Recall Z-0870-2015 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Maquet Cardiovascular Us Sales, Llc
Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000 For cardiac surgery in combination with a heart lung machine to oxygenate blood, remove carbon dioxide and adjust blood temperature.
| Date | Dec 24, 2014 (initiated Nov 5, 2014) |
| Status | Terminated |
| Reason | Maquet has confirmed through a customer complaint that while the oxygenators and the pouches for a single lot of Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioliine Coating are labeled correctly with the Bioline coating, the individual cartons and 4-pack shipping containers of this lot incorrectly bear Softline coating labels instead of the bioline coating labels. |
| Root cause | Process control |
| Action | Maquet Inc. sent Urgent Product Recall - Removal Letters/Response Forms dated 11/5/2014. |
| Quantity | 28 units |
| Distribution | Distributed in DC, MA, & MI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100278 | QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USA Maquet Cardiopulmonary, AG, Apr 30, 2010 |