Terumo Advanced Perfusion System 1 Electronic Patient Gas System — Class II medical device recall Z-1337-2019
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2019-05-22, distributed nationwide. The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter.
| Recall number | Z-1337-2019 |
|---|---|
| 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 | 2019-04-18 |
| Classified | 2019-05-15 |
| Reported by FDA | 2019-05-22 |
| Terminated | 2020-05-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, CA, CL, HK, ID, JP, KR, MX, PH, SG, TH, TW |
| Quantity | 1,258 |
| UPC / GTIN / UDI-DI | 00886799000588 |
| Model numbers | 801188 |
Product
Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit.
Reason for recall
The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter.
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-1337-2019. 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.