[pending] Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, single-use, disposable set u
Pending LLM rewrite. Source: FDA_DEVICE Z-1674-2025.
What this means for you
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: Pending LLM scoring against the rubric.
Plain-English summary
Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.
The recalled product
- Product
- Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Hyperthermia Procedure kit (P/N 902-00045) consists of 4.4 Liter Reservoir (P/N 902-00034P), Heat Exchanger set (P/N 902-00006P) and HP Procedu
- Manufacturer
- Belmont Instrument LLC
- Category
- Medical Device — Devices
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 (2)
- Model Number: 902-00045. UDI-DI: 00896128002589. Lot Numbers: 20241005
- 20241108
Distribution
Distributed nationwide across the United States.
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