Home / Recalls / SenTec AG / Z-0148-2023

Z-0148-2023 Class II Terminated

Recalled by SenTec AG — Therwil, N/A

FDA device recall Z-0148-2023 was initiated by SenTec AG on August 22, 2022 and is designated Class II. Reason for recall: Weak skin adhesion. The recall status is terminated (terminated May 26, 2026). Affected quantity: 17208 units.

Recall Details

Product Type: Devices
Report Date: November 9, 2022
Initiation Date: August 22, 2022
Termination Date: May 26, 2026
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 17208 units

Product Description

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

Reason for Recall

Weak skin adhesion.

Distribution Pattern

US Nationwide distribution.

Code Information

batch #220139

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