Recall Z-1371-2016 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Maquet Cardiovascular Us Sales, Llc
QUADROX-i oxygenators 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
| K082117 | QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODEL# HMO 70000, HMO 71000 Maquet Cardiopulmonary, AG, Feb 18, 2009 |
| K090689 | QUADROX-I SMALL ADULT WITH AND WITHOUT INTERGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODELS HMO 50000, HMO 51000 Maquet Cardiopulmonary, AG, Oct 29, 2009 |
| K093522 | QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR; W/ BIOLINE COATING AND W/ INTEGRATED ARTERIAL FILTER W/ BIOLINE C Maquet Cardiopulmonary, AG, Dec 7, 2009 |
| K101153 | QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMOD Maquet Cardiopulmonary, AG, Dec 8, 2010 |
| K102464 | QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATING Maquet Cardiopulmonary, AG, Mar 4, 2011 |
| K150267 | QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators Maquet Cardiopulmonary, AG, May 7, 2015 |