BEUDAMED
    FDA Enforcement Class II Terminated

    Laparoscopy CDS

    Recall: Z-2978-2018 · Reported September 12, 2018

    Enforcement

    Recall Number
    Z-2978-2018
    Event ID
    78411
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medline Industries, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 12, 2018
    Initiation Date
    April 12, 2017
    Classification Date
    September 6, 2018
    Termination Date
    August 5, 2019
    Address
    1170 S Northpoint Blvd, N/A, Waukegan, IL, 60085-6757, United States

    Description

    Laparoscopy CDS

    Reason

    One manufacturing lot of a non-sterile pack was assembled with a non-sterile component labeled sterile (kit component #80532NS). The non-sterile component 80532NS was supposed to be placed inside the sterile portion of the pack where it would subsequently be exposed to the ethylene oxide sterilization process. However, the component was not placed in the sterile portion of the pack during assembly and was never exposed to the sterilization process. Component 80532NS was inadvertently released non-sterile. Component 80532NS is packaged by Medline and is an Anti-fog kit that contains 1 bottle of 6g Anti-Fog solution and an adhesive backed sponge.

    Code Info

    Model: CDS920114F. Lot: 17MB5499

    Distribution

    CA, NM

    Quantity

    15 kits