Sorin Group USA, Inc. recalls St¿ckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console Product Usage: The St¿cker…

Recall date

August 25, 2016

Source

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

Recall number

Z-2866-2016

FDA classification

Class II

Brand / firm

Sorin Group USA, Inc.

Sold / distributed

Worldwide Distribution - US Nationwide in the states of AZ, CA, CO, FL, HI, KS, MA, NC, TX, UT and the countries of: Great Brittan, Peru, Russia, India, Hungary, Thailand, Germany, Azerbaijan, Austria, Italy, Slovakia, Bahrain, and Malaysia.

Why it was recalled

Sorin/LivaNova is initiating a field correction on the S5 Heart-lung machine because of the potential for failure of the Uninterruptible Power Supply.

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

What was recalled

St¿ckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console Product Usage: The St¿ckert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.