BEUDAMED
    FDA Enforcement Class II Ongoing

    AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation

    Recall: Z-0360-2024 · Reported November 29, 2023

    Enforcement

    Recall Number
    Z-0360-2024
    Event ID
    93305
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Avanos Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 29, 2023
    Initiation Date
    October 13, 2023
    Classification Date
    November 20, 2023
    Address
    5405 Windward Pkwy, N/A, Alpharetta, GA, 30004-3894, United States

    Description

    AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation

    Reason

    Certain lots of BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI were labeled as not being made with Di(2-ethylhexyl) phthalate (DEHP); however, Avanos has determined that the tubing components of the product did contain DEHP.

    Code Info

    UDI/DI 00609038945064, Lot Numbers: 30112716, 30122936, 30116495, 30122179, 30116496, 30124942, 30117487, 30126227, 30117488, 30124946, 30117632, 30127429, 30117633, 30127494, 30113925, 30137504, 30119101, 30153170, 30119102, 30151042, 30116223, 30194152, 30123991

    Distribution

    US and South Africa

    Quantity

    4730 cases (94600 devices)