FDA Device

Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794

Hazard

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.

What You Should Do

Remedy

Urgent Medical Device Recall - Removal notification letters dated 7/11/19 were sent to customers.

Products

Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794
Brand
Maquet Cardiovascular Us Sales, Llc
UPC
Lot 70131093; UDI 04037691741543

Units Affected

54