Terumo Sarns Centrifugal Pump Recalled for Pumphead Leaks
Terumo is recalling 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 functional defect (leaks) poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling Sarns Disposable Centrifugal Pumps without X-Coating (Catalog No. 164275). The affected lots are RA07 and QP02. These sterile, single-use devices are 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 products were distributed nationwide.
Healthcare facilities should stop using the affected devices and contact Terumo Cardiovascular Systems Corporation for further instructions regarding the recall.
The recalled product
- Product
- Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Category
- Medical Device — Cardiovascular
- 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 (2)
- Lot No. RA07
- Lot No. QP02
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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