Recall Z-1828-2015— Terumo Cardiovascular Systems Corp

Name: FDA recall Z-1828-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-06

Class II · Terminated

Class II FDA medical device recall by Terumo Cardiovascular Systems Corp, initiated 2015-05-06, terminated 2015-07-27. It names one FDA 510(k) clearance: K820297. Product: Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it.. Reason: The Overpressure Safety Valve is not cleared with an indication for use on the arterial side of the extracoporeal bypass circuit. It is intended for use only on the venous side. There is a remote possibility of minimal blood loss, fluid weeping, or dripping on the user..

Recalling firm: Terumo Cardiovascular Systems Corp
Classification: Class II
Status: Terminated
Initiated: 2015-05-06
Terminated: 2015-07-27
Firm location: Ashland, MA, 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

Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it.

Reason for recall

The Overpressure Safety Valve is not cleared with an indication for use on the arterial side of the extracoporeal bypass circuit. It is intended for use only on the venous side. There is a remote possibility of minimal blood loss, fluid weeping, or dripping on the user.

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