NOVEMBER
2001
WEEK ENDING NOVEMBER 3
PRODUCT AND CODE: MTI FlowRider, Flow
Directed Micro Catheter.
Codes:
Model Lot Exp
Date
105-5060
650514J June
2003
105-5063 650524J June
2003
105-5063 660224J June
2003
105-5063 660294J July
2003
REASON: Catheter lumen obstructed.
MANUFACTURER/RECALLING FIRM: Micro Therapeutics, Inc.,
Irvine, CA
DISTRIBUTION: NY and Australia, Austria, Denmark,
Finland, Japan, Korea, Turkey, United Kingdom, France, Germany, Italy, Spain
and Switzerland
QUANTITY: 332
PRODUCT AND CODE: Marconi MX8000 Computed
Tomography X-ray System, Codes: All Marconi MX8000 CT Scanners, running with
Version 2.0 and 2.01 software.
REASON: Software in version 2.0 / 2.01 software may lead
to improper patient treatment.
MANUFACTURER/RECALLING FIRM: Marconi Medical Systems,
Inc., Highland Heights, OH
DISTRIBUTION: Nationwide and Worldwide
QUANTITY: 150 (76 domestic)
PRODUCT AND CODE: Medronic malleable single
stage venous cannula.
A)
Medtronic DLP 12 Fr Malleable single stage venous cannula, Code: 68112, lot
number: 200104P025
B)
Medtronic DLP 14 Fr Malleable single stage venous cannula, Code: 68114, lot
number: 200103P092
C)
Medtronic DLP 16 Fr Malleable single stage venous cannula, Code: 68116, lot
number: 2001060028
D)
Medtronic DLP 18 Fr Malleable single stage venous cannula, Code: 68118, lot
number: 200103P085
E)
Medtronic DLP 20 Fr Malleable single stage venous cannula, Code: 68120, lot
number: 200102P022
F)
Medtronic DLP 22 Fr Malleable single stage venous cannula, Code: 68122, lot
number: 200104O052
G)
Medtronic DLP 24 Fr Malleable single stage venous cannula, Code: 68124, lot
number: 2001060019
H)
Medtronic DLP 26 Fr Malleable single stage venous cannula, Code: 68126, lot
number: 200102P010
I)
Medtronic DLP 28 Fr Malleable single stage venous cannula, Code: 68128, lot
number: 200105P001 and 200105P002
J)
Medtronic DLP 30 Fr Malleable single stage venous cannula, Code: 68130, lot
numbers: 200105P003
K) Medtronic
DLP 32 Fr Malleable single stage venous cannula, Code: 68132, lot numbers:
2001060024, 2001070027 and 2001070150
L)
Medtronic DLP 34 Fr Malleable single stage venous cannula, Code: 68134. lot
number: 200105P010
M)
Medtronic DLP 36 Fr Malleable single stage venous cannula, Code: 68136. lot
number: 2001060025
REASON: Guide wire may break through cannula wall and 1
lot labeled with incorrect size.
MANUFACTURER/RECALLING FIRM: Medtronic Cardiac Surgical
Products, Grand Rapids, MI
DISTRIBUTION: Nationwide, and Australia, Canada and the
Netherlands
QUANTITY: 2056
PRODUCT AND CODE: Premier HSV-1 IgM ELISA, a
diagnostic test kit for the detection of IgM antibody to Herpes Simplex Virus
Type 1 in human serum.
Codes:
Lot Number: H1E150.010 Catalog Number: H1E150
REASON: The test kit may exhibit false positive test
results.
MANUFACTURER/RECALLING FIRM: Meridian Diagnostics,
Inc., Cincinnati, OH
DISTRIBUTION: Nationwide
QUANTITY: 384 kits
PRODUCT AND CODE: Invacare Mobilare
Concentrators, 5 Liter,
Codes:
Serial Numbers: 94K thru 94L, 95A thru 95L, 96A thru 96L, and 97A.
REASON: A faulty capacitor may fail and cause the unit to
overheat and damage the concentrator.
There is a potential fire hazard.
MANUFACTURER/RECALLING FIRM: Invacare Corp., Sanford,
FL
RECALLED BY: Invacare Corp., Elyria, OH
DISTRIBUTION: Nationwide and Worldwide
QUANTITY: 147,458
PRODUCT AND CODE: SSA-340A Optional Biopsy
adaptor UAGV015A for Endovaginal probe, Codes: Model number UAGV015A.
REASON: Biopsy probe adaptor fork breaks, risk of vaginal
damage.
