Maquet Cardiovascular Us Sales, Llc recalls HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usa…

Recall date

November 20, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0632-2021

FDA classification

Class II

Brand / firm

Maquet Cardiovascular Us Sales, Llc

Sold / distributed

Worldwide distribution - US Nationwide distribution and the countries of Argentina, Australia, Austria, Belgium, Brazil, Brunei Darussal, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong K…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.