BEUDAMED
    FDA Recall Terminated

    BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.

    Recall: Z-1189-2023 · Initiated February 3, 2023

    Recall

    Recall Number
    Z-1189-2023
    Event Number
    91663
    Firm
    Avanos Medical, Inc.
    FEI Number
    3011270181
    Product Code
    BSY
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    February 3, 2023
    Posted
    March 13, 2023
    Terminated
    September 5, 2024
    Address
    5405 Windward Pkwy, Alpharetta, GA, 30004-3894

    Description

    BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.

    Reason

    Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving inadequate ventilation.

    Action

    Avanos hand-delivered the recall notification to the single consignee on 02/03/2023. The letter instructed the customer to discontinue use of and quarantine their stock of all lots of affected units and return them. Additionally, the customer was instructed to complete and return the acknowledgement form.

    Distribution

    US Nationwide distribution in the state of Oklahoma.

    Quantity

    780 units