AUGUST 2006
WEEK ENDING AUGUST 5
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 and 971084,
CODE
Serial numbers
80104, 80119, 80120, 80204, 80211, 80212, 80429, 80432, 80569, 80627, 80661,
80685, 80880, 80964, 81056, 81134, 81263, 81293/81295, 81303, 81445/ 81448,
81733, 81738, 81739, 81744/81752, 81757, 81761/81781, 81802/81807, 81824, 81825,
81835, 81845, 81846, 81852, 81864, 81865, 81868, 81869, 81884/81886,
81892/81897, 81918/81955, 81957, 81983/81990, 81996/82025, 82027/82033,
82035/82039, 82043, 82044, 82061/82080, 82084, 82097/82111, 82122/82128, 82133,
82136/82143, 82150/82169, 82172/82204, 82245, 82252/82273, 82283/82286,
82307/82330, 82340/82349, 82405/82426, 82430, 82460/82490, 82498/82553,
82555/82565, 82568/82570, 82612/82631, 82654/82673, 82689, 82690, 82773/82813,
82827/82830, 82852, 82856/82859, 82906, 82936, 82937, 82958/82977, 82983/83013,
83060/83071, 83083/83090, 83093, 83142/83147, 83153/83172, 83198/83239, 83255,
83368/83370, 83400/83407, 83414/83418, 83420/83429, 83440/83443, 83499/83517,
83578/83580, 83633, 83644, 83645, 83654, 85001/85005, 85009/85013, 85026/85029,
85032/85052, 85073/85079, 85093, 85094, 85110, 85111, 85143/85157, 85187/85201,
85223, 85224, 85226/85238, 85244/85249, 85329, 85332/85334, 85337/85350, 85364,
85365, 85368/85370, 85381, 85388/85398, 85402/85404, 85410/85414, 85420/85433,
85441, 85505/85515, 85517/85520, 85522/85530, 85534, 85552, 85554/85557,
85587/85589, 85602/85607, 85619/85623, 85630, 85645/85655, 85658/85667, 85686,
85728/85734, 85755/85757, 85761/85766, 85771/85785, 85787/85793, 85810,
85812/85823, 85825/85838, 85856/85872, 85877/85884, 85888/85902, 85931/85933,
85945, 85955, 85964, 85967/85970, 86017, 86018, 86024/86029, 86055/86057, 86103,
86104, 86118, 86141/86147, 86149, 86150, 86222/86228, 86230, 86245, 86256/86258,
86261/86268, 86281/86283, 86289/86293, 86295, 86296, 86299, 86305, 86306, 86314,
86315, 86320/86322, 86324/86328, 86334, 86335, 86358, 86359, 86385, 86387,
86389/86399, 86400, 86411, 86412, 86419, 86420, 86439, 86440
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Welch Allyn Inc., Skaneateles
Falls, NY,
Manufacturer: MRL, Inc., A
Welch Allyn Company, Buffalo, IL.
REASON The Welch Allyn PIC 50 Defibrillators may display a
"Defib Comm" or "Pace Comm" error message on the device display during use which
may result in a terminal failure of the device to analyze the patient’s ECG and
deliver the appropriate therapy.
VOLUME OF PRODUCT IN COMMERCE 1184
units
DISTRIBUTION Nationwide and Internationally
PRODUCT
a) MD3 X-ray system,
b) MD4 X-ray system,
CODE
a) Site numbers 59515, 38929, 76329, 83654, 82673,
35471, 59524,
86146, 38922, 101151, 38714, 38716, 44865, 6847, 103855,
26071,
103856, 40941, 83047, 62502, 38266, 38422, X1198, 50317, 38289,
17669, 6931, X0917, 26019, 26020, 13661, 38418, 59571, 41462,
82721,
101782, 103209;
b) Site numbers 102550 (20279385), 103023, 38783, 102562
(20279430),
83957, 101155, 82628, 38442, 83038, 13721, 85034, 102583, 80306,
41156, 38993, 84930, X1321, 41032, X1077, 100014, 50328, 17656,
83367,
38586, 100954, 76834, 87176, 41426, 104137, 82800, 103651,
10388, 41111,
17622, 13918, 103377, 101038, X0934, 102034, 52471,
76804, 50251, 44898,
13258, 86545, 101863, 38587, 103043 (20283876),
82688, 38635, 47160, 14099,
45042, 38917, 101156 (20278521), 86328,
38501, 13879, 41439, 41069, 76975,
X1277, 100637, X1078, 35484,
101759, 84463, 105022, X1751, 76877, 13172,
38944, 41143, 85694,
87140, 59546, 13704, 10458, 45039, 76869, 52455, 84892,
41271,
87302, 6842, 41031, 41000, X0662, 87030, 76808, 6838, 62938, 86218,
85491, 50340, 82687, 38912, 101153, 103210
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North
America Co. Phillips, Bothell, WA
Manufacturer: Philips Medical Systems, Best, Netherlands.
REASON
Potential for unexpected table
movement.
VOLUME OF PRODUCT IN COMMERCE 137
units
DISTRIBUTION Nationwide
PRODUCT
a) Kimberly-Clark/Ballard
medical R2 triangle shaped non-radiolucent
multifunction electrode products
for pediatrics. Catalog number 30-595,
Catalog number 3100-1700, Catalog
number 3111-1720,
Catalog number 3112-1730, Catalog number 3114-1740,
Catalog number 3200-1711,
b) Kimberly-Clark/Ballard
medical R2 triangle shaped non-radiolucent
multifunction electrode products
for adults, Catalog number 30-585,
Catalog number 30-590, Catalog number
30-591, Catalog number 30-593,
Catalog number 3100-1702, Catalog number
3100-703,
Catalog number 3111-1721, Catalog number 3112-1731,
Catalog
number 3114-1741, Catalog number 3200-1715,
Catalog number 3250-1780,
CODE
a) Lot number 288003; Lot numbers 284026 and
299215;
Lot numbers 288963, 288969, 290317, 291534, 293216, 294205,
295161, 296269, 298031, 300851, 301438, 303002, 304752, 305508;
Lot
number 282182, 286334, 286341, 290319, 290906, 291536, 293219,
294865,
295602, 296272, 298034, 299217, 301440, 302660, 303005, 305511;
Lot numbers
290321, 297265 and 302661; Lot numbers 282187, 282941,
288973, 290910,
291540, 292666, 293223, 294209, 294869, 295606,
297268, 298037, 299990,
300856, 301443, 302664, 303007, 305514;
b) Lot number 300847; Lot numbers
28802, 297261, 304750;
Lot number 299214; Lot number 288962, 293213, 294860,
302657;
Lot number 297735; Lot number 282936, 293214, 300849, 303000;
Lot numbers 282181, 282938, 286332, 286339, 288964, 288970,
290318,
290905, 291535, 292660, 293217, 294206, 294862, 295600,
296270, 297263,
298032, 299985, 302659, 303003, 304091, 304753,
305509; Lot numbers 282183,
282939, 285955, 286335, 286342, 290320,
290907, 291537, 292662, 293220,
294208, 294866, 295603, 296273,
299218, 299987, 300853, 304093, 305512; Lot
numbers 282185, 284030,
290322, 291538, 292664, 295604, 297266, 300854,
304095;
Lot numbers 282188, 282942, 284031, 288004, 288005, 288966,
288967, 288974, 288975, 290911, 291541, 292667, 293224,
294210 294870,
295607, 296276, 297269, 298038, 299221,
299991, 301444, 302665, 303008,
304097, 304757, 305515;
Lot numbers 292086, 297270, 301445,
302666
RECALLING FIRM/MANUFACTURER Kimberly-Clark Corporation,
Roswell, GA
REASON The tinfoil in the triangle electrodes has the
potential to develop cracks, which may hinder electrical flow and product
performance during defibrillation.
VOLUME OF PRODUCT IN
COMMERCE 95,639 electrode sets
DISTRIBUTION Nationwide and
Internationally
PRODUCT SoftPath ASXII Software
Releases 2.3.0 and 4.3.7. The software is used in pathology labs for
administrative and clinical documentation and data processing,
CODE
Software Releases 2.3.0 and 4.3.7
RECALLING
FIRM/MANUFACTURER SCC Soft Computer, Palm Harbor, FL
REASON Text
from one case is overwriting another. This could cause an incorrect diagnostic
report to be sent to a clinician/surgeon.
VOLUME OF PRODUCT IN
COMMERCE 4 units
DISTRIBUTION Nationwide and Canada
PRODUCT
a) Hamilton brand RAPHAEL
Ventilator (Software Version 2.2x),
b) Hamilton brand
RAPHAEL Silver Ventilator (Software Version 2.2xS),
c) Hamilton brand RAPHAEL Color Ventilator (Software Version
2.2xC, 2.2xCU),
CODE a), b) and c) Serial
Numbers: 2975 to 5360
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Hamilton Medical, Inc., Reno, Nevada,
Manufacturer: Hamilton Medical AG,
Bonaduz, Switzerland.
