NOVEMBER 2004
WEEK ENDING NOVEMBER 6
PRODUCT
a) AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
b) AXIOM Sensis Programmable diagnostic comp uter, Model number 66 34 633.
c) AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641.
d) AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658.
e) AXIOM Sensis Programmable diagnostic computer, Model number 66 48 161.
CODE
a) Serial numbers: 1155, 6002, 6006-6014, 6016, 6018-6021, 6023-6025, 6027-6053, and 6100-6125. Model number 66 34 641
involves the following serial numbers: 4001-4008 and 4050- 4056. Model number 66 34 658 involves the following serial
numbers: 8001-8003, 8006-8007, 8009-8010, and 8050-8055.
Model number 66 48 161 involves the following serial numbers: 11001-11014, 11016, 11018, and 11050-11054;
b) Serial numbers: 2001-2011, 2013-2023, 2025-2026, 2028, 2031-2067, 2069-2090, 2092-2132, 2134-2143, 2145-2148,
2150-2158, 2160-2260, 2262, and 2265-2266;
c) Serial numbers: 4001-4008 and 4050-4056;
d) Serial numbers: 8001-8003, 8006-8007, 8009-8010, and 8050-8055.
e) Serial numbers: 11001-11014, 11016, 11018, and 11050-11054.
RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Malvern,
PA.
REASON Possible error calculating valve area with the AXIOM Sensis.
VOLUME OF PRODUCT IN COMMERCE143 units.
DISTRIBUTION
Nationwide.
PRODUCT NOVAPLUS Electrosurgical Grounding Pads, Split with Cord Catalog No. 7179V.
CODE Lot 2007-06 HP.
RECALLING FIRM/MANUFACTURER 3 M Company/Medical Division, South St Paul,
MN.
REASON Improper wire placement from the patient plate to the ESU connector plug results
in an intermittent displacement connection.
VOLUME OF PRODUCT IN COMMERCE15,360 pads.
DISTRIBUTION
Nationwide.
PRODUCT V.A.C. X-Large Granufoam Dressing Part Numbers M6275065/5, V.A.C. ATS and V.A.C.
Freedom and M6275043/5 V.A.C. Classic.
CODE Part M6275043-5: 01.27.04.21v; 01.27.04.22v; 01.27.04.23v; 02.23.04.03; 05.06.04.07;
05.17.04.01; 05.20.04.08; 06.23.04.12; 07.07.04.13; and 08.11.04.04 Part M6275065-5:
11.06.03.01V; 11.06.03.02V; 11.06.03.03V; 11.21.03.15; 12.01.03.25; 12.15.03.14;
12.18.03.07; 01.16.04.09; 01.08.04.10; 01.20.04.10; 12.15.03.14; 02.04.04.23;
01.21.04.24; 02.09.04.22; 02.23.04.07; 03.30.04.13; 03.22.04.10; 05.04.04.08;
05.14.04.04; 05.26.04.09; 06.02.04.07; 06.04.04.15; 06.17.04.12; 07.07.04.11;
07.07.04.12; 07.20.04.14; 07.30.04.03; and 08.03.04.06.
RECALLING FIRM/MANUFACTURER Kinetic Concepts, Inc., San Antonio, TX.
REASON The seal on the pouch may open during shipping and sterility may be compromised.
VOLUME OF PRODUCT IN COMMERCE 29,610 units.
DISTRIBUTION Nationwide, and Internationally.
PRODUCT Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories.
Catalog number SSS-CTP-QFT.
CODE Lot number 45535 exp 9/2008.
RECALLING FIRM/MANUFACTURER Medrad Inc., Indianola, PA.
REASON Sterility can be compromised by a component tearing the outer packaging.
VOLUME OF PRODUCT IN COMMERCE 1.650 kits.
DISTRIBUTION Nationwide.
PRODUCT ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001,
product is packaged in trays.
CODE Serial Numbers: ATO-001 through ATO-0082.
RECALLING FIRM/MANUFACTURER Zimmer Spine, Inc., Minneapolis, MN.
REASON To date, there has been one complaint reported. During a Trinica surgical case,
the surgeon was provided a standard disposable, Trinica Drill Bit (part number
07.00166.001) for use with the Trinica All Through One Drill Guide Instrumentation,
instead of the ALL Through One Drill Bit. This enabled the physician to drill
a few millimeters further than expected.
VOLUME OF PRODUCT IN COMMERCE 82 sets.
DISTRIBUTION Nationwide.
PRODUCT Ultra Power Burs, Sterile, Single-Use.
CODE All product with an expiration date between August 2004 and August 2009.
RECALLING FIRM/MANUFACTURER Linvatec Corp, Largo, FL.
REASON The pouch containing the sterile product is not completely sealed on all products.
Therefore, the sterility of the device is questionable.
VOLUME OF PRODUCT IN COMMERCE 58,510 Bars.
DISTRIBUTION Nationwide and Internationally.
PRODUCT DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro
coagulation studies.
CODE Lot numbers 57295, 57304, 57400, 57463, 57504, 57562, 57579, 57601, 57674, 57685,
57755, 57819, 57820, and 57832.
RECALLING FIRM/MANUFACTURER Dade Behring, Inc., Newark, DE.
REASON APTT determinations when using affected rotors may lead to incorrectly shortened
times.
VOLUME OF PRODUCT IN COMMERCE 7,140 units.
DISTRIBUTION Nationwide.
PRODUCT The MDA system with MDA Antithrombin III MDA Heparin.
CODE All product numbers.
RECALLING FIRM/MANUFACTURER BioMerieux, Durham, NC.
REASON The firm received complaints regarding an observed bias in percent activity
between capped and uncapped speciments.
VOLUME OF PRODUCT IN COMMERCE 588 units.
DISTRIBUTION Nationwide and Internationally.
PRODUCT
a) Advanced Bionics implantable cochlear stimulator CLARION 1.2 Models AB-5100L AB-5100R AB-5100ML/R
(For Export Only) AB-5100H AB-5100H-01A.
b) Advanced Bionics implantable cochlear stimulator CLARION CII Models AB-5100H-11A AB-5100h-12A.
c) Advanced Bionics implantable cochlear stimulator HiRes 90, Models CI-1400-01 CI-1400-02.
CODE
a) Unimplanted CLARION 1.2;
b) Unimplanted CLARION CII;
c) HiRes 90K Implantable Cochlear Stimulator, Model Number CI-1400-01, manufactured prior to December 1, 2003.
RECALLING FIRM/MANUFACTURER Advanced Bionics, Sylmar, CA.
REASON All unimplanted CLARION and HiResolution cochlear implants due to the potential
presence of moisture in the internal circuitry, which can cause the device to
stop functioning.
VOLUME OF PRODUCT IN COMMERCE 42 units.
DISTRIBUTION Nationwide, Canada and France.
PRODUCT Hem-o-lok® Endo5™ Ligation Applier.
CODE Catalog number 544965, Lot 943704, 943705, 954592.
RECALLING FIRM/MANUFACTURER Weck, Research Triangle Park, NC.
REASON The jaws may break during clip loading or clip application.
VOLUME OF PRODUCT IN COMMERCE 119 units.
DISTRIBUTION Nationwide and Internationally.
WEEK ENDING NOVEMBER 13
PRODUCT
a) X-ray system GE OEC Series 7600.
b) Compact Series 7600.
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
GE OEC Medical Systems, Salt Lake City, UT.
REASON
The x-ray product failed to comply with the Federal x-ray product performance
standard, whereby unintended x-rays are emitted upon boot-up if the footswitch
is engaged.
VOLUME OF PRODUCT IN COMMERCE
323 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
MUX-100H Mobile Radiography System.
CODE
All MUX-100H Mobile Radiography Systems.
RECALLING FIRM/MANUFACTURER
Shimadzu Corp., Torrance, CA.
