989, 13070990, 13076034, 13076424,
13078567, 13080115, 13080116, 13082796, 13085573, 13085574,
13088352, 13088353, 13091447, 13093420, 13093421, 13096355,
13099291, 13109368, L0104097, L0104215, L0104266, L0105104,
L0105214, L0106131, L0106132, L0106208, L0106234, L0106270,
L0106285, L0204006, L0204061, L0204111, L0204167, L0204238,
L0205091, L0205143, L0205192, L0206043, L0206068, L0206124,
L0206125, L0206151, L0206191, L0206192, L0206218, L0206219,
L0206234, L0304028, L0304057, L0304183, L0304236, L0304299,
L0306043, L0306063, L0306083, L0306110, L0306158, L0306159,
L0306208, L0306283, L0404094, L0404117, L0404178, L0503121,
L0503213, L0504077, L0504275, L0505136, L0505137, L0505220,
L0505268, L0603074, L0603133, L0603177, L0603236, L0604058,
L0604088, L0604144, L0604188, L0604208, L0604209, L0604210,
L0604241, L0605013, L0605214, L0702464, L0704071, L0704146,
L0704226, L0704270, L0704299, L0802069, L0803131, L0804040,
L0804100, L0804171, L0804296, L0805078, L0805118, L0805163,
L0805226, L0902225, L0902617, L0903105, L0903142, L0903195,
L0904055, L0904070, L0904133, L0904149, L0904191, L0904224,
L0905030, L0905120, L1002270, L1003019, L1003256, L1004024,
L1 004056, L1004186, L1005083, L1005085, L1005200, L1005274,
L1103144, L1104011, L1104268, L1105121, L1203210, L1204008,
L1205168, L1205169, L204167 & LO604088;
c) Lot numbers: 13073872, 13078568, 13082798, 13084602, 13088356,
13096358, 40206984, 40604122, 40804442, 50205751, 50306355,
50403002, 50405034, 51104857, A0105904, A0106063, A0206419,
A1102924, X0105497, X0205439, X0305391, X0306127, X0306956,
X0405043, X0505118, X0704423, X0802743, X0805081 & X0905452;
d) Lot numbers: L0103107, L0103244, L0206088, L0306027, L0306082,
L0405345, L0704269, L0804090, L0902372, L1002091 & L1004055;
e) Lot numbers: 13073871, 13085576, L0103109, L0203006, L0206046,
L0206153, L0306085, L0504274, L0604126, L0702465, L0704300,
L0802224, L0802580, L0804091 & L0902619
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biosense Webster, Inc., Irwindale, CA,
Manufacturer: Cordis de Mexico, S.A. de C.V., Cd. Juarez, Chihuahua, Mexico. 
REASON Biosense Webster, Inc. has received a number of complaints regarding the radiopaque tip separating or partially detaching from the PREFACE Sheath during use in the left atrium.
VOLUME OF PRODUCT IN COMMERCE 32,317
DISTRIBUTION Nationwide and Internationally

PRODUCT LifeShield Latex-Free Primary I.V. Pump Set with Distal Microbore Patient Line and Gravity Flow Prevention Valve, Convertible Pin, 110 Inch with High-Pressure Filter, Orange Polyethylene-Lined/Light Resistant Tubing and Option-Lok for use with Omni-Flow Medication Management System, 
CODE List 12163-01, lot 39-126-5H
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake Forest, IL, 
Manufacturer: Hospira Holdings de, Costa Rica Ltd., La Aurora de Heredia, Costa Rica.
REASON The tubing can separate from the set at the filter inlet post.
VOLUME OF PRODUCT IN COMMERCE 7,656 units
DISTRIBUTION Nationwide

PRODUCT LifeSync ECG System – Disposable leadwear, Ls-222, Ls-223, CODE C6310, C6324 and C6297
RECALLING FIRM/MANUFACTURER
Recalling Firm: GMP Companies/Lifesync Corp., Ft. Lauderdale, FL
Manufacturer: Printec H. T. Electronics Corp., Chung-Ho City, Taipei Hsien. REASON When the V-lead is separated from the rest of the lead set, the laminate may tear, exposing the dielectric layer causing a break in the silver ink. If the product is used during a defibrillation after such a de-lamination, it could burn the skin and may compromise the efficacy of the defibrillation.
VOLUME OF PRODUCT IN COMMERCE 272 cases
DISTRIBUTION Nationwide

PRODUCT
a) Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized
polymer over acitivated carbon, 50mL, 
b) Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized
polymer over acitivated carbon, 100mL, 
c) Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized
polymer over acitivated carbon, 175 mL,
d) Clark Biocompatible Hemoperfusion Cartridge, sorbent: Heparinized
polymer over acitivated carbon, 250mL,
CODE Lot number 564 though 577
RECALLING FIRM/MANUFACTURER Clark Research and Development, Inc., Folsom, LA
REASON Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions
VOLUME OF PRODUCT IN COMMERCE 292 units
DISTRIBUTION Nationwide

PRODUCT BD Integra 1ml Insulin Syringe with Retracting Precision Guide Needle 1 ml 29g 1/2' (0.33mm x 13 mm) Re-Order No. 305282 U-100 insulin , CODE Lot # 6073436
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ,
Manufacturer: BD Medical - Diabetes Care, Holdrege, NB. 
REASON The needle becomes detached from the hub/syringe
VOLUME OF PRODUCT IN COMMERCE 247,824 units
DISTRIBUTION Nationwide

PRODUCT Microalbumin Multi-Calibrator Set, in vitro diagnostic. Catalog Number: SE-252, 
CODE Lot Number: 28423
RECALLING FIRM/MANUFACTURER Diagnostic Chemicals, Ltd., Charlottetown, Prince Edward Island, Canada, 
REASON Microalbumin Multi Calibrator mislabeled label on Level 5 and Level 6, cap label correct
VOLUME OF PRODUCT IN COMMERCE 38 kits
DISTRIBUTION Nationwide

PRODUCT
a) Terumo L Series 1863 type arterial perfusion cannulae, straight open tip,
1/4" connector, arterial cannula, 10 FR, 17.5 cm (7") long; Catalog no. L7350,
b) Terumo L Series 1863 type arterial perfusion cannulae, straight open tip,
1/4" connector, arterial cannula, 12 FR, 17.5 cm (7") long; Catalog no. L7351,
CODE
a) Lot 2119436, exp. October 2009;
b) Lot 2119905, exp. October 2009.
RECALLING FIRM/MANUFACTURER Terumo Cardiovascular Systems Corp, Ann Arbor, MI,
REASON The cannula connector is an incorrect size: It is actually 1/4" by 3/8" instead of the correct 1/4" by 1/4".
VOLUME OF PRODUCT IN COMMERCE 60 units
DISTRIBUTION Nationwide

PRODUCT CELL-DYN Diluent/Sheath Reagent, for use with CELL-DYN Ruby, Sapphire and 4000 systems. List #01H73-01. Packaged in 20 Liter cubitainers, 
CODE Lot Number 42063I2, List Number 01H73-01
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Santa Clara, CA, 
REASON Results for tests of RBC, MCV, RDW, MPV and PLT may be falsely elevated or falsely decreased when the Cell Dyn Diluent/Sheath reagent is used with Cell-Dyn 4000, Ruby and Sapphire systems.
VOLUME OF PRODUCT IN COMMERCE 652 units
DISTRIBUTION Nationwide and Internationally

Defibtech Announces a  Recall of Lifeline and ReviveR Automated External Defibrillators

Defibtech, LLC, is  recalling Lifeline AED® and ReviveR AEDTM (semi-automatic external defibrillators). This recall affects all Lifeline and ReviveR AEDs with software versions 2.002 and earlier. The self-test software for these devices may allow a self-test to clear a previously detected low battery condition. If this situation occurs, the operator may be unaware of the low battery, and the device may be unable to deliver a defibrillation shock, which could result in failure to resuscitate a patient.

