APRIL 2002
WEEK
ENDING APRIL 6
PRODUCT FlexiLab Laboratory Information System, versions
5.23 and 5.3 with Specimen Management Routing and Tracking (SMART).
CODE FlexiLab version 5.23 and version 5.3.
RECALLING FIRM/MANUFACTURER Sunquest Information Systems,
Inc., Tucson, AZ
REASON Container ID labels print incorrectly, names of
patients mix.
VOLUME OF PRODUCT IN COMMERCE 164.
DISTRIBUTION Nationwide and the United Kingdom, Denmark,
Canada, Ireland and Bermuda.
PRODUCT ID-MTS (Micro Typing System) IMPACT Pipettor
CODE ID-MTS Impact Pipettor
Catalog
Number: 1022-05
Serial
Numbers: 182189 182190 182191 182192 182193 182194 182195 182196 182197 182198
182199 182200 182201 182202 182203 182204 182205 182206 182207 182208 182209
182210 182211 182212 182213 182214 182215 182216 182218 182219 182220 182221
182222 182223 182224 182225 182226 182269 182270 182271 182272 182274 182278
182227 182228 182229 182230 182231 182232 182233 182234 182235 182236 182237
182238 182239 182240 182241 182245 182246 182248 182260 182262 182263 182264
182266 182267 182268 182289 182291 182294 182302 182305 182306 182307 182309
182310 182311 182312 182316 182317 182318 182371 182372 182375 182376 182381
182242 182243 182244 182390 182392 182421 182427 182429 182432 182440 182441
182443 182446 182448 182449 182450 182460 182461 182474 182475 182482 182487 182492 182495 182498 182509 182510
182511 182512 182513.
RECALLING FIRM/MANUFACTURER Matrix Technologies Corp.,
Hudson, NH
REASON Motor may fail resulting in inaccurate volume filling
and causing a false negative test result.
VOLUME OF PRODUCT IN COMMERCE 147 units.
DISTRIBUTION FL.
PRODUCT Haemophilus Test Medium Agar, catalog #221954,
packaged as plated media, 8 plates per plastic package.
CODE Lot 1275334, exp 1/22/02.
RECALLING FIRM/MANUFACTURER Recalling Firm: Becton
Dickinson, Sparks, MD
Manufacturer:
Becton Dickinson Microbiology Systems, Cockeysville, MD.
REASON Micobiological test media may exhibit insufficient
growth of bacteria.
VOLUME OF PRODUCT IN COMMERCE 2009 packages.
DISTRIBUTION Nationwide and Belgium, Taiwan and Canada.
PRODUCT Beckman Coulter Synchron LX20 Clinical System.
This
is a machine used to perform clinical chemistry tests on patient
specimens.
CODE Part number 466000.
RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc. Brea,
CA
REASON Synchron LX20 Low cc side chemistries.
VOLUME OF PRODUCT IN COMMERCE 793.
DISTRIBUTION Nationwide and Canada.
PRODUCT Smoke Evacuator Hoses, sterile and non-sterile,
single use only. Each hose unit is packaged in a Tyvek bag under the DM Medical
label, with a disposable aspirator adapter.
The following items are recalled:
Catalog
# Description
HA-3 1 1/4" X 5' Sterile tubing, 10/box.
HA-4 1 1/4" X 5' Non-Sterile tubing, 10/box.
HA-8 1 1/4" X 10' Sterile tubing, 5/box.
HA-9 7/8" X 10' Sterile tubing, 10/box.
HA-9N 7/8" X 10' Non-sterile tubing, 10/box.
0007-1810 7/8" X 10' Sterile tubing, 10/box.
CODE All lot numbers.
RECALLING FIRM/MANUFACTURER DM Medical, Inc. Cincinnati,
OH
REASON QSR deviations including: no validated sterilization
process, and lack of 510 (k).
VOLUME OF PRODUCT IN COMMERCE 440 boxes (3,240 hoses).
DISTRIBUTION Nationwide.
PRODUCT DynaGraft Gel and Putty, a mixture of human
demineralized allograft bone powder mixed with a reverse-phase medium and
formulated into a gel or putty consistency. Packed into 10 cc plastic syringes,
10 cc Nagalene vials or 1 cc Nagalene vials.
CODE DynaGraft Gel from Lot LN1990721001 to LN1990721041;
DynaGraft Putty, 10 cc vial from LN1990489001 to LN1990489025; DynaGraft Putty,
1 cc vial from LN1990489026 to LN1990489028 and LN1990489030.
RECALLING FIRM/MANUFACTURER GenSci OrthoBiologics, Inc.,
Irvine, CA
REASON Donor Screening Problems.
VOLUME OF PRODUCT IN COMMERCE 68 units.
DISTRIBUTION Nationwide and Canada.
PRODUCT PASV (Pressure Activated Safety Valve) PICC
Peripherally Inserted Central Catheters.
CODE PASV PICC Peripherally Inserted Central Cathters
Catalog
Number Product Description
PIC401CK PASV PICC 4F/SL/S/CK
PIC501CK PASV PICC 5F/SL/S/CK
PIC601CK PASV PICC 6F/SL/S/CK
PIC402CK PASV PICC 4F/DL/S/CK
PIC502CK PASV PICC 5F/DL/S/CK
PIC602CK PASV PICC 6F/DL/S/CK
PIC301CKP PASV PICC 3F/SL/P/CK
PIC401CKP PASV PICC 4F/SL/P/CK
PIC501CKP PASV PICC 5F/SL/P/CK
PIC502CKP PASV PICC 5F/DL/P/CK
Devices
shipped between 6/2001-9/19/2001.
RECALLING FIRM/MANUFACTURER Recalling Firm: Boston
Scientific Corp./Medi Tech Division, Natick, MA
Manufacturer:
Medi Tech a division of Boston Scientific, Salt Lake City, UT.
REASON Instructions for use and/or patient information
guides may be omitted.
VOLUME OF PRODUCT IN COMMERCE 64 units.
DISTRIBUTION Nationwide.
PRODUCT Roche CSA Cobas Integra 700 Cyclosporine reagent.
CODE Catalog # 2064391, Art # 0753564. All lots.
RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Diagnostics
Corp., Indianapolis, IN
Manufacturer:
Roche Diagnostics, Mannheim, Germany.
REASON Revised calibration frequency due to reduced
standard curve stability.
VOLUME OF PRODUCT IN COMMERCE 221.
DISTRIBUTION Nationwide.
WEEK ENDING APRIL 13
PRODUCT PT-One Cards
CODE 308020107 and 308020101.
RECALLING FIRM/MANUFACTURER Recalling Firm: Cardiovascular Diagnostics, d/b/a
Pharmanetics, Inc. Morrisville, NC
Manufacturer:
Cardiovascular Diagnostics, Inc., d/b/a Pharmanetics, Inc.
REASON Incorrect inserts were found in some boxes of the
product.
VOLUME OF PRODUCT IN COMMERCE 94 boxes/9,400 cards.
DISTRIBUTION AZ, CA, IA, MN, NY, OH, OR and PA.
PRODUCT Pentax brand Video Colonoscopes and Fiber
Colonoscopes. The Angle Wire Receptacle
component is the affected part. Common Names: Video Colonoscope; Fiber
Colonoscope Classification Name: Colonoscope (CFR 876.1500).
CODE
MODEL
# PMN
# 510(k)REF. # OPERATOR MANUAL #
Video
Colonoscopes:
XEC-3830L K951574
EC-3800L Z231 R05
EC-2930F K951574
EC-3800L Z231 R05
EC-2930FK K951574
EC-3800L Z270 R01
EC-3400F K951574
EC-3800L Z207 R04
EC-3400L K951574
EC-3800L Z207 R04
EC-3430F K951574
EC-3800L Z207 R04
EC-3430FK K951574
EC-3800L Z270 R01
EC-3430L K951574
EC-3800L Z231 R05
EC-3430LK K951574
EC-3800L Z270 R01
EC-3430LZ K951574
EC-3800L Z231 R05
EC-3431L K951574
EC-3800L Z237 R06
EC-3440F K961570
EC-3840L Z237 R06
EC-3440L K961570
EC-3840L Z237 R06
EC-3800F K951574
EC-3800L Z270 R01
EC-3800L K951574
Original Z207 R04
EC-3800TL K951579
Original Z213 R02
EC-3801F K951574
EC-3800L Z207 R04
EC-3801F2 K951574
EC-3800L Z207 R04
EC-3801L K951574
EC-3800L Z207 R04
EC-3801L30 K951574 EC-3800L Z207 R04
EC-3801S2 K951574
EC-3800L Z207 R04
EC-380LP K951574
EC-3800L Z207 R04
EC-381L30 K951574 EC-3800L
Z207 R04
EC-3830F K951574
EC-3800L Z207 R04
EC-3830FK2 K951574 EC-3800L Z207 R04
EC-3830L K951574
EC-3800L Z231 R05
EC-3830LK K951574
EC-3800L Z207 R04
EC-3830LZ K951574
EC-3800L Z242 R05
EC-3830LZK K951574
EC-3800L Z242 R05
EC-3830M2 K951574
EC-3800L Z231 R05
EC-3830MK K951574
EC-3800L Z207 R04
EC-3830MK2 K951574
EC-3800L Z207 R04
EC-3830S2 K951574
EC-3800L Z207 R04
EC-3830TL K951579
EC-3800TL Z231 R05
EC-3830TLK K951579
EC-3800TL Z270 R01
EC-3831L K951574
EC-3800L Z231 R05
EC-3831LK K951574
EC-3800L Z207 R04
EC-3831TL K951574
EC-3800L Z231 R05
EC-3832L K951574
EC-3800L Z231 R05
EC-3840F2 K961570
EC-3840L Z237 R05
EC-3840L K961570
Original Z237 R05
EC-3840LK K961570
EC-3840L Z207 R04
EC-3840TL K961563
Original Z237 R06
EC-3841LK K961570
EC-3840L Z207 R04
EC-38TL30 K951579 EC-3800TL Z207 R04
EC-O2930MK K951574
EC-3800L Z270 R01
EC-O2930FK K951574
EC-3800L Z270 R01
ECX-3830L K951574
EC-3800L Z231 R05
Fiber
Colonoscopes:
FC-34FH K951580 FC-38LH Z127
FC-38FV K951578 FC-38LX Z171 R04
FC-38FX2 K951578 FC-38LX Z140
FC-38LA K822846 Original FC-38LA
FC-38LH K951580 Original Z127
FC-38LP K951580 FC-38LH Z150 R02
FC-38LV K951578 FC-38LX Z171 R04
FC-38LX K951578 Original Z140
FC-38MX K951578 FC-38LX Z140
FC-38SH K951580 FC-38LH Z127
FC-38SX2 K951578 FC-38LX Z140
FC-38TLH K951575 Original Z127
FC-P34 K951580 FC-38LH Z127
FC-PP34L K951580 FC-38LH Z127
(Note:
The 510(k) Model Reference # is the model on the PMN, clearance reference is
made as 'not significant change').
There
are 3,630 affected Serial Numbers involved in this action:
Video
Colonoscopes:
Model
Number Serial Number(s)
~XEC-3830L A01002
EC-2930F A01001,
A01002, A01003, A01007
EC-2930FK A01001, A01002, A01003
EC-3400F A01016,
A01024, A01025, A01036, A01042, A01047, A01056, A01058, A01060, A01063, A01064,
A01074, A01076, A01084, A01090, A01092, A01093, A01099, A01101, A01105, A01106,
A01112, A01114, A01119, A01122, A01124, A01131, A01137, A01141, A01142, A01145, A01159, A01161, A01162,
A01172, A01176, A01177, A01179, A01187, A01210, A01211, A01212, A01223, A91001,
B01241, B01245, B01250, B01252, C01280, C01281, C01282, C01291, C01296, C01311
EC-3400L A01014,
A01015, A01018, A01020, A01022, A01023, A01026, A01030, A01037, A01038, A01039,
A01052, A01064, A01065, A01067, A01068, A01072, B01084, C01091, C01093, C01094,
C01096, C01098, C01099, C01100, C01109, C01111, C01113, C01116, C01122, C01124, C01125, C01127,
C01135, C01140, C01147, C01148, C01150, C01154, C01155, C01156, C01159, C01164,
C01165, C01171, C01175, C01182, C01183, C01187, C01188, C01189, C01190, C01191,
C01193, C01195, C01199, C01201, C01202, C01203, C01205, C01207
EC-3430F A01011,
A01013, A01014, A01016, A01017, A01020, A01027, A01032, A01039, A01046, A01048,
A01050, A01051
EC-3430FK A01001,
A01012, A01013, A01015
EC-3430L 1015A, A01001, A01012, A01014, A01017, A01019,
A01020, A01026, A01029, A01030, A01031, A01032, A01033, A01034, A01035, A01037,
A01042, A01045, A01050, A01052, A01054, A01056, A01059, A01060, A01062, A01063,
A01064, A01065, A01067, A01070,
A01072, A01073, A01075, A01077, A01078, A01079, A01080, A01081, A01083,
A01084, A01089, A01090, A01091, A01093, A01095, A01096, A01097, A01098, A01102,
A01105, A01110, A11178, A11180, A11181, A11182, A1183, A11184, A11185, A11186,
A11190, A11191, A11192, A11193, A11194, A11195, A11196, A11197, A11198, A11202,
A11206, A11207, A11209, A11210, A11211, A11214, A11215, A11217, A11222, A11223,
A11224, A11225, A11227, A11229, A11232, A11235, A11236, A11237, A11238, A11243,
A11246, A11249, A11250, A11251, A11252, A11253, A11257, A11260, A11262, A11265,
A11266, A11267, A11269, A11270, A11272, A11273, A11274, A11275, A11276, A11277,
A11278, A11279, A11282,
A11284, A11286, A11288, A11289, A11290, A11291, A11294, A11295, A11299, A11301,
A11302, A11306, A11307, A11308, A11309, A11310, A11311, A11312, A11314, A11315,
A11316, A11318, A11319, A11321, A11322, A11323, A11325, A11330, A11331, A11332,
A11333, A11334, A11335, A11336, A11344, A11345, A11346, A11347, A11350, A11357,
A11361, A11362, A11366, A11367, A11368, A11370, A11373, A11375, A11376, A11377,
A11378, A11381, A11382, A11383, A11384, A11385, A11388, A11389, A11392, A11395,
A11399, A11402, A11403, E110535, T01117, T01118, T01119, T01120, T01121,
T01123, T01124, T01125, T01126, T01127, T01128, T01129, T01130, T01133, T01134, T01135, T01139, T01141,
T01142, T01143, T01145, T01146, T01147, T01148, T01149, T01150, T01152, T01154,
T01155, T01158, T01161, T01162, T01163, T01165, T01166, T01168, T01169, T01172,
T01173, T01174, T01175
EC-3430LK A01001,
A01002, A01013, A01014, A01015, A01016, A01017, A01018, A01019, A01020, A01021,
A01023, A01024, A01025, A01026, A01027, A01028, A01029, A01030, A01031, A01032,
A01033, A01034, A01035, A01036, A01037, A01038, A01039, A01042, A01044, A01045, A01046, A01047, A01048,
A01049, A01050, A01051, A01052, A01056, A01057, A01061, A01062, A01063, A01064,
A01065, A01066, A01067, A01068, A01069, A01070, A01071, A01072, A01074, A01076,
A01077, A01078, A01079, A01080, A01081, A01082, A01083, A01084, A01085, A01086,
A01087, A01088, A01089, A01091, A01092, A01094, A01095, A01099, A01100, A01101,
A01102, A01103, A01104, A01105, A01106, A01107, A01108, A01109, A01110, E01194,
E01220
EC-3430LZ A01001
EC-3431L A01001,
A01002, A01003, A01005
EC-3440F A01019
EC-3440L A01012,
A01014, A01020, A01021, A01022, A01023, A01027, A01028, A01030, A01031, A01032,
A01033, A01034, A01035, A01036, A01037, A01038, A01042, A01044, A01045, A01046,
A01047, A01048, A01051, A01053, A01056, A01059, A01061, A01063, A01064, A01065, A01066, A01069, A01071,
A01074, A01075, A01081, A01082, A01086, A01087, A01088, A01090, A01091, A01093,
A01100, A01110, E010121
EC-3800F C92145
EC-3800 A71012,
A71013, A71014, A71016, A71017, A71018, A71023, A71025, A71029, A71033, A71036,
A71039, A71047, A71049, A71055, A71058, A71060, A71065, A81080, A81081, A81082,
A81089, A81091, A81099, A81100, A81101, A81102, A81103, A81104, A81107, A81109, A81115, A81116, A81117,
A81123, A81127, A81135, A81146, A81148, A81153, A81155, B91161, B91163, B91166,
B91169, C02290, C02293, C02294, C02297, C02298, C91179, C91180, C91186, C91188,
C92200, C92201, C92204, C92205, C92209, C92212, C92213, C92214, C92216, C92217,
C92220, C92221, C92224, C92232, L01002, L01005, P98001
