BEUDAMED
    FDA Enforcement Class II Terminated

    Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440

    Recall: Z-1269-2020 · Reported February 26, 2020

    Enforcement

    Recall Number
    Z-1269-2020
    Event ID
    84722
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    TELEFLEX MEDICAL INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 26, 2020
    Initiation Date
    January 13, 2020
    Classification Date
    February 19, 2020
    Termination Date
    November 24, 2021
    Address
    3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437, United States

    Description

    Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440

    Reason

    There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.

    Code Info

    Lot Number 74B1500674

    Distribution

    Worldwide

    Quantity

    1764 units