BEUDAMED
    FDA Recall Terminated

    Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000. Used for fat transfer and liposuction.

    Recall: Z-0170-2018 · Initiated October 20, 2017

    Recall

    Recall Number
    Z-0170-2018
    Event Number
    78392
    Firm
    Shippert Medical Technologies
    FEI Number
    3008719017
    Product Code
    MUU
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    October 20, 2017
    Terminated
    October 9, 2018
    Address
    6248 S Troy Cir, Ste A, Centennial, CO, 80111-6485

    Description

    Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000. Used for fat transfer and liposuction.

    Reason

    Potential breach of sterility of the packaging.

    Action

    A n Urgent: Medical Device Recall letter, dated October 20, 2017, was mailed to the user, identifying the affected device and describing the reason for the recall. The letter also provided the risk to health involved and discussed how the user can recognize the failure. Customers were instructed to remove all affected product from their inventory and quarantine them. Additionally, the letter should be forwarded to all necessary staff. Customers are to complete the Recall Response letter within 10 calendar days. Only the affected products listed should be returned per the instructions provided. Questions should be directed to Customer Service at 800-888-8663.

    Distribution

    Worldwide Distribution -- United States, Australia, and Netherlands.

    Quantity

    56 units