The company has provided a maintenance procedure that can be used to verify functionality of the device until the software upgrade has been installed, allowing the device to remain in service. A copy of this maintenance procedure is being mailed to customers. This procedure, as well as instructions on determining the software version of a unit, can be found on the www.defibtech.com/fa2007 web page. For questions regarding this recall, please refer to the above referenced web page, contact your distributor or contact Defibtech at techsupport@defibtech.com, 1-877-453-4507 or 1-203-453-4507.

Defibtech will provide customers with a free software upgrade to address this issue for all affected AEDs. This software upgrade will be able to be installed in the field where the unit is located. The software upgrade is expected to be available within the next 10 weeks.

WEEK ENDING MARCH 17

PRODUCT
a) Defibtech Sentry Semi-Automatic External Defibrilator (AED)
sold as "Lifeline AED" brand -Model DDU-100A (version 2.002 and earlier), b) Defibtech Sentry Semi-Automatic External Defibrilator (AED)
sold as "ReviveR AED" brand -Model DDU-100B (version 2.002
and earlier),
CODE Software versions earlier than version 2.002
RECALLING FIRM/MANUFACTURER Defibtech, LLC, Guilford, CT, 
REASON Device Malfunction-The self-test software may allow a self-test to clear a previously detected low battery condition. If this occurs, the operator may be unaware of the low battery and the device may be "unable" to deliver a defibrillation shock, which could result in failure to resuscitate a patient.
VOLUME OF PRODUCT IN COMMERCE 42,650 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Sample Management System software for in vitro diagnostic testing Product # 030102-03, 
CODE Serial #’s D0314, D0280, E0545, C0081, C0026, D0384, D0244, E0515, E0511, E0550, C0222, C0223, C0207, D0355, E0517, C0219R,C0221, B0021, B0022, D0353, E0503, E0446, C0193, E0471, E0566, D0299, E0513, D0281, D0356, C0101, C0203, C0205, B0027, E0426, E0440, C0176, C0182, E0504, C0220, E0495, D0272, E0490, E0534, C0208, C0218, C0191, E0473, D0296, C0168, E0470, C0199, D0330, C0206, D0313, C0192, E0509, D0369, E0492, E0493, D0304, D0310, D0311, E0563, D0331, C0204, E0589, D0327, D0275, E0514, E0443, E0444, D0243, C0216, C0217, E0546, E0548, C0209, E0450, D0291, D0276, D0273, D0332, E0508, B0033, E0449, E0516, D0357
RECALLING FIRM/MANUFACTURER Siemens Medical Solutions Diagnostics, Flanders, NJ
REASON Under limited circumstances, an incorrect patient result could be printed on the optional chartable patient report.
VOLUME OF PRODUCT IN COMMERCE 558 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Alcon Custom-Pak®, part #10975-02, containing BD Beaver™ Mini-Blade
(part #BD6400 or part #BD6900); individual blades repackaged into custom
ophthalmic surgical packs and resterilized, 
b) Alcon Custom-Pak®, part #2638-17, containing BD Beaver™ Mini-Blade
(part #BD6400 or part #BD6900); individual blades repackaged into custom
ophthalmic surgical packs and resterilized,
c) Alcon Custom-Pak®, part #4917-54, containing BD Beaver™ Mini-Blade
(part #BD6400 or part #BD6900); individual blades repackaged into custom
ophthalmic surgical packs and resterilized, 
d) Alcon Custom-Pak®, part #6515-51, containing BD Beaver™ Mini-Blade
(part #BD6400 or part #BD6900); individual blades repackaged into custom
ophthalmic surgical packs and resterilized, 
e) Alcon Custom-Pak®, part #11148-02, containing BD Beaver™ Mini-Blade
(part #BD6400 or part #BD6900); individual blades repackaged into custom
ophthalmic surgical packs and resterilized,
CODE
a) Lot #649244H;
b) Lot #627618H and 636380H;
c) Lot #629460H, 631237H, 632356H and 642330H;
d) Lot #633317H, 645074H, and 629784H;
e) Lot #632178H, 634400H and 642229H
RECALLING FIRM/MANUFACTURER Alcon Laboratories, Inc., Houston, TX
REASON Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs.
VOLUME OF PRODUCT IN COMMERCE 206 custom surgical packs
DISTRIBUTION Nationwide

PRODUCT Coulter LH700 Series Hematology Analyzers, Part Number 6605632 with 2B Software (2B3, 2B4 and 2B5), 
CODE 2B Software (2B3, 2B4 and 2B5)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA.,
Manufacturer: Beckman Coulter, Inc., Miami, FL. 
REASON There is a potential for erroneous yet credible results for Body Fluids on the LH700 series hematology analyzers when a cassette label fails to read and the subsequent sample is cycled in Body Fluid mode.
VOLUME OF PRODUCT IN COMMERCE 1,987 units
DISTRIBUTION Nationwide and Canada

PRODUCT
a) Wright Medical Technology, Gladiator™ Bipolar Hip Prosthesis,
REF: GLBP-2241, Size 41mm O.D., use with 22 mm Head,
b) Wright Medical Technology, Gladiator™ Bipolar Hip Prosthesis,
REF: GLBP-3650, Size 50mm O.D., use with 36 mm Head,
c) Wright Medical Technology, Gladiator™ Bipolar Hip Prosthesis,
REF: GLBP-3651, Size 51mm O.D., use with 36 mm Head,
d) Wright Medical Technology, Gladiator™ Bipolar Hip Prosthesis,
REF: GLBP-3652, Size 52mm O.D., use with 36 mm Head,
e) Wright Medical Technology, Gladiator™ Bipolar Hip Prosthesis,
REF: GLBP-3653, Size 53mm O.D., use with 36 mm Head,
f) Wright Medical Technology, Gladiator™ Bipolar Hip Prosthesis,
REF: GLBP-3654, Size 54mm O.D., use with 36 mm Head,
g) Wright Medical Technology, Gladiator™ Bipolar Hip Prosthesis,
REF: GLBP-3655, Size 55mm O.D., use with 36 mm Head,
CODE
a) Lot Nos.: 106379171, 106380364, 106382079;
b) Lot Nos.: 106381250, 106382088, 116389380 (3 were implanted);
c) Lot Nos.: 106381252, 106382089, 116389381;
d) Lot Nos.: 106381253, 106382090
e) Lot Nos.: 106381255, 106382091;
f) Lot Nos.: 106381256, 106382092;
g) Lot Nos.: 106379830, 106382095, 116389421
RECALLING FIRM/MANUFACTURER Wright Medical Technology Inc., Arlington, TN,
REASON Product specification failure which could result in improper locking of the cup onto the femoral head.
VOLUME OF PRODUCT IN COMMERCE 84 units
DISTRIBUTION Nationwide and Japan

PRODUCT AB5000 Console Circulatory Support System, Catalog number: 0015-000, 
CODE Serial Numbers: 5261-5317
RECALLING FIRM/MANUFACTURER Abiomed, Inc., Danvers, MA
REASON Unit may alarm “Low Pressure” due to manufacturing material in the pressure source.
VOLUME OF PRODUCT IN COMMERCE 55 units
DISTRIBUTION Nationwide and Internationally

