JULY 2005
WEEK ENDING JULY 2
Boston Scientific Announces Worldwide Recall of Hemashield® Vantage™ Peripheral Vascular Grafts
Boston Scientific Corporation (NYSE: BSX) today announced that it is voluntarily recalling worldwide all Hemashield ® VANTAGE™ Vascular Grafts, which are used in peripheral procedures. No other Hemashield ® products are affected by this recall. The Company is recalling all Hemashield VANTAGE Vascular Grafts manufactured in the last two years due to the potential of the device to fray or tear during suturing and the possibility that it could lead to post-operative complications. The Company is aware of three reported post-operative failures which occurred between three and seven days post-procedure. In all of these cases, the patients were successfully treated by re-suturing the graft or replacing it.
The recalled devices include all Hemashield VANTAGE Vascular Grafts. The Company initiated the recall after a review of complaint records and analysis of product revealed the potential problem. The total number of devices shipped but not yet implanted is estimated to be 500. The Company ships approximately 2,180 Hemashield VANTAGE Vascular Grafts per year.
The products were distributed to hospitals worldwide. Boston Scientific is notifying hospitals through detailed Recall Packages, including instructions on how to return recalled product, as well as physician letters. All unimplanted product is to be returned to Boston Scientific.
Physicians with questions may contact the Company at 1-888-272-1001.
Absent symptoms of graft failure, Boston Scientific is recommending that physicians continue routine post-operative clinical evaluation. The signs and symptoms that a Hemashield VANTAGE Vascular Graft might be starting to fail include: pain, swelling, bruising, bleeding through incision, rapid pulse or low blood pressure. If a patient experiences any of these symptoms, he or she should contact their physician immediately.
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: http://www.bostonscientific.com/.
WEEK ENDING JULY 9
PRODUCT
FHC 66-ZD-MD micro Targeting Drive System: System for Stereotactic Positioning Used with the Power Assist (66-DA-ME) or Display Assembly
(66-DA-EN)
CODE
All codes
RECALLING FIRM/MANUFACTURER FHC, Inc, Bowdoinham, ME
REASON
Potential for non-sterile pin to contaminate sterile field.
VOLUME OF PRODUCT IN COMMERCE
169 units
DISTRIBUTION
Nationwide
PRODUCT
View Forum 2003 software, SW 3.4L1,
CODE
The firm utilizes site numbers: 534544, 520177, 520633, 532261, 504927, 532134, 534573, 531862, 521928, 522027, 521424, 533804, 532053
RECALLING FIRM
Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell,
WA.
Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands.
REASON
Automated analysis of vascular obstruction tool in software gives unreliable calibration and analysis results when using unprocessed images acquired on the Philips Allura FD10.
VOLUME OF PRODUCT IN COMMERCE
13 devices
DISTRIBUTION
Nationwide
PRODUCT
Dr. Fog Endoscopic fog prevention kit
CODE
Lot 2007-05; exp. May 2007
RECALLING FIRM/MANUFACTURER
Aspen Surgical Products, Inc, Byron Center, MI
REASON
An improper expiration date was placed on the individual packages, although the dispenser box and carton contained the correct expiration date.
VOLUME OF PRODUCT IN COMMERCE
2460 packages
DISTRIBUTION
Nationwide
PRODUCT
a) Gold Hub Capistrano Cannula, Catalog Nos. HK10C15;
HK10C23; HK12C15; HK12C23; HK14C15; HK14C23; HK16C5;
HK16C8; HK16C12; HK16C15; HK18C8; HK18C6,
b) Gold Hub Finesse Cannula, Catalog Nos. HK10F23;
HK12F10; HK12F15; HK12F23; HK14F10; HK14F15; HK14F23;
HK16F5; HK16F8, Recall # Z-0899-05
c) Gold Hub Monty Cannula, Catalog Nos. IC14HM20;
IC16HM15; IC18HM15; IC14HM20; IC16HM15; IC18HM15,
CODE
All codes
RECALLING FIRM
HK Surgical Inc, San Juan Capistrano, CA
REASON
Risk of hubs becoming disconnected from the cannula.
VOLUME OF PRODUCT IN COMMERCE
732 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT
a) Pronto Series Power Wheelchair, model M50,
b) Pronto Series Power Wheelchair, model M51,
c) Pronto Series Power Wheelchair, model M61,
CODE
All serial numbers between 05A000-05C999
RECALLING FIRM/MANUFACTURER
Invacare Corporation, Elyria, OH
REASON
If the arm of the wheelchair is overloaded, the joystick mounting bracket and/or arm pivot may fail due to variability in the plastic used by the supplier to make the components. This failure may cause the user or a caregiver to fall if they are leaning on the arm, and result in injury.
VOLUME OF PRODUCT IN COMMERCE
1556 units
DISTRIBUTION
Nationwide and France
PRODUCT
a) Virotek SAFEL*E*T 1.0 mm Safety Lancets, 1.0 mm depth,
stock code 5000052, packaged in single unit blister
packs, 150 or 200 per box, 6 boxes per carton,
b) Virotek SAFEL*E*T 2.0 mm Safety Lancets, 2.0 mm depth,
stock code 5000052, packaged in single unit blister
packs, 200 per box, 6 boxes per carton, stock code
5000101, packaged in single unit blue cap packaging, 100
per box and stock code 5000115, packaged in single unit
blue cap packaging, 200 per box
CODE
a) Lot numbers 0013, 0014, 0015, 0016, 0017, 0019, 0021
b) Lot numbers 0018, 0023, 0024, 0025, 0026, 0027, 0028
RECALLING FIRM Efoora, Inc. dba Virotek, L.L.C., Buffalo Grove, IL
REASON
The sterility of the lancets may be compromised due to inadequate packaging seals.
VOLUME OF PRODUCT IN COMMERCE
1,013,650 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT
a) B-Sure brand one step home pregnancy test, Items 28030
(case of 48 kits) and 28031 (case of 144 kits)
b) Lover brand lubricated latex condoms in various
presentations, item numbers 29042, 29044, 29045, 29047,
29095, 29095D, 29096, 29097, 29111, 29112, 29145, 29146,
29147 and 29148
c) Lover brand lubricated latex condoms spermicidal, item
number 29043
CODE
All lots
RECALLING FIRM/MANUFACTURER
Harmony Brands Llc, Oak Park, MI
REASON
Lack of assurance of safety and efficacy; products are from unknown sources.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide
PRODUCT i-STAT Celite ACT Cartridge. ACT, activated clotting time, celite activated clotting time test.
i-STAT Catalog Number -- 420300; Abbott Catalog Number -- 07G01-01 (USA and Canada); Abbott Catalog Number -- 07G10-02 (Rest of world).
CODE
Lot Numbers: R04174B; R04175; R04175A; R04183; R04183A; R04183B; R04183C; R04190A; R04190B; R04205; R04205A; R04212A; R04212B; R04233; R04239; R04245; R04245A; R04245B; R04253; R04261; R04261A; R04262; R04274; R04274A; R04275; R04293; R04293A; R04294; R04294A; R04305; R04305A; R04305B; R04306; R04309; R04309A; R04315; R04315A; R04315B; R04322; R04323; R04323A; R04329; R04337; R04337A; R04342; R04343; R04350; R04350A; R04350B; R05006; R05014; R05014A; R05032B; R05032C; R05043; R05043A; R05044; R05048B; R05048C
RECALLING FIRM
Abbott Laboratories, East Windsor, NJ
REASON
Misidentification of Celite ACT cartridge as kaolin ACT Cartridge in the analyzer.
VOLUME OF PRODUCT IN COMMERCE
256,125 cartridges
DISTRIBUTION
Nationwide and Internationally
PRODUCT
LeadCare Blood Lead Testing System Kits, Catalog number: 70-2233
CODE
Lot CA6, Expiration date 2/5/05
Lot CA7, Expiration date 2/06/05
Lot CA8, Expiration date 5/18/05
Lot CA9, Expiration date 10/5/05
Lot CCA, Expiration date 12/11/05
Lot CCE, Expiration date 6/17/06
Lot CCF, Expiration date 7/11/06
Lot CCH, Expiration date 7/12/06
RECALLING FIRM/MANUFACTURER
Esa Biosciences, Inc, Chelmsford, MA
REASON
Lead test results may be reported lower than the actual value.
VOLUME OF PRODUCT IN COMMERCE
14,760 test kits
DISTRIBUTION
Nationwide and Internationally
PRODUCT
ACL Futura, ACL Advance and ACL TOP Coagulation Analyzers used with the HemosIL RecombiPlasTin reagent, Models: 290001
999001
CODE
Serial Number's beginning with 05041164 280000 with S/N's beginning with 0505354
RECALLING FIRM
Instrumentation Laboratory Co, Lexington, MA
REASON
Patient prothrombin time (PT) may report low for individuals on anticoaglant therapy.
VOLUME OF PRODUCT IN COMMERCE
617 units
DISTRIBUTION
Nationwide and Canada
PRODUCT
a) Carroll Healthcare brand Arro bed models BA3180-151 AE,
BA3180-151 PE, BA3180-151 FE, BA3180-171 AE, BA3180-171
FE and BA3180-171 FE.
b) Carroll Healthcare brand Spirit bed; models BBH2180-
111AE, BBH2180-111PE and BBH2180-111FE.
