Recall Z-0058-2013 ยท FRN Pump, Infusion
Belmont Instrument Corporation
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
| Date | Oct 12, 2012 (initiated Sep 25, 2012) |
| 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. |
| Root cause | Device Design |
| 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. |
| 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 Ara |
| FDA record | Open on fda.gov |