BEUDAMED
    FDA Recall Terminated

    Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core temperature

    Recall: Z-0407-2013 · Initiated August 17, 2012

    Recall

    Recall Number
    Z-0407-2013
    Event Number
    63532
    Firm
    Vital Signs Colorado Inc.
    FEI Number
    1718887
    Product Code
    KAK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 17, 2012
    Posted
    November 20, 2012
    Terminated
    June 14, 2013
    Address
    11039 East Lansing Circle, Englewood, CO, 80112-5909

    Description

    Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core temperature

    Reason

    There is a potential for epistaxis during use of the Disposable General Purpose 9 French Temperature Probe.

    Action

    The firm,GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter and Confirmation form on August 17, 2012 via Fed Ex to its consignees/customers. The letter describes the product, problem and action to be taken. The customers were instructed to do the following: Do not use the Disposable General Purpose 9 French Temperature Probe P/N 1016 or 1016EU; return all unopened product(s) to Vital Signs Devices (VSD) 11039 East Lansing Circle, Englewood, CO 80112-note: replacements and/or refunds discussed in letter are available only in exchange for the return of any unopened product(s); complete and return the URGENT MEDICAL DEVICE CORRECTION CONFIRMATION via fax to: 800-535-7923; forward a copy of the letter to any institutions they may have forwarded the product and for customers using the GXXXXX64 kit that includes the Disposable General Purpose 9 French Temperature Probe follow the directions listed in the letter. Note: VSD is removing p/n 1016 and 1016EU, Disposable General Purpose 9 French Temperature Probe, from the market and offering a replacement. If you have any questions or concerns regarding this notification, contact Customer Service at +1-800-932-0760 (Domestic & International). Hours of Operation 8:00 am EST to 6:00 pm EST.

    Distribution

    Worldwide distribution: USA (nationwide) including states of: AR, CA, FL,GA, IL, LA, MA, MI, MO, NC, NH, NY, OH, OK, PA, RI, SE,TX, and WA; and countries of: AUSTRALIA, BARCELONA, GERMANY, NEW ZEALAND, NETHERLANDS, SWITZERLAND, and UNITED KINGDOM.

    Quantity

    243,685 units