APRIL 2005

WEEK ENDING APRIL 2

PRODUCT Heartsine Samaritan AED Defibrillators -- Models: SAM 001, SAM 002,SAM 003. 
CODE Serial numbers within range of 1270 -- 2324 (not all are affected).
RECALLING FIRM/MANUFACTURER Heartsine Technologies, Inc., San Clemente, CA
REASON The affected Automatic External Defibrillators (AED) announce a fault warning and shut themselves off before a shock can be delivered to the patient. This is reportedly due to slow capacitor charging rates which are interpreted by the AED software as a fault condition.
VOLUME OF PRODUCT IN COMMERCE 672 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Uterine Introducing Catheter 5F, 300 mm in length. The product is shipped in a sterile tyvck pouch. 
CODE Lot Number 741105 exp. 11/07.
RECALLING FIRM/MANUFACTURER Bioteque America Inc., Langhorne, PA
REASON Product is marked without a 510(k).
VOLUME OF PRODUCT IN COMMERCE 115 units.
DISTRIBUTION OH and MI.

PRODUCT
a) BD Exacta 8.5 Fr Percutaneous Sheath Introducer Tray. Ref. No 680124. 
b) Careflow 14Ga x 20cm 2-lumen Central Venous Catheter Tray. Ref. No. 681714.
c) Careflow 7Fr x 20cm 3-lumen Central Venous Catheter Tray. Ref. No. 681725.
d) BD Exacta 6Fr Percutaneous Sheath Introducer Tray. 
CODE
a) Lot No's. 406462 and 311197;
b) Lot No. 404567;
c) Lot No. 405622;
d) Lot No. 407458.
RECALLING FIRM/MANUFACTURER Becton Dickinson Infusion Therapy, Sandy, UT
REASON Various procedure trays and kits may have an insufficient seal, thus compromising sterility.
VOLUME OF PRODUCT IN COMMERCE 30 units.
DISTRIBUTION WI, Puerto Rico, Virgin Islands.

PRODUCT DiaSorin Anti-Cardiolipin IgA ELISA kit for the detection in human serum or plasma of antoantibodies specific for Cardiolipin IgA. Catalog No.: 7800. 
CODE Lot # 039229, Exp. date 12/23/04.
RECALLING FIRM/MANUFACTURER Diasorin Inc., Stillwater, MN
REASON DiaSorin Anti-Cardiolipin IgA kit's positive control is out of acceptable limits.
VOLUME OF PRODUCT IN COMMERCE 16 kits.
DISTRIBUTION GA, NY, and KS.

PRODUCT Mikro-Tip Disposable Angiographic Catheter. 
CODE Lot numbers L034403 and L034731.
RECALLING FIRM/MANUFACTURER Millar Instruments, Inc., Houston, TX
REASON Wire braiding protruding from the catheter.
VOLUME OF PRODUCT IN COMMERCE 28 catheters.
DISTRIBUTION MN, CA, and NY.

PRODUCT Constellation Advanced Mapping Catheter, Model numbers 8031, 8038, 8060, 8075. 
CODE Model numbers 8031, 8038, 8060, 8075. 510(k) numbers K983171, K992777, K000277, K021232, K003782. Product Code DXQ. Product UPN numbers: Domestic: Constellation 31 mm/2mm: M004 US8031 0, M004 US8031 L0, M004 US8031 M0. 38mm/3mm: M004US8038 0, 4004 US8038 L0, M004 US8038P0. 48MM/4MM M004 US8048 0, M004 US8048B0, M004 US8048P0. 60mm/5mm: M004 US8060 0, M004 US8060B0, M004 US8060P0. 75mm/7mm: M004 US0875 0, M004 US0875B0, M004 US8075P0. Outside of US product: Constellation 31 mm/2mm: M004 EPT8031 0, M004 EPT8031 L0, M004 EPT8031 M0. 38mm/3mm: M004EPT8038 0, 4004 EPT8038 L0, M004 EPT8038P0. 48MM/4MM M004 EPT8048 0, M004 EPT8048B0, M004 EPT8048P0. 60mm/5mm: M004 EPT8060 0, M004 EPT8060B0, M004 EPT8060P0. 75mm/7mm: M004 EPT0875 0, M004 EPT0875B0, M004 EPT8075P0.
RECALLING FIRM/MANUFACTURER Boston Scientific, San Jose, CA
REASON The coating on the product's surface can generate debris, which could then move from the heart towards the brain, resulting in Ischemic events.
VOLUME OF PRODUCT IN COMMERCE 6,694 units.
DISTRIBUTION Nationwide and Internationaly.

PRODUCT Xcelera R1.2. Cardiology image and information management solution software. 
CODE Xcelera Software version R1.2.
RECALLING FIRM/MANUFACTURER Philips Medical Systems Sales and Service Region No. America, Bothell, WA
REASON Loss of image data from image repository and archive requiring patients to undergo repeat imaging.
VOLUME OF PRODUCT IN COMMERCE 33 units.
DISTRIBUTION Nationwide.

PRODUCT
a) Manual Mechanical Wheelchair, 18" seat, maximum patient weight: 250 lbs.; Made in China; the wheelchairs were sold in the following
configurations: reorder 16-7901: Fixed Full Arm, Fixed Footrest reorder 16-7902: Fixed Full Arm, Swing Footrest reorder 16-7903: Fixed Full Arm, Elevating Adjustable Legrest reorder 16-7904: Removable Desk Arm, Swing Footrest reorder 16-7905: Removable Desk Arm, Elevating Adjustable Legrest reorder 16-7906: Removable Full Arm, Elevating Adjustable Legrest. 
b) Manual Mechanical Wheelchair, 16" seat, maximum patient weight: 250 lbs.; Made in China; the wheelchairs were sold in the following
configurations: reorder 16-7910: Fixed Full Arm, Swing Footrest reorder 16-7911: Fixed Full Arm, Elevating Adjustable Legrest reorder
16-7912: Removable Desk Arm, Swing Footrest reorder 16-7913: Removable Desk Arm, Elevating Adjustable Legrest reorder 16-7914: Removable Full Arm, Elevating Adjustable Legrest.
c) Manual Mechanical Wheelchair, 24" seat, maximum patient weight: 450 lbs.; Made in China; the wheelchairs were sold in the
following configurations: reorder 16-7920: Removable Desk Arm, Swing Footrest reorder 16-7921: Removable Desk Arm, Elevating
Adjustable Legrest reorder 16-7922: Removable Full Arm, Elevating Adjustable Legrest.
d) Manual Mechanical Wheelchair, 20" seat, maximum patient weight: 350 lbs., Made in China; the wheelchairs were sold in the
following configurations: reorder 16-7942: Removable Desk Arm, Swing Footrest reorder 16-7943: Removable Desk Arm, Elevating
Adjustable Legrest reorder 16-7944: Removable Full Arm, Elevating Adjustable Legres.
e) Manual Mechanical Wheelchair, 22" seat, maximum patient weight: 350 lbs.; Made in China; the wheelchairs were sold in the
following configurations: reorder 16-7952: Removable Desk Arm, Swing Footrest reorder 16-7953: Removable Desk Arm, Elevating Adjustable Legrest reorder 16-7954: Removable Full Arm, Elevating Adjustable Legrest. 
CODE All serial numbers.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cypress Medical Products, Ltd., McHenry, IL
Manufacturer: Marketed by McKesson Corporation, McKesson Medical-Surgical, Richmond, VA. 
REASON The seat of the wheelchair may come loose from the frame with the screws and the collars still attached when the seat is pulled upward to fold the wheelchair.
VOLUME OF PRODUCT IN COMMERCE 332 chairs.
DISTRIBUTION Nationwide, and Canada.

PRODUCT ETI-MP IgM Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative detection of specific IgM antibodies to Mycoplasma pneumoniae in human serum. Test kit for 192 determinations. Catalog No. 4700. For In Vitro Diagnostic use. 
CODE Lot # E052660D, E052790D.
RECALLING FIRM/MANUFACTURER DiaSorin Inc., Stillwater, MN
REASON 2 lots of ETI-MP IgM assay kits showed a decline in Optical Density (OD) reading of the positive control and calibrators, P10 and P50. The decline in OD of the positive control and calibrators (P10 & P50) would cause the assay validation criteria to fail.
VOLUME OF PRODUCT IN COMMERCE 12.
DISTRIBUTION MA, OH, and IL.

