BEUDAMED
    FDA Recall Terminated

    enFlow IV Fluid Warmer Part number 980105VS; (510K name: enFlow IV Fluid Warmer Model 100, EFlow Disposable Cartridge, Model 200 and EFlow AC Power Supply Model 120) Intended for warming blood, blood products, and intravenous solutions, prior to administration. Intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.

    Recall: Z-3040-2011 · Initiated June 30, 2011

    Recall

    Recall Number
    Z-3040-2011
    Event Number
    59688
    Firm
    Vital Signs Devices, a GE Healthcare Company
    FEI Number
    2242551
    Product Code
    LGZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 30, 2011
    Posted
    August 19, 2011
    Terminated
    June 14, 2013
    Address
    20 Campus Rd, Totowa, NJ, 07512-1210

    Description

    enFlow IV Fluid Warmer Part number 980105VS; (510K name: enFlow IV Fluid Warmer Model 100, EFlow Disposable Cartridge, Model 200 and EFlow AC Power Supply Model 120) Intended for warming blood, blood products, and intravenous solutions, prior to administration. Intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.

    Reason

    enFlow IV Fluid Warmer may have an issue which results in excessive external surface temperature on the underside of the warmer.

    Action

    GE Healthcare sent UMDC Letters/UMDC Confirmation Letters to customers on June 30, 2011. GE Healthcare sent UMDC Letters/UMDC Confirmation Letters on October 24, 2011 reflecting a new recall strategy.

    Distribution

    Worldwide Distribution - USA (nationwide) and the country of Vietnam

    Quantity

    1307 units