FDAFDA · Food and drugs·Recall number Z-0603-2014
Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line
Published January 8, 2014 · Recall initiated: June 4, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Distributor
- Nationwide Canada
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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