Surge Medical Sales, LLC (DBA Surge Cardiovascular) recalls Retrograde Cardioplegia Cannula, Model Number RMG-0015S The Retrograde Cardioplegia Cannula is intended for use in perf…

Recall date

July 18, 2018

Source

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

Recall number

Z-0068-2019

FDA classification

Class II

Brand / firm

Surge Medical Sales, LLC (DBA Surge Cardiovascular)

Sold / distributed

US Distribution to state of: SC.

Why it was recalled

The device was built with the rigid insertion stylet instead of the flexible stylet.

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

What was recalled

Retrograde Cardioplegia Cannula, Model Number RMG-0015S The Retrograde Cardioplegia Cannula is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction.