BEUDAMED
    FDA Enforcement Class II Terminated

    10mm Weck Vista Cannula-only, Catalog No. 405910C, 12mm Weck Vista Cannula-only, Catalog No. 405912C. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.

    Recall: Z-1324-2014 · Reported April 9, 2014

    Enforcement

    Recall Number
    Z-1324-2014
    Event ID
    67819
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 9, 2014
    Initiation Date
    March 11, 2014
    Classification Date
    April 2, 2014
    Termination Date
    January 28, 2016
    Address
    4024 Stirrup Creek Dr, N/A, Durham, NC, 27703-9000, United States

    Description

    10mm Weck Vista Cannula-only, Catalog No. 405910C, 12mm Weck Vista Cannula-only, Catalog No. 405912C. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.

    Reason

    Complaints of leakage of insufflation gas through the device.

    Code Info

    Lots - Catalog No. 405910C - 01G1200243, 01J1200226, 01L1200368, 01A1300177, 01D1300107, 01E1300140, 01E1300435, Catalog No. 405912C - 01J1200384, 01K1200725, 01L1200352, 01D1300319

    Distribution

    Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, MD, MA, MI, MN, MS, MO, NH, NJ, NY, NC, ND, OH, OR, PA, SC, TN, UT, VA, WA, WV, WI and the countries of Australia, Brazil, Canada, China, Israel, Korea, Malaysia, Singapore, and Vietnam.

    Quantity

    55,521 total