Terumo Sarns Temperature Control Devices Recalled for Cleaning Protocol Validation Issues
Terumo is recalling Sarns Temperature Control Monitor units (1,176 devices) because it cannot validate a cleaning protocol meeting current FDA requirements. Users should discontinue use and dispose of affected devices immediately.
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: This is a Class II FDA device recall with no reported illnesses or injuries. The issue is regulatory non-compliance with cleaning protocol validation rather than an observed patient safety hazard, making this a precautionary discontinuation.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling the Sarns Temperature Control Monitor (TCM) units used in extracorporeal circulation, patient heating and cooling, and cardioplegia applications. The recall affects 1,176 devices that were distributed domestically and internationally from May 1985 through June 2015.
Terumo CVS was unable to validate a cleaning protocol that satisfies current FDA regulatory requirements and expectations. As a result, the company has determined that discontinuation and disposal of affected HX2, TCM I, and TCM II devices is the appropriate course of action.
Users and healthcare facilities should immediately discontinue use of the affected Temperature Control and Monitor units and dispose of them according to applicable regulations.
The recalled product
- Product
- The Sarns Temperature Control and Monitor unit (TCM) 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. The TCM with options will also supply water for cardioplegia, free
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Hazard
- contamination-risk
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 numbers distributed from 05/02/1985 thru 06/10/2015
Distribution
Distribution scope not specified by the agency.
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