Terumo Sarns TCM II Recall for Updated Cleaning Instructions
Terumo is recalling Sarns TCM II devices to update cleaning instructions. The recall covers 2,393 units distributed worldwide.
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: The recall is classified as FDA Class II and involves an update to cleaning instructions without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling the Sarns TCM II, a device indicated for controlling and monitoring patient temperature. The recall involves catalog numbers 4415, 4416, 164925, 164930, 164935, and 164940, with a total of 2,393 units affected. The reason for the recall is an update to the cooler-heater cleaning instructions.
The affected devices were distributed worldwide, including the United States, Australia, Canada, and numerous other countries. The recall applies to all lot codes for the specified catalog numbers.
Healthcare facilities and users should refer to the updated cleaning instructions provided by the manufacturer. No specific consumer action is detailed in the source text beyond the update to the instructions.
The recalled product
- Product
- Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00886799000014 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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