BEUDAMED
    FDA Enforcement Class II Terminated

    NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005

    Recall: Z-1853-2017 · Reported April 26, 2017

    Enforcement

    Recall Number
    Z-1853-2017
    Event ID
    76347
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Angiodynamics Inc. (Navilyst Medical Inc.)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    April 26, 2017
    Initiation Date
    January 13, 2017
    Classification Date
    April 18, 2017
    Termination Date
    June 25, 2018
    Address
    10 Glens Falls Tech Park, N/A, Glens Falls, NY, 12801-3864, United States

    Description

    NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005

    Reason

    The product has the potential to be non-sterile as it was not packaged in accordance to specification.

    Code Info

    Lot Number: 5122528

    Distribution

    CA, KY, MD, OR, VA, TX

    Quantity

    8 boxes/25 units