BEUDAMED
    FDA Recall Terminated

    NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part Number: NN-8024

    Recall: Z-2822-2018 · Initiated June 19, 2018

    Recall

    Recall Number
    Z-2822-2018
    Event Number
    80540
    Firm
    Nico Corp.
    FEI Number
    3007456622
    Product Code
    GZT
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    June 19, 2018
    Terminated
    November 9, 2018
    Address
    250 E 96th St, Ste 125, Indianapolis, IN, 46240-3872

    Description

    NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part Number: NN-8024

    Reason

    Mislabeled hook pouch included a transport/storage label rather than the product label containing key product information such as part number, lot number, and expiration date, etc

    Action

    On June 19, 2018 , NICO issued letter by mail and/or email letters to consignees that have received hooks from the affected lot. The letter provides instructions to inspect all of its current stock of NN-8024, Greenberg Hooks for the proper pouch label. if an incorrect label is discovered, the hook should be removed from stock and returned to NICO. Questions or need additional information, please contact [email protected] or 317-660-7118 ext. 104.

    Distribution

    US Nationwide distribution

    Quantity

    204 devices