REASON
The spacer hardware does not maintain the proper minimum distance allowed.
VOLUME OF PRODUCT IN COMMERCE
Approximately 219 units.
DISTRIBUTION
Nationwide.
PRODUCT
a) 8 ml Inject8 Coronary Control Syringe, sterile.
Product Number CCS880.
b) 10 ml Inject 10 Palm Pad, sterile, Product Number CCXB010/A.
c) Convenience Kits containing Inject8 or Inject10 syringes.
CODE
a) Lot numbers A333586, A337519, A341381, A337458, A341399.
b) Lot Number A337459.
c) Part No. K07-00116AP, Lot Nos A340949, A346191.
Part No. K09-00302FP, Lot # A340485, A341488.
Part No. K09-00579CP,
Lot # A339214, A345673
Part No. K09-00585LP, Lot # A338201, A344694
Part No. K09-00759DP, Lot #A342359, A345674, A347263.
Part No. K09-00946MP, Lot # A341491
Part No. K09-00970K, Lot # A337245
Part No. K09-01574G, Lot # A343825
Part No. K09-01673H, Lot # A342676
Part No. K09-01908AP, Lot # A338729, A344187, A344382.
Part No. K09-02104HP,
Lot # A337839, A346138 Part No. K09-02249H, Lot # A343819 Part No. K09-02249HP, Lot # A339688 Part No. K09-02334K,
Lot # A345405
Part No. K09-02353G, Lot # A342675
Part No. K09-03242C, Lot # A342165
Part No. K09-03528D, Lot # A341710
Part No. K09-03978HP, Lot # A339229, A340896, A344386.
Part No. K09-04000HP, Lot # A338208, A339231, A341504,
A344612, A341505, A341504.
Part No. K09-04017C, Lot # A337857
Part No. K09-04316H, Lot # A342071.
Part No. K09-04488A, Lot # A338228, A341118.
Part No. K09-04863C, Lot # A337204, A338112.
Part No. K09-04863C, Lot # A337204.
Part No. K09-04923B, Lot # A340508, A 343196.
Part No. K09-05138CP, Lot # A339425, A342802.
Part No. K09-05229G, Lot # A339926.
Part No. K09-05229GP, Lot # A345552.
Part No. K09-05477A, Lot # A342803.
Part No. K09-05785DP, Lot # A340897.
Part No. K09-05939C, Lot # A337947, A342379.
Part No. K09-05947D, Lot # A342670.
Part No. K09-06262P, Lot # A341604.
Part No. K09-07470C, Lot # A342173.
Part No. K09-07547B, Lot # A340375.
Part No. K09-07573AP, Lot # A344373.
Part No. K09-07573P, Lot # A342349.
Part No. K09-07589P, Lot # A347257, A347985.
Part No. K09-07629CP, Lot # A344853.
Part No. K09-07746A, Lot # A337319.
Part No. K09-07759, Lot # A341614.
Part No. K09-07779P, Lot # A344855, A347876.
Part No. K09-07847, Lot # A342385.
Part No. K09-07883B, Lot # A336474.
Part No. K09-07924AP, Lot # A346124.
Part No. K09-07943AP, Lot # A345851.
Part No. K09-07944A, Lot # A339427.
Part No. K09-08020B, Lot # A331903.
Part No. K09-08065P, Lot # A345570.
Part No. K09-08150AP, Lot # A340352, A342387.
Part No. K09-08214B, Lot # A340534
Part No. K09-08369, Lot # A342388.
Part No. K09-08391AP, Lot # A340252, A343600.
Part No. K09-08397, Lot # A335968.
Part No. K09-90270KP, Lot # A3412623, A343596.
Part No. K09-90358DP, Lot # A345692.
Part No. K09-MS2366H, Lot # A341693.
Part No. K09-MS2450B, Lot # A338759.
Part No. K09-MS2550A, Lot # A343809.
Part No. K09-MS2602A, Lot # A342813.
Part No. K09-MS2638B, Lot # A341694,
Part No. K09-MS2703B, Lot # A336929, A343808.
Part No. K10-01223B, Lot # A339948.
Part No. K10-03441P, Lot # A336328, A343551.
Part No. K10-03616, Lot # A339959.
Part No. K12-01176B, Lot # AS345883.
RECALLING FIRM/MANUFACTURER
Merit Medical Systems, Inc., South Jordan, UT.
REASON
Certain syringes exhibit a potential for air to be drawn into the syringe due
to a dimensional mismatch.
VOLUME OF PRODUCT IN COMMERCE
20,452 syringes.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
CIDEX OPA Solution, ortho-Phthalaldehyde Solution.
CODE
Product Code: 20390, 20391, 20394.
RECALLING FIRM/MANUFACTURER
Advanced Sterilization Products, Irvine, CA.
REASON
Anaphylactic-like reactions were reported following repeated cystoscopy for
bladder cancer patients where the scope had been reprocessed in CIDEX OPA Solution.
VOLUME OF PRODUCT IN COMMERCE
NA.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
BD Vactuainer SST glass and plastic tubes.
CODE
There is no linkage to any particular lot of BD product.
RECALLING FIRM/MANUFACTURER
Becton Dickinson and Company, Franklin Lakes, NJ.
REASON
There is an apparent bias in the determination of Total T3, Total T4, HBsAg,
Folate BA, VB 12, BR, FSH and Cortisol hormones used to determine thyroid disease
states, and adrenal gland function. The immunoassay results are high when BD
serum separator tubes are used in certain instruments platforms.
VOLUME OF PRODUCT IN COMMERCE
Unspecified.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
a) MDA® Fibriquik™. ;
b) Fibriquik™.
CODE
a) Product number 252560, Lot number 505046;
b) Product number 235531, Lot number 113101, 113049,
113050 and Product number 235529, Lot number 111169.
RECALLING FIRM/MANUFACTURER BioMerieux, Durham, NC.
REASON
Complaints were received from the field regarding prolonged clot times, high
control values and erratic results.
VOLUME OF PRODUCT IN COMMERCE
3,571 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
Genital Protector Shield used with Fuji Computed Radiography (FCR) system models
5501D and XU/D1. Model: GP344.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Fujifilm Medical System USA, Inc., Stamford, CT.
REASON
Model GP344 may detach from the mounting block and fall during use.
VOLUME OF PRODUCT IN COMMERCE
16 units.
DISTRIBUTION
CO, CT, NY, MD, MI, MN, NV, and UT.
PRODUCT
a) SafeSheath KR under the Pressure Products label. Tearaway KR Kit.
Catalog number HLS/KR-1007. The product is shipped in cartons
containing 5 units.
b) SafeSheath KR under the Pressure Products label. Tearaway KR Kit.
Catalog number HLS/KR-1009. The product is shipped in cartons
containing 5 units.
c) SafeSheath KR under the Pressure Products label. Tearaway KR Kit.
Catalog number HLS/KR-1011. The product is shipped in cartons
containing 5 units.
CODE
a) Lot number F4910 exp 12/05, Lot number F5678 exp. 4/06,
and Lot number F6251 exp. 6/06;
b) Lot number F5861 exp. 6/06 and Lot number 6724 exp. 8/06;
c) Lot number F6824 exp. 8/06.
RECALLING FIRM/MANUFACTURER
Thomas Medical Products Inc., Malvern, PA.
REASON
Sheaths may fracture if exposed to excess fluorescent light.
VOLUME OF PRODUCT IN COMMERCE
2,770 kits.
DISTRIBUTION
CA.
PRODUCT
Sterile Multi-Purpose Solution, NO RUB, for soft hydrophilic contact lenses.
12 fl oz. bottles. Sold under the following brand names: Family Dollar HomeBest
HEB Meijer Food Lion health PRIDE Stop and Shop Super G sunmark Brite-Life Wegmans
Our Family Healthy Generations GoodSense Winn Dixie Finast Western Family K
C Pharmaceuticals.