PRODUCT DiaSorin GammaCoat Androstenedione - [125I] RIA Kit Catalog No. CA-1725. for the quantitative determination of androstenedione levels in serum. 
CODE Lot # 05144.
RECALLING FIRM/MANUFACTURER DiaSorin, Stillwater, MN
REASON Standards used in the GammaCoat Androstenedione Radioimmunoassay Kit appeared yellowish in color and were gelatinous upon reconstitution.
VOLUME OF PRODUCT IN COMMERCE 258.
DISTRIBUTION MN, MA, KY, and Internationally.

PRODUCT
a) Lp(a) Diluent packaged into 60 mL bottles, Catalog #23817, 480 mL bulk catalog # 95046B;
b) 60 mL bottles can be part of DiaSorin Lp(a) Antibody Reagent Kits Catalog # 86084, for use in DiaSorin Antibody Reagent Set for
Lp(a) SPQ Test System. 
CODE
a) Lot #s 238017-01 & 238017-03, Lot # 238017-02;
b) Lot #s 1144332, 114432A,13656, 113656A, and 113656B.
RECALLING FIRM/MANUFACTURER DiaSorin, Inc., Stillwater, MN
REASON QC testing of the Antibody Reagent Set for Lp(a) SPQ Test System it was discovered that the background was failing high of the specification. Through substitution testing it was determined that the Lp(a) diluent, part #238017 was the cause of the failing background specification.
VOLUME OF PRODUCT IN COMMERCE 631 as individual vials, 1 bulk unit and 401 sold in kits.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Liaison 25 OH Vitamin D Assay, catalog # 310900. .
CODE Lot 114439E.
RECALLING FIRM/MANUFACTURER DiaSorin, Inc., Stillwater, MN
REASON Results of an internal inspection show Lot 114439E to have calibrator 1 and calibrator 2 switched in their position in the integral. This results in an inability to calculate a curve, due to the reversal of calibrator values.
VOLUME OF PRODUCT IN COMMERCE 131.
DISTRIBUTION MI, NJ, Germany, Spain and Belgium.

PRODUCT Liaison 25 OH Vitamin D Assay, Manufacturer part # 310900. 
CODE Lot # 114668.
RECALLING FIRM/MANUFACTURER DiaSorin, Inc., Stillwater, MN
REASON An internal inspection indicates that calibrator 2 and conjugate are switched in their positions in the integral. This will result in calibrator 1 RLU's similar to that of background RLU, and calibrator 2 RLU's near expected range. A curve can not be calculated from this data.
VOLUME OF PRODUCT IN COMMERCE 31.
DISTRIBUTION MA, Spain, Germany, and Belgium.

WEEK ENDING  APRIL 9

PRODUCT
a) Compumedics E-Series Digital Amplifier System part number 8008-0001-01 and 8008-0001-02, manufactured by Compumedics Limited, Australia. 
b) Nonin Xpod Oximeter model numbers 3011 and 3012, distributed for use with the Compumedics E-Series Digital Amplifier. 
CODE All codes.
RECALLING FIRM Compumedics USA, Ltd., El Paso, TX
REASON Under specific conditions, the housing of the pulse oximeter connected to the amplifier can become excessively warm causing a burn upon contact with skin.
VOLUME OF PRODUCT IN COMMERCE 1,376 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT
a) ABSOLOK Extra Absorbable Ligating Clip cartridges, small, code AP100. Ten cartridges are packaged per box.
b) ABSOLOK Extra Absorbable Ligating Clip cartridges, medium, code AP200. Ten cartridges are packaged per box. 
c) ABSOLOK Extra Absorbable Ligating Clip cartridges, medium/large, code AP300. Ten cartridges are packaged per box. 
d) ABSOLOK Extra Absorbable Ligating Clip cartridges, large, code AP400. Ten cartridges are packaged per box. 
CODE
a) Lot: SL2102, exp. date 07/08; SL2116, exp. date 07/08; SL2123, exp. date 07/08; SM7266, exp. date 07/08; SP2618, exp. date 07/08; TB2043, exp. date 01/09; TB2044, exp. date 01/09; TB2199, exp. date 01/09; TB2333, exp. date 01/09; TB7971, exp. date 01/09; TD7873, exp. date 01/09; TG8166, exp. date 01/09; TJ2047, exp. date 07/09; TJ2331, exp. date 07/09; TJ8306, exp. date 07/09; TK8398, exp. date 07/09; TL2243, exp. date 07/09; TL2352, exp. date 07/09; and TP7672, exp. date 07/09.
b) Lot: SK2046, exp. date 07/08; SK2054, exp. date 07/08; SL2103, exp. date 07/08; SL2111, exp. date 07/08; SL2112, exp. date 07/08; SL2117, exp. date 07/08; SL2128, exp. date 07/08; SM2549, exp. date 07/08; SM2621, exp. date 07/08; TA2977, exp. date 01/09; TA7272, exp. date 01/09; TA7585, exp. date 01/09; TB2644, exp. date 01/09; TB7702, exp. date 01/09; TC2648, exp. date 01/09; TC7050, exp. date 01/09; TD2574, exp. date 01/09; TE2828, exp. date 01/09; TE7186, exp. date 01/09; TG2562, exp. date 01/09; TG2789, exp. date 01/09; TH2052, exp. date 07/09; TH2350, exp. date 07/09; TH7091, exp. date 07/09; TJ2137, exp. date 07/09; TJ2506, exp. date 07/09; TJ7414, exp. date 07/09; TL2620, exp. date 07/09; TL7452, exp. date 07/09; TP7673, exp. date 07/09; UA2003, exp. date 01/10; UA2244, exp. date 01/10; UA2309, exp. date 01/10; UA2440, exp. date 01/10; UA2608, exp. date 01/10;
UA2822, exp. date 01/10; and UA2823, exp. date 01/10.
c) Lot: SK2037, exp. date 07/08; SK2055, exp. date 07/08; SL2104, exp. date 07/08; SL2118, exp. date 07/08; SL2445, exp. date 07/08; SM2135, exp. date 07/08; SP2530, exp. date 07/08; SP2711, exp. date 07/08; TA2840, exp. date 01/09; TB2335, exp. date 01/09; TC7957, exp. date 01/09; TD2044, exp. date 01/09; TD2280, exp. date 01/09; TD2664, exp. date 01/09; TD2938, exp. date 01/09; TE7512, exp. date 01/09; TG7713, exp. date 01/09; TG7825, exp. date 01/09; TG7936, exp. date 01/09; TK2477, exp. date 07/09; TK7626, exp. date 07/09; TL2169, exp. date 07/09; TL7265, exp. date 07/09; TP7279, exp. date 07/09; UA2517, exp. date 01/10; UA2747, exp. date 01/10; UA2932, exp. date 01/10; and UA7902, exp. date 01/10.
d) Lot: TE7978, exp. date 01/09; TE8279, exp. date 01/09; TE2018, exp. date 01/09; TG2223, exp. date 01/09; TG7067, exp. date 01/09; TL7643, exp. date 07/09; SK2036, exp. date 07/08; SL2110, exp. date 07/08; SM2078, exp. date 07/08; SM2353, exp. date 07/08; TA7932, exp. date 01/09; TB2334, exp. date 01/09; TE2375, exp. date 01/09; and TE2486, exp. date 01/09.
RECALLING FIRM/MANUFACTURER Ethicon Endo-Surgery, Cincinnati, OH
REASON The product is being recalled because the possibility exists that the sterility of the ligating clips may have been compromised by a tear in the ABSOLOK Extra packaging.
VOLUME OF PRODUCT IN COMMERCE 56,934 devices.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Bio-Rad Pathfinder RSV Test Kit. Top of kit labeled PATHFINDER RSV DIRECT ANTIGEN DETECTION SYSTEM 79674 IN VITRO TEST DIAGNOSTIC USE. Side of kit states Bio-Rad 3, boulevard Raymond Poincare France. 
CODE Lot # & Expiration dates: 1L044 3/31/03; 2C047 7/31/03; 2H049 9/30/03; 2L050 9/30/03; 2M051 9/30/03; 2M052 11/30/03; 3D053 10/31/04; 3H0055 10/31/04; 3K0054 10/31/04; 4A0056 7/5/2005.
RECALLING FIRM Bio-Rad Laboratories, Inc, Redmond, WA
REASON New instructions to recommend against using samples with visibly high level of blood.
VOLUME OF PRODUCT IN COMMERCE 1,547 kits.
DISTRIBUTION Nationwide.