EC-3800TL A01012,
A01014, A01019, A01021, A01022, A01023, A01025, A01026, A01036, A01037, A01039,
A01041, A01042, A01043, A01044, A01046, A01055, A01056, A01059, A01060, A01065,
A01069, A01074, A01075, A01076, A01080, A01082, A01083, A01084, A01090, A01094, A01095, A01100, A01101,
A01102, A01116, A01118, A01136, A01137, A01138, A01141, A01148, A01149, A01150,
A01151, A01153, A01154, A01156, A01160, A01161, A01172, A01177, A01181, A01183,
A01184, A01185, A01187, A01191, A01192, A01197, A01199, A01204, A01206, A01209,
A01217, A01220, A01223, A01225, A01232, A01233, A01234, A01237, A01238, A01240,
A01243, A01247, A01250, A01251, A01252, A01254, A01255, A01257, A01261, A01266,
A01270, A01271, A01273, A01274, A01275, A01280, A01285, A01289, A01290, A01291,
A01296, A01298, A01299, A01300, A01310, A01311, A01312, A01313, A01318, A01326,
A01327, A01328, A01331, A01332, A01336, A01337, A01338, A01341, A01342, A01348, A01352, A01356,
A01359, A01360, A01361, A01363, A01365, A01367, A01369, A01370, A01377, A01387,
A01391, A01404, A01406, A01407, A01408, A01411, A01424, A01425, A01435, A01436,
A01438, A01439, A01446, A01448, A01461, A01467, A01469, A01472, A01474, A01482,
A01486, A01490, A01493, A01496, A01497, A01500, A01502, A01503, A01505, A01513,
A01514, A01518, A01520, A01521, A01522, A01524, A01531, A01532, B01537, B01538,
B01540, B01541, B01543, B01547, B01553, B01556, B01559, B01562, B01563, B01564,
B01566, B01572, B01573, B01574, B01579, B01582, B01587, B01596, B01599, B01602,
B01604, B01606, B01608, B01610, B01613, B01615, B01618, B01620, B01621, B01624,
B01625, B01627, B01630, B01637, B01640, C01643, C01645, C01648, C01651, C01654,
C01655, C01659, C01662, C01665, C01668, C01669, C01670, C01675, C01676, C01678,
C01679, C01681, C01682, C01687, C01694, C01700, C01719, C01722, C01723, C01726, C01727, C01740, C01742,
C01745, C01746, C01753, C01755, C01772, C01778, C01790, C01796, C01809, C01812,
C01813, C01815, C01816, C01820, C01821, C01822, C01824, C01827, C01828, C01833,
C01834, C01835, C01836, C01838, C01841, C01843, P98005
EC-3801F A01161
EC-3801F2 A01048
EC-3801 920001, A01012, A01013, A01014, A01015,
A01016, A01017, A01018, A01019, A01020, A01029, A01031, A01032, A01036, A01038,
A01041, A01043, A01048, A01049, A01051, A01054, A01059, A01060, A01066, A01067,
A01070, A01076, A01077, A01079, A01080, A01085, A01088, A01089, A011001, A011007, A011013,
A011020, A011024, A011025, A011030, A011032, A011033, A011034, A01104, A011047,
A011051, A011053, A011054, A011057, A011058, A01106, A011060, A011061, A011062, A011066, A011067, A011072, A011079,
A011082, A011086, A011087, A011089, A011090, A011091, A011094, A011095,
A011096, A011097, A011099, A01110, A011102, A011103, A011104, A011111, A011114,
A011115, A011121, A011124, A011128, A011129, A011131, A011133, A01115, A011155,
A011156, A011158, A011160, A011163, A011165, A011170, A011171, A011172,
A011175, A011176, A011177, A011179, A011183, A011186, A011187, A011189, A01120, A011201, A011204, A011219, A011221,
A01123, A011230, A011240, A011241,
A011242, A011243, A011246, A011255, A01126,
A011260, A011265, A011274, A011276, A011280, A011285, A011286, A011288,
A01129, A011297, A011298, A011299,
A011301, A011302, A011309, A011310, A011311, A011315, A011317, A011321,
A011324, A011329, A01133, A011330,
A011331, A011332, A011333, A011336, A011342, A011343, A011344, A011347,
A011348, A011349, A01135, A011350,
A011357, A011360, A011362, A011363, A011373, A011379, A01138, A011383, A011386, A011387, A011389, A011390,
A011391, A011392, A011393, A011394, A011395, A011396, A011397, A011402, A011406, A011407, A011408,
A011409, A011416, A01142, A011422,
A011423, A01143, A011433, A011436,
A011437, A011439, A011442, A011445, A011447, A011448, A011451, A011453,
A011455, A011456, A011457, A011462, A011463, A011468, A011469, A01147, A011471, A011473, A011484, A011485, A011488,
A011489, A01149, A011493, A011494,
A011495, A01150, A011501, A011502,
A011504, A011505, A011506, A01151,
A011519, A011523, A011524, A011525, A011527, A01153, A011532, A011534,
A011535, A011536, A011538, A011539, A01154,
A011540, A011542, A011543, A011544, A011547, A011554, A011555, A011559,
A011562, A011564, A011566, A011567, A011568, A011572, A011573, A011574, A011578, A011579,
A011581, A011583, A011588, A011592, A011593, A011594, A011595, A011598,
A011599, A011600, A011601, A011604, A011605, A011607, A011618, A011621,
A011625, A01163, A011630, A011632,
A011635, A011638, A011641, A011651, A011654, A011655, A011666, A011673,
A011676, A011692, A011695, A011697, A011702, A011707, A011709, A011712,
A011714, A011715, A011718, A01172, A011720, A011722, A011732, A011735, A011738,
A011740, A011742, A011743, A011746, A011747, A011750, A011763, A011765,
A011774, A011778, A01178, A011789,
A011793, A011797, A011798, A011803, A011811, A01182, A011820, A011825,
A01183, A011836, A011837,
A011838, A011842, A011843, A011844, A011846, A011847, A01185, A011853, A011866,
A011868, A01187, A011871, A011876,
A011878, A011890, A011892, A011895, A011914, A011916, A011917, A011918,
A011919, A011923, A011925, A011929, A011931, A011933, A011936, A011937,
A01194, A011940, A011945, A011946,
A011947, A01195, A011959, A011962,
A011966, A011969, A01197, A01198, A01199, A011996, A011998, A01200, A012006, A012007, A01201, A012028, A012029, A012032, A012033, A012035,
A012036, A012039, A012040, A012042, A012048, A012049, A012071, A012079,
A012080, A012081, A012082, A012083, A012084, A012085, A01210,
A012104, A012108, A012110, A012111, A01212, A012120, A012129, A01213,
A012131, A012132, A012135, A012138, A012139, A012140, A012147, A012148,
A012153, A012167, A01217, A012172, A012174, A012180, A012182, A012184, A12186,
A012187, A012188, A012189, A012191, A012193, A012196, A012206, A01221, A012215, A012217, A012218, A012219, A012223,
A012226, A012227, A012228, A01224,
A012240, A012245, A012246, A012251, A012259, A012260, A012261, A012270,
A012273, A012277, A012279, A01228, A012280, A012283, A012292, A012294, A01230,
A012302, A012310, A012312, A012313, A012316, A012318, A01232, A012320, A012322, A012327,
A012328,
A012330, A012332, A012334, A012337, A012339, A01234, A012342, A012344, A012346, A012347, A01235, A012354, A012356, A012358, A012360, A012362,
A012364, A012365, A012368, A01237,
A012376, A012382, A012384, A012386, A012387, A012388, A012389,
A01239, A012390, A012391, A012397,
A012399, A012403, A012404, A012408, A01241,
A012411, A012417, A012421, A012423, A012424, A012425, A012426, A012427,
A012429, A01243, A012431, A012435,
A012436, A012437, A012438, A012439, A01244,
A012440, A012443, A012446, A012447, A012448, A012449, A01245, A012452, A01246, A01248, A01250,
A01251, A01252, A01253,
A01255, A01259, A01262, A01264,
A01272, A01292, A01295, A01297, A01298, A01302, A01303,
A01305, A01307, A01308, A01310,
A01312, A01319, A01320, A01321,
A01325, A01326, A01328, A01333, A01346, A01349, A01350,
A01352, A01356, A01357, A01359,
A01363, A01364, A01369, A01370, A01371,
A01373, A01374, A01375, A01376,
A01377, A01400, A01403, A01404, A01405, A01413, A01418,
A01423,
A01426, A01430, A01432,
A01433, A01434, A01435, A01437,
A01448, A01450, A01457, A01458, A01463, A01464, A01467,
A01469, A01470, A01472, A01473, A01474, A01475, A01477, A01485, A01489, A01490,
A01499, A01509, A01511, A01513, A01517, A01518, A01527, A01528, A01529, A01531,
A01534, A01546, A01558, A01567, A01575, A01577, A01578, A01580, A01581, A01585,
A01589, A01590, A01596, A01602, A01610, A01611, A01617, A01618, A01620, A01625,
A01626, A01630, A01632, A01641, A01644, A01645, A01647, A01648, A01656, A01659,
A01662, A01665, A01666, A01681, A01686, A01689, A01690, A01691, A01692, A01698,
A01699, A01715, A01722, A01724, A01728, A01730, A01735, A01736, A01739, A01752,
A01756, A01761, A01764, A01765, A01768, A01770, A01777, A01784, A01787, A01793,
A01797, A01802, A01806, A01807, A01810, A01812, A01814, A01831, A01837, A01838,
A01839, A01840, A01843, A01844, A01847, A01849, A01857, A01859, A01861, A01863,
A01865, A01866, A01869, A01872, A01875, A01876, A01877, A01879, A01882, A01886,
A01896, A01898, A01899, A01900, A01901, A01909, A01911, A01914, A01917, A01920,
A01921, A01926, A01927, A01935, A01936, A01937, A01943, A01945, A01946, A01947,
A01948, A01949, A01950, A01951, A01952, A01955, A01968, A01970, A01973, A01974,
A01981, A01986, A01987, A01993, A01L01, A81097, B012460, B012467, B012468,
B012473, B012476, B012482, B012490, B012498, B012508, B012509, B012510,
B012522, B012524, B012527, B012530, B012535, B012537, B012538, B012542,
B012550, B012551, B012552, B012560, B012568, B012572, B012576, B012580,
B012582, B012587, B012590, B012599, B012602, B012610, B012611, B012613,
C012629, C012643, C012648, C012653, C012655, C012670, C012675, C012676,
C012677, C012681, C012682, C012688, C012691, C012694, C012697, C012716,
C012717, C012718, C012722, C012723, C012725, C012727, C012728, C012739,
C012740, C012744, C012749, C012754, C012756, C012777, C012788, C012794, C012797,
C012798, C012808, C012809, C012810, C012811, C012812, C012825, C012828,
C012846, C012856, C012866, C012867, C012869, C012870, C012871, C012876,
C012884, C012886, C012890, C012891, C012893, C012901, C012928, C012929,
C012930, C012937, C012941, C012962, C012967, C012968, C012972, C012973,
C012984, C012988, C012992, C012996, C012997, C013002, C013004, C013007,
C013008, C013009, C013011, C013015, C013021, C013022, C013028, C013029,
C013030, C013040, C013042, C013045, C013048, C013049, C013055, C013064, C013070,
C013078, C013080, C013082, C013084, C113098, C113100, C113106, C113108,
C113113, C113117, C113141, L01006, NY011269, NY01394, NY01785, NY01809, P98002
EC-3801L30 B012561
EC-3801S2 A01012
EC-380LP A01016,
A01189, A01193
EC-381L30 A012378
EC-3830F A01030
EC-3830FK2 A01012,
A01014, A01017, A01020, A01021, A01022
EC-3830L 1070A,
1081A, 1085A, 1149A, 1162A, 1187A, A01001, A01001T, A01002, A01002T, A01005T,
A01012, A01013, A01014, A01015, A01017, A01018, A01020, A01021, A01022, A01024,
A01025, A01028, A01034, A01037, A01041, A01042, A01043, A01045, A01046, A01048,
A01049, A01050, A01051, A01053, A01056, A01057, A01058, A01060, A01061, A01063,
A01067, A01068, A01073, A01075, A01076, A01077, A01082, A01083, A01084, A01085,
A01086, A01087, A01088, A01091, A01093, A01100, A01103, A01104, A01106, A01111,
A01112, A01113, A01119, A01127, A01129, A01130, A01133, A01139, A01141, A01142,
A01144, A01145, A01147, A01149, A01157, A01158, A01165, A01168, A01173, A01175,
A01176, A01181, A01190, A01191, A01192, A01194, A01196, A01198, A01205, A01209,
A01214, A01216, A01217, A01218, A01222, A01229, A01230, A01231, A01234, A01237,
A01240, A01242, A01246, A01248, A01250, A01251, A01254, A01255, A01256, A01261,
A01263, A01264, A01266, A01274, A01275, A01280, A01284, A01286, A01287, A01288,
A01310, A01316, A01318, A01320, A01323, A01324, A01330, A01331, A01334, A01336,
A01340, A01341, A01342, A01344, A01345, A01348, A01349, A01350, A01351, A01352,
A01354, A01356, A01358, A01360, A01361, A01362, A01364, A01366, A01367, A01372,
A01376, A01377, A01382, A01383, A01386, A01389, A01391, A01392, A01393, A01397,
A01400, A01403, A01405, A01411, A01414, A01416, A01419, A01421, A01424, A01428,
A01429, A01430, A01445, A01448, A01449, A01456, A01457, A01462, A01463, A01467,
A01468, A01469, A01471, A01474, A01475, A01478, A01481, A01485, A01487, A01489,
A01496, A01497, A01499, A01502, A01506, A01507, A01509, A01510, A01511, A01512,
A01513, A01514, A01515, A01516, A01517, A01519, A01524, A01526, A01535, A01536,
A01537, A01538, A01539, A01540, A01542, A111000, A111001, A111002, A111003,
A111004, A111005, A111007, A111010, A111011, A111013, A111014, A111015,
A111016, A111017, A111019, A111020, A111022, A111024, A111025, A111026, A111028, A111030,
A111032, A111033, A111034, A111035, A111036, A111037, A111040, A111042,
A111045, A111047, A111048, A111049, A111050, A111052, A111055, A111057,
A111058, A111060, A111061, A111062, A111063, A111072, A111074, A111078,
A111079, A111084, A111086, A111087, A111089, A111092, A111099, A111101,
A111105, A111106, A111109, A111110, A111115, A111116, A111117, A111123,
A111126, A111127, A111128, A111129, A111130, A111133, A111134, A111135,
A111138, A111139, A11705, A11709, A11713, A11716,
A11718, A11720, A11721, A11722, A11724, A11725, A11726,
A11727, A11730, A11731, A11733,
A11734, A11735, A11736, A11737,
A11739, A11740, A11742, A11744, A11746, A11747, A11749,
A11751, A11752, A11755, A11760,
A11761, A11762, A11764, A11765,
A11767, A11768, A11770, A11774, A11775, A11776, A11777,
A11778, A11779, A11782, A11784,
A11785, A11786, A11787, A11788,
A11789, A11793, A11795, A11800, A11802, A11804, A11805,
A11806, A11810, A11812, A11814,
A11817, A11818, A11819, A11823,
A11824, A11825, A11827, A11831, A11832, A11834, A11835,
A11836, A11838, A11839, A11840,
A11842, A11843, A11844, A11845,
