BEUDAMED
    FDA Enforcement Class II Terminated

    Bio-MAC Cannula (Needle) Set

    Recall: Z-1373-2015 · Reported April 8, 2015

    Enforcement

    Recall Number
    Z-1373-2015
    Event ID
    70445
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biologic Therapies, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 8, 2015
    Initiation Date
    January 23, 2015
    Classification Date
    April 2, 2015
    Termination Date
    August 6, 2015
    Address
    5817 Nw 44th Ave, N/A, Ocala, FL, 34482-7891, United States

    Description

    Bio-MAC Cannula (Needle) Set

    Reason

    Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution

    Code Info

    Catalog Numbers: Part # BMAC.25, BMAC.45, BMAC.60, BMAC.80, and BMAC.105

    Distribution

    US Distribution in states of: MA, CA, WA, NJ, TX, IL, and FL.

    Quantity

    2797 units