PRODUCT StarClose Vascular Closure System (Clip Applier & Exchange System), Catalog Number: 14677, 
CODE Lot Numbers starting from 43034-6H to 47139-6H
RECALLING FIRM/MANUFACTURER Abbott Vascular Inc., Redwood City, CA, 
REASON Premature release of the vessel locator wings, which stabilize the device prior to clip deployment, will result in no hemostasis.
VOLUME OF PRODUCT IN COMMERCE 97,952 units
DISTRIBUTION Nationwide and Internationally

PRODUCT EKOS EndoWave Infusion System and EKOS Lysus Infusion Systems - drug delivery catheters. EKOS Corporation Bothell, WA Packaging: *EndoWave(TM) Ultrasound Accelerated Thrombolysis (USAT) EKOS EndoWave Infusion System Drug Delivery Catheter with Ultrasound Core. and ''Lysus Infusion System''. EndoWave Infusion Systems 06, 2.7W, part #4599-001, catalog #500-52106; Systems 12, 2.7W, part #4599-002, catalog 500-52112; Systems 18, 2.7W, part #4599-003, catalog #500-52118; Systems 24, 2.7W, part #4599-004, catalog #500-52124; Systems 30, 2.7W, part #4599-005, catalog #500-52130; Systems 40, 2.7W, part 4599-006, catalog #500-52140; Systems 50, 2.7W, part #4599-007, catalog #500-52150; Systems 06, 3.5W, part #5199-001, catalog #500-54106; Systems 12, 3.5W, part #5199-002, catalog #500-54112; Systems 18, 3.5W, part #5199-003, catalog #500-54118; Systems 24, 3.5W, part #5199-004, catalog #500-54124; Systems 30, 3.5W, part #5199-005, catalog #500-54130, Systems 40, 3.5W, part #5199-006, catalog #500-54140; Systems 50, 3.5W, part #5199-007, catalog #500-54150; Lysus Infusion Systems 06, 2.7W, part #4599-001, catalog 500-52106; Systems 12, 2.7W, part #4599-002, catalog 500-52112; Systems 18, 2.7W, part #4599-003, catalog #50-52118; Systems 24, 2.7W, part #4599-004, catalog #500-52124; Systems 30, 2.7W, part #4599-005, catalog #500-52130; Systems 40, 2.7W, part #4599-006, catalog #500-52140; Systems 50, 2.7W, part #4599-007, catalog #500-52150; Systems 06, 3.5W, part #5199-001, catalog 500-54106; Systems 12, 3.5W, part #5199-002, catalog #500-54112; Systems 18, 3.5W, part #5199-003, 500-54118; Systems 24, 3.5W, part #5199-004, catalog #500-54124; Systems 30, 3.5W, part #5199-005, catalog #500-54130; Systems 40, 3.5W, part #5199-005, catalog #500-54140; Systems 50, 3.5W, part #5199-007, catalog #500-54150, 
CODE All Models with Serial Number greater than and equal to 0610XXXX-XXX
RECALLING FIRM/MANUFACTURER Ekos Corp, Bothell, WA
REASON Ekos Corporation received three reports that distal radiopaque marker bands on the EndoWave Drug Delivery Catheter became detached from the catheter during use and remained in the patient.
VOLUME OF PRODUCT IN COMMERCE 446 devices
DISTRIBUTION Nationwide

PRODUCT
a) AXIOM Artis MP, Angiographic x-ray system, model number 5904466,
b) AXIOM Artis MP, Angiographic x-ray system, model number 7555365,
CODE
a) Serial numbers: 20281, 20294, 20264, 20295, 20265, 20303, and 20282;
b) Serial numbers 57012, 57045, 57016, 57024 and 57041
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA,
Manufacturer: Siemens Medical Solutions, Forchheim, Germany. 
REASON C-arm gantry could rapidly descend without command during use.
VOLUME OF PRODUCT IN COMMERCE 12 units
DISTRIBUTION Nationwide

PRODUCT ThromCat Thrombectomy Catheter System. 7F 2.5 -7.0 mm 150 cm. Catalogue number 63000-01. It is a single-use, disposable device that is used to perform percutaneous maceration and removal of thrombus and restoration of blood flow,
CODE
Lot number 54877 exp December 2007, Lot number 55318 exp January 2008, Lot number 55218 exp January 2008, and Lot number 54821 exp December 2007
RECALLING FIRM/MANUFACTURER Kensey Nash Corp, Exton, PA, REASON Face seal may wear excessively and cause particulate matter.
VOLUME OF PRODUCT IN COMMERCE 165 units
DISTRIBUTION Nationwide

PRODUCT Architect i System Assay CD-ROM, U.S. Version 21.0, for use on the Architect i System, list number 06E58-21, in vitro diagnostic, 
CODE Lot: 45572P100
RECALLING FIRM/MANUFACTURER Abbott Laboratories MPG, Abbott Park, IL
REASON The Architect Ausab and Architect Anti-HCV assay parameter default interpretation screens when using Architect Assay CD-ROM US Version 06E58-21 does not align with the result interpretation options in the Architect Ausab Reagent Package Insert (PI) 34-4162/R1 and ARCHITECT Anti-HCV PI 34-4152/R1.
VOLUME OF PRODUCT IN COMMERCE 51 CD-ROMs
DISTRIBUTION Nationwide

PRODUCT AccuGuide Injection Needles (Surface electrodes) The AccuGuide EMG Injection Needle, product 8263210, contains 5 individually packaged and sterilized injection needles and 10 nonsterile surface electrodes that are packaged 2 per non-breathable pouch, but are not sterilized, 
CODE Lot Numbers: 45648300, 46526000, 46709500, 48166300
RECALLING FIRM/MANUFACTURER Medtronic Xomed, Inc., Jacksonville, FL,
REASON A labeling discrepancy was internally identified for the surface electrode component of REF 8263210 AccuGuide EMG Injection Needle, 30G X 25MM. The outside box label correctly indicates 'Content: 5 sterile Injection Needles and 10 non-sterile Surface electrodes'; however, the pouches for the 10 surface electrodes inside the box are incorrectly labeled as “sterile”.
VOLUME OF PRODUCT IN COMMERCE 48 boxes
DISTRIBUTION Nationwide

PRODUCT Medtronic 2T10R1 Intersept Custom Tubing Pack. Pack 2T10R1 consists of two PVC lines; one of them is 132 inch in length and is capped. The second line is 102 inch in length and has a one way vacuum relief valve assembled in one end. Tubing is used in the vent roller heads of the heart lung machine. This tubing is connected to the cannula in the patient in order to divert blood to the circuit when the patient is on bypass, 
CODE Lot 5666215
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Perfusion Systems, Brooklyn Park, MN,
Manufacturer: Medtronic Mexico, S. De R. L. De C.V. Tijuana, Baja California, Mexico. 
REASON One lot of Custom Perfusion Sets, Catalog 2T10R1 was incorrectly assembled. The one way vacuum relief valve on the 102 inch line is attached backwards, thus preventing flow.
VOLUME OF PRODUCT IN COMMERCE 17 packs
DISTRIBUTION IL

