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Showing 67901–67920 of 68218 results

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Respironics California Inc: Esprit Ventilator.

Valves may stick in the closed position due to manufacturing error.

FDAJul 14, 2003CO, GA, IL +6 more• Respironics California Inc

Molnlycke Health Care Inc: Barrier Hip Sheet with Side Pockets

pouch may tear which could result in contamination of sterile field

FDAJul 14, 2003Nationwide• Molnlycke Health Care Inc

Diametrics Medical, Inc.: IRMA SL Blood Analysis System CC pH, pCO2, pO2, Hct, Na+,...

An incorrect lot designation, when entered into the blood analysis device, caused the device to give an error message and not operate.

FDAJul 14, 2003CA, CO, FL +6 more• Diametrics Medical, Inc.

Vital Concepts, Inc.: HYDRO-PRO brand Irrigation Aspiration System with double ...

The suction valve may become stuck in the 'suction on' position under vacuum.

FDAJul 11, 2003AZ, IL, IN +7 more• Vital Concepts, Inc.

Vital Concepts, Inc.: Irrigation Aspiration System with Double Spike Tubing and...

The suction valve may become stuck in the 'suction on' position under vacuum.

FDAJul 11, 2003AZ, IL, IN +7 more• Vital Concepts, Inc.

Vital Concepts, Inc.: HYDRO-PRO brand Suction-Irrigation System without Probe, ...

The suction valve may become stuck in the 'suction on' position under vacuum.

FDAJul 11, 2003AZ, IL, IN +7 more• Vital Concepts, Inc.

Vital Concepts, Inc.: Quanta Technologies L.L.C. brand REORDER # LAPKIT 3. Con...

The suction valve may become stuck in the 'suction on' position under vacuum.

FDAJul 11, 2003AZ, IL, IN +7 more• Vital Concepts, Inc.

Vital Concepts, Inc.: Huntington Instruments brand Irrigation Aspiration System...

The suction valve may become stuck in the 'suction on' position under vacuum.

FDAJul 11, 2003AZ, IL, IN +7 more• Vital Concepts, Inc.

Vital Concepts, Inc.: Irrigation Aspiration System for Nezhat Dorsey Type Pumps...

The suction valve may become stuck in the 'suction on' position under vacuum.

FDAJul 11, 2003AZ, IL, IN +7 more• Vital Concepts, Inc.

Fresenius Hemocare, Inc.: Prosorba Protein A Immunoadsorption Column

No package insert

FDAJul 11, 2003AZ, CA, IN +7 more• Fresenius Hemocare, Inc.

Blue Torch Medical Technologies: CaverMap Surgical Aid Disposable Kit with Focused Probe T...

Product's sterility is compromised due to a failed sterility audit

FDAJul 10, 2003NY, TX• Blue Torch Medical Technologies

Cryolife Inc: CryoValve, Synegraft Pulmonary Valve & Conduit

Human tissue for transplantation, which was associated with a donor whose pre-processing culture detected microorganisms, was distributed.

FDAJul 10, 2003CA, IN• Cryolife Inc

Deltec, Inc: Ventra Percutaneous Intravenous Catheter Repair Kit for L...

Silicone adhesive in kits used to repair damaged catheters did not set (cure) properly and remained in a tacky state.

FDAJul 8, 2003CA, IL, IN +6 more• Deltec, Inc

Arrow International Inc: 9 French Super Arrow-Flex Percutaneous Sheath Introducer ...

separation of sheath

FDAJul 8, 2003Nationwide• Arrow International Inc

Misys Healthcare Systems: Misys Laboratory System, Versions 5.2, 5.23, 5.3 up to 5....

Software defect causes orders to be lost under certain conditions of use. A typographical error at the Accept/Modfy/Reject prompt will cause the order not to be processed by the system.

FDAJul 7, 2003Nationwide• Misys Healthcare Systems

Boston Scientific Corporation: ASAP Channel Cut Biopsy System, 14 gauge Reference Number...

Sterility of the device may be compromised due to a lack of package integrity

FDAJul 3, 2003Nationwide• Boston Scientific Corporation

Siemens Medical Solutions USA, Inc: MagicView 1000 and Magic View Mondo. Digital Image Commu...

Potential error can occur with the 3D post processing options MPR, MIP, and VRT.

FDAJul 3, 2003Nationwide• Siemens Medical Solutions USA, Inc

Elite Medical Group: MSI-EpiDermGlu (Iso-Butyl 2 Cyanoacrylate) tissue adhesiv...

The liquid tissue adhesive was marketed without FDA pre-market clearance.

FDAJul 3, 2003IL, KS, KY +3 more• Elite Medical Group

Allergan Medical Optics Inc: AMO PhacoFlex II Model SI40NB, Intraocular Lenses

Post operative complaints of cloudiness in the intraocular lenses.

FDAJul 2, 2003Nationwide• Allergan Medical Optics Inc

Misys Healthcare Systems: Misys Laboratory System version 5.3

Patient files become mixed up due to a software defect.

FDAJul 2, 2003NY• Misys Healthcare Systems

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