FDA-Device2012-10-24Class II
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
Belmont Instrument Corporation
Hazard
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.
Sold states
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.
Affected count
2,913 units
Manufactured in
780 Boston Rd, N/A, Billerica, MA, United States
Products
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0058-2013Don't want to check this manually?
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