BEUDAMED
    FDA Enforcement Class III Terminated

    Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip. Model Number ERGF01330. The Edwards Surgical Instruments are designed to perform specialized functions in specific cardiac surgical or endoscopic procedures.

    Recall: Z-0560-2014 · Reported January 1, 2014

    Enforcement

    Recall Number
    Z-0560-2014
    Event ID
    66934
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Edwards Lifesciences, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 1, 2014
    Initiation Date
    November 20, 2013
    Classification Date
    December 21, 2013
    Termination Date
    February 10, 2014
    Address
    12050 Lone Peak Pkwy, N/A, Draper, UT, 84020-9414, United States

    Description

    Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip. Model Number ERGF01330. The Edwards Surgical Instruments are designed to perform specialized functions in specific cardiac surgical or endoscopic procedures.

    Reason

    Edwards Lifesciences is recalling one lot of Ergonic instrument due to mislabeling. Ergonic scissors standard curved labeled as a Double Acting DeBakey forcep. Edwards control confirmed that the laser etching on the device was incorrect.

    Code Info

    Lot Number: 11211566.1, Exp. Date: 09/01/2017.

    Distribution

    Distributed to 3 customers in FL only.

    Quantity

    3