The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2210-2016·Announced 2016-07-27

Terumo Sarns Dual Cooler-Heater Recalled Due to Missing Sanitizer

Terumo CVS is voluntarily recalling Sarns Dual Cooler-Heater devices because the distributor no longer sells the Inter chlor sanitizer required for cleaning.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 due to a supply chain issue (missing cleaning agent) rather than a direct product defect or reported injury, fitting the Moderate criteria.

Plain-English summary

Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its Sarns Dual Cooler-Heater devices. The recall is being conducted because the distributor no longer sells the Inter chlor sanitizer (Product Code 205) that is referenced in the heater-cooler cleaning instructions.

The Sarns Dual Cooler-Heater is a self-contained unit indicated for use as a water supply system to a blood heat exchanger in open-heart surgery. It supplies cold and warm water to heat exchangers at a rate of up to 6.5 gallons per minute. The affected units include various voltage models (115V/60Hz, 220V/50Hz, 100V/60Hz, and 100V/50Hz).

A total of 6,412 units were 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. Consumers and healthcare facilities should contact Terumo CVS for further instructions regarding the recall.

The recalled product

Product
Preamendments device-Sarns Dual Cooler-Heater. The Sarns Dual Cooler-Heater is a self-contained unit for supplying cold and warm water to heat exchangers during open heart surgery. It supplies water at a rate of up to 6.5 gallons per minute (25 liters per minute) at zero…
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 (5)

  • The Sarns Dual Cooler-Heater
  • Dual Cooler Heater 115V/60Hz (P/N 11160)
  • Dual Cooler Heater 220V/50Hz (P/N 4332)
  • Dual Cooler Heater 1 OOV/60Hz (P/N 14114)
  • Dual Cooler Heater 1 OOV/50Hz (PIN 13460)

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 →

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