BEUDAMED
    FDA Enforcement Class II Terminated

    FREEDOMAIRE(R) HELMET WITH MOTOR MODULE, REF 11113STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment and the surgical personnel in order to protect against contamination, body fluids and microorganisms.

    Recall: Z-1339-2015 · Reported April 8, 2015

    Enforcement

    Recall Number
    Z-1339-2015
    Event ID
    70721
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Microtek Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 8, 2015
    Initiation Date
    March 10, 2015
    Classification Date
    March 27, 2015
    Termination Date
    January 21, 2017
    Address
    602 N Lehmberg Rd, N/A, Columbus, MS, 39702-4406, United States

    Description

    FREEDOMAIRE(R) HELMET WITH MOTOR MODULE, REF 11113STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment and the surgical personnel in order to protect against contamination, body fluids and microorganisms.

    Reason

    This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.

    Code Info

    Lot Numbers: C9257, C9324, C10025, C10043, C10067, C10165, C10230, C10237, C11321, C11325, C12251, C13063, C13325

    Distribution

    US (nationwide) Distribution.

    Quantity

    153 Units