BEUDAMED
    FDA Recall Terminated

    HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status System Only. Product Usage: is indicated for use in patients greater than or equal to 2 years old with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters.

    Recall: Z-1147-2013 · Initiated March 28, 2013

    Recall

    Recall Number
    Z-1147-2013
    Event Number
    64770
    Firm
    Transonic Systems Inc 34 Dutch Mill Rd Warren Road Business Park Ithaca NY 14850-9785
    FEI Number
    1319030
    Product Code
    DXG
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    March 28, 2013
    Posted
    April 18, 2013
    Terminated
    March 5, 2014

    Description

    HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status System Only. Product Usage: is indicated for use in patients greater than or equal to 2 years old with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters.

    Reason

    Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit.

    Action

    Transonic Systems Inc. sent an Urgent: Medical Device Recall dated March 27, 2013 to all affected customers. The letter identified the recalled product, problem and actions to be taken. Customers were instructed to examine inventory, quarantine, discontinue use and return any recalled product via FedEx. Transonic Systems Inc. has offered to reimburse the firm for the return of these recalled products by check or credit memo for the returned goods and postage. Transonic Systems Inc. has requested that if a firm has further distributed any of the above lots, that they immediately contact their accounts, inform them of the recall, and have them return their outstanding recalled stocks to you. Transonic Systems Inc. have included copies of the product labeling and a Recall Return Response Form in their packet. Completed Recall Return Response Forms should be faxed to 607-257-5310.

    Distribution

    Worldwide Distribution - USA Nationwide including the states of AZ, CA, FL, GA, NM, NY, TX, VA and WA and countries of Netherlands, Canada and Russia.

    Quantity

    195 units total (140 units Domestic, 55 units Foreign)