MANUFACTURER/RECALLING FIRM: Toshiba America Medical
Systems, Inc., Tustin, CA
DISTRIBUTION: Nationwide and Puerto Rico
QUANTITY: 92
PRODUCT AND CODE: FlexiLab Laboratory
Information System, Anatomic Pathology Pathologist Workstation, Codes: Versions
3.0.7.2, 3.0.9.1 and 3.0.10.1.
REASON: Data on one patient's pathology file overwrites to
another patient's file.
MANUFACTURER/RECALLING FIRM: Sunquest Information
Systems, Inc., Tucson, AZ
DISTRIBUTION: Nationwide and Canada, Ireland, United
Kingdom and Saudi Arabia.
QUANTITY: 102
PRODUCT AND CODE: Bayer brand Clinitek 50
Urine Chemistry Analyzer. Analyzer
catalog numbers 6510A, 6513, 6514, 6514C, 6515, 6515C, 6516 and 6516C. Codes:
Serial numbers 150424 through 153031.
REASON: Erratic results if plugged into an ungrounded
outlet
MANUFACTURER/RECALLING FIRM: Bayer Corp., Mishawaka, IN
RECALLED BY: Bayer Corp., Elkhart, IN
DISTRIBUTION: Nationwide and Worldwide
QUANTITY: 2,572
PRODUCT AND CODE: The device is a hand piece
drill used in oral surgery. It is
labeled in part: "Osteomed OsteoPower Handpiece System 1:1 Straight Drill," Codes: Lot numbers: 011352, 011855, 011939,
12079, 012080, 012486, 012487
REASON: Corrosion stress failure may prevent collet from
locking burr in place.
MANUFACTURER/RECALLING FIRM: Osteomed Corp., Addison,
TX
DISTRIBUTION: Nationwide and Italy, Spain and Canada
QUANTITY: 239
PRODUCT AND CODE: ImmunoCard Toxin A, a
rapid enzyme immunoassay for the detection of Clostridium difficile Toxin A in
human stool, Codes: The following 24 Lot Numbers were recalled:
LOT
NO. EXP DATE LOT NO. EXP DATE
711050.125 9/23/00
711050.126 9/23/00
711050.127 9/23/00
711050.128 11/11/00
711050.129 11/11/00
711050.130 11/11/00
711050.131 11/11/00 711050.132 11/11/00
711050.133 11/25/00 711050.134 12/14/00
711050.135 12/14/00 711050.136 1/28/01
711050.137 1/28/01 711050.138 1/28/01
711050.139 12/14/00 711050.140 3/08/01
711050.141 3/08/01 711050.156 8/17/01
711050.157 8/17/01 711050.160 8/17/01
711050.161 8/17/01 711050.162 8/17/01
711050.163 8/17/01 711050.165 9/16/01
711050.166 9/16/01 711050.167 9/16/01
REASON: The substrate exhibits a blue color that may
result in a false positive test.
MANUFACTURER/RECALLING FIRM: Meridian Diagnostics,
Inc., Cincinnati, OH
DISTRIBUTION: Nationwide and Canada, New Zealand,
Venezuela, Costa Rica, and Argentina
QUANTITY: 4252 kits
PRODUCT AND CODE: Physiometrix PSARRAY EEG
ELECTRODE Part Number: 4300-40 Lot Numbers: 010302A, 010303A, 010305A, 010308A,
010310A, 010314A, 010316A
REASON: Stud in the electrode separates from the substrate
and remains in the lead wire
MANUFACTURER: Conmed Corp., Utica, NY
RECALLED BY: Physiometrix, Inc., North Billerica, MA
DISTRIBUTION: IL, Sweden and, UK
QUANTITY: 132 cases
PRODUCT AND CODE: Itrel 3 Implantable Pulse
Generator (Neurostimulator), Model 7425
Codes: Serial Numbers NAT118756H, NAT118757H,
NAT118758H, NAT118759H, NAT118760H, NAT118761H, NAT118762H, NAT118763H,
NAT118768H, NAT118769H, NAT118770H, NAT118771H, NAT118776H, NAT118777H,
NAT118778H, NAT118779H, NAT118788H, NAT118789H, NAT118790H, NAT118791H,
NAT118792H, NAT118793H, NAT118794H, NAT118795H, NAT118828H, NAT118829H,
NAT118836H, NAT118838H, NAT118839H, NAT122388H, NAT122389H, NAT122390H,
NAT122391H, NAT122392H, NAT122393H, NAT122394H, NAT122395H, NAT122410H,
NAT122411H, NAT122412H, NAT122413H, NAT122414H, NAT122415H, NAT122432H,
NAT122433H,
NAT122435H, and NAT122439H
REASON: Shocks to the patient at the implant site can occur
due to missing insulation for the battery.
