BEUDAMED
    FDA Recall Open, Classified

    Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery

    Recall: Z-1690-2023 · Initiated April 6, 2023

    Recall

    Recall Number
    Z-1690-2023
    Event Number
    92283
    Firm
    Cardinal Health 200, LLC
    FEI Number
    3001236905
    Product Code
    OHD
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    April 6, 2023
    Posted
    June 6, 2023
    Address
    3651 Birchwood Dr, Waukegan, IL, 60085-8337

    Description

    Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery

    Reason

    Inadvertently released for distibution without sterility assurance.

    Action

    Cardinal Health initially notified customer on 04/06/2023, via telephone, on 04/12/2023, via email and followed up with a recall notification letter on 05/05/2023. Customer was instructed to return affected product.

    Distribution

    Distribution in the US to Georgia

    Quantity

    5 units