BEUDAMED
    FDA Recall Terminated

    RUSCH Crystal Clear PDT, Sterile Crystal Clear Tracheostomy Tube is a device inserted into a patients trachea surgically via the neck to maintain an open airway.

    Recall: Z-2696-2011 · Initiated April 4, 2011

    Recall

    Recall Number
    Z-2696-2011
    Event Number
    58592
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    JOH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 4, 2011
    Posted
    June 29, 2011
    Terminated
    March 2, 2012
    Address
    4024 Stirrup Creek Dr, Durham, NC, 27703-9000

    Description

    RUSCH Crystal Clear PDT, Sterile Crystal Clear Tracheostomy Tube is a device inserted into a patients trachea surgically via the neck to maintain an open airway.

    Reason

    Recalled due to air leakage from the main ventilation lumen through air passageway, resulting in potential injury requiring medical intervention.

    Action

    Teleflex Medical sent an URGENT FIELD SAFETY NOTICE dated January 4, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their stock for product, cease use and distribution of stock from the affected lot number and quarantine all products from the affected lot number immediately. Customers were instructed to complete the field safety corrective action acknowledgement and stock status form and fax to their local Teleflex Medical Customer Service Sales Rep. If the customers did have stock from the affected lot number, they were to contact their local Teleflex Medical Customer Service/Sales Rep or distributor as indicated on the attached field safety corrective action acknowledgement and stock status form for a Return Autorization Number. Distributors were to communicate the field safety corrective action notice to their customers and forward the completed Acknoweldgement Form to [email protected] or fax to +353 1 437 0773. For questions regarding this recall call +353 906 460 838

    Distribution

    Worldwide Distribution - Arabia, Asia, Austria, Belgium, Czech Republic, Denmark, Estonia, Germany, Greece, Ireland, Italy, Spain, Saudi Kuwait, Portugal, Russia Federation, Sweden, Slovenia and South America.

    Quantity

    see line 1.