BEUDAMED
    FDA Enforcement Class II Terminated

    B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (cardiac) Catheter Tray (REF number corrected 11/23/2022)

    Recall: Z-0265-2023 · Reported November 30, 2022

    Enforcement

    Recall Number
    Z-0265-2023
    Event ID
    91017
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medical Action Industries, Inc. 306
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 30, 2022
    Initiation Date
    September 15, 2022
    Classification Date
    November 18, 2022
    Termination Date
    February 19, 2025
    Address
    25 Heywood Rd, N/A, Arden, NC, 28704-9302, United States

    Description

    B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (cardiac) Catheter Tray (REF number corrected 11/23/2022)

    Reason

    The kits were incorrectly labeled with an extended expiration date of 02/21/2024 instead of 02/10/2024.

    Code Info

    UDI/DI 10809160283875, Batch/Lot number 298442

    Distribution

    US Nationwide distribution in the state of Pennsylvania.

    Quantity

    240 cases of 20 units