FDANovember 20, 2020device
HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.
What to do
FDA enforcement status: Terminated
Brands named
maquet cardiovascular us salesmaquetmaquet cardiovascular
UPCs
04037691773513
Recall history
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