CODE
a) Serial numbers 374061 through 374065, 374489 through
374519, 374521 through 374531, 375262, 376203 through
376211, 376229 through 376236, 376268 through 376284,
376698, 377647, 377648, 380181, 381593, 382244, 382373
through 382382, 383163 through 383166, 384390 through
384399, 386463 through 386468, 387057 through 387066,
387977 through 388004, 388039 through 388046, 388049
through 388063, 388153 through 388195, 388515 through
388527, 388529, 388728 through 388735 and 389410 through
389414
b) Serial numbers 376078, 376079, 376155, 376156, 376219,
376220, 376223 through 376225, 376228, 376680 through
376683, 377067, 377262, 378422 through 378424, 378543
through 378552, 378698 through 378700, 378801 through
378806, 378811, 379168 through 379178, 379191, 379419
through 379421, 379472 through 379476, 379605 through
379611, 379719, 379720, 379831 through 379842, 379957
through 379959, 380047 through 380050, 380172 through
380180, 381130 through 381139, 381215, 381320 through
381326, 381416, 381589, 381590, 381595 through 381599,
381964, 381965, 382007 through 382010, 382167, 382168,
382171, 382172, 382283, 382422, 382764 through 383767,
383127, 383148, 383286 through 383288, 383484 through
383488, 383521, 383624, 383625, 383642, 383643, 383787,
383788, 384091 through 384100, 384225, 384226, 384480,
384727 through 384750, 384839, 384840, 385291 through
385297, 385752 through 385796, 385958, 386044 through
386063, 386327 through 386336, 386356 through 386361,
386366, 386412, 386435 through 386438, 386487 through
386492, 386511, 386530, 386570 through 386572, 386719
through 386724, 386733, 386746, 386776, 386926 through
386935, 386942, 386943, 387054 through 387056, 387495
through 387498, 387568, 387823, 388035 through 388038,
388207, 388468, 388542 through 388551, 388765 through
388771, 388796, 388877 through 388881, 389124, 389274,
389340 through 389389, 389417 through 389431 and 390437
through 390442
RECALLING FIRM/MANUFACTURER
Carroll Healthcare Inc, London, Ontario, Canada
REASON
The diodes in the control panel may fail, which could result in the thermal breakdown of the circuit board inside of the control box, and cause the bed to cease functioning.
VOLUME OF PRODUCT IN COMMERCE
361 units
DISTRIBUTION
Nationwide
PRODUCT
Flexible Implant tube, blind end, 350 mm, part #GM11003730, Available as single unit or contained in the Flexible Interstital Implant Tube Set, part number GM11004680. For use with the Varian GammaMed Plus brachytherapy afterloader device.
CODE
Lot 04/21/1
RECALLING FIRM
Recalling Firm: Varian Medical Systems, Charlottesville, VA,
Manufacturer: Willy Rusch AG GmbH, Kernen-Rommelshausen, Germany.
REASON
A defective treatment applicator in a cancer therapy medical device may become separated potentially causing patient injury.
VOLUME OF PRODUCT IN COMMERCE
392 devices
DISTRIBUTION
CT, MI, PA, CO, VT and MO and Internationally
PRODUCT Envisor, M2540 Diagnostic Ultrasound System, Part numbers: 453561193003, SW
C.O.O.
CODE
Serial numbers(domestic) 20505841, 20505867, 20505884, 20505885, 20505886, 20505890, 20505898, 20505907, 20505908, 20505913, 20505923, 20505925, 305056015, 30505960, 30505978, 30505980, 30505997. System Base ID (international): US30505949, US20505848, US20505899, US20505900, US30505999, US30506012, US30506013, US30506016, US30506017, US30506014, US30505977, US30505976, US30505984, US30505985, US30505986, US30505975, US30505987, US20505850, US20505849, US20505840, US30505993, US30505992, US20505865, US20505874, US20505872, US20505873, US20505864, US20505868, US20505877, US30505950, US20505838, US20505857, US20505858, US20505901, US20505905, US20505906, US30505965, US20505918, US30505938, US30505939, US30505942, US30505930, US30505988, US30505964, US30505967, US30505973, US20505837, US20505856, US20505879, US20505883, US20505922, US20505924, US20505844, US20505832, US20505847, US20505845, US20505833, US20505846, US20505871, US20505870, US30505958, US30505957, US30505959, US30505946, US20505881, US20505916, US30505937, US20505882, US30505963, US20505914, US20505921, US30505995, US30505996, US30506000, US30506018, US30505991, US30505983, US30505989, US30505990, US20505843, US20505842, US30506001, US20505828, US30505994, US20505829, US30505966, US20505862, US20505861, US20505859, US20505860, US30505981, US30505982, US20505896, US20505895, US30505933, US30505926, US30505929, US30505927, US30505928, US30505932, US20505869, US30505954, US30505952, US30505953, US30505934, US30505935, US30505951, US30505940, US30505941, US30505945, US20505912, US30506005, US30506006, US30506003, US30506008, US30506007, US30506002, US30506004, US30506009, US30506011, US30506010, US30505974, US30505962, US30505972, US20505866, US20505855, US20505834, US20505830, US20505917, US20505888, US20505889, US20505887, US20505878, US20505897, US30505971, US30505970, US30505943, US30505947, US20505903, US20505904, US30505944, US30505979, US20505892, US20505891, US20505893, US20505876, US20505880, US30505936, US30505955, US30505956, US30505948, US30505968, US20505902, US20505894, US30505969, US20505875
RECALLING FIRM/MANUFACTURER
Philips Ultrasound, Inc., Bothell, WA
REASON
A defect in the software allows incorrect measurement results to be entered into the system's built-in report.
VOLUME OF PRODUCT IN COMMERCE
194 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT
Cancellous Bone Screw, 6.5 x 50 mm, Model 0214807
CODE
Lot/Unit Code: 044152
RECALLING FIRM
Recalling Firm: Plus Orthopedics USA, San Diego, CA
Manufacturer: Intraplant AG, Cham, Switzerland.
REASON
Screw is mislabeled as a 50 mm screw when in fact it is 45 mm long.
VOLUME OF PRODUCT IN COMMERCE
54 in the USA and 78 in Europe
DISTRIBUTION
ID, TX, VA and Europe
PRODUCT
BD 25G Spinal Needles. (Spinal Anesthesia Needle)
CODE
Reorder Number, Lot Number: 400440, 4275101; 400440, 4282078; 400440, 4317744; 400479, 3196624; 400479, 4161815; 400479, 4254414; 400479, 4324795; 400496, 4173091; 400590, 3191978; 400590, 4121350; 400621, 4146482; 401586, 3182399; 405078, 3196618; 405078, 4169804; 405078, 4194109; 405078, 4268754; 405078, 4282079; 405078, 4324791; 405078, 4349021; 405138, 4173087; 405138, 4181398; 405140, 3224096; 405140, 4110295; 405140, 4237191; 405140, 4295872, 405140, 4314481; 405140, 4336365; 405170, 4201356; 405170, 4201357 405180, 4096782; 405180, 4145523; 405180, 4148675; 405234, 3174061; 405234, 4062807; 405234, 4105111; 405234, 4163586; 405234, 4265265; 405234, 4282715; 405234, 4282716; 405234, 4314480; 405234, 4358850; 409442, 3174062; 409442, 3226365; 409442, 4110275; 409442, 4121348; 409442, 4230810; 409442, 4230813; 409442, 4257418; 409442, 4300308; 409442, 4320423; 409442, 4329215; 409442, 4349941
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ
Manufacturer: Becton-Dickinson P R, Inc, Juncos, PR.
REASON
A significant level of 25G spinal needle hub leakage complaints was observed. Subsequent investigation found the leakage to be attributable to improper formation of the spinal needle hub, specifically an undersized taper and the prescence of a slight sink in the taper surface.
VOLUME OF PRODUCT IN COMMERCE
801,580 units
DISTRIBUTION
Nationwide
PRODUCT
Animas Model IR 1250 Insulin Pump
CODE
All units Model IR1250.
RECALLING FIRM
Animas Corporation, West Chester, PA
REASON
Pump failed to respond to keypad button presses after using the food database feature.
VOLUME OF PRODUCT IN COMMERCE
1,866 units
DISTRIBUTION
Nationwide
PRODUCT
Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5 mm
obturator; product code 67P035
CODE
Lot G651610
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc, Gary, IN
REASON
The obturator may be 3.0 mm in length instead of the labeled 3.5 mm.
VOLUME OF PRODUCT IN COMMERCE
48 units
DISTRIBUTION
CT, GA, IL, IN, MN, MO, NM and NC
PRODUCT
PTFE (Polytetrafluoroethylene) felt. Catalog #s: M002000193041, M002000193061, M002000193811, M002000193821, M002000193931, M002000193841, M002000193861,
M002000193881
CODE
Lot Numbers: 7337514; 7337515; 7337516; 7337717; 7350604; 7356745; 7356747; 7359759; 7359760; 7360535; 7360536; 7384480; 7384483; 7384484; 7384485; 7384486; 7384487; 7412113
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Scimed, Maple Grove, MN.
Manufacturer: Boston Scientific Corp, Wayne, NJ.
REASON
Units of these lots may have areas of lower density resulting in lower tensile and suture retention strength.
VOLUME OF PRODUCT IN COMMERCE
290 multi-pack units (5 per package)
DISTRIBUTION
Nationwide
PRODUCT
Tyco Healthcare Kendall Argyle Neonatal Pediatric PICC, 1.9 Fr/Ch x 30 cm Dual Lumen PICC Catheter, REF 43304. A single catheter in a thermoformed tray with a Tyvek lid. The lidded tray is packaged one per carton.
CODE
158125 and 158128
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kendall Healthcare Products Co, Mansfield, MA
Manufacturer: Kendall a Division of Tyco Healthcare Group LP, Argyle, NY.
REASON
Holes in thermoformed tray compromising the sterility of the product.
VOLUME OF PRODUCT IN COMMERCE
120 units
DISTRIBUTION
AZ, CA, IL, IN, NY, and TX
PRODUCT
Radical Handheld Pulse Oximeter,
CODE
Serial numbers-- P3027 through P3148 and serial numbers less than or equal to 102999.
RECALLING FIRM
Masimo Corporation, Irvine, CA
REASON
Speaker component failure resulting in cessation of an audible alarm even though the condition continues that caused the alarm.
VOLUME OF PRODUCT IN COMMERCE
8110
DISTRIBUTION
Nationwide and Worldwide.
PRODUCT
a) Ev3 Protégé GPS Self-Expanding Nitinol Stent and
Delivery Technology (Biliary System). Model No. SERB65-
09-60-120.
Sterile EO, Single Use,
b) Ev3 Protégé GPS Self-Expanding Nitinol Stent and
Delivery Technology (Biliary System). Model No. SERB65-
08-20-120.
Sterile EO, Single
Use
c) Ev3 Protégé GPS Self-Expanding Nitinol Stent and
Delivery Technology (Biliary System). Model No. SERB65-
10-30-120.
Sterile EO, Single
Use
CODE
a) Lot 117182
b) Lot 1179167
c) Lot 1179173
RECALLING FIRM
Ev3, Plymouth, MN
REASON
3 devices from 3 separate lots were re-labeled with incorrect stent dimensions (diameter and length).
