Terumo Cardiovascular Systems Corporation: Medical Device Recall in 2014 - (Recall #: Z-0603-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line

Product Classification:

Class II

Date Initiated: June 4, 2013

Date Posted: January 8, 2014

Recall Number: Z-0603-2014

Event ID: 67064

Reason for Recall:

Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit.

Status: Terminated

Product Quantity: 24,227.

Code Information:

Distribution Pattern:

Nationwide Canada

Voluntary or Mandated:

Voluntary: Firm initiated