REASON Alarm Failure -- Following an oxygen cell
calibration, the user may inadvertently and unknowingly disable the alarm
system.
VOLUME OF PRODUCT IN COMMERCE 2,385
units
DISTRIBUTION Nationwide and Internationally
PRODUCT SoftPath ASCII Software,
used in pathology labs to track and report specimens and diagnostic results.
Releases 1.2, 2.1, and 2.3,
CODE Software
Releases 1.2, 2.1, and 2.3
RECALLING FIRM/MANUFACTURER SCC Soft
Computer, Palm Harbor, FL
REASON The client had made a decision to use the
SoftPath Module in a nonstandard manner. User specific circumstances, incorrect
text may appear on a patient report.
VOLUME OF PRODUCT IN
COMMERCE 171
DISTRIBUTION Nationwide and Canada
PRODUCT ExacTrac Robotics, sold
alone as Robotic Tilt Module catalog 49720 and in a bundle as catalog 49700, for
installation on the Varian Exact Couch, a component of the Novalis Shaped Beam
Surgery System; a table tilt device - powered radiation therapy patient support
assembly,
CODE Bundle #06-69448-49700, tilt
module #3520-05-011-49720; bundle #06-69445-49700, tilt module
#3520-05-006-49720; bundle #06-78573-49700, tilt module #3520-05-017-49720;
bundle #06-69573-49700, tilt module #3520-05-002-49720; bundle #06-78149-49700,
tilt module #3520-05-015-49720; bundle #06-66427-49700, tilt module
#3520-05-013-49720; bundle #06-62416-49700, tilt module #3520-05-008-49720; tilt
module #3520-05-018-49720; bundle #06-77290-49700, tilt module
#3520-05-019-49720; bundle #06-77669-49700, tilt module #3520-05-020-49720;
bundle #06-78440-49700, tilt module #3520-05-014-49720; bundle #06-74601-49700,
tilt module #3520-05-010-49720; bundle #06-64377-49700, tilt module
#7520-05-005-49720
RECALLING FIRM/MANUFACTURER Brainlab AG,
Kirchheim B. Muenchen, Germany,
REASON During ExacTrac Robotics
installation on the Varian Exact Couch, the couch height position indication is
re-calibrated to read out the correct positions. This re-calibration could cause
the eventual failure of the vertical lift mechanism of the couch, which might
result in patient injury or death.
VOLUME OF PRODUCT IN COMMERCE 19
devices
DISTRIBUTION Nationwide
PRODUCT Soft Cosmetic Contact
Lenses sold under the brand names: Circle Lens, Europa, Pacifica, Gothika and
Water Color,
CODE All lots
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Hebron International, Inc.,
Atlanta, GA,
Manufacturer: Mi Gwang
Contact Lens Co., Ltd., Kyungsan, Korea.
REASON Contact lenses were distributed and sold to
inappropriate retail establishments without professional eye care
involvement.
VOLUME OF PRODUCT IN COMMERCE 334,187
lenses
DISTRIBUTION Nationwide
PRODUCT St. Francis Medical
Technologies brand X STOP® Interspinous Process Decompression (IPD) System, 14
mm X STOP implants in peel pouch, Catalog #1-2210; The X STOP consists of a main
body, a spacer, and a tissue expander that is secured using a universal wing
assembly consisting of a wing and a setscrew,
CODE Lot numbers 051122, 060126, 060213, 060306, 060322, 060405,
060413, 060420, 060504, 060509
RECALLING FIRM/MANUFACTURER St.
Francis Medical Technologies, Inc., Alameda, CA,
REASON Some units may be
mislabeled as 10 mm X STOP implant that actually contain 14 mm X STOP
implant.
VOLUME OF PRODUCT IN COMMERCE 440
units
DISTRIBUTION Nationwide and Internationally
PRODUCT Beckman Coulter Cytomics
FC 500 Flow Cytometry System, Part Numbers 626553 (TN; FC500 with UPS), 6605627
(TN; 5 CLR, FC500 (100V), 6605628 (TN; 5CLR, FC500 (120V), 6605629 (TN; 5 CLR,
FC500 (220V), 6605630 (TN; 5 CLR, FC500 (240V) with CXP Software Versions 2.0
and 2.1,
CODE Software Versions 2.0 and
2.1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman
Coulter, Inc., Brea, CA,
Manufacturer:
Applied Cytometry, Sheffield, United Kingdom.
REASON Beckman Coulter has determined that under certain
conditions a system error generated during a Pause and rotate routine may result
in a sample misidentification with a risk of reporting erroneous results.
VOLUME OF PRODUCT IN COMMERCE 424
devices
DISTRIBUTION Nationwide and Canada
PRODUCT Waste tubing, Model #
842-326 (pump tube for waste) and Model # 842-327 (pump tube for solution),
Waste Tubing used on ABL 7xx and ABL8xx component of the ABL700/800 Blood Gas
Analyzers, also included in service kits part no. 905-671,
CODE No lot numbers supplied.
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Radiometer America, Inc.,
Westlake, OH,
Manufacturer: Radiometer
A/S, Copenhagen, Denmark.
REASON An increased failure rate was observed with the
yellow rubber tubing. The tubing was found to be leaking blood and solutions
after distribution.
VOLUME OF PRODUCT IN COMMERCE 2,576
units
DISTRIBUTION Nationwide and Canada
PRODUCT Dri-Tex BG-OX Cartridge,
Model # D7120, Catalog # 946-003. Cartridges used in the NPT7 Analyzer, an in
vitro diagnostic device,
CODE Lot # R0299,
Expiration Date: 02/2008
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Radiometer America, Inc., Westlake, OH,
Manufacturer: Radiometer A/S, Copenhagen, Denmark.
REASON
Air bubbles may be trapped on
or close to the O2 sensor in the pO2 chamber of the cuvettes in cartridges used
for blood gas analysis on NPT7 analyzer. This produces too high pO2 readings
without a question mark.
VOLUME OF PRODUCT IN COMMERCE 185
units
DISTRIBUTION Nationwide
PRODUCT Radiance Data
Management System Software Version 2.42 (Stand-alone software package) for the
Radiance STAT Analyzer Management System, in vitro diagnostic, Model 914-317
Radiance Basic Kit,
CODE Version 2.42 operating
software
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Radiometer America, Inc., Westlake, OH,
Manufacturer: Radiometer A/S, Copenhagen, Denmark.
REASON
Software anomaly. Data
generated by blood gas equipment did not correlate with data shown in the
Radiance Data Management System.
VOLUME OF PRODUCT IN COMMERCE 306
units
DISTRIBUTION Nationwide
PRODUCT
a) Microcuff Endotracheal
Tube; Pediatric Oral/Nasal Magill: ID Size: 3,0mm,
Microcuff Product
Reference: I-MPEDC-30; ID Size: 3,5mm, Product
Reference: I-MPEDC-35; ID
Size: 4,0mm, Product Reference: I-MPEDC-40;
ID Size: 4.5mm, Product
Reference: I-MPEDC-45; ID Size: 5,0mm, Product
Reference: I-MPEDC-50; ID
Size: 5,5mm, Product Reference: I-MPEDC-55;
ID Size: 6,0mm, Product
Reference: I-MPEDC-60; ID Size: 6,5mm, Product
Reference: I-MPEDC-65 and ID
Size: 7,0mm, Product Reference: I-MPEDC-70
* Sterile * Single use only * ,
b) Microcuff Pediatric Endotracheal Tubes - Oral
Pre-Curved: ID Size: 3,0mm,
Microcuff Product Reference: I-MPEDC-30; ID
Size: 3,5mm, Product Reference:
I-MPEOC-35; ID Size: 4,0mm, Product
Reference: I-MPEOC-40; ID Size: 4.5mm,
Product Reference: I-MPEOC-45; ID
Size: 5,0mm, Product Reference: I-MPEOC-50;
ID Size: 5,5mm, Product
Reference: I-MPEOC-55; ID Size: 6,0mm, Product
Reference: I-MPEOC-60; ID
Size: 6,5mm, Product Reference: I-MPEOC-65 and ID
Size: 7,0mm, Product
Reference: I-MPEOC-70 * Sterile * Single use only *,
c) Microcuff Adult Endotracheal Tubes - Oral/Nasal Magill with
Murphy Eye *
ID Size: 5,0mm, Microcuff Product Reference: I-HMICU-50; ID
Size: 5.5mm,
Product Reference: I-HMICU- 55; ID Size: 6.0mm, Product
Reference:
I-HMICU- 60; ID Size: 6.5mm, Product Reference: I-HMICU- 65; ID
Size: 7.0mm, Product Reference: I-HMICU- 70; ID Size: 7.5mm,
Product
Reference: I-HMICU-75; ID Size: 8.0mm, Product Reference: I-HMICU-80;
ID Size: 8.5mm, Product Reference: I-HMICU-85; ID Size: 9.0mm, Product
Reference: I-HMICU-90; and ID Size: 10.0mm Product Reference: I-HMICU-10 *
Sterile * Single use only *,
CODE All
lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Microcuff
Gmbh, Weinheim, Germany,
Manufacturer: Unomedical Industries, Kedah, Malaysia.
