Device 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.
Z-0148-2023
Product summary
- Firm
- SenTec AG
- Event
- Event 90938
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17208 units
- Official record key
device-enforcement:Z-0148-2023
Official wording
Reason: Weak skin adhesion.
Code information: batch #220139
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Weak skin adhesion.