VOLUME OF PRODUCT IN COMMERCE
3 devices
DISTRIBUTION
FL and PA
PRODUCT
Potassium Electrode Tip; Part No.s: 668281 Tip Assembly - Synchron Family 669117 Packaged - Synchron Family 441104 Electrode
Assembly-EL-ISE 445604 Electrode Packaged- EL-ISE,
CODE
Multiple lots are involved. |SYNCRHON: | | | |Lot 446 - Manufactured 20 NOV 2004* |231 |N/A** | |Lot 450 - Manufactured 12 DEC 2004 |880 | | |Lot 501 - Manufactured 03 JAN 2005 |30 | | |Lot 504 - Manufactured 24 JAN 2005 |698 | | |Lot 507 - Manufactured 21 FEB 2005 |400 | | |Lot 508 - Manufactured 28 FEB 2005 |130 | | |Lot 512 - Manufactured 28 MAR 2005 |1643 | | |Lot 517 - Manufactured 02 MAY 2005 |2020 | | | | | |
|EL-ISE: | | | |Lot 0446 - Manufactured 20 NOV 2004* |20 |N/A** | |Lot 0504 - Manufactured 24 JAN 2005 |30 | | |Lot 0508 - Manufactured 28 FEB 2005 |30 | | |---------------------------------------------+---------------+---------------------|
RECALLING FIRM
Beckman Coulter, Inc, Brea, CA
REASON
Does not meet performance criteria and exhibits upward trend of result recoveries during calibration period.
VOLUME OF PRODUCT IN COMMERCE
2,686 units
DISTRIBUTION
Nationwide and Canada
PRODUCT
Misys Laboratory with Lab Access Results application for versions 5.3 and later.
CODE
Versions 5.3 and later
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ
REASON
Software anomaly may rarely allow modification of previously reported specimen results.
VOLUME OF PRODUCT IN COMMERCE
258 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT
Mysis Laboratory version 6.1
CODE
Version 6.1
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ
REASON
When a previously reported microbiology organism result is deleted on a selected patient, reported susceptibilities will not stay with associated organisms and one or more susceptibilities on the culture will be deleted.
VOLUME OF PRODUCT IN COMMERCE
21
DISTRIBUTION
Nationwide, United Kingdom and Denmark
PRODUCT
a) CLBS-7-12* Cotton-Leung Biliary Stent Set * Stent
Diameter: 7 Fr. * Length (Between Flaps): 12 CM. *
Standard Wire Guide: .035"/480 CM. *Pushing Catheter:
7 FR. Disposable - Single Use Only - Rx Only,
b) Low Profile Gatrostomy - Contents include: Passport &
Obturator * Disposable - Single Use Only,
CODE
a) Lot Number: R1698831, Labeled Reorder Number CLBS-7-12
b) Lot Number: WR1827952, Labeled Reorder Number LPG-20-
2.4-A and Lot Number: W1834577, Labeled Reorder Number
PASS-20-3.4-A
RECALLING FIRM/MANUFACTURER
Wilson-Cook Medical Inc, Winston Salem, NC
REASON
The reorder number listed on the product label is inaccurate.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
Brazil, Japan and Hong Kong
PRODUCT
AxSYM total B-hCG Ragent is composed of one bottle of Coated Microparticles, one bottle of Alkaline Phosphatase Conjugate and one bottle of Specimen
Diluent. Recall # Z-0893-05
CODE
2614Q100 (5/13/2005); 26278Q100, 26381Q100 (6/21/2005)
RECALLING FIRM/MANUFACTURER
Abbott Health Products, Inc., Barceloneta, PR, by letter on March 24, 2005. Firm initiated recall is ongoing.
REASON
Abbott Diagnostics is investigating a recent increase in customer complaints for AxSYM calibration error code 1048 and controls out of range when using AxSYM Total
B-hCG reagent lots. Testing has shown that protein aggregates are present in the specimen diluents of both IMx and the AxSYM Total
B-hCG reagent kits. This is responsible for the calibration errors and shift in control values.
VOLUME OF PRODUCT IN COMMERCE
2,496 kits
DISTRIBUTION
Nationwide and Internationally
PRODUCT
IMx total B-hCG Reagent is composed of one bottle of Coated Microparticles, one bottle of Alkaline Phosphatase Conjugate, one bottle of 4 Methylumbelliferyl Phosphate and one bottle of Specimen
Diluent,
CODE
25459Q100
RECALLING FIRM
Abbott Health Products, Inc., Barceloneta, PR.
REASON
Abbott Diagnostics is investigating a recent increase in customer complaints for IMx calibration error code 157 and controls out of range when using IMx total
B-hCG Reagent Lot 25459Q100. Testing has shown that protein aggregates are present in the specimen diluents of both IMx and the AxSYM Total
B-hCG reagent kits. This is responsible for the calibration errors and shift in control values.
VOLUME OF PRODUCT IN COMMERCE
793 kits
DISTRIBUTION
Nationwide and Internationally
PRODUCT
VITROS Immunodiagnostic Products TOTAL T4 Reagent Pack, Ref #874 4468, 100 coated wells.
CODE
Lot 710, Exp. 7/28/05
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ortho-Clinical Diagnostics, Rochester, NY.
Manufacturer: Ortho-Clinical Diagnostics, Cardiff, United Kingdom.
REASON
Potential for positively biased results in QC and patient samples.
VOLUME OF PRODUCT IN COMMERCE
2,199 reagent packs
DISTRIBUTION
Nationwide and Internationally
PRODUCT
a) EBI Ball Tip Guide Wire 3.2mm x 55cm found in the Ankle
Arthrodesis Nail Instr., Part Number 469055.
b) EBI Ball Tip Guide Wire 3.2mm x 98cm found in the
Holland Nail Flexible Reamer Accessory P/N 469060.
c) Threaded Tip GD Pin 1/8in x 9in Pk 5 Sterile found in
Uniflex Profile Tibial Nail P/N 329640.
CODE
a) Lot Number: 069811; 120055; 120056; 120057; 123827;
125637; 125638
b) Lot Numbers: 130843; 130846
c) Lot Numbers: 065882; 122235; 132557; 132560; 877265
RECALLING FIRM EBI, L.P., Parisippany, NJ.
REASON
The wire appears to be soft and the wire bent during insertion. This causes kinks in which the reamer could not pass over the bent/kinked wire.
VOLUME OF PRODUCT IN COMMERCE
599 units
DISTRIBUTION
Nationwide, Italy and Spain
PRODUCT
Prostate Seeding Needle for Use with the Mick Applicator; an 18 gauge needle, 17 cm long with a white molded plastic hub. The non-sterile prostate seeding needles were shipped in bulk for packaging, sterilization and distribution by the customers; the bulk packages were labeled as follows: a) part no. B0140268, Prostate Seeding Set, MICK, and b) part no. 2380US-18E-17, 18GA x 17CM MK Prostate Seeding Nee, InterV -
CODE
Part number B0140286, lot numbers 0747, 0839, 0840, 3412, 3413, 3414, 3415, 4078, 4088 and 4089; Part number 2380US-18E-17, lot number 0015
RECALLING FIRM/MANUFACTURER
Manan Medical Products, Inc., Wheeling, IL
REASON
The hub of the prostate seeding needle does not release as expected from the applicator as expected during procedures.
VOLUME OF PRODUCT IN COMMERCE
22,900 needles
DISTRIBUTION
FL and GA
PRODUCT
a) The Maestro System 204-503, Straight Permucosal Ext, 5mm
x 3mm
b) The Maestro System 225-312, Profile Abutment for Cement, 5mm
CODE
a) Lot Number: C0205048
b) Lot Number: C0205065
RECALLING FIRM
BioHorizons Implant Systems, Inc., Birmingham, AL
REASON
The product labeled as a profile abutment for Cement contained a Straight Permucosal Ext, 5mm x 3mm.
VOLUME OF PRODUCT IN COMMERCE
28 units
DISTRIBUTION
PA, TX, MI, VA and Russia
PRODUCT
DiaSorin Anti-Cardiolipin IgA ELISA Kit, catalog no. 7800. Made in the United
Kingdon.
CODE
Lots FS1123 and FS2184
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stillwater, MN
Manufacturer: Euro Diagnostica AB, Malmo, Sweden.
REASON
DiaSorin Anti-Cardiolipin IgA Kit, positive control was on the low limit of the acceptable range (1-35
U/mL).
VOLUME OF PRODUCT IN COMMERCE
49 kits
DISTRIBUTION
NY, KS, GA and MT
WEEK ENDING JULY 16
PRODUCT
a) Vaxcel Plastic Low Profile Port (non-valved) chest port,
with 6Fr Polyurethane Catheter, Catalog 45-333, Material
#M001453330.
b) Vaxcel Plastic Low Profile (non-valved) chest port, with
8Fr Silicone Catheter, Catalog #45-336, Material
#M001453360.
c) Vaxcel Plastic Low Profile (non-valved) chest port, with
8Fr Polyurethane Catheter, Catalog # 45-338, Material
#M001453380
CODE
a) 914663, 914663D, 924196, 927904, 973169, 994958,
1000904, 1000905, 1003264, 1017119, 1018949, 1023552,
1033976, 1037228, 1037879;
b) 791550, 915867, 1010168, 1017745, 1022134, 1022488,
1024234, 1038298, 791550D;
c) 791549, 915868, 919482, 922594, 923705, 1000906,
1001279, 1003265, 1022911, 1034615, 922594D, 923705D
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corporation, Natick,
MA
Manufacturer: Boston Scientific Corporation, Glens Falls, NY.
.
REASON
Potential for port housing separation after implantation.
VOLUME OF PRODUCT IN COMMERCE
970 units
DISTRIBUTION
Nationwide
PRODUCT
Hill-Rom Century+ Bed, Model P1400.
CODE
Beds built between March 2005 and May 2005.
RECALLING FIRM/MANUFACTURER
Hill-Rom, Inc., Batesville, IN
REASON
Sleep bed pivot bolts may break, allowing the head section to shift or
to drop to one side.
VOLUME OF PRODUCT IN COMMERCE
218 beds
DISTRIBUTION
Nationwide, Brazil and Canada.
