BEUDAMED
    FDA Recall Terminated

    JUDKINS PACK

    Recall: Z-1256-2021 · Initiated February 11, 2021

    Recall

    Recall Number
    Z-1256-2021
    Event Number
    87343
    Firm
    Cardinal Health 200, LLC
    FEI Number
    3001236905
    Product Code
    OEQ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 11, 2021
    Terminated
    December 22, 2022
    Address
    3651 Birchwood Dr, Waukegan, IL, 60085-8337

    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.

    Action

    The notice "Presource Kits Containing an Incorrect Medication Label Sheet" and reply form dated 02/11/2021 were sent to the customer. For questions, requiring additional labels, or desire special assistance relating to this notice, contact Cardinal Health Quality Systems at 800.292.9332.

    Distribution

    US state of VA.

    Quantity

    298 units