PRODUCT JariTrak™ Table Clamp, 1 inch diameter, vertical post, Catalog Number 206-160. The JariTrak™ Table Clamp with vertical post (206-160) is part of the Table Mounted Hardware that is used with the JariTrak™ Retractor System. The JariTrak™ self-retaining retractor system consists of the Table Clamp with Vertical Post, Flexible or Horizontal Bar with Universal Joint, Oval or Segment Rings, Tilting Blade Clamps and various blades. The product is supplied non-sterile and may be packaged individually or as part of the JariTrak™ retractor set, 
CODE Manufacturer lot numbers 55L and 125L
RECALLING FIRM/MANUFACTURER
Recalling Firm: J. Jamner Surgical Instruments, Inc. Hawthorne, NY
Manufacturer: Koros USA Inc., Moorpark, CA. 
REASON The JariTrak™ Table Clamp may not securely fasten to the bed rail of the OR table during set up of the retractor system. In the event that the clamp is not securely fastened to the bed rail, the system may move during surgery. The firm received several complaints from hospitals.
VOLUME OF PRODUCT IN COMMERCE 41 units
DISTRIBUTION Nationwide

WEEK ENDING MARCH 24

PRODUCT
a) FRAZIER Surgical Suction Instrument, 3 Fr. with Control Vent and Obturator, REF 0031030. Assembled in Mexico, 
b) FRAZIER Surgical Suction Instrument, 5 Fr. with Control Vent and Obturator, REF 0031050. Assembled in Mexico,
c) FRAZIER Surgical Suction Instrument, 7 Fr. with Control Vent and Obturator, REF 0031070. Assembled in Mexico, 
d) FRAZIER Atraumatic Soft Tip Surgical Suction Instrument with Control Vent and Obturator, 10 French, REF 0031100. Assembled in Mexico
e) FRAZIER Surgical Suction Instrument, 8 Fr. with Control Vent and Obturator, REF 0033080. Assembled in Mexico, 
f) FRAZIER Surgical Suction Instrument, 10 Fr. with Control Vent and Obturator, REF 0033100. Assembled in Mexico, 
g) FRAZIER Surgical Suction Instrument, 12 Fr. with Control Vent and Obturator, REF 0033120. Assembled in Mexico,
h) FRAZIER Surgical Suction Instrument, 18 Fr. with Obturator, REF 0033180. Assembled in Mexico,
i) FRAZIER Olive Tip Suction Instrument, 10 Fr. with Control Vent and Obturator (Bend with Obturator in Place), REF 0033110. Assembled in Mexico,
j) POOLE Suction Instrument, REF 0035040. Assembled in Mexico,
CODE All lots manufactured between 10/04/2001 and 10/04/2006. Lot codes on boxes and packaging contain a 7 digit lot code: For example, lot 0409271: the first 2 digits represent the year manufactured (04 represents 2004), next 2 digits represent the month (09 represents September), the next 2 digits represent the day of the month (27), and the last digit represents the manufacturing shift code (1).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Conmed Corporation, Utica, NY,
Manufacturer: SEISA, Sarabia Parque Industrial, Aeropuerto Jaurez, Mexico. REASON Firm was made aware of instances where the sterile barrier of the instruments had been compromised.
VOLUME OF PRODUCT IN COMMERCE 7,401,479 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Clearview Simplify D-dimer, in vitro diagnostic for qualitative detection of D-dimer in human whole blood and plasma. Product No. 61100KVC 10 test devices containing anti D-dimer monoclonal antibody and sheep anti-mouse antibody 1 x 2.6 mL buffer containing 0.9% sodium chloride and 0.05% sodium azide 10 plastic pipettes, 
CODE Kit lot number: PX018A Test device batch number: 682-024, Expiration date: 3/2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Inverness Medical Professional Diagnostics, Princeton NJ,
Manufacturer: Agen Biomedical, Ltd., Acacia Ridge, Australia. 
REASON Lot PX018A is exhibiting a decrease in sensitivity affecting the qualitative result around the cut off.
VOLUME OF PRODUCT IN COMMERCE 377 devices
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Wallstent Endoscopic Biliary Endoprosthesis- 8mm x 40mm, UPN H965430100,
b) Wallstent Endoscopic Biliary Endoprosthesis 8mm x 60mm, UPN H965430200,
c) Wallstent Endoscopic Biliary Endoprosthesis 8mm x 80mm, UPN H965430300,
d) Wallstent Endoscopic Biliary Endoprosthesis 10mm x 40mm, UPN H965430400,
e) Wallstent Endoscopic Biliary Endoprosthesis 10mm x 60mm, UPN H965430500;
f) Wallstent Endoscopic Biliary Endoprosthesis 10mm x 80mm, UPN H965430600,
CODE
a) Lot Numbers: 8243354, 8243355, 8243356, 8521620, 8913445;
b) Lot Numbers: 7991049, 8056668, 8263142, 8502337, 8502338, 8521621, 8628863, 8770896, 8829555, 8909937;
c) Lot Numbers: 7892444, 7909244, 7909250, 8326863, 8502339, 8541943, 8652467, 8771022, 8831247, 8956367, 8956369;
d) Lot Numbers: 7928218, 7940824, 7959297, 7979465, 8016999, 8017000, 8041037, 8052775, 8093630, 8113554, 8113555, 8155386, 8155387, 8222854, 8247383, 8247384, 8247385, 8251326, 8251327, 8263403, 8263404, 8268291, 8364159, 8389892, 8423296, 8431392, 8442255, 8449736, 8490449, 8490450, 8502340, 8502341, 8502343, 8502344, 8502345, 8502346, 8503289, 8530084, 8530085, 8547344, 8603144, 8620590, 8624525, 8688101, 8688102, 8724565, 8727811, 8736211, 8797653, 8797654, 8829556, 8829557, 8831248, 8871693, 8871694, 8876235, 8876236, 8909940, 8909941, 8948216, 8948216, 8952271, 8952271, 8952432, 9131974, 9131975, 9131976, 9131977, 9131978, 9131979, 9131980;
e) Lot Numbers: 7889255, 7892445, 7905372, 7905374, 7920200, 7920201, 7920402, 7924984, 7928220, 7928221, 7940540, 7940541, 7944156, 7944157, 7948736, 7959298, 7967031, 7967032, 7974510, 7974511, 7979467, 7987625, 7987626, 7987628, 7991050, 7996574, 7996575, 8002683, 8014023, 8014024, 8037243, 8037244, 8037245, 8037246,
8041303, 8041304, 8052776, 8056276, 8056277, 8071724, 8071725, 8075136, 8075137, 8090847, 8090848, 8090849, 8093631, 8097643, 80097646, 8111219, 8117677, 8129796, 8129797, 8135040, 8150710, 8150711, 8166095, 8166096, 8170748, 8170749, 8187006, 8187007, 8191491, 8191492, 8195575, 8206782, 8211777, 8221857, 8221858, 8226825, 8226826, 8251328, 8268292, 8284683, 8286814, 8286815, 8286816, 8290951, 8290953, 8303330, 8303331, 8306943, 8322847, 8322848, 8326864, 8338442, 8346569, 8346570, 8359761, 8359762, 8359863, 8364161, 8364162, 8381248, 8381249, 8381250, 8401049,
8401050, 8410838, 8410839, 8410840, 8423298, 8423299, 8431393, 8442256, 8442257, 8446291, 8446292, 8449737, 8463164, 8463246, 8470264, 8470590, 8470592, 8482831, 8482832, 8490451, 8502347, 8502348, 8502609, 8502727, 8502728, 8502869, 8502973, 8502974, 8502975, 8502976, 8502977, 8502978, 8502979, 8502980, 8502981, 8502982, 8503290, 8503291, 8503292, 8503293, 8503294, 8503295, 8503296, 8503297, 8507018, 8507019, 8511086, 8511087, 8521622, 8526130, 8541944, 8541945, 8551221, 8563750, 8563751, 8563752, 8567702, 8567703, 8588514, 8588516, 8591865, 8591866, 8603141,
8603142, 8620591, 8620592, 8624527, 8624528, 8645198, 8645199, 8645203, 8652468, 8652469, 8655870, 8662303, 8662304, 8662305, 8666752, 8666753, 8666754, 8671097, 8683742, 8683743, 8692107, 8692108, 8705449, 8705846, 8714060, 8714427, 8714428, 8732163, 8732165, 8736497, 8748514, 8748520, 8748521, 8752576, 8752577, 8771059, 8775285, 8789042, 8789044, 8793117, 8793118, 8819197, 8819198, 8831249, 8833912, 8833913, 8834149, 8867179, 8867180, 8871566, 8889077, 8889079, 8889080, 8893395, 8893396, 8898056, 8898057, 8913684, 8913687, 8917868, 8917869, 8931675, 8931676,