REASON
Inadequate seals and/or holes
in the pouch may compromise the sterility of the product.
VOLUME OF
PRODUCT IN COMMERCE 1,730 units
DISTRIBUTION Nationwide
PRODUCT
a) Terumo Advanced
Perfusion System 4 inch diameter Roller Pump;
Model 801040,
b) Terumo Advanced Perfusion System 1 Large Roller Pump; Model
801041,
CODE
a) Serial numbers: 0031 through
1188;
b) Serial numbers: 0033 through 1339
RECALLING
FIRM/MANUFACTURER Terumo Cardiovascular Systems Corp., Ann Arbor, MI,
REASON
The pump may stop during the autodose
delivery without completion of the dose delivery to the patient.
VOLUME OF
PRODUCT IN COMMERCE 1,898 devices
DISTRIBUTION Nationwide
and Internationally
PRODUCT
a) Gamma Win software,
part number GM11019110, versions up to and
including 1.62, for the
GammaMedplus radionuclide applicator system,
for radiation therapy,
b) Gamma Win software, part number GM11019110, versions up to and
including 1.62, for the GammaMedplus 3/24 radionuclide applicator system,
for radiation therapy,
c) Gamma Win software, part
number GM11019110, versions up to and
including 1.62, for the Mammo Source
radionuclide applicator system,
for radiation therapy,
CODE
All lots are recalled. Serial numbers are described:
a)
H64Y001 H64A032 H64A052 H64B074 H64C096 H64D120 H64Y002 H64A033 H64A053 H64B075 H64C097 H64D121 H64Y003 H64A034 H64A054 H64B076
H64C098 H64D122
H64Y006 H64A035 H64A055 H64B077 H64C099 H64D123 H64Y007 H64A036 H64A056
H64B078 H64C100 H64D124 H64Y009 H64A037 H64A057 H64B079 H64C101 H64D127
H64Y012 H64A038 H64A058 H64B080 H64C102 H64D128 H64Y013 H64A039 H64A059
H64B081 H64C103 H64D129 H64Z015 H64A040 H64A060 H64B082 H64C104 H64D130
H64Z018 H64A041 H64A061 H64B083 H64C106 H64D131 H64Z019 H64A042 H64A062
H64B084 H64C107 H64D132 H64Z021 H64A043 H64A063 H64B085 H64C108 H64D133 H64Z022 H64A044 H64A064 H64B087 H64C109 H64D134 H64Z024 H64A045 H64A066
H64B088 H64C110 H64D135 H64Z025 H64A046 H64A067 H64B089 H64C112 H64D136
H64Z026 H64A047 H64A068 H64B090 H64C113 H64E137 H64Z027 H64A048 H64B070
H64B091 H64D115 H64E138 H64Z028 H64A049 H64B071 H64C093 H64D116 H64E140
H64Z029 H64A050 H64B072 H64C094 H64D117 H64E141 H64Z030 H64A051 H64B073
H64C095 H64D118 H64E142 H64E143 H64E166 H64F191 H64F211 H640234 H640254
H64E147 H64E167 H64F192 H64F212 H640235 H640255 H64E148 H64E168 H64F193 H64F213
H640236 H640256 H64E149 H64E169 H64F194 H64F216 H640237 H640257 H64E150 H64E170 H64F195 H640217 H640238 H640258 H64E151 H64E171 H64F196 H640218 H640239 H640259 H64E152 H64E172 H64F197 H640219 H640240 H640260 H64E153 H64E173 H64F198 H640220 H640241 H640261 H64E154 H64E175 H64F199 H640221 H640242 H640262 H64E155 H64E176 H64F200 H640222 H640243 H640264 H64E156 H64E177 H64F201 H640224 H640244 H640265 H64E157 H64E178 H64F202 H640225 H640245 H640266 H64E158 H64E179 H64F203 H640226 H640246 H640267 H64E159 H64E180 H64F204 H640227 H640247 H640268 H64E160 H64F181 H64F205 H640228
H640248 H640269 H64E161 H64F182
H64F206 H640229 H640249 H640270 H64E162 H64F183 H64F207 H640230 H640250 H640271 H64E163 H64F184
H64F208
H640231 H640251 H640273 H64E164 H64F185 H64F209 H640232 H640252
H640275
H64E165 H64F189 H64F210 H640233 H640253;
b) All lots are recalled. Serial
numbers are described: H64Y001 H64A032 H64A052 H64B074 H64C096 H64D120
H64Y002 H64A033 H64A053 H64B075 H64C097 H64D121 H64Y003 H64A034 H64A054
H64B076 H64C098 H64D122 H64Y006 H64A035 H64A055 H64B077 H64C099 H64D123
H64Y007 H64A036 H64A056 H64B078 H64C100 H64D124 H64Y009 H64A037 H64A057
H64B079 H64C101 H64D127 H64Y012 H64A038 H64A058 H64B080 H64C102 H64D128
H64Y013 H64A039 H64A059 H64B081 H64C103 H64D129 H64Z015 H64A040
H64A060 H64B082 H64C104 H64D130 H64Z018 H64A041 H64A061 H64B083 H64C106
H64D131 H64Z019 H64A042 H64A062 H64B084 H64C107 H64D132 H64Z021 H64A043
H64A063 H64B085 H64C108 H64D133 H64Z022 H64A044 H64A064 H64B087 H64C109
H64D134 H64Z024 H64A045 H64A066 H64B088 H64C110 H64D135 H64Z025
H64A046 H64A067 H64B089 H64C112 H64D136 H64Z026 H64A047 H64A068 H64B090
H64C113 H64E137 H64Z027 H64A048 H64B070 H64B091 H64D115 H64E138 H64Z028
H64A049 H64B071 H64C093 H64D116 H64E140 H64Z029 H64A050 H64B072 H64C094
H64D117 H64E141
H64Z030 H64A051 H64B073 H64C095 H64D118 H64E142 H64E143 H64E166 H64F191 H64F211 H640234 H640254 H64E147 H64E167
H64F192 H64F212
H640235 H640255 H64E148 H64E168 H64F193 H64F213 H640236 H640256 H64E149
H64E169 H64F194 H64F216 H640237 H640257 H64E150 H64E170 H64F195 H640217
H640238
H640258 H64E151 H64E171 H64F196 H640218 H640239 H640259 H64E152
H64E172 H64F197 H640219 H640240 H640260 H64E153 H64E173 H64F198 H640220
H640241 H640261 H64E154 H64E175 H64F199 H640221 H640242 H640262 H64E155
H64E176 H64F200 H640222 H640243 H640264 H64E156 H64E177 H64F201 H640224 H640244 H640265 H64E157 H64E178 H64F202 H640225 H640245
H640266 H64E158
H64E179 H64F203 H640226 H640246 H640267 H64E159 H64E180 H64F204 H640227
H640247 H640268 H64E160 H64F181 H64F205 H640228 H640248 H640269 H64E161
H64F182 H64F206 H640229 H640249 H640270 H64E162 H64F183 H64F207 H640230
H640250 H640271 H64E163 H64F184 H64F208 H640231 H640251 H640273 H64E164
H64F185 H64F209 H640232 H640252 H640275 H64E165 H64F189 H64F210 H640233
H640253;
c) All lots are recalled. Serial numbers are described: H64Y001 H64A032 H64A052 H64B074 H64C096 H64D120 H64Y002 H64A033
H64A053 H64B075
H64C097 H64D121 H64Y003 H64A034 H64A054 H64B076 H64C098 H64D122 H64Y006
H64A035 H64A055 H64B077 H64C099 H64D123 H64Y007 H64A036 H64A056 H64B078
H64C100
H64D124 H64Y009 H64A037 H64A057 H64B079 H64C101 H64D127 H64Y012
H64A038 H64A058 H64B080 H64C102 H64D128 H64Y013 H64A039 H64A059 H64B081
H64C103 H64D129 H64Z015 H64A040 H64A060 H64B082 H64C104 H64D130 H64Z018
H64A041 H64A061 H64B083 H64C106 H64D131 H64Z019 H64A042 H64A062 H64B084 H64C107 H64D132 H64Z021 H64A043 H64A063 H64B085 H64C108
H64D133 H64Z022
H64A044 H64A064 H64B087 H64C109 H64D134 H64Z024 H64A045 H64A066 H64B088
H64C110 H64D135 H64Z025 H64A046 H64A067 H64B089 H64C112 H64D136 H64Z026
H64A047 H64A068 H64B090 H64C113 H64E137 H64Z027 H64A048 H64B070 H64B091
H64D115 H64E138 H64Z028 H64A049 H64B071 H64C093 H64D116 H64E140 H64Z029
H64A050 H64B072 H64C094 H64D117 H64E141 H64Z030 H64A051 H64B073 H64C095
H64D118 H64E142 H64E143 H64E166 H64F191 H64F211 H640234 H640254 H64E147 H64E167 H64F192 H64F212 H640235 H640255 H64E148 H64E168
H64F193 H64F213
H640236 H640256 H64E149 H64E169 H64F194 H64F216 H640237 H640257 H64E150
H64E170 H64F195 H640217 H640238H640258 H64E151 H64E171 H64F196 H640218
H640239 H640259 H64E152 H64E172 H64F197 H640219 H640240 H640260 H64E153
H64E173 H64F198 H640220 H640241 H640261 H64E154 H64E175 H64F199 H640221
H640242 H640262 H64E155 H64E176 H64F200 H640222 H640243 H640264 H64E156
H64E177 H64F201 H640224 H640244 H640265 H64E157 H64E178 H64F202 H640225 H640245 H640266 H64E158 H64E179 H64F203 H640226 H640246
H640267 H64E159
H64E180 H64F204 H640227 H640247 H640268
H64E160 H64F181 H64F205 H640228
H640248 H640269 H64E161 H64F182 H64F206 H640229 H640249 H640270 H64E162
H64F183 H64F207 H640230 H640250 H640271 H64E163 H64F184 H64F208 H640231
H640251 H640273 H64E164 H64F185 H64F209 H640232 H640252 H640275 H64E165
H64F189 H64F210 H640233 H640253
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Varian Medical Systems,
Charlottesville, VA,
Manufacturer: Varian
Medical Systems, Haan, Germany.
