FDA recall Z-2149-2019

Maquet Cardiovascular Us Sales, Llc · Class II · device

Product

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

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.

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.

Key facts

Status: Terminated
Initiation date: 2019-07-11
Report date: 2019-09-25
Termination date: 2020-12-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Wayne, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2149-2019