A11847, A11848, A11851, A11853, A11854, A11857, A11859,
A11860, A11861, A11864, A11867,
A11868, A11869, A11871, A11872, A11877, A11878, A11881, A11882, A11885, A11887, A11890,
A11892, A11894, A11896, A11897,
A11900, A11901, A11903, A11904,
A11909, A11912, A11913, A11914, A11915, A11916, A11918,
A11919, A11922, A11925, A11927,
A11930, A11936, A11941, A11947,
A11950, A11951, A11953, A11954, A11956, A11957, A11960,
A11961, A11965, A11966, A11967,
A11969, A11970, A11976, A11978,
A11985, A11988, A11989, A11993, A11996, A11997, A11998,
DS9006, P20006, P20007, T01545,
T01546, T01547, T01549, T01551,
T01553, T01557, T01558, T01561, T01562, T01563, T01566,
T01570, T01571, T01572, T01573,
T01576, T01578, T01580,
T01583, T01585, T01587,
T01590, T01593, T01599, T01601,
T01607, T01608, T01609, T01611,
T01613, T01614, T01619, T01620, T01622, T01623, T01626,
T01628, T01630, T01632, T01633, T01634, T01636, T01638, T01639, T01641, T01642,
T01656, T01659, T01661, T01663, T01664, T01668, T01669, T01681, T01682, T01683,
T01686, T01690, T01691, T01694, T01695, T01696, T01697
EC-3830LK A01011,
A01012, A01015, A01016, A01017, A01018, A01020, A01021, A01022, A01023, A01026,
A01030B, A01031, A01032, A01033, A01034, A01035, A01037, A01040, A01044,
A01048, A01050, A01051, A01052, A01053, A01054, A01057, A01060, A01063,
A01064B, A01065, A01067, A01069, A01070, A01071, A01072,
A01073, A01075, A01080, A11173, A11176B, A11180, A11181, A11182, A11184,
A1187B, A11188, A11189, A11190, A11191, A11193, A11194, A11195, A11196, A11197,
A11198, A11199, A11200, A11201, A11202, A11203, A11207, A11208B, A11209,
A11211, A11216, A11217, A11221, A11224, A11225, A11226, A11227, A11228, A11229,
A11230, A11231, A11232, A11234, A11236B, A11237, A11240, A11241, A11242,
A11243, A11245, A11248, A11251, B11256, B11257, B11258, B11259, B11260, B11261,
B11262, B11263, B11265, B11266, B11267, B11268, B11269, B11272, B11273, B11274,
B11275, B11276, B11282, B11283, B11284, B11287, B11289, B11290, B11291, B11292,
B11293, B11296, B11298, B11299, B11300, B11301, B11302, B11304, B11305, B11306,
B11308, B11309, B11310, B11311, B11312, B11313, B11316, B11317, B11319, B11324,
B11325, B11328, B11329, B11330, B11331, B11332, B11335, B11336, B11337, B11338,
B11340, B11341, B11342, B11343, B11345, B11350, B11352, B11356, B11357, B11358,
B11359, B11361, B11362, B11363, B11365, B11366, B11370, B11372, B11373, B11374,
B11375, B11376, B11379, B11381, B11383, B11384, B11385, B11386, B11387, B11388,
B11389, B11390, B11391, B11392, B11393, B11395,
B11396,
B11397, B11398, B11400, B11402, B11403, B11410, B11413, B11414, B11419, B11420,
B11421, B11422, B11423, B11427, B11428, B11430, B11432, B11436, B11437, B11439,
B11440, B11441, B11442, B11444, B11445, B11449, B11450, B11451, B11452, B11454,
B11458, B11459, B11464, B11465, B11466, B11467, B11469, B11470, B11471, B11474,
B11476, B11477, B11480, B11487, B11493, B11495, B11496, B11497, B11499, B11502,
B11503, B11504, B11506, B11510, B11511, B11512, B11513, B11514, B11515, B11516,
B11517, B11522, B11523, B11524, B11525, B11526, B11527, B11528, B11530, B11531,
B11532, B11534, B11536, B11537, B11541, B11544, B11549, B11551, B11553, B11554,
B11556, B11558, B11559, B11560, B11561,
B11562, B11564, B11565, B11567, B11568, B11571, B11574, B11575, B11578, B11580,
B11582, B11583, B11585, B11586, B11587, B11588, B11589, B11590, B11591, B11592, B11594, B11595,
B11596, B11601, B11602, B11603, B11604, B11606, B11608, B11610, B11612, B11613,
B11614, B11616, B11617, B11620, B11621, B11623, B11624, B11625, B11626, B11635,
B11636, B11637, B11638, B11639, B11640, B11641, B11643, B11649, B11650, B11652,
B11653, B11656, B11657, B11831, C11659, C11664, C11665, C11674, C11675, C11676,
C11677, C11680, C11683, C11685, C11686, C11688, C11689, C11691, C11694, C11695,
C11696, C11697, C11698, C11699, C11701, C11703, C11704, C11705, C11706, C11707,
C11709, C11710, C11711, C11712, C11713, C11714, C11715, C11716, C11717, C11718,
C11719, C11721, C11722, C11723, C11724, C11725, C11726, C11729, C11741, C11744,
C11746, C11748, C11749, C11753, C11755, C11763, C11764, C11765, C11766, C11767,
C11768, C11769, C11770, C11772, C11773, C11775,
C11777,
C11778, C11779, C11780, C11781, C11782, C11783, C11784, C11786, C11787, C11788,
C11790, C11791, C11793, C11795, C11797, C11798, C11800, C11802, C11805, C11806,
C11807, C11808, C11809, C11810, C11813, C11815, C11818, C11819, C11820, C11821,
C11823, C11825, C11828, C11829, C11830, C11832, C11833, C11838, C11840, C11841,
C11842, C11843, C11844, C11845, C11846, C11847, C11849, C11850, C11851, C11853,
C11855, C11856, C11857, C11858, C11859, C11860, C11862, C11863, C11868, C11869,
C11870, C11873, C11874, C11875, C11878, C11880, C11883, C11884, C11885, C11886,
C11887, C11888, C11889, C11891, C11892, C11893, C11894, C11895, C11896, C11897,
C11898, C11899, C11900, C11901, C11902, C11903, C11904, C11905, C11906, C11907,
C11909, C11910, C11911, C11913, C11914, C11915, C11916, C11918, C11919, C11922,
C11923,
C11924,
C11925, C11926, C11928, C11930, C11931, C11933, C11934, C11935, C11937, C11940,
C11941, C11942, C11943, C11944, C11945, C11947, C11949, C11951, C11953, C11954,
C11955, C11956, C11957, C11958, C11963, C11965, C11966, C11968, C11969, C11970,
C11971, C11973, C11975, C11976, C11977, C11978, C11979, C11980, C11981, C11982,
C11983, C11984, C11985, C11986, C11987, C11988, C11989, C11990, DS2001, P99007,
T01082, T01083, T01084B, T01085, T01087, T01088, T01091, T01092, T01094,
T01095, T01096, T01098, T01099, T01100, T01103, T01105, T01107, T01108, T01109,
T01114, T01115, T01118, T01120, T01121, T01122, T01124, T01125, T01126, T01127,
T01128, T01131, T01132, T01134,
T01135,
T01136, T01137, T01142, T01143, T01144, T01145, T01146, T01147, T01148, T01149,
T01151, T01152, T01153, T01155, T01156, T01157, T01158, T01159, T01161, T01162,
T01163, T01165, T01166, T01167, T01168, T01169
EC-3830LZ A01002,
A01013, A01014, A01016, A01017, A01018, A01022, A01026, A01028, A01029, A01032,
A01034, A01037, A01056
EC-3830LZK E01001
EC-3830M2 A01014
EC-3830MK A01036
EC-3830MK2 A01016,
A01022, A01024, A01026
EC-3830S2 A01016,
A01017
EC-3830TL 1020A,
1021A, 1115A, 1127A, 1134A, A01012, A01016, A01017, A01018, A01019, A01020,
A01022, A01023, A01024, A01025, A01026, A01029, A01030, A01031, A01032, A01035,
A01036, A01039, A01040, A01043, A01045, A01046, A01047, A01048, A01049, A01050, A01051, A01052, A01053,
A01055, A01056, A01057, A01058, A01059, A01060, A01061, A01069, A01072, A01082,
A01085, A01086, A01092, A01095, A01096, A01098, A01099, A01102, A01105, A01110,
A01111, A01115, 01120, A01122, A01123, A01125, A01129, A01138, A01139, A01141,
A01144, A01148, A01151, A01153, A01155, A01161, A01163, A01164, A01169, A01171,
A01173, A01174, A01175, A01176,
A01177, A01193, A01195, A01197, A01200, A01202, A01207, A01209, A01214,
A01215, A01216, A01221, A01222, A01223, A01224, A01225, A01227, A01228, A01229,
A01230, A01231, A01232, A01233, A01234, A01235, A01236, A01240, A01243, A01246,
A01247, A01249, A01250, A01251, A01252, A01254, A01255, A01260, A01261, A01269,
A01270, A01274, A01277, A01279, A01288, A01290, A01291, A01292, A01293, A01294, A01298, A01299, A01301, A01302, A01304,
A01311, A01314, A01316, A01322, A01323, A01326, A01327, A01330, A01333, A01334,
A01335, A01336, A01337, A01339, A01340, A01341, A01342, A01344, A01346, A01347,
A01349, A01351, A01353, A01355, A01356, A01357, A01360, A01362, A01363, A01366,
A01370, A01371, A01372, A01379, A01382, A01389, A01392, A01393, A01402, A01404,
A01407, A01409, A01410,
A01415, A01420, A01421, A01422, A01425, A01430, A01433, A01434, A01438, A01441,
A01446, A01451, A01452, A01453, A01454, A01455, A01456, A01458, A01459, A01461,
A01463, A01464, A01466, A11471, A11472, A11474, A11476, A11480, A11484, A11485,
A11487, A11488, A11491, A11493, A11494, A11500, A11501, A11502, A11503, A11505,
A11507, A11509, A11510, A11512, A11513, A11519, A11532, A11533, A11535, A11541, A11545,
A11548, A11553, A11555, A11556, A11557, A11558, A11561, A11566, A11568, A11569,
A11572, A11576, A11577, A11579, A11581, A11582, A11584, A11585, A11589, A11595,
A11596, A11597, A11598, A11599, A11600, A11603, A11606, A11607, A11611, A11612,
A11613, A11614, A11619, A11621, A11628, A11629, A11630, A11635, A11637, A11640,
A11641, A11642, A11644, A11647,
A11648, A11652, A11654, A11661, A11662, A11667, A11669, A11671, A11672,
A11676, A11680, A11683, A11684, A11685, A11686, A11689, A11704, A11719, DS2002,
DS9008, DS9009, P99008
EC-3830TLK A01001,
A01003, A01012, A01013, A01017, A01019, A01023, A01024, A01025, A01026, A01027,
A01028, A01030, A01031, A01032, A01033, A01034, A01035, A01036, A01037, A01038,
E01077
EC-3831L A01002A,
A01013, A01017, A01021, A01022, A01023, A01024, A01025, A01027, A01033, A01034,
A01037, A01045, A01046, A01056, A01057, A01058, A01059, A01066, A01067, A01068,
A01069, A01070, E11318
EC-3831LK
E01001,
E01002, E01003, E01005
EC-3831TL A01001,
A01002, A01003
EC-3832L A01001,
A01002, A01003
EC-3840F2 A01149,
A01151
EC-3840L A01023,
A01026, A01059, A01061, A01062, A01064, A01065, A01067, A01069, A01071, A01072,
A01073, A01075, A01076, A01077, A01080, A01082, A01083, A01086, A01088, A01089,
A01090, A01092, A01094, A01096, A01097, A01099, A01102, A01104, A01105, A01107, A01110, A01120, A01124,
A01126, A01128, A01129, A01130, A01133, A01139, A01140, A01141, A01146, A01152,
A01158, A01160, A01165, A01166, A01170, A01172, A01173, A01191, A01198, A01199,
A01201, A01202, A01205, A01206, A01207, A01208, A01209, A01210, A01211, A01212,
A01216, A01218, A01219, A01220, A01223, A01226, A01229, A01234, A01235, A01236,
A01237, A01238, A01241, A01244,
A01246, A01254, A01255, A01256, A01259, A01262, A01264, A01269, A01272,
A01273, A01275, A01276, A01279, A11438, A11440, A11503, A11504, A11512, A11514,
A11516, A11521, A11531, A11567, A11609, A11610, A11615, A11625, A11627, A11638,
A11639, A11640, A11662, VET33
EC-3840LK A01002
EC-3840TL A01013,
A01018, A01019, A01025, A01028, A01029, A01031, A01034, A01035, A01037, A01039,
A01042, A01043, A01044, A01046, A01051, A01053, A01054, A01055, A01060, A01062,
A01065, A01070, A01071, A01072, A01079, A01081, A01082, A01083, A01087, A01091, A01095, A01096, A01101,
A01105, A01109, A01110, A01112, A01113, A01119, A01120, A01124, A01126, A01129,
A01131, A01145, A01146, A01147, A01149, A01151, A01153, A01157, A01158, A01159,
A01166, A01167, A01170, A01176, A01177, A01180, A01183, A01184, A01185, A01191,
A01205, A01207, A01211, A01212, A01213, A01216, A01221, A01224, A01226, A01227,
A01231, A01233, A01244, A01246,
A01249, A01250, A01251, A01257, A01259, A01261, A01262, A01272, A01279,
A11281
EC-3841LK E01001
EC-38TL30 A01295
EC-O2930FK A01001
EC-O2930MK A01001,
A01002
ECX-3830L A01001
Fiber
Colonoscopes:
Model
Number Serial Numbers
FC-34FH A71019, A71020, A71026, A71039,
A71042, A71046, A71052, R149
FC-34FX A01039, A91001, A91017, A91021,
A91024, B01052, B01063, B01075, B01097, B01098, B01100
FC-38FV A01269, A01271, A01273
FC-38FX2 B91028,
C02433
FC-38LA B91085, P40006
FC-38LH A51026, A51039, A51050, A51054,
A51072, A51075, A51081, A51089, A51095, A51101, A51104, A51119, A51129, A51141,
A51172, A51195, A51225, A51242, A51247, A61004, A61275, B011197, B011332,
B011358, B011368, B011446, B011456, B011459, B61346, B61368, B61377, B61378,
B61391, B61403, B61467, B61492, B61519, B71574, B71609, B71650, B71683, B71747,
B71752, B71779, B71782, B81959,
R009, R010, R106, R118, R123, R128, R145
FC-38LP A01033,
A01067, A01068, A01078, A01094, A01109, A01125, A01127, A01129, A01140, A01141,
A01143, A01149, A01151, A01152, A01179, A01221, A01248
FC-38LV A01002, A01003, A01025, A01026, A01033,
A01037, A01088, A01109, A01114, A01116, A01143, A01147, A01148, A01157, A01159,
A01166, A01191, A110341, A110343, A11196, A11210, A11211, A11212, A11213,
A11223, A11238, A11257, A11268R, A11290, A11313, A11336
FC-38LX A13112,
A81003, A81012, A81017, A81024, A81026, A81028, A81034, A81037, A81038, A81050,
A81059, A81065, A81068, A81071, A81075, A81078, A81090, A81093, A81103, A81110,
A81111, A81114, A81122, A81132, B02419, B02426, B91150, B91151, B91157, B91180, B91187, B91188, B91195,
B91203, B92215, B92243, B92254, B92257, B92262, B92265, B92284, B92285,
C021019, C021021, C021023, C02476, C02495, C02517, C02520, C02535, C02544,
C02545, C02557, C02565, C02572, C02587, C02590, C02623, C02631, C02634, C02637,
C02648, C02664, C02665, C02669, C02672, C02704, C02735, C02756, C02758, C02762,
C02763, C02764, C02771, C02784, C02824, C02857, C02860, C02867, C02889, C02901,
C02905, C02966, C02973, C02984, LX1001, LX1002, LX1003, P98003, P99005
FC-38MX C02417, C02420, C02426, C02427,
C02428
FC-38SH A41003, A51013, A51014, A61079,
A71095, A71108, A71110, A81154, A81158, A81161
FC-38SX2 A81014,
A81019, B02066, B02071, B02074, B02086, B92059, C02108, C02125
FC-38TLH A01050,
A71001
FC-P34
R031
FC-PP34L A01001.
