Maquet Cardiovascular Us Sales, Llc: Medical Device Recall in 2019 - (Recall #: Z-2149-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 11, 2019

Date Posted: September 25, 2019

Recall Number: Z-2149-2019

Event ID: 83336

Reason for Recall:

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.

Status: Terminated

Product Quantity: 54

Code Information:

Lot 70131093; UDI 04037691741543

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated