BEUDAMED
    FDA Recall Open, Classified

    Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access

    Recall: Z-2249-2023 · Initiated June 22, 2023

    Recall

    Recall Number
    Z-2249-2023
    Event Number
    92608
    Firm
    Creganna Medical Devices Parkmore House Mweeloon Galway Ireland
    FEI Number
    3004193842
    Product Code
    DYB
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    June 22, 2023
    Posted
    July 28, 2023

    Description

    Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access

    Reason

    Three lots of product may be labeled with an incorrect expiration day

    Action

    Creganna Medical notified its sole consignee on 06/22/2023 via email. The notice explained the problem with the product and informed the consignee of their intention to collaboratively conduct a recall. The sole consignee is notifying their customers by letter delivered by FedEX on 06/28/2023. The product is to be returned to the consignee.

    Distribution

    US Nationwide distribution in the state of AZ.

    Quantity

    194 units