REASON Medical device software for brachytherapy may cause
erroneous data to be recorded and affect patient radiation treatments. Erroneous
data may be listed on the treatment history report, and the default step size
may lead to a misadministration if treatment data is entered
manually.
VOLUME OF PRODUCT IN COMMERCE 254
units
DISTRIBUTION Nationwide and Internationally
PRODUCT
a) Zimmer Trabecular
Metal Shoulder Instrumentation Distal Pilot, 8 mm diameter, 130 mm length
non-sterile, catalog no. 4309-08-13 (00-4309-008-13),
b) Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot,
9 mm diameter, 130 mm length non-sterile, catalog no. 4309-09-13 (00-4309-009-13),
c) Zimmer Trabecular Metal Shoulder
Instrumentation Distal Pilot, 10 mm diameter, 130 mm length non-sterile,
catalog no. 4309-10-13 (00-4309-010-13),
d) Zimmer
Trabecular Metal Shoulder Instrumentation Distal Pilot, 11 mm diameter, 130
mm length non-sterile, catalog no. 4309-11-13 (00-4309-011-13),
e) Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot,
12 mm diameter, 130 mm length non-sterile, catalog no. 4309-12-13 (00-4309-012-13),
f) Zimmer Trabecular Metal Shoulder
Instrumentation Distal Pilot, 13 mm diameter, 130 mm length non-sterile,
catalog no. 4309-13-13 (00-4309-013-13),
g) Zimmer
Trabecular Metal Shoulder Instrumentation Distal Pilot, 14 mm diameter, 130
mm length non-sterile, catalog no. 4309-14-13 (00-4309-014-13),
h) Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot,
15 mm diameter, 130 mm length non-sterile, catalog no. 4309-15-13 (00-4309-015-13),
i) Zimmer Trabecular Metal Shoulder
Instrumentation Distal Pilot, 16 mm diameter, 130 mm length non-sterile,
catalog no. 4309-16-13 (00-4309-016-13),
j) Zimmer
Trabecular Metal Shoulder Instrumentation Distal Pilot, 17 mm diameter, 130
mm length non-sterile, catalog no. 4309-17-13 (00-4309-017-13),
k) Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot,
18 mm diameter, 130 mm length non-sterile, catalog no. 4309-18-13 (00-4309-018-13),
l) Zimmer Trabecular Metal Shoulder
Instrumentation Distal Pilot, 8 mm diameter, 170 mm length non-sterile,
catalog no. 4309-08-17 (00-4309-008-17),
m) Zimmer
Trabecular Metal Shoulder Instrumentation Distal Pilot, 10 mm diameter, 170
mm length non-sterile, catalog no. 4309-10-17 (00-4309-010-17),
n) Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot,
12 mm diameter, 170 mm length non-sterile, catalog no. 4309-12-17 (00-4309-012-17),
o) Zimmer Trabecular Metal Shoulder
Instrumentation Distal Pilot, 14 mm diameter, 170 mm length non-sterile,
catalog no. 4309-14-17 (00-4309-014-17),
CODE All lots
RECALLING
FIRM/MANUFACTURER Zimmer Inc., Warsaw, IN
REASON During provisional
trialing, the instrument may become stuck in the humeral canal and require
surgical removal.
VOLUME OF PRODUCT IN COMMERCE 324
units
DISTRIBUTION Nationwide and Internationally
PRODUCT
a) Guidant CONTAK RENEWAL
3 (models H170, H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardiac
Resynchronization Therapy Defibrillator (CRT-D). Cardiac resynchronization
therapy defibrillators (CRT-D) provide ventricular tachyarrhythmia and
cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricular tachycardia (VT) and ventricular
fibrillation (VF), rhythms that are associated with sudden cardiac death
(SCD). Cardiac resynchronization therapy is for the treatment
of heart
failure (HF) and uses biventricular electrical stimulation to synchronize
ventricular contractions. Cardioversion/defibrillation therapies include a
range of low-and high-energy shocks using either a biphasic or monophasic
waveform,
b) These models are not available in the US.
Guidant CONTAK RENEWAL 4 (models H190, H195). Cardiac Resynchronization
Therapy Defibrillator (CRT-D). Cardiac resynchronization therapy
defibrillators (CRT-D) provide ventricular tachyarrhythmia and cardiac
resynchronization therapies. Ventricular tachyarrhythmia therapy is for the
treatment of ventricular tachycardia (VT) and ventricular fibrillation (VF),
rhythms that are associated with sudden cardiac death (SCD). Cardiac resynchronization therapy is for the treatment of heart failure
(HF) and
uses biventricular electrical stimulation to synchronize ventricular
contractions. Cardioversion/defibrillation therapies include a range of
low-and high-energy shocks using either a biphasic or monophasic waveform,
c) CONTACT RENEWAL 4 AVT HE model numbers M177. Cardiac
Resynchronization Therapy Defibrillator. CONTAK RENEWAK AVT models
provide both atrial and ventricular tachyarrhythmia and cardiac resynchronization therapies,
d) VITALITY AVT, model
A155. Implantable Cardioverter, Defibrillator, Atrial and Ventricular
Therapies, Model A155, Recall # Z-1291-06;
e) Guidant VITALITY 2 (models
T165, T175), VITALITY DS (model T125), VITALITY EL (model T135), Implantable
Cardioverter Defibrillators (ICD), are designed to detect and terminate
ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide
bradycardia therapy (atrial and ventricular pacing). Therapies include both
low- and high-energy shocks
using either a biphasic or monophasic waveform.
Vitality 2 devices also offer a wide variety of antitachycardia pacing
schemes to terminate slower, more stable ventricular tachyarrhythmias.
