SenTec Membrane Changer Set Recalled for Potential Electrolyte Application Failure
SenTec AG is recalling 3 sets of Membrane Changer Sets because there is a 5% chance of insufficient electrolyte application during sensor changes.
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: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical monitoring device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
SenTec AG is recalling 3 sets of SenTec Membrane Changer Sets (1 charger plus 1 insert) due to a potential defect in the membrane change procedure. The affected lots are 180961, 181097, and 190053. These devices are indicated for continuous, non-invasive monitoring of carbon dioxide tension, oxygen tension, oxygen saturation, and pulse rate in adult and pediatric patients, with specific indications for neonatal patients.
The recall is being issued because there is an increased chance (approximately 5%) that no electrolyte or a reduced amount of electrolyte will be applied to the sensor during the membrane change procedure. This defect could compromise the accuracy of the monitoring device. The products were distributed worldwide, including in the United States (specifically Missouri) and numerous international locations.
Users of these devices should stop using the affected Membrane Changer Sets and contact SenTec AG for further instructions. The recall number is Z-2155-2019.
The recalled product
- Product
- SenTec Membrane Changer Set (1 charger plus 1 insert) - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is i
- Manufacturer
- SenTec AG
- Affected units
- 3
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 (3)
- Lots: 180961
- 181097
- and 190053
Distribution
Part of a larger recall action
This product is one of 5 recalled by SenTec AG under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · SenTec AG
See all →- ModerateSentec Membrane Changer components recalled for manufacturing defect
FDA (Devices) · 2023-09-27
- ModerateV-Sign Sensor 2 May Experience Out-of-Box Failure Due to Software Configuration
FDA (Devices) · 2023-06-28
- HighTranscutaneous monitor attachment rings recalled for weak skin adhesion
FDA (Devices) · 2022-11-09
- ModerateSenTec Digital Monitor Recalled for Missing Isolation Transformer Requirement
FDA (Devices) · 2021-02-24
- HighSenTec Standard Starter Set Recalled for Potential Electrolyte Deficiency
FDA (Devices) · 2019-08-14
Same hazard · defective component
See all →- HighBeckman Coulter Sample Probes with Defective Tips Clinical Chemistry
FDA (Devices) · 2025-06-11
- SevereMedline Medical Convenience Kits Recalled for Defective Endotracheal Tubes
FDA (Devices) · 2025-04-16
- SevereMedline Medical Procedure Kits with Medtronic Aortic Cannula Recalled
FDA (Devices) · 2025-04-16
- SevereExactech AcuMatch XLE Hip Implant Liner Recall
FDA (Devices) · 2025-02-19
- ModerateMedline Medical Convenience Kits Recall Due to Recalled Component
FDA (Devices) · 2024-12-11