BEUDAMED
    FDA Recall Terminated

    The Alternans Sensor Kit Assembly is a sealed kit that contains the components necessary for conducting a Microvolt Twave Alternans test.

    Recall: Z-1776-2010 · Initiated April 29, 2010

    Recall

    Recall Number
    Z-1776-2010
    Event Number
    55505
    Firm
    Cambridge Heart, Inc.
    FEI Number
    3000215432
    Product Code
    DRX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 29, 2010
    Posted
    June 7, 2010
    Terminated
    September 20, 2011
    Address
    100 Ames Pond Dr, Tewksbury, MA, 01876-1293

    Description

    The Alternans Sensor Kit Assembly is a sealed kit that contains the components necessary for conducting a Microvolt Twave Alternans test.

    Reason

    Some kits contained a component with expiration date prior to the date of expiry on the outside of the kit. The user receives feedback of potential unreliable results at several stages during the test process, so any risk of unreliable results is low.

    Action

    The Alternate Sensor Kit Assembly P/N 203270209 may contain a pouch of standard ECG electrodes with an expiry date which is earlier than the expiration date on the outside label of the kit. All customers were sent a letter dated April 23, 2010 with information that included instructions for returning the kits. Questions are directed to the company's Quality Manager and Recall Coordinator at phone number 978-654-7625.

    Distribution

    Nationwide

    Quantity

    2740