Maquet Medical Systems USA recalls BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70106.9077. A preconnected set used for extracorporeal respiratory and/…

Recall date

July 22, 2022

Source

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

Recall number

Z-1766-2022

FDA classification

Class II

Brand / firm

Maquet Medical Systems USA

Sold / distributed

Worldwide distribution - US Nationwide and the countries Canada and Australia.

Why it was recalled

The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020).

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

What was recalled

BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70106.9077. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.