MANUFACTURER: Medtronic Med Rel, Inc.,
Humacao, RQ
RECALLED BY: Medtronic, Inc., Minneapolis, MN
DISTRIBUTION: Nationwide
QUANTITY: 47 units (28 implanted)
PRODUCT AND CODE: Novametrix NICO Monitor,
Model 7300 with software versions below 4.3
REASON: Monitor may miscalculate Pulse Rate and Oxygen
Saturation (SpO2) values.
MANUFACTURER/RECALLING FIRM: Novametrix Medical Systems,
Inc., Wallingford, CT
DISTRIBUTION: Nationwide and Australia,
Japan, Canada and Europe
QUANTITY: 699 units
PRODUCT AND CODE: Roche Modular Analytics
immunoassay based clinical analyzer, model E170, catalog number 7656961.
REASON: May give incorrect thyroid test results
MANUFACTURER: Hitachi Ltd. Japan
RECALLED BY: Roche Diagnostics Corp., Indianapolis, IN
DISTRIBUTION: IL, IN, MD, NY, NC, PA and
WA
QUANTITY: 7
PRODUCT AND CODE: DCA2000 Hemoglobin A1c
Normal and Abnormal Control kit, catalog number 5068, Lot 0009
REASON: Defective Vials
MANUFACTURER/RECALLING FIRM: Canterbury Scientific Ltd.
Christchurch 1, New Zealand,
RECALLED BY: Bayer Corp., Elkhart, IN
DISTRIBUTION: Nationwide and Worldwide
QUANTITY: 1902
PRODUCT AND CODE: V40 Zirconia Femoral Heads,
Model Nos. h 6364-4-028, h 6364-4-032, h 6364-4-122, h 6364-4-126, h
6364-4-128, h 6364-4-132, h 6364-4-222, h 6364-4-226, h 6364-4-228, h
6364-4-232; Osteonics µ Zirconia C-Taper Femoral Bearing Head, Model Nos.
h
16-2600, h 16-2605, h 16-2800, h 16-2805, h 16-3200, h 16-3205, h 16-3299;
Exeter Ceramic Femoral Head, Model Nos.4658-2-801, 4658-2-802,
4658-3-201,
4658-3-202, 4658-3-203
REASON: Higher than expected failure rate with certain
batches of Saint Gobain Desmarquest Zirconia Ceramic Heads
MANUFACTURER/RECALLING FIRM: Howmedica Osteonics Corp.,
Allendale, NJ
DISTRIBUTION: Nationwide
QUANTITY: Model 6364: 3364, Model 16: 8585, and Model
4658: 352
PRODUCT AND CODE:
Modular
Head Hip Joint Prostheses (22 mm and 28 mm), Reference No. 163110;
Modular
Head Hip Joint Prostheses (22 mm and 28 mm), Reference No. 163111;
Modular
Head Hip Joint Prostheses (22 mm and 28 mm), Reference No. 163130;
Modular
Head Hip Joint Prostheses (22 mm and 28 mm), Reference No. 163131;
Modular
Head Hip Joint Prostheses (22 mm and 28 mm), Reference No. 163132;
Modular
Head Hip Joint Prostheses (22 mm and 28 mm), Reference No. 163113;
REASON: Higher than expected failure rate with certain
batches of Saint Gobain Desmarquest Zirconia Ceramic Heads.
MANUFACTURER/RECALLING FIRM: Biomet, Inc., Warsaw, IN
DISTRIBUTION: Nationwide & worldwide
QUANTITY: 4,200
PRODUCT AND CODE: Zirconia Femoral Head
Prosthesis, Catalog No. CFHS-028;
Zirconia
Femoral Head Prosthesis, Catalog No. CFHM-028;
Zirconia
Femoral Head Prosthesis, Catalog No. CFHL-028.
REASON: Higher than expected failure rate with certain
batches of Saint Gobain Desmarquest Zirconia Ceramic Heads
MANUFACTURER/RECALLING FIRM: Osteoimplant Technology
(OTI), Inc., Hunt Valley, MD
DISTRIBUTION: OK, IL & Spain
QUANTITY: 37 units.
PRODUCT AND CODE: Modular Zirconia Femoral
Head, Catalog No. 322899; Modular Zirconia Femoral Head, Catalog No.