8931677, 8947925, 8968803, 8968804, 8968805, 8972725, 8972726, 9132193, 9132194, 9132195, 9132196, 9132197, 9132198, 9132199, 9132200, 9132201, 9132206, 9132207, 9132208, 9132209, 9132210, 9132211, 9132292, 9132293, 9132294, 9132295;
f) Lot Numbers: 7889257, 7892749, 7924670, 7924672, 7944542, 7948443, 7948444, 7959299, 7959300, 7975078, 7975079, 7979468, 7979469, 7991051, 7991054, 7998758, 7998759, 7998760, 8002684, 8002685, 8014025, 8041040, 8041041, 8041222, 8052772, 8052774, 8060259, 8071855, 8071856, 8075138, 8080170, 8093632, 8109650, 8109651, 8114689, 8117678, 8131078, 8151476, 8155398, 8166781, 8170747, 8174687, 8174689, 8187008, 8191493, 8206779, 8206780, 8211778, 8211779, 8214766, 8226828, 8230827, 8230830, 8231159, 8268293, 8272150, 8272151, 8284684, 8284685, 8290955, 8306944, 8319230, 8319231, 8339003, 8339005, 8343275, 8343279, 8347008, 8367859, 8367860, 8367861, 8385775, 8385776, 8385777, 8389894, 8389895, 8401051, 8406650, 8406651, 8406652, 8427648, 8427649, 8431394, 8449739, 84623248, 8466568, 8466569, 8466570, 8474529, 8474530, 8474531, 8482833, 8486629, 8486630, 8486631, 8503298, 8503299, 8503300, 8505352, 8505353, 8505354, 8505355, 8505356, 8505357, 8505358, 8505359, 8505360, 8505361, 8505362, 8505363, 8505364, 8507020, 8511088, 8526132, 8526135, 8547345, 8547346, 8551223, 8551224, 8567704, 8571917, 8571918, 8571919, 8583897, 8583898, 8583899, 8591867, 8611580, 8611581, 8614222, 8648847, 8648849, 8648850, 8655868, 8655869, 8683744, 8688103, 8692109, 8706158, 8709576, 8709923, 8709975, 8724559, 8724560, 8727932, 8727933, 8752575, 8766341, 8766342, 8775286, 8775287, 8810553, 8810554, 8810570, 8814730, 8815105, 8844670, 8844671, 8844872, 8849235, 8849236, 8849237, 8853318, 8853319, 8867181, 8893397, 8898058, 8902082, 8902083, 8913833, 8935976, 8935977, 8935978, 8948215, 8976949, 9132297, 9132373, 9132374, 9132375, 9132376, 9132377, 9132378, 9132379, 9132380, 9132381, 9132382, 9132383, 9132384, 9132385, 9132386, 9132387, 9132388, 9132389
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corporation, Natick, MA,
Manufacturer: Boston Scientific Ireland, Ltd., Galway, Ireland. 
REASON Guidewire restriction during use (excessive adhesive in the guidewire lumen).
VOLUME OF PRODUCT IN COMMERCE 8,511 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Guidant Acrobat Vacuum Stabilizer, Model Number OM-9000, 
b) Guidant Acrobat Vacuum Stabilizer, Model number-OM-9100,
CODE
a) All products with expiry dates of June 2008, lot codes ranging from 4120181 to 6100281.
See below. 5042281 5071983 5041981 5090881 5102481 5120581 6020881 6050281 6061581 6080581 6091281 4120181 5042581 5072181 5051881 5091281 5102482 5120681 6021081 6050381 6061981 6080781 6091381 4120381 5042981 5072281 5051981 5091381 5102581 5120781 6021381 6050681 6062081 6080881 6091382 4120681 5050281 5072681 5052181 5091481 5102681 5120881 6021581 6050881 6062181 6080882 6091481 4120781 5050381 5072781 5053181 5091981 5102682 5120981 6021681 6051081 6062281 6080981 6092081 4120881 5050481 5072782
5060281 5091982 5102781 5121481 6022281 6051181 6062381 6080982 6092181 4121081 5051081 5080381 5060381 5092081 5102881 5121981 6022781 6051281 6062382 6081081 6092681 4121381 5051181 5080382 5060681 5092082 5102882 5121982 6022782 6051381 6062681 6081082 6092781 4121481 5051281 5080481 5060781 5092181 5103181 5122081 6022881 6051681 6062781 6081281 6092881 4121881 5051381 5080482 5062181 5092182 5110781 6010381 6030181 6051682 6062881 6081481 6092981 4122081 5051681 5080581 5062281 5100181 5110881 6010382 6030381 6051981 6062981 6081482 6100281 4122181 5051781 5080881
5062282 5100381 5110981 6010481 6030881 6052282 6070681 6081581 4122881 5020781 5080882 5062381 5100481 5111081 6010981 6030981 6052381 6070781 6081781 4122981 5020981 5080981 5062382 5100681 5111082 6011181 6031081 6052382 6070782 6082181 4123081 5021081 5081081 5062881 5100682 5111181 6011281 6031381 6052581 6071081 6082281 4123082 5021681 5081181 5071881 5101081 5111182 6011381 6031481 6052681 6071082 6082282 5010481 5021781 5082281 5071981 5101082 5111281 6011382 6032481 6053081 6071181 6082381 5010581 5022181 5082282 5071982 5101181 5111481 6011781 6032482 6053082
6071281 6082481 5010682 5022481 5032881 5082381 5101182 5111581 6011881 6032781 6053181 6071381 6082581 5011081 5022581 5033081 5082481 5101281 5111582 6012381 6032981 6060281 6071382 6082681 5011181 5022881 5033181 5082482 5101282 5111681 6012382 6040681 6060282 6071781 6082881 5011381 5030181 5040481 5082681 5101381 5111781 6012481 6041081 6060381 6071881 6082882 5011481 5030281 5040581 5082981 5101382 5112181 6012581 6041181 6060581 6071981 6082981 5011881 5030481 5040881 5083081 5101481 5112281 6012681 6041281 6060681 6072082 6083081 5011981 5030781 5041181 5090181
5101581 5112282 6012781 6041381 6060682 6072281 6090582 5012181 5031481 5041281 5090281 5101781 5112881 6013081 6041781 6060781 6072481 6090681 5012781 5031581 5041381 5090681 5101782 5112981 6020281 6041881 6060881 6072482 6090781 5020181 5031782 5041481 5090682 5101783 5112982 6020681 6042082 6060981 6072681 6090881 5020281 5031881 5041581 5090683 5101881 5113081 6020781 6042481 6061281 6072781 6091181;
b) All products with expiry dates of June 2008, lot codes ranging from 4120281 to 6102381.
See Below: 4120281 5020781 5051381 5062181 5091481 5110182 6013181 6040581 6062481 6091881 6101881 4120681 5021481 5052381 5072881 5092781 5110381 6020681 6050181 6070581 6091981 6101882 4121581 5031681 5052382 5081081 5092782 5110481 6020682 6050681 6081781 6092581 6102381 5010681 5032181 5061581 5081681 5101881 5120181 6022181 6051881 6081782 6092582 5011881 5040681 5061681 5081781 5101981 5120281 6030681 6052081 6081881 6101181 5012881 5041881 5061781 5081782 5101982 6010481 6030781 6060981 6083081
6101681 5020381 5050281 5062081 5081881 5110181 6011981 6040481 6061981 6083181 6101682
RECALLING FIRM/MANUFACTURER Guidant Cardiac Surgery, Santa Clara, CA, 
REASON Vacuum Tubing Failure. Vacuum tubing fails before the labeled two year shelf life. This may result in partial or complete vacuum loss during surgery.
VOLUME OF PRODUCT IN COMMERCE 57,691 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Gyrus ACMI Tripolar Ultra Cutting Forceps: 5 mm X 32 cm-Reference Number: TRU5-32, 
b) Gyrus ACMI Tripolar Ultra Cutting Forceps: 10 mm X 32 cm-Reference Number: 006689-901, 
c) Gyrus ACMI Tripolar Ultra Cutting Forceps: 10 mm X 32 cm w/rotation-Reference Number: 006689-903, 
CODE
a) Lot Numbers: 6236019, 6236020, 6236021, 6258015, 6297001, 6300013, 6306015, 6320041, 6326021, 6326097, 6335042, 6342008, 6349001, 6349002, 6355029, 7011002, 7011003, 7019012;
b) Lot Numbers: 6258014, 6303028, 6306017, 6312602, 6314021, 6320034, 6326096, 6335040, 6342010, 6362025, 7004015, 7009015;
c) Lot Numbers: 6236022, 6236023, 6236024
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gyrus ACMI Corp., 
Manufacturer: Gyrus Medical, Inc., Maple Grove, MN. 
REASON Product sterility may be compromised due to failure of the tray seal packaging.
VOLUME OF PRODUCT IN COMMERCE 922 boxes (5 units to a box)
DISTRIBUTION Nationwide and Internationally