RECALLING FIRM/MANUFACTURER Recalling Firm: Pentax
Precision Instrument Corp. (PPIC), Orangeburg, NY
Manufacturer:
Asahi Optical Co., Ltd. (AOC) Tokyo, Japan.
REASON Angle Wire Connecting Receptacle component was
observed to be cracking, resulting in a loss of angulation control for the
direction in which the part was applied (up, down).
VOLUME OF PRODUCT IN COMMERCE 3630 units.
DISTRIBUTION Nationwide and Internationally.
PRODUCT
Small
power chairs and TurnAbout power chairs (510(k) # 972370). The small power
chairs include the following product names:
Chauffeur
Littlest Viva, Chauffeur Littlest Viva Plus, Rascal Model 250, Rascal Model
255, Rascal Model 410, Rascal Model 415, Chauffeur Model 250 and Chauffeur
Model 255. The TurnAbout power chairs
include the following product names: TurnAbout and TurnAbout Heavy
Duty.
These power chairs are personal motorized vehicles intended to provide mobility
for individuals, such as the handicapped and the
elderly,
who are limited in movement. The power chairs are shipped either covered in
plastic or in a brown cardboard unit container labeled with “***MADE WITH PRIDE
IN THE U.S.A. ***ELECTRIC MOBILITY***”.
The
products are labeled with stick-on labels.
Labeling information follows.
1. Chauffeur Littlest Viva models are labeled
as: a) “LITTLEST VIVA” in black
letters on silver background; and b)
“Chauffeur mobility” in silver letters, except for the second “f” which is red, outlined in
black on a silver background. The Littlest Viva Plus is also labeled with
“plus” in black letters on a silver background.
2. Rascal models are labeled as: a) “ELECTRIC
MOBILITY in gold letters; b) “Rascal”
in gold letters; and, depending on the model number, c) either “250 PC”, “255 PC”, “4 10 PC”, or “415 PC”
in gold letters.
3. Chauffeur models are labeled as: a)
“Chauffeur mobility” in silver letters, except for the second “f” which is red,
outlined in black on a silver background; and, depending on the model number,
b) either “250 PC” or “255 PC” in black on a silver background.
4. TurnAbout models are labeled as: a)
“ELECTRIC MOBILITY in gold letters; and
b) “TurnAbout***by Rascal” in gold letters.
CODE Serial codes from JS001011 to JS010742 Serial
numbers JS001011 to JS010742 are affected.
These serial numbers were manufactured between March 1, 1999 and
September 28, 2001. The serial number
is attached to the frame of the power chairs.
It is located on the rear of the Rascals and Chauffeur models and near
the foot-plates of the TurnAbout models.
RECALLING FIRM/MANUFACTURER Electric Mobility Corp.,
Sewell, NJ
REASON The wheel bolt can loosen and cause the wheel to
separate from chair.
VOLUME OF PRODUCT IN COMMERCE 8,293 chairs.
DISTRIBUTION Nationwide and Internationally.
PRODUCT Interlink System Continu-Flo Solution Set, 10
drops/ml. approximately, 110" (2.8m), with 3 injection sites and a male
luer lock
adapter;
product code 2C6537W.
CODE All lots of product code 2C6537W.
RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter
Healthcare Corp. Round Lake, IL
Manufacturer: Baxter Healthcare Corp. Singapore, SG.
REASON Retrograde flow during direct injection.
VOLUME OF PRODUCT IN COMMERCE 368,419 sets.
DISTRIBUTION Nationwide.
PRODUCT Helix Diagnostics, Enzyme Immunoassay Helicobacter
pylori H. pylori) IgM Test Kits.
CODE Catalog # 96HPM, All lot numbers.
RECALLING FIRM/MANUFACTURER Bio-Rad Laboratories, Inc.,
West Sacramento, CA
REASON Device marketed without a 510(k) or PMA.
VOLUME OF PRODUCT IN COMMERCE 284 kits.
DISTRIBUTION NJ, TX and CA.
PRODUCT Haemonetics PCS2 Harness Set, Sterile List Number:
620.
CODE PCS2 Harness Set REF: 620 Lot Numbers: 010515530, 010515531, 010516330, 010516532,
010517331, 010518332, 010518333, 010519330, 0105121331,010521332, 010912330,
010913331.
RECALLING FIRM/MANUFACTURER Recalling Firm: Haemonetics
Corp., Braintree, MA
REASON Potenial leakage at needle adapter site may expose
user to donor blood.
VOLUME OF PRODUCT IN COMMERCE 119,100 units.
DISTRIBUTION CA, CO and NM
PRODUCT FlexiLab Laboratory Information System.
CODE Version 5.3.
RECALLING FIRM/MANUFACTURER Sunquest Information
Systems, Inc., Tucson, AZ
REASON Date Format Issue--Flexilab Software converts
specimen collect and receipt dates to American standard format
'mm/dd/yyyy'. For sites using the Euro
date format this can alter the generation of QA warnings or flags based on
collect or receipt date.
VOLUME OF PRODUCT IN COMMERCE 264.
DISTRIBUTION Nationwide and the United Kingdom, Ireland,
Canada, Denmark, Bermuda and Saudi Arabia.
PRODUCT On-Site Alcohol test kit.
CODE All lots of Catalog # 47464. Lots: 0110201, 0110202, 0110203, 0110204,
0110205, 0110208, 0110304, 0110305, 0110306, 0110307, 0110308, 0110309,
0110310, 0110311, 0110401, 0110402, 0110404, 0110502, 0110503, 0110504,
0110506, 0110507, 0110508, 0110601, 0110604, 0110605, 0110607, 0110608,
0110701, 0110703, 0110704, 0110705, 0110707, 0110805, 0110806, 0110807,
0110902, 0110904, 0110906, 0110907, 0110908, 0111001, 0111003, 0111006,
0111008, 0111102, 0111103, 0111104, 0111107, 0111201, 0111202, 0111203, 0111204
and 0111205.
RECALLING FIRM/MANUFACTURER Recalling Firm: Roche
Diagnostics Corp., Indianapolis, IN
Manufacturer:
ANSYS Technologies Inc., Lake Forest, CA.
REASON False negative results or false positive may be
reported.
VOLUME OF PRODUCT IN COMMERCE Approx. 10,000 kits.
DISTRIBUTION Nationwide.
PRODUCT PORT-A-CATH II Dual-Lumen Low Profile
Polysulfone/Titanium (Implantable) Venous Access System, with 1.0mm I.D
PolyFlow
Polyurethane
Catheter and 7 French Introducer Set.
CODE Reorder Number 21-8065-24, Lot Number 75702; Reorder
Number 21-8066-24, Lot Numbers 75703 and 75467.
RECALLING FIRM/MANUFACTURER Sims Deltec, Inc. St. Paul,
MN
REASON The Wing-Lock catheter connectors of some of the
devices will not snap into place as described in the Instructions for Use.
VOLUME OF PRODUCT IN COMMERCE 74 devices.
DISTRIBUTION CA, FL, MI, NY, SC, TX and Italy and
Switzerland.
PRODUCT AngioJet Drive Units (product number 101973-TAB) for
the AngioJet Rheolytic Thrombectomy System (AngioJet System).
CODE Drive Unit serial numbers 11881, 11882, 11883,
11887, 11888, 11889, 11898, 11899, 11900, 11901, 11902, 11903, 11907, 11908,
11909, 11910,
11911,
11912, 11913, 11914, 11915, 11916, 11917, 11918, 11919, 11920, 11921, 11922,
11924, 11925, 11929, 11930, 11932, 11937, 11938, 11939,
11941,
11942, 11948, 11950, 11951, 11952, 11953, 11955, and 11958.
RECALLING FIRM/MANUFACTURER Possis Medical, Inc.,
Minneapolis, MN
REASON Loose hardware can fall on the circuit board
producing an intermittent or permanent electrical failure of the Drive Unit.
VOLUME OF PRODUCT IN COMMERCE 45 units.
DISTRIBUTION Nationwide.
PRODUCT Comp-Air Elite Rechargeable Battery and DC Auto
Adapter for NE-C21 Comp-Air Elite Compressor, Model C21BATKIT; Made in Italy.
CODE Catalog #C21BATKIT, lots 00X and 00Y.
RECALLING FIRM/MANUFACTURER Recalling Firm: Omron
Healthcare, Inc. Vernon Hills, IL
Manufacturer: Medel Italiana Srl Polo di Torrile, Italy.
REASON Premature failure of rechargeable battery.
VOLUME OF PRODUCT IN COMMERCE 3000 batteries.
DISTRIBUTION Nationwide.
PRODUCT
1)
Merit Manifolds
2) Merit
Coronary Control Syringes
3)
Merit Fluid Administration Sets
4)
Merit Custom Convenience Sets
5)
Merit Contrast Management System
6)
Merit Disposal Depot
7)
Merit Pressure Monitoring Tubing
8)
Merit VacLok Syringes.
CODE Manifolds:
Part
Number Lot Number
203BF-R A197475, A200008, A201610
203HF-F A197472
203HF-R A199074
203HN-R A197468, A199073, A200709, A204267
204BF-FT A200707
204BN-R A197467
204HN-R A197465
205BF-F A197464
503BF-R A195336, A197454, A199071
503HF-R A197450, A198412
503HN-R A197448, A200692
504BN-R A203641
504HN-R A201604
Control
Syringes:
Part
Number Lot Number
CCS100E/B A197836, A198569, A202912
CCS101E/B A200938, A203843
CCS200E/B A199196, A199849
CCS201E/B A201571
CCS320E/B A201573, A202055, A203848
CCS600E/B A204443
CCS880 A198081, A199260, A201728, A203046
CCS881 A198012, A198563, A199259,
A201729, A205109
CCS900E/B A202061
CCS901E/B A199203, A202919
CCSB900E/B A200946, A204449
CCSB901E/B A197126, A204377
CCSB910E/B A200948
CCSB911E/B A199860, A202066
Fluid
Administration Sets:
Part
Number Lot Number
FAS1072 A202694
FAS1108 A199659
FAS1272 A202690
FAS5072 A199661
FAS5108 A201100
FAS6072 A199662
Custom
Kits:
Part
Number Lot Number
K02-00112 A203976
K02-00204B A200254
K02-00342 A203986
K02-00377B A200256
K02-00425A A203989
K02-00493 A200908
K02-00519 A203995
K02-00565A A203997
K02-00660 A202235
K02-00665 A200262
K02-00666 A200263
K02-00672 A202025
K02-MS2367B A201699
K02-MS2467A A201714
K04-00476 A202346
K07-00081B A200250
K08-00078A A203531
K08-00417B A204101
K08-00572 A201874
K08-00575 A204180
K08-00669 A201670
K08-00674 A199131, A201143
K08-00807 A201775
K08-00892 A198806
K08=01075 A202926
K08-01164 A200980
K08-01189 A204106
K08-01196 A203418
K08-01254 A203628
K08-01257 A197768
K08-01264 A201170
K08-01341A A199520
K08-01357A A199517
K08-MP5100F A203052
K08-MP5128A A198620
K09-00317H A197932
K09-00378J A198421, A202152
K09-00378K A202929
K09-00386M A197564, A201206
K09-00526D A200744
K09-00590G A199701
K09-00611H A200745, A203185
K09-00848L A199133
K09-01002H A202934
K09-01056D A198873
K09-01803F A197775, A202941
K09-01975H A200028, A203438
K09-02112C A198886
K09-02130M A199141, A200791
K09-02277B A205024
K09-02353B A199144, A203479
K09-02489M A196525
K09-02571F A202581
K09-02900C A197710, A204601
K09-02988C A204103
K09-03013 A204035
K09-03242 A201297
K09-03634D A203497
K09-03671J A200033
K09-03696J A203500
K09-03743 A204625
K09-03764F A200034
K09-03829H A200037
K09-04020 A199747
K09-04098C A203668
K09-04297F A201907
K09-04316B A199160, A201908
K09-04696D A203678
K09-04904G A195924, A201843
K09-04923A A200356
K09-04962 A201915
K09-05015A A197680
K09-05043A A201916
K09-05069B A199168
K09-05289 A199169
K09-05297 A205038
K09-05458 A204431
K09-05522 A201848
K09-05582 A203857
K09-05664 A201921
K09-05709 A196570, A200982
K09-05717 A203866
K09-05735B A205672
K09-05759A A197591
K09-05759B A204663
K09-05824 A202158
K09-05839 A203743
K09-05859 A201651
K09-05891 A201646
K09-05895 A202593
K09-05939A A202899
K09-05948 A201205
K09-05949 A200979
K09-05966 A200533
K09-06143 A205663
K09-90075M A203872
K09-90091D A199172
K09-90496G A203885
K09-KH001 A200136
K09-MM2000D A201784, A202395
K09-MM2114C A201785
K09-MM2134A A203419
K09-MM2193 A203887
K09-MM2237 A202636
K09-MM2289 A202900
K09-MM2290A A204423
K09-MS2020C A203891
K09-MS2050J A199177, A200532, A202398
K09-MS2061D A202654, A204724
K09-MS2082C A204839
K09-MS2105C A203896
K09-MS2124C A204672
K09-MS2137B A203898
K09-MS2139 A203899
K09-MS2146C A203900
K09-MS2152B A203901
K09-MS2155B A203902
K09-MS2179 A203083
K09-MS2186B A203086
K09-MS2187B A201424
K09-MS2192A A203905
K09-MS2201C A204674
K09-MS2211 A203087
K09-MS2223A A200176
K09-MS2239B A203909
K09-MS2252 A203911
K09-MS2286B A199758, A204676
K09-MS2301 A201794
K09-MS2352 A203555
K09-MS2393 A203916
K09-MS2409 A203089
K09-MS2415 A204679
K09-MS2423 A203917
K09-MS2426 A201438, A203557
K09-MS2427A A202403, A203918
K09-MS2480C A202404
K09-MS2531 A203922
K09-MS2550 A203924
K09-MS2584 A203560
K09-MS2594 A199843, A202807
K09-MS2602 A204424
K09-MS2606 A205674
K09-MS2608 A204104
K09-MS2619 A204425
K09-MST2000E A203090
K09-MST2040 A203092
K09-MST2041C A203926
K09-MST2054C A203093
K09-YSI029 A201801
K10-00076F A206478
K10-00127L A199567, A202577
K10-00149H A200462, A201781
K10-00227K A203935
K10-00389H A203941
K10-00414B A203942
K10-00445 A203943
K10-00630F A200441
K10-00731J A200439
K10-00778 A201121
K10-00785J A197634, A199354, A203155
K10-00869H A200437
K10-01078A A196646
K10-01152F A198408
K10-01231 A204363
K10-01236 A204362
K10-01245F A200423
K10-01305 A200837
K10-01402 A199097, A202638
K10-01440 A204354
K10-01613A A204346
K10-01658 A199404, A201488
K10-01721A A201547
K10-01740 A201490
K10-01750 A204338
K10-01758 A196664
K10-01816 A201546
K10-01887 A198517
K10-01901 A205175
K10-01914 A200166
K10-01925 A199839
K10-01967 A200543
K11-00096 A200384
K11-00099 A197918
K11-00100 A199398, A200382, A204332
K11-00137 A199397
K11-00144 A201506
K11-00202 A201505
K11-00301 A201503, A203621
K11-00357D A204330
K11-00382B A204327
K11-00392 A202145
K11-00546 A196198
K11-00584 A201500
K11-00588 A197657
K11-00605 A205045
K11-00611 A204105
K11-00630 A202902
K11-00635 A198516
K11-00637 A201763
K12-00040 A204324
K12-00196C A198800
K12-00246B A201870
K12-00263 A199379
K12-00316 A202631
K12-00326 A201871
K12-00391 A203035
K12-00429A A201498, A204322
K12-00530A A201776
K12-00530B A207470
K12-00604 A197928
K12-00643 A201668
K12-00657 A202703
K12-00679 A199782
K12-YP017 A193612
Disposal
Depot:
Part
Number Lot Number
MDD200H A199651, A201096, A202680, A202684
MDD220 A204808
MDD220H A202685
MDD600 A199657
Pressure
Monitoring Line:
Part
Number Lot Number
PM6048 A203084
PM6112 A203077
PM6136 A203079
Vaclok
Syringe
Part
Number Lot Number
VAC120E A204504.
RECALLING FIRM/MANUFACTURER Merit Medical Systems, Inc.,
South Jordan, UT
REASON Seals on Tyvek/Nylon pouches are potentially
defective.