322800;
Modular
Zirconia Femoral Head, Catalog No. 322835; Modular Zirconia Femoral Head,
Catalog No. 322807;
REASON: Higher than expected failure rate with certain
batches of Saint Gobain Desmarquest Zirconia Ceramic Heads.
MANUFACTURER/RECALLING FIRM: Apex Surgical, LLC,
Lakeville, MA
DISTRIBUTION: FL, NV, OK, SC, TN, TX
QUANTITY: 55
PRODUCT AND CODE: Zirconia Ceramic Articul/eze
Femoral Ball, Catalog Nos. 1365-41-00, 1365-42-000, 1365-43-000, 1365-44,000,
1365-45-000, 1365-46-000, 1365-47-000, 1365-48-000;
Zirconia
Ceramic SROM Taper Femoral Head, Catalog No. 56-0028, 56-00298;
Zirconia
Ceramic Elite Taper Femoral Head, Catalog No. 9621-25-000, 9621-26-000,
9621-27-000, 9621-30-000, 9621-31-000, 9621-16-000,
9621-17-000,
9621-18-000, 9621-19-000, 9621-20-000, 9621-21-000, 9621-22-000, 9621-23-000,
9621-24-000;
Zirconia
Ceramic PFC Head, Catalog No. 85-3878, 85-3879, 85-3880
REASON: Higher than expected failure rate with certain
batches of Saint Gobain Desmarquest Zirconia Ceramic Heads.
MANUFACTURER/RECALLING FIRM: DePuy Orthopaedics, Inc.,
Warsaw, IN
IMPORTER: Apex Surgical, LLC, Lakeville, MA
DISTRIBUTION: United States, Brazil,
Canada and England
QUANTITY: Over 20,000
PRODUCT AND CODE: Versys Hip System, Catalog
Nos. 00-8118-022-02, 00-8118-028-01, 00-8118-028-02, 00-8118-028-03,
00-8118-032-02 and 00-8118-032-03; Zirconia Ceramic Femoral Head, Catalog Nos.
00-9030-028-00, 00-9030-028-35, 00-9030-029-00, and 00-9030-029-35
REASON: Higher than expected failure rate with certain
batches of Saint Gobain Desmarquest Zirconia Ceramic Heads.
MANUFACTURER/RECALLING FIRM: Zimmer, Inc., Warsaw, IN
DISTRIBUTION: Nationwide &
International
QUANTITY: 10,328
PRODUCT AND CODE: Zirconia Taper Femoral Head,
Catalog No. 71320828;
REASON: Higher than expected failure rate with certain
batches of Saint Gobain Desmarquest Zirconia Ceramic Heads.
MANUFACTURER/RECALLING FIRM: Smith & Nephew, Inc.,
Memphis, TN
DISTRIBUTION: Nationwide, Canada, &
Greece
QUANTITY: 49
PRODUCT AND CODE: Zirconia 12/14 Taper Femoral
Head, 26mm, +0, Part No. 71320026, Lot
Nos. 90611570, 00810016, 00810019, 01203382, 01203383; Zirconia 12/14 Taper
Femoral Head, 26mm, +4, Part No.
71320426, Lot Nos. 00810020, 00810021, 01203384, 01203385;
Zirconia
12/14 Taper Femoral Head, 26mm, +8, Part No. 71320826, Lot Nos. 90611571,
00810022, 00810023, 01203380, 01203381;
Zirconia
12/14 Taper Femoral Head, 28mm, +0, Part No. 71320028, Lot Nos. 90107821,
90107822, 90107823, 90108442, 90108443, 90202378, 90202379, 90300445, 90300447,
90611572, 90306983, 90306984, 90306985, 90306997, 90306986, 90306987, 90306988,
90411386, 90411387, 90502073, 90502079, 90502080, 90502081, 90502082, 90502083,
90411388, 90411389, 90700276, 90700278, 90700279, 90700280, 90700281, 90700282,
90802697, 90802698, 90802699, 90802700, 90901889, 90901892, 90901893, 90901895,
90901897, 90901899, 90901900, 90901901, 90901902, 91005226, 91005227, 91005228,
91005229, 91005230, 91005231, 91005232, 91103444, 91103445, 91103446, 91103447,
91103448, 91103449, 91103450, 91204696, 91204697, 91204698, 91204699, 91204700,
91204701, 01204700, 00105762, 00105757, 00105759, 00105760, 00105803, 00105805,
00105806, 00105807, 00207310, 00207311, 00207312, 00207313, 00211929, 00211930,
00211931, 00211932, 00311848, 00311849, 00311850, 00311851, 00311852, 00311853,
00311854, 00511770, 00511772, 00603275, 00603276, 00603277, 00603279, 00603280,
00603281, 00603283, 00603285, 00603287, 00610965, 00610966, 00701793, 00701795,
00701796, 00701797, 00701798, 00706338, 00706339,
00901714,
00901715, 00901716, 00901717, 00901718, 00901720, 00901721, 00910581, 00910582,
00910583, 00910584, 00910617, 00910587, 01001665, 01001666, 01001667, 01104354,
