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FDAJuly 11, 2019device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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 to do

FDA enforcement status: Terminated

Brands named

maquet cardiovascular us salesmaquetmaquet cardiovascular

UPCs

04037691741543

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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