PRODUCT
Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R
CODE
All serial numbers with software version 4.0 or below
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Renal Div, McGaw Park, IL
Manufacturer: Baxter Healthcare Corporation, Largo, FL.
REASON
The saline bags may inappropriately empty/fill during the recirculation mode
of the hemodialysis system.
VOLUME OF PRODUCT IN COMMERCE
2986 units
DISTRIBUTION
Nationwide, Korea, Mexico, Guatemala, China and Hong Kong
WEEK ENDING JULY 23
PRODUCT
a) Vail 500
Enclosed Bed System,
b) Vail 1000 Enclosed Bed System,
c) Vail 2000 Enclosed Bed System,
CODE
All serial numbers
RECALLING
FIRM/MANUFACTURER Vail Products, Inc., Toledo, OH
REASON
Risk of patient entrapment, may result in
serious injury or death.
VOLUME OF PRODUCT IN
COMMERCE 4496 units
DISTRIBUTION Nationwide,
Canada and Saudi
Arabia
PRODUCT Ventak
PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator (AICD),
Dual Chamber. VENTAK PRIZM 2 ICDs are designed to detect and terminate
ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide
bradycardia therapy.
CODE Serial
number range 118626 - 243772 includes ICDs manufactured prior to November 13,
2002. This range includes all affected devices but may include some unaffected
devices.
RECALLING FIRM
Recalling Firm: Guidant
Corp-Cpi
Division, Saint Paul, MN
Manufacturer: Guidant-Ireland, Clomel,
Ireland. .
REASON Laboratory analysis of returned devices revealed
that deterioration in a wire insulator within the lead connector block, in
conjunction with other factors, resulted in an electrical short. The short may
cause diversion of shock therapy energy away from the heart and into device
circuitry.
VOLUME OF PRODUCT IN COMMERCE 37,000
defibrillators
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a)
CONTAK RENEWAL (model H135) Heart Failure Device Cardiac Resynchronization
Therapy Defibrillators (CRT-Ds). Renewal provides ventricular
tachyarrhythmia and cardiac resynchronization therapies. b) CONTAK RENEWAL 2 (model H155) Heart Failure Device.
Renewal
provides ventricular tachyarrhythmia and cardiac resynchronization
therapies.
CODE
a) Serial number range
100027 - 999983 includes CRT-Ds manufactured on or before August 26, 2004.
These ranges include all affected devices but may include some unaffected devices.;
b) Serial number range 173277 - 777182 includes
CRT-Ds manufactured on or before August 26, 2004
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Guidant Corp-Cpi Division, Saint
Paul, MN,
Manufacturer:
Guidant-Ireland, Clomel, Ireland.
REASON Laboratory analysis revealed that a
deterioration in a wire insulator within the lead connector block, in
conjunction with other factors, could cause a short circuit and loss of device
function due to diversion of therapy energy away from the heart and into device
circuitry.
VOLUME OF PRODUCT IN COMMERCE 16,000
(approximately 11,900 remain implanted worldwide)
DISTRIBUTION
Nationwide and Internationally
PRODUCT
AccuSure
Insulin Syringe, lcc, 28 guage, ½”, packaged in boxes of 100, each containing 10
bundles of 10 syringes, disposable, NDC 0603-6996-21,
CODE
All codes
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Qualitest Pharmaceuticals, Inc,
Huntsville, AL,
Manufacturer:
Shin Chang Medical Co., Ltd, Gumi-Shi, Kyungsangbuk-Do, Korea.
REASON
Labeling error. There is a
possibility that 1cc syringes are labeled at 1/2cc on the plastic inner wrap
holding bundles of 10 syringes.
VOLUME OF PRODUCT IN
COMMERCE 14,400 boxes of 100 syringes
DISTRIBUTION Nationwide
PRODUCT
Baxter
Interlink System Continu-Flo Solution Set with Large Bore 4-Way Stopcock
Extension Set, 10 drops/mL, product code 3C0062s; a sterile, nonpyrogenic fluid
pathway for administration of IV fluids, CODE Lot numbers R04D28173, R04D28181,
R04D28199, R04F22288, R04F23237, R04F25273, R04G24100, R04G26071, R04H12020,
R04H13085, R04H13242, R04H30303, R04I21151, R04J06227, R04J07076, R04J07092,
R04J28122, R04K08064, R04K08221, R04K26090, R04K29086, R04L09110, R04L17055,
R04L17188, R04L18137, R05A20092, R05A20217, R05B03187, R05B04060,
R05B28192
RECALLING FIRM
Recalling Firm: Baxter
Healthcare Corp, Round Lake, IL, .
Manufacturer: Baxter Productos Medicos Ltda., Cartago, Costa Rica.
REASON
There is an unsecure
connection between the male Luer and the stopcock on the I.V. extension
set.
VOLUME OF PRODUCT IN COMMERCE 197,832
sets
DISTRIBUTION Nationwide, American Samoa and
Venezuela
PRODUCT
a)
CONTAK RENEWAL 3 CRT-D (model no. H170, H173, H175) and CONTAK RENEWAL 3 HE
CRT-D(model no. H177 and H179). Cardiac Resynchronization Therapy
Defibrillator. CONTAK RENEWAL 3 devices provide ventricular tachyarrhythmia and cardiac resynchronization therapies.
b) CONTAK RENEWAL 4 CRT-D (model no. H190 and H195) and
CONTAK
RENEWAL 4 HE CRT-D (model no. H197 and H199).Cardiac Resynchronization
Therapy Defibrillator. CONTAK RENEWAL 4 devices provide ventricular tachyarrhythmia and cardiac resynchronization therapies.
c) CONTAK RENEWAL 3 AVT CRT-D (model no. M150 and M155)
and
CONTAK RENEWAL 3 AVT HE CRT-D(model no. M157 and M159) Cardiac
Resynchronization Therapy Defibrillator. CONTAK RENEWAL 3 AVT devices
provide both atrial and ventricular tachyarrhythmia and cardiac resynchronization therapies.
d) CONTAK RENEWAL 4 AVT
CRT-D (model no. M170 and M175) and CONTAK RENEWAL 4 AVT HE CRT-D (model no.
M177 and M179). Cardiac Resynchronization Therapy Defibrillator. CONTAK
RENEWAL 4 AVT devices provide both atrial and ventricular tachyarrhythmia
and cardiac resynchronization therapies.
e) CONTAK
RENEWAL 4 RF (model no. H230 and H235) and CONTAK RENEWAL 4 RF HE (model no.
H239). Cardiac Resynchronization Therapy Defibrillator. CONTAK RENEWAL 4
RF devices provide ventricular tachyarrhythmia and cardiac resynchronization therapies.
CODE
All serial
numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Guidant Corp-Cpi Division, Saint Paul, MN,
Manufacturer: Guidant-Ireland, Clomel, Ireland.
REASON
Engineering analysis has determined
that the magnetic switch in certain devices may stick in the closed position.
When the magnetic switch becomes stuck in the closed position treatment of
ventricular or atrial tachyarrhythmias is inhibited, while bradycardia pacing is
unaffected.
VOLUME OF PRODUCT IN COMMERCE 58,062
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a)
Ventak Prizm Avt model no, 1900, Atrial and Ventricular Therapies,
b) Ventak Prizm Avt model A135 and model A155.
Implantable, Cardioverter Defibrillator. Atrial and Ventricular Therapies,
c) CONTACT RENEWAL 3 AVT model numbers
M150 and M155;CONTACT RENEWAL 3 AVT HE model numbers M157 and M159; CONTACT RENEWAL 4 AVT model numbers M170 and M175;
CONTACT RENEWAL 4 AVT
HE model numbers M177 and M179. Cardiac Resynchronization Therapy
Defibrillator. CONTAK RENEWAK AVT models provide both atrial and ventricular tachyarrhythmia and cardiac
resynchronization therapies,
CODE All serial numbers
RECALLING FIRM
Recalling Firm: Guidant Corp-Cpi
Division, Saint Paul, MN,
Manufacturer:
Guidant-Ireland, Clomel, Ireland.
REASON The atrial therapy (AVT) subgroups of
certain Guidant ICD and CRT-D product families are subject to a condition in
which a random memory error causes functional “latching” that limits available
therapy.
VOLUME OF PRODUCT IN COMMERCE 25,716
devices
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a)
Ultra Z 90 X-Ray Computed Tomography Scanners.These scanners were sold
under the brand names:
Picker, Marconi or Philips,
b)
AcQSim X-Ray Computed Tomography Scanners.These scanners were sold under
the brand names:
Picker, Marconi or Philips,
CODE All devices manufactured between January
1996 and June, 2004 were subject to recall
RECALLING
FIRM/MANUFACTURER Philips Medical Systems (Cleveland), Inc, Cleveland, OH,
REASON
Software anomaly in the DICOM Modality
Worklist. When restoring a patient’s images from the optical disk, images from
the wrong patient may be displayed.
VOLUME OF PRODUCT IN
COMMERCE 44 devices
DISTRIBUTION Nationwide
and
Internationally
PRODUCT
Spectre
brand AC wall adapter to be used with ProControl 2 or ProHand battery powered
upper limb prosthesis,
CODE Part
number PD1880 PL6A
RECALLING FIRM Motion Control, Inc.,
Salt Lake City, UT,
REASON Incorrect AC wall adapter was distributed
with prostheses. Incorrect use of adapters could damage the battery and cause a
potential fire hazard.
VOLUME OF PRODUCT IN COMMERCE 20
units
DISTRIBUTION CA, DC, FL, NJ, OH, PA, SC, TN, TX,
and PR
PRODUCT
10
French Ross Flexiflo Lap J Laproscopic Jejunostomy Kit with Brown/Mueller T-F
Fastener Set (list #51442),
CODE Lot
13978GZ, exp. date 02/01/2007; Lot 17165GZ, exp. date 06/01/2007; Lot 18190GZ,
exp. date 07/01/2007; Lot 19257GZ, exp. date 08/01/2007; Lot 22355, exp. date
11/01/2007; Lot 24440GZ, exp. date 01/01/2008; Lot 26509GZ, exp. date
02/01/2008; Lot 27530GZ, exp. date 02/01/2008
RECALLING
FIRM/MANUFACTURER Abbott Laboratories, Columbus, OH
REASON
The kits contain a 12 Fr. Introducer
Tear-Away BNS component. The tearaway introducer sheaths may have cracked
hubs/handles and/or improper peeling of the sheath during use in a small
percentage of the affected lots.
