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Showing 22301–22320 of 22623 results

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Baxter Healthcare Corp. Rt: Fenwal Y-Type Blood/Solution Set with Large Standard Bloo...

There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.

FDAJul 16, 2003Nationwide• Baxter Healthcare Corp. Rt

Unknown Manufacturer: Intralase FS Laser System. Laser Keratome

Gantry moves toward patient when 'Home' button is used after procedure.

FDAJul 15, 2003Nationwide

Guidant Corporation ACS: Guidant Multi-Link Zeta Coronary Stent System

Potential loss of package sterility.

FDAJul 15, 2003Nationwide• Guidant Corporation ACS

Datex-Ohmeda Inc One Ohmeda: Datex-Ohmeda S/5 Anesthesia Delivery Units

Possible disruption of mechanical ventilation or disruption of anesthetic agent delivery.

FDAJul 15, 2003Nationwide• Datex-Ohmeda Inc One Ohmeda

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.

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

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

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.: 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 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.

Fresenius Hemocare, Inc.: Prosorba Protein A Immunoadsorption Column

No package insert

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

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

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

separation of sheath

FDAJul 8, 2003Nationwide• Arrow International 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

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

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