BEUDAMED
    FDA Recall 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 · Initiated February 2, 2018

    Recall

    Recall Number
    Z-1335-2019
    Event Number
    81837
    Firm
    Shippert Medical Technologies
    FEI Number
    3008719017
    Product Code
    MUU
    Status
    Completed
    Root Cause
    Packaging process control
    Initiated
    February 2, 2018
    Address
    6248 S Troy Cir, Ste A, Centennial, CO, 80111-6485

    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.

    Action

    Letters dated 1/9/2018 were issued beginning 2/2/2018 via registered mail and Fed Ex explaining the reason for recall, risk to health, description of how to recognize the device failed, and actions to be taken.

    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