Recall Z-1416-2018— Terumo Cardiovascular Systems Corporation

Name: FDA recall Z-1416-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-16

Class II · Terminated

Class II FDA medical device recall by Terumo Cardiovascular Systems Corporation, initiated 2018-03-16, terminated 2020-06-10. It names one FDA 510(k) clearance: K071521. Product: Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Management System is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery.. Reason: Update to cooler-heater cleaning instructions..

Recalling firm: Terumo Cardiovascular Systems Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-03-16
Terminated: 2020-06-10
Firm location: Ann Arbor, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K071521 — TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEMTerumo Cardiovascular Systems Corp.·cleared 2007-11-21

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 HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Management System is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery.

Reason for recall

Update to cooler-heater cleaning instructions.

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