PRODUCT The iSight PACS (picture archiving and communications system) a software package used with general purpose computer hardware to acquire, store, distribute, process, and display images/associated data throughout a clinical environment, 
CODE Version 3.5
RECALLING FIRM/MANUFACTURER Stentor Inc., A Phillips Medical Systems Co., Foster City, CA,
REASON A defect may cause patient image orientation markers to be incorrectly labeled on Multi-Planar Reformation (MPR) images. Left and Right Anatomical orientation markers may be reversed.
VOLUME OF PRODUCT IN COMMERCE 54 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System; Catalog No. 164268, 
CODE Serial numbers 0001 through 2696
RECALLING FIRM/MANUFACTURER Terumo Cardiovascular Systems, Corp., Ann Arbor, MI
REASON Internal friction may cause the centrifugal manual drive to be inoperable when a disposable pump is attached.
VOLUME OF PRODUCT IN COMMERCE 2,696 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Baxter Clearlink System Vented Paclitaxel Set; a sterile fluid pathway with
polyethylene lined tubing, non-DEHP 12 inch pump segment, 0.22 micron
downstream high pressure filter, Luer activated valve, male Luer lock adapter;
for use with rigid nonvented solution containers on Colleague and Flo-Gard 6201 and 6301 series pumps; Baxter Healthcare, Deerfield, IL 60015; product code 2C8857,
b) Baxter Interlink System Vented Paclitaxel Set; a sterile fluid pathway with polyethylene lined tubing, non-DEHP pump segment, 0.22 micron downstream high pressure filter, injection site, male Luer lock adapter; for use with rigid nonvented solution containers on Colleague and Flo-Gard 6201 and 6301 series pumps; product code 2C7557,
c) Baxter Vented Paclitaxel Set; a sterile fluid pathway with polyethylene lined tubing, non-DEHP pump segment, 0.22 micron downstream high pressure filter, injection site, male Luer lock adapter; for use with rigid nonvented solution containers on Colleague and Flo-Gard 6201 and 6301 series pumps; product code 2C7553, 
CODE
a) Lots R06F05158, R06F22013, R06F22112;
b) Lots R06I12067, R06J07025, R06J19079, R06J20044;
c) Lots R06E13105, R06E17114, R06E25042, R06F15058, R06G11030,
R06I13107, R06K03071
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, 
Manufacturer: Baxter Productos Medicos Ltda., Cartago, Costa Rica.
REASON Baxter has received reports of disconnections/leaks during use of vented Paclitaxel administration sets.
VOLUME OF PRODUCT IN COMMERCE 215,886 sets
DISTRIBUTION Nationwide and Internationally

PRODUCT Remel MacConkey Agar w/Sorbitol, growth medium, Catalog R01556, packaged 10/box, 
CODE Lot 506069, Exp. 2007/30/20
RECALLING FIRM/MANUFACTURER Remel, Inc., Lenexa, KS.
REASON Some of the units exhibited false negative results for sorbitol fermenting bacteria such as E. Coli 0157.
VOLUME OF PRODUCT IN COMMERCE 694/10-pack boxes
DISTRIBUTION Nationwide

PRODUCT
a) StayFix Fixation Device for Percutaneous catheters, REF 680ME, (small) 5F - 14F,
b) StayFix Fixation Device for Percutaneous catheters, REF 685ME, (large) 12F - 22F,
c) EpiFix Fixation Device for Epidural Catheters, REF 670M, 
CODE
a) Lot numbers: 551268, 551537, 551615, 551616, 551702, 551703, 551704, 553104, 553360, 553361, 553362, 553363, 554362, 554367, 554368, 554483, 554497, 554504, 554505, 554506, 554723, 554764, 554765, 554766, 555638, 555639, 555655, 555656, 555657, 555658, 556406, 556407, 556408, 556409, 556410, 556411, 556842, 556843,
556844, 556845, 556846, 556847, 556871, 556872, 556873, 556874, 556875, 562518, 562748, 562874, 563254, 563255, 563388, 563389, 566538, 566899, 566900, 566901, 566902, 566903, 566904, 567248, 567515, 567596, 567599, 567600, 567601, 567767, 567835;
b) Lot Numbers: 547745, 551172, 554699, 555705, 555706, 556394, 556395, 556396, 556876, 556877, 558988, 560767, 560768, 560781, 561127, 561144, 562749, 562750, 563256, 563257, 563387, 564684, 564685, 565284, 565285, 565353, 565955, 566684, 566905, 566906, 566907, 567383, 567513, 567728, 569474;
c) Lot Numbers: 546350, 551766, 551767, 554738, 558995, 560148, 560149, 564569, 567538.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Merit Medical Systems, Inc., South Jordan, UT
Manufacturer: Unomedical, Ltd., Stonehouse, Glos, UK. 
REASON Sterility of some units may be compromised due to damaged packaging.
VOLUME OF PRODUCT IN COMMERCE 250,808 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Vaxcel Implantable Vascular Access System - Titanium Mini-Port with PASV
Valve and 8F Polyurethane Catheter, REF/Catalog No. 45-215,
UPN/Material No. M001452150, 
b) Vaxcel Implantable Vascular Access System - Titanium Mini-Port with PASV Valve and 8F Silicone Catheter, REF/Catalog No. 45-220, UPN/Material No. M001452200, 
CODE
a) Lots 1137363, 1137364, 1137733, and 1137734;
b) Lot 1137368
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Glens Falls, NY,
Manufacturer: Boston Scientific Corp., Glens Falls NY. 
REASON Sterile barrier may have been compromised. Firm received one complaint which demonstrated that the inner and outer seals of the port tray packaging had been compromised.
VOLUME OF PRODUCT IN COMMERCE 236 units
DISTRIBUTION Nationwide

