The Recall Desk
ModerateFDA (Devices)·Z-2207-2016·Announced 2016-07-27

Terumo HX2 Temperature Management Systems Recalled Due to Sanitizer Availability

Terumo CVS is voluntarily recalling HX2 Temperature Management Systems because the Interchlor sanitizer required for cleaning is no longer available.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a voluntary precautionary recall driven by a supply chain issue (unavailable sanitizer) rather than a direct defect causing injury or a high-risk pathogen, fitting the criteria for moderate severity.

Plain-English summary

Terumo Cardiovascular Systems Corporation is conducting a voluntary recall of its HX2 Temperature Management Systems. These devices are used during open heart surgery to control the temperature of patient blood and cardioplegia solution. The recall involves 6,412 units distributed domestically across the United States and internationally to numerous countries.

The recall is being conducted because the distributor no longer sells the Interchlor sanitizer (Product Code 205) that is referenced in the device's cleaning instructions. This change in product availability affects the ability to follow the specified cleaning protocols for the heater-cooler devices.

Healthcare facilities and users of these devices should contact Terumo Cardiovascular Systems Corporation for further instructions regarding the recall and alternative cleaning procedures.

The recalled product

Product
HX2" Temperature Management Systems; The Terumo¿ HX2" Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery. The system cons
Manufacturer
Terumo Cardiovascular Systems Corporation
Category
Medical Device — Surgical Equipment
Hazard
Affected units
6,412

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 (3)

  • HX2" Temperature Management Systems
  • P/N 809810
  • Catalog Number 809810

Distribution

Distributed in 51 states:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Related recalls

Same manufacturer · Terumo Cardiovascular Systems Corporation

See all →