BEUDAMED
    FDA Recall Terminated

    Kit: Central Line Dres Change 20/Cs

    Recall: Z-0147-2022 · Initiated September 8, 2021

    Recall

    Recall Number
    Z-0147-2022
    Event Number
    88687
    Firm
    Medical Action Industries, Inc.
    FEI Number
    1030451
    Product Code
    PEZ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 8, 2021
    Terminated
    October 13, 2023
    Address
    306 25 Heywood Rd, Arden, NC, 28704-9302

    Description

    Kit: Central Line Dres Change 20/Cs

    Reason

    The ChloraPrep 3ml kit component has a shorter expiry date than the labeled kit expiry date.

    Action

    A customer email was sent to the impacted distributor dated 09/16/2021. The distributor was notified of the recall issue and instructed to inventory and segregate affected product. Warning labels were provided and are to be affixed to the affected kits. Relabeling should be conducted in a manner that does not allow other pertinent labeling information to be covered up. The distributor was also notified that the recall should be carried out to the end user level.

    Distribution

    Distribution to a single US distributor in Michigan

    Quantity

    42 cases