01104355, 01104356, 01104357, 01104358, 01104362, 01012015, 01012016, 01012017,
01012018, 01012019, 01111813, 01111814, 01111815, 01111816, 01AM03161,
01AM03162, 01BM09428, 01BM09429, 01BM09430, 01BM09431 01BM09432, 01BM09434,
01BM09435, 01BM09436, 01BM12590, 01BM12591, 01CM08887, 01CM08889, 01CM08891,
01DM07940, 01DM07940A, 01DM07941, 01DM07942, 01DM07943, 01DM07944, 01DM07945,
01DM07946, 01DM07947, 01DM07948, 01EM01314, 01EM01315, 01EM01316, 01EM01317, 01EM01318,
01EM01319, 01EM01320, 01EM01321, 01EM01322, 01EM1322A, 1EM01323, 01EM01324,
01EM01325, 01FM05743, 01FM05744, 01FM05745, 01FM05746, 01FM05747, 01FM05748,
01FM05749, 01FM05750, 01FM05751, 01FM05752, 01FM05753, 01FM05754, 01FM05755,
01FM05756, 01FM05757, 01FM11567, 01FM11568, 01FM11569, 01FM11570, 01FM11571,
01FM11572, 01FM11573, 01FM11574, 01FM11575, 01FM11576, 01FM11578, 01FM11579,
01FM11580;
Zirconia
12/14 Taper Femoral Head, 28mm, +4,
Part No. 71320428, Lot Nos. 90107826, 90209515, 90209516, 90209517,
90209518, 90300451, 90300452, 90300449, 90506988, 90306989, 90306990, 90306991,
90306992, 90306993, 90502084, 90502085, 90502086, 90502074, 90502075,
90704484,
90602245, 90602246, 90602247, 90601125, 90601126, 90704485, 90704486, 90704487,
90704489, 90704490, 90704491, 90805027, 90805028, 90805030, 90805032, 90902941,
90902942, 90902943, 90902944, 90902945, 90902946, 90902947, 91002327, 91002328,
91002329, 91002330, 91002331, 91002332, 91002333, 91002334, 91202989, 91202990,
91110490, 91110491, 91110492, 91110493, 00104731, 00104732, 00104733, 00104734,
00104735, 00104736, 00104737, 00104738, 00104739, 00104740, 00207979, 00207980,
00207981, 00207982, 00207983, 00311855,
00311856, 00311857, 00311858, 00311859, 00311860, 00311861, 00607784, 00607785,
00607786, 00607787, 00610967, 00610968, 00610970, 00607788, 00901725, 00901726,
00901727, 00901743, 00701799, 00701800, 00701801, 00701802, 00701803, 00712034,
00712035, 00910592, 00910593, 01001668, 01001669, 01001670, 01001671, 01111817,
01111818, 01111819, 01111820, 01AM09107, 01AM09108, 01AM09109,
01AM09110,
01AM09111, 01AM09112, 01DM04535, 01CM01170, 01CM01171, 01CM01172, 01CM01173,
01BM12595, 01CM08894, 01CM08895, 01DM04536, 01DM13966, 01DM13967, 01DM13968,
01DM13969, 01DM13970, 01EM09820, 01EM09821, 01EM09822, 01EM09823, 01EM09825,
01EM09824, 01EM12680, 01EM12681, 01EM12682, 01EM12683, 01FM09026, 01FM09027,
01FM09028, 01FM09029, 01FM06259, 01FM06260, 01FM06261, 01FM06262, 01FM06263,
01FM06264, 01FM09030, 01GM06910, 01GM06912, 01GM06913, 01GM06915, 01GM06917,
01GM06918, 01GM06919, 01FM02976, 01FM03087;
Zirconia
12/14 Taper Femoral Head, 28mm, +8, Part No. 1320828, Lot Nos. 80801579,
80800947, 80800948, 80801580, 90106724, 90106725,
90205143,
90205144, 90205145, 90205146, 90611573, 90307988, 90307989, 90307990, 90403953,
90403955, 90402819, 90402820, 90403958, 90502076, 90502077, 90502072, 90502078,
90601127, 90601128, 90601129, 90610106, 90610107, 90704492, 90704493, 90802694,
90802695, 90805041, 90805042, 90900206, 90900207, 91002326, 91006420, 91006421,
91006422, 91006423, 91006424, 91103451, 91204695, 00105584, 00105585, 00106970,
00106971, 00106972, 00106973, 00106974, 00106975, 00106976, 00106977, 00401125,
00401126,
00403537, 00403539, 00403540, 00407473, 00407476, 00407477, 00407478, 00701804,
00701805, 00810024, 00810025, 01200544, 01200545, 01200546, 01200547, 00810027,
00810028, 01203386, 01203387, 01203391, 01203392, 01CM08905, 01CM08906,
01CM04105, 01CM04106, 01CM08908, 01DM13971, 01DM13973, 01EM09826, 01EM09828,
01EM09829, 01EM09830, 01FM06266, 01FM06267, 01FM06268, 01FM06269, 01FM06270,
01FM06280, 01FM06282, 1FM06271, 01FM06272, 01FM09031, 01FM09032, 01FM09033,
01FM09034, 01FM09035.
