Sorin Group USA, Inc. recalls AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8)…

Recall date

June 22, 2016

Source

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

Recall number

Z-2147-2016

FDA classification

Class II

Brand / firm

Sorin Group USA, Inc.

Sold / distributed

Worldwide Distribution: US (nationwide) to states of: LA, Ml, MO, OH, TN, and TX; and countries of: Italy and Canada.

Why it was recalled

Sorin Group USA is recalling Aortic Arch Cannulae (part numbers NA-55X7 and NA-55X8) because the distal end may be less than specified. The defective cannula are showing an angle that is about 15-20 degrees instead of approximately 45 degrees.

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

What was recalled

AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8) Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that terminates in an angled tip. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.