BEUDAMED
    FDA Enforcement Class II Terminated

    12mm Weck¿ Vista" Cannula-only, Teleflex Medical, Product Usage: 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-1282-2014 · Reported April 2, 2014

    Enforcement

    Recall Number
    Z-1282-2014
    Event ID
    67710
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 2, 2014
    Initiation Date
    March 11, 2014
    Classification Date
    March 25, 2014
    Termination Date
    August 15, 2017
    Address
    2917 Weck Dr., N/A, Research Triangle Park, NC, 27709, United States

    Description

    12mm Weck¿ Vista" Cannula-only, Teleflex Medical, Product Usage: 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 were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.

    Code Info

    Product Code: 405910R, Lot Numbers: 01J1200009, 01J1200234, 01J1200380, 01K1200142, 01M1200251, 01A1300140, 01A1300376, 01A1300419, 01A1300370, 01A1300179, 01A1300419, 01A1300373.

    Distribution

    Worldwide Distribution - USA Nationwide including Puerto Rica and the countries of: Australia, Brazil, China, Canada, Malaysia, Korea, Ireland Singapore and Vietnam.

    Quantity

    55,521 ea. in total