BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported July 10, 2024

    Enforcement

    Recall Number
    Z-2243-2024
    Event ID
    94749
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    WOM World Of Medicine AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 10, 2024
    Initiation Date
    May 24, 2024
    Classification Date
    July 1, 2024
    Address
    Alte Poststr. 11, N/A, Ludwigsstadt, N/A, N/A, Germany

    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

    Code Info

    UDI: 04056702003678 Lot Numbers: 4030902, 4030903

    Distribution

    US Nationwide distribution.

    Quantity

    1700 units