BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0410-2018 · Initiated May 22, 2017

    Recall

    Recall Number
    Z-0410-2018
    Event Number
    78349
    Firm
    Somatex Medical Technologies GmbH Rheinstr. 7 d Teltow Germany
    FEI Number
    1000408433
    Product Code
    NEU
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 22, 2017
    Terminated
    August 30, 2018

    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.

    Action

    On May 22, 2017, Somatex Medical Technologies distributed notices to their customers advising them of the reason for recall. Customers are advised to inspect stock, quarantine and not use affected product. Products will be exchanged free of charge and a replacement delivery will be arranged promptly. All customers are expected to complete and return the response form via fax.

    Distribution

    NY - Only one US distributor