Class II — Belmont Instrument Corporation
| Recalling firm | BELMONT INSTRUMENT LLC. |
|---|---|
| Registered facility | BELMONT MEDICAL TECHNOLOGIES (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | Belmont Rapid Infuser, a Fluid Management System, Model FMS2000. |
| Quantity | 2,913 units |
| 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, U… |
| Initiated | 2012-09-25 |
| Classified | 2012-10-12 |
| Terminated | 2014-02-28 |
| Recall number | Z-0058-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Belmont Instrument Corporation (Z-0058-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/62703/
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