medical Class II Updated 2020-12-23

Maquet Cardiovascular Us Sales, Llc recalls HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced

Recalled Product

HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.


Hazard / Issue

The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model Number: BEQ-HLS 7050 Part Number: 70105.2794 UDI Code: 04037691773513 Lot Codes: 70130364, 70132269, 70133476, 70133592, 70133623, 70133624, 70133625, 70134790, 70135038
View official government recall

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