Terumo Advanced Perfusion System 1 Electronic Patient Gas System… — Class II medical device recall Z-2350-2021
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2021-09-01. intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attemp
| Recall number | Z-2350-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corporation, Ann Arbor, MI, United States |
| Recall initiated | 2021-06-08 |
| Classified | 2021-08-26 |
| Reported by FDA | 2021-09-01 |
| Terminated | 2022-06-28 |
| Countries outside the US | PA |
| Quantity | 1 units |
| UPC / GTIN / UDI-DI | 00886799000588 |
| Model numbers | 801188 |
Product
Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188
Reason for recall
intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attempt following the 15-minute warm-up period. The control sliders on the Central Control Monitor (CCM) are disabled and the gas system can only be controlled by the local control knobs
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-2350-2021. 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.