Terumo Cardiovascular Systems Corporation: Medical Device Recall in 2012 - (Recall #: Z-0279-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Tested AC Control BD, 120V, X2 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.

Product Classification:

Class II

Date Initiated: October 16, 2012

Date Posted: November 21, 2012

Recall Number: Z-0279-2013

Event ID: 63344

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

Status: Terminated

Product Quantity: 15 units

Code Information:

Catalog number: 817168 and serial numbers: 824POOO023, 831 P001130, 831 P001133, 831 P001136, 831 P001140, 831 POO1141 , 831 P001144, 831 P001145, 831 P001146, 831 P001149, 831 P001151, 831 P001159, 831P001161, 831P001164, and 836POOOO05.

Distribution Pattern:

Nationwide Distribution including CA, HI, KS, LA, MI, MO, OR, PA, UT, and WI

Voluntary or Mandated:

Voluntary: Firm initiated