BEUDAMED
    FDA Recall Terminated

    LoFric Origo, Nelaton, 16in, FR10 urinary catheters

    Recall: Z-2643-2020 · Initiated June 17, 2020

    Recall

    Recall Number
    Z-2643-2020
    Event Number
    85905
    Firm
    Wellspect HealthCare (Division of DENTSPLY IH AB) Aminogatan 1 Molndal Sweden
    FEI Number
    3009632672
    Product Code
    EZD
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    June 17, 2020
    Terminated
    April 9, 2021

    Description

    LoFric Origo, Nelaton, 16in, FR10 urinary catheters

    Reason

    Wellspect Healthcare is voluntarily recalling certain LoFric Origo" urethral catheters due to a potential defect which may be present in the catheter s distal tip.

    Action

    Effected catheters must be not used and should be immediately returned. Wellspect issued an urgent medical device field notice dated June 19, 2020 to customers.

    Distribution

    AL, AZ, CA, CT, FL, GA, IL, IN, KY, MA, MD, MI, MO, NC, NH, NJ, OH, PA, RI, SC, TX, VA and Australia, Brazil, Canada, European Union, China, South Korea, Kuwait, New Zeeland, Singapore, United Kingdom