PRODUCT Hill-Rom Total Care SpO2RT pulmonary therapy bed system, Model 1900. 
CODE Lot # & Expiration dates: 1L044 3/31/03; 2C047 7/31/03; 2H049 9/30/03; 2L050 9/30/03; 2M051 9/30/03; 2M052 11/30/03; 3D053 10/31/04; 3H0055 10/31/04; 3K0054 10/31/04; 4A0056 7/5/2005.
RECALLING FIRM/MANUFACTURER Hill-Rom, Inc., Batesville, IN
REASON Siderails may stay up without latching into place.
VOLUME OF PRODUCT IN COMMERCE 228 beds.
DISTRIBUTION Nationwide and Canada.

PRODUCT
a) Nellcor brand Pulse Oximeter, Model NPB290, MALLINCKRODT, Made in Ireland.
b) Nellcor Puritan Bennett brand Pulse Oximeter, Model NPB295, Made in Ireland;
c) Nellcor brand OxiMax Pulse Oximeter, model number N-595 Made in Ireland;
d) Nellcor brand Pulse Oximeter, model N-395, Made in Ireland; 
CODE All units with serial numbers beginning with G01844386.
RECALLING FIRM Nellcor Puritan Bennett, Pleasanton, CA
REASON The internal speaker components are failing and do not produce an audio alarm in the event of patient emergency.
VOLUME OF PRODUCT IN COMMERCE 56,471 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT
a) Terumo Advanced Perfusion System 1 (with 6 inch diameter roller pump), Catalog number 801041.
b) Terumo Advanced Perfusion System 1 (with 4 inch diameter roller pump), Catalog number 801040.
CODE
a) Serial numbers 0028 through 0527 and 0700 through 0874;
b) Serial numbers 0030 through 0587 and 0700 through 0975.
RECALLING FIRM/MANUFACTURER Terumo Cardiovascular Systems Corp, Ann Arbor, MI
REASON The pumps will stop, show an overspeed error message, and will not restart using routine procedures if the user reduces the pump speed to zero RPM while the pump is operating in pulse mode.
VOLUME OF PRODUCT IN COMMERCE 1,509 pumps.
DISTRIBUTION Nationwide and Internationally.

WEEK ENDING APRIL 16

PRODUCT MicroScan Ô Rapid Pos Inoculum Broth, Catalog #: B1015-14. 
CODE Lot Nos: 050905A-1, 051005A-1, 051605A-1, 051705A-1, 052305A-1, 052805B-1.
RECALLING FIRM/MANUFACTURER Dade Behring Inc, West Sacramento, CA
REASON There is a potential for reporting of false susceptible anti-microbic results that could result in inappropriate and/or less effective therapy.
VOLUME OF PRODUCT IN COMMERCE 324 boxes.
DISTRIBUTION Nationwide and Puerto Rico.

PRODUCT PET/CT Software Versions MSV 1.0 and 1.1 used in the following PET (Positron Emission Tomography) and X-Ray Computed Tomography (CT) systems: • Siemens Models: Biograph PET/CT • CTI Models: Reveal PET/CT. 
CODE 0054081001, 0054081002, 0054081003, 0054081004, 0054081006, 0054081007, 0054081008, 0054081009, 0054081010, 0054081011, 0054081012, 0054081013, 0054081014, 0054081015, 0054081016, 0054081017, 0054081018, 0054081020, 0054081021, 0054081022, 0054081023, 0054081024, 0054081025, 0067331002, 0067331003, 0067331004, 0067331005, 0067331006, 0067331007, 0067331008, 0067331009, 0067331010, 0067331011, 0067331012, 0067331013, 0067331014, 0067331015, 0067331016, 0067331017, 0067331018, 0067331019, 0067331020, 0067331021, 0067331022, 0067331023, 0067331024, 0067331025, 0067331026, 0067331027, 0067331029, 0067331030, 0067331031, 0067331032, 0067331033, 0067331034, 0067331035, 0067331036, 0067331037, 0067331038, 0067331039, 0067331040, 0067331041, 0067331042, 0067331043, 0067331044, 0067331045, 0067331046, 0067331047, 0067331048, 0067331049, 0067331050, 0067331051, 096-001002, 096-001004, 096-001005, 096-001006, 096-001007, 096-001008, 096-001009, 096-001011, 096-001012, 096-001013, 096-001014, 096-001015, 096-001016, 096-001017, 096-011002, 096-011003, 096-011005, 096-011006, 096-011007, 096-011008, 096-011009, 096-011010, 096-011011, 096-011012, 096-011013, 096-011014, 096-011015, 096-011016, 096-011017, 096-011018, 096-011019, 096-011020, 214-001002, 214-001003, 214-001004, 214-001005, 214-001006, 214-001007, 214-001008, 214-001016, 214-01001A, 214-011001, 214-011002, 214-011003, 214-011004, 214-011005, 214-011006, 214-011007, 214-011008, 214-011009, 214-011010, 214-011011, 214-011012, 214-011013, 214-011014, 214-011015, 214-011017, 214-011018, 214-011019, 214-011020, 214-011021, 214-011022, 214-011023, 214-011024, 214-011025, 214-011026, 214-011027, 214-011028, 214-011029, 214-011030, 214-011031, 214-011032, 214-011033, 214-011034, 214-011035, 214-011036, 214-011037, 214-011038, 214-011039, 214-011040, 214-011041, 214-011042, 216-001001, 216-001006, 216-001009, 216-001011, 216-001013, 216-001014, 216-001015, 216-001016, 216-001017, 216-001018, 216-001019, 216-001020, 216-001021, 216-001022, 216-001023, 216-001024, 216-001026, 216-001027, 0064871002, 0064871003, 0064871004, 0064871005, 0064871006, 0064871007, 0064871008, 0064871009, 0064871010, 0064871011, 0064871012, 0064871013, 0064871014, 0064871015, 0064871016, 0064871017, 0064871018, 0064871019, 0064871020, 0069391014, 0071301002, 0071301003, 0071301004, 0071301005, 0071301006, 0071301007, 0071301008, 0071301009, 0071301010, 0067331011, 0071301012, 0071301013, 0071301015, 0071301016, 0071301017, 0071301018, 0071301019, 0071301020, 0071301021, 0071301022, 0071301024.
RECALLING FIRM CTI PET Systems, Inc, Knoxville, TN
REASON Misalignment of CT and PET scans from performing additional CT scans may produce an incorrect fused data set. In performing additional CT scans, the original PET and CT scans may become misaligned and produce an incorrect fused data set.
VOLUME OF PRODUCT IN COMMERCE 214.
DISTRIBUTION Nationwide and Internationally.

PRODUCT CryoValve, Pulmonary Valve and Conduit. Donor Number: 70022, Model Number: PV00. 
CODE Serial Number: 8056613.
RECALLING FIRM/MANUFACTURER Cryolife Inc., Kennesaw, GA
REASON During a retrospective review CryoLife's Medical Director identified pre-processing and incoming bioburden cultures of the heart tissue, which detected Staphylococcus aureas.
VOLUME OF PRODUCT IN COMMERCE 1 tissue.
DISTRIBUTION KS.

PRODUCT Electri-Cool II. 
CODE All units manufactured from 3/04-5/04.
RECALLING FIRM Cincinnati Sub-Zero Products, Cincinnati, OH
REASON There is the potential that the power switch assembly can dislodge from the cabinet during use.
VOLUME OF PRODUCT IN COMMERCE 116 devices.
DISTRIBUTION Nationwide.

PRODUCT Micro-temp II heat therapy unit, model #747. 
CODE All units containing version 0.70 software.
RECALLING FIRM/MANUFACTURER Cincinnati Sub-Zero Products, Cincinnati, OH
REASON There is the potential that the power switch assembly can dislodge from the cabinet during use.
VOLUME OF PRODUCT IN COMMERCE 553 devices.
DISTRIBUTION Nationwide.