CODE
All Codes.
RECALLING FIRM/MANUFACTURER
K C Pharmaceuticals, Inc., Pomona, CA.
REASON
Routine testing indicates product does not meet the expiration date in all cases.
VOLUME OF PRODUCT IN COMMERCE
2,252,664.
DISTRIBUTION
Nationwide.
PRODUCT
Infusion Dynamics Power Infuser pump. Model number M100B-3A.
CODE
Serial numbers 13-05863 through 13-05929 and 13-6005 through 13-06036.
RECALLING FIRM/MANUFACTURER
Infusion Dynamics, A Div. Of Zoll Med Corpinfusion Dynamics, Plymouth Meeting,
PA.
REASON
Front Panel may be cracked on some units. If cracked fluid can enter the infuser
and short the start/stop button. Shorting would cause the infuser to stay in
the open position
VOLUME OF PRODUCT IN COMMERCE
99 units.
DISTRIBUTION
TX, MO, VT, CA, NV, NY, pa, and Germany.
PRODUCT
Pagewriter Touch Cardiograph Software.
CODE
Software Versions A.01.01 or A.01.02.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Andover, MA.
REASON
Software can generate printed ECG's that associate incorrect patient data with
the waveform.
VOLUME OF PRODUCT IN COMMERCE
768 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
a) SOMATOM CT System Emotion Duo, X-Ray, Tomography, Computed System,
Model number 38 13 933.
b) SOMATOM CT System Emotion 6, Computed Tomography X-Ray System,Model
Number: 38 15 490.
c) SOMATOM CT System Sensation 16, Computed Tomography X-Ray, Model
Number 73 93 114.
d) SOMATOM CT System Sensation 16 (+ Straton), Computed Tomography
System, Model Number 73 93 114.
e) SOMATOM CT System Sensation Cardiac, Computed Tomography X-Ray,
Model Number 75 43 106.
f) SOMATOM CT System Sensation Cardiac (+ Straton), Computed
Tomography X-Ray System, Model Numbers 75 43 106.
g) SOMATOM CT System Sensation 10, Computed Tomography X-Ray System,
Model Number 75 43 015.
h) LEONARDO MM-WS, Computed Tomography X-Ray, Model Number 71 29 534.
CODE
a) Serial Number 36716;
b) Serial Numbers: 43007, 43014, 43015, 43020, 43024, 43031, 43032,
43052, 43053, 43097, 43098, 43114, 43199, 43218, 43222, 43228,
43244, 43258, 43269, 43273, 43287, 43298, 43308, 43329, 43343,
43346, 43347, 43349, and 43361;
c) Serial Numbers: 50008, 50013, 50014, 50022, 50025, 50026, 50027,
50029, 50034, 50036, 50037, 50040, 50042, 50044, 50048, 50050,
50054, 50058, 50062, 50066, 50073, 50075, 50079, 50081, 50085,
50086, 50089, 50093, 50096, 50097, 50100, 50105, 50106, 50110,
50113, 50123, 50124, 50131, 50134, 50138, 50139, 50141, 50142,
50146, 50152, 50154, 50156, 50158, 50162, 50165, 50166, 50168,
50174, 50175, 50178, 50181, 50183, 50186, 50190, 50192, 50193,
50194, 50202, 50203, 50205, 50212, 50219, 50222, 50224, 50226,
50234, 50238, 50245, 50249, 50250, 50255, 50258, 50262, 50263,
50266, 50273, 50274, 50278, 50283, 50285, 50288, 50293, 50300,
50308, 50310, 50316, 50317, 50325, 50327, 50332, 50334, 50340,
50343, 50351, 50356, 50365, 50374, 50379, 50380, 50391, 50392,
50394, 50394, 50396, 50409, 50412, 50416, 50421, 50429, 50433,
50435, 50452, 50454, 50455, 50458, 50459, 50461, 50462, 50465,
50466, 50467, 50471, 50472, 50473, 50479, 50482, 50483, 50488,
50490, 50491, 50494, 50497, 50501, 50512, 50525, 50530, 50534,
50535, 50540, 50543, 50549, 50550, 50555, 50556, 50557, 50560,
50561, 50564, 50568, 50570, 50573, 50575, 50576, 50577, 50579,
50580, 50582, 50585, 50588, 50590, 50591, 50595, 50597, 50600,
50609, 50610, 50611, 50615, 50621, 50622, 50626, 50627, 50628,
50631, 50632, 50636, 50639, 50640, 50643, 50644, 50545, 50650,
50651, 50653, 50665, 50668, 50669, 50672, 50674, 50682, 50683,
50685, 50686, and 50999;
d) Serial Numbers: 51796, 51798, 51799, 51800, 51801, 51806, 51808,
51809, 51811, 51813, 51814, 51820, 51822, 51823, 51828, 51829,
51831, 51832, 51834, 51835, 51836, 51837, 51838, 51839, 51841,
51845, 51846, 51847, 51851, 51852, 51853, 51854, 51855, 51856,
51858, 51862, 51864, 51865, 51867, 51868, 51869, 51870, 51872,
51875, 51877, 51880, 51881, 51884, 51885, 51886, 51887, 51889,
51890, 51892, 51897, 51899, 51900, 51903, 51904, 51905, 51907,
51908, 51911, 51912, 51914, 51916, 51917, 51918, 51920, 51921,
51925, 51928, 51929, 51930, 51931, 51932, 51935, 51936, 51938,
51940, 51943, 51944, 51945, 51947, 51948, 51949, 51953, 51954,
51957, 51959, 51961, 51962, 51963, 51964, 51965, 51966, 51967,
51968, 51971, 51972, 51973, 51975, 51979, 51980, 51982, 51985,
51988, 51989, 51990, 51991, 51997, 51998, and 51999;
e) Serial Numbers: 52001, 52005, 52006, 52007, 52008, 52009, 52010,
52011, 52013, 52015, 52016, 52017, 52018, 52019, 52020, 52021,
52022, 52023, 52024, 52026, 52027, 52028, 52030, 52032, and 52033;
f) Serial Numbers: 52948, 52950, 52951, 52952, 52953, 52954, 52955,
52956, 52957, 52958, 52959, 52960, 52961, 52962, 52963, 52964,
52965, 52966, 52967, 52968, 52969, 52971, 52972, 52973, 52974,
52975, 52976, 52977, 52978, 52979, 52980, 52981, 52982, 52983,
52984, 52985, 52986, 52988, 52989, 58990, 52991, 52992, 52993,
52994, 52996, 52997, and 58999;
g) Serial Numbers: 53001, 53009, 53014, 53054, 53069, 53081, 53084,
53085, 53091, 53096, 53100, 53119, 53126, 53128, 53135, 53139,
53144, 53145, 53147, 53151, and 53154;
h) Serial Numbers: 6026, 6037, 6047, 6106, 6114, 6115, 6116, and
20014.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA.
REASON
Calcium Scoring feature on the devices is not closing properly after patient's
exams.
VOLUME OF PRODUCT IN COMMERCE
126 units.
DISTRIBUTION
Nationwide.
PRODUCT
Counterfeit contact lenses labeled as: "CooperVision Proclear compatibles
(omafilcon A)". Labeling on outer box reads in part: "CooperVision
proclear compatibles (omafilcon A) ***Norfolk, VA *** MADE IN USA ** Tinted
soft contact lenses *** in a buffered 0.9% saline solution***".
CODE
(Identified as Lot number , power): 200218733K, -0.75; 200221583L, -1.00; 200221758L,
-1.25; 200217599K, -1.50; 200219058K; -1.75; 200203444G, -2.00; 200217595K,
-2.25; 200221190L, -2.50; 200219740K, -2.75; 200217588K, -3.00; 200323296A,
-3.25; 200222445L, -3.50; 200325268A, -3.75; 200292234E, -4.00; 2002922484E,
-4.00; 200213996J, -4.25; 200218908K, -4.50; 200214236J, -4.75; 200215709J,
-5.00; 200212242J, -5.25; 200325303A, -5.50; 200213136J, -5.75; 200213135J,
-6.00; 200208401H, -6.50; 200219479K, -7.00; and 200218545K, -7.50.