Bradycardia pacing, including adaptive-rate features, is available to detect
and treat bradyarrhythmias and to support the cardiac rhythm after
defibrillation therapy. Devices denoted with DR offer dual-chamber
bradycardia features (atrial and/or ventricular pacing and sensing), and the
devices denoted with VR offer single-chamber bradycardia features
(ventricular pacing and sensing),
CODE
a)
Model H170, Serial numbers: 509659, 509677, 509678, 509679, 509685, 509694,
509695, 509696, 509762, 509884, 509974, 510012
model H175, serial numbers:
512665, 512666, 512667, 512668, 512708, 512709, 512710, 512711, 512713,
512719, 512721, 512722, 512723, 512759, 512791, 512793, 513062, 513064,
513073, 513085, 513086, 513227
model H177, serial numbers: 506951, 506953,
506954, 506955, 506956, 506957, 506959, 506960, 506967, 506969, 506970,
506973, 506974, 507013, 507014, 507472
model H179, serial numbers: 508312,
508316, 508322, 508325, 508326, 508336, 508342, 508349, 508404;
b) Model
H190, Serial numbers: 301196, 301198, 301204, 301206
Model H195, Serial
numbers: 306327, 306332, 306333, 306334, 306337, 306339, 306348, 306349,
306351, 306367, 306368, 306378, 306380, 306447;
c) Serial numbers:
100160, 100161, 100162;
d) Serial numbers: 113567, 113568, 113569, 113570,
113572, 113574, 113585, 113586, 113587, 113591, 113612, 113613, 113616,
113617, 113618, 113619, 113620, 113621, 113623, 113624, 113626, 113627, 113628, 113629, 113631, 113633, 113635, 113637, 113639, 113640,
113641,
113654, 113659, 113660, 113672, 113674, 113675, 113676,
113678, 113679,
113680, 113681, 113682, 113684, 113686, 113687, 113690, 113693, 113694,
113695, 113696, 113778, 113779, 113781, 113783, 113784, 113789, 113791,
113792, 113814, 113908, 113910, 113912, 113913, 113914, 114083;
e) Model
T165, Serial numbers: 106641, 106643, 106644, 106645, 106646, 106647,
106648, 106649, 106651, 106652, 106676, 106677, 106678, 106679, 106680,
106681, 106683, 106685, 106686, 106687, 106691, 106692, 106693, 106694,
106696, 106697, 106700, 106701, 106702, 106778, 106779, 106780, 106781,
106782, 106788, 106789, 106790, 106792, 106793, 106794, 106795, 106796,
106797, 106798, 106799, 106803, 106804, 106805, 106806, 106807, 106808,
106810, 106813, 106815, 106816, 106817, 106818, 106819, 106820, 106821, 106822, 106823, 106824, 106825, 106826, 106827, 106828, 106829,
106830,
106831, 106832, 106833, 106834, 106835, 106836, 106837, 106838, 106839,
106840, 106841, 106842, 106843, 106844, 106845, 106846, 106847, 106849,
106850, 106851, 106852, 106853, 106854, 106855, 106856, 106857, 106858,
106860, 106861, 106862, 106863, 106864, 106865, 106867, 106868, 106869,
106870, 106871, 106872, 106873, 106874, 106875, 106876, 106877, 106878,
106879, 106880, 106881, 106882, 106883, 106884, 106885, 106886, 106888,
106889, 106890, 106891, 106892, 106894, 106895, 106896, 106898, 106899, 106900, 106901, 106903, 106905, 106906, 106907, 106908, 106909,
106910,
106911, 106914, 106915, 106916, 106917, 106919, 106920, 106922, 106923,
106925, 106926, 106929, 106932, 106935, 106936, 106937, 106939, 106940,
106941, 106942, 106943, 106945, 106946, 106947, 106948, 106949, 106952,
106953, 106954, 106955, 106956, 106957, 106959, 106960, 106962, 106963,
106964, 106965, 106968, 106969, 106970, 106971, 106972, 106973, 106974,
106975, 106976, 106977, 106978, 106979, 106980, 106981, 106982, 106983,
106984, 106985, 106987, 106990, 106991, 106992, 106993, 106996, 106997, 106998, 106999, 107000, 107001, 107002, 107003, 107004, 107007,
107008,
107009, 107010, 107011, 107012, 107013, 107015, 107017, 107018, 107019,
107020, 107021, 107033, 107034, 107035, 107036, 107037, 107039, 107043,
107044, 107045, 107046, 107047, 107057, 107058, 107059, 107060, 107061,
107062, 107064, 107065, 107066, 107067, 107068, 107069, 107070, 107072,
107075, 107077, 107078, 107079, 107082, 107087, 107091, 107092, 107099,
107101, 107102, 107103, 107106, 107110, 107116, 107123, 107124, 107141,
107208, 107210, 107254, 107263, 107264, 107265, 107266, 107267, 107298, 107299, 107300, 107301, 107303, 107304, 107306, 107307, 107308,
107315,
107316, 107317, 107318, 107320, 107321, 107322, 107389, 107718, 108310,
108376, 115934
Model T175, serial numbers: 105118, 105119, 105120, 105122,
105126, 105130, 105131, 105140, 105141, 105156, 105157, 105158, 105161, 105162, 105165, 105166, 105167, 105169 105170, 105172, 105173,
105174,
105176, 105177, 105178, 105179, 105180, 105181, 105182, 105183, 105184,
105186, 105187, 105189, 105191, 105192, 105194,
105196, 105197, 105200,
105207, 105208, 105209, 105210, 105211, 105212, 105213, 105217, 105304,
105305, 105306, 105307, 105308, 105364, 105365, 105366, 105367, 105368,
105369, 105370, 105371, 105372, 105373, 105374, 105375, 105376, 105377,
105378, 105379, 105380, 105381, 105382, 105383, 105384, 105385, 105386,
105387,
105388, 105389, 105390, 105391, 105393, 105395, 105397, 105398, 105399, 105400, 105401, 105402, 105403, 105404, 105405, 105406,
105407,
105409, 105410, 105411, 105412, 105413, 105414, 105415, 105416, 105417,
105418, 105419, 105420, 105421, 105422, 105423, 105424, 105425, 105426,
105427, 105428, 105429, 105431, 105432,
105433, 105434, 105435, 105436,
105437, 105438, 105439, 105440, 105442, 105443, 105444, 105445, 105446,
105447, 105448, 105449, 105450, 105451, 105452, 105453, 105454, 105455,
105456, 105458, 105459, 105460, 105461, 105462, 105463, 105464, 105465,
105466, 105467, 105468, 105469, 105470, 105471, 105472, 105473, 105474,
105476, 105477, 105478, 105479, 105480, 105481, 105482, 105483, 105484,
105485, 105487, 105488, 105573, 105575, 105576, 105577, 105578, 105579,
105580, 105581, 105584, 105586, 105587, 105588, 105589, 105590, 105591,
105592, 105593, 105594, 105595, 105596, 105598, 105599, 105600, 105602,
105603, 105604, 105605, 105606,
105607, 105611, 105613, 105624, 105625,
105627, 105628, 105629, 105630, 105632, 105633, 105634, 105635, 105636,
105638, 105639, 105640, 105642, 105643, 105644, 105645, 105646, 105647,
105648, 105649, 105650, 105651, 105652, 105654, 105655, 105656, 105657, 105658, 105659, 105660, 105661, 105662, 105663, 105664, 105665,
105666,
105667, 105668, 105669, 105670, 105671, 105672, 105673, 105674, 105675,
105676, 105677, 105678, 105679, 105680, 105681, 105682, 105683, 105687,
105688, 105689, 105690, 105691, 105694, 105705, 105706, 105707, 105712,
105713, 105714, 105715, 105716, 105717, 105718, 105720, 105721, 105722,
105723, 105724, 105725,
105726, 105727, 105728, 105739, 105740, 105741,
105743, 105744, 105745, 105746, 105747, 105748, 105749, 105750, 105752,
105753, 105754, 105755, 105756, 105757, 105758, 105759, 105760, 105762, 105763, 105764, 105765, 105766, 105767, 105768, 105785, 105786,
105790,
105792, 105796, 105820, 105857, 105881, 105884, 105885,
105895, 105898,
105914, 105915, 105917, 105919, 105923, 105924, 105925, 105926, 105927,
105928, 105929, 105930, 105931, 105932 105933, 105934, 105935, 105936,
105937, 105940, 105944, 105945, 105946, 105947, 105948, 105949, 105950,
105951, 105952, 105953, 106074, 106155, 106156, 106157, 106171, 106172,
106173, 106174,
106177, 106178, 106186, 106187, 106189, 106191, 106199,
106200, 106201, 106212, 106213, 106235, 106282, 106361, 106503,
107047, 107301, 107593, 108285
Model T125, Serial numbers: 113211,
113221, 113222, 113223, 113224, 113241, 113243, 113244, 113272, 113273,
113274, 113275, 113276, 113277, 113278, 113279, 113282, 113283, 113284,
113285, 113286, 113287, 113288, 113291, 113292, 113294, 113295, 113296,
113297, 113298, 113299, 113300, 113301, 113317, 113318, 113319, 113320,
113322, 113323, 113324, 113325, 113326, 113327, 113328, 113329, 113330,
113331, 113333, 113334, 113335, 113336, 113337, 113339, 113340, 113341,
113342, 113343, 113344, 113345, 113346, 113347, 113348, 113349, 113350,
113351, 113352, 113353, 113355, 113356, 113359, 113360, 113362, 113363,
113364, 113365, 113366, 113367,
113368, 113369, 113370, 113372, 113373,
113374, 113375, 113378, 113379, 113380, 113381, 113383, 113384, 113385,
113386, 113387, 113388, 113389, 113390, 113391, 113393, 113394, 113396,
113397, 113398, 113399, 113400, 113403, 113408, 113414, 113417,
113420, 113422, 113425, 113427, 113428, 113429, 113430, 113431, 113433,
113434, 113435, 113487, 113492, 113495, 113496, 113500, 113557, 113643,
113847, 113850, 114102
Model T135, Serial numbers: 941570, 941572, 941573,
941574, 941578, 941585, 941589, 941590, 941591, 941592, 941593, 941595,
941597, 941601, 941602, 941603, 941604, 941605, 941606, 941607, 941608, 941609, 941610, 941613, 941614, 941615, 941616, 941618, 941619,
941620,
941621, 941622, 941623, 941624, 941625, 941626, 941627,
941628, 941629,
941630, 941632, 941633, 941634, 941652, 941653, 941654, 941680, 941681,
941682, 941683, 941688, 941689, 941690, 941691 941692, 941695, 941696,
941697, 941698, 941699, 941700, 941701, 941702, 941703, 941704, 941709,
941710, 941712, 941715, 941716, 941717, 941718, 941719, 941721, 941722,
941723, 941724,
941725, 941727, 941728, 941732, 941734, 941735, 941736,
941737, 941738, 941739, 941740, 941741, 941742, 941743, 941745, 941747, 941748, 941749, 941750, 941752, 941753, 941754, 941756, 941757,
941759,
941762, 941767, 941775, 941776, 941777, 941778, 941781, 941784, 941786,
941787, 941788, 941789, 941800, 941802, 941803,
941804, 941805, 941807,
941810, 941812, 941813, 941814, 941819, 941829, 941830, 941831, 941845,
941846, 941929, 941930, 941933, 941940, 941948, 941953, 941956, 941962,
941970, 941975, 941978, 941979, 942017
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Guidant Corporation, Saint Paul,
MN,
Manufacturer: Guidant-Ireland, Clomel, Ireland.
