BEUDAMED
    FDA Enforcement Class II Completed

    Tissu-Trans MEGA 1500, Catalog 3-TT-MEGA 1500, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.

    Recall: Z-1335-2019 · Reported May 22, 2019

    Enforcement

    Recall Number
    Z-1335-2019
    Event ID
    81837
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Shippert Medical Technologies
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 22, 2019
    Initiation Date
    February 2, 2018
    Classification Date
    May 15, 2019
    Address
    6248 S Troy Cir Ste A, Centennial, CO, 80111-6485, United States

    Description

    Tissu-Trans MEGA 1500, Catalog 3-TT-MEGA 1500, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.

    Reason

    The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.

    Code Info

    61471, 61625, 61754, 61840, 61945, 61950, 62135, 62137, and 62157

    Distribution

    Distribution was nationwide, including PR. There was government/military distribution. Foreign distribution was made to Australia, Austria, Belgium, Denmark, Germany, Greece, India, Italy, Japan, Netherlands, New Zealand, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom,

    Quantity

    6,553 units were distributed for all catalog numbers