Recall Z-0256-2018— Terumo Cardiovascular Systems Corporation

Name: FDA recall Z-0256-2018
Creator: U.S. Food and Drug Administration
Published: 2017-06-27

Class II · Terminated

Class II FDA medical device recall by Terumo Cardiovascular Systems Corporation, initiated 2017-06-27, terminated 2019-07-16. It names one FDA 510(k) clearance: K820297. Product: TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J. Reason: Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (OPS) Valve..

Recalling firm: Terumo Cardiovascular Systems Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-06-27
Terminated: 2019-07-16
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(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J

Reason for recall

Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (OPS) Valve.

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