Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing… — Class II medical device recall Z-0603-2014
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2014-01-08, distributed nationwide. Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal
| Recall number | Z-0603-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corporation, Elkton, MD, United States |
| Recall initiated | 2013-06-04 |
| Classified | 2013-12-27 |
| Reported by FDA | 2014-01-08 |
| Terminated | 2014-10-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 24,227 |
| Reason classes | unapproved product |
Product
Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line
Reason for recall
Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit.
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-0603-2014. 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.