VOLUME OF PRODUCT IN COMMERCE 57,301 units.
DISTRIBUTION Nationwide and Brazil, Canada, China, Egypt,
England, France, Ireland, Japan, Kuwait, Lebanon, New Zealand, Pakistan and
Venezuela.
PRODUCT Baxter Spinal Anesthesia Trays, product code
1T2356.
CODE Product code 1T2356, lot GD734509.
RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Healthcare Corp., Round Lake, IL
Manufacturer: Baxter Healthcare Corporation Cleveland, MS.
REASON Trays labeled with incorrect expiration date.
VOLUME OF PRODUCT IN COMMERCE 3,978 trays.
DISTRIBUTION Nationwide.
PRODUCT Nichols Advantage Thyroglobulin Assay An in-vitro
diagnostic intended for the quantitative mesurement of Thyroblobulin in human serum.
CODE All Lots.
RECALLING FIRM/MANUFACTURER Nichols Institute
Diagnostics, San Juan Capistrano, CA
REASON Dilution result may read less than the 0.9 ng/mL
negative out-off.
VOLUME OF PRODUCT IN COMMERCE 53.
DISTRIBUTION Nationwide and Germany, France, Chile,
Brazil, Greece, Spain and Portugal.
PRODUCT Premium Abduction Pillow with Kodel Band; Custom
Abductor Pillow; and 6” Patella Strap.
CODE Premium Abduction Pillow with Kodel Band Model
Number, M60- 025-S, codes: 854182, 85861, 856410, 858472, 859513
Premium
Abduction Pillow with Kodel Band Model Number, M60-025-M, codes: 854181,
857959, 858506, 859263, 859515, 860769
Premium
Abduction Pillow with Kodel Band Model Number, M60-075, codes: 849938, 857077
Custom
Abductor Pillow Universal Model Number, M60-081, code: 858686
6”
Patella Strap Model Number, 6P, code: 860305.
RECALLING FIRM/MANUFACTURER Recalling Firm: Deroyal
Industries, Inc., Powell, TN
Manufacturer:
Deroyal Orthopedic Fabrication, Maynardville, TN
REASON Undeclared natural rubber.
VOLUME OF PRODUCT IN COMMERCE 506 units.
DISTRIBUTION Nationwide.
PRODUCT Sysmex Automated Hematology Analyzers and Sysmex Automated
Reticulocyte Analyzers.
Models:a) K-4500, Automated Hematology
Analyzer, an in-vitro device for use in clinical laboratories to analyze whole
blood samples as a
screening
device for identifying samples with abnormal cells.
b)
R-3500, Automated Reticulocyte Analyzer, a fully automated reticulocyte
analyzer for in-vitro diagnostic use in clinical laboratories.
c)
SF-3000, Automated Hematology Analyzer, an in-vitro device for blood cell
analysis in clinical laboratories, as a screening device for
identifying
samples with abnormal cells. Medical
Technologists are responsible for final review of abnormal cells.
d)
SE-9000, Automated Hematology Analyzer, 23 parameters, an in-vitro device for
whole blood cell analysis in clinical laboratories, as a screening device to
flag specimens containing abnormal blood cells. Medical Technologists are responsible for final review of
abnormal cells.
e)
SE-9500, Automated Hematology Analyzer, 25 parameters, an in-vitro device for
whole blood cell analysis in clinical laboratories, as a screening device to
flag specimens containing abnormal blood cells. Medical Technologists are responsible for final review of
abnormal cells.
f)
SP-100, Automated Hematology Slide Preparation Unit.
g) XE-2100,
Automated Hematology Analyzer, 32 parameters, networking capability, intended
to classify formed elements in EDTA anti-
coagulated
blood.
h)
XE-2100L, Automated Hematology Analyzer, 26 parameters, networking capability,
expandable to the XE-2100L Twin System, intended to classify formed elements in
EDTA anti-coagulated blood.
i)
SE-Alpha, Integrated Hematology System, receives the data from the SE-9000/9500
automated hematology analyzer and directs the SP-100 to prepare a blood film
and stain on appropriate samples, to perform complete hematology analysis,
slide preparation and staining in a walk-away environment.
j)
SE-HST, Total Hematology Automation System, receives the data from the
SE-9000/9500 automated hematology analyzer and the R-3500
automated
reticulocyte analyzer, and directs the SP-100 to prepare a blood film and stain
on appropriate samples, utilizing the HST conveyor
transport
system which automates the manual transfer of blood sample racks between
devices and to automate manual blood film preparation.
k)
XE-Alpha, Hematology Alpha Transportation System, receives the data from the
XE-2100 automated hematology analyzer and directs the SP-100 to prepare a blood
film and stain on appropriate samples, to perform complete hematology analysis,
slide preparation and staining in a walk-away environment.
l)
XE-HST, Total Hematology Automation System, receives the data from the XE-2100
automated hematology analyzer and the R-3500
automated
reticulocyte analyzer, and directs the SP-100 to prepare a blood film and stain
on appropriate samples, utilizing the HST conveyor
transport
system which automates the manual transfer of blood sample racks between
devices and to automate manual blood film preparation.
CODE Model numbers K-4500, R-3500, SF-3000, SE-9000,
SE-9500, SP-100,XE-2100, XE-2100L, SE-Alpha, SE-HST, XE-Alpha, XE-HST; all
serial Numbers.
RECALLING FIRM/MANUFACTURER Recalling Firm: Sysmex
Corporation of America, Long Grove, IL
Manufacturer: Sysmex Corporation Kobe, Japan.
REASON Potential misidentification of samples.
VOLUME OF PRODUCT IN COMMERCE 1,092 systems.
DISTRIBUTION Nationwide.
PRODUCT Boston Scientific Medi-Tech Imager II 4 Fr
Angiographic Catheters
in
the types and models described below:
Product
Description Catalog
Numbers
a)
4F/Tennis Racquet .035”/65 cm M001315001
b)
4F Tennis Racquet .035”/90 cm M001315011
c)
4F Pigtail .035”/65 cm M001315091
d)
4F Straight .035”/65 cm M001315101
e)
4F Pigtail .035”/90 cm M001315111
f)
4F Straight .035”/90 cm M001315121
g)
4F Contra .035”/65 cm M001315251
h)
4F Contra .035”/90 cm M001315261
i)
4F Contra .035”/100 cm M001315271
CODE
By product
descriptions below, the lot numbers are listed:
a)
lot numbers FA12902, FA13151, and FA14089;
b)
lot numbers 5671, FA13152, FA14220, and FA13921;
c)
lot numbers FA13156 and FA14088;
d)
lot numbers 5674, FA12802, FA13127, FA13511, and FA14090;
e)
lot numbers 5675, FA13922, and FA13157;
f)
lot numbers FA12907, 5676, FA12804, FA13513, FA13514, FA13615, and FA13616;
g)
lot numbers FA13130, FA13619, FA13620, 5677, and FA12805;
h)
lot numbers 5678, FA12806, FA12908, FA13797, FA13798, and FA14724;
h)
lot numbers FA12807, FA13795, and FA13796.
RECALLING FIRM/MANUFACTURER Recalling Firm: Boston
Scientific Scimed, Inc., Maple Grove, MN
Manufacturer: TFX Medical Annacotty, Co., Liomerick,
REASON Catheter tip may separate from the device if
significant flexing forces are applied.
VOLUME OF PRODUCT IN COMMERCE 752 boxes (5 catheters per
box).
DISTRIBUTION Nationwide and the Netherlands.
PRODUCT Becton Dickinson's ColorPAC brand
Giardia/Cryptosporidium Rapid Assay in-vitro diagnostic kit, packaged in papercard
box, each kit containing instructions, reagents and components to perform 30
tests.
CODE Lot 219370 exp June 5, 2002.
RECALLING FIRM/MANUFACTURER Recalling Firm: Becton
Dickinson Microbiology Systems Sparks, MD
Manufacturer:
Genzyme Corp., Cambridge, MA.
REASON IVD kit may exhibit false positive results.
VOLUME OF PRODUCT IN COMMERCE 695 kits.
DISTRIBUTION Nationwide and Australia, Canada and
Shanghai.
PRODUCT Kendall Mahurkar 12Fr Triple Lumen Catheter Kits and
Trays.
CODE
Description Lot Number
8888101002 Mahurkar 12Fr Triple Lumen Catheter
Tray 120883 16 cm
8888101002 Mahurkar 12Fr Triple Lumen Catheter
Tray 121590 16 cm
8888101003 Mahurkar 12Fr Triple Lumen Catheter
Tray 121118 20 cm
8888101003 Mahurkar 12Fr Triple Lumen Catheter
Tray 121934 20 cm
8888102003 Mahurkar 12Fr Triple Lumen Catheter
Tray 122470 w/str Ext 20 cm
8888345611 Mahurkar 12Fr Triple Lumen Catheter Kit 120506 16
cm
International
Only:
8888345611 Mahurkar 12Fr Triple Lumen Catheter Kit 121427 16 cm
8888345611 Mahurkar 12Fr Triple Lumen Catheter Kit 121805 16
cm
8888345629 Mahurkar 12Fr Triple Lumen Catheter Kit 120878 20
cm
RECALLING FIRM/MANUFACTURER Recalling Firm: Tyco
Healthcare/ Kendall Mansfield, MA
Manufacturer: The Kendall Co. lp, Argyle, NY
REASON Dialysis catheter connection may crack and cause
leakage of fluid.
VOLUME OF PRODUCT IN COMMERCE 1595 units.
DISTRIBUTION Nationwide and Belgium and Canada.
PRODUCT Mammary sizer; intraoperative determination for
volume of breast implants.
CODE MSA300 Lot# 1M217 (5 units) MSR450 Lot# 1M213 (1
unit).
RECALLING FIRM/MANUFACTURER Specialty Surgical Products,
Inc., Victor, MT
REASON Product mislabeled as sterile when it was
non-sterile.
VOLUME OF PRODUCT IN COMMERCE 6.
DISTRIBUTION PA, FL and NY.
PRODUCT Roche/Hitachi Tina-quant IgM.
CODE Catalog # 1929305.
Lots 61361701, 61947001, 62245301, 62246301 and 62377001. Exp.
2/28/2002, 6/30/2002, 12/31/2002, 8/31/2002 and 2/28/2003 respectively.
RECALLING FIRM/MANUFACTURER Recalling Firm: Roche
Diagnostics Corp., Indianapolis, IN
Manufacturer: Roche Diagnostics, Mannheim, Germany.
REASON Precipitate in r2 bottle causes false high or low
results.
VOLUME OF PRODUCT IN COMMERCE 870 units.
DISTRIBUTION Nationwide.
PRODUCT Sysmex Automated Hematology Analyzers.
Models:
a) XE-2100, Automated Hematology Analyzer, 32 parameters, networking
capability, catalog #983-1341-1;
b)
XE-2100L, Automated Hematology Analyzer, 26 parameters, networking capability,
expandable to the XE-2100L Twin System,
catalog
#993-3731-9 (L).
CODE All serial numbers of models XE-2100 and XE-2100L.
RECALLING FIRM/MANUFACTURER Recalling Firm: Sysmex
Corporation of America, Long Grove, IL
REASON Potential misidentification of samples due to a time
out error.
VOLUME OF PRODUCT IN COMMERCE 132 units.
DISTRIBUTION Nationwide and Puerto Rico.
PRODUCT Sysmex Automated Hematology Analyzers.
Models:
a) XE-2100, Automated Hematology Analyzer, 32 parameters, networking
capability, catalog #983-1341-1;
b)
XE-2100L, Automated Hematology Analyzer, 26 parameters, networking capability,
expandable to the XE-2100L Twin System,
catalog
#993-3731-9 (L).
CODE Models XE-2001 and XE-2100L, all serial numbers.
RECALLING FIRM/MANUFACTURER Recalling Firm: Sysmex
Corporation of America, Long Grove, IL
REASON Potential misidentification of samples.
VOLUME OF PRODUCT IN COMMERCE 132 units.
DISTRIBUTION Nationwide and Puerto Rico.
PRODUCT Aspiration tube of I/A stainless steel handpieces
part number 10-030. I/A handpieces are
used in cataract surgery to aspirate and irrigate the lens cavity.
CODE I/A Handpiece P/Ns: IH-90200, SI-98200 and MH311;
Lot #'s 012096, 012772, 012989, 013036,
013470, 013624, 013726, 013803, 014354, 014363, 014392, 014413, 014437, 014438,
014462, 014467, 014471, 014478
Aspiration slug P/N: 10-030.
RECALLING FIRM/MANUFACTURER Microsurgical Technology,
Inc., Redmond, WA
REASON Leaking aspiration tubes.
VOLUME OF PRODUCT IN COMMERCE 282 handpieces.
DISTRIBUTION CA, ID, FL, MO, PA, TN and UT.
PRODUCT Vitros
Digoxin Slides, for use with Vitros Chemistry Systems to quantitatively measure
Digoxin concentration in serum and plasma.
CODE 1921-0074-0782
RECALLING FIRM/MANUFACTURER Ortho-Clinical Diagnostics, INC.
Rochester, NY
REASON Analyzer could produce biased results due to
incorrect lot # on barcode.
VOLUME OF PRODUCT IN COMMERCE 168 cartridges/18 slides per
cartridge.
DISTRIBUTION FL, IL, and NY
PRODUCT All DataCare Systems Software, as follows:
a)
DataCare ABG Data Management System for use in a blood gas point of care
testing environment; Catalog GD9200
b)
DataCare ABG Data Management System for use in a blood gas point of care
testing environment; Catalog GD9201
c)
DataCare ABG Data Management System for use in a blood gas point of care
testing environment; Catalog BP9251
d)
DataCare ABG Data Management System for use in a blood gas point of care
testing environment; Catalog BP9252
e)
DataCare POC Data Management System for use in a blood gas, glucose and
coagulation point of care testing environment;
Catalog
GD9200
f)
DataCare POC Data Management System for use in a blood gas, glucose and
coagulation point of care testing environment;
Catalog
GD9201
g)
DataCare POC Data Management System for use in a blood gas, glucose and
coagulation point of care testing environment;
Catalog;
GD9206
h)
DataCare POC Data Management System for use in a blood gas, glucose and
coagulation point of care testing environment;
Catalog;
GD9207
i)
DataCare POC Data Management System for use in a blood gas, glucose and
coagulation point of care testing environment;
Catalog;
GD9208
j)
DataCare POC Data Management System for use in a blood gas, glucose and
coagulation point of care testing environment;
Catalog;
BP9251
k)
DataCare POC Data Management System for use in a blood gas, glucose and
coagulation point of care testing environment;
Catalog;
BP9252
l)
DataCare GM Data Management System for use in a glucose only point of care
testing environment; Catalog GD9202
m)
DataCare GM Data Management System for use in a glucose only point of care
testing environment; Catalog GD9209
n)
DataCare GM Data Management System for use in a glucose only point of care testing
environment; Catalog GD9010
o)
DataCare GM Data Management System for use in a glucose only point of care
testing environment; Catalog GD9211
p)
DataCare GM Data Management System for use in a glucose only point of care
testing environment; Catalog GD9212
q)
DataCare GM Data Management System for use in a glucose only point of care
testing environment; Catalog BP9215
r)
DataCare GM Data Management System for use in a glucose only point of care
testing environment; Catalog BP9216.
CODE All units.
RECALLING FIRM/MANUFACTURER Roche Diagnostics Corp.,
Indianapolis, IN
REASON Potential patient/sample mismatch.
VOLUME OF PRODUCT IN COMMERCE Approx. 450 installations.
DISTRIBUTION Nationwide, Canada and the United Kingdom.
PRODUCT DynaTorq brand Dental Torque Wrench
CODE Model/Lots: DTW4321 (lots 33670, 33586, 33496)
DTW4331 (lots 33491, 33611, 33495) GTW4331 (lots 33671, 33658).
RECALLING FIRM/MANUFACTURER Micro Motors, Inc. Santa
Ana, CA
REASON Error in torque setting.
VOLUME OF PRODUCT IN COMMERCE 205.
DISTRIBUTION CA.
PRODUCT Hill-Rom Utility Shelf for placement of equipment on
the Uniflex headwall. Model P105001
CODE All model P105001 utility shelves distributed
between February 1996 and April 2001.
