CDI H/S Cuvette recalled over sterility concerns

Recall date

January 19, 2016

Source

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

Official notice title

Sorin Group USA, Inc. recalls CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack. Prod…

Recall number

Z-1018-2016

FDA classification

Class III

Brand / firm

Sorin Group USA, Inc.

Sold / distributed

US Nationwide Distribution and Canada.

Why it was recalled

The CDI System 500 monitor displays the "H/S DISCONNECT AT CUVETTE" error message when the CDI HIS Cuvette does not make a proper connection with the CDI H/S Probe. When this occurs, blood parameter values for HCT, Hgb and S02 do not display.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack. Product Usage: Heart/Lung Perfusion Pack is either a customized tubing pack built to user specifications or a stock tubing pack, designed for use during surgery requiring cardiopulmonary bypass. It is not designed for long-term use (greater than six hours). Perfusion Packs labeled as SMART¿ contain components that have an additive to improve blood compatibility. Non-SMART packs may contain some SMART tubing and/or connectors depending on the customer requirements.