Recall Z-0633-2021 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Maquet Cardiovascular Us Sales, Llc
HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.
| Date | Nov 20, 2020 |
| Status | Terminated |
| Reason | The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier. |
| Root cause | Package design/selection |
| Action | Actions to be taken: Please examine your inventory immediately to determine if you have any of the affected HLS Set Advanced with the product codes and lot numbers listed on page 1 of this notice and acknowledge that you have received this notification by following the instructions below. If an affected device is already in use, please continue using according to normal practices. Should you have any un-used and un-expired affected product you are eligible to return the affected product for credit. Please contact Getinge Customer Service at (888) 9GETUSA / (800) 943-8872 (press option 2) |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Argentina, Australia, Austria, Belgium, Brazil, Brunei Darussal, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Ko |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112360 | QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIES Maquet Cardiopulmonary, AG, Sep 15, 2011 |