Straight Inflow/Bifurcated Outflow Line Kit — Class II medical device recall Z-1676-2025
Ongoing recall by Belmont Instrument LLC, reported 2025-05-07, distributed nationwide. Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid l
| Recall number | Z-1676-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Belmont Instrument LLC, Billerica, MA, United States |
| Recall initiated | 2025-03-31 |
| Classified | 2025-04-25 |
| Reported by FDA | 2025-05-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, HU, KR, LV, MY |
| Quantity | 136 sets |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00896128002220 |
| Lot numbers | 20241013 |
| Model numbers | 902-00038 |
Product
Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient Line Kit (P/N 902-00038) consists of 4.4 Liter Reservoir (P/N 902-00034P), Heat Exchanger set (P/N 902-00006P) and Straight Inflow/Bifurcated Outflow Patient Line (P/N 902-00040P). The three components are packaged separately in individual pouches and boxes and placed in the same case for shipment. All three components are connected prior to use. The female quick connector that may be cracked is located on the Heat Exchanger set (P/N 902-00006P).
Reason for recall
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.
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-1676-2025. 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.