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: