BEUDAMED
    FDA Enforcement Class II 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 · Reported June 22, 2016

    Enforcement

    Recall Number
    Z-1957-2016
    Event ID
    74156
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Miami Fat Supply, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 22, 2016
    Initiation Date
    April 21, 2016
    Classification Date
    June 13, 2016
    Termination Date
    December 14, 2016
    Address
    1510 Max Hooks Rd Ste F, Groveland, FL, 34736-8032, United States

    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.

    Code Info

    Lots 1165 and 1271.

    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