Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA device recall Z-0058-2013 · posted 2012-10-12 · Terminated
Recall details
- Recalling firm
- Belmont Instrument Corporation
- Reason for recall
- 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 taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 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,
- Date initiated
- 2012-09-25
- Date posted
- 2012-10-12
- Date terminated
- 2014-02-28
- Location
- Billerica, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000 (K091855) | Belmont Instrument Corp. | 2009-07-01 |
| BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000 (K032674) | Belmont Instrument Corp. | 2003-09-16 |
| FLUID MANAGEMENT SYSTEM (K972284) | Belmont Instrument Corp. | 1997-11-13 |