Flowmeter Module — Class II medical device recall Z-1478-2018
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2018-05-02, distributed in IL, KY, MI. Inaccurrate flow readings. Depending on the degree of inaccuracy, this issue may not be easy for the user to d
| Recall number | Z-1478-2018 |
|---|---|
| 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 | 2018-01-19 |
| Classified | 2018-04-20 |
| Reported by FDA | 2018-05-02 |
| Terminated | 2018-07-18 |
| Distributed | IL, KY, MI |
| Countries outside the US | SG |
| Quantity | 7 |
| UPC / GTIN / UDI-DI | 00886799000687 |
| Serial numbers | 01662, 01672, 01680, 01681, 01682, 01683, 01687 |
| Model numbers | 802018 |
Product
Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and the system.
Reason for recall
Inaccurrate flow readings. Depending on the degree of inaccuracy, this issue may not be easy for the user to detect during setup or use (for example, following a Flow Probe relocation or manipulation).
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-1478-2018. 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.