Recall Z-0058-2013— Belmont Instrument Corporation
Class II · Terminated
Class II FDA medical device recall by Belmont Instrument Corporation, initiated 2012-09-25, terminated 2014-02-28. It names 3 FDA 510(k) clearances: K091855, K032674, K972284. Product: Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.. 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..
- Recalling firm
- Belmont Instrument Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-09-25
- Terminated
- 2014-02-28
- Firm location
- Billerica, MA, United States
510(k) clearances named in this recall
3 on FDA's record- K091855 — THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000
- K032674 — BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000
- K972284 — FLUID MANAGEMENT SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.