PRODUCT
a) Sheridan Sher-I-Bronch Left Endobronchial Tube; an Rx, sterile, sinlge use endobronchial tube with modified tip for left bronchial intubation, 37 Fr.; sold under the following catalog numbers: catalog number (REF) V5-16037: Novaplus Sterile Sher-I-Bronch Endobronchial Tube for Left Bronchial Intubation, 37 Fr., Novation Corporation, catalog number (REF) 5-16037: Hudson RCI Sheridan
b) Sheridan Sher-I-Bronch Endobronchial Tube for Right Bronchial Intubation; an Rx, sterile, sinlge use endobronchial tube with modified tip for right bronchial intubation, 37 Fr.; catalog number (REF) 5-16137. 
CODE
a) a) Lot number 1145385; b) Lot numbers 1147855 and 1146242;
b) Lot numbers 1148460 and 1147062.
RECALLING FIRM
Recalling Firm: Teleflex Medical, Bannockburn, IL
Manufacturer: Hudson RCI Tecate S. de R.L. de C.V., Mexico. 
REASON The distal end of the tube may be printed incorrectly, with catalog numbers V5-16037 and 5-16037 stating "Bronchial - Right" instead of "Bronchial - Left", and catalog number 5-16137 stating "Bronchial - Left" instead of "Bronchial - Right".
VOLUME OF PRODUCT IN COMMERCE 4,941 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Tomoscan. 
CODE The firm utilizes site numbers: 6902, 6916, 6975, 6976, 13568, 13616, 13701, 13881, 13945, 14054, 15313, 17178, 17363, 17393, 17438, 17447, 26147, 35424, 35466, 35487, 35499, 37835, 37975, 38026, 38107, 38112, 38264, 38282, 38302, 38347, 38404, 38560, 38596, 38638, 38659, 38721, 38723, 38983, 40234, 40313, 40318, 40387, 41078, 41087, 41194, 41331, 41332, 41338, 41400, 41427, 41428, 41429, 44291, 44710, 44715, 44830, 45021, 45055, 45056, 46641, 50149, 50166, 50304, 50404, 59280, 59287, 59378, 59456, 59537, 59651, 59657, 59705, 62358, 62613, 62654, 62793, 62836, 62860, 62943, 62944, 68203, 73906, 73958, 73990, 74004, 74005, 74020, 76037, 76211, 76361, 76367, 76415, 76416, 76598, 76599, 76929, 82611, 82649, 82830, 82900, 83049, 83055, 84426, 85076, 86024, 86363, 104223, 104301, X0191, X0206, X0224, X0247, X0733, X0927, X1018, X1047, X1058, X1129, X1130, X1133, X1170, X1187, X1213, X1214, X1243, X1245, X1307, X1354, X1368, X1369, X1370, X1432, X1479, X1481, X1482, X1532, X1533, X1672.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems Sales and Service, Region No. America, Bothell, WA
Manufacturer: Hitachi Medical Systems, CT Product Division, Kashiwa, Japan. 
REASON Potential for shift of reference lines.
VOLUME OF PRODUCT IN COMMERCE 138 devices.
DISTRIBUTION Nationwide.

PRODUCT

a) CryoValve, Aortic Valve & Conduit SG. Donor #63601, Model #SGAV00. 
b) CryoValve, Pulmonary Valve & Conduit. Donor #65989, Model #PV00. 
c) CryoValve, Aortic Valve & Conduit. Donor #75651, Model #AV00.
CODE
a) Serial #7846205;
b) Serial #8095375;
c) Serial #7439561.
RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, GA
REASON During a retrospective review, CryoLife noted that the donor tissue exceeded the acceptable warm ischemic time when utilizing the “Last Seen Alive” time in their calculation.
VOLUME OF PRODUCT IN COMMERCE 3 tissues.
DISTRIBUTION CA, NJ, and TX.

 

PRODUCT

a) Latex-Free REF B1000, Belly Bag Urine Collection Bag with Hip Belt,***1000 ml Lot ***Sterile EO.
b) Latex-Free REF B1000P Belly Bag Urine Collection Bag with Sample Port ***1000 ml Lot ***Sterile EO*** Single use only. 
CODE
a) Lots 121870, 121871, 121872, 122515, 122517, 122518, 123273, 123274, 123275, 124066, 124333 and 124334;
b) Lots 121848, 122514, 124332, 125309 and 125885.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teleflex Medical, Inc., Duluth, GA
Manufacturer: Rusch Inc, Duluth, GA. 
REASON Firm received complaints of leaking urine collection bags.
VOLUME OF PRODUCT IN COMMERCE 7,256 bags.
DISTRIBUTION Nationwide, Australia, Japan and the UK.

 

PRODUCT

a) Roche COBAS INTEGRA HBA1c Kits for use with COBAS INTEGRA 400, 400+, 700 and 800 analyzers; catalog 20753521322. 
b) Roche ULTIMATE 3 HBA1C test kit for use with MIRA analyzers; catalog number 20755648322.
c) Roche ULTIMATE 5 HBA1C test kit for use with MIRA analyzers; catalog number 20755656322.
CODE
a) Lots 660587, 659867, 657295, 657344, 658498, 656157, 655052, 653288, 653424, 652153, 650988, 650430, 650119, 649291, 647186, 646336, 644962, 643398 and 642104;
b) Lots 646340, 650984, 651640 and 653292;
c) Lots 645515, 650134, 655120, 660108.
FIRM/MANUFACTURER Roche Diagnostics, Corp., Indianapolis, IN.
REASON The product is not uniform across the cassettes of some lots, which will result in an inconsistent bias of patient results.
VOLUME OF PRODUCT IN COMMERCE 347,000 Integra cassettes and 1,800 MIRA kits.
DISTRIBUTION Nationwide.

 

WEEK ENDING APRIL 23

PRODUCT
a) ENTrak Navigation and Visualization System. The particular accessories (“Sensors”) involved are:

b) ENTrak Plus Navigation and Visualization System. The particular accessories (“Sensors”) involved are:

c) Insta Trak 3000 Navigation and Visualization System. The particular accessories (“Sensors”) involved are:

d) Insta Trak 3500 Navigation and Visualization System. The particular accessories (“Sensors”) involved are:

1) Short Range Transmitter;

e) Insta Trak 3500 Plus Navigation and Visualization System. The particular accessories (“Sensors”) involved are:

1) Short Range Transmitter;

f) Fluro Trak 9800 Plus Navigation and Visualization System. The particular accessories (“Sensors”) involved are:

1) Short Range Transmitter;

CODE
a), b), c), d), e) and f) 1) (P/N 1004587 or 1002008); 2) (P/N 1004069 or 1001989);

RECALLING FIRM/MANUFACTURER GE OEC Medical Systems, Inc., Salt Lake City, UT
REASON Enhanced sterility testing revealed the sterilization efficacy of accessories (“Sensors”) used with certain Navigation and Visualization systems may be compromised.
VOLUME OF PRODUCT IN COMMERCE 502 units.
DISTRIBUTION Nationwide and Canada.

PRODUCT

a) Baxter Posiflow Access Device for IV Access; a single use, sterile device with Posiflow Positive Displacement Feature and Male Luer Lock Adapter, 0.06 mL. 

b) Baxter Extension Sets with Posiflow Access Device for IV Access; a single use, sterile fluid pathway devices with Posiflow Positive Displacement Feature. 
CODE
a) Product code 2N9050; all lots without expiration dating; 

b) P roduct codes 2N9051, 2N9052, 2N9053, 2N9054, 2N9055, 2N9057; all lots without expiration dating.
RECALLING FIRM Recalling Firm: Baxter Healthcare Corp, Round Lake, IL

Manufacturer: Baxter Healthcare Corp, Aibonito, PR. Firm initiated recall is ongoing.
REASON Product older than three years may not operate as intended.
VOLUME OF PRODUCT IN COMMERCE 1,585,542 units.
DISTRIBUTION Nationwide and Venezuela.