VOLUME OF PRODUCT IN
COMMERCE 1,892 kits
DISTRIBUTION Nationwide
PRODUCT
Portex
HEPA Bacterial/Viral Filter, Non-Latex Ref: 002890,
CODE
Lot Number: 634418
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Smiths Medical International Ltd,
Hythe, UK,
Manufacturer: Smiths Healthcare
Manufacturing Sa De Cv, Tijuana, Mexico.
REASON Mislabeled: The package contains a Heat
and Moisture (HME) filter instead of a HEPA filter stated on the product
label.
VOLUME OF PRODUCT IN COMMERCE 292
units
DISTRIBUTION CA, NJ, PA,
WV
PRODUCT
a) Boston
Scientific brand Low Profile PEG (percutaneous endoscopic gastrostomy tubes)
Kit, 18/2.4, pull; Catalog number 6314.
b) Boston Scientific
brand Standard PEG (percutaneous endoscopic gastrostomy tubes) Kit, 20 Fr,
pull; catalog number 6820.
c) Boston Scientific brand
Standard PEG (percutaneous endoscopic gastrostomy tubes) Kit, 20 Fr, push; catalog number 6821.
d) Boston Scientific brand
Standard PEG (percutaneous endoscopic gastrostomy tubes) Kit, 24 Fr, pull; catalog number 6824.
e) Boston Scientific brand
Standard PEG (percutaneous endoscopic gastrostomy tubes) Kit, 24 Fr, push; catalog number 6825.
f) Boston Scientific brand pull
Gastro-dome (percutaneous endoscopic gastrostomy tubes) Kit, 20 Frl; catalog number 6838.
g) Boston Scientific brand pull
Gastro-dome (percutaneous endoscopic gastrostomy tubes) Kit, 24 Frl; catalog number 6839.
h) Boston Scientific brand One Step
Button (percutaneous endoscopic gastrostomy tubes) Kit, 18/4.4 pull; catalog number 6848.
i) Boston Scientific brand One
Step Button (percutaneous endoscopic gastrostomy tubes) Kit, 24/2.4 pull; catalog number 6851.
j) Boston Scientific brand One
Step Button (percutaneous endoscopic gastrostomy tubes) Kit, 24/3.4 push; catalog number 6852.
k) Boston Scientific brand One
Step Button (percutaneous endoscopic gastrostomy tubes) Kit, 24/1.7 push; catalog number 6860.
CODE
a) Lot
number: 7564877;
b) Lot numbers: 7511185, 7511184, 7423558, 7421294, 7421292, 7393128, 7411790, 7411788, 7411787, 7389202,
7410534, 7410533,
7407840, 7407839, 7407838 and 7421293;
c) Lot numbers: 7397623, 7393130
and 7393129;
d) Lot number: 7406777;
e) Lot number: 7404367;
f) Lot
numbers: 7452729, 7448186, 7426909 and 7385202;
g) Lot numbers: 7452728,
7442432, 7430336 and 7397622;
h) Lot number: 7467697;
i) Lot numbers:
7471765, 7471766, 7434813, 7471767 and 7434812;
j) Lot numbers: Lots
7467759, 7434810, 7477229, 7434811 and 7401901;
k) Lot number:
7467761
RECALLING FIRM/MANUFACTURER Boston Scientific
Corp, Spencer, IN
REASON Two blades may be heat staked onto the
stiletto instead of the expected one blade.
VOLUME OF PRODUCT IN
COMMERCE 1,366 Kits
DISTRIBUTION Nationwide
and Panama
PRODUCT
RN
synOcta Meso Abutment, crown margin 8.0mm, Ti Article: 048.560,
CODE
Lot Number: 1007
RECALLING
FIRM
Recalling Firm: Straumann Manufacturing, Inc., Andover, MA,
.
Manufacturer: Instituit Strauman, Basel,
Switzerland.
REASON Basal screw is too short to adequately
hold the dental abutment in the implant.
VOLUME OF PRODUCT IN
COMMERCE 23 units
DISTRIBUTION AZ, CA, DE,
FL, NY, OH, OK, and
TX
PRODUCT
a)
Accu-Chek Compact Blood Glucose Meter; catalog number 3183572,
b) Accu-Chek Compact Care Kit; catalog number 3149137,
CODE
All units
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp,
Indianapolis, IN,
Manufacturer: Sanmina SCI,
Fermoy, Ireland.
REASON The meter may self-start without a sample having
been applied and report erroneous results without an error message if the nose
cover is not properly snapped in place and the undosed test strip is bent
upwards while the meter is waiting for the sample, or if excess control solution
or blood has been applied to the test strip.
VOLUME OF PRODUCT IN
COMMERCE 1,760,000 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a)
Accu-Chek Instant Blood Glucose Meter; Catalog numbers 914 and 924, ;
b) Accu-Chek Instant Care Kit; Catalog number
91490,
CODE All units
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp,
Indianapolis, IN,
Manufacturer: Roche
Diagnostics GmbH, Mannheim, Germany.
REASON The meter may self-start without a sample
having been applied and report erroneous results without an error message if an
undosed test strip is bent upwards while the meter is waiting for the sample or
if the test strip opening has been previously flooded with excess control
solution or blood.
VOLUME OF PRODUCT IN COMMERCE 100,000
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
LifeScan
brand One Touch UltraSmart Blood Glucose Meter Owners Booklet AW 060-788-01A;
All One Touch UltraSmart Meters shipped with OneTouch UltraSmart Owner’s Booklet
AW 060-788-01A are affected by this Field Correction.
CODE
All One Touch UltraSmart Meters shipped
with OneTouch UltraSmart Owner’s Booklet AW 060-788-01A are affected by this
Field Correction. Part Number, Description: 020-524-01, System,OUS,US;
020-524-01F, System,OUS,US; 020-524-01Y, UltraSmart Meter; 020-524-02,
System,OUS,EAS-C,US; 020-524-03, System,OUS,EAS-S,US; 020-524-04F, OT UltraSmart
System Kit V. 4 USA; 020-524-04Y, UltraSmart System; 020-524-05, UltraSmart
System -EAS-C; 020-524-06, UltraSmart System -EAS-S; 020-524-10, OT UltraSmart
System Kit; 020-524-10F, OT UltraSmart System Kit; OT UltraSmart System Kit V.
10 USA; 020-524-10Y, OT UltraSmart System Kit; 020-524-11, System, EAS-C, OUS,
US; 020-524-12, System, EAS-S, OUS, US; 020-524-13, OT UltraSmart System;
020-759-02F, OT UltraSmart Meter V.2 USA; 020-759-03F, OT UltraSmart Meter V.3
USA; 020-761-01F, Starter,OUS,US; 020-761-02, OT UltraSmart Starter;
020-761-02F, OT UltraSmart Starter; 020-761-04, OT UltraSmart Starter;
020-761-04F OT UltraSmart Starter; 020-761-05 OT UltraSmart Starter Kit;
020-761-05F, OT UltraSmart Starter Kit; 020-926-01, Dist Kit,SM,OTU,US;
020-930-01, Dist,Kit,OTU/OUS,US; 020-971-01, Disp,Counter,Ultra Kits;
021-075-01, UltraSmart SVP; 021-113-01, Display, Hanging, OUT/OUS, US;
021-133-01, Display, Counter, OTU/OUS Kits; 021-135-01, Span Display, Hanging,
OTU, US; and 021-166-01, Display, Hanging, OTU/OUS Kits.
RECALLING
FIRM/MANUFACTURER LifeScan Inc, Milpitas, CA
REASON
Meter
labeling (Owner’s Booklet and Quick Reference Guide) is incorrect as it
indicates that the meter displays the message “Do you need a snack” for glucose
values between 20 and 70 mg/dL; whereas the OneTouch UltraSmart meter displays
the message, “Do you need a snack?” for glucose values from 20 through 59
mg/dL.
VOLUME OF PRODUCT IN COMMERCE 584,291
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
Clinician
Workstation Software, product code 2M5042,
CODE Software versions 3.4, 4.0 and
4.1
RECALLING FIRM
Recalling Firm: Baxter Healthcare,
Corp, Round Lake, IL,
Manufacturer: Baxter
Healthcare, Corp/Patient Care System, Toronto, Canada. F
REASON
The medication administration results
displayed in the “View Results” link may be inaccurate.
VOLUME OF
PRODUCT IN COMMERCE 5 units
DISTRIBUTION MO,
MA, VT, CA, and
Canada
PRODUCT
Aplio
Diagnostic Ultrasound System (SSA-770A),
CODE Software versions 6.0er001 and
002
RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba
American Med Systems, Inc., Tustin, CA,
Manufacturer: Toshiba, Japan.
REASON
If the measurement mode is started from
the Doppler mode and then sweep speed setting is changed by the assigned user
function, the measurement of the time direction results don’t correspond to the
actual values.
VOLUME OF PRODUCT IN COMMERCE 106
units
DISTRIBUTION Nationwide
PRODUCT
TaqMan
HBV Analyte Specific Reagent, Material Number 3322092018, containing HBV
Quantitation Standard (HBV QS),
CODE Lot number: F10185;
Lot number:
F10513
RECALLING FIRM/MANUFACTURER Roche Molecular
Systems, Inc., Somerville, NJ
REASON Low level of recombinant HIV
DNA found in one lot of HBV QS which is a component of one lot of the TaqMan HBV
ASR.
VOLUME OF PRODUCT IN COMMERCE 14
kits
DISTRIBUTION NC
PRODUCT
Lifepak
20 defbrillator/monitor, Part numbers: 3202487-xxxd and 3202488-xxx,
CODE
Various, noncontiguous serial
numbers
RECALLING FIRM/MANUFACTURER Medtronic Emergency
Response Systems, Inc., Redmond, WA, REASON The device defibrillator may
not operate if the device is turned on during an AC Loss
Alert.
VOLUME OF PRODUCT IN COMMERCE 3,924
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
Natus
Algo Pre-Amplifier 3 cable assembly (Component of the Algo 3 Newborn Hearing
Screener and Algo 3i Newborn Hearing screener, Algo Portable Newborn Hearing
Screener, and Algo 2ec Newborn Hearing Screener.)
CODE
Product order numbers 010038, 010049,
010050, 010065, 010067, 010073, 010085, 030534, 040664, 040700, 040703, 040847,
DM010038, DM010039, DM010049, DM010067, DM010074, LN030534. Serial numbers
include P3 0547-P3 3404
RECALLING FIRM Natus Medical,
Inc, San Carlos, CA
REASON Internal investigation revealed that
Preamp cable assemblies in the device had not been properly tested, which could
lead to potential shock to users.
VOLUME OF PRODUCT IN
COMMERCE 2,473 units
DISTRIBUTION Nationwide
and
Internationally
PRODUCT
Magnetic
Resonance Imaging Systems; Visart, Excelart / Excelart P2 / Excelart P3 /
Excelart SPIN & Excelart Vantagae,
CODE All codes
RECALLING
FIRM
Recalling Firm: Toshiba American Med Systems, Inc, Tustin, CA,
Manufacturer: Matsushita Communication Industrial
Co., Ltd, Hanishina-Gun, Japan.
REASON Patient information A is displayed with
images of patient B.
VOLUME OF PRODUCT IN COMMERCE 103
units
DISTRIBUTION Nationwide
PRODUCT
a)
Axiom Aristos TX. Model number 58 94 873 Radiology system,
b) Axiom Aristos MX/VX. Model number 58 95 003,
c) Axiom Aristos FX. Model number 74 14 803,
CODE
a) Serial numbers 1001 through 1077;
b)
Serial numbers 1001 through 1017, 1019 through 1071, and 1073 through 1469;
c) Serial numbers 1001 through 1003, 1005 through 1047, and 1049 through
1247
RECALLING FIRM
Recalling Firm: Siemens Medical
Solutions USA, Inc., Malvern, PA,
Manufacturer:
Siemens Medical Solutions, Forchheim, Germany.
REASON Potential issue (system may lock up) when
repeating patient registrations.
VOLUME OF PRODUCT IN
COMMERCE 72 units
DISTRIBUTION Nationwide
PRODUCT
a)
Medtronic Sofamor Danek brand METRx System 16 mm Med Procedure Kit; Ref
9560016,
b) Medtronic Sofamor Danek brand METRx
System 18 mm Med Procedure Kit; Ref 9560018,
c)
Medtronic Sofamor Danek brand METRx System MD Procedure Kit; Ref 9560030.
CODE All
lots.
RECALLING FIRM/MANUFACTURER Warsaw Orthopedic,
Inc., Warsaw, IN,
REASON The package is labeled as sterile, but
there may be a hole in the immediate package caused by the carton
design.
VOLUME OF PRODUCT IN COMMERCE 2,493
kits
DISTRIBUTION Nationwide and Internationally
PRODUCT Smith &
Nephew Grasper, Cupped 3.4mm REF: 011014,
CODE Lot Number: 50088937
RECALLING
FIRM/MANUFACTURER Smith & Nephew, Inc., Endoscopy Div.,
Mansfield, MA,
REASON Cupped Grasper Handle marked incorrectly
as Duckbill Upbiter.
VOLUME OF PRODUCT IN COMMERCE 12
units
DISTRIBUTION CA, OH, MA, and
TX
PRODUCT PG910
Spacers, Part number SP101, loaded into Bard® Express Seeding Cartridges
containing TheraSeed® Pd-103 devices. The product is shipped non-sterile in a
foil pouch, packed 50 loose spacers per pouch.
CODE Lot #RR13N101L and
RR13N101Q
RECALLING FIRM
Recalling Firm: Theragenics
Corporation, Buford, GA,
Manufacturer: Ethicon, Inc., Cornelia, GA.
REASON
The spacers loaded in the seeding
cartridges were expired and/or the extra loose spacers were labeled with an
incorrect expiration date.
VOLUME OF PRODUCT IN
COMMERCE 13 loads
DISTRIBUTION OH and
VA
PRODUCT Claris
Cleaning and Soaking Solution, 4 fl. oz.,
CODE Lot numbers: AA00785, AA00786, AA01050,
AA01076
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Allergan Medical Optics, Inc., Santa Ana, CA,
Manufacturer: Advanced Medical Optics Manufacturing Spain, Alcobendas
(Madrid), Spain.
REASON Component mix-up of caps/tips. Absence of
red tip indicates improperly that the solution is safe for application to the
eye.
VOLUME OF PRODUCT IN COMMERCE 32,916
DISTRIBUTION Nationwide
Baxter Healthcare's Colleague Volumetric Infusion Pumps Recalled
Baxter Healthcare Corporation of Deerfield, Ill., has initiated a worldwide recall of all models of its Colleague Volumetric Infusion Pumps because they can shut down while delivering critical medication and fluids to patients. Baxter has received six reports of serious injury and three reports of death associated with this shut-down problem. The affected are: Models 2M8151, 2M8151R, 2M8161, 2M8161R, 2M8153, 2M8153R, 2M8163, and 2M8163R.
The firm notified customers today that it has voluntarily stopped shipping Colleague Volumetric Infusion Pumps until the problems are resolved. Baxter also advised customers on March 15, 2005, to stop using any pumps that exhibit a failure code beginning with 402, 403, 533, 535, or 599, related to these electronic problems. Additionally, Baxter advised customers to take out of service any pumps that exhibit failure codes 810:04 and 810:11 related to air-in-line sensor problems, until they are inspected by authorized service personnel.
In addition to the shut-down problem, the device may exhibit two additional failure modes:
Also, these failures may occur during the infusion of therapy, so it is imperative that health care institutions have a contingency plan to mitigate any disruptions of infusions of life-sustaining drugs or fluids.
Approximately 255,000 Colleague Volumetric Infusion Pumps are currently in use, including 206,000 distributed in the United States. They have been sold to physicians, hospitals, pharmacies, and a variety of other medical facilities.
At this time, users should not return the pumps to Baxter.
Baxter's letters to customers are available on its web site at http://www.baxter.com/. Consumers who have questions about the recall may contact Baxter Healthcare at 1-800-422-9837. Those who have technical questions may contact Baxter Healthcare at 1-800-THE-PUMP (800-843-7867).
If you are a physician or a patient who has experienced a problem with any of these infusion pumps, please send a report to FDA's MedWatch program and to Baxter. See http://www.fda.gov/medwatch/index.html for filing information or call 1-800-FDA-1088 (1-800-332-1088).
Guidant’s Pacemaker Recall
Guidant Corporation is voluntarily recalling certain pacemakers. A seal within the devices can leak, allowing moisture to affect the electronic circuits. This defect can cause the pacemakers to fail to provide pacing or can cause a rapid heart rate. Other unexpected device behaviors are also possible. The problems may occur without warning and can lead to loss of consciousness, and possibly heart failure and death.
Only the following models are affected by this recall. All were manufactured between November 25, 1997 and October 26, 2000.
* VIRTUS PLUS II and INTELIS II models available only outside the U.S.
Guidant's proposed recommendation to patients, which are consistent with the physician recommendations previously set forth are as follows:
Guidant has posted information for physicians on its web site at http://www.guidant.com/. Information for patients will be posted soon. If you have further questions, you may contact Guidant at 1-866-GUIDANT (1-866-484-3268).
WEEK ENDING JULY 30
PRODUCT
a) Baxter Colleague
Single Channel Volumetric Infusion Pumps, product codes: 2M8151, 2M8151R, 2M8161,
2M8161R
b) Baxter Colleague triple
Channel Volumetric Infusion Pumps, product codes: 2M8153, 2M8153R,
2M8163, 2M8163R,
CODE All serial
numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter
Healthcare Corporation, Deerfield, IL
Manufacturer: Baxter Healthcare Corporation, Singapore,
Singapore.
REASON The pumps may
experience inadvertent power off, external communications port failures and
electronic pump failure codes 402, 403, 533, 535, 599, 810:04 and
810:11.
VOLUME OF PRODUCT IN COMMERCE 253,185
pumps
DISTRIBUTION Nationwide and Internationally
PRODUCT
a) Right Heart Catheter
Product Line: Catalog Number 601129-----5011094 0106 x 1007BBMWS
b) Right Heart Catheter Product Line:
Catalog Number
601258-----WP604P Wedge Press Catheter
c) Right
Heart Catheter Product Line: Catalog Number 601261-----WP605P Wedge Press
Catheter
d) Right Heart Catheter Product Line: Catalog Number 601272-----WP1106 Wedge
Press Catheter
e) Right Heart Catheter Product Line: Catalog Number
601276-----WP1107 Wedge Press Catheter,
f) Right
Heart Catheter Product Line: Catalog Number 601285-----WP11055 Wedge Press
Catheter
g) Right Heart Catheter Product Line: Catalog Number 601293-----WP1107S Monitory
Wedge Press
h) Right Heart Catheter Product Line: Catalog Number
604000-----417D10061
i) Right Heart Catheter Product
Line: Catalog Number 604025-----T046-02 0426D10091 RMM
j) Right Heart Catheter Product Line:
Catalog Number
604028-----T047(90) 427D10221
k) Right Heart
Catheter Product Line: Catalog Number 604037-----T047-02 0427D10061
l) Right Heart Catheter Product Line:
Catalog Number
604057----T147 A427D1014KANI
m) Right Heart Catheter
Product Line: Catalog Number 604100----T147-03 A427D1014KANI 25PP
n) Right Heart Catheter Product Line:
Catalog Number
604103-----T047(97) 427D4036I,
o) Right Heart
Catheter Product Line: Catalog Number 604165-----T047-04 0427D1022I,
p) Right Heart Catheter Product Line: Catalog
Number 604239-----426D1009I,
q) Right Heart Catheter
Product Line: Catalog Number 604264-----427D1006I Round Molded Manifold, r) Right Heart Catheter Product Line:
Catalog Number
604315-----406-1H-018 426D1009I18PP
s) Right Heart
Catheter Product Line: Catalog Number 608054-----827D1006I 4P BBM RMM
Catheter, t) Right Heart Catheter Product Line: Catalog Number 608055-----827D1006I 4P
BBM RMM Catheter
CODE
a) Lot Number, exp.date: 0060436563, 3/31/05;
0060449283, 4/30/05; 0060460576, 6/30/05;
0060478672, 7/31/05;
0060479191, 6/30/05; 0060485755, 7/31/05; 0060488734, 8/31/05;
0060496446, 9/30/05; 0060514308, 10/31/05; 0060520693, 11/30/05;
0060541501, 1/31/06;
0060551085, 2/28/06; 0060558243, 3/31/06; 0060572138, 4/30/06; 0060572440, 4/30/06;
0060577179, 5/31/06;
0060577413, 4/30/06; 0060706970, 6/30/06; 0060710249, 8/31/06;
0060721648, 9/30/06; 0060724465, 10/31/06; 0060732313, 10/31/06;
0060738463, 12/31/06;
0060746723, 1/31/06.
