Recall Z-2149-2019 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Maquet Cardiovascular Us Sales, Llc
Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794
| Date | Jul 11, 2019 |
| Status | Terminated |
| Reason | The sets are configured with quick connectors that have been assembled in reverse on the arterial and venous lines, resulting in blue (venous) to red (arterial) and red (arterial) to blue (venous) connections. Due to this incorrect assembly, the sets cannot be primed from the reservoir prior to use, and the device may not function as intended. |
| Root cause | Under Investigation by firm |
| Action | Urgent Medical Device Recall - Removal notification letters dated 7/11/19 were sent to customers. |
| Quantity | 54 |
| Distribution | The products were distributed to the following US states: AR, CA, FL, GA, IA, IL, IN, KY, NC, NE, NM, NV, NY, OH, OR, TN, and WI. |
| 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 |