PRODUCT Easy Access Image Management System with CL. Net. 
CODE Part Numbers: SW R9.2 for Easy Access Enterprise Edition (W2K); R9.2, R8.2 for Easy Access Enterprise (HPUX 11); Easy Access entry R8.2 and R9.2; R2.1 and R3.1 for Easy Access Modality. The firm utilizes site numbers instead of serial numbers. Site numbers include: 530649, 505274, 506461, 505267, 87076, 101168, 101378, 101590, 102520, 103216, 103220, 103224, 103513, 103767, 104599, 104653, 104679, 104751, 104849, 105106, 105374, 105419, 105517, 105592, 105765, 105826, 105931, 250195, 504436, 504984, 505001, 505025, 505065, 505070, 505183, 505390, 505427, 505506, 505609, 505674, 505778, 505829, 505897, 505973, 506046, 506259, 506330, 506367, 506413, 506453, 506454, 506472, 506699, 519629, 519703, 519977, 520441, 521847, 522273, 526142, 526150, 526153, 526186, 530629.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems Sales & Service Region No. America, Bothell, WA
Manufacturer: Philips Medical Systems, Netherlands. 
REASON Failure to update correctly when re-transmitting an image from the modality.
VOLUME OF PRODUCT IN COMMERCE 60 units.
DISTRIBUTION Nationwide.

PRODUCT Automatic Cutting Needle Model: NAC-1820B, Size 18 GA x 20 CM, Single use: Ethylene Oxide sterilized. 
CODE Lot number 04351 and 043272.
RECALLING FIRM/MANUFACTURER Remington Medical Inc., Alpharetta, GA
REASON The stylet hub detaches from the stylet needle.
VOLUME OF PRODUCT IN COMMERCE 1,737 units.
DISTRIBUTION Nationwide.

PRODUCT
a) ESD-5, ESD Flexible Endoscopic Suturing Device, Flexible Sew - Right Device: Flexible TI - Knot Device: External Accessory Channel: 6mm./75 cm.; * Suture Quickload Units (2); TI - Knot Quickload Units (2) * Disposable - Single Use Only * Sterile/EO * Rx Only. 

b) BCP-7A, Quick Silver Bipolar Coagulation Probe, For use w/dual Plug Bipolar Generators * Catheter Diameter: 7 FR. Catheter Length: 35 CM. Disposable – Single Use Only * Sterile/EO * Rx Only * 
CODE
a) Product Order #ESD-5:
Lot #1519202, Vendor Exp. 05/2002 * Label Exp. 08/2006, Lot #1520620, Vendor Exp. 05/2002 * Label Exp. 08/2006, Lot #1521208, Vendor Exp. 06/2003 * Label Exp. 08/2006, Lot #1521209, Vendor Exp. 06/2003 * Label Exp. 08/2006, Lot #1521210, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1521211, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1537952, Vendor Exp. 06/2003 * Label Exp. 08/2006, Lot #1540901, Vendor Exp. 06/2003 * Label Exp. 08/2006, Lot #1540902, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1541688, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1542196, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1545823, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1546030, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1548352, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1550759, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1551793, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1553535, Vendor Exp. 06/2003 * Label Exp. 09/2006, Lot #1577921, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1577922, Vendor Exp. 09/2003 * Label Exp. 01/2007, Lot #1577923, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1581400, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1582964, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1584872, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1584573, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1584928, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1585415, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1593074, Vendor Exp. 08/2002 * Label Exp. 01/2007, Lot #1595660, Vendor Exp. 09/2003 * Label Exp. 01/2007, Lot #1595661, Vendor Exp. 09/2003 * Label Exp. 01/2007, Lot #1595662, Vendor Exp. 09/2003 * Label Exp. 01/2007, Lot #1595663, Vendor Exp. 09/2003 * Label Exp. 01/2007, Lot #1695664, Vendor Exp. 09/2003 * Label Exp. 01/2007, Lot #1695665, Vendor Exp. 09/2003 * Label Exp. 01/2007, Lot #1595666, Vendor Exp. 09/2003 * Label Exp. 03/2007;
b) Product Order #BCP-7A:
Lot #1331630, Vendor Exp. Date 01/2005 * Label Exp. Date 02/2005.
RECALLING FIRM/MANUFACTURER Wilson-Cook Medical, Inc., Winston Salem, NC
REASON The expiration date listed on the product label is greater than the vendor recommended expiration date.
VOLUME OF PRODUCT IN COMMERCE 249 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT
a) CSN00210 8MHz blood flowmeter probe used with the Quantix/OR system. 
b) CSN00200 4MHz blood flowmeter probe used with the Quantix/OR system. 
CODE All serial numbers.
RECALLING FIRM/MANUFACTURER Neoprobe Corp, Dublin, OH
REASON The probe’s faceplate seal can fail and allow penetration of cleaning fluids during the cleaning and soaking cycle between uses or ingress of biohazard fluids during surgical procedures.
VOLUME OF PRODUCT IN COMMERCE 83 devices.
DISTRIBUTION MA, CA, FL, MO, UK, Taiwan, Japan, Hong Kong, Turkey and Switzerland.

PRODUCT Voyager RX Coronary Dilatation Catheter. 
CODE Catalog numbers apply in this recall situation as follows: Balloon Diameter (mm) Balloon Length (mm) 8 12 15 20 25 30 1.50 N/A 1011391-12 1011391-15 N/A N/A N/A 2.00 1011392-08 1011392-12 1011392-15 1011392-20 1011392-25 1011392-30 2.25 1011393-08 1011393-12 1011393-15 1011393-20 1011393-25 1011393-30 2.50 1011394-08 1011394-12 1011394-15 1011394-20 1011394-25 1011394-30 2.75 1011395-08 1011395-12 1011395-15 1011395-20 1011395-25 1011395-30 3.00 1011396-08 1011396-12 1011396-15 1011396-20 1011396-25 1011396-30 3.25 1011397-08 1011397-12 1011397-15 1011397-20 1011397-25 1011397-30 3.50 1011398-08 1011398-12 1011398-15 1011398-20 1011398-25 1011398-30 Column at the left represents the diameter. The last two digits after the hyphen indicate the length. Lot Numbers The full list of lot numbers being recalled exceeds 1000. The scope of the recall involves all lots of the sizes given above that have lot numbers in the range: 40101XX through 41231XX, inclusive where XX can be any digits. For reference lot numbers are date coded: YMMDDLS Where Y=last digit of year manufactured, MM=month manufactured, DD=day manufactured, L=location manufactured, (5= Temecula CA, 3= Clonmel Ireland, S=sequence (1= first lot of day, 2= second lot of day). TO IDENTIFY A UNIQUE PRODUCT ONE NEEDS BOTH THE PART NUMBER AND LOT NUMBER (MULTIPLE PART NUMBERS ARE ASSIGNED THE SAME LOT NUMBER PER THE CONVENTION ABOVE.
RECALLING FIRM/MANUFACTURER Guidant Corporation Advanced Cardiovascular System, Temecula, CA
REASON Leak at guide wire exit notch could introduce air into the artery.
VOLUME OF PRODUCT IN COMMERCE 180,000 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Implantable Cardioverter-Defibrillator Models affected include the following: Atlas+ Models V-193, V-193C and V-243 Epic+ Models V-196, V-236 and V-239 Epic Models V-197 and V-233 Atlas Model V-242 Epic HF Models V-337 and V-338 Epic+HF Models V-339 and V-350 Atlas+ HF Models V-340, V-341 and V-343. 
CODE To numerous to include here.
RECALLING FIRM St. Jude Medical, Sylmar, CA
REASON Sensitivity of a magnetic switch was not being set correctly. This could result in delivery of an unneeded shock during surgery with use of electrocautery.
VOLUME OF PRODUCT IN COMMERCE 1,488 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT KION Anesthesia System. 
CODE Serial Number: 2034; 3416; 3417; 3418; 3419; 3420; 3027; 0501; 3394; 3395; 3396; 3433; 3444; 3445; 3446; 2355; 2356; 2033; 2035; 1838; 1839; 1840; 1841; 1842; 1873; 1874; 1875; 1876; 1877; 1899; 1900; 1902; 1903; 2132; 2032; 1723; 1724; 1725; 1726; 1727.
RECALLING FIRM/MANUFACTURER Maquet, Inc., Bridgewater, NJ
REASON Software update so US customers will be updated equally with worldwide customers. Ver. 5.0 will be upgraded to ver 7.0. Quality will improve and enhance functionality.
VOLUME OF PRODUCT IN COMMERCE 40 systems.
DISTRIBUTION Nationwide.

PRODUCT Stealth Station Cranial Application v.4.5. Catalog Numbers: 960-201 and 9730888. 
CODE Software v.4.5.
RECALLING FIRM Medtronic Surgical Navigation Technologies, Inc., Louisville, CO
REASON The Stealth Station Cranial Application Version 4.5 contains a software anomaly, which may present a hazard to the patient. The user has the option to create and make visible supplemental contours of specific anatomy viewable during a surgical procedure. Activation of a new tip extension feature will move the location of these contours in such a manner that they no longer correlate to the intended anatomy. Potential consequences may include improper resection of the brain tissue.
VOLUME OF PRODUCT IN COMMERCE 44 systems.
DISTRIBUTION Nationwide and Internationally.

PRODUCT DiaSorin ETI-EA-G assay kit, Catalog No. 7570. .
CODE Lot # 113963C.
RECALLING FIRM/MANUFACTURER Diasorin Inc., Stillwater, MN
REASON The kits contained the wrong microtiter plate. The plate provided in the kits was for a different product, the Pro Trac II Tacrolimus kit.
VOLUME OF PRODUCT IN COMMERCE 46 kits.
DISTRIBUTION FL, TX, and UT.

PRODUCT IMx HAVAB Controls in Vitro Test. 
CODE Lot # 21059Q100 Expiration Date: May 20, 2005.
FIRM/MANUFACTURER Abbott Health Products, Inc., Barceloneta, PR
REASON Abbott identified through investigational studies that IMxHAVAB Controls is generating Negative Control values outside the upper range specified in the IMxHAVAB Package Insert.
VOLUME OF PRODUCT IN COMMERCE 373 kits.
DISTRIBUTION Nationwide and Internationally.

PRODUCT DiaSorin programming software written for a specific automated microtiter plate instrument, Bio-Tek Elx800 reader for use with the ENA 6 Screen ELISA kit assay. 
CODE Software versions 9 thru 12.
RECALLING FIRM/MANUFACTURER Diasorin, Inc., Stillwater, MN
REASON An error in the Bio-Tek Elx800 microplate reader programming specifications for the ENA screen Assay exists in that an equivocal (borderline) zone is missing.
VOLUME OF PRODUCT IN COMMERCE 16.
DISTRIBUTION CT, FL, NY, WA, TX, AR, TN, and Canada.

PRODUCT Data reduction program written specifically for Bio-Tek Elx800 automated microtiter plate reader with use of Diastat Anti-Mitochondrial Antibody Kit. 
CODE Software version 12.
RECALLING FIRM Diasorin, Inc., Stillwater, MN
REASON The data reduction program written for a specific automated microtiter plate instrument (Bio-Tek Elx800 reader) was found to be faulty. This program is used to calculate the cut off values for Diastat Anti-Mitochondrial Antibody Kit. Program should include a borderline specification to indicate repeat testing is needed.
VOLUME OF PRODUCT IN COMMERCE 8.
DISTRIBUTION CA, CT, KS, MA, and WA.

PRODUCT Data reduction program written for a specific automated microtiter plate instrument (Bio-Tek Elx800 reader) for use with Diastat Anti-Beta2 Glycoprotein ELISA assay kit. 
CODE Software version 12.
RECALLING FIRM/MANUFACTURER Diasorin, Inc., Stillwater, MN
REASON The data reduction program written for a specific automated microtiter plate instrument (Bio-Tek Elx800 reader) is faulty in that the positive result limit is to be greater than 15 U/ml, rather than greater than or equal to 15 U/ml.
VOLUME OF PRODUCT IN COMMERCE 7.
DISTRIBUTION CT, MI, MT, UT, and Canada.

PRODUCT Data reduction program software written specifically for Bio-Tek Elx800 (DiaSorin part # 15713) automated microtiter plate reader with use of Diastat Anti-Thyroglobulin Assay (manufacturer part #7700). 
CODE Software version 9 thru 12.
RECALLING FIRM/MANUFACTURER Diasorin, Inc., Stillwater, MN
REASON The data reduction program written for a specific automated microtiter plate reader (Bio-Tek Elx800) was found to be faulty. This program is used to calculate the cut off values for the Diastat Anti-Thyroglobulin Kit assay. The negative Control Upper Limit should be less than 0.95, rather than less than 1.0.
VOLUME OF PRODUCT IN COMMERCE 6.
DISTRIBUTION CA, FL, MA, NY, and TX.

PRODUCT PolyTiter software version 2.8 for use in the Polymedco PolyTiter Immunofluorescent Titration System, DiaSorin part # PT100 which is programmed for DiaSorin ANAFLUOR Indirect fluorescent Antibody Test For the detection and titration of circulating antinuclear antibodies. REF: 1624, 1662, 1660, 6624, 1604.
CODE PolyTiter software version 2.8.
RECALLING FIRM/MANUFACTURER Diasorin, Inc., Stillwater, MN
REASON The program is for a specific immunofluorescent titration system (Polymedco PolyTiter immunofluorescent Titration System) was found faulty in that the calibrator 2 value was incorrectly programmed as 1:120 instead of 1:160.
VOLUME OF PRODUCT IN COMMERCE 14.
DISTRIBUTION Nationwide.

PRODUCT
a) Fill Tube, diverted, Catalog # 300-1002, is used for the delivery of granular autograft or allograft into Spineology’s OptiMesh implant. Fill tube is identified with Spineology, catalog number and lot number printed directly onto the metal. 

b) Fill Tube, straight, Catalog # 300-1001, is used for the delivery of granular autograft or allograft into Spineology's OptiMesh implant. Fill tube is identified with Spineology, catalog number and lot number printed directly onto the metal. 

c) Platen, Catalog # 301-124, is a mechanism used to lock or hold the fill tube in place as it is filled with graft material. Platen is identified with Spineology, catalog number and lot number printed directly onto the metal. 
CODE
a) Lot # UN02002, 71-1057, UN04003 and UN04004; 

b) Lot # UN02001, 71-1057, UN04001, UN04004, and M04041;

c) Lot # UT04005.
RECALLING FIRM/MANUFACTURER The Spineology Group, Stillwater, MN
REASON Three malfunctions, due to jamming of bone material in the fill tube occurred. Fill tubes are used in delivery of bone graft materials.
VOLUME OF PRODUCT IN COMMERCE 4,302 units.
DISTRIBUTION Nationwide and UK.

PRODUCT CryoValve, Aortic Valve and Conduit. Donor #56844, Model #AV00. 
CODE Serial #7399626.
RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, GA
REASON An incorrect lot number was entered in the production record for the solution in which this allograft was packaged.
VOLUME OF PRODUCT IN COMMERCE 1 tissue.
DISTRIBUTION TN.

Kingswood Laboratories, Inc. Issues Nationwide Recall of Moi-Stir Oral Swabsticks

Kingswood Laboratories, Inc., Indianapolis, IN, is initiating a nationwide recall of Moi-Stir Oral Swabsticks.   Some of the swabsticks have been found to contain molds including Aspergillus and Penicillium which could result in respiratory infections.Consumers who have any of the recalled Moi-Stir Swabsticks should stop using them immediately and return them to the point of purchase.

 Doctors and dentists should consider screening patients who are at risk for infections, especially those with weakened immune systems (low white blood cell counts) who have used the Moi-Stir Swabstick.

Moi-Stir Swabsticks are oral swabs used to moisten the mouths of patients.  Moi-Stir is a saliva supplement intended to relieve dry mouth, physically clean the oral cavity, thin phlegm, and lower dental caries rates.  The product was distributed to hospitals, hospital wholesalers, pharmacies, nursing homes, physician and dentist offices, consumers, some government medical facilities, and as free samples to a small number of individuals.  The swabsticks are packaged as three sticks in a white foil pouch, with "Moi-Stir" on the front of the pouch, in green lettering.

