BEUDAMED
    FDA Recall Terminated

    HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel, Rx Only, Sterile. Used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.

    Recall: Z-2370-2015 · Initiated June 1, 2015

    Recall

    Recall Number
    Z-2370-2015
    Event Number
    71360
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    CBI
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    June 1, 2015
    Posted
    August 20, 2015
    Terminated
    April 16, 2018
    Address
    2917 Weck Dr, Research Triangle Park, NC, 27709-0186

    Description

    HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel, Rx Only, Sterile. Used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.

    Reason

    The double swivel connector may crack or separate on the endobronchial tube.

    Action

    Teleflex Medical sent an Urgent Medical Device Recall Notification letter dated June 1, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were directed to contact any customers who had received the product included within the scope of this recall. Customers were directed to immediately discontinue use and quarantine any products with the referenced catalog numbers and lot numbers listed in the notification. Additionally, customers were asked to return any affected product together with a completed Recall Acknowledgement Form, for consolidation and return to Teleflex Medical. For questions contact your local sales representative or Customer Service at 1-866-246-6990.

    Distribution

    Worldwide Distribution - US (nationwide) and the countries of: The Bahamas, Belgium, Argentina, Canada, China, India, Japan, South Korea, Mexico, New Zealand and Vietnam.

    Quantity

    188,195 total units