The Recall Desk
HighFDA (Devices)·Z-0279-2013·Announced 2012-11-21

Terumo HX2 Temperature Management System Recalled for Board Defect

Terumo is recalling 15 HX2 Temperature Management Systems because AC Control boards were manufactured with incorrect flux, which may cause premature failure.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk-of-harm product (medical device) where failure has been reported (3 complaints), but no serious injury or death is explicitly stated in the source text.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling 15 units of the HX2 Temperature Management System. The system is a self-contained, dual-channel device used to supply temperature-controlled water to heat exchangers in extracorporeal circuits. The recall is due to a retrospective review of quality data that identified AC Control boards manufactured using incorrect flux material.

The use of incorrect flux may contribute to premature board failure. A search of company complaints revealed three instances of HX2 failure, each occurring during setup. The affected units were distributed nationwide, including in California, Hawaii, Kansas, Louisiana, Michigan, Missouri, Oregon, Pennsylvania, Utah, and Wisconsin.

Healthcare facilities should stop using the affected units and contact Terumo Cardiovascular Systems Corporation for instructions on return or replacement. The affected units are identified by catalog number 817168 and specific serial numbers listed in the official recall notice.

The recalled product

Product
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.
Manufacturer
Terumo Cardiovascular Systems Corporation
Category
Medical Device — Temperature Management System
Hazard
Affected units
15

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (15)

  • 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

Distributed nationwide across the United States.

The notice also names 10 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Terumo Cardiovascular Systems Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Terumo Cardiovascular Systems Corporation

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Same hazard · premature failure

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