BEUDAMED
    FDA Recall Terminated

    Precision Bipolar Device 6 pack Consists of a six-pack of the Precision Bipolar Device. Manufactured for: Datascope Cardiac Assist 15 Law Drive Fairfield, NJ 07004-0011

    Recall: Z-1158-2007 · Initiated May 7, 2007

    Recall

    Recall Number
    Z-1158-2007
    Event Number
    38005
    Firm
    Datascope Corporation
    FEI Number
    1000222374
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 7, 2007
    Posted
    August 9, 2007
    Terminated
    March 4, 2008
    Address
    15 Law Dr, Fairfield, NJ, 07004-0011

    Description

    Precision Bipolar Device 6 pack Consists of a six-pack of the Precision Bipolar Device. Manufactured for: Datascope Cardiac Assist 15 Law Drive Fairfield, NJ 07004-0011

    Reason

    Datascope has experienced a higher than usual number of reports involving the Precision Bipolar Device. Reports include the locking or sticking of the buttons of the device which operate the jaws, particularly when a side load is placed on the shaft of the device.

    Action

    Letters were sent to all hospitals, (contact: Hospital Administrators) the week of May 7, 2007 (certified mail, Return Receipt requested) with Urgent Medical Device Field Correction. The letter requests that all potential users of the devices at the institution be mdae aware of the situation. The letter instructs clinicians what to do if they experience problems with locking buttons of the Precision Device and also if the device is clamped closed on a vein branch and cannot be opened. Institutions are also requested to sign and return a postal card acknowledging receipt of the Field Correct notification and Datascope provides telephone numbers for customer service.

    Distribution

    Worldwide, including USA, Belgium, the Netherlands, and Germany.

    Quantity

    114