Terumo Sarns TCM Recall for Updated Cooler-Heater Cleaning Instructions
Terumo is recalling Sarns TCM devices to update cleaning instructions for the cooler-heater component.
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 classified as FDA Class II, but the source text indicates the issue is an update to cleaning instructions without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary or documentation-related recall.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling the Sarns TCM, Catalog No. 15747. This medical device is indicated for controlling and monitoring patient temperature. The recall involves 2,393 units distributed worldwide, including the United States, Australia, Canada, and numerous other countries.
The reason for the recall is an update to the cooler-heater cleaning instructions. The source text does not specify any reported injuries, illnesses, or specific defects beyond the need for updated documentation.
Healthcare facilities and users should refer to the updated instructions provided by the manufacturer for cleaning the cooler-heater component. The recall covers all lot codes for this specific catalog number.
The recalled product
- Product
- Sarns TCM, Catalog No. 15747 The Sarns TCM is indicated for controlling and monitoring patient temperature .
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Hazard
- Affected units
- 2,393
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 (1)
- All Lot Codes
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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.
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