BEUDAMED
    FDA Enforcement Class II Ongoing

    Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and manipulation of the vagina during the procedure. Material No. M0068318210

    Recall: Z-1490-2021 · Reported May 5, 2021

    Enforcement

    Recall Number
    Z-1490-2021
    Event ID
    87709
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 5, 2021
    Initiation Date
    April 15, 2021
    Classification Date
    April 23, 2021
    Address
    100 Boston Scientific Way, N/A, Marlborough, MA, 01752-1234, United States

    Description

    Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and manipulation of the vagina during the procedure. Material No. M0068318210

    Reason

    Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection

    Code Info

    All unexpired lots: C003699 C003715 C003735 C003750 C003775 C003804 C003813 C003842 C003853 C003887 C003905 C003936 C003950 C003960 C003966 C003986 C003997 C004028 C004041 C004078 C004091 C004107 C004117 C004128 C004136 C004160 C004186 C004206 C004221 GTIN 08714729848097

    Distribution

    Worldwide distribution - US Nationwide distribution and the countries of Algeria, Brazil, Colombia, Estonia, Germany, Hong Kong, Australia, Canada, Costa Rica, Finland, Great Britain, Italy, Austria, Chile, Czech Republic, France, Greece, Jordan, Belgium, Lebanon, Mauritius, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan.

    Quantity

    4,549 WW