Zirconia
12/14 Taper Femoral Head, 32mm, +0, Part No. 71927729, Lot Nos. 01FM03862,
01AM14139, 01EM07106;
Zirconia
12/14 Taper Femoral Head, 32mm, +4, Part No. 71927734, Lot Nos. 01FM14438,
01AM14153, 01FM03863;
Zirconia
12/14 Taper Femoral Head, 32mm, +8, Part No. 71927735, Lot No. 01AM14150;
Zirconia
14/16 Taper Femoral Head, 32mm, +0, Part No. 427815, Lot Nos. 00105698,
00105699, 00105700, 00105701;
Zirconia
14/16 Taper Femoral Head, 32mm, +4, Part No. 427816, Lot Nos. 00105702,
00105703, 00105704;
Zirconia
14/16 Taper Femoral Head, 32mm, +8, Part No. 427817, Lot No. 00105705.
REASON: Higher than expected failure rate with certain
batches of Saint Gobain Desmarquest Zirconia Ceramic Heads.
MANUFACTURER/RECALLING FIRM: Smith & Nephew, Inc.,
Memphis, TN
DISTRIBUTION: Nationwide &
International
QUANTITY: 8,040
PRODUCT AND CODE: A) Homedics brand Model
PowerDent battery operated toothbrushes; all lots. The toothbrushes are sold as in packages of 1 as Model HD-30,
packages of two as Model HD-30DP, and packages of 12 as Model HD-30-12PK.
B)
Homedics brand Model PowerDent Jr. battery operated toothbrush; all lots. The toothbrushes are sold as in packages of
1 as Model HD-20, packages of two as Model HD-20DP, and packages of 12 as Model
HD-20-12PK.
REASON: Defective seal allows water into handle
MANUFACTURER: Teamedics Shenzhen, China,
RECALLED BY: Homedics, Inc., Commerce Township, MI
DISTRIBUTION: Nationwide
QUANTITY: 935,000 toothbrushes
PRODUCT AND CODE: CEDIA Phenobarbital II
Reagent, Lot No. 28105900, Catalog No. 1775936
REASON: The kit’s bottles 1 and 2 were mislabeled.
MANUFACTURER: Microgenics, Fremont, CA
RECALLED BY: Roche Diagnostics Corporation, Indianapolis,
IN
DISTRIBUTION: United States, Australia,
Canada, New Zealand
QUANTITY: 476
PRODUCT Stryker Model No. 2500 Go Bed
CODE Serial Nos. C01001 through C03551.
RECALLING FIRM/MANUFACTURER Stryker Corp., Kalamazoo, MI
REASON Side rail does not always lock in the highest
position and it may drop suddenly causing injury or falls to patients or caregivers.
VOLUME OF PRODUCT IN COMMERCE 201 beds
DISTRIBUTION Nationwide
WEEK
ENDING NOVEMBER 24
PRODUCT Melt-spun Cellulose Diacetate Hemodialyzers; a
single use sterile device for hemodialysis of patients with acute or chronic
renal failure; 12 units per case; A-Series Dialyzers made from Altra Nova
Fibers, AF-Series Dialyzers made from Altra Flux Fiber and AX-Series Dialyzers
made from Altrex Fiber
CODE a) A-11 Dialyzer, product code 237011, 237511,
237311; b) A-15 Dialyzer, product code 237015, 237515, 237315; c) A-18
Dialyzer, product code 237018, 237518, 237318; d) A-22 Dialyzer, product code
237022; e) AF-150 Dialyzer, product code 238015, 238515; f) AF-180 Dialyzer,
product code 238018, 238518; g) AF-220 Dialyzer, product code 238022, 238522;
h) AX-15 Dialyzer, product code 239015;
i)
AX-22 Dialyzer, product code 239022, 239522.