REASON
Guidant
had identified a pattern of premature battery depletion in devices manufactured
with a single lot of capacitors from a single supplier. If function of this low
voltage capacitor is compromised, the battery may deplete
prematurely.
VOLUME OF PRODUCT IN COMMERCE 996
devices
DISTRIBUTION Nationwide and Internationally
PRODUCT Boston Scientific Urovac
Bladder Evacuator, sterile, single use only, REF/Catalog no. 730-125 and sold
individually as UPN M0067301250 and in packaged of ten as UPN M0067301251,
CODE
All lots expiring on or before June 12,
2010
RECALLING FIRM/MANUFACTURER Boston Scientific Corp., Spencer, IN
REASON
Sterility is compromised because the product is
labeled as sterile, but the packages may have holes in them.
VOLUME OF
PRODUCT IN COMMERCE 446,097 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT Ultra-Filtration (UF)
Removal Regulators(Rgltr Assy UF REM Molded Spare); a spare part used with
Baxter’s System 1000, Tina, Arena, Altratouch and Aurora Hemodialysis
Instruments; item numbers 6001276024 and 6001276028,
CODE Lot numbers 01095126 and 01092479; Lot number
01095127
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter
Healthcare Renal Div., Mc Gaw Park, IL,
Manufacturer: Baxter Healthcare Corporation, Largo, FL.
REASON
The UF Removal Regulators were
assembled incorrectly. The mis-assembly results in a failure to successfully
calibrate the instrument and begin patient therapy.
VOLUME OF PRODUCT IN
COMMERCE 569 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT VIASYS Healthcare
Disposable Bar Electrodes. Re-order No. 019-435600. Single Use only,
CODE
Lot 604664
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Nicolet Biomedical Div. of
Viasys Healthcare, Madison, WI,
Manufacturer: Tyco Healthcare Uni-Patch, Wabasha, MN.
REASON
The Bar Electrodes do not meet
performance specification for electrode impedance. A manufacturing defect was
discovered in disposable bar electrodes, part number 019-435600, lot 604664,
that has the potential to reduce the amplitude of a motor or sensory nerve
action potential. These possible lower amplitudes will be measured only if the
bar electrode is used as a bar.
VOLUME OF PRODUCT IN COMMERCE 53
boxes, 10 electrodes per pouch, 10 pouches per
box
DISTRIBUTION Nationwide and Internationally
PRODUCT IMPAX 4.5 Systems, used
in the acceptance, transfer, display, storage and digital processing of medical
images,
CODE All Impax 4.5 sites running Solaris
9 (Sun OS 5.9) that do not have Sun Patch ID 118305-08
installed.
RECALLING FIRM/MANUFACTURER AGFA Corp., Greenville, SC,
REASON
Possible corrupted image
appearing after System Start.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION NY
PRODUCT
a) Terumo Advanced
Perfusion System 1; 100V -- 120V, 15 A (circuit breaker), 50/60 Hz (20A
power source required); Models 801763 and 801763 (Japan unit).
Units using
Power Manager software versions 1.10, Recall # Z-1286-06;
b) Terumo Advanced
Perfusion System 1; 220V -- 240V, 7 A (circuit breaker),50/60 Hz (10A power
source required); Model 801764. Not distributed within
the United States.
Units using Power Manager software versions 1.10,
CODE
a) Serial numbers 11 through 339;
b) Serial
numbers 6 through 156
RECALLING FIRM/MANUFACTURER Terumo
Cardiovascular System Corp., Ann Arbor, MI,
REASON While on battery power,
the system may flash a low battery warning even though the battery is adequately
charged.
VOLUME OF PRODUCT IN COMMERCE 442
units
DISTRIBUTION Nationwide and Internationally
WEEK ENDING AUGUST 12
PRODUCT TriActiv
ProGuard Embolic Protection System, Part number 61000-01. The product is shipped
as a procedure kit. It is used with a standard 6F guide catheter using the
standard femoral approach,
CODE Lot
number 48275, exp. 1/07
RECALLING
FIRM/MANUFACTURER Kensey Nash Corp., Exton, PA,
REASON
Alarm
activation-A priming issue involving the flow control unit due to a software
problem has caused false positive Extraction Line Block (ELB) alarming. Use of
this product may result in a health hazard resulting from early termination of
the flush and extraction procedure after stenting.
VOLUME OF PRODUCT
IN COMMERCE 69 kits
DISTRIBUTION Germany and
Italy
PRODUCT Beckman Coulter
Access Immunoassay system CEA, in vitro diagnostic, Part No. 33200,
CODE
All
CODEs
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc.,
Brea, CA,
Manufacturer:
Beckman Coulter, Inc., Chaska, MN.
REASON Firm has confirmed that the Access CEA
Assay may generate decreased values with certain frozen platelet
specimens.
VOLUME OF PRODUCT IN COMMERCE 775
units
DISTRIBUTION Nationwide and Canada
PRODUCT Medplus ER Drug
Screen Test, Model # 5800KAB, packaged as 25 individually pouched devices in a
labeled kit box,
CODE
a) Lot number:
85699 and
b) Lot number: 85671
RECALLING
FIRM/MANUFACTURER Applied Biotech, Inc., San Diego, CA,
REASON
The firm has discovered that a number of
distributed devices of the Medplus ER Drug Screen Test may be incorrectly
assembled which may give incorrect results. The product is an in vitro test for
rapid detection of various drugs such as Amphetamines, Barbiturates,
Phencyclidine, Cocaine, Methamphetamine, Tricyclic Antidepressants, Morphine,
Tetrahydrocannabinol, & Benzodiazepines in human urine.
VOLUME OF
PRODUCT IN COMMERCE a) 71 kits (1775 devices) & b) 44 kits (1100
devices)
DISTRIBUTION Nationwide
PRODUCT D 744 Chloride
membrane, CI, REF Model #942-061, accessory to the ABL700 blood analyzer,
CODE
Lot number: R0053
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Radiometer America, Inc.,
Westlake, OH,
Manufacturer:
Radiometer Medical, Bronshoj, Denmark.
REASON The CI membrane units generate to low
values for status and sensitivity during calibration.
VOLUME OF
PRODUCT IN COMMERCE 85/4 units per
box
DISTRIBUTION Nationwide
PRODUCT Package Insert
which accompanies the Hematocrit and Metabolite QUALICHECK LEVEL 2 Quality
Control of Hematocrits and Metabolites, used with the ABL 77/70/555 Blood Gas
& Electrolyte Analyzers. The QC reagents are packaged in a box of 30 glass
vials of (1.5 ml) per box. The package insert is packed one per box. Model
#.S7180, Part Number: 944040, Recall # Z-1316-06 Package Insert which
accompanies the Hematocrit and Metabolite QUALICHECK LEVEL 2 Quality Control of
Hematocrits and Metabolites, used with the ABL 77/70/555 Blood Gas &
Electrolyte Analyzers. The QC reagents are packaged in a box of 30 glass vials
of (1.5 ml) per box. The package insert is packed one per box. Model #.S7180,
Part Number: 944040,
CODE Lot #
15
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Radiometer America, Inc., Westlake, OH,
Manufacturer: Radiometer Medical,
Bronshoj, Denmark.
