BEUDAMED
    FDA Enforcement Class II 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 · Reported April 24, 2013

    Enforcement

    Recall Number
    Z-1147-2013
    Event ID
    64770
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Transonic Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 24, 2013
    Initiation Date
    March 28, 2013
    Classification Date
    April 18, 2013
    Termination Date
    March 5, 2014
    Address
    34 Dutch Mill Rd, Warren Road Business Park, Ithaca, NY, 14850-9785, United States

    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.

    Code Info

    Lot numbers: 102810, 010311 and 111810.

    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)