SenTec Membrane Changer Recall Due to Electrolyte Application Defect
SenTec AG is recalling 198 Membrane Changer units because a defect may result in 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 involves a medical device defect that could lead to inaccurate monitoring of vital signs. Per the rubric, this is classified as High because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
SenTec AG is recalling 198 units of the SenTec Membrane Changer (reloadable) [9 pcs]. The product is indicated for continuous, non-invasive monitoring of carbon dioxide tension, oxygen tension, oxygen saturation, and pulse rate in adult and pediatric patients. In neonatal patients, the system is indicated for carbon dioxide and oxygen tension monitoring only.
The recall is due to a defect that creates an increased chance (approximately 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure. This issue may affect the accuracy of the monitoring device.
The affected lots are 180763, 180834, 180872, 180