FDA Device recall Z-0603-2014
Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation L…
- FDA Device
- Class II
- terminated
- Published 2014-01-08
On 2014-01-08 the FDA classified a Class II recall of Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation L… by Terumo Cardiovascular Systems, citing over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0603-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-06-04 |
| Published | 2014-01-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | US |
Product
Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line
Reason
Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit.
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0603-2014%22
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