BEUDAMED
    FDA Enforcement Class II Terminated

    Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), sterile; and Medical Action Industries Inc. IV Start Kit, REF #78019 (on kit label), sterile. Kit components are the Port Access Kit.

    Recall: Z-0464-2023 · Reported December 14, 2022

    Enforcement

    Recall Number
    Z-0464-2023
    Event ID
    91065
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medical Action Industries, Inc. 306
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 14, 2022
    Initiation Date
    October 12, 2022
    Classification Date
    December 8, 2022
    Termination Date
    March 25, 2025
    Address
    25 Heywood Rd, N/A, Arden, NC, 28704-9302, United States

    Description

    Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), sterile; and Medical Action Industries Inc. IV Start Kit, REF #78019 (on kit label), sterile. Kit components are the Port Access Kit.

    Reason

    The Port Access Kits were incorrectly labeled as IV Start Kits on the kit label. The case label was correctly labeled as Port Access Kits.

    Code Info

    Port Access Kit case label - Lot 294281, exp. 9/28/2023, UDI #1080916018095. IV Start Kit label - Lot 294589, exp. 12/20/2024, UDI #20809160195991.

    Distribution

    Distribution was made to MN. There was no foreign/government/military distribution.

    Quantity

    24 cases (480 kits)