REASON The package insert,
which accompanied the QC reagents used with ABL blood gas analyzers, referenced
incorrect control ranges for Hct (hematocrit) testing. The range stated on the
package insert was too low to generate accurate Hct test results (The control
ranges were acceptable for the glucose and lactate testing).
VOLUME
OF PRODUCT IN COMMERCE 55
boxes
DISTRIBUTION Nationwide, London, and Canada
WEEK ENDING AUGUST 20
PRODUCT
Fugo Blade Incising Tip
Assembly. Incising tips to be used with the Fugo Blade M1000 Anterior
Capsulotomy Unit. For Ophthalmic Use Only. The product is shipped 12 units per
carton
CODE Lot numbers 01013786, 01017917,
01017918, 01017684 and 01017442
RECALLING
FIRM/MANUFACTURER Medisurg Research & Management Corp, Norristown PA,
REASON
No documentation to support shelf
life/sterility
VOLUME OF PRODUCT IN COMMERCE 155
bags
DISTRIBUTION Nationwide and Canada
PRODUCT
a) Abbott brand FreeStyle
Blood Glucose Meter,
b) Abbott brand FreeStyle Flash Blood
Glucose Meter,
CODE All codes
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Abbott Diabetes Care, Inc.
AlamedaCA,
Manufacturer: Flextronics
International, Shenzhen, China,
REASON The products may encounter display problem,
'Er 4'
message, during prolonged use when the low battery symbol is displayed. The
situation can render the meter either inoperable or operable with invalid user
configuration data including selectable unit of measure, and strip calibration
code.
VOLUME OF PRODUCT IN COMMERCE Approx. 2,365,000
meters
DISTRIBUTION Nationwide and Internationally
PRODUCT TEKLENS II (TEKIA label)
and Polylens A60 (Polytech label) Model 614, intraocular lens (IOL) :
1a)
Products labeled with TEKIA as manufacturer: IOLs with power of 17.0 D;
1b)
IOLs with power of 22.5 D;
2a) Products labeled with Polytech as
manufacturer: IOLs with power of 17.0 D:
2b)IOLs with power of 22.5 D,
CODE
1a) 616170E031002180207,
616170E031002190207, 616170E031002200207, 616170E031002210207;
1b)
616225E031001460207, 616225E031001470207, 616225E031001480207,
616225E031001490207, 616225E031001500207, 616225E031001510207;
616225E031001520207, 616225E031001530207.
2a) 613170E031000640207,
613170E031000650207, 613170E031000660207, 613170E031000670207,
613170E031000680207, 613170E031000690207, 613170E031000700207,
613170E031000710207,613170E031000720207, 613170E031000730207,
613170E031000740207, 613170E031000750207, 613170E031000760207,
613170E031000770207, 613170E031000780207, 613170E031000790207,
613170E031000800207, 613170E031000810207, 613170E031000820207,
613170E031000830207, 613170E031000840207, 613170E031000851207,
613170E031000860207, 613170E031000870207, 613170E031000880207,
613170E031000890207;
2b)613225E031000990207, 613225E031001000207,
613225E031001010207, 613225E031001020207, 613225E031001030207,
613225E031001040207, 613225E031001050207, 613225E031001060207,
613225E031001070207, 613225E031001080207, 613225E031001090207,
613225E031001100207, 613225E031001110207, 613225E031001120207,
613225E031001130207, 613225E031001140207, 613225E031001150207,
613225E031001160207, 613225E031001170207, 613225E031001180207,
613225E031001190207, 613225E031001200207
RECALLING
FIRM/MANUFACTURER Tekia, Inc., Irvine, CA
REASON Intraocular lenses
(IOLs) with power of 17.0 D and
22.5 D are mislabeled with each other's labels.
VOLUME OF PRODUCT IN
COMMERCE 60 IOLs
DISTRIBUTION Germany
PRODUCT OPUS SpeedStitch Suture
Cartridge with Magnumwire, a component of the OPUS MiniPlus Implant Set, for use
in placement of sutures through soft tissue in endoscopic and other limited
access procedures., Catalog number OM-6006. This catalog number is referred to
as the OPUS MiniPlus Implant Set,
CODE Lot
number: 110399
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Arthrocare, Corp., Sunnyvale, CA,
Manufacturer: Arthrocare, Corp., Aurora de
Heredia, Costa Rica.
REASON The product may lose
sterility due to omission of the final pouch seal.
VOLUME OF PRODUCT IN
COMMERCE 170 units
DISTRIBUTION Nationwide
PRODUCT
a) Blood Gas and Co-Ox
Electrolyte & Metabolyte Analyzer, ABL-700 series,
b) Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer,
ABL-800 series,
CODE
a) All analyzers
manufactured from 1/1999-12/2005. The devices contain serial numbers
902-441RxxxNxxx. The Rxxx number denotes manufacturing run, and the Nxxx
number denotes the individual instrument within the run;
b) All analyzers
manufactured from 1/2005-10/31/2005. The devices contain serial numbers
902-441RxxxNxxx. The Rxxx number denotes manufacturing run, and the Nxxx
number denotes the individual instrument within the run.
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Radiometer America Inc,
WestlakeOH,
Manufacturer: Radiometer
Medical ApS, Bronshoj, Denmark.
REASON Software defect. pO2 and pCO2 sample test results
run on the firm's ABL700/800 Series Blood Gas Analyzers are not being properly
flagged during the sample calibration phase.
VOLUME OF PRODUCT IN
COMMERCE
Series 700 -- 1,635 Analyzers;
Series 800 -- 108
Analyzers
DISTRIBUTION Nationwide
PRODUCT ABL 5 Capillary Adaptor
(a connection that fits the capillary tube on to the aspirator on the ABL 5
& BPH 5 Analyzers), in vitro diagnostic accessory,
CODE Part #906-018
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Radiometer America Inc,
WestlakeOH,
Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark.
REASON
The dimensions and shape of the analyzer adaptor
do not fit the analyzer tubes or probe, causing air to be aspirated with the
blood sample and causing a deviation in the p02 sample results.
VOLUME OF
PRODUCT IN COMMERCE 155 bags
DISTRIBUTION Nationwide and
Canada
PRODUCT
a) Capillary (end) caps,
accessory for use with blood gas analyzers included in
Radiometer's
CLINITUBES kits. The end caps are packaged in bags.
These bags are placed in
the capillary tube kit which also contains: capillary tubes,
end caps,
mixing wires, and a magnet. Each kit may contain 1 or 5 bags depending
on
the kit model. Each bag contains: 110 Green caps per bag and 160 Red caps per
bag,
b) Capillary (end) caps, accessory for use with
blood gas analyzers included in
Radiometer's CLINITUBES kits. The end caps
are packaged in bags.
These bags are placed in the capillary tube kit which
also contains: capillary tubes,
end caps, mixing wires, and a magnet. Each
kit may contain 1 or 5 bags depending on
the kit model. Each bag contains:
110,
CODE
a) Model # 904-439;
b) Model #
904-453
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Radiometer America Inc, WestlakeOH,
Manufacturer: Radiometer Medical
ApS, Bronshoj, Denmark.
REASON Capillary end caps, an
accessory for ABL blood gas analyzers, leak blood from capillary tubes during
transport.
VOLUME OF PRODUCT IN COMMERCE 386
kits
DISTRIBUTION Nationwide, Canada and Istanbul
PRODUCT
a) Pointe Scientific
Liquid Glucose HEX (R1) Reagent Set, for the quantitative
determination of
glucose in serum, 5 x 600 ml R1 glucose HEX, for use with Hitachi
analyzer;
in vitro diagnostic, Catalog number HG420-R1,
b) Pointe
Scientific Liquid Glucose HEX (R2) Reagent Set, for the quantitative
determination of glucose in serum, 5 x 600 ml R2 glucose HEX, for use with
Hitachi
analyzer; in vitro diagnostic, Catalog number HG420-R2,
c) Pointe Scientific Liquid Glucose (HEX) Reagent Set, for the
quantitative determination
of glucose in serum, 10 x 5 ml R1 and 5 x 20 ml
R2, or 9 x 67 ml R1and 9 x 17 ml R2
glucose reagent, for use with Hitachi
analyzer; in vitro diagnostic, Catalog numbers
HG720-600 and HG920-756,
d) Pointe Scientific Liquid Glucose
(HEXO) Reagent Set,
for the quantitative
determination of glucose in serum, 10 x 100 ml R1, 10 x
20 ml R2 glucose reagent,
or 1 x 2 L R1 x 500 ml R2, for use with Hitachi
analyzer; in vitro diagnostic, Catalog
numbers HG920-1200 and HG920-2500,
e) Glucose Hex reagent sold by Pointe Scientific; in vitro
diagnostic, Catalog no.
