BEUDAMED
    FDA Recall Terminated

    Smiths Medical, BCI Remote Alarm Cable (Normally Open & Normally Closed), Reorder Numbers: WW3398NO & WW3398NC. For use with respiration carbon dioxide measurement equipment. Product Usage: The BCI Remote Alarm Cable is designed for use with the 9004 Capnocheck Capnography (Plus or Sleep) system to transfer alarm signals from the Capnocheck Capnography system to a remote alarm system. The BCI Remote Alarm Cable and the 9004 Capnocheck Capnography systems are intended for use in all critical environments including ventilatory applications, patient transport, and anesthesia.

    Recall: Z-1014-2013 · Initiated February 6, 2013

    Recall

    Recall Number
    Z-1014-2013
    Event Number
    64543
    Firm
    Smiths Medical ASD, Inc.
    FEI Number
    2183502
    Product Code
    CCK
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 6, 2013
    Posted
    March 29, 2013
    Terminated
    July 12, 2013
    Address
    1265 Grey Fox Rd, Saint Paul, MN, 55112-6929

    Description

    Smiths Medical, BCI Remote Alarm Cable (Normally Open & Normally Closed), Reorder Numbers: WW3398NO & WW3398NC. For use with respiration carbon dioxide measurement equipment. Product Usage: The BCI Remote Alarm Cable is designed for use with the 9004 Capnocheck Capnography (Plus or Sleep) system to transfer alarm signals from the Capnocheck Capnography system to a remote alarm system. The BCI Remote Alarm Cable and the 9004 Capnocheck Capnography systems are intended for use in all critical environments including ventilatory applications, patient transport, and anesthesia.

    Reason

    In rare instances, the BCI Remote Alarm Cables (BCI Cable) are not transferring alarms when used with some remote nurse alarm systems.

    Action

    Smiths Medical sent an "Urgent Medical Device Field Safety Notice-Recall" letter dated February 96, 2013 via UPS to all affected customers. The letter described the affected product, problem and actions to be taken. Customers were instructed to inspect their inventory and remove all affected devices from use, complete and return the attached "Confirmation Form", by fax to 1-800-237-8033 or email to [email protected]. The letter stated that a Customer representative will contact customers with instructions for returning affected products for replacement or credit. For questions contact Smiths Medical's Customer Service Department at 10-800-258-5361.

    Distribution

    USA Nationwide Distribution - including the states of: CO, IL, IN, MA, SC and WI.

    Quantity

    39