Terumo Cardiovascular Systems product recalled over sterility concerns

Recall date

May 27, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Terumo Cardiovascular Systems Corporation recalls The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single sterile i…

Recall number

Z-1235-2017

FDA classification

Class II

Brand / firm

Terumo Cardiovascular Systems Corporation

Sold / distributed

Terumo CVS has identified 33 domestic consignees and 0 international consignee that are affected by this recall

Why it was recalled

Terumo Cardiovascular Systems Corporation has received complaints indicating that the Sarns Centrifugal Pump (disposable pump heads) have exhibited leaks. The leaks were detected during priming of the bypass circuit and during CPB procedures. In each of the reported incidents, there were no reports of patient injury as a result of the centrifugal pump leaks. Terumo Cardiovascular System's investigation into the incident has identified the cause of the leaks to be cracks in both the Top Housing and Magnet Back Housing of the pump. When the cracks cause the housing to become compromised, it is possible for fluid to leak from the pump head.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single sterile in cartons of 8 units, or may be provided in bulk, non-sterile to another Terumo location for inclusion in Cardiovascular Procedure Kits. Cardiovascular Procedure kits are packaged individually.