RECALLING FIRM/MANUFACTURER
1-800 Contacts Inc., Draper, UT.
REASON
Identified lots of Proclear Compatible contact lenses are counterfeit and may
not be sterile.
VOLUME OF PRODUCT IN COMMERCE
82,268.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
a) CryoValve, Pulmonary Valve & Conduit.
b) CryoValve, Aortic Valve & Conduit.
c) Alt Pulmonary Valve & Conduit.
d) CryoValve, Aortic Valve.
e) CryoValve, Pulmonary Valve & Conduit - SG.
f) CryoValve, Aortic Valve & Conduit w/o AML.
g) CryoValve, Pulmonary Valve.
h) CryoValve, Aortic Valve & Conduit SG.
i) Alt. Aortic Valve & Conduit.
CODE
a) Donor #40003, Serial #6528309, Model #PV00*
Donor #40017, Serial #6528244, Model #PV00*
Donor #41194, Serial #6575765, Model #PV00*
Donor #41205, Serial #6575951, Model #PV00*
Donor #41983, Serial #6601316, Model #PV00*
Donor #45463, Serial #6708282, Model #PV00*
Donor #45539, Serial #6697697, Model #PV00*
Donor #45616, Serial #6735116, Model #PV00*
Donor #46477, Serial #6741538, Model #PV00*
Donor #46894, Serial #6768760, Model #PV00*
Donor #49793, Serial #6888973, Model #PV00*
Donor #50045, Serial #7110175, Model #PV00*
Donor #50982, Serial #7004457, Model #PV00*
Donor #50986, Serial #7048353, Model #PV00*
Donor #51902, Serial #7037079, Model #PV00*
Donor #59101, Serial #7387145, Model #PV00*
Donor #61954, Serial #7682701, Model #PV00;
b) Donor #25741, Serial #6048048, Model #PV00*
Donor #34696, Serial #6356176, Model #PV00*
Donor #40017, Serial #6528252, Model #AV00*
Donor #41180, Serial #6575609, Model #AV00*
Donor #41204, Serial #6575862, Model #AV00*
Donor #41737, Serial #6593488, Model #AV00*
Donor #45446, Serial #6714974, Model #AV00*
Donor #45592, Serial #6735875, Model #AV00*
Donor #46183, Serial #6736590, Model #AV00*
Donor #46484, Serial #6774373, Model #AV00*
Donor #46505, Serial #6770996, Model #AV00*
Donor #47518, Serial #6761788, Model #AV00*
Donor #50045, Serial #7110160, Model #AV00*
Donor #50098, Serial #7106597, Model #AV00*
Donor #50953, Serial #7000596, Model #AV00*
Donor #50982, Serial #7090443, Model #AV00*
Donor #53789, Serial #7013389, Model #AV00*
Donor #54935, Serial #7235057, Model #AV00*
Donor #59111, Serial #7343716, Model #AV00*
Donor #59407, Serial #7322607, Model #AV00;
c) Donor # 4039, Serial #6531822, Model #PV05;
d) Donor #46496, Serial #6741341, Model #AV10;
e) Donor #55634, Serial #7250375, Model #SGPV00*
Donor #60740, Serial #7756769, Model #SGPV00*
Donor #60758, Serial #7765469, Model #SGPV00*
Donor #60760, Serial #7753955, Model #SGPV00*
Donor #63969, Serial #7907208, Model #SGPV00*
Donor #64863, Serial #7865589, Model #SGPV00;
f) Donor #56596, Serial #7410328, Model #AV40;
g) Donor #59446, Serial #7352907, Model #PV10;
h) Donor #60727, Serial #7763406, Model #SGAV00*
Donor #62532, Serial #7818159, Model #SGAV00*
Donor #64863, Serial #7865603, Model #SGAV00*
Donor #65932, Serial #8105091, Model #SGAV00;
i) Donor #34698, Serial #6356222, Model #AV05.
RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, GA.
REASON
CryoLife conducted a retrospective review which revealed the sterilization cycle
of instruments used during processing of various tissues could not be confirmed
as acceptable.
VOLUME OF PRODUCT IN COMMERCE
51.
DISTRIBUTION
Nationwide, Austria, Canada, Germany.
PRODUCT
a) Stryker brand Neptune waste management system, Neptune Rover, 20
amp plug; model 0700-001-000.
b) Stryker brand Neptune waste management system, Neptune Rover, 15
amp plug; model 0700-003-000.
CODE
a) All units with an Interpower brand AC power plug, which includes
serial numbers 0101014 through 03227006033.
b) All units with an Interpower brand AC power plug, which includes
serial numbers 0203177 through 0406301403.
RECALLING FIRM/MANUFACTURER
Stryker Instruments, Div. Of Stryker Corp., Kalamazoo, MI.
REASON
The grounding pin may break inside of the electrical plug, resulting in a shock
hazard.
VOLUME OF PRODUCT IN COMMERCE
1,682
DISTRIBUTION
Nationwide and Canada.
PRODUCT
Alto and Alto 2 implantable cardioverter defibrillator.
CODE
Model Numbers DR model 614, VR model 615.
RECALLING FIRM/MANUFACTURER
ela Medical Llc, Plymouth, MMN.
REASON
These models can experience sudden no output, and early end of life characteristics
due to metal migration in their controlling hybrids, causing high current drain
leading to premature battery depletion.
VOLUME OF PRODUCT IN COMMERCE
450 devices.
DISTRIBUTION
Nationwide.
PRODUCT
Aeroneb Go Micropump Nebulizer Featuring OnQ electronic micropump, RX, Manufactured
by Medical Industries America Inc., Adel, IA. The product is sold individually
or in master packs of 8 under the following model numbers (all using the same
box label): Model 7000 - Consisting of the Aeroneb Go, battery controller, battery
controller cable, 3 AA alkaline batteries, mask elbow, mouthpiece, carry bag,
and user manual; Model 7030 - Consisting of the Aeroneb Go, AC wall adapter,
mask elbow, mouthpiece, carry bag, and user manual; Model 7070 - Consisting
of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline
batteries, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual;
Model 7000-1 - Consisting of the Aeroneb Go, battery controller, battery controller
cable, 3 AA alkaline batteries, European mask elbow, mouthpiece, carry bag,
and user manual; Model 7030-1 - Consisting of the Aeroneb Go, AC wall adapter,
European mask elbow, mouthpiece, carry bag, and user manual; Model 7070-1 -
Consisting of the Aeroneb Go, battery controller, battery controller cable,
3 AA alkaline batteries, AC wall adapter, European mask elbow, mouthpiece, carry
bag, and user manual. 7000LINCARE - Consisting of the Aeroneb Go, battery controller
with a Lincare private label cover plate, battery controller cable, 3 AA alkaline
batteries, mask elbow, mouthpiece, carry bag, and user manual; 7070LINCARE -
Consisting of the Aeroneb Go, battery controller with the Lincare private label
cover plate, battery controller cable, 3 AA alkaline batteries, AC wall adapter,
mask elbow, mouthpiece, carry bag, and user manual.
CODE
040120, 040127, 040129, 040130, 040201, 040202, 040203, 040205, 040209, 040210,
040216, 040219, 040227, 040301, 040303, 040305, 040311, 040317, 040406, 040407,
040415, 040427, 040421, 040428, 040506, 040721, 040723, 040726, 040730, 080504,
080904, 081104, 081604, 081704, 081904, 082004, 082304, 082504, 082704, 083004,
083104, 080304.
RECALLING FIRM/MANUFACTURER
Medical Industries America, Inc., Adel, ID.
REASON
The nebulizer can either fail or provide a low flow (partial dose) of medication.
VOLUME OF PRODUCT IN COMMERCE
17,464 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
HDI 4000 Ultrasound System & the Philips 4000 Ultrasound System (same system).
CODE
Part # 9896 053 15031 (8500-0066-01), 9896 053 18811 (8500-0080-01), 9896 053
22011 (8500-0087-01) Site numbers: A42000896, A3B000796, A34000603, A2C000441,
A32000483, A33000540, A28000273, A35000637, A35000649, A26000159, A45001061,
A28000241, A37000732, A25000143, A35000663, A42000932, A32000505, A42000898,
A33000546, A24000084, A26000165, A28000255, A28000266, A28000276, A45001050,
A36000692, A45001066, A34000559, A24000052, A32000501, A2C000460, A3C000853,
A34000582, A2A000350, A2C000458, A2B000408, A28000277, A27000197, A25000136,
A33000550, A34000596, A24000104, A34000621, A33000549, A2B000374, A34000607,
A43001003, A28000238, A34000568, A28000275, A36000674, A29000323, A2A000354,
A29000318, A29000325, A27000188, A36000678, A28000253, A34000628, A27000204,
A3B000804, A36000687, A3C000825, A25000140, A3B000799, A28000267, A2A000335,
A2A000353, A31000489, A29000289, A2A000338, A39000780, A26000153, A35000636,
A2A000348, A38000760, A42000916, A2B000395, A42000912, A24000101, A36000706,
A35000665, A34000629, A42000907, A43001005, A25000131, A27000189, A25000123,
A42000889, A2C000438, A2B000420, A28000231, A26000160, A37000735, A32000502,
A34000595, A24000067, A42000885, A28000270, A24000054, A2B000358, A39000776,
A2C000448, A3C000846, A24000087, A35000659, A2C000455, A39000769, A43001006,
A26000161, A24000057, A42000945, A34000589, A37000723, A31000477, A31000488,
A2B000411, A2C000440, A2C000452, A2C000456, A31000466, A31000467, A31000479,
A31000480, A31000481, A32000509, A26000154, A27000181, A42000925, A33000523,
A34000577, A3C000812, A29000290, A31000474, A34000602, A26000157, A2A000349,
A42000901, A42000947, A23000047, A36000702, A25000146, A2A000345, A44001022,
A28000280, A2C000449, A3C000850, A41000861, A24000060, A2A000330, A42000895,
A27000212, A26000170, A27000192, A42000931, A37000738, A26000173, A26000179,
A26000178, A29000300, A38000753, A39000783, A24000061, A2A000327, A27000186,
A2C000463, A31000478, A2C000446, A31000492, A28000235, A28000229, A25000144,
A2B000399, A27000198, A27000202, A2C000445, A34000588, A36000677, A3C000824,
A43000982, A2B000365, A36000707, EMO00005, A36000705, A34000623, A26000176,
A26000180, A25000106, A25000108, A25000115, A34000565, A34000578, A31000476,
A32000504, A36000670, A2B000385, A3B000794, A2A000344, A36000694, A3B000806,
A3C000826, A39000767, A42000899, A2C000437, A21000016, A25000118, A2C000444,
A38000756, A37000720, A45001058, A37000721, A34000612, A32000490, A28000226,
A28000260, A24000077, A25000111, A31000475, A33000534, A24000076, A25000116,
A35000652, A31000470, A36000716, A35000630, A44001032, A41000872, A2C000451,
A2C000457, A32000498, A29000319, A27000210, A24000051, A31000468, A34000557,
A34000567, A3B000802, A42000934, A42000921, A35000650, A27000203, A23000040,
A34000563, A21000018, A32000495, A36000717, A39000778, A24000096, A25000126,
A26000164, A27000194, A42000893, A42000903, A32000515, A34000615, A34000616,
A2C000439, A33000536, A34000587, A34000606, A32000507, A25000137, A24000056,
A34000614, A25000133, A44001045, A25000147, A23000042, A35000664, A25000130,
A25000148, A32000516, A34000611, A43000995, A37000736, A42000894, A31000482,
A2A000331, A32000499, A43000980, A35000654, A44001019, A25000110, A34000556,
A35000641, A35000642, A44001027, A44001028, A42000913, A3C000813, A42000928,
A45001051, A2B000381, A2B000372, A2C000450, A32000513, A24000073, A3B000790,
A34000597, A25000145, A31000493, A28000220, A34000627, A35000669, A28000265,
A37000743, A35000645, A27000200, A29000310, A28000247, A26000171, A42000922,
A27000184, A34000560, A28000243, A24000055, A35000644, A29000292, A21000015,
A33000528, A32000517, A27000211, A28000257, A28000230, A2A000340, A34000599,
A28000262, A2C000443, A2C000465, A35000643, A2A000337, A28000250, A31000491.
RECALLING FIRM/MANUFACTURER
Philips Ultrasound, Inc., Bothell, WA.
REASON
Potential for device to cause burning of the skin.
VOLUME OF PRODUCT IN COMMERCE
333 to domestic customers, 29 demos, 704 international.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
V. Mueller Pfister-Schwartz Stone Retriever 4-Wire Basket, Without Filiform
Tip; a sterile, single use kidney stone retriever device; Product code GU6397.
CODE
Lot number 1041194, exp. 2009/08.
RECALLING FIRM/MANUFACTURER
Cardinal Health, Medical Products & services, McGaw Park, IL.
REASON
The dispenser box was mislabeled with the wrong length and the wrong wire gauge.
VOLUME OF PRODUCT IN COMMERCE
32 units.
DISTRIBUTION
SC, NY, MO, WV, TX and MS.
PRODUCT
VITROS CRP Slides: (1) Cat # 192 6740, 250 slides per box, and (2) Cat # 809
7990, 90 slides per box. Firm on the label: Ortho-Clinical Diagnostics, Inc.,
Rochester, NY 14626. The CRP Slides are for use on the Vitros 250/250AT and/or
Vitros 950/950AT Clinical Chemistry Systems. For in vitro diagnostic use. Vitros
CRP slides quantitatively measure C-reactive protein concentration in serum
and plasma.
CODE
Coatings 401 thru 409 (Generations 92, 93, 94, 99, 01, 02, 03, 04, and 05).
RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY.
REASON
The Immuno-rate (IR) wash detection algorithm may result in inappropriate wash
detections.
VOLUME OF PRODUCT IN COMMERCE
1) 5,912 cartons x 250 slides;
2) 10,344 x 90 slides.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
RESOLVE Hemoglobin Test Kits. Kit codes: FR-9120 -- 120 tests per kit; FR-9400
-- 360 tests per kit; and FR-9360 --3600 tests per kit.
CODE
FR-9120 - Lot Number: 243309 FR-9360 - Lot Numbers: 213926, 213932, 213939,
213944, 220789, 220794, 220804, 220809, 220799, 220814, 220819, 220824, 220829,
220834, 220839, 220848, 220855, 220860, 220865, 220870, 220875, 220882, 220892,
220898, 228304, 228309, 228314, 228319, 228325, 228330, 228335, 228341, 228348,
228353, 228358, 228363, 228368, 228374, 228379, 228386, 228391, 228396, 229401,
228406, 234161, 234172, 234177, 234182, 234190, 234195, 234200, 234205, 234210,
234222, 234231, 234240, 234247, 234252, 234257, 234262, 238917, 234267, 234272,
234277, 238920, 238923, 238926, 238929, 238932, 238946, 238950, 238953, 238960,
238963, 242331, 242334, 242334. FR-9400 - Lot Numbers: 213941, 220791, 220901,
220806, 220811, 220801, 220816, 220826, 220831, 220836, 220841, 220857, 220862,
220902, 220872, 220894, 220900, 228306, 228316, 228327, 228332, 228344, 228350,
228355, 228360, 228365, 228376, 228381, 228388, 228398, 228403, 228408, 2234192.
