BEUDAMED
    FDA Enforcement Class II Terminated

    Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems.

    Recall: Z-1390-2018 · Reported April 25, 2018

    Enforcement

    Recall Number
    Z-1390-2018
    Event ID
    79558
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Angiodynamics Inc. (Navilyst Medical Inc.)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    April 25, 2018
    Initiation Date
    January 18, 2018
    Classification Date
    April 17, 2018
    Termination Date
    September 21, 2018
    Address
    10 Glens Falls Tech Park, Glens Falls, NY, 12801-3864, United States

    Description

    Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems.

    Reason

    NAMIC Fluid Management Convenience Kits contains a Fluid Delivery Set that was not assembled in accordance with specification, and prevents the device from being used, resulting in a minor delay in procedure.

    Code Info

    Lot Numbers: 5284422 5286610 5283649 5290525 5286542

    Distribution

    Recall conducted to end user level. Recall Notifications were delivered by Fed Express.

    Quantity

    38 units