Recall Z-1018-2016 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Sorin Group USA, Inc.
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
| Date | Jan 19, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Component design/selection |
| 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. |
| Quantity | 6859 |
| Distribution | US Nationwide Distribution and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K881330 | COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK Cobe Laboratories, Inc., Jun 10, 1988 |