BEUDAMED
    FDA Recall 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 · Initiated September 15, 2022

    Recall

    Recall Number
    Z-0265-2023
    Event Number
    91017
    Firm
    Medical Action Industries, Inc.
    FEI Number
    1030451
    Product Code
    OFF
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    September 15, 2022
    Posted
    November 18, 2022
    Terminated
    February 19, 2025
    Address
    306 25 Heywood Rd, Arden, NC, 28704-9302

    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.

    Action

    Owens & Minor/Medical Action INDUSTRIES, INC. issued an URGENT: MEDICAL DEVICE FIELD CORRECTION to its sole consignee on 09/23/2022 by email. The notices explained the issue and requested they take the following actions: "Please review your inventory, and segregate and quarantine all affected Kits. If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. A labeling template is enclosed for printing labels which can be affixed on all affected kits in inventory. This label should be applied to each affected convenience kit and product case in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. If you prefer to have labels printed for your facility, please send quantity and end-user information to [email protected]. Any adverse events associated with the use of the affected products should be reported to [email protected]. The FDA requires that we account for all affected products. Therefore, please complete the attached Response Form and return to [email protected] as soon as possible even if you have no current product inventory. If you have any questions, please send an email to [email protected]."

    Distribution

    US Nationwide distribution in the state of Pennsylvania.

    Quantity

    240 cases of 20 units