BEUDAMED
    FDA Recall Terminated

    The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile. Intended for use in aspirating subcutaneous fatty tissue in patients desiring aesthetic body contouring and autologous fat collection.

    Recall: Z-1957-2016 · Initiated April 21, 2016

    Recall

    Recall Number
    Z-1957-2016
    Event Number
    74156
    Firm
    Miami Fat Supply, Inc
    FEI Number
    3008872140
    Product Code
    MUU
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    April 21, 2016
    Terminated
    December 14, 2016
    Address
    1510 Max Hooks Rd, Ste F, Groveland, FL, 34736-8032

    Description

    The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile. Intended for use in aspirating subcutaneous fatty tissue in patients desiring aesthetic body contouring and autologous fat collection.

    Reason

    During an FDA inspection it was found that the products are marketed without a cleared 510k, nor is approved for multiple use.

    Action

    Customers were sent an Urgent: Medical Device Recall/Correction letter, dated 04/19/2016, on 04/21/2016 that served as a notification of the Red Head 2 voluntary recall. Customers were informed that there were previous complaints of compromised product integrity and performance following sterilization. Lids are subject to fracture and fail after steam sterilization. Customers were advised to destroy used product and to ship unused product back to the manufacturer. Customers were to return an acknowledgement form to confirm their notification of the voluntary recall.

    Distribution

    Worldwide Distribution -- US, including the states of AL, AZ, CA, CO, FL, GA, IL, MD, MI, MO, NM, NY, OH, TX, UT, and VA; and, the country of Dominican Republic.

    Quantity

    443 units