BEUDAMED
    FDA Recall Terminated

    Rsch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx only, Teleflex Medical.

    Recall: Z-0245-2016 · Initiated August 24, 2015

    Recall

    Recall Number
    Z-0245-2016
    Event Number
    72037
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    BSR
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    August 24, 2015
    Posted
    November 6, 2015
    Terminated
    September 25, 2017
    Address
    2917 Weck Dr, Research Triangle Park, NC, 27709-0186

    Description

    Rsch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx only, Teleflex Medical.

    Reason

    Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet.

    Action

    Consignees were notified by letter on 08/24/2015. They were instructed to immediately discontinue use and quarantine any products with the listed catalog numbers. They were to return the product, complete the enclosed Recall Acknowledgement Form and fax or e-mail to [email protected], even if they do not have any of the affected stock. Distributors were instructed to communicate the recall to any of their customers who have received the affected product and to have the customers return any affected product to them with the completed Recall Acknowledgement Form.

    Distribution

    Worldwide Distribution -- U.S. Nationwide; International Distribution: Argentina, Austria, Belgium, Belgrade, Cameroon, Canada, Chile, Costa Rica, Croatia, Czech Republic, Ecuador, Denmark, Estonia, Finland, France, French Polynesia, Great Britain, Greece, Guyana, Hong Kong, Ireland, Italy, Jordan, Kuwait, Latvia, Lebanon, Martinique, Netherlands, Panama, Peru, Poland, Portugal, Reunion, Romania, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Venezuela, and the United Arab Emirates.

    Quantity

    233,641 units