BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1853-2017 · Initiated January 13, 2017

    Recall

    Recall Number
    Z-1853-2017
    Event Number
    76347
    Firm
    Angiodynamics Inc. (Navilyst Medical Inc.)
    FEI Number
    3017892510
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    January 13, 2017
    Posted
    March 29, 2017
    Terminated
    June 25, 2018
    Address
    10 Glens Falls, Tech Park Glens Falls, NY, 12801-3864

    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.

    Action

    On January 13, 2017 Navilyst Medical initiated a recall action by contacting the 6 consignees by telephone and directing them to stop using the affected product and segregate until receipt of written Recall Notification. Recall Notifications dated January 19, 2017 were delivered by Federal Express to these consignees on January 20, 2017. Per the Recall Notification, Consignees are instructed to segregate and return all affected devices to Navilyst Medical, Inc. (an AngioDynamics Company) and complete and return the Reply Verification Tracking Form, provided in the recall notification.

    Distribution

    CA, KY, MD, OR, VA, TX

    Quantity

    8 boxes/25 units