RECALLING FIRM/MANUFACTURER
Perkin Elmer LAS Inc., Norton, OH.
REASON
The product insert for the test kits is incorrect with regard to the acceptable
storage temperature for the Agarose IEF gel component. The kit and IEF gel labels
indicate the correct storage temperature of 2-8 degrees C. The product insert
incorrectly indicates that the product may be stored at 2-30 degrees C.
VOLUME OF PRODUCT IN COMMERCE
873 test kits.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
Arrowg+ard Blue Two Lumen CVC Super Kit, Catalog number AK-22802-SK. The kit
actually contains Arrowg+ard Blue Plus Two Lumen CVC Super Kit. Catalog number
AK-42802-SK, 8 Fr x 16 cm Two Lumen Arrowg+ard Blue Plus Catheters. The plus
indicates that the line extension clamps are attached to the catheters.
CODE
Lot number RF4066579.
RECALLING FIRM/MANUFACTURER
Arrow International, Inc., Reading, PA.
REASON
Labeling error. Kits contains the correct components for AK-42802-SK but may
have a package label indicating that it is product number AK-22802-SK.
VOLUME OF PRODUCT IN COMMERCE
290 kits.
DISTRIBUTION
KS, VA, AR, FL, and GA.
PRODUCT
Excelart™ VANTAGE P2 & P3, Magnetic Resonance Imaging System.
CODE
Serial numbers: A4512006, A452017, A4532011, A3612004, A4532014, A4572020, A4572021,
A3622005, A4562003, A3592003, A4562018, A4522008, A4532010, A4542015, A4532013,
A3622001, A3582001, A4522009, A4532012, A3592002, A4522007, A4552016.
RECALLING FIRM/MANUFACTURER
Toshiba American Med Systems, Inc., Tustin, CA.
REASON
Scanned images are acquired at a position that is shifted relative to the intended
position in the slice direction due to a software anomaly.
VOLUME OF PRODUCT IN COMMERCE
22 units.
DISTRIBUTION
Nationwide.
Access Cardiosystems, Inc. Issues a Worldwide Recall of Automated External Defibrillators (AED'S)
Access CardioSystems, Inc., Concord, Massachusetts, initiated a voluntary recall of all of its Automated External Defibrillators (AED's). Additionally, for reasons beyond its control, the Company is no longer doing business.
We have identified two potential problems with certain AED's that warrant your immediate attention:
1. Potential Failure of the Shock Delivery Circuit:
The Company is aware of a situation involving certain of its AEDs in which the device may experience a catastrophic failure of the shock delivery circuit. The Company's investigation indicates to date that this failure mode is restricted to a specific batch of one device component. To date, the company has received 11 complaints of this occurrence in devices containing the component shown to be associated with this failure mode (representing a 0.8% complaint rate within the affected units). When this potential problem occurs, it is not possible to deliver additional defibrillation shocks.
Although the investigation of this issue is still ongoing, the Company has determined that AEDs with the following serial numbers may have this problem: 075690 - 077140.
2. Potential of the AED to Turn on Unexpectedly:
The Company is aware of a situation involving certain of its AEDs in which the "ON/OFF" button of the device may become inoperative after the device turns on unexpectedly. The Company's investigation indicates to date that this failure mode is related to a specific manufacturer of a specific device component. To date, the Company has received 33 complaints of this occurrence in devices containing the component (representing a 0.3% complaint rate within the affected units), none of which have involved a patient treatment. If this potential problem occurs, the device may not defibrillate.
Although the investigation of this issue is still ongoing, the Company has determined that AEDs with the following serial numbers may have this problem: 075180 - 084760.
USERS ARE ADVISED TO IMMEDIATELY DISCONTINUE USE OF AND TO REMOVE FROM SERVICE ACCESS CARDIOSYSTEMS AED DEVICES WITH THE ABOVE REFERENCED CATALOG AND SERIAL NUMBERS: 075690 - 077140 OR 075180 - 084760.
The Company discontinued manufacturing and marketing ALL models of its AEDs and discontinued supporting its AEDs that are currently in service. The Company cannot accept orders for new AEDs, for consumable components (specifically disposable battery packs and electrode sets) used with its AEDs, and cannot service, repair or answer technical questions for existing AEDs.
For units not affected by the recall Access Cardiosystems is no longer accepting orders for disposable parts used with our AEDs. Therefore, when your supply of disposable parts is depleted, please immediately discontinue use of and remove from service all of the Company's AEDs that you have in your possession. Customers should consider replacing the AED's as soon as possible. It is your responsibility to equip yourself with AEDs that meet your medical needs.
Access CardioSystems, Inc. has notified affected customers on November 3, 2004 by registered mail return receipt requested mail. All interested parties with any questions should contact the Recall Coordinator at 1 978 405-1057.
In order to obtain the most updated information you may e-mail the Company at recall@accesscardiosystems.com or visit the Company's website at accesscardiosystems.com.
WEEK ENDING NOVEMBER 20
PRODUCT
a) Oral-B CrossAction Power Toothbrush, Soft (Battery Operated) Handle Colors:
Blue, Pink, Green and Purple NDC 0-69055-82662-1.
b) Oral-B CrossAction Power Toothbrush, Medium (Battery Operated) Handle Colors:
Blue, Pink, Green and Purple NDC 0-69055-82445-0.
c) Oral-B CrossAction PowerMAX Rechargeable Toothbrush, Soft 4 Accent Colors:
Blue, Pink, Green and Purple NDC 0-69055-83293-6.
d) Oral-B CrossAction PowerMAX Rechargeable Toothbrush, Medium NDC 0-69055-83120-5.
e) Oral-B CrossAction Power Brushhead Refills, Soft 2-Count Pack NDC 0-69055-82663-8.
f) Oral-B CrossAction Power Brushhead Refills, Medium 2-Count Pack NDC 0-69055-82448-1.
CODE
All.
RECALLING FIRM/MANUFACTURER
Gillette Research Institute, Needham, MA.
REASON
Brushhead may unlatch from the power handle.
VOLUME OF PRODUCT IN COMMERCE
22,304 million.
DISTRIBUTION
Nationwide
PRODUCT
The Enfant Evoked Response Photic Stimulator. The Enfant A Pediatric Vision
Testing Device. Each medical device unit is assembled and contains an 18 inch
flat panel vision stimulator panel, a 17 inch flat panel operator monitor, a
2.25 inch thermal printer, a mobile point of care cart, medical grade battery
back-up, speaker, a CPU with floppy and CD drives, a camera and an isolation
transformer.
CODE
No manufacturing codes are affixed to the units. The firm maintains some in-house
identification numbers which are: 10001; 10003; 10004; 10005; 10006; 10007;
10008; 10009; 100010; 100011; 100012; 100013; 100014; 100015; 100016.
RECALLING FIRM/MANUFACTURER
Diopsys Inc., Metuchen, NJ.
REASON
The firm has not established a medical device quality system, a quality plan,
nor quality procedures.
VOLUME OF PRODUCT IN COMMERCE
18 units.
DISTRIBUTION
NY, NJ, and CT.
WEEK ENDING NOVEMBER 27
PRODUCT
Coherent brand DUO Diode Laser Systems. A Non-medical, class IV industrial materials
processing machine.
CODE
The following Model---Serial Numbers (S/N) are affected: P/N 1024403---S/Ns
10026 Through 10088; P.V. ‚ 4240/4475---S/Ns 2, 7, 3053, and 10002 through 10024;
and P.V. ‚4458 - S/Ns 10019, 10019, 10020, 10043, and 10052.
RECALLING FIRM/MANUFACTURER
Coherent, Inc, Santa Clara, CA.
