Recall Z-0278-2013— Terumo Cardiovascular Systems Corporation

Name: FDA recall Z-0278-2013
Creator: U.S. Food and Drug Administration
Published: 2012-10-16

Class II · Terminated

Class II FDA medical device recall by Terumo Cardiovascular Systems Corporation, initiated 2012-10-16, terminated 2013-07-11. It names one FDA 510(k) clearance: K071521. Product: HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.. Reason: Based on a retrospective review of quality data, AC Control boards used in the manufacture of the HX2 Temperature Management System were identified as being manufactured using the incorrect flux material. Use of the incorrect flux may contribute to premature board failure. A search of TCVS complaints revealed 3 complaints received related to the HX2 failure. Each failure occurred during set up.

Recalling firm: Terumo Cardiovascular Systems Corporation
Classification: Class II
Status: Terminated
Initiated: 2012-10-16
Terminated: 2013-07-11
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

HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.

Reason for recall

Based on a retrospective review of quality data, AC Control boards used in the manufacture of the HX2 Temperature Management System were identified as being manufactured using the incorrect flux material. Use of the incorrect flux may contribute to premature board failure. A search of TCVS complaints revealed 3 complaints received related to the HX2 failure. Each failure occurred during set up

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