BEUDAMED
    FDA Recall Terminated

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    Recall: Z-0058-2013 · Initiated September 25, 2012

    Recall

    Recall Number
    Z-0058-2013
    Event Number
    62703
    Firm
    Belmont Instrument Corporation
    FEI Number
    1219702
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 25, 2012
    Posted
    October 12, 2012
    Terminated
    February 28, 2014
    Address
    780 Boston Rd, Billerica, MA, 01821-5925

    Description

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    Reason

    Leak from a saline bag caused saline to drip along the back of the Rapid infuser close to the Power Entry Module causing an electrical flash at the power entry area.

    Action

    Belmont Instrument initiated recall on 9/25/12. A "Field Correction" notice was provided that described the product issue and recommended actions. US-based sales representatives visited all facilities to provide the modified power cord/shield. For units sold outside the United States, the modified power cords were sent to distributors who would ensure the new power cords were provided to all facilities within their accounts.

    Distribution

    Worldwide Distribution including Nationwide (USA) and the countries of Australia, Austria, Belgium, Brazil, Canada, China, Denmark, England, Estonia, France, Germany, Hong Kong, India, Israel, Italy, Jordan, Mongolia, Netherlands, New Zealand, Norway, Pakistan, Peru, Puerto Rico, S. Korea, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, UK, United Arab Emirates, and Vietnam.

    Quantity

    2,913 units