Belmont Rapid Infuser — Class II medical device recall Z-0058-2013
Terminated recall by Belmont Instrument Corporation, reported 2012-10-24, distributed nationwide. Leak from a saline bag caused saline to drip along the back of the Rapid infuser close to the Power Entry Modu
| Recall number | Z-0058-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Belmont Instrument Corporation, Billerica, MA, United States |
| Recall initiated | 2012-09-25 |
| Classified | 2012-10-12 |
| Reported by FDA | 2012-10-24 |
| Terminated | 2014-02-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BR, CA, CH, CN, DE, DK, EE, ES, FR, GB, HK, IL, IN, IT, JO, KR, LK, NL, NO, NZ, PE, PK, SA, SE, SG, SI, TR, TW, VN, ZA |
| Quantity | 2,913 units |
| Reason classes | packaging |
| Serial numbers | 2012012793, 2012012795, 2012012801, 2012012802, 2012012803, 2012012805, 2012012806, 2012012808, 2012012809, 2012022821, 2012022822, 2012022830, 2012022831, 2012022832, 2012022833, 2012022834, 2012022850, 2012022854, 2012022855, 2012032876, 2012032877, 2012032880, 2012032881, 2012032882, 2012032883 and 475 more |
| Model numbers | FMS2000 |
Product
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0058-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.