BEUDAMED
    FDA Enforcement Class II Terminated

    CaviWipes1 Extra Large, Part No. 13-5150 The brand name of the device is CaviWipes1 Extra Large, a surface disinfectant. The device has been assigned the product code LRJ (General Purpose Disinfectant) by the FDA and is classified as a Class I Medical Device. CaviWipes1 Extra Large is intended to be used to disinfect surfaces.

    Recall: Z-1402-2017 · Reported March 15, 2017

    Enforcement

    Recall Number
    Z-1402-2017
    Event ID
    76318
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Metrex Research, LLC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 15, 2017
    Initiation Date
    January 20, 2017
    Classification Date
    March 3, 2017
    Termination Date
    September 1, 2017
    Address
    28210 Wick Rd, N/A, Romulus, MI, 48174-2639, United States

    Description

    CaviWipes1 Extra Large, Part No. 13-5150 The brand name of the device is CaviWipes1 Extra Large, a surface disinfectant. The device has been assigned the product code LRJ (General Purpose Disinfectant) by the FDA and is classified as a Class I Medical Device. CaviWipes1 Extra Large is intended to be used to disinfect surfaces.

    Reason

    Metrex is recalling the CaviWipes Extra Large because they may have been contaminated during the packaging process.

    Code Info

    Lot No. 16-2340PA

    Distribution

    Nationwide Distribution to PA, FL, IL, MN, TX, AL, NY

    Quantity

    960 cases