BEUDAMED
    FDA Recall Terminated

    Vital Signs Inc. enFlow Disposable IV Fluid/Blood Warmer Cartridge. Medical point-of-care device designed to warm blood and IV fluids.

    Recall: Z-2380-2010 · Initiated July 15, 2010

    Recall

    Recall Number
    Z-2380-2010
    Event Number
    56561
    Firm
    Vital Signs Inc
    FEI Number
    2242551
    Product Code
    LGZ
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    July 15, 2010
    Posted
    September 3, 2010
    Terminated
    April 27, 2015
    Address
    20 Campus Rd, Totowa, NJ, 07512

    Description

    Vital Signs Inc. enFlow Disposable IV Fluid/Blood Warmer Cartridge. Medical point-of-care device designed to warm blood and IV fluids.

    Reason

    The enFlow Disposable IV Fluid/Blood Warmer Cartridge's male luer-lock fitting may be oversized and may not fit properly with standard female luer fittings.

    Action

    GE Healthcare issued an "Urgent Medical Device Correction" letter, dated July 15, 2010, to consignees, identifying the reason for the recall and the affected lots. Customers were instructed to discontinue use of and quarantine the affected devices, and contact Vital Signs Inc. Customer Service to arrange for return and replacement of the affected devices. Consignees were instructed to complete and return the Confirmation Form. Consignees can contact Vital Signs Inc. Customer Service at 1-973-956-5300 .

    Distribution

    Worldwide Distribution; USA (all states), and to the countries of Australia, Ecuador, Finland, India, Israel, Latvia, Lebanon, Malaysia, Mexico, Morocco, New Zealand, Panama, Philippines, Qatar, Saudi Arabia, Singapore, Switzerland, the Netherlands, and Vietnam.

    Quantity

    385,820 domestic - 20,776 international