REASON
Software problem that may cause unintended emission of laser radiation.
VOLUME OF PRODUCT IN COMMERCE
93 units.
DISTRIBUTION
NC, Canada, Germany, and Japan.
PRODUCT
a) HomeChoice and Yume Automated Peritoneal Dialysis Systems;
catalog numbers 5C4471, 5C4471R, T5C4441,T5C4441R.
b) HomeChoice PRO and Yume Plus Automated Peritoneal Dialysis
Systems; catalog numbers 5C8310, 5C8310R, T5C8300, T5C8300R.
CODE
All units that do not bear the CE marking.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Renal Div., McGaw Park, IL.
REASON
The on/off power switch is not grounded as a separate component in the device,
and can loosen from its housing, which may result in an electrical shock to
the user.
VOLUME OF PRODUCT IN COMMERCE
23,00 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
a) Safety Paracentesis Procedure Tray.
b) Custom Convenience Kit.
CODE
a) Catalog # SPPT-100, Lot #ís A343633, A344897, A349218.
Catalog # SPPT-5F-10, Lot #ís A343629, A343630, A344898,
A347256.
Catalog # SPPT-5F-7, Lot #ís A343631, A343632, A347254, A349221;
b) Catalog # K09-00318FP, Lot # A348888. Catalog # K09-00378R,
Lot #ís A335890, A337933, A339213, A342799, A345077, A347860.
Catalog # K09-00946MP, Lot # A353710. Catalog # K09-01732HP,
Lot #ís A341495, A348992. Catalog # K09-03251TP,
Lot # A347976. Catalog # K09-05064D, Lot # A343197.
Catalog # K09-05218BP, Lot # A347495. Catalog # K09-05475DP,
Lot #ís A340512, A343609, A350138. Catalog # K09-05588C,
Lot # A342348. Catalog # K09-05604DP, Lot #A339243.
Catalog # K09-05608DP, Lot #ís A339690, A349600.
Catalog # K09-05894F, Lot # A342805.
Catalog # K09-07970A, Lot #ís A342665, A345567.
Catalog # K09-08150AP, Lot #A340352. Catalog # K09-90100T,
Lot # A353161. Catalog # K10-00091MP, Lot # A349569.
Catalog # K10-01684BP, Lot # A352021. Catalog # K10-02936CP,
Lot # A349696. Catalog # K10-03091B, Lot # A347572.
Catalog # K10-03237AP, Lot #ís A339280, A348945.
Catalog # K10-03247P, Lot # A347910. Catalog # K10-03256P,
Lot #ís A345788, A350183. Catalog # K10-03281P,
Lot #ís A346956, A348009. Catalog # K12-01191C,
Lot # A347022. Catalog # K12-01242P, Lot # A350194.
Catalog # K12-01304P, Lot #ís A346945, A349053, A350907.
Catalog # K12-01356P, Lot #ís A343540, A351436.
Catalog # K12-01372P, Lot #ís A343539, A346944.
Catalog # K12-01402P, Lot # A352329.
Catalog # K12-01427P, Lot # A352036.
Catalog # K12-01507P, Lot #ís A349066, A351446.
Catalog # K12-01512, Lot # A348216. Catalog # K12-01560,
Lot # A347564.
RECALLING FIRM/MANUFACTURER
Merit Medical Systems, Inc., South Jordan, UT.
REASON
Merit Safety Paracentesis Procedure Trays and Merit Custom Convenience Kits
contain Monoject Magellan safety needles which have been recalled by Tyco Healthcare.
These needles may detach from their hub during use.
VOLUME OF PRODUCT IN COMMERCE
12,821 units.
DISTRIBUTION
Nationwide.
PRODUCT
APL Valve used on some Fabius GS (Catalog number 4117110), Fabius Tiro (Catalog
number 4118350) and Narkomed 6000 (Catalog number 4118070) series Anesthesia
Machines.
CODE
APL Valve part number MK00625.
RECALLING FIRM/MANUFACTURER
Draeger Medical Inc., Telford, PA.
REASON
Rotating knob of the rotary style APL valve can become separated from the assembly.
VOLUME OF PRODUCT IN COMMERCE
2,321 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
a) Baxter Clearlink Intravenous (IV) Delivery System;
the system consists of solution sets, extension sets and
blood sets that have a luer activated valve for IV access,
which allows the administration of medications/solutions
with a needleless luer syringe. Recall # Z-0193-05;
b) Baxter Clearlink System Luer Activated Universal VIal
Adapter, product code 2N8395. Recall # Z-0194-05.
CODE
All lots of product code 2N8399, 1C8678, 1C8680, 1C8683,
1C8684, 1C8687, 1C8693, 1C8702, 1C8704, 1C8705, 1C8706,
1C8707, 1C8712, 1C8722, 1C8723, 1C8727, 2C0168, 2C6254,
2C6255, 2C6256, 2C7461, 2C7462, 2C8401, 2C8402, 2C8419,
2C8425, 2C8428, 2C8515, 2C8519, 2C8537, 2C8541, 2C8546,
2C8548, 2C8571, 2C8593, 2C8606, 2C8607, 2C8610, 2C8612,
2C8632, 2C8634, 2C8671, 2C8700, 2C8720, 2C8750, 2C8751,
2C8819, 2C8851, 2C8857, 2C8858, 2C8860, 2C8862, 2C8864,
2C8865, 2C8875, 2C8891, 2C8895, 2C8920, 2C8921, 2C8930,
2C8931, 2H7462, 2H7463, 2H8401, 2H8480, 2H8486, 2H8519,
2H8603, 2H8720, 2H8750, 2H8819, 2H8860, 2H8862, 2H8864,
2H8865, 2N8300, 2N8334, 2N8335, 2N8341, 2N8371, 2N8373,
2N8374, 2N8377, 2N8378, 2N9204K, 2N9205K, 3C0122, 3C0134,
3C0139, 3C0143, 3C0148, 3C0150, 3C0151, 3C0157, 3C0158,
3C0159, 3C0160, 3C0162, 3C0165, 4C8714, 4C8723, 4H8723;
b) Product code 2N8395, all lots.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corp., Round Lake, IL.
REASON
Inadequate directions for use may have contributed to an increase in infection
rates at a small number of customers beginning use of the Clearlink needleless
device.
VOLUME OF PRODUCT IN COMMERCE
29,492,8006 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
MX20170: Pediatric 40 In Sampling Kit w/10cc syringe, MX20443: LogiCal Single
Pressure Kit, MX20470: Pressure Monitoring Kit, MX20477: LogiCal Double Kit,
MX20730: Double LogiCal Kit, MX20760: Neonatal 18'' Add-On Kit, MX20822: TranStar
Monitoring Set, MX4033: Kids Kit 18in (45.7cm) Add-on Blood Sampling Kit, MX4037:
Kids Kit Add-On Blood Sampling Kit, MX700376: TranStar Triple Monitoring Kit,
MX700377: Double TranStar Kit, MX7781R1: St Judes Secure Kit, MX8004CSTT: Novatrans
Mtring Kit 60 (152.4cm) Single Line, MX8033T: Novatrans Kids Kit Neonatal
Mtring,
MX9502CSTT: TranStar 72in (183cm) Secure Double Kit, MX9504CSTT: TranStar 60in
(152cm) Secure Monitoring Kit, MX9505CSTT: TranStar 84in (213) Secure Monitoring
Kit, MX9506CSTT: TranStar 72in Secure Triple Kit, MX9533T: TranStar Kids Kit
Neonatal Monitoring Kit, MX9534T: TranStar Kids Kit, MX9537T: TranStar Kids
Kit, MX9602CSTA: LogiCal 72in (183cm) Secure Double Kit, MX9604CSTA: LogiCal
60in (152cm) Secure Monitoring Kit, MX9605CSTA: LogiCal 84in (213cm) Secure
Monitoring Kit, MX9606CSTA: LogiCal 72in (183cm) Secure Monitoring Kit, MX9607CSTA:
LogiCal Triple Secure Kit, MX9634A: LogiCal Kids Kit Neonatal Monitoring Kit,
MX9637A: LogiCal Kids Kit Neonatal Monitoring Kit, SX02: Sterile Sample.
