The Recall Desk
ModerateFDA (Devices)·Z-2209-2016·Announced 2016-07-27

Terumo Recalls Sarns TCM II Heater-Cooler Units Due to Sanitizer Discontinuation

Terumo CVS is voluntarily recalling Sarns TCM II heater-cooler units because the Interchlor sanitizer referenced in cleaning instructions 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: The recall is a voluntary precautionary measure due to a supply chain issue with a cleaning agent, with no reported illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

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

The Sarns TCM II system is used to provide temperature-controlled water for blood heat exchangers in extracorporeal circuits and for blankets to heat or cool patients. It also freezes water for ice supply and monitors temperatures in the patient and circuit. The recall affects 6,412 units distributed domestically across numerous US states and territories, as well as internationally to countries including Argentina, Australia, Canada, China, France, Germany, Japan, and the United Kingdom.

This recall is a precautionary measure to address the unavailability of the specified cleaning agent. The source text does not report any illnesses, injuries, or deaths associated with this recall. Users of these devices should contact Terumo CVS for further instructions regarding the recall and alternative cleaning protocols.

The recalled product

Product
Sarns TCM II; The Sarns Temperature Control and Monitor unit (TCM) II (system) 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. It also freezes water for an ice su
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 (11)

  • The Sarns Temperature Control and Monitor unit (TCM)
  • TCM II TUV
  • 115V (P/N 4415)
  • 220V (P/N 4416)
  • TCM II
  • with Cardioplegia
  • 11 OV/60Hz (P/N 164925) TCM II
  • without Cardioplegia
  • 110V/60Hz (P/N 164930) TCM II
  • 220V/50Hz (P/N 164935) TCM II
  • 220V/50Hz (P/N 164940)

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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