FDAJanuary 16, 2024device
BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.
What to do
FDA enforcement status: Ongoing
Brands named
maquet medical systemsmaquetmaquet medical
UPCs
04058863080383
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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