Recall Z-1018-2016— Sorin Group USA, Inc.

Name: FDA recall Z-1018-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-19

Class III · Terminated

Class III FDA medical device recall by Sorin Group USA, Inc., initiated 2016-01-19, terminated 2016-10-24. It names one FDA 510(k) clearance: K881330. Product: 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.. Reason: 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..

Recalling firm: Sorin Group USA, Inc.
Classification: Class III
Status: Terminated
Initiated: 2016-01-19
Terminated: 2016-10-24
Firm location: Arvada, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K881330 — COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACKCobe Laboratories, Inc.·cleared 1988-06-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.