FDA Medical Device Recalls (openFDA)
SenTec AG: sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carbon dioxide and/or oxygen tension monitoring.
- Recall number
- Z-0148-2023
- Recalling firm
- SenTec AG
- 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.
- Status
- Terminated
- Initiated
- 2022-08-22
- Posted
- 2022-10-28
- Terminated
- 2026-05-26
- Reason
- Weak skin adhesion.
- Root cause
- Under Investigation by firm
- Action
- The firm issued a letter to its consignees on 08/22/2022 regarding below standard adhesion properties of the MARe-SF (Multisite Attachment Rings - for Sensitive, Fragile skin) product containing replacement product in the form of the premium product - the Patient Application Kit (PAK-SF) and the recommendation to discard the affected product.
- Quantity
- 17208 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- batch #220139
- 510(k) numbers
- ["K151329"]
- PMA numbers
- not on file
- Product code
- LKD
- Firm FEI
- 3004149774
- Firm city
- Therwil
- Firm state
- not on file
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28