FDA Device recall Z-1678-2025
3.0 Liter Disposable Set (4 sets/case)
- FDA Device
- Class II
- ongoing
- Published 2025-05-07
On 2025-05-07 the FDA classified a Class II recall of 3.0 Liter Disposable Set (4 sets/case) by Belmont Instrument, citing potential crack in the female connector located on the Heat Exchanger/patient line set, which will lead to a fluid leak through the crack during priming of the Rapid Infuser.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1678-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-31 |
| Published | 2025-05-07 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Belmont Instrument |
| Distribution | US |
Product
3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032 consists of 4 Large Volume Reservoirs (P/N 903-00018) and 4 Heat Exchanger/Patient Line set (P/N 403-00382). The two components are packaged separately in individual pouches and placed in the same case for shipment. The female quick connector that may be cracked is located on the Heat Exchanger/Patient Line set.
Reason
Potential crack in the female connector located on the Heat Exchanger/patient line set, which will lead to a fluid leak through the crack during priming of the Rapid Infuser.
Identifiers
| code_info | Model Number: 903-00032. UDI-DI: 00896128002534. Lot Numbers: 20240911, 20241004, 20241011, 20241105 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1678-2025%22
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