RECALLING FIRM/MANUFACTURER Hill-Rom Co. Inc.,
Batesville, IN
REASON Electrical shock hazard.
VOLUME OF PRODUCT IN COMMERCE 1,372.
DISTRIBUTION Nationwide, Canada, Great Britain, Jordan,
Lebanon, Mexico, Taiwan and Turkey
PRODUCT Boston Scientific/Medi-Tech:Vaxcel PICC Peripherally
Inserted Central Catheter 6 Fr Dual Lumen Clampable Hub, 130 cm Wire
Catalog
Number: 45-426.
CODE Lot Numbers: 109282, 111270.
RECALLING FIRM/MANUFACTURER Recalling Firm: Medi-Tech a
division of Boston Scientific Corp., Watertown, MA
Manufacturer: Becton Dickinson Infusion Therapy Systems,
Inc., Sandy, UT.
REASON Outer Carton is mislabeled as 6 Fr Dual Lumen, inner
label correctly identifies product as a 5 Fr Single Lumen.
VOLUME OF PRODUCT IN COMMERCE 1914.
DISTRIBUTION Nationwide.
PRODUCT Aspiration Slug in the Phaco handpieces - Phaco
handpieces are AC-powered devices with a fragmenting needle intended for use in
cataract surgery to disrupt a cataract with ultrasound and extract the
contaract.
CODE Phaco handpiece P/N PH-10441and PH-10140 Aspiration
slug P/N 40-030, Lot #104244.
RECALLING FIRM/MANUFACTURER Microsurgical Technology,
Inc., Redmond, WA
REASON Burr in aspirator pathway.
VOLUME OF PRODUCT IN COMMERCE 61 handpieces.
DISTRIBUTION CA, CO and KY and Italy and Hong Kong.
PRODUCT a) Cook Check-Flo Plus Introducer Set, 12 French; b)
Cook Check-Flo Plus Introducer Set, 14 French; c) Cook Check-Flo Plus
Introducer Set, 16 French.
CODE All of these sets containing catalog number prefixes
VCF, VCFW, RCF, RCFW and RCFN are being recalled.
RECALLING FIRM/MANUFACTURER Cook, Inc., Bloomington, IN
REASON Valve may move into patient through introducer.
VOLUME OF PRODUCT IN COMMERCE 7,348.
DISTRIBUTION Nationwide.
WEEK ENDING APRIL 20
PRODUCT Various OB/GYN surgical devices labeled as sterile or
processed by ETO.
CODE All lots labeled as sterile
RECALLING FIRM/MANUFACTURER A & A Medical/Rocket
USA, (also labeled Lifequest), Alpharetta, GA
REASON Devices may not have been adequately sterilized.
VOLUME OF PRODUCT IN COMMERCE Unknown at this time.
DISTRIBUTION Nationwide, worldwide.
PRODUCT Bard RapidFire Multiple Band Ligator.
CODE Bard RapidFire Multiple Band Ligator Item Number:
000608
70
Lots: 88BL0653, 88BL0654, 88BL0618, 88BL0623, 88CL0220, 88CL0224, 88CL0229,
88CL0488, 88CL0489, 88CL0868, 88DL0139, 88DL0331, 88DL0339, 88DL0410, 88DL0430,
88DL0494, 88DL0744, 88DL0955, 88EL0163, 88EL0359, 88EL0376, 88EL0459, 88EL0524,
88EL0555, 88EL0769, 88EL1012, 88EL1004, 88FL0158, 88FL0267, 88FL0373, 88FL0453,
88FL0491, 88FL0510, 88FL0652, 88FL0996, 88GL0036, 88GL0076, 88GL0352, 88GL0382,
88GL0493, 88GL0847, 88HL0070, 88HL0298, 88HL0372, 88HL0454, 88HL0504, 88HL0552,
88HL0645, 88HL0827, 88HL0974, 88IL0001, 88IL0215, 88IL0288, 88IL0391, 88IL0407,
88IL0466, 88JL0043, 88JL0268, 88JL0373, 88JL0439, 88JL0494, 88JL0545, 88JL0600,
88JL0890, 88JL0975, 88KL0108, 88KL0317, 88KL0387, 88KL0408, 88LL0208.
RECALLING FIRM/MANUFACTURER Recalling Firm: Bard Endscopic Technologies, Division
C.R.Bard, Inc., Billerica, MA
Manufacturer: Proximal Inc., Largo, FL
REASON Band Ligator may fail to deploy and prevent control
of bleeding.
VOLUME OF PRODUCT IN COMMERCE 12,206 units.
DISTRIBUTION Nationwide.
PRODUCT PROSORBA Protein A Immunoadsorption Column -
indicated for use in the therapeutic removal of immunoglobulin G (IgG) and
IgG-containing circulating immune complexes from plasma in patients with
idiopathic thromocytopenic purpura (ITP) having patelet counts less than
100,00mm3. The Prosorba column is
indicated for use in the therapeutic reduction of the signs and symptoms of
moderate to severe rheumatoid arthritis in adult patients with long standing
disease who have failed or are intolerant to disease-modifying anti-rheumatic
drugs (DMARDS).
CODE
Lot
No. Expiration Date
E022801 2002-02
E051501 2002-05
MGN001 2002-07
MGN002 2002-08
MMN001 2002-11.
RECALLING FIRM/MANUFACTURER Fresenius Hemocare, Inc.,
Redmond, WA
REASON Increased potential to develop vasculitis.
VOLUME OF PRODUCT IN COMMERCE 1737 columns distributed
that are still within date.
DISTRIBUTION Nationwide and Wendel and Hong Kong.
PRODUCT a) ORTHOARTS Lower Extremity Drape, Bulk Pack,
Non-sterile; b) ORTHOARTS Lower Extremity Drape, Sterile;
c)
ORTHOARTS Lower Extremity Pack, Sterile; d) ORTHOARTS Hip Drape, Bulk Pack,
Non-sterile; e) ORTHOARTS Hip Drape, Sterile;
f)
ORTHOARTS Hip Pack, Sterile; g) ORTHOARTS Knee Arthroscopy Drape, bulk,
non-sterile; h) ORTHOARTS Knee Arthroscopy Drape, sterile; i) ORTHOARTS Knee
Arthroscopy Pack; j) Canton-Potsdam Lower Extremity Pack; k) Mercer Orthopedic
II Pack;
l)
ORTHOARTS Lower Extremity Pack; m) Sharon Regional Total Knee Pack.
CODE a) Lower Extremity Drape, Bulk Pack Non-sterile -
Cat. No. 79278-10 - Lots
0311C01, 0311C02, 0321C01, 0321C02,
0381C01, 0381C02, 0381C03, 0381C04, 0381C05, 0381C06, 0381C07, 0431C01,
0431C02, 0431C03, 0431C04, 0431C05, 0431C06, 0441C01, 0441C02, 0441C03,
0501C01, 0501C02, 0501C03, 0501C04, 0501C05, 0501C06, 0501C07, 0501C08,
0571C01, 0571C02, 0571C03, 0571C04, 0571C05, 0571C06, 0571C07, 0571C08,
0571C09, 0641C01, 0641C02, 0641C03, 0641C04, 0641C05, 0641C06, 0641C07,
0641C08, 0641C09, 0711C01, 0711C02, 0711C03, 0711C04, 0711C05, 0711C06,
0711C07, 0711C08, 0711C09, 0781C01, 0781C02, 0781C03, 0791C01, 0791C02,
0791C03, 0791C04, 0851C01, 0851C02, 0851C03, 0851C04, 0851C05, 0851C06,
0851C07, 0851C08, 0851C09, 0941C01, 0941C02, 0941C03, 0941C04, 0951C01,
1071C01, 1071C02, 1071C03, 1071C04, 1131C01, 1131C02, 1131C03, 1131C04,
1131C05, 1131C06, 1131C07, 1141C01, 1141C02, 1211C01, 1211C02, 1211C03,
1211C04, 1211C05, 1211C06, 1211C07, 1211C08, 1221C01, 1221C02, 1271C01,
1271C02, 1271C03, 1271C04, 1271C05, 1281C01, 1281C02, 1281C03, 1281C04,
1341C01, 1341C02, 1351C01, 1351C02, 1351C03, 1351C04, 1351C05, 1351C06,
1351C07, 1421C01, 1421C02, 1421C03, 1421C04, 1421C05, 1421C06, 1421C07,
1421C08, 1431C01, 1571C01, 1571C02, 1571C03, 1571C04, 1581C01, 1581C02,
1581C03, 1581C04, 1581C05, 1581C06, 1691C01, 1691C02, 1691C03, 1691C04,
1701C01, 1701C02, 1701C03, 1701C04, 1701C05, 1701C06, 1771C01, 1771C02, 1771C03,
1771C05, 1771C06, 1771C07, 1771C08, 1771C09, 1841C01, 1841C02, 1841C03,
1841C04, 1841C05, 1901C02, 1901C03, 1901C04, 1901C05, 1901C06, 1971C01,
1971C04, 1971C05, 1971C06, 1971C08, 1971C13, 1971C14, 1981C03, 1981C04,
2041C11, 2041C12, 2041C13, 2041C14, 2041C17, 2041C23, 2041C26, 2051C08,
2051C09, 2121C07, 2121C08, 2121C15, 2131C03, 2131C04, 2191C07, 2191C08,
2191C09, 2191C10, 2191C11, 2331C06, 2331C08, 2331C09, 2331C10, 2331C12,
2341C05, 2341C06, 2341C07, 2471C01, 2471C02, 2471C03, 2471C07, 2471C08,
2471C09, 2471C10, 2531C06, 2531C07, 2531C08, 2531C09, 2531C10, 2611C05,
26611C06, 2611C07, 2621C04, 2751C01, 2751C02, 2751C04, 2751C05, 2751C10.
2761C## through 2911C##
b)
Lower Extremity Drape, Sterile, Cat. No. 89278-10 - Lots 0311C02, 0391C11, 0391C12, 0391C13, 0401C08, 0401C09,
0401C10, 0401C11, 0401C12, 0411C01, 0431C01, 0451C18, 0461C19, 0461C20,
0461C21, 0461C22, 0461C23, 0461C24, 0461C34, 0461C35, 0461C36, 0531C18,
0531C19, 0531C20, 0531C21, 0531C22, 0531C23, 0531C24, 0531C25, 0531C26,
0531C27, 0531C28, 0541C19, 0541C20, 0541C21, 0541C22, 0581C11, 0581C12,
0581C13, 0581C14, 0591C12, 0591C13, 0591C14, 0591C15, 0661C01, 0661C02,
0661C11, 0661C12, 0661C13, 0661C14, 0661C20, 0661C21, 0671C05, 0671C06,
0801C05, 0801C06, 0801C07, 0801C08, 0801C09, 0801C10, 0801C11, 0801C12,
0861C18, 0861C19, 0861C20, 0861C21, 0861C22, 0861C23, 0871C01, 0871C02,
0881C02, 0881C03, 0941C28, 0941C29, 0951C01, 0951C15, 0951C19, 0951C20,
1061C11, 1061C12, 1061C13, 1061C14, 1071C11, 1071C12, 1081C04, 1341C13,
1341C14, 1341C15, 1341C16, 1341C17, 1341C18, 1361C21, 1361C22, 1421C03,
1421C04, 1421C05, 1421C06, 1421C07, 1421C08, 1421C09, 1421C10, 1481C22,
1481C23, 1491C01, 1491C02, 1491C03, 1491C04, 1491C05, 1491C06, 1571C11,
1571C12, 1571C13, 1571C14, 1571C15, 1571C16, 1571C39, 1571C10, 1641C25,
1641C26, 1641C27, 1661C04, 1661C05, 1661C06, 1661C11, 1661C12, 1711C21,
1711C22, 1711C23, 1711C24, 1721C06, 1721C07, 1721C08, 1781C05, 1781C06,
1781C07, 1781C11, 1781C12, 1781C19, 1841C01, 1841C02, 1841C03, 1841C04,
1911C23, 1911C24, 1911C25, 1911C26, 1911C27, 1911C28, 1911C29, 1911C30,
1981C13, 1981C14, 1981C15, 2051C17, 2051C18, 2051C19, 2051C20, 2051C24,
2051C25, 2061C13, 2111C04, 2111C05, 2111C06, 2111C08, 2111C20, 2111C21,
2111C22, 2121C06, 2121C07, 2121C08, 2141C06, 2181C03, 2181C04, 2181C16,
2181C17, 2191C03, 2191C04, 2251C07, 2251C08, 2261C11, 2261C12, 2261C13,
2261C14, 2321C11, 2321C12, 2321C13, 2321C14, 2321C15, 2331C09, 2331C10,
2331C11, 2331C12, 2331C13, 2391C12, 2391C13, 2391C14, 2391C21, 2391C22,
2391C23. 2391C24, 2391C25, 2401C06, 2401C07, 2471C08, 2471C09, 2471C10,
2471C11, 2471C12, 2471C13, 2611C14, 2611C15, 2611C16, 2611C17, 2681C10,
2681C17, 2681C19, 2681C20, 2691C03, 2741C01, 2741C02, 2741C03, 2741C10,
2741C11, 2751C01, 2751C02. 2761## through 2911C##
c)
Lower Extremity Pack, Sterile - Cat. No. 88471-20 Lots 0311C01, 0311C02,
0311C03, 0311C04, 0311C05, 0311C06, 0311C07, 0311C08, 0311C09, 0311C10,
0381C01, 0381C02, 0381C03, 0381C04, 0381C05, 0471C01, 0471C02, 0471C03,
0471C04, 0471C05, 0471C06, 0471C07, 0471C08, 0471C09, 0531C01, 0531C02, 0531C03, 0531C04, 0531C05, 0531C06, 0541C01,
0541C02, 0541C03, 0541C04, 0541C05, 0541C06, 0581C01, 0581C02, 0581C03,
0581C04, 0581C05, 0581C06, 0671C01, 0671C02, 0711C01, 0711C02, 0711C03,
0711C04, 0711C05, 0751C01, 0751C02, 0751C03, 0751C04, 0751C05, 0761C01, 0761C02, 0761C03, 0761C04,
0781C01, 0781C02, 0781C03, 0781C04, 0781C05, 0781C06, 0781C07, 0781C08,
0781C09, 0781C10, 0781C11, 0791C01, 0791C02, 0791C03, 0871C01, 0871C02,
0871C03, 0871C04, 0871C05, 0871C06, 0871C07, 0871C08, 0871C09, 0871C10,
0871C11, 0941C01, 10941C02, 0941C03,
0941C04, 0941C05, 0941C06, 1011C01, 1011C02, 1011C03, 1011C04, 1011C05,
1061C01, 1061C02, 1061C03, 1061C04, 1061C05, 1061C06, 1141C01, 1141C02,
1141C03, 1141C04, 1141C05, 1141C06, 1141C07, 1281C01, 1281C02, 1281C03,
1281C04, 1281C05, 1281C06, 1281C07, 1281C08, 1281C09, 1281C10, 1281C11,
1281C12, 1281C13, 1281C14, 1281C15, 1281C16, 1281C17, 1281C18, 1281C19,
1281C20, 1281C21, 1281C22, 1371C01, 1371C02, 1371C03, 1371C04, 1371C05,
1371C06, 1371C07, 1421C01, 1421C02, 1421C03, 1491C01, 1491C02, 1491C03,
1491C04, 1491C05, 1491C06, 1491C07, 1491C08, 1491C09, 1491C10, 1491C11,
1491C12, 1591C01, 1591C02, 1591C03, 1591C04, 1591C05, 1591C06, 1591C07,
1641C01, 1641C02, 1641C03, 1641C04, 1641C05, 1641C06, 1641C07, 1701C01,
1701C02, 1701C03, 1701C04, 1761C01, 1761C02, 1761C03, 1761C04, 1761C05,
1761C06, 1761C07, 1761C08, 1761C09, 1831C01, 1831C02, 1831C03, 1831C04,
1831C05, 1831C06, 1831C07, 1831C08, 1831C09, 1911C06, 1911C07, 1911C08,
1911C09, 1911C10, 1971C01, 1971C02, 1971C03, 1971C04, 1991C01, 1991C02,
2011C05, 2011C06, 2011C07, 2051C06, 2051C07, 2051C08, 2051C09, 2061C09,
2061C10, 2061C11, 2121C08, 2121C09, 2121C10, 2121C10, 2121C11, 2121C12,
2121C13, 2201C01, 2201C02, 2201C03, 2201C04, 2201C05, 2251C05, 2251C06, 2251C07,
2251C08, 2251C09, 2251C10, 2331C13, 2331C14, 2331C15, 2331C16, 2341C01,
2341C02, 2341C03, 2411C14, 2411C15, 2461C01, 2461C02, 2461C03, 2461C04,
2461C05, 2461C06, 2461C07, 2461C08, 2461C09, 2461C10, 2461C11, 2461C12,
2461C13, 2461C14, 2461C15, 2461C16, 2461C17, 2461C18, 2531C09, 2531C10,
2531C11, 2531C12, 2541C01, 2541C02, 2541C03, 2541C04, 2541C05, 2541C06,
2611C06, 2611C07, 2611C08, 2621C02, 2621C03, 2621C04, 2621C05, 2621C06,
2621C07, 2621C08, 2671C07, 2671C08, 2671C09, 2671C10, 2671C11, 2671C12, 2681C02,
2681C03, 2681C04, 2681C07, 2681C08, 2681C09, 2681C10. 2761C## through 2911C##
d)
Hip Drape, Bulk Pack - Non-sterile, Cat. No. 79346-10 - Lots 0451C01, 0671C01,
0811C01, 0811C02, 1001C01, 1001C02, 1011C01, 1151C01, 1151C02, 1731C01, 1731C02,
1731C03, 1761C01, 1761C02, 1911C08, 1921C09, 1921C10, 2071C08, 2071C10,
2631C05, 2631C06, 2641C11.
