BEUDAMED
    FDA Recall Terminated

    BCI Non Invasive Blood Pressure Monitor Product/Catalog number 6004,

    Recall: Z-1649-2008 · Initiated April 2, 2008

    Recall

    Recall Number
    Z-1649-2008
    Event Number
    47800
    Firm
    Smiths Medical PM, Inc.
    FEI Number
    2183502
    Product Code
    DXN
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    April 2, 2008
    Posted
    August 25, 2008
    Terminated
    December 17, 2011
    Address
    N7w22025 Johnson Dr, Waukesha, WI, 53186-1856

    Description

    BCI Non Invasive Blood Pressure Monitor Product/Catalog number 6004,

    Reason

    Due to a component that may be installed backwards, the device may turn off or may immediately reset.

    Action

    Consignees were contacted on 4/2/08 with a Safety Action Bulletin, 08-SAB02, and Technical Worksheet 08-TW01 dated April 1, 2008, which included information regarding the potential safety issue and the proper inspection method for the monitor(s). If you have not received the Safety Action Bulletin or the Technical Worksheet contact Smiths Medical PM, Inc. at Telephone: (262) 542-3100 or Toll Free: (USA): (800) 558-2345 or email [email protected].

    Distribution

    USA: IL, FL, TX, IA, CA, ID, MD, AZ, MN, PA, CO, IN, KS, WA, TN, AL, WI, NM, LA, and PR. OUSA: Argentina, Canada, Ecuador, Greece, Hong Kong, Italy, Pakistan, Peru, Russia, saudi Arabia, Slovakia, Thailand, United Kingdom

    Quantity

    195