Health Canada — Medical Devices · Canada · 2013-02-18 · Type II
As described by Health Canada — Medical Devices: Sarns Cannulas - Flexible Arterial and High-Flow Aortic Arch (January 14, 2013)
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Reported risk: During an in-house inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of excess plastic material, or flash, on a proportion of conenctors used for the Sarns Flexible Arterial Cannula and the Sarns High-flow Aortic Arch Cannula. The flash originated from a molding tool and is located on the exterior of the connector. There is a potential for the flash to detach. Terumo CVS is advising users to discontinue use and return all affected cannulae in inventory.
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