The recall includes Moi-Stir Swabsticks with lot numbers A2, 1193, 1209, 1233, 1260, and 1725. Lot numbers are marked on each case, carton, and individual pouch of swabs. (The lot number for A2 is embossed into the right side of the pouch.  All other lot number's are embossed into the pouch, at the bottom right corner.)   No expiration dates are included in the labeling.

Kingswood Laboratories, Inc. is notifying its distributors and customers by phone, fax, and e-mail and is arranging for the immediate return of all recalled product.

Consumers and healthcare professionals with questions may contact Lynn Meng, RN, MSN, Quality Assurance Manager or Suchinda Stithit, R.Ph., Ph.D., Director of Regulatory Affairs, Kingswood Laboratories, Inc. at 1-800-968-7772 between the hours of 8:30 AM and 5:00 PM, Monday through Friday.

Medtronic Announces Additional Devices Affected in Voluntary Recall of Certain Monophasic LifePak ® 500 Automated External Defibrillators

Medtronic, Inc. (NYSE: MDT) today announced that it has identified an additional 396 monophasic LIFEPAK ® 500 automated external defibrillators (AEDs) to be included in a voluntary recall originally announced on Feb. 25, 2005. The company will be contacting the owners of the additional 396 devices that are in use worldwide.

The affected AEDs may continue to display a “connect electrodes” message and may not analyze the patient’s heart rhythm even when the electrodes are properly connected. Failure to analyze the patient’s heart rhythm will inhibit defibrillation, if it is needed.

The company has already completed the updates or upgrades to the devices originally identified as affected. The company plans to complete the update or upgrade to the additional affected devices by May 31, 2005. Affected AEDs may remain in service, and customers with devices in this additional group are currently being contacted with recommendations for use and replacement schedules. Only certain monophasic LIFEPAK 500 AEDs manufactured in 1997 are included in this action. Customers with further questions about this issue should call 1-877-873-7630 or visit www.medtronic-ers.com/500 to determine if their device is included in the action.

The LIFEPAK 500 is used by first responders such as firefighters, police and others trained in CPR/AED use and are first to arrive at the scene of a cardiac incident but do not have significant medical training.

Medtronic, Inc., headquartered in Minneapolis, is the world’s leading medical technology company, providing lifelong solutions for people with chronic disease. Its internet address is www.medtronic.com.

WEEK ENDING APRIL 30

PRODUCT Bloom DTU-215-B Programmable Stimulator.
CODE All Bloom DTU-215-B Programmable Stimulators.
RECALLING FIRM/MANUFACTURER Fischer Imaging Corporation, Denver , CO 
REASON Possibility that after a loss of power or brown-out, the device may transmit unintended stimulation to patients.
VOLUME OF PRODUCT IN COMMERCE 712 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT
a) Site-Rite Sterile Needle Guide Kit – 18 gauge. Product Code 9001C0212. 
b) Site-Rite Sterile Needle Guide Kit – 20 gauge. Product Code 9001C0214. 
c) Site-Rite Sterile Needle Guide Kit – 21 gauge. Product Code 90013B01. 
d) Site-Rite Sterile Ultrasound Probe Cover with Gel. Product Code 9001C0197. 
e) Intraoperative Ultrasound Cover Kit. Product Code 900023B01. 
f) Ultra/Phonic Conductivity Gel, 20 ml, each unit is a oil to foil pouch. Product is packaged 25 pouches per box. Product Code 9001C0200.
g) Site Rite II, Site Rite 3, and Site Rite IV Systems with 2 Sterile Kits each. 
CODE
a) Lot numbers: 61208, 61233, 61258, 61287, 61308, 63189, 63220, 63225, 63263, 63305, 63338, 63360, 63383, 63402, 63414, 63442, 63472, 63515, 63530, 63564, 63597, 63646, 63720, 63766, 63783, 63817, 63845, 63875, 63924, 63953, 63991, 64056, 64063, 64125, 64164, 64191, 64258, 64261, 64269, 64330, 64364, 64401, 64420, 64433, 64448, 64452, 64514, 64652;

b) Lot numbers: 61187, 61233, 61258, 61302, 61332, 63189, 63220, 63245, 63270, 63339, 63360, 63398, 63401, 63402, 63422, 63451, 63515, 63521, 63538, 63564, 63612, 63615, 63666, 63729, 63766, 63783, 63830, 63862, 63925, 63957, 63973, 64042, 64094, 64108, 64148, 64182, 64218, 64229, 64258, 64261, 64268, 64378, 64419, 64420, 64440, 64460, 64493;

c) Lot Numbers 61189, 61219, 61280, 61302, 61332, 63141, 63147, 63171, 63245, 63262, 63339, 63360, 63401, 63421, 63422, 63450, 63451, 63521, 63538, 63590, 63615, 63666, 63723, 63729, 63770, 63814, 63830, 63862, 63913, 63925, 63991, 63998, 64028, 64063, 64080, 64137, 64151, 64192, 64218, 64229, 64261, 64289, 64330, 64353, 64375, 64401, 64447, 64492, 64550, 64591;

d) Lot numbers 61177, 61189, 61211, 61219, 61250, 61280, 61293, 61304, 63141, 63147, 63200, 63210, 63235, 63269, 63304, 63324, 63357, 63372, 63375, 63398, 63409, 63421, 63442, 63450, 63458, 63494, 63505, 63533, 63558, 63559, 63584, 63590, 63616, 63634, 63685, 63723, 63750, 63782, 63798, 63824, 63846, 63895, 63913, 63933, 63952, 63981, 64006, 64024, 64028, 64029, 64053, 64079, 64094, 64109, 64126, 64137, 64147, 64148, 64163, 64183, 64205, 64206, 64220, 64228, 64236, 64257, 64290, 64305, 64317, 64318, 64329, 64351, 64352, 64376, 64377, 64400, 64434, 64459, 64512, 64540, 64586, 64606, 64645, 64646;

e) Lot numbers 61233, 63200, 63235, 63263, 63270, 63324, 63357, 63375, 63401, 63409, 63414, 63451, 63458, 63515, 63530, 63559, 63612, 63615, 63646, 63674, 63770, 63824, 63875, 63953, 63998, 64080, 64191, 64258, 64269, 64289, 64317, 64493, 64586, 64646;

f) Lot Numbers 021404-4, 010904, 091403, 060303, 050403, 011003, 071202, 111300, 120998, 021202, 100101, 112703, 011202, 091398, 080900, 060500;

g) Site Rite II System - Item Numbers: 9740001-9740006. Serial number ranges: 32563-32624, 33450-33549, 35900-35999, 37300-37399, 37950-38028. Site Rite 3 System - Item Numbers: 9740010-9740019. Serial number ranges: 32774-32974, 34900-35149, 36100-36199, 36450-36510, A02001-A02383. Site Rite IV System - Item Numbers: 9740050-9740052, 9740059, 9740091, 9760004, 9760018. Serial number ranges: B03001-B03588, B03590-B03601, B03603-B03607, B03609, B03632, B03636, B03647. 

RECALLING FIRM Bard Access Systems, Inc., Salt Lake City , UT 
REASON Conductivity gel pouches, labeled as sterile, and packaged in various needle guide kits may not be sterile.
VOLUME OF PRODUCT IN COMMERCE 241,180 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Shiley FlexTra brand Flexible Dual- Cannula Tracheostomy Tube, Models: 358060, Size 6, FlexTra Cuffed; 358070, Size 7, FlexTra Cuffed; 358080, Size 8, FlexTra Cuffed; 358090, Size 9, FlexTra Cuffed; 358100, Size 10, FlexTra Cuffed; 359060, Size 6, FlexTra Uncuffed; 359070, Size 7, FlexTra Uncuffed; 359080, Size 8, FlexTra Uncuffed; 359090, Size 9, FlexTra Uncuffed; 359100, Size 10, FlexTra Uncuffed. 
CODE All codes are affected.
RECALLING FIRM/MANUFACTURER Recalling Firm: Nellcor Puritan Bennett, Pleasanton , CA 
REASON Outer cannula has the potential to separate from the head/flange assembly, leading to ineffective ventilation, which could result in serious injury.
VOLUME OF PRODUCT IN COMMERCE Approx. 17,056 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Allen A-91000 Shoulder Positioner. 
CODE Serial Numbers: 260227 260228 260229 260230 262208 A032121 A032122 A032123 A032124 A032125 A032126 A032128 A032129 A032340 A032942 A032944 A033038 A033039 A033040 A033920 A033921 A033922 A033923 A033924 A033925 A033927 A033928 A033929 A034241 A034242 A034243 A034623 A034624 A034626 A034627 A034628 A034877 A034907 A034909 A035239 A035242 A035243 A035623 A035624 A035625 A037489 A040087 A040359 A040360 A040361 A040362 A040363 A040364 A040650 A040693 A040694 A040778 A040779 A040780 A040781 A040782 A041742 A041743 A041744 A041745 A041746 A041747 A042080 A042081 A042082 A042159 A042533 A042534 A042640 A042641 A043683 A043684 A043953.
RECALLING FIRM/MANUFACTURER Allen Medical Systems, Acton, MA
REASON Shoulder positioner may break near the rail that attaches to the operating table.
VOLUME OF PRODUCT IN COMMERCE 78 units.
DISTRIBUTION Nationwide, Australia , Greece , Italy , and Ireland .

PRODUCT Intuitive Surgical da Vinci 8 mm Endo Wrist Curved Scissors, in box. FDA Device Listing Number R100529, Model Number 400178-01.510(k) number K021036. 
CODE All lots. P/N 400178-01.
RECALLING FIRM/MANUFACTURER Intuitive Surgical, Inc, Sunnyvale , CA
REASON Blades on the scissor may break and separate from the main unit as a result of corrosion damage.
VOLUME OF PRODUCT IN COMMERCE 278 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Centurion brand sterile Huber needle infusion set, 20 GA x 1 inch; product EXHNO10S. 
CODE Lots 11014, 12134 and 01105.
RECALLING FIRM/MANUFACTURER Tri-State Hospital Supply Corp., Howell, MI
REASON Some of the needles in these sets are ¾ inches in length instead of the labeled 1 inch.
VOLUME OF PRODUCT IN COMMERCE 1,350 sets.
DISTRIBUTION AL, KY, MI, MS, MO, NC, and SC.

PRODUCT Version 12 software program written for the Bio- Tek ELx800 automated microtiter plate reader with use of PRO- Trac Tacrolimus ELISA kit. 
CODE Version 12.
FIRM/MANUFACTURER Diasorin , Inc., Stillwater , MN 
REASON The software program written for use in the automated microtiter plate reader (Bio- Tek ELx800) for use with the Pro- Trac II Tacrolimus ELISA kit was found to be faulty. Assay software program did not include the Calibrator Zero OD specification (STDO>=1.500) as specified in the product insert.
VOLUME OF PRODUCT IN COMMERCE 8 kits.
DISTRIBUTION CA, DC, FL, KY, and Canada .

PRODUCT Version 7 software for wash program on Bio Tek Automated Microplate Washer Model Elx50 which performs the washing steps for various programmed mictotiter plate assays. 
CODE Version 7.
RECALLING FIRM/MANUFACTURER Diasorin , Inc., Stillwater , MN
REASON When software was updated for the Washer program of the Bio Tek Automated Microplate Washer Model Elx50, the software did not automatically clear old versions of the wash program when new ones were added.
VOLUME OF PRODUCT IN COMMERCE 9 kits.
DISTRIBUTION CA, FL, NH, PA, SD, TX, and WA.

PRODUCT DiaSorin GammaCoat Androstenedione - 125 I, RIA Kit for the quantitative determination of androstenedione levels in serum. Catalog No. CA-1725. 
CODE Lot # 04164.
RECALLING FIRM Diasorin, Inc., Stillwater , MN 
Manufacturer: Diagnostic Systems Laboratories, Inc., Webster, TX. 
REASON Standards contained in the GammaCoat Androstenedione RIA Kit appeared yellowish in color and were gelatinous upon reconstitution. The assay validation criteria failed when the gelatinous standards were used.
VOLUME OF PRODUCT IN COMMERCE 70 kits.
DISTRIBUTION MA and Internationally.

PRODUCT DiaSorin 25-HydroxyvitaminD [125I] RIA Kit. For the quantitative determination of 25-OH-D and other hydroxylated metabolites in serum or plasma. REF: 68100E. 
CODE Lot # 113300B.
RECALLING FIRM/MANUFACTURER Diasorin , Inc., Stillwater , MN 
REASON An incorrect expiration date of 2005/08/18 was placed on the kit box label for 25-hydroxyvitamin D [125I] RIA kits, Catalog 68100E, Lot 113300B. Correct label expiration date is 2004/08/18.
VOLUME OF PRODUCT IN COMMERCE 181 kits.
DISTRIBUTION Nationwide and Internationally.

PRODUCT DiaSorin Analyte Specific Reagent. 
CODE Lot # 926603-08.
RECALLING FIRM/MANUFACTURER Diasorin , Inc., Stillwater , MN 
REASON Expiration date of 2005/1/6 stamped on vial label of Anti-Human igG, Fluorescein Conjugate is incorrect. Correct expiration date is 2006/1/6.
VOLUME OF PRODUCT IN COMMERCE 6 (PRODUCT /ALB-IGGFITC-QTY 1; C3-IGGFITC-1; IGA-IGGFITC-2; IGG-IGGFITC-1; KAP-IGGFITC-1)
DISTRIBUTION WA, MA, and Korea .

PRODUCT Versa TREK REDOX 2 80 ml Anaerobic blood culture bottles, Product Code: 7103-44. The product was distributed in cases containing 50 bottles per case. 
CODE Lot #144444SA, Expiration Date: 01/2006.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Trek Diagnostic Systems, Cleveland, OH
Manufacturer: Trek Diagnostic Systems, Inc., Sun Prairie, WI. 
REASON Blood culture bottles with an error in the bar code on the labels, were shipped.
VOLUME OF PRODUCT IN COMMERCE 193 cases (9,650).
DISTRIBUTION Nationwide.

PRODUCT MEDPOR® Surgical Implant * POREX Surgical Products Group * Sterile/EO * Implant, Non- Pyrogenic, For Single Use Only, CAT #6317 DIM 20mm Diameter * Lot xxxxxx * QTY: 1 *. 
CODE Lot A004A02.
RECALLING FIRM/MANUFACTURER Porex Surgical, Inc., Newnan , GA 
REASON The product, which is a 20mm MEDPOR Sphere, was mislabeled in that the package contained 18mm MEDPOR Spheres.
VOLUME OF PRODUCT IN COMMERCE 30 units.
DISTRIBUTION AZ, IL, NJ and Korea .

Laerdal Medical Announces Voluntary Nationwide Recall of Adapter Cable for Certain Defibrillators 

Laerdal Medical Corporation, Wappingers Falls, New York, a subsidiary of Laerdal Medical AS, Stavanger, Norway, today announced that it is voluntarily recalling all lots of CM 100-Heartstart Adapter Cable, Cat. No. 920650 (Adapter Cable). 

Wires within the defibrillator adapter cables are susceptible to breakage.  The test method described in the defibrillator instructions for use will not detect internal breaks in the adapter cables. Use of these Adapter Cables should be discontinued. The Adapter Cable allows Laerdal Heartstart brand defibrillation electrodes with snap connecter to be used with HP/Agilent/Philips CodeMaster 100 and CodeMaster SL+/XL/XE defibrillators, Laerdal Heartstart 4000 defibrillators, and Philips HeartStart XLT, HeartStart XL, HeartStart MRx defibrillators. The Adapter Cable was supplied as a standard accessory with most CodeMaster 100 defibrillators that Laerdal distributed, and was sold as an optional accessory for use with the Laerdal Heartstart 4000 automated external defibrillator (AED). Cable Description: A 26” long black-colored “Y” configuration cable assembly with one cylindrical white two-pole connecter at its base, and a patient electrode snap connector on each of the two remaining leads, one red and one white. The number 281-132-00 appears on a white label band affixed to one of the leads. 

Over 3,000 Adapter Cables have been sold throughout the U.S. since 1996. Replacement cables from Laerdal are not available.

 Compatible alternative cabled electrodes that do not require adapters are available from Philips Medical Systems. 

Consumers with questions about the recall should contact NNC at 1-800-668-4391. 

Other inquiries should be addressed to Laerdal at 1-877-523-7325, or customerservice@laerdal.com.