All
lots of the A-Series Dialyzers, AF-Series Dialyzers and AX-Series
DialyzersBaxter also recalled the following lots of cellulose
acetate
fibers as a precautionary measure: catalog numbers 100-416, 100-923, 700-098,
700-150.
1)
Altra Nova, lots 990924P1D1 thru 011019P4A; 2) Altra Flux, lots 990904P6A1 thru
011017P7A; 3) Altrex, lots 990929P6A1 thru 000203P6A1.
RECALLING FIRM/ MANFACTURER Recalling Firm: Baxter
Healthcare Corp. Round Lake, IL
Manufacturer:
Baxter/Althin Medical AB Ronneby, SW.
REASON Hemodialyzers associated with deaths in Croatia and
Spain.
PRODUCT 2,435,306 dialyzers.
DISTRIBUTION Nationwide and international. The AX-series dialyzers were not distributed
in the United States.
PRODUCT The FREEHAND System, a hand grasp implanted
functional electrical stimulator
CODE All serial numbers.
RECALLING FIRM/ MANFACTURER Neurocontrol Corp.,
Valleyview, OH
REASON If the electrode is implanted too deeply, the device
will not operate properly.
PRODUCT Nationwide and International.
DISTRIBUTION 78.
PRODUCT WatchChild Obstetrical Data Management System
CODE None (No catalog or serial numbers)- Recall affects
all WatchChild Systems in the field.
RECALLING FIRM/ MANFACTURER Hill-Rom/Netlinx Cary, NC
REASON Problem with data from fetal and maternal monitors.
PRODUCT 335 units.
DISTRIBUTION Nationwide and Canada.
PRODUCT Inovision/Victoreen NERO mAx, Model 8000, radiologic
quality assurance instrument
CODE Serial Numbers:
00107, 000113, 000123, 000132, 000134, 000135, 000142, 000145, 000149,
000156, 000161, 000167, 000168, 000178, 000179, 000180, 000192, 000202, 000213,
000216, 000227, 000234, 000235, 000254, 000259, 000262, 000264, 000268, 000272,
000280, 000287, 000289, 000294, 000296, 000316, 000317, 000323, 000326, 000330,
000335, 000338, 000354, 000362, 000379, 000385, 000390, 000392, 000393, 000394,
000399, 000402, 000420, 089847, 089855, 089860, 089863, 089869, 093754, 093755,
093771, 093773, 095421, 095426, 095431, 095442, 096432, 096433, 096434, 096442,
096444, 097913, 097914, 097920, 097921, 097922, 097923, 097924, 097925, 101889,
101890, 101891, 101892, 101893, 101894, 101895, 101896, 101897, 101898, 102193,
102194, 102195, 102196, 102197, 102198, 102199, 102200, 102201, 102202, 102244,
102445, 102446, 102447, 102448, 102449, 102450, 102451, 102452, 102453, 103036,
103037, 103038, 103039, 103040, 103041, 103042, 103043, 103044, 103045, 103521,
103522, 103523, 103524, 103525, 103526, 103527, 103528, 103529.
RECALLING FIRM/ MANFACTURER Inovision Radiation
Measurements, Solon, OH
REASON Due to improper calibration, the units will read 10X
higher than actual.
PRODUCT Nationwide and international.
DISTRIBUTION 127 units.
PRODUCT CircuVent
CODE Part Number 68-1000 Packed 10 units per case. Responsible firm on label: DHD Healthcare,
Wampsville, NY.
Codes:
120503, 121306, 122710.
RECALLING FIRM/ MANFACTURER DHD Healthcare Corp.,
Wampsville, NY
REASON Indicator labels in wrong orientation.
PRODUCT 273 cases (10 per case).
DISTRIBUTION Nationwide.
PRODUCT Steris brand S2000 Sterilant, packaged in cases
containing 20 boxes of Steris 20 Sterilant Concentrate, each box containing 2
bottles, 160.7 gm dry powder component in one bottle and 2.02 fl ounce liquid
component in the other.
