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.
FDA Recall Z-1018-2016 · Posted None
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Recalling FirmSorin Group USA, Inc.
Recall StatusTerminated
Product CodeDWF
Date Initiated2016-01-19
Date Terminated2016-10-24
Product Quantity6859
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.
Firm Action
A Safety Alert letter dated January 13, 2015 via registered mail to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to check the communication of the Cuvette prior to initiating Cardiopulmonary Bypass (CPS).
The Terumo Safety Alert did not request removal or return of the product. The instructions that Sarin has communicated to the customers is identical to the information from Terumo. Acknowledgement of the letter and understanding of
the contents is required for all customer responses.
Root Cause
Component design/selection
Distribution Pattern
US Nationwide Distribution and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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