Terumo Sarns Centrifugal Pump Recalled for Pumphead Leaks
Terumo is recalling specific lots of Sarns Disposable Centrifugal Pumps because leaks were detected on the pumphead during set-up and priming.
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 high-risk medical device used in cardiopulmonary bypass where a leak could cause harm, but the source text does not report any injuries or illnesses, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling the Sarns Disposable Centrifugal Pump with X-Coating, model 164275X. This sterile, single-use device is intended for use in cardiopulmonary bypass procedures.
The recall was initiated because leaks were detected on the centrifugal pumphead during the set-up and priming of the bypass circuit. The affected lots are RC07, QM03, QN07, and RA09. The products were distributed nationwide.
Healthcare facilities and users should stop using the affected devices and contact Terumo Cardiovascular Systems Corporation for further instructions or a return.
The recalled product
- Product
- Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Hazard
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 (4)
- Lot No. RC07
- QM03
- QN07
- and RA09.
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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