BEUDAMED
    FDA Enforcement Class II Ongoing

    Perifix¿ / Epidural anesthesia set, medicated

    Recall: Z-2627-2023 · Reported September 27, 2023

    Enforcement

    Recall Number
    Z-2627-2023
    Event ID
    92913
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    B. Braun Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 27, 2023
    Initiation Date
    July 31, 2023
    Classification Date
    September 21, 2023
    Address
    901 Marcon Blvd, Allentown, PA, 18109-9512, United States

    Description

    Perifix¿ / Epidural anesthesia set, medicated

    Reason

    Product may be mislabeled with an incorrect lid stock label.

    Code Info

    UDI-DI: 04046964178726 Product Code: 332250; Lot Number 0061863524, expiration date 30.APR.2025

    Distribution

    US Distributions to states of - AR, AZ, CA, FL, GA, IL, MA, MO, NC, NJ, PA, TX, WA

    Quantity

    3440 units