The Recall Desk
ModerateFDA (Devices)·Z-2208-2016·Announced 2016-07-27

Terumo Recalls Sarns Temperature Control Units Due to Sanitizer Discontinuation

Terumo CVS is voluntarily recalling Sarns TCM units because the Interchlor sanitizer referenced in cleaning instructions is no longer sold by the distributor.

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 (FDA Class II) driven by a supply chain issue regarding cleaning supplies rather than a direct defect causing injury or illness, fitting the criteria for moderate severity.

Plain-English summary

Terumo Cardiovascular Systems Corporation (Terumo CVS) is conducting a voluntary recall of its Sarns Temperature Control and Monitor (TCM) units. The recall is being initiated because the distributor no longer sells the Interchlor sanitizer (Product Code 205) that is referenced in the device's cleaning instructions.

The Sarns TCM is a medical device used to provide temperature-controlled water for blood heat exchangers in extracorporeal circuits and for blankets to heat or cool patients. It is also used to supply water for cardioplegia and to monitor temperatures. The recall affects 6,412 units distributed domestically across the United States and in numerous foreign countries.

Healthcare facilities and users of these devices should stop using the Interchlor sanitizer for cleaning the Sarns TCM units. Users should contact Terumo CVS for further instructions on how to proceed with the recall and for guidance on alternative cleaning methods or device replacement.

The recalled product

Product
Sarns TCM; The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient The TCM with options will also supply water for card
Manufacturer
Terumo Cardiovascular Systems Corporation
Category
Medical Device — Cardiovascular / Extracorporeal
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)

  • The Sarns Temperature Control and Monitor unit (TCM)
  • PIN 15747
  • Catalog Number 15747

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

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