PRODUCT COOK Triple Lumen Central Venous Catheter Tray with Cook Spectrum® Glide® Antimicrobial Catheter with EZ--Pass® Hydrophilic Coating: Reorder Number C-UTLMY-701J-RSC-ABRM-HC-FST-A,
CODE Lots 1794998 and 1793611
RECALLING FIRM/MANUFACTURER Cook, Inc., Bloomington, IN
REASON These catheters do not include the proximal sidehole as required by the specification.
VOLUME OF PRODUCT IN COMMERCE 100 units
DISTRIBUTION Nationwide

PRODUCT CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, 
CODE Lot Numbers: 1445412, 1445512, 1445612, 1445712, 1561112
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Santa Clara, CA, 
REASON Incorrect Test Results. Test results may show a higher than expected platelet background count when used on the CELL-DYN 4000 System and report patient results that are unacceptable (out-of-range).
VOLUME OF PRODUCT IN COMMERCE 6,893 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 DNA Probe Set; fluorescence in situ hybridization (FISH) analyte specific reagents, in vitro diagnostic; list 05J83-001; The probe set consists of a 200 microliter vial of Vysis LSI D13S319 SO/LSI 13q34 SA/CEP 12 SG Probe, reference 30-191024, and a 200 microliter vial of Vysis LSI ATM SG/p 53 SO Probe, reference 30-191025, 
CODE Lot numbers 79500, exp. 8-9-08 and 80178, exp.10-16-08
RECALLING FIRM/MANUFACTURER Abbott Molecular, Des Plaines, IL, 
REASON The LSI D13S319 SO/13q34 SA/CEP 12 SG probe of the two mixture DNA-Probe was contaminated with LSI ATM SG/p53 SO probe. This contamination would result in 10 FISH signals in each normal cell rather than the expected 6 FISH signals in each normal cell.
VOLUME OF PRODUCT IN COMMERCE 109 Probe sets
DISTRIBUTION Nationwide and Internationally

PRODUCT 19 Gauge Trocar Cannula Replacement Plug, Catalog Number 617.32, 
CODE Lot F58507
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alcon Research, Ltd, Fort Worth, TX, 
Manufacturer: Alcon Grieshaber AG, Schaffhausen, Switzerland. 
REASON Product is misbranded; 19 gauge Schlera Plugs distributed in containers labeled as 19 gauge Trochar Cannula Plugs.
VOLUME OF PRODUCT IN COMMERCE 15 units
DISTRIBUTION Nationwide

WEEK ENDING MARCH 31

Smith & Nephew Issues Recall of RF Denervation Probes Used for the Spine

Smith & Nephew Inc. is recalling 539 RF Denervation probes for the part numbers and models listed in the table below.

The Smith & Nephew RF Denervation probes are indicated for use exclusively with the Smith & Nephew ELECTROTHERMAL(TM) 20S SPINE SYSTEM in RF heat lesion procedures for the relief of pain. The RF Denervation Probes, which are provided in a non-sterile condition, were mislabeled as sterile which potentially could result in a patient infection.

Customers who have product that is being recalled should return it to Smith & Nephew per the recall instructions. The recall includes the following products and lot numbers:

Product was distributed to 134 domestic and international customers. It can be identified by the product number, name, and lot numbers identified above. Smith & Nephew has notified its distributors and customers and is arranging for return and replacement of all recalled products.

Consumers with questions may contact the company at 1-800-343-5717.

PRODUCT
a) One Touch Ultra Blood Glucose Test Strips,
b) One Touch Ultra Basic/Profile Test Strips,
CODE
a) Lot #’s: 2691191, 2691261;
b) Lot #’s 272894A, 2619932, 2606340, 2651211
RECALLING FIRM/MANUFACTURER Matrix Distributors, Inc., E Brunswick, NJ, 
REASON Counterfeit Test Strips (manufacturer unknown)
VOLUME OF PRODUCT IN COMMERCE 800 units
DISTRIBUTION Nationwide

PRODUCT
a) HoMedics Thera P Standard size Dry Heating Pad; Model No. HP-100,
UPC 031262003621, 
b) Thera-P Standard size Moist/Dry Heating Pad, Model No. HP-150 (UPC 031262003638) and sold as Walgreens by HoMedics model number 802857 (UPC 04922149892),
c) HoMedics Thera P Standard size Moist/Dry Heating Pad with Auto Shut-off,
Model No. HP-200 (UPC 031262007926), 
d) HoMedics Thera P King size Moist/Dry Heating Pad; Model No. HP-300
(UPC 031262003645), 
e) HoMedics Thera P Model King size Moist/Dry Heating Pad with Auto Shut-off; Model No. HP-500 (UPC 031262003652), 
CODE All units with a four digit date code ending in '01' (this code is located on the hand control and on the bottom panel of the heating pad box).
RECALLING FIRM/MANUFACTURER
Recalling Firm: HoMedics, Inc., Commerce Township, MI,
Manufacturer: Teamedics, Shenzhen, China. 
REASON Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.
VOLUME OF PRODUCT IN COMMERCE 292,108 devices
DISTRIBUTION Nationwide and Canada

DEVICE RECALL EXTENSION
Originally listed for week ending  December 30, 2006 

PRODUCT
KaVo QUATTROcare Spray, 500 ml aerosol can; a maintenance spray for lubrication of KaVo turbines, air motors, straight and contra-angle dental handpieces. For use with the KaVo QUATTROcare maintenance unit only; Made in Germany The spray was produced under the following labels: a) KaVo QUATTROcare Spray AMERICA, Kaltenbach & Voigt GmbH, Biberach/Riss Germany, single can: item #04117630, type 2106, 6-pack: item #04117640, type 2106A b) KaVo QUATTROcare Spray CANADA, Kaltenbach & Voigt GmbH, Biberach/Riss Germany; Distributed by SciCan, 1440 Don Mills Rd, Toronto, Ontario, Canada M3B 3P9, single can: item #04117680, type 2107, 6-pack: item #04117690, type 2107A c) KaVo QUATTROcare Spray, Kaltenbach & Voigt GmbH, Postfach 1454, D-88396 Biberach/Riss Germany, single can: item #04117590, type 2108, 6-pack: item #04117720, type 2108A, CODE
All cans manufactured prior to 11/18/06 Replacement product will have a new date/lot code on the bottom of the can which will end in R3X.
******* On 2/26/07 the firm expanded the recall to include the replacement product which has a lot code on the bottom of the can that ends in R3X.
RECALLING FIRM/MANUFACTURER
Recalling Firm: KaVo America Corp, Lake Zurich IL, 
******* KaVo expanded the recall to include the replacement cans with lot numbers ending in R3X via letters dated 2/26/07. The instructions and recall strategy remain the same as in the 11/22/06 letter, but requesting the dealers to notify their customers by 2/28/07. The QUATTROcare Spray will be replaced with Kavo Spray until the problem with the QUATTROcare Spray is resolved.
Manufacturer: Kaltenbach & Voigt Gmbh & Co. KG, Biberach, Germany. Firm initiated recall is ongoing.
REASON The QUATTROcare Spray cans may allow the gas (propane) to escape from the can under certain circumstances. In rare cases, when an ignition source is nearby, this escape of gas may lead to the emission of smoke and possibly flames from the can which could lead to property damage or personnel injury.
VOLUME OF PRODUCT IN COMMERCE 619,434 cans plus 23,088 replacement cans
DISTRIBUTION Nationwide and Canada

