Recall Z-1372-2016 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Maquet Cardiovascular Us Sales, Llc
HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator
| Date | Feb 23, 2016 |
| Status | Terminated |
| Reason | Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products. |
| Root cause | Unknown/Undetermined by firm |
| Action | The firm, Maquet Inc., sent an "URGENT MEDICAL DEVICE RECALL" Letter/Response Form dated 2/23/2016 via Fed Ex to their customers. The letter describes the product, problem and actions to be taken. The customers were instructed to review the list to determine if you have the affected products; monitor patients for signs; monitor and treat signs according to your protocols and clinical judgments; support shock symptoms and maintain circulatory and hemodynamics per your facility's protocol and care guidelines, and complete and and return the enclosed Response Form by email to: MCPrecall2016@maque |
| Quantity | 72,000 units in total |
| Distribution | US Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102726 | CARDIOHELP SYSTEM Maquet Cardiopulmonary, AG, Apr 4, 2011 |