CODE Item # S2000, Lot #A48301121, labeled as exp. June
2002.
RECALLING FIRM/ MANFACTURER MDR Specialty Distribution
Corporation Williamsburg, VA
REASON Distributor relabeled sterilant with extended
expiration date.
PRODUCT 100 cases/20 bottles per case.
DISTRIBUTION Distribution centers in NC, VA, TN, and IL.
PRODUCT Radionics XKnife RT Software
CODE Version 1.02 and lower.
RECALLING FIRM/ MANFACTURER Radionics, A Division of
Tyco Healthcare, Billerica, MA
REASON Software error may cause incorrect jaw settings for
a record/verify system.
PRODUCT 51.
DISTRIBUTION Nationwide and International.
PRODUCT Sterile 3.5mm x 25.0mm Cortical Screw, lot #W02675.
This implant belongs to the Polarus Humeral Rod System product line which is a
system of rods and screws for the fixation of humeral fractures and their
accompanying instrumentation. This
device is single use and provided sterile as stated on the labeling.
CODE Lot #W02675.
RECALLING FIRM/ MANFACTURER Acumed, Inc. Beaverton, OR
REASON Extended sterilization expiration date.
PRODUCT 91.
DISTRIBUTION CA, UT, GA, KS, MO and Sweden, Denmark,
United Kingdom, Korea, Japan, and Australia.
PRODUCT Model 93 Series, Squadmate Ambulance Cots
CODE Cot Models: 93-ES, 93-EX, 93-ESST, 93-EXST, 93-IT,
93-ITA having serials number between L-611423 and L-639553, were subject to
correction.
RECALLING FIRM/ MANFACTURER Ferno-Washington, Inc.
Wilmington, OH
REASON The locking mechanism may fail and cause injury to
the patient or operator.
PRODUCT 658 units
DISTRIBUTION Nationwide.
PRODUCT Stryker Endoscopy
brand disposable Arthroscopic Bur with 4.0mm Barrel Bur Model #s/Part#s:
a)
275-941-000, 6 Flute, Hooded Barrel Bur; b) 275-941-012, 12 Flute, Hooded
Barrel Bur; c) 275-941-200, 6 Flute, Unhooded Barrel Bur
CODE a) Part #: 275-941-000, 4.0mm 6 Flute Barrel Bur
Lot
#s: 01085692; 01085772; 01065512; 01065552; 01065572; 01075612; 01075652.
b)
Part #: 275-941-012, 4.0mm 12 Flute Barrel Bur Lot #s: 01085752; 01085772;
01055492; 01065512; 01075592.
c) Part
No. 275-941-200, 4.0mm 6 Flute Unhooded Barrel Bur Lot#s: 01085732; 01085752.
RECALLING FIRM/ MANFACTURER Stryker Endoscopy, Santa
Clara, CA
REASON The bur head can separate from the shaft during use.
PRODUCT 6,400 units
DISTRIBUTION Nationwide.
PRODUCT Vacutainer Sodium Polyanethol Sulfonate (SPS) Blood
Culture Specimen Collection Tube, Catalog #366404
CODE Catalog No. 366404, Lot 0339536, 1037417, and
1127925.
RECALLING FIRM/ MANFACTURER Recalling Firm: Becton
Dickinson & Co., Franklin Lakes
Manufacturer:
Becton Dickinson & Co., Broken Bow, NE.
REASON When stopper is pulled out, healthcare worker may
contact collected blood specimen.
PRODUCT Lot 0339536--approx. 240,000; Lot 1037417
--approx..243,000; Lot 1127925 -- approx. 193,000
DISTRIBUTION Nationwide and Canada.
PRODUCT Deproteinizer Solution B
CODE Lot R1D123, Exp. 3/03
RECALLING FIRM/ MANFACTURER Recalling Firm: Diamond
Diagnostics Inc., Holliston, MA.
Manufacturer:
Ameresco Solon, OH.
REASON Product may be contaminated with salmonella.
PRODUCT 48 vials.
DISTRIBUTION Malayasia and Indonesia.
PRODUCT Kodak 100-film autoloader for the Kodak LS40, LS50,
LS75, and LS85 Film Digitizers and Lumisys Autoloader Film Autoloader
CODE Cat. # 0072-745:
S/Ns 39667, 40020, 13926; Cat. # 808224: S/N A0002.
RECALLING FIRM/ MANFACTURER Eastman Kodak Co., Rochester
REASON Potential shock hazard
PRODUCT 4 units
DISTRIBUTION CO, TX, and WV.