PRODUCT Salivart Oral Moisturizer, packaged in 2.5 fluid ounce (73.9 mL) spray cans, Part Number: 0386-0009-75, 
CODE
Lot ''06AA003'', expiration date 06/08 Lot ''06AA001'', expiration date 06/08 Lot ''06AA002'', expiration date 06/08 Lot ''06AA004'', expiration date 07/08 Lot ''06AA005'', expiration date 07/08 Lot ''06AA006'', expiration date 10/08 Lot ''06AA007'', expiration date 10/08
RECALLING FIRM/MANUFACTURER Gebauer Company, Cleveland, OH,
REASON Microbial Contamination. Certain lots of product failed USP <61> Microbial Limits Testing for total aerobic count during 6 month stability testing.
VOLUME OF PRODUCT IN COMMERCE 34545 cans
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) OEC 9800 Fluoroscopic X-ray System, Model Number A349855,
GE Healthcare, Surgery, 
b) OEC FluoroTrak Plus 9800 Fluoroscopic X-ray System, 
c) OEC 9800 Plus Fluoroscopic X-ray System, Recall # Z-0558-2007;
d) OEC 9800MD Motorized C-arm System, Fluoroscopic X-ray System, CODE Serial numbers: 82-7092-MH, 89-0247-RC, 89-0599, 89-0972, 89-1001, 89-1685, 89-2383, 89-2877, 89-2907, 89-2987, 89-3330
RECALLING FIRM/MANUFACTURER GE OEC Medical Systems, Inc, Salt Lake City, UT, 
REASON During routine service, a cover may have been installed without the required proper lead shielding.
VOLUME OF PRODUCT IN COMMERCE 11 units
DISTRIBUTION Nationwide

PRODUCT
a) Baxter Flo-Gard 6201 Volumetric Infusion Pump, catalog #2M8063, 2M8063R (refurbished), 
b) Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump, catalog #2M8064, 2M8064R (refurbished), 
c) Baxter Flo-Gard 6200 Volumetric Infusion Pump, catalog #2M8043, 2M8043R (refurbished), 
d) Baxter Flo-Gard 6300 Dual Channel Volumetric Infusion Pump, catalog #2M8048, 2M8048R (refurbished), Recall # Z-0635-2007
CODE All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp, Round Lake, IL, 
Manufacturer: Baxter Healthcare Corp, Singapore. 
REASON There is the potential for non-detection of, and no alarm for, upstream occlusion for Flo-Gard Volumetric Infusion Pumps, if an occlusion occurs above a flexible chamber such as a drip chamber, Buretrol or blood filter.
VOLUME OF PRODUCT IN COMMERCE 219,566 pumps
DISTRIBUTION Nationwide and Internationally

PRODUCT Brilliance CT System, Big Bore Configuration, Model #728243. (version 2.2.1), 
CODE Serial numbers: 7009, 7056, 7060, 7066, 7069, 7072, 7079, 7088, 7111, 7112, 7113, 7114, 7117, 7118, 7119, 7121, 7125
RECALLING FIRM/MANUFACTURER Phillips Medical Systems (Cleveland) Inc, Cleveland, OH,
REASON Two conditions have been identified with the Philips Medical System Brilliance Bore ,version 2.2.1 Tumor Localization, that may lead the user to misinterpret the displayed data.
VOLUME OF PRODUCT IN COMMERCE 17 units
DISTRIBUTION Nationwide

PRODUCT VIASYS VELA Ventilator, Viasys Respiratory Care, Inc., 
CODE Lot numbers: AGT03640 thru AGT06049
RECALLING FIRM/MANUFACTURER Viasys Respiratory Care, Inc.dba Bird Products, Palm Springs, CA,
REASON The graphical user interface may become slow in its response and in some cases non-responsive. Under some circumstances this situation may cause the ventilator to delay the annunciation of alarms.
VOLUME OF PRODUCT IN COMMERCE 878 units
DISTRIBUTION Nationwide and Internationally

PRODUCT CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, 
CODE Lot Numbers: 1091612, 1091712, 1091812, 1091912, 1092012, 1092112
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Santa Clara, CA, 
REASON Incorrect Test Results. Product may show a higher than expected platelet background count when used on the CELL-DYN 4000 System and report patient results that are unacceptable (out-of-range).
VOLUME OF PRODUCT IN COMMERCE 9,800 units
DISTRIBUTION Nationwide and Internationally

PRODUCT BacT/ALERT® FA Culture Bottles, 30 ml, for in vitro diagnostic use, 
CODE Lot 1014768
RECALLING FIRM/MANUFACTURER bioMerieux, Inc., Durham, NC, REASON Bacillus sp. contamination was detected in inoculated and uninoculated bottles of BacT/ALERT FA Culture bottles.
VOLUME OF PRODUCT IN COMMERCE 2136 cases (100 bottles per case)
DISTRIBUTION Nationwide and Internationally

PRODUCT BacT/VIEW C.30a Software update (P/N 514515-1) diagnostic data management system, 
CODE All BacT/ALERT 3D instruments (version C.30a only, not the C.30 version of software).
RECALLING FIRM/MANUFACTURER bioMerieux, Inc., Durham, NC, REASON Bottle data is not sent to BacT/ALERT 3D instrument.
VOLUME OF PRODUCT IN COMMERCE 1233 disks
DISTRIBUTION Nationwide and Internationally

PRODUCT ADVIA Centaur CP System, Catalog/Part Number 086-A001. Automated Immunoassay Analyzer, 
CODE All serial numbers of the ADVIA Centaur CP System.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bayer Healthcare, LLC (Diagnostics Division), Tarrytown, NY, 
Manufacturer: Stratec Biomedical Systems AG, Birkenfeld, Germany. 
REASON Firm received complaints for signal 2 & 4 errors, and shifts in Relative Light Units (RLU). Investigations showed that the On-Board Stability (OBS) of the acid & base reagents may be compromised after 4 days after installation onto the Centaur CP system due to evaporation.
VOLUME OF PRODUCT IN COMMERCE 306 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Boston Scientific Medi-Tech(R) Katzen (TM) Infusion Wire, for the infusion of therapeutic agents (i.e. heparin, saline, thrombolytic agents, etc.) in the peripheral vasculature. The wire allows for the delivery of agents in either a "pulse-spray" or "slow weep" technique. Order No. REF: 46-193 (M001461930), 
CODE Lot/Batch #: 9052739
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific, Maple Grove, MN, 
Manufacturer: Boston Scientific Corporation, Miami, FL. 
REASON Boston Scientific is voluntarily recalling one lot/batch of Katzen Infusion Wires because they have identified that the label on the carton may indicate a different length device than what is actually in the carton. The affected batch was manufactured using the Katzen Core Assembly of 146 cm, instead of a 177cm assembly.
VOLUME OF PRODUCT IN COMMERCE 10 units
DISTRIBUTION Nationwide

PRODUCT Thyrotest TSH POC Rapid membrane test. In vitro diagnostic, Product Code 1020, 
CODE Lot numbers 21086-02 expiration 06/08 and Lot number 02106-06 expiration 04/08.
RECALLING FIRM/MANUFACTURER Thyro Tec Inc., Honey Brook, PA, 
REASON Positive control showed little or no positive line.
VOLUME OF PRODUCT IN COMMERCE 284 units
DISTRIBUTION Nationwide