BEUDAMED
    FDA Enforcement Class II Terminated

    Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425

    Recall: Z-1312-2015 · Reported April 1, 2015

    Enforcement

    Recall Number
    Z-1312-2015
    Event ID
    70216
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Advanced Sterilization Products
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 1, 2015
    Initiation Date
    December 24, 2014
    Classification Date
    March 23, 2015
    Termination Date
    September 4, 2015
    Address
    33 Technology Dr, Irvine, CA, 92618-2346, United States

    Description

    Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425

    Reason

    Advanced Sterilization Products (ASP) is recalling the Tyvek Rolls with STERRAD Chemical Indicator because they were shipped to customers after its expiration date of May 18, 2013.

    Code Info

    Lot No. 68965-1241

    Distribution

    Saudi Arabia and Portugal

    Quantity

    2 units