BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1390-2018 · Initiated January 18, 2018

    Recall

    Recall Number
    Z-1390-2018
    Event Number
    79558
    Firm
    Angiodynamics Inc. (Navilyst Medical Inc.)
    FEI Number
    3017892510
    Product Code
    OEQ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    January 18, 2018
    Terminated
    September 21, 2018
    Address
    10 Glens Falls, Tech Park Glens Falls, NY, 12801-3864

    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.

    Action

    Recall Notifications were delivered by Fed Express. Consignees instructed to segregate and return all affected devices to Angiodynamics and complete and return the Reply Verification Tracking Form.

    Distribution

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

    Quantity

    38 units