Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794
Check against the official notice below — it lists the full affected range.
Maquet Cardiovascular US Sales, LLC is recalling 54 Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0 devices (Model Number BEQ-HLS-7050, Part Number 701052794) due to quick connectors that were assembled in reverse on the arterial and venous lines. This reversal causes the blue venous connector to attach to red arterial ports and vice versa, preventing the sets from being properly primed from the reservoir before use and potentially causing the device to malfunction.
The affected devices were distributed across 17 states including Arkansas, California, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, North Carolina, Nebraska, New Mexico, Nevada, New York, Ohio, Oregon, Tennessee, and Wisconsin. The recalled products are from Lot 70131093 with UDI 04037691741543. The recall notice does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Quantity: 54 Lot/code info: Lot 70131093; UDI 04037691741543
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.