BEUDAMED
    FDA Recall Terminated

    Teleflex Pilling Aortic Punch, 4.0mm. Sterile, Rx Only, disposable. Included as part of Intl-Cardiac Surgery Kit - Product Usage: This device is used for cardiovascular surgical procedures.

    Recall: Z-1483-2020 · Initiated February 6, 2020

    Recall

    Recall Number
    Z-1483-2020
    Event Number
    84943
    Firm
    Deroyal Industries, Inc. Lafollette
    FEI Number
    3005011024
    Product Code
    DWS
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    February 6, 2020
    Posted
    February 19, 2020
    Terminated
    February 11, 2021
    Address
    1501 E Central Ave La, Follette, TN, 37766-2892

    Description

    Teleflex Pilling Aortic Punch, 4.0mm. Sterile, Rx Only, disposable. Included as part of Intl-Cardiac Surgery Kit - Product Usage: This device is used for cardiovascular surgical procedures.

    Reason

    The sterile packaging has the potential to be compromised.

    Action

    DeRoyal notified customers on about 02/06/2020 via "URGENT! RECALL NOTICE" letter. Customers were informed that the Teleflex Pilling Aortic Punch is an item that is not placed inside the sterile tray, is a sterile item that is placed on the outside of the sterilized kit/tray. Instructions included to identify and quarantine any affected products on hand and complete and return the Notice of Return Form-Credit Only via fax to 865-362-3716 or email to [email protected]. Questions or concerns can be directed to Camden Kitchen at [email protected] or by phone 865-362-6171, or email at [email protected].

    Distribution

    International distribution of Kuwait City, Kuwait.

    Quantity

    669 units