BEUDAMED
    FDA Recall Terminated

    CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector

    Recall: Z-0540-2021 · Initiated October 16, 2020

    Recall

    Recall Number
    Z-0540-2021
    Event Number
    86634
    Firm
    Avanos Medical, Inc.
    FEI Number
    3011270181
    Product Code
    KNT
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 16, 2020
    Terminated
    September 30, 2022
    Address
    5405 Windward Pkwy, Alpharetta, GA, 30004-3894

    Description

    CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector

    Reason

    Detachment of the Male AIV Adaptor from the Y-Connector.

    Action

    On 10/16/2020 the firm sent a notification to its consignees with the following instructions: - CHECK all storage and usage locations to determine if any impacted product remains within your possession. Product Currently In-Use -DISCONTINUE using the impacted product (Note: If you decide not to replace the device, please consider taping over the adaptor to prevent any potential detachment and be sure to check on the tube and adaptor frequently throughout the day for potential detachment). -REPLACE the impacted product with a unit of a different lot. -IMMEDIATELY COMPLETE and RETURN the attached Recall Acknowledgement Form to Avanos . Via email to [email protected] -DESTROY the devices in your inventory following your facility's destruction procedures . Unused Inventory -SEGREGATE and QUARANTINE the devices according to your facility's procedures. -IMMEDIATELY COMPLETE and RETURN the attached Recall Acknowledgement Form to Avanos. Via email to fieldactioncare@avanos .com -DESTROY the devices in your inventory following your facility's destruction procedures.

    Distribution

    Domestic distribution only: CA, CO, IL, LA, OH, VA.

    Quantity

    710 units