b) Lot Number, Exp Date:
0060554715, 2/28/06; 0060558246, 2/28/06; 0060568209, 4/30/06;
0060721656, 8/31/06.
c) Lot Number, Exp Date: 0060461139, 5/31/05; 0060468252, 6/30/05; 0060484327, 7/31/05;
0060490856, 8/31/05;
0060534557, 12/31/05; 0060541502, 1/31/06; 0060558248, 2/28/06;
0060561935, 3/31/06; 0060565937, 4/30/06; 0060572444, 4/30/06;
0060577415, 5/31/06;
0060708815, 6/30/06; 0060710255, 7/31/06; 0060733103, 12/31/06; 0060743198, 1/31/06.
d) Lot Number, Exp. Date:
0060460588, 6/30/05; 0060478671, 6/30/05; 0060499553, 9/30/05;
0060514303, 10/31/05; 0060541506, 12/31/05; 0060558250, 3/31/06;
0060707682, 7/31/06;
0060715898, 8/31/06; 0060721686, 9/30/06; 0060724934, 9/30/06; 0060741461, 12/31/06;
0060746728, 1/31/06.
e) Lot
Number, Exp. Date: 0060447424, 4/30/05; 0060449287, 4/30/05; 0060460591,
5/31/05;
0060461660, 6/30/05; 0060479198, 7/31/05; 0060485764, 8/31/05;
0060499554, 9/30/05;
0060503596, 10/31/05; 0060510910,
10/31/05; 0060534551, 12/31/05; 0060542987, 1/31/06;
0060551093, 2/28/06;
0060558251, 2/28/06; 0060563877, 3/31/06; 0060568298, 4/30/06;
0060577421,
4/30/06; 0060704964, 6/30/06; 0060707117, 8/31/06; 0060709910, 7/31/06;
0060720394, 9/30/06; 0060724488, 9/30/06; 0060724492, 10/31/06;
0060730638, 11/30/06;
0060733105, 11/30/06; 0060735054,
11/30/06; 0060741469, 12/31/06; 0060743202, 1/31/06.
f) Lot Number, Exp.Date: 0060449299, 5/31/05;
0060451743, 4/30/05; 0060460616,
8/31/05;
0060465318, 8/31/05; 0060488695, 9/30/05; 0060507456, 9/30/05;
0060515836, 10/31/05;
0060538329, 2/28/06; 0060541514,
12/31/05; 0060749802, 1/31/06.
g) Lot Number, Exp. Date: 0060443014,
4/30/05; 0060496739, 9/30/05; 0060534548, 12/31/05;
0060541540, 1/31/06;
0060707630, 6/30/06; 0060721175, 9/30/06; 0060724938,
9/30/06;
0060741497, 12/31/06.
h) Lot Number, Exp. Date: 0060444167,
3/31/05; 0060449163, 4/30/05; 0060451494, 4/30/05;
0060451497, 4/30/05;
0060460629, 6/30/05; 0060471018, 6/30/05; 0060480355, 7/31/05;
0060488611,
10/31/05; 0060537207, 1/31/06; 0060551137, 2/28/06; 0060554768, 2/28/06;
0060564022, 3/31/06; 0060575807, 4/30/06; 0060709793, 10/31/06;
0060721740, 9/30/06;
0060725206, 11/30/06; 0060725207, 11/30/06; 0060735650, 1/31/06; 0060743268, 1/31/06.
i) Lot Number, Exp. Date:
0060575999, 4/30/06; 0060581062, 5/31/06; 0060717194, 8/31/06;
0060725153, 9/30/06; 0060730984, 10/31/06; 0060733271, 11/30/06.
j)
Lot Number, Exp.Date: 0060714530, 8/31/06; 0060714554, 10/31/06; 0060715260,
9/30/06;
0060716585, 8/31/06; 0060721764, 10/31/06; 0060730636,
11/30/06; 0060737274, 12/31/06;
0060738518, 11/30/06.
k) Lot Number, Exp.
Date: 0060460638, 5/31/05; 0060471048, 6/30/05; 0060486204, 7/37/05;
0060490913, 8/31/05; 0060510913, 11/30/05; 0060514285, 10/31/05;
0060527620, 11/30/05;
0060537029, 12/31/05; 0060541565,
1/31/06; 0060551161, 2/28/06; 0060558495, 2/28/06;
0060568861, 3/31/06;
0060579881, 5/31/06; 0060714560, 9/30/06; 0060716589, 8/31/06;
0060726783, 10/31/06; 0060733295, 10/31/06; 0060738519,11/30/06;
0060741037, 12/31/06;
0060745654, 12/31/06; 0060746780, 1/31/06.
l) Lot
Number, Exp. Date: 0060709903, 7/31/06.
m) Lot Number, Exp.Date: 0060708624,
7/31/06; 0060720757, 8/31/06.
n) Lot Number, exp.Date: 0060454893,
4/30/05; 0060467329, 6/30/05'' 0060486208, 7/31/05;
0060486209, 7/31/05;
0060491077, 9/30/05; 0060510922, 11/30/05; 0060514276, 10/31/05;
0060537036, 12/31/05; 0060541575, 2/28/06; 0060551166, 2/28/05;
0060568862, 5/31/06;
0060570914, 5/31/06; 0060579875, 5/31/06; 0060710236, 8/31/06; 0060716577, 8/31/06;
0060721776, 9/30/06;
0060721777, 8/31/06; 0060721778, 10/31/06; 0060726790, 11/30/06.
o) Lot
Number, Exp. Date: 0060709920, 08/31/06; 0060725197, 8/31/06; 0060732988,
10/31/06;
0060741502, 11/30/06.
p) Lot Number, exp. Date: 0060460643,
4/30/05; 0060461604, 5/31/05; 0060471050, 6/30/05;
0060476785, 7/31/05;
0060486210, 8/31/05; 0060488589, 9/30/05; 0060507464, 10/31/05;
0060537807, 2/28/06; 0060541581, 1/31/06; 0060545788, 1/31/06;
0060550249, 2/28/06;
0060551170, 2/28/06; 0060710289,
8/31/06; 0060733310, 10/31/06.
q) Lot Number, Exp. Date: 0060443003,
3/31/05; 0060460648, 5/31/05; 0060471074, 6/30/05;
0060479256, 6/30/05;
0060486212, 7/31/05; 0060491081, 8/31/05; 0060514268, 10/31/05;
0060552185, 2/28/06; 0060577425, 5/31/06; 0060714385, 10/31/06;
0060720571, 8/31/06;
0060721744, 10/31/06; 0060733328, 11/30/06; 0060741506, 11/30/06; 0060741512, 12/31/06.
r) Lot Number, exp date:
0060514256, 01/31/06; 0060721684, 8/31/06.
s) Lot Number, exp date:
0060429437, 3/31/05; 0060448163, 4/30/05; 0060451580, 5/31/05;
0060464460, 6/30/05; 0060478913, 7/31/05; 0060487419, 8/31/05;
0060507290, 9/30/05;
0060535169, 12/31/05; 0060541493, 1/31/06; 0060549785, 2/28/06; 0060552125, 2/28/06;
0060558241, 3/31/06;
0060714523, 8/31/06; 0060735748, 11/30/06; 0060738710, 12/31/06;
0060746883, 1/31/06.
t) Lot Number, exp date: 0060420041, 3/31/05; 0060448164, 4/30/05; 0060451583, 4/30/05;
0060464461, 6/30/05;
0060470936, 7/31/05; 0060485412, 8/31/05; 0060499041, 8/31/05;
0060516425, 10/31/05; 0060535170, 13/31/05; 0060549811, 2/28/06;
0060558242, 4/30/06;
0060714514, 8/31/06; 0060714518, 10/31/06; 0060726942, 10/31/06; 0060738704, 11/30/06;
0060746884,
1/31/06.
RECALLING FIRM/MANUFACTURER
Recalling Firm: B.
Braun Medical, Inc., Allentown, PA
Manufacturer: B. Braun Medical, Inc., Cherry Hill, NJ.
REASON
Reports in a small percentage
of Right Heart Catheter Products Line related to cracked catheter tips, leaking
at the manifold and cracked hubs.
VOLUME OF PRODUCT IN
COMMERCE 6,867 units
DISTRIBUTION Nationwide, Germany and
Japan
PRODUCT Immulite/Immulite 1000
Carcinoembryonic Antigen (CEA) LKCE1
CODE Lots
302 and 303
RECALLING FIRM
Recalling Firm: Diagnostic
Products Corp, Los Angeles, CA
Manufacturer: EURO/DPC Limited.
REASON
Adverse trend in stability, controls biased or out
of range.
VOLUME OF PRODUCT IN COMMERCE 269
units
DISTRIBUTION Nationwide, Syria, United Kingdom, Puerto Rico,
Aruba, Kuwait
PRODUCT Vitros Chemistry CRBM
Slides, REF 889 2382. There are 90 slides per box. For in vitro diagnostic use.
CODE
Generations 18, 19, 20, 21, and
23
RECALLING FIRM/MANUFACTURER Ortho-Clinical Diagnostics,
Rochester, NY
REASON Falsely elevated Carbamazepine
results.
