BEUDAMED
    FDA Recall 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 · Initiated January 20, 2017

    Recall

    Recall Number
    Z-1402-2017
    Event Number
    76318
    Firm
    Metrex Research, LLC.
    FEI Number
    1000117344
    Product Code
    LRJ
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    January 20, 2017
    Posted
    March 3, 2017
    Terminated
    September 1, 2017
    Address
    28210 Wick Rd, Romulus, MI, 48174-2639

    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.

    Action

    Metrex sent an Urgent Medical Device Recall letter dated January 20, 2017, to all affected customers to inform them that Metrex is recalling one lot of CaviWipes Extra Large because they may have been contaminated during the packaging process. Customers were informed that while handling sealed containers, a production worker sustained a minor finger cut which may have come in contact with the exterior surface of the container. Customers were instructed to contact Metrex Customer care at (800) 537-7123 to receive a RMA number. The RMA will allow for a quick return and replacement or credit. Customers were instructed to identify any customers that may have been shipped the affected product and contact their customers using the customer notification letter that Metrex issued. Metrex requests that those customers contact Metrex Customer Care at (800) 537-7123 and complete the attached acknowledgement form. For questions regarding this recall call 734-947-6700.

    Distribution

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

    Quantity

    960 cases