CODE
MX20170: Lot #'s 33D160090, 33J100011,34A12D017, 34D28D092. MX20443: Lot #'s
32J240054, 32K140054, 32L110056, 32L260051, 33A160015, 33B120027, 33B260040,
33C200060, 33D090064, 33D230066, 33E210102, 33E290113, 33F110010, 33G240058,
33H080024, 33I040010, 33J020029, 33J160008, 33J230033, 33K120027, 33L030054,
34B04D092, 34B16D019, 34B26D023, 34C11D001. MX20470: Lot 34A22D075. MX20477:
Lot #'s 33D020091, 33K120026. MX20730: Lot #'s 33C050084, 33D110030, 33E010093,
33F030094, 33G030104, 34A12D137, 34C31D055. MX20760: Lot #'s 33C270065, 33I230822,
33K100055, 33K240050, 34A12D082, 34B26D099, 34C04D029. MX20822: Lot #'s 33I090048,
34A22D110. MX4033: Lot #'s 32L120073, 33A06143, 33A080077, 33B040079, 33C040104,
33C270062, 33D250039, 33E050044, 34B02D072, 34C08D038. MX4037: Lot #'s 33A080069,
33B110006, 33C270063, 33D220026, 33F020063, 33G080019, 33G230005, 33J140016,
34A26D108, 34C08D034. MX700376: Lot 33A2220390. MX700377: Lot #'s 33A2220392,
33A2920402. MX7781R1: Lot #'s 32L040106, 33H080048. MX8004CSTT: Lot 33K140086.
MX8033T: Lot #'s 32L040021, 33B040050, 33H220097, 34B03D044. MX9502CSTT: Lot
#'s 32K150075, 33A310026, 33G150105, 33K250018, 34B04D014. MX9504CSTT: Lot #'s
32J250089, 32L050045, 33A240034, 33B130060, 33C060003, 33D280078, 33F040042,
33H140037, 33H200018, 34A26D097. MX9505CSTT: Lot #'s 33D2322860, 34C22D067.
MX9506CSTT: Lot 33L020058. MX9533T: Lot #'s 32K260078, 33A090065, 33C140050,
33E290013, 33H070093, 33I090014, 33K040033, 33L020068, 34A26D098, 34B25D049,
34C30D034, 34D27D047. MX9534T: Lot #'s 33A160085, 33B250064, 33D100061, 33F250042,
33H140048, 33J070023. MX9537T: Lot #'s 33A090071, 33B250065, 33D230022, 33F100153,
33G090033, 33H070089, 33I020046, 33J070024, 33K180032, 34A15D040, 34B04D022,
34B16D081, 34C03D039. MX9602CSTA: Lot #'s 32K150073, 33A240039, 33D160033, 33G090027,
33G230029. MX9604CSTA: Lot #'s 33A240037, 33A310028, 33C140029, 33D100058, 33F040040,
33L190038. MX9605CSTA: Lot #'s 32J310063, 32L270023, 33B250063, 33C140031, 33D100054,
33E290017, 33F100155, 33F250061, 33G300021, 33H140043, 33I300032, 33K180035,
33L190036, 34A26D089, 34B19D098. MX9606CSTA: Lot #'s 32L050050, 33A090069, 33A310031,
33C060008, 33C200010, 33D230031, 33E130048, 33F250040, 33G230030, 33H140044,
33I170051, 33K040035, 33K250040, 34A12D037, 34A26D083, 34B16D083, 34C03D040.
MX9607CSTA: Lot #'s 32J300018, 33E050037, 33J280007, 34B02D043. MX9634A: Lot
#'s 33A160083, 33A310034, 33C200011, 33D100072, 33E280100, 33G230025, 33I170052,
33K180034, 33L190040, 34A26D099, 34B25D046. MX9637A: Lot #'s 33A160084, 33B130050,
33D230021, 33E200059, 33F170096, 33K250042, 34A26D086, 34C03D036. SX02: Lot
33G080023.
RECALLING FIRM/MANUFACTURER Medex, Inc., Dublin, OH.
REASON
Sampling port bodies on the device are cracking which can allow the sampling
site to become dislodged from the body.
VOLUME OF PRODUCT IN COMMERCE
71,132 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
a) Terumo Advanced Perfusion System 1; 100V -120V, 15 A
(circuit breaker), 50/60 Hz (20A power source required);
Model 801763.
b) Terumo Advanced Perfusion System 1; 220V -240V, 7A
(circuit breaker), 50/60 Hz (10A power source required);
Model 801764.
CODE
All units bearing serial numbers 20 through 109.
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor, MI.
REASON
The central control monitor screen may go blank during use because of a bad
wiring connection in the wiring harness or a low voltage setting on the potentiometer.
VOLUME OF PRODUCT IN COMMERCE
90 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
Deltec Cozmo Insulin Pump.
CODE
Pump Serial Numbers A20721; A20722; A20723; A20724; A20741; A20742.
RECALLING FIRM/MANUFACTURER
Smiths Medical MD, Inc., Saint Paul, MN.
REASON
The vibratory alarm motor installed in a small number of Deltec Cozmo Insulin
Pumps may function intermittently.
VOLUME OF PRODUCT IN COMMERCE
36.
DISTRIBUTION
Nationwide and France.
PRODUCT
IR1200 Insulin Pump. IPX8 Rx only. Label P/N 400-125-00 Revision C.
CODE
Model IR 1200.
RECALLING FIRM/MANUFACTURER
Animas Corp., West Chester, PA.
REASON
Suspend mode not functioning properly.
VOLUME OF PRODUCT IN COMMERCE
7,395 units.
DISTRIBUTION
Nationwide and Israel.
PRODUCT
a) POLYSTAR, Angiographic X-Ray System, Model 1148902.
b) POLYSTAR T.O.P., Angiographic X-Ray System,
Model Numbers 1148902 and 4784505.
CODE
a) Serial Numbers 01000 through 01267 and 02001 through 02117;
b) Serial Numbers for model 1148902: 01000 through 01267,
02001 through 02117. Serial numbers for model 4784505:
03001 through 035158, 04001 through 04136, and
05001 through 05098.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA.
REASON
Orbital gears may exhibit excess wear.
VOLUME OF PRODUCT IN COMMERCE
125 units.
DISTRIBUTION
Nationwide.
PRODUCT
Tosoh brand AIA-PACK CA 19-9 Test Cup Set used in TOSOH AIA Immunoassay Analyzers,
A pack contains 10 trays of 20 test cups, Catalog #: 020271, For IN VITRO Diagnostic
Use.
CODE
Lot #: DX10789, Expiration Date 10/31/2004.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tosoh Biosience, Inc., South San Francisco, CA.
Manufacturer: Tosoh Corporation, Tokyo, Japan.
REASON
The Product may produce high reading in patientís values, which may lead to
inappropriate treatment.
VOLUME OF PRODUCT IN COMMERCE
22 boxes/10 trays of 20 test cups.
DISTRIBUTION
Nationwide.
PRODUCT
Medtronic CapSureFix Novus Lead Model 5076.
CODE
Model 5076 45 cm leads (PJN631011V and PJN631012V).
RECALLING FIRM/MANUFACTURER
Medtronic Inc, Cardiac Rhythm Management, Fridley, MN.
REASON
A specific lot of leads are labeled incorrectly. The leads are 45 cm in length
and labeled as 52 cm lead length.
VOLUME OF PRODUCT IN COMMERCE
35 leads.
DISTRIBUTION
Nationwide.