Z-0148-2023Class II

sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous...

Name: Z-0148-2023 sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous...
Creator: SenTec AG
Published: 2022-08-22
License: https://open.fda.gov/license/

Sentec AG / initiated 2022-08-22 / Terminated

FDA source

SenTec AG began a recall of sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carbon dioxide and/or oxygen tension... on 2022-08-22. FDA classified it as Class II and gives the reason as "Weak skin adhesion". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0148-2023
Classification: Class II
Status: Terminated
Initiated: 2022-08-22
Posted: 2022-10-28
Terminated: 2026-05-26
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.
Product code: LKD Monitor, Carbon-Dioxide, Cutaneous
Reason for recall: Weak skin adhesion.
FDA 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 in commerce: 17208 units
Distribution: US Nationwide distribution.
Product codes and lots: batch #220139

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0148-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0148-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-09	2022-10-28

Product code LKD

K151329Class IISenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNetSentec AG / cleared 2015-12-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)