Sorin Group USA, Inc. recalls Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are in…

Recall date

June 9, 2017

Source

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

Recall number

Z-2871-2017

FDA classification

Class II

Brand / firm

Sorin Group USA, Inc.

Sold / distributed

Worldwide Distribution - US Nationwide in the states of : AR, AZ, CA, GA, IL, IN, KS, MI, MN, MO, NC, NE, NY, OK, PA, SD, TX, & VA. and foreign countries of: Canada, Iran, Mexico, & New Zealand.

Why it was recalled

Identification of excess plastic on the tip of the cannula.

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

What was recalled

Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.