BEUDAMED
    FDA Recall Terminated

    Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Only, Teleflex Medical.

    Recall: Z-1404-2015 · Initiated March 13, 2015

    Recall

    Recall Number
    Z-1404-2015
    Event Number
    70723
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    KDQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 13, 2015
    Posted
    April 8, 2015
    Terminated
    August 14, 2017
    Address
    2917 Weck Dr, Research Triangle Park, NC, 27709-0186

    Description

    Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Only, Teleflex Medical.

    Reason

    Package contains incorrect sized unit: The adult sized S-1100-08LF product contains an infant sized chest drainage system.

    Action

    Teleflex Medical sent an Urgent Medical Device Recall Notification dated March 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine any of the affected listed catalog numbers and to return the product. Complete the enclosed acknowledgement form to Teleflex Medical. The form is to be returned even if they have not products. For further questions contact your local sales representative or Customer Service at 1-866 246-6990.

    Distribution

    US Distribution to the states of : AK, AL, AR, CA, CO, FL, GA, IL, IN, KY, KS, MA, MD, MI, MN, NY, OH, PA, RI, SC, TX, VA WI and WV.

    Quantity

    2,148 units