BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-2822-2018 · Reported August 22, 2018

    Enforcement

    Recall Number
    Z-2822-2018
    Event ID
    80540
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nico Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 22, 2018
    Initiation Date
    June 19, 2018
    Classification Date
    August 14, 2018
    Termination Date
    November 9, 2018
    Address
    250 E 96th St Ste 125, Indianapolis, IN, 46240-3872, United States

    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

    Code Info

    Lot Number: 37LG1834 Exp. Date: 11Jan 2020

    Distribution

    US Nationwide distribution

    Quantity

    204 devices