BEUDAMED
    FDA Enforcement Class II Terminated

    TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE

    Recall: Z-0410-2018 · Reported January 31, 2018

    Enforcement

    Recall Number
    Z-0410-2018
    Event ID
    78349
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Somatex Medical Technologies GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 31, 2018
    Initiation Date
    May 22, 2017
    Classification Date
    January 24, 2018
    Termination Date
    August 30, 2018
    Address
    Rheinstr. 7 d, N/A, Teltow, N/A, N/A, Germany

    Description

    TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE

    Reason

    There is a potential risk of puncture to the packaging material which can compromise the devices sterility, making it non-sterile.

    Code Info

    Lot numbers: 47883, 47910 & 47911

    Distribution

    NY - Only one US distributor

    Quantity

    N/A