BEUDAMED
    FDA Recall Terminated

    Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter introduction kit

    Recall: Z-0751-2023 · Initiated November 4, 2022

    Recall

    Recall Number
    Z-0751-2023
    Event Number
    91180
    Firm
    Medical Action Industries, Inc.
    FEI Number
    1030451
    Product Code
    OFD
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    November 4, 2022
    Posted
    December 21, 2022
    Terminated
    March 18, 2026
    Address
    306 25 Heywood Rd, Arden, NC, 28704-9302

    Description

    Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter introduction kit

    Reason

    XXX

    Action

    The recalling firm issued an URGENT: MEDICAL DEVICE FIELD CORRECTION to its sole consignee by email on 11/04/2022. The notice explained the issue and request the following actions be taken: "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 for each LOT 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]." "If you have any questions, please send an email to [email protected]."

    Distribution

    US Nationwide distribution in the state of VA.

    Quantity

    198 cases