Medical device recalls Moderate risk

SenTec AG recalls sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carb…

Recall date
August 22, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0148-2023
FDA classification
Class II
Brand / firm
SenTec AG
Sold / distributed
US Nationwide distribution.

Why it was recalled

Weak skin adhesion.

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

What was recalled

sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carbon dioxide and/or oxygen tension monitoring.

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