2761C##
through 2911C##
e)
Hip Drape, Sterile - Cat. No. 89346-10, Lots 0601C28, 0601C29, 0741C01,
0741C02, 0741C03, 0941C06, 0941C07, 0941C25, 1491C28, 1491C29, 1491C30,
1691C21, 1701C01, 1991C05, 1991C06, 1991C07, 1991C08, 2201C09, 2201C10,
2201C11, 2201C12, 2431C02, 2431C03, 2491C20.
2761C##
through 2911C##
f)
Hip Pack, Sterile - Cat. No. 88453-20 - Lots 0311C01, 0311C02, 0371C01,
0731C01, 1091C01, 1131C01, 2071C12, 2361C01, 2631C08.
2761C##
through 2911C##
g)
ORTHOARTS Knee Arthrscopy Drape, Bulk Non-Sterile - Cat. No. 79267-10, Lots
0311C## through 2911C##
h)
ORTHOARTS Knee Arthroscopy Drape, Sterile, Cat. No. 89267-10, Lots 0311C##
through 2911C##
i)
ORTHOARTS Knee Arthroscopy Pack, Sterile, Cat. No. 88481-20, Lots 0311C##
through 2911C##
j)
Canton-Potsdam Lower Extremity Pack, Cat. No. 76091-ACM7539, Lots 1291B01,
1571B01, 1921B01, 1981B01, 2071B01, 2211B01, 2411B01
k)
Mercer Orthopedic II Pack, Cat. No. 76095-ACM5054, Lots 0321B01, 1171B01,
1231B01, 1481B01, 1571B01, 1721B01, 1911B01, 2121B01, 2321B01, 2641B01
l)
0ORTHOARTS Lower Extremity Pack, Cat. No. 76095-ACM5331, Lots 1011B01, 1231B01,
1441B01, 1801B01, 2211B01, 2401B01, 2551C02
m)
Sharon Regional Total Knee Pack, Cat. No. 76097-ACM5463, Lots 1351B01, 1861B01,
2151B01
(Where
## = all sublot numbers)
RECALLING FIRM/MANUFACTURER Recalling Firm: Kimberly-Clark Corp., Roswell, GA
Manufacturer: Avent SA de CV Nogales, Sonora, Mexico.
REASON The fenestrated elastic film can separate from drape
causing a break in sterility.
VOLUME OF PRODUCT IN COMMERCE 234,166 drapes.
DISTRIBUTION Nationwide and Internationally.
PRODUCT HA threaded Implant 4.0mm X13.0mm Sterile Endosseous
Implants for use in Dental Implant Surgery.
CODE Catalog Number HT413, Lot number 150159.
RECALLING FIRM/MANUFACTURER Implant Innovations, Inc.,
Palm Beach Gardens, FL
REASON Implants may not have the labeled hydroxylapatite
coating.
VOLUME OF PRODUCT IN COMMERCE 25.
DISTRIBUTION CA, NV and MI.
PRODUCT First Aid Only All Purpose First Aid Kit (Item#
FA-143C).
CODE Kit Lot #'s: G0060, G0070, G0140, G0210, G0270
H0040,
H0110, H0170, H0250
I0010,
I0130, I0140, I0180, I0220, I0060
J0180,
J0270,
K0020
L0190
A0051,
A0121
D0061,
D0110.
RECALLING FIRM/MANUFACTURER First Aid Only, Vancouver,
WA
REASON First aid kits were made using a recalled antiseptic
spray that may be subpotent.
VOLUME OF PRODUCT IN COMMERCE 89,213 kits containing the
antiseptic spray.
DISTRIBUTION Nationwide.
PRODUCT InstaTrak Adult Headset (Part No 1000497); InstaTrak
Large Pediatric (Part No 1000948); InstaTrak Small Pediatric (Part No 1000949).
The InstaTrak system is intended as an aid to the surgeon for precisely
locating anatomical structures anywhere in the human body during either open or
percutaneous procedures.
CODE InstaTrak Adult Headset (Part No 1000497); InstaTrak
Large Pediatric (Part No 1000948); InstaTrak Small Pediatric (Part No 1000949).
Lot
#’s Product Number Description
M004524 1000949 Sm Pediatric Headset
M004677 1000497 Adult Headset
M004680 1000497 Adult Headset
M004681 1000497 Adult Headset
M004684 1000497 Adult Headset
M004687 1000497 Adult Headset
M004387 1000497 Adult Headset
M004688 1000497 Adult Headset
M004693 1000497 Adult Headset
M004694 1000948 Lg Pediatric Headset
M005716 1000497 Adult Headset
M005717 1000497 Adult Headset
M005720 1000497 Adult Headset
M005725 1000497 Adult Headset
M005728 1000497 Adult Headset
M005730 1000497 Adult Headset
M005734 1000497 Adult Headset
M005735 1000497 Adult Headset
M005736 1000948 Lg Pediatric Headset.
RECALLING FIRM/MANUFACTURER Visualization Technology, Inc.,
Lawrence, MA
REASON Use of headset in a rotated position may result in
undetected system inaccuracy.
VOLUME OF PRODUCT IN COMMERCE 2624 Adult; 65 Pediatric.
DISTRIBUTION Nationwide.
PRODUCT Misys Laboratory (formerly FlexiLab) information
system.
CODE Versions 5.2, 5.23, and 5.3.
RECALLING FIRM/MANUFACTURER Misys Healthcare Systems,
Tuscon, AZ
REASON Software anomaly may allow patient results to be
transposed against another patient header or identification.
VOLUME OF PRODUCT IN COMMERCE 765.
DISTRIBUTION Nationwide and to United Kingdom, Ireland,
Canada, Denmark, Bermuda, Saudi Arabia.
PRODUCT Kappa 700/600 Dual Chamber (D, DR, and VDD)
Implantable Pulse Generator Pacemakers, Models KD700, KD701, KD703, KD706,
KDR600, KDR601, KDR603, KDR606, KDR651, KDR653, KDR700, KDR701, KDR703, KDR706,
KDR720, KDR721, KDR730, KDR731, KDR733, KVDD700, and KVDD701.
CODE Model KD700, serial numbers
PHJ600001S
- PHJ600953S
PHJ200017K
- PHJ200142K
Model
KD701, serial numbers
PHK600001S
- PHK603292S
PHK620001S
- PHK625072S
PHK100001H
- PHK100351H
PHK110000H
- PHK110072H
PHK200001K
- PHK200283K
PHK600001K
- PHK600050K
Model
KD703, serial numbers
PHM600001S
- PHM600853S
PHM620001S
- PHM621580S
PHM200001K
- PHM200057K
PHM600001K
- PHM600115K
Model
KD706, serial numbers
PHL600001S
- PHL600326S
PHL620001S
- PHL620311S
PHL200001K
- PHL200044K
PHL600001K
- PHL600045K
Model
KDR600, serial numbers
PHE600010S
- PHE600474S
PHE200021K
- PHE200077K
Model
KDR601, serial numbers
PHF600001S
- PHF600445S
PHF620001S
- PHF621222S
PHF100001H
- PHF132349H
PHF200001K
- PHF200220K
Model
KDR603, serial numbers
PHH600001S
- PHH600101S
PHH620001S
- PHH620264S
PHH100001H
- PHH101083H
PHH110000H
- PHH110161H
PHH200025K
- PHH200087K
PHH600001K
- PHH600006K
Model
KDR606, serial numbers
PHG600001S
- PHG600046S
PHG620001S
- PHG620024S
PHG100001H
- PHG110045H
PHG200001K
- PHG200037K
Model
KDR651, serial numbers
PLJ100001H
- PLJ102138H
Model
KDR653, serial numbers
PLK100001H
- PLK100424H
Model
KDR700, serial numbers
PGT600001S
- PGT602146S
PGT100001H
- PGT100359H
PGT200005K
- PGT200687K
PGT240001K
- PGT240027K
PGT600001K
- PGT600066K
Model
KDR701, serial numbers
PGU200001S
- PGU200727S
PGU600001S
- PGU608746S
PGU620001S
- PGU642826S
PGU100001H
- PGU157379H
PGU174000H
- PGU199999H
PGU400000H
- PGU408983H
PGU200001K
- PGU200590K
PGU600001K
- PGU600257K
Model
KDR703, serial numbers
PGY600001S
- PGY601668S
PGY620001S
- PGY623754S
PGY100001H
- PGY105283H
PGY114000H
- PGY116188H
PGY200014K
- PGY200136K
PGY600002K
- PGY600105K
Model
KDR706, serial numbers
PGW600001S
- PGW600825S
PGW620001S
- PGW621062S
PGW100001H
- PGW102263H
PGW112005H
- PGW112647H
PGW200001K
- PGW200121K
PGW600001K
- PGW600033K
Model
KDR720, serial numbers
PGP600001S
- PGP600156S
PGP200001K
- PGP200070K
PGP600001K
- PGP600005K
Model
KDR721, serial numbers
PGR600001S
- PGR602899S
PGR620001S
- PGR628686S
PGR100001H
- PGR104567H
PGR114004H
- PGR120551H
PGR200001K
- PGR200018K
Model
KDR730, serial numbers
PHA600001S
- PHA601345S
PHA100001H
- PHA100104H
PHA200001K
- PHA200135K
PHA600001K
- PHA600032K
Model
KDR731, serial numbers
PHB100000S
- PHB100011S
PHB200001S
- PHB200335S
PHB600001S
- PHB604053S
PHB620001S
- PHB634479S
PHB100001H
- PHB100012H
PHB200001K
- PHB200188K
PHB600002K
- PHB600054K
Model
KDR733, serial numbers
PHD600001S
- PHD602923S
PHD620001S
- PHD628838S
PHD100001H
-PHD100054H
PHD200001K
- PHD200027K
PHD600001K
- PHD600052K
Model
KVDD700, serial numbers
PHN600001S
- PHN600373S
PHN000131K
PHN600001K
- PHN600110K
Model
KVDD701, serial numbers
PHP200001S
- PHP200301S
PHP600001S
- PHP604347S
PHP620001S
- PHP632878S
PHP100001H
- PHP101406H
PHP111005H
- PHP111887H
PHP200001K
- PHP200470K
PHP600002K
- PHP600034K.
RECALLING FIRM/MANUFACTURER Medtronic, Inc.,
Minneapolis, MN
REASON Submuscular implant locations (subpectoral, abdominal,
etc.) can result in additional stress and repetitive flexing on the implanted
pacemaker, causing excessive fatigue and fracture of internal wires supplying
power to the pacemaker.
VOLUME OF PRODUCT IN COMMERCE 256,759 pacemakers.
DISTRIBUTION Nationwide and Internationally.
PRODUCT Brand Name: IMMULITE 2000 Anti-Thyroglobulin
Antibody Common/ Usual Name: IMMULITE 2000 Anti-Thyroglobulin Antibody,
Intended for the quantitative measurement of autoantibodies to Thyroglobulin in
serum EDTA and heparinized plasma.
CODE Model, catalog or code number and manufacturing lot
or serial number:
200
test: lot numbers: L2KTG2 202 and L2KTG2 203
600
test: lot numbers: L2KTG6 202 and L2KTG6 203.
RECALLING FIRM/MANUFACTURER Recalling Firm: Diagnostic Products Corp., Los Angeles, CA
Manufacturer: EURO/DPC, Ltd. Wales, The United Kingdom.
REASON Insufficient stability at certain temperatures
causes control values to be high.
VOLUME OF PRODUCT IN COMMERCE 174.
DISTRIBUTION Nationwide and Brazil, Saudi Arabia and
People's Republic of China.
PRODUCT Brand/Common/Usual Name of Device: IMMULITE Anti-TPO
This is an in-vitro diagnostic device. It is supplied in 100 and
500
test kits. Model/catalog numbers are:
100
test: LKT01 175
500
test: LKT05 175.
CODE Lot numbers include: L2KTG 202, L2KTG 203, L2KTG
204.
RECALLING FIRM/MANUFACTURER Diagnostic Products Corp.,
Los Angeles, CA
REASON Instability caused positively biased control values.
VOLUME OF PRODUCT IN COMMERCE 82.
DISTRIBUTION Nationwide.
PRODUCT DeRoyal Vasectomy Tray, a surgical kit, P/N 50-9112.
CODE Lot 660242.
RECALLING FIRM/MANUFACTURER Recalling Firm: Deroyal
Industries, Inc., Powell, TN
Manufacturer: DeRoyal Surgical, New Tazewell, TN.
REASON Surgical kits contained recalled Ethicon sutures.
VOLUME OF PRODUCT IN COMMERCE 1 case of 20 kits.
DISTRIBUTION WI.
PRODUCT Selector Ultrasonic Surgical Aspirator System;
affected part is the Selector Integra Ultrasonic Aspirator Operator's Manual,
Part
Number:
OM 1530000M1; Issue C168-4.
CODE Part Number: OM 1530000M1; Issue C168-4.
RECALLING FIRM/MANUFACTURER Recalling Firm: Integra Neurocare Llc., San Diego, CA
Manufacturer: Spembly Medical Ltd., England.
REASON Directions cite Euro approved not US approved
sterilization cycle parameters.
VOLUME OF PRODUCT IN COMMERCE 88.
DISTRIBUTION Nationwide and DC.
PRODUCT STA-Deficient VIII Immuno-depleted Plasma for Factor
VIII: C Assay by STA Analyzers.
CODE
Lot
#003221, Exp. Date 11/2002
Lot
#003431, Exp. Date 12/2002
Lot
#011171, Exp. Date 04/2003
Lot
#011722, Exp. Date 06/2003.
RECALLING FIRM/MANUFACTURER Recalling Firm: Diagnostica
Stago, Inc., Parsippany, NJ
Manufacturer: Diagnostic Stago, Taverny, France.
REASON Gradual decline in stability of the reagent after
reconstitution.
VOLUME OF PRODUCT IN COMMERCE 1249 boxes x 6 vials.
DISTRIBUTION Nationwide and France, Finland, Greece and
Germany.
PRODUCT Immuclone APhL ELISA Kit (IgG and IgM) calibrators.
CODE Lot No. 010213.
RECALLING FIRM/MANUFACTURER Louisville APL Diagnostics,
Inc., Doraville, GA
REASON IgG and IgM calibrators took too long for color
reactions.
VOLUME OF PRODUCT IN COMMERCE 50 kits IgG and 50 kits of
IgM.
DISTRIBUTION CT.
PRODUCT Unizyme
CODE Lot U0090, exp. 2002/09 Lot U0110, exp. 2002/10.
RECALLING FIRM/MANUFACTURER Recalling Firm: Ciba Vision
Corp., Duluth, GA
Manufacturer: Cfh Laboratories, L.P., Morris Plains, NJ.
REASON Contamination with brass particles from the tablet
press.
VOLUME OF PRODUCT IN COMMERCE 269,807 kits.
DISTRIBUTION Nationwide and Internationally.
