BEUDAMED
    FDA Enforcement Class II Terminated

    Teleflex MEDICAL Pilling(R) UNIVERSAL SHEARS 7 1/2", REF 142542 Product Usage: general surgical scissors

    Recall: Z-2287-2018 · Reported July 4, 2018

    Enforcement

    Recall Number
    Z-2287-2018
    Event ID
    80279
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical Europe Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 4, 2018
    Initiation Date
    June 12, 2018
    Classification Date
    June 26, 2018
    Termination Date
    April 2, 2021
    Address
    Ida Business Park, Athlone, N/A, Ireland

    Description

    Teleflex MEDICAL Pilling(R) UNIVERSAL SHEARS 7 1/2", REF 142542 Product Usage: general surgical scissors

    Reason

    The incorrect plastic was used to manufacture the handles of these shears, which causes the handles to melt if sterilized.

    Code Info

    Lot Numbers: F7, G7

    Distribution

    Worldwide Distribution - US Nationwide and the countries of Canada, India

    Quantity

    573 units