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:

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