WEEK ENDING APRIL 27
PRODUCT a) Zoll M Series Advisory Defibrillator; b) Zoll M
Series AED Defibrillator (semi automatic defibrillator).
CODE a) Serial Numbers: T98F00046-T01K27762 with System
Software Version below 30.00
b) Serial
Numbrs: T98F0092-T01J27533 with System Software Version below 30.0.
RECALLING FIRM/MANUFACTURER Zoll Medical Corp.,
Burlington, MA
REASON Defibrillator may fail to detect ventricular
fibrillation and fail to deliver shock.
VOLUME OF PRODUCT IN COMMERCE 13,667.
DISTRIBUTION Nationwide and worldwide.
PRODUCT a) Hi Torque Balance Middle Weight Guide Wire; b)
Dock Extension Wire. Guide Wires intended to facilitate the placement of
balloon dilation catheters during percutaneous transluminal angioplasty.
CODE a) Part number:1001780J Lot 1120851.
b)
Part number: 22260 Lot 1111551.
RECALLING FIRM/MANUFACTURER Guidant Corp., Temecula, CA
REASON Sterility compromised.
VOLUME OF PRODUCT IN COMMERCE 789.
DISTRIBUTION Nationwide and Poland, Japan and Italy.
PRODUCT Passport 2/Passport 2 LT Vital Signs Monitor. Multi-parameter patient monitoring system.
CODE
0998-00-170-0002(A)
0998-00-170-0005(A)
0998-00-170-0006(A)
0998-00-170-0010(A,F)
0998-00-170-0011(A)
0998-00-170-0012(A)
0998-00-170-0013(A)
0998-00-170-0014(A,D,F,T)
0998-00-170-0015(A)
0998-00-170-0016(A)
0998-00-170-0025(A)
0998-00-170-0030(A)
0998-00-170-0032(A)
0998-00-170-0038(A,P)
0998-00-170-0042(A)
0998-00-170-0045(A)
0998-00-170-0046(A,F,G,P)
0998-00-170-0048(A)
0998-00-170-0058(A)
0998-00-170-3014(A,T)
0998-00-170-3015(A)
0998-00-170-3016(A)
0998-00-170-3038(G)
0998-00-170-3040(A)
0998-00-170-3046(A,P)
0998-00-170-3048(A,G,P).
RECALLING FIRM/MANUFACTURER Datascope Corp., Mahwah, NJ
REASON Power Supply problems for the monitor may shut down
without notice.
VOLUME OF PRODUCT IN COMMERCE 203.
DISTRIBUTION Nationwide and Internationally.
PRODUCT Ventrix NL950-V Ventricular Tunneling Pressure
Monitoring Kit; consists of a sterile, transducer tipped catheter that is used
to
continuously
monitor intracranial pressure and drain cerebrospinal fluid. Kit includes a
trocar, introducer stylet, suture loops, a drill bit and
hex
wrench.
CODE V1299, V1300A, V1301, V1302, V1303, V1304, V1305,
V1306, V1307, V1308, V1309, V1310, V1311, V1312, V1313, V1314, V1315, V1316,
V1317,
V1318, V1319, V1320, V1321, V1322, V1323, V1324, V1325, V1326, V1327, V1330,
V1331, V1052, V1053, V1054.
RECALLING FIRM/MANUFACTURER Integra Neurocare LLC., San
Diego, CA
REASON Directions have blank pages.
VOLUME OF PRODUCT IN COMMERCE 806 units.
DISTRIBUTION Nationwide and Australia, Brazil, Colombia,
Chile, England and France.
PRODUCT Portex Hypodermic NEEDLE-PRO Needle with Needle
Protection Device (Small Gauge Safety), Sterile:
a)
Catalog No. 4320 (25g x 5/8"); b) Catalog No. 4322 (26g x 1/2"); c)
Catalog No. 4323 (27g x 1/2").
CODE a) Lot Nos.: K102024; b) Lot Nos: 111914, 111917,
and K102025; c) Lot No.: K102026.
RECALLING FIRM/MANUFACTURER Portex, Inc., Keene, NH
REASON Sterility of the device may be compromised due to a
loss of package integrity.
VOLUME OF PRODUCT IN COMMERCE 74,045 units.
DISTRIBUTION Nationwide.
PRODUCT SoftPerm Daily Wear Soft (Hydrophilic) Contact Lens.
CODE Lot Number 40114586200611, exp. 2006/11.
RECALLING FIRM/MANUFACTURER Ciba Vision Corp. Duluth, GA
REASON Improper sterilization cycle.
VOLUME OF PRODUCT IN COMMERCE 8 individual lenses.
DISTRIBUTION CA, MA, MS, NY, OH, OR & WV and Nova
Scotia.
PRODUCT Boston Scientific/Medi-Tech RENEGADE Hi-Flo
Microcatheter Kit.
CODE
Catalog
No. Product Description Lot Number Exp. Date
18-303 RENEGADE HI FLO 135/20 KIT 4500101 12/01/2003
4503702 12/01/2003
4519516 01/01/2004
4551582 01/01/2004.
RECALLING FIRM/MANUFACTURER Recalling Firm: Boston
Scientific Corp./Medi-Tech Natick, MA
Manufacturer:
Medi-Tech a division of Boston Scientific Corp., Watertown, MA.
REASON Kit packaged with an incorrect quidewire length of
135 cm instead of 165 cm.
VOLUME OF PRODUCT IN COMMERCE 46.
DISTRIBUTION CA, FL, MI, NY, SC and TX.
PRODUCT Cordis Temp 4F Diagnostic Catheter WITH THE
FOLLOWING CATALOG NUMBERS OR ITEM NUMBERS (SEE CODES SECTION FOR CORRESPONDING
LOT NUMBERS UNDER RECALL): 451406H0, 451406H2, 451406P0, 451406P2, 451406S0,
451406S2,
451406V0,
451407H2, 451407S2, 451407V0, 451413H0, 451413V0, 451414H0, 451415H0, 451415V0,
451423H0, 451424H0, 451425H0, 451430H0, 451430H2, 451431H0, 451431H2, 451432H0,
451435H0, 451442V0, 451442V2, 451443H0, 451443V0, 451443V2, 451444V0, 451444V2,
451446S0, 451446V2, 451447S0, 451447S2, 451449V0, 451450V0, 451457V0, Total
Items38
CODE
LOT
NUMBER ITEM NUMBER
R0101089
451406H0
R0101210 451406H2
R0101214 451406P0
R0101319 451406P2
R0101320 451406S0
R0101471 451406S2
R0101512 451406V0
R0101680 451407H2
R0101820 451407S2
R0101821 451407V0
R0101822 451413H0
R0101911 451413V0
R0101913 451414H0
R0201062 451415H0
R0201064 451415V0
R0201140 451423H0
R0201460 451424H0
R0201552 451425H0
R0201686 451430H0
R0201687 451430H2
R0201688 451431H0
R0201689 451431H2
R0201690 451432H0
R0201870 451435H0
R0201958 451442V0
R0201959 451442V2
R0301044 451443H0
R0301045 451443V0
R0301279 451443V2
R0301281 451444V0
R0301496 451444V2
R0301574 451446S0
R0301575 451446V2
R0301714 451447S0
R0301779 451447S2
R0301897 451449V0
R0301899 451450V0
R0900022 451457V0
R0900175 Total Items38
R0900267
R0900367
R0900514
R0900515
R0900635
R0900730
R1000075
R1000196
R1000333
R1000335
R1000533
R1000534
R1000535
R1000536
R1000653
R1000922
R1000927
R1000983
R1000984
R1100042
R1100043
R1100046
R1100072
R1100311
R1100312
R1100747
R1100748
R1100827
R1100862
R1100932
R1100933
R1100935
R1100936
R1200003
R1200139
R1200357
R1200475
R1200567
R1200568
S0101190
S0101191
S0101193
S0101194
S0101305
S0101334
S0101640
S0101643
S0101645
S0101646
S0101651
S0101760
S0101761
S0101762
S0201023
S0201025
S0201059
S0201060
S0201351
S0201352
S0201502
S0201680
S0201859
S0201931
S0201935
S0301209
S0301210
S0301212
S0301240
S0301427
S0900105
S0900167
S0900168
S0900260
S0900262
S0900512
S0900515
S0900517
S0900637
S0900741
S0900742
S0900743
S1000063
S1000084
S1000085
S1000174
S1000368
S1000375
S1000376
S1000541
S1000574
S1000709
S1000710
S1000850
S1100019
S1100060
S1100061
S1100252
S1100253
S1100254
S1100255
S1100256
S1100257
S1100362
S1100490
S1100800
S1100936
S1100937
S1200070
S1200071
S1200072
S1200226
S1200610
S1200789
S1200790
S1200791
W0101028
W0101033
W0101092
W0101093
W0101157
W0101401
W0101506
W0201079
W0201080
W0201081
W0201170
W0201171
W0301027
W0301116
W0800231
W0800232
W0800233
W0800373
W0800465
W0800466
W0800469
W0800740
W0800743
W0900305
W1000248
W1000252
W1000253
W1000376
W1000377
W1000378
W1000379
W1000380
W1000381
W1000477
W1100025
W1100027
W1100029
W1100030
W1100337
W1100338
Total
Lots 194
RECALLING FIRM/MANUFACTURER Recalling Firm: Cordis
Corp., Miami Lakes, FL
Manufacturer: Cordia Europa Roden, Netherlands.
REASON Instances of catheter tip separation.
VOLUME OF PRODUCT IN COMMERCE 11,255.
DISTRIBUTION Nationwide and Brazil, Canada, Puerto Rico,
Argentina and Mexico.
PRODUCT Liver Dialysis Unit: Treatment Kit/Disposable Pack.
This is a disposable, single use kit used during dialysis.
CODE Serial numbers 00041-44 thru 00050-77.
RECALLING FIRM/MANUFACTURER Recalling Firm: HemoTherapies, Inc., San Diego, CA
Manufacturer: HemoCleanse, Inc., Rochester, NY.
REASON The filtrate generator was installed backwards,
causing tension and crimping in the tubing line.
VOLUME OF PRODUCT IN COMMERCE 13.
DISTRIBUTION MN, NY and AZ.
PRODUCT Liver Dialysis Unit Machine (LDU1) and Treatment
Kits.
CODE All codes.
RECALLING FIRM/MANUFACTURER Recalling Firm:
HemoTherapies, Inc., San Diego, CA
Manufacturer: UMM Electronics Inc., Indianapolis, IN.
REASON Electronic controler board overheats causing alarm
and device failure.
VOLUME OF PRODUCT IN COMMERCE 21.
DISTRIBUTION Nationwide.
PRODUCT Gray Tip Drill, 1 x 0.126 x 8".
CODE Catalog Number 5800-8-125 Lot Code: K700436.
RECALLING FIRM/MANUFACTURER Recalling Firm: Howmedica Osteonics Corp., Rutherford, NJ
Manufacturer: Stryker Trauma GmbH, D24232 Schoenkirchen,
Germany.
REASON Gray Tip Drill mislabeled as lag screw.
VOLUME OF PRODUCT IN COMMERCE 201.
DISTRIBUTION Nationwide.
PRODUCT Liver Dialysis Unit Machines and kits. (aka LDU2)
Product was previously named BioLogic DT System with
BioLogic
DT TK1000 kits.
CODE All units all codes.
RECALLING FIRM/MANUFACTURER Recalling Firm:
HemoTherapies Inc., San Diego, CA
Manufacturer: UMM Electronics, Inc., Indianapolis, IN.
REASON Units alarm and shut down for unexplained reason.
VOLUME OF PRODUCT IN COMMERCE 6.
DISTRIBUTION MA, IL and LA.
PRODUCT Caleo Infant Warming System. The product is an
incubator. The device provides access for minor surgical procedures and allows
endotracheal
intubation without having to slide the baby out of the incubator.
CODE Catalog numbers 4117025-006, 4117025-007,
4117025-008, 4117025-009, and 4117025-018.
The
following serial numbers were distributed in the US: ARRE-0026, ARRE-0027,
ARRF-0006, ARRF-0008, ARRJ-0021, ARRJ-0019, ARRJ-0020, ARRJ-0024, ARRJ-0029,
ARRJ-0030, AARJ-0031, AARJ-0032, AARJ-0033, ARRK-0002, ARRK-0023, ARRK-0029,
ARRM-0274, ARRM-0275, ARRM-0276, ARRM-0277, ARRM-0278, ARRM-0279, ARRM-0281,
ARRN-0033, ARRN-0038, ARRN-0335, ARRN-0036, ARRN-0037, ARRN-0038, ARRN-0039,
ARRN-0040, ARRN-0041, ARRN-0042, and ARRN-0043.
The
following serial numbers were distributed in Canada: ARPN-0028, ARRF-0007,
ARRF-0009, ARRH-0027, ARRH-0028, ARRH-0029, ARRH-0030, ARRH-0031, ARRH-0039,
ARRH-0040, ARRH-0041, ARRJ-0010, ARRJ-0011, ARRJ-0012, ARRJ-0013, ARRJ-0014,
ARRJ-0015, and ARRJ-0070.
RECALLING FIRM/MANUFACTURER Recalling Firm: Drager
Medical Inc Telford, PA
Manufacturer:
Drager Medical AG & Co KGaA Lubeck, Germany.
REASON May short circuit.
VOLUME OF PRODUCT IN COMMERCE 56 units.
DISTRIBUTION CA, FL, GA, MO, NY, OH, TX, and Canada.
PRODUCT a) Polarus Humeral Rod System, part #HCO3275-S,
3.5mm x 27.5mm b) Cortical Screw, and part #HCO3325-S, 3.5mm x 32.5mm Cortical
Screw. The Polarus Humeral Rod System
is a system of rods and screws for the fixation of humeral fractures and their
accompanying instrumentation.
CODE a) Lot #W02947; b) Lot #W02508.
RECALLING FIRM/MANUFACTURER Acumed, Inc., Beaverton, OR
REASON Extended sterilization expiration date.
VOLUME OF PRODUCT IN COMMERCE Part #HCO3275-S - 143 Part
#HCO3325-S – 81.
DISTRIBUTION Nationwide.
PRODUCT Misys Laboratory for Windows version 5.3.
CODE Versions 5.3.
RECALLING FIRM/MANUFACTURER Sunquest Information
Systems, Inc., aka Misys Healthcare Systems Tucson, AZ
REASON Software QA code of BOTH for patient sex can result
in QA flags not being generated for abnormal results.
VOLUME OF PRODUCT IN COMMERCE 345.
DISTRIBUTION Nationwide, internationally to United
Kingdom, Ireland, Denmark, Canada, Bermuda and Saudi Arabia.
PRODUCT Avanta Orthopaedics, Proximal Radial Head Stem,
Product Code RHA-S2, Lot RS0099.
CODE Lot RS0099.
RECALLING FIRM/MANUFACTURER Avanta Orthopaedics, Inc.,
San Diego, CA
REASON Label mix-up. Incorrect size on label.
VOLUME OF PRODUCT IN COMMERCE 6.
DISTRIBUTION TX, OH and Netherlands, Spain and Australia.
PRODUCT a) Integris Allura X-ray system with Ultrasound
option. The Integris Alluras x-ray system
is used as an imaging device for:
dedicated
vascular and neurovascular imaging applications, including diagnostic and
interventional procedures; cardiac imaging applications including diagnostics,
interventional procedures, pacemaker implantations, and electrophysiology;
non-vascular interventions such as drainage and biopsies.
b)
MultiDiagnost 3 with Ultrasound Option.
c)
MultiDiagnost 4 with Ultrasound Option The MultiDiagnost 3 and MultiDiagnost 4
are multi functional/universal systems used for general R/F. Fluoroscopy,
Radiography and Angiography can be performed with other specialized
interventional applications. The
ultrasound system is used for diagnostic ultrasound imaging or fluid flow
analysis of the human body. Recall # Z-0892-2.
CODE 9896 001 40621, 9896 000 12821.
RECALLING FIRM/MANUFACTURER Recalling Firm: Philips
Medical Systems North America, Inc., Bothell, WA
Manufacturer:
Philips Medical Systems Nederland, B.V. 5680 Da Best,
REASON Potential for supporting arm and keyboard to strike patient.
VOLUME OF PRODUCT IN COMMERCE 94.
DISTRIBUTION Nationwide.