BEUDAMED
    FDA Enforcement Class II Terminated

    PICC Tray, STERILE, 12 packs each per case.

    Recall: Z-2977-2018 · Reported September 12, 2018

    Enforcement

    Recall Number
    Z-2977-2018
    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

    PICC Tray, STERILE, 12 packs each per case.

    Reason

    Multiple surgical packs were assembled with a non-sterile CHG disk labeled as BIOPATCH" (kit component #52655) attached to the outside of the sterile pack. This may pose potential risk of infection. However, the kits have been in distribution since March 2016. Many of these kits have been used with no reported infections or adverse patient events. In addition, the BIOPATCH is impregnated with CHG, a well-known antiseptic agent with broad-spectrum anti-microbial and antifungal activity.

    Code Info

    Item number: DYNJ49177C. Lots: 16HB4700, 16UB5076, 17MB6837

    Distribution

    CA, NM

    Quantity

    144 kits