VOLUME OF PRODUCT IN COMMERCE 5,846
boxes
DISTRIBUTION Nationwide and Internationally
PRODUCT Implantable Cardioverter
Defibrillators Epic DR/HF (V-233/V-337/V-338), Epic Plus DR/VR/HF
(V-236/V-239/V-196/V-239T/V-196T/V-350) Atlas DR (V242),and Atlas Plus DR/VR/HF
(V-243/V-193C/V-340/V-341/V-343)
CODE No serial
numbers were given. All mentioned models are recalled.
RECALLING
FIRM St Jude Medical, Sylmar, CA
REASON Two corrections to firmware due
to Skipped-Charge Shock and Sensor Noise Anomaly are being made with one
noninvasive upgrade.
VOLUME OF PRODUCT IN COMMERCE 30,000
domestically, 11,684 internationally
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) HomeChoice Automated
Peritoneal Dialysis Systems; Made in U.S.A.; catalog numbers
5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R,
b) HomeChoice PRO Automated Peritoneal Dialysis
Systems; Made
in U.S.A.; catalog numbers
5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300,
T5C8300R
CODE All serial
numbers.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter
Healthcare Renal Division, McGaw Park, IL
Manufacturer: Baxter Healthcare Corporation, Largo, FL.
REASON
The screws that secure the
Power Entry Module (PEM) to the base of the HomeChoice device are not reliably
grounded to the device's ground system, posing an electric shock
hazard.
VOLUME OF PRODUCT IN COMMERCE 72,752
units
DISTRIBUTION Nationwide and Internationally
PRODUCT Adapter for ACMI
Hysteroscope, Catalog Number: 55035
CODE Lot
Number: 20410191
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Boston Scientific Marlborough, Marlborough, MA
Manufacturer: Nexcore Technology, Inc., Hackensack, NJ.
REASON
The Hysteroscope Adapter used
with the HTA System may disassemble and result in a fluid leak.
VOLUME OF
PRODUCT IN COMMERCE 73 units
DISTRIBUTION Nationwide
PRODUCT
a) Depuy brand LCS
Complete metal backed patella, porocoat, STD; REF 1294-09-640.
b) Depuy brand LCS Complete metal backed
patella, porocoat,
STD+; REF 1294-09-650;
c) Depuy brand LCS Complete
metal backed patella, porocoat, LRG; REF 1294-09-660.
d) Depuy brand LCS Complete metal backed
patella, porocoat, LRG+; REF 1294-09-670,
e) Depuy brand LCS Complete
metal backed patella, cemented, STD; REF 1294-09-740.
f) Depuy brand LCS Complete metal backed
patella, cemented,
STD+; REF 1294-09-750,
g) Depuy brand LCS Complete
metal backed patella, cemented, LRG; REF 1294-09-760,
h) Depuy brand LCS Complete metal backed
patella, cemented, LRG+; REF 1294-09-770,
CODE
a) Lots 1831720,
1831721, 1837366, 1837367, 1840603, 1845651 and 1855830;
b) Lots 1829091,
1831724, 1834697, 1834698, 1837368, 1840605, 1840609, 1851643,
1859876,
1859879 and 1862192;
c) Lots 1829092, 1831726, 1837370, 1845654, 1848385
and 1855839;
d) Lot 1851632;
e) Lots 1831957, 1831958, 1843280, 1850752, 1850753, 1855845, 1858741and 1858742;
f) Lots 1837372, 1840611, 1848388,
1855864, 1855865 and 1859890;
g) Lots 1850754 and 1855867;
h) Lots
1834705, 1837376 and 1851641
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Depuy Orthopedics, Inc, Warsaw,
IN
Manufacturer: Depuy Ireland, Ltd.,
Cork, Ireland.
REASON There may
be dissociation of the polyethylene from the baseplate because the inside
diameter of the polyethylene articular bearing was manufactured to an oversized
condition.
VOLUME OF PRODUCT IN
COMMERCE 846
DISTRIBUTION Nationwide and Internationally
PRODUCT Dade Fibrin(ogen)
Degradation Products (FDP) Detection Set. Catalog number B4233-10E, CODE Lot number P152010 exp 4/30/06
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Dade Behring, Inc., Newark, DE
Manufacturer: Aventis Behring
Gmbh, Marburg, Germany.
REASON Positive
control shows weak agglutination reaction.
VOLUME OF PRODUCT IN
COMMERCE 364 kits
DISTRIBUTION Nationwide and
Internationally
PRODUCT Beckman Coulter 1500
Series Hematology Automation System; Part Number: 988609 (LH Basic Unit) 988610
(LH Connection Unit),
CODE N/A
RECALLING
FIRM Beckman Coulter Inc, Brea, CA
REASON Risk of injury to workers
due to mechanical or electrical hazards. Corrective action will include shields,
covers, software interlocks, a spill tray, and edge smoothing.
VOLUME OF
PRODUCT IN COMMERCE 34
DISTRIBUTION Nationwide and
Canada
PRODUCT Healing Labsô Rite
Choice Pregnancy Test Kit, packed in a cellophane display box, containing one
test strip and materials for one test, Made in China, UPC 087399430205. Packed
48 boxes/case.
CODE All lots
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Core Brands, Baltimore, MD
Manufacturer: Ningbo Powerwell Fine Chemical Industrial Co., Ltd.,
Ningbo, China.
REASON Home
pregnancy test kit lacks 510k approval and cannot be assured as safe and
effective.
VOLUME OF PRODUCT IN COMMERCE 2,710
cases
DISTRIBUTION MI, NY, MD, MA, PA, NJ and RI
PRODUCT ArthoCare Caps-Lock
Cannula, polypropylene 70 mm cannula sterile, in double pouch, 10 pouches per
chipboard box, Catalog number 22-1006
CODE Lot
number 1905, Class I exempt device, Listing B091417
RECALLING
FIRM
Recalling Firm: Arthocare Corp, Sunnyvale, CA
Manufacturer: Clearform Plastics Ltd., North Shields
Tyne& Wear NE298SE, United Kingdom.
REASON Potential loss of product sterility due to breach of outer
and inner seal packages, which may result in infection.
VOLUME OF PRODUCT
IN COMMERCE 500 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT IMMULITE 2000. An
Automated, Quantitative Immunoassay Analyzer for In Vitro Diagnostic Use,
CODE
All analyzers; all serial numbers
RECALLING
FIRM/MANUFACTURER DPC Cirrus, Flanders, NJ
REASON In the Tube Transport
Chain Sensor, used to move a Reaction Tube within the Immulite 2000, a false
trigger can occur due to particulate contamination or dust. Although extremely
remote, this behavior can cause the instrument to process a test using an
incorrect bead. The failure occurs when debris in the sensor triggers the
signal, indicating the flag was detected before the chain reaches position. In
this case, the Processor Shuttle pushes a blank space, and the instrument
generates an error "473 - Reaction Cup is not in the pipetting position." The
reaction cup containing the bead remains on the chain and moves to the pipette
position for the launch of the next test. Meanwhile, the reaction cup intended
for the current test remains in the indexer, where a second bead is dispensed.
This generates an error "408 - Two beads detected rerunning test". The test is
question is launched between the two errors. After these two cycles the
instrument returns to normal operation.
VOLUME OF PRODUCT IN
COMMERCE 941 units nationwide; 3014 units
Internationally
DISTRIBUTION Nationwide and Internationally
PRODUCT EMCEE Obturator (7F) for
use with 8F Sheath, REF #92580008, packaged in individual labeled pouches, 10
units per box, 40 boxes per case.
CODE
884421
Exp 05/2006; 885027 Exp 05/2006; 937757 Exp 01/2007
RECALLING
FIRM Boston Scientific Corporation, Glens Falls, NY
REASON Product labeled to contain Emcee Obturators
contained Emcee Dilators.
VOLUME OF PRODUCT IN COMMERCE 90 units
(pouches)
DISTRIBUTION NJ, IN, and Belgium
Disetronic Medical Systems, Inc. Announces a Voluntary Recall of the D-TRON Adapters, Used With the D-TRONplus Insulin Pump
Disetronic Medical Systems, Inc., Fishers, Indiana is announcing a voluntary nationwide recall of its D-TRON adapters, used with the D-TRONplus insulin pump, because they can potentially over-deliver a maximum amount of up to 1.8 I.U. of insulin. Use of these recalled adapters may pose a potential life-threatening situation to certain children using the pump. Other users who are insulin sensitive may also be at increased risk. The affected D-TRON adapters are part number REF 3000803, Lots 4013674 through 4022628. Other adapter lots are not affected.
The root cause of this issue is a sporadic failure of a valve inside the D-TRON adapter to close completely, which can result in a potential over-delivery of a maximum amount of up to 1.8 I.U. of insulin. This may occur up to 15 minutes after replacing the adapter and priming the set. If this situation occurs, the pump will give an A-4 alarm and will continue to deliver insulin. Over infusion may also occur with no alarm if the pressure does not drop below the alarm threshold nevertheless we did not have any reports of such cases. If an A-4 alarm sounds the caregiver should check blood glucose levels, take other actions as indicated in the D-TRONplus insulin pump manual, and consult with their health care team if necessary. If the patient has symptoms that cause the caregiver to be concerned that over infusion may have occurred without an alarm, the caregiver should take similar measures. Signs and symptoms of excessive insulin dosing may include: sweating, thirst, confusion, nausea and loss of consciousness.
Disetronic has notified the caregivers and physicians of the pump users 13 years of age and under to immediately discontinue the use of the affected adapters. These caregivers have also been provided with new D-TRONplus adapters, which can be identified by the part number. The new part number is located on each adapter and is REF 04574826001. Only adapters that are not affected by the recall are now being shipped by Disetronic, in order to ensure that customers of all ages will have the new adapters as soon as possible. Approximately 110 D-TRONplus insulin pumps are in use by children age 13 years and younger in the United States.
Users should contact the Disetronic Pump User Support Group for information regarding replacement of affected D-TRON adapters at 1-800-688-4578. Users, caregivers and physicians who have questions about the recall may contact Disetronic Medical Systems, Inc. at 1-800-688-4578 24-hours a day, 365 days a year or visit http://www.disetronic-usa.com. If you are a physician or a patient who has experienced a problem with any of these insulin pump adapters, please send a report to FDA’s MedWatch program and to Disetronic. See http://www.fda.gov/medwatch/ for filing information or call 1-800-FDA-1088 (1-800-332-1088).