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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
Recalled August 16, 2017 · FDA recall Z-2871-2017 · Sorin Group USA
Hazard
Identification of excess plastic on the tip of the cannula. · FDA Class II
Units
105,770 units
Sold at
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.
Description
Identification of excess plastic on the tip of the cannula.
Product
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.
Manufacturer(s)
Sorin Group USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →