Recall Z-0148-2023— SenTec AG

Name: FDA recall Z-0148-2023
Creator: U.S. Food and Drug Administration
Published: 2022-08-22

Class II · Ongoing

Class II FDA medical device recall by SenTec AG, initiated 2022-08-22. It names one FDA 510(k) clearance: K151329. Product: 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: Weak skin adhesion..

Recalling firm: SenTec AG
Classification: Class II
Status: Ongoing
Initiated: 2022-08-22
Firm location: Therwil, N/A, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K151329 — SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNetSentec AG·cleared 2015-12-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.