Coronary Artery Perfusion Cannula with Balloon recalled over mold contamination

Recall date

August 12, 2016

Source

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

Official notice title

Sorin Group USA, Inc. recalls Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The Coronary Artery Perfusion Cannula with Ballo…

Recall number

Z-2757-2016

FDA classification

Class II

Brand / firm

Sorin Group USA, Inc.

Sold / distributed

Worldwide Distribution - US including IL, MO, TX. Internationally to Canada and Italy.

Why it was recalled

The tip of the cannula should be bent at either a 45 or 90 degree angle. Samples have been returned where the angle of the tip is less than the requirement.

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

What was recalled

Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The Coronary Artery Perfusion Cannula with Balloon The Cannula consists of a single lumen vinyl tube provided for with a vinyl female luer connector bonded proximally and a vinyl cuff bonded distally. The cuff is pre-molded to its inflated configuration and is purposely positioned directly over a hole generated in the extruded tube for purposes of receiving the infused cardioplegia solution. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.