Z-0603-2014 Class II Terminated
FDA device recall Z-0603-2014 was initiated by Terumo Cardiovascular Systems Corporation on Jun 4, 2013 and is designated Class II. Reason for recall: Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit. The recall status is terminated (terminated Oct 1, 2014). Affected quantity: 24,227.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 8, 2014
- Initiation Date
- Jun 4, 2013
- Termination Date
- Oct 1, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24,227.
Product Description
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.
Distribution Pattern
Nationwide Canada
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0603-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026