Belmont Rapid Infuser Recalled Due to Electrical Flash Hazard
Belmont Instrument Corporation is recalling 2,913 Rapid Infuser units because saline leakage caused an electrical flash at the power entry area.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (electrical flash) where injury has not yet been reported, which aligns with the 'High' severity criteria for medical devices.
Plain-English summary
Belmont Instrument Corporation is recalling 2,913 units of the Belmont Rapid Infuser, a Fluid Management System, Model FMS2000. The recall is due to a defect where a leak from a saline bag caused saline to drip along the back of the device, close to the Power Entry Module. This leakage resulted in an electrical flash at the power entry area.
The affected units were distributed worldwide, including in the United States and numerous international markets such as Australia, Canada, China, and the United Kingdom. The recall covers specific serial numbers listed in the official FDA record Z-0058-2013.
Healthcare facilities and users should stop using the affected devices immediately. Users should contact Belmont Instrument Corporation for instructions on how to return or repair the units to prevent potential electrical hazards.
The recalled product
- Product
- Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
- Manufacturer
- Belmont Instrument Corporation
- Affected units
- 2,913
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- T081797 T081798
- T081800 T081799
- T081801 T081802
- T081803 T081804
- U052056 U112184
- V062426 V072490
- V022258 Q080723
- N100302 O060374
- O070377 P120576
Distribution
Distributed nationwide across the United States.
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