BEUDAMED
    FDA Enforcement Class II Terminated

    Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock, Labeled as: SUMMIT MEDICAL PRODUCTS, REF 220227; MPS Acacia CAT NO: BC-006-04; MEDICAL PRODUCTS SPECIALISTS EXTENSION SET, Catalog Number BC00604, pain control pump accessory

    Recall: Z-0195-2023 · Reported November 16, 2022

    Enforcement

    Recall Number
    Z-0195-2023
    Event ID
    90964
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Avanos Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 16, 2022
    Initiation Date
    September 14, 2022
    Classification Date
    November 7, 2022
    Termination Date
    August 31, 2023
    Address
    5405 Windward Pkwy, N/A, Alpharetta, GA, 30004-3894, United States

    Description

    Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock, Labeled as: SUMMIT MEDICAL PRODUCTS, REF 220227; MPS Acacia CAT NO: BC-006-04; MEDICAL PRODUCTS SPECIALISTS EXTENSION SET, Catalog Number BC00604, pain control pump accessory

    Reason

    Sterile extension sets were distributed without an expiration date

    Code Info

    ALL LOT CODES

    Distribution

    US: CA, CO, FL, MI, NM, OH, OR, TN, TX, UT, WI

    Quantity

    1378 units