BEUDAMED
    FDA Enforcement Class II Ongoing

    The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not made with natural rubber latex. Model Number(s): KCP-30-2

    Recall: Z-1686-2021 · Reported June 2, 2021

    Enforcement

    Recall Number
    Z-1686-2021
    Event ID
    87849
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CooperSurgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 2, 2021
    Initiation Date
    April 23, 2021
    Classification Date
    May 26, 2021
    Address
    95 Corporate Dr, N/A, Trumbull, CT, 06611-1350, United States

    Description

    The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not made with natural rubber latex. Model Number(s): KCP-30-2

    Reason

    The affected Koh Cup were incorrectly packaged with a 3.5cm Ultem Koh cup, P/N 34131-04, instead of a 3.0cm Ultem Koh cup, P/N 34131-03 as required.

    Code Info

    Lot 280819

    Distribution

    Domestic: UT, OH, DE

    Quantity

    6 boxes or 12 units