Terumo Recalls Sarns TCM II Temperature Control Modules Due to Assembly Defect
Terumo is recalling seven Sarns TCM II Temperature Control Modules because internal testing found incorrectly assembled heatsinks that could cause unit failure.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a defect that could cause unit failure, posing a risk of harm to patients, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling seven units of the Sarns TCM II Temperature Control Module. These devices are used to provide temperature-controlled water for blood heat exchangers in extracorporeal circuits and are indicated for controlling and monitoring patient temperature.
The recall was initiated after internal testing revealed that certain systems were released with incorrectly assembled heatsink assemblies. This defect could cause the units to fail. The affected units are identified by Catalog Number 4416 and Serial Numbers 4656, 4657, 4658, 4659, 4661, 4662, and 4663.
The affected products were distributed worldwide, including the United Arab Emirates, Hong Kong, and Thailand. The source text explicitly states that these units were not distributed in the USA. Users should contact the manufacturer for further instructions regarding the recall.
The recalled product
- Product
- Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Control Module is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and is indicated for controlling and monitoring patient temperature
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Hazard
- Affected units
- 7
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 (7)
- Catalog Number 4416 and Serial Numbers: 4656
- 4657
- 4658
- 4659
- 4661
- 4662
- and 4663.
Distribution
Distribution scope not specified by the agency.
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