BEUDAMED
    FDA Recall Terminated

    enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120). The Enginivity enFlow TM IV Fluid Warmer is intended for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.

    Recall: Z-1972-2012 · Initiated February 20, 2012

    Recall

    Recall Number
    Z-1972-2012
    Event Number
    62441
    Firm
    Vital Signs Devices, a GE Healthcare Company
    FEI Number
    2242551
    Product Code
    LGZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 20, 2012
    Posted
    July 9, 2012
    Terminated
    August 19, 2013
    Address
    20 Campus Rd, Totowa, NJ, 07512-1210

    Description

    enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120). The Enginivity enFlow TM IV Fluid Warmer is intended for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.

    Reason

    The EnFlow Warmer Strap does not meet the requirements of the biocompatibility standard (ISO 10993) for products that may have contact with skin for less than 24 hours.

    Action

    GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter included customer instructions and a Customer Response Form to be completed and returned to the firm. Contact Customer Service at 1-800-932-0760 for questions regarding this recall.

    Distribution

    Nationwide Distribution.

    Quantity

    11803 cases