3-HG920-L,
f) Glucose HEX
reagent sold by Pointe Scientific; in vitro diagnostic, Catalog no.
3-HG920-L,
g) Glucose HEX R1 reagent sold by Pointe
Scientific; in vitro diagnostic, Catalog no’s
3-HG920-R1, 7-HG920-R1-67,
7-HG920-R1-600 and 7-HG920-R1-800,
h) Glucose HEX R2
reagent sold by Pointe Scientific; in vitro diagnostic,
Catalog no’s
3-HG920-R2, 7-HG920-R2-17, 7-HG920-R2-200 and 7-HG920-R2-300,
CODE
a) and b) Lots 511901, exp. 4/07 and 525101, exp.
9/07;
c), d), e) and f) Lots 431704, exp. 11/06 and 511901, exp. 4/07;
g)
and h) Lots 431704, exp. 11/06, 511901, exp. 4/07 and 525101, exp.
9/07
RECALLING FIRM/MANUFACTURER Pointe Scientific, Inc., Lincoln
Park, MI
REASON Product does not meet performance specification
through its labeled expiration period.
VOLUME OF PRODUCT IN
COMMERCE 13 boxes
DISTRIBUTION Nationwide and Canada
PRODUCT
a) Zimmer M/DN
Intramedullary Fixation 4.5 dia. cortical screw, 3.5 mm hex head,
52.5 mm
length, 22-13-5 stainless steel, sterile bone screw;
Cat. no. 2253-52-45
(00225305545),
b) Zimmer M/DN Intramedullary Fixation 4.5 dia. cortical screw, 3.5 mm
hex head, 55 mm length, 22-13-5 stainless steel,
sterile bone screw;
Cat. no. 2253-55-45 (00225305545),
c) Zimmer M/DN Intramedullary Fixation 4.5
dia. cortical screw,
3.5 mm hex head,
65 mm length, 22-13-5 stainless steel, sterile bone screw;
Cat. no. 2253-65-45
(00225306545),
d) Zimmer M/DN
Intramedullary Fixation 4.2 dia. cortical screw, 3.5 mm hex head,
70 mm
length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-70-42
(00225307042),
e) Zimmer M/DN Intramedullary Fixation
5.5 dia. cortical screw, 3.5 mm hex head,
70 mm length, 22-13-5 stainless
steel, sterile bone screw; Cat. no. 2253-70-55
(00225307055),
f) Zimmer
M/DN Intramedullary Fixation 4.2 dia. cortical screw,
3.5 mm hex head,
75 mm length, 22-13-5 stainless steel, sterile bone screw;
Cat. no. 2253-75-42
(00225307542),
g) Zimmer M/DN
Intramedullary Fixation 4.2 dia. cortical screw, 3.5 mm hex head,
85 mm
length, 22-13-5 stainless steel, sterile bone screw; Cat. no.
2253-85-42
(00225308542).
h) Zimmer M/DN
Intramedullary Fixation 5.5 dia. cortical screw, 3.5 mm hex head,
95 mm
length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-95-55
(00225309555),
i) Zimmer M/DN Intramedullary Fixation
5.5 dia. cortical screw, 3.5 mm hex head,
100 mm length, 22-13-5 stainless
steel, sterile bone screw; Cat. no. 2253-100-55
(00225310055),
j) Zimmer Bone Screw, self tapping, 6.5 mm
dia., 20 mm length,
tivanium TI-6AL-4V
alloy, sterile, Catalog no. 6250-65-20 (00625006520),
k) Zimmer HGP II Acetabular Components Bone Screw,
self-tapping, 6.5 mm dia.,
30 mm length, tivanium TI-6AL-4V alloy, sterile,
Catalog no. 6624-65-30
(00662406530),
l) Zimmer HGP II
Acetabular Components Bone Screw, self-tapping, 6.5 mm dia.,
35 mm length,
tivanium TI-6AL-4V alloy, sterile, Catalog no. 6624-65-35
(00662406535);
m) Zimmer HGP II Acetabular Components Bone Screw,
self-tapping, 6.5 mm dia.,
40 mm length, tivanium TI-6AL-4V alloy, sterile,
Catalog no. 6624-65-40
(00662406540);
n) Zimmer
Herbert Cannulated Bone Screw System Bone Screw, 4.5 mm dia.,
25 mm length,
tivanium TI-6AL-4V alloy, sterile, Catalog no. 47-1155-25-05
(47115502505),
o) Zimmer Herbert Cannulated Bone Screw System Bone
Screw, 6.5 mm dia.,
35 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog
no. 47-1155-35-07
(47115503507),
p) Zimmer Herbert
Cannulated Bone Screw System Bone Screw, 4.5 mm dia.,
45 mm length, tivanium
TI-6AL-4V alloy, sterile, Catalog no. 47-1155-45-05
(47115504505);
q) Zimmer Herbert Cannulated Bone Screw System Bone Screw, 4.5 mm
dia.,
50 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no.
47-1155-50-05
(47115505005),
CODE
a) Lots
24122200, 24730600, 25342400, 25765300, 60025157 and 60034732;
b) Lots
24122600, 24122700, 24123000, 24667300, 24730700, 24730800,
25769900,
26003200, 26113700, 26435200, 60005229, 60019022,
60034734, 60034735,
60043306, 60043307 and 60043308;
c) Lots 24667700, 24732400, 24732500,
24732600, 24732700, 25770200,
26003400, 26435500, 60005230, 60019029,
60030638, 60034743,
60034748, 60043067 and 60043311;
d) Lots 17035000,
17308200, 17600700, 17733300, 18277400, 19001000,
19148900 and
19149000;
e) Lot 60310724;
f) Lots 14865700, 17308800, 17733600, 17733700,
19001400, 24543400
and 25105000;
g) Lots 15887800, 16568000, 17310000,
17310100, 17657500, 17734300
and 23083300;
h) Lots 17036400, 17658000,
17734800, 17887700, 18279700, 21846200,
22983000 and 23083900;
i) Lots
16568200, 16706800, 16706900, 17036500, 17658100, 17887900,
18129600,
18448200, 19501900, 19682100, 19805800, 22708900
and 23843500;
j) Lot
60330168;
k) Lots 12921700, 14414400, 14915600, 15878600, 70234200;
l)
Lots 12662700, 12718800, 12718900, 12757600, 12808600, 13331900,
13776600,
13776700, 13935600, 14196100, 14238900, 15590000, 15590100,
15610700,
16419200, 16579200, 16718400, 16718500, 16718600, 43764000,
48387800,
49078400, 49539800, 51295600, 52044900, 57690600, 57690800,
58905500,
59114400, 59476000, 66527800, 66527900, 66816800, 68890400,
68890500,
68890600 and 69606300;
m) Lots 42330300, 56131900, 71517900, 73057500 and
77838200;
n) Lots 15550200 and 19495400;
o) Lot 15751900:
p) Lot
14878500;
q) Lot 19908900
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Zimmer Caribe, Inc., Warsaw, IN,
REASON
Lack of assurance of sterility, as the sterile
barrier packaging may have been compromised.
VOLUME OF PRODUCT IN
COMMERCE 43
DISTRIBUTION Nationwide and
Internationally
PRODUCT D711, Reference
Membranes, Part #942-058, used with the ABL835 Blood Gas Analyzers,
CODE
Lot Code: R0308, Expiration Date: 4/07; Lot Code:
R0309, Expiration Date: 5/07; and Lot Code: R0310, Expiration Date:
5/07.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer
America Inc, WestlakeOH,
Manufacturer:
Radiometer Medical ApS, Bronshoj, Denmark.
REASON The recalled membranes cause the status value of
the pH and electrolyte electrodes to be offset causing readings outside of the
acceptable range.
VOLUME OF PRODUCT IN COMMERCE 13
boxes
DISTRIBUTION Nationwide and Canada
PRODUCT ABL800 Series Blood Gas
Analyzer equipped with Software Version 5.21,
CODE Software Versions 5.21 i.e. ABL8xx 754R00xx
N0xx
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer
America, Inc., Westlake, OH,
Manufacturer: Radiometer Medical
Aps, Bronshoj, Denmark.
REASON ABL800 Series Blood Gas
Analyzer became inoperable when the restore default setup button was
touched.
VOLUME OF PRODUCT IN COMMERCE 36
analyzers
DISTRIBUTION Nationwide and Internationally