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Showing 89661–89680 of 92409 results

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Unknown Manufacturer: EBI VueCath Endoscopic Spinal System

Non sterile device is labeled sterile.

FDAJun 17, 2003Nationwide

Mitek Worldwide: Profile 8 x 20 mm Cannulated Interference Screw Round Hea...

Mislabeled -Incorrect Screw Size. The unit labeled 7x 25 mm screw may be a 8 x2 0 mm; and the unit labeled 8 x20mm may be a 7 X 25mm

FDAJun 16, 2003CA, FL, MO +5 more• Mitek Worldwide

Mitek Worldwide: Profile 7 x 25 mm Cannulated Interference Screw Round Hea...

Mislabeled -Incorrect Screw Size. The unit labeled 7x 25 mm screw may be a 8 x2 0 mm; and the unit labeled 8 x20 mm may be a 7 X 25mm

FDAJun 16, 2003CA, FL, MO +5 more• Mitek Worldwide

Misys Healthcare Systems: Misys Laboratory System versions 5.3 up to 5.3.2 with Ana...

Software anomaly allows patient reports to contain incomplete data used for diagnosis or treatment.

FDAJun 16, 2003Nationwide• Misys Healthcare Systems

Sanarus Medical Inc: Sanarus Visica Treatment System (disposable), Model/Produ...

Corrosion in stainless steel device shaft that allows Argon gas to escape from device during a cryoablation procedure.

FDAJun 16, 2003Nationwide• Sanarus Medical Inc

Ballard Medical Products: Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Ca...

Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases.

FDAJun 13, 2003Nationwide• Ballard Medical Products

DPC Cirrus: Immulite 2000. Immunoassay system. Software version 2.6...

Version 2.6 software was released however it will not properly handle adjustment slopes.

FDAJun 13, 2003IN• DPC Cirrus

Ohmeda Medical, A division of Datex-Ohmeda, Inc.: Servo Controlled Oxygen System for Ohmeda''s Medical Gira...

Firm's received complaints of medical device malfunction affecting instrument's calibration and alarm systems.

FDAJun 13, 2003Nationwide• Ohmeda Medical, A division of Datex-Ohmeda, Inc.

Zeus Scientific Inc: Cytomegalovirus (CMV) IgG ELISA Test System, In-Vitro Dia...

The Calibrator included within the kit may be losing reactivity.

FDAJun 12, 2003Nationwide• Zeus Scientific Inc

Abbott Laboratories HPD/ADD: AxSYM AFP Reagent Pack, list 7A48-22 (100 test kit), 7A48...

AFP results obtained when using the 1:101 automated dilution protocol showed an overestimation of AFP of up to 30.5%

FDAJun 12, 2003Nationwide• Abbott Laboratories HPD/ADD

Beckman Coulter Inc: Synchron Systems Drug Calibrator 1 (Carbamaxepine, Phenob...

Product was found to produce higher recoveries by about 7-12% compared to other lots.

FDAJun 11, 2003Nationwide• Beckman Coulter Inc

Rx Textiles Inc: PHS, Tubular Stockinette Cotton, 6''x 48'' , 8''x 72'', 4...

Product may not be sterile.

FDAJun 11, 2003CA, IN, NV• Rx Textiles Inc

Misys Healthcare Systems: Misys Laboratory System, versions 5.2, 5.23 and 5.3

Software anomally Results with a global flag failure that autofile without review can cause abnormal results being communicated without associated abnormal designations.

FDAJun 10, 2003Nationwide• Misys Healthcare Systems

Medex Inc: Medex 2000 Series Syringe Infusion Pumps. The 2001 serie...

Inadequate warning label as pertains to use of the pump in conjunction with Extracorporeal Membrane Oxygenation (ECMO) procedures.

FDAJun 9, 2003Nationwide• Medex Inc

Abbott Laboratories HPD/ADD: Primary I.V. Gravity Administration Sets; sterile, Rx, si...

The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.

FDAJun 9, 2003Nationwide• Abbott Laboratories HPD/ADD

Abbott Laboratories HPD/ADD: Secondary I.V. Gravity Feed Sets; sterile, Rx, single use...

The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.

FDAJun 9, 2003Nationwide• Abbott Laboratories HPD/ADD

Abbott Laboratories HPD/ADD: 75-1650 Drip Chambers .138rr; Abbott, Ashland, Ohio 44805...

The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.

FDAJun 9, 2003Nationwide• Abbott Laboratories HPD/ADD

Invacare Corporation One Invacare Way: Invacare IVC Home Care Bed (Foot Section with new head ac...

Pull tube on bed may bend or separate causing inoperability of bed or head section to fall.

FDAJun 9, 2003IN• Invacare Corporation One Invacare Way

Abbott Laboratories HPD/ADD: 96-8366 Drip Chambers, Convertible with Pierce Pin .138 ...

The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.

FDAJun 9, 2003Nationwide• Abbott Laboratories HPD/ADD

Abbott Laboratories HPD/ADD: I.V. Pump Sets with Cassettes for use with Abbott Plum Se...

The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.

FDAJun 9, 2003Nationwide• Abbott Laboratories HPD/ADD

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