BEUDAMED
    FDA Enforcement Class II Terminated

    LoFric Origo, Nelaton, 16in, FR10 urinary catheters

    Recall: Z-2643-2020 · Reported July 29, 2020

    Enforcement

    Recall Number
    Z-2643-2020
    Event ID
    85905
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Wellspect HealthCare (Division of DENTSPLY IH AB)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 29, 2020
    Initiation Date
    June 17, 2020
    Classification Date
    July 17, 2020
    Termination Date
    April 9, 2021
    Address
    Aminogatan 1, N/A, Molndal, N/A, N/A, Sweden

    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.

    Code Info

    Lot # 447123

    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

    Quantity

    N/A