BEUDAMED
    FDA Enforcement Class II Terminated

    JUDKINS PACK

    Recall: Z-1256-2021 · Reported March 24, 2021

    Enforcement

    Recall Number
    Z-1256-2021
    Event ID
    87343
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cardinal Health 200, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 24, 2021
    Initiation Date
    February 11, 2021
    Classification Date
    March 15, 2021
    Termination Date
    December 22, 2022
    Address
    3651 Birchwood Dr, N/A, Waukegan, IL, 60085-8337, United States

    Description

    JUDKINS PACK

    Reason

    Component Part Number: 19537LBL (LBL, SHEET OF 39, ASSORTED, STDSZ, MULTI W/BLK INK, WATERPROOF) is being reported as intermittently mixed with an incorrect medication label sheet throughout the specific Presource¿ kit SANHDJTVCF Judkins Pack lot # 525067.

    Code Info

    Model SANHDJTVCF, lot 525067.

    Distribution

    US state of VA.

    Quantity

    298 units