BEUDAMED
    FDA Recall Terminated

    Weck Vista" Universal Laparoscopic Port, Size 5/10/12mmx125mm, 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-1281-2014 · Initiated March 11, 2014

    Recall

    Recall Number
    Z-1281-2014
    Event Number
    67710
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    GCJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 11, 2014
    Posted
    March 25, 2014
    Terminated
    August 15, 2017
    Address
    2917 Weck Dr., Research Triangle Park, NC, 27709

    Description

    Weck Vista" Universal Laparoscopic Port, Size 5/10/12mmx125mm, 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.

    Action

    Teleflex sent an Urgent Medical Device Recall Notification letter dated March 11, 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to return all affected product to Teleflex Medical per the instructions provided in the letter. Customers were asked to complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service. For questions contact your local sales representative or Customer Service at 1-866-246-6990.

    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