Recall Z-0603-2014— Terumo Cardiovascular Systems Corporation

Name: FDA recall Z-0603-2014
Creator: U.S. Food and Drug Administration
Published: 2013-06-04

Class II · Terminated

Class II FDA medical device recall by Terumo Cardiovascular Systems Corporation, initiated 2013-06-04, terminated 2014-10-01. It names one FDA 510(k) clearance: K820297. 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..

Recalling firm: Terumo Cardiovascular Systems Corporation
Classification: Class II
Status: Terminated
Initiated: 2013-06-04
Terminated: 2014-10-01
Firm location: Elkton, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K820297 — WM. HARVEY OVERPRESSURE SAFETY VALVEC.R. Bard, Inc.·cleared 1982-03-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.