FDA-Device2014-07-23Class II
Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
Terumo Cardiovascular Systems Corporation
Hazard
During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.
Sold states
Nationwide Distribution
Affected count
N/A
Manufactured in
125 Blue Ball Rd, N/A, Elkton, MD, United States
Products
Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2029-2014Don't want to check this manually?
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