BEUDAMED
    FDA Enforcement Class II 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 · Reported March 25, 2020

    Enforcement

    Recall Number
    Z-1483-2020
    Event ID
    84943
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Deroyal Industries, Inc. Lafollette
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 25, 2020
    Initiation Date
    February 6, 2020
    Classification Date
    March 13, 2020
    Termination Date
    February 11, 2021
    Address
    1501 E Central Ave, La Follette, TN, 37766-2892, United States

    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.

    Code Info

    Catalog Number DP40K; Lot Numbers: 74F1802710, 74G1802678, 74H1800763, 74D1900657, 74C1900811, 74D1700564

    Distribution

    International distribution of Kuwait City, Kuwait.

    Quantity

    669 units