FDA recall Z-0148-2023

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 for recall

Weak skin adhesion.

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2022-08-22

Report date

2022-11-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Therwil, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0148-2023