BEUDAMED
    FDA Recall Open, Classified

    WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic surgeries. Distr. by Endoscopy Smith & Nephew Inc. REF Numbers: T0449-01

    Recall: Z-2243-2024 · Initiated May 24, 2024

    Recall

    Recall Number
    Z-2243-2024
    Event Number
    94749
    Firm
    WOM World Of Medicine AG Alte Poststr. 11 Ludwigsstadt Germany
    FEI Number
    3002914049
    Product Code
    HRX
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    May 24, 2024
    Posted
    July 1, 2024

    Description

    WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic surgeries. Distr. by Endoscopy Smith & Nephew Inc. REF Numbers: T0449-01

    Reason

    Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery

    Action

    Smith & Nephew Issued Urgent Field Safety Notice (FSN) - MEDICAL DEVICE RECALL WOM reference no.: 2024-0001 via email on 5/24/23. Letter states reason fo recall, health risk and action to take; lnform individuals within your organization who need to be aware of this recall. - Check all stock areas and/or operating room storage to determine if any tube sets with lol numbers from Annex 'l are at your facility, - Dispose of all affected tube sets properly. Confirm this on the customer response form. Return the form to [email protected]. Please send any questions to [email protected]

    Distribution

    US Nationwide distribution.

    Quantity

    1700 units