BEUDAMED
    FDA Recall Terminated

    TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft tissue.

    Recall: Z-1552-2014 · Initiated April 14, 2014

    Recall

    Recall Number
    Z-1552-2014
    Event Number
    68074
    Firm
    Tenex Health Inc
    FEI Number
    1000135560
    Product Code
    LFL
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    April 14, 2014
    Posted
    May 6, 2014
    Terminated
    July 16, 2014
    Address
    26902 Vista, Terrance Lake Forest, CA, 92630

    Description

    TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft tissue.

    Reason

    The sterile barrier in the packaging may be compromised due to cracks in the thermoform tray that may occur during transport of the product in extreme cold weather conditions, in conjunction with mechanical impact.

    Action

    Tenex Health sent an Urgent Medical Device Recall notification letter dated April 15, 2014, to all consigness. The letter informed consignees of the recall, manufacturer, product name, product code, reason for recall, recall carried out to the user level, instructions to customers, contact information, label examples, and response form was provided. Consignees were instructed to immediately examine their inventory per the enclosed instructions, if they identify any of the affected product within their inventory, they should segregate the product and immediately return only MicroTips with damaged trays to the address below, using the Tenex Health, Inc. FEDEX account number and referencing the Returned Goods Authorization (RGA) number. RGA# Tenex Health, Inc. 26902 Vista Terrace Lake Forest, CA 92630 Customers were asked to complete and return the enclosed response form as soon as possible. Customers with questions should contact Tenex at (949) 454-7500, ext. 209 or email [email protected]. For questions regarding this recall call (949) 454-7500.

    Distribution

    Worldwide Distribution - USA (Nationwide) and Internationally to Panama and Singapore.

    Quantity

    9,927 units