Transcutaneous monitor attachment rings recalled for weak skin adhesion
SenTec AG voluntarily recalled 17,208 units of transcutaneous CO2/O2 monitor attachment rings due to weak skin adhesion. The devices, used in noninvasive patient monitoring, were distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II classification with weak adhesion that poses risk of device detachment and loss of critical patient monitoring capability. This meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' as no illnesses or injuries have been documented.
Plain-English summary
SenTec AG recalled the sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, a device designed for continuous, noninvasive monitoring of carbon dioxide and oxygen tension levels. This attachment ring is intended for use on sensitive or fragile skin. A total of 17,208 units from batch #220139 were included in the recall.
The recall was initiated due to weak skin adhesion on the attachment ring, which could affect the device's ability to maintain proper contact with the patient's skin and result in loss of monitoring capability. No injuries or illnesses have been reported associated with this issue.
The affected units were distributed nationwide throughout the United States. SenTec AG voluntarily initiated this recall on August 22, 2022, and it was terminated on May 26, 2026.
Patients and healthcare providers currently using this device should contact SenTec AG for further information and guidance regarding the recalled units.
The recalled product
- 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.
- Manufacturer
- SenTec AG
- Hazard
- weak-adhesion
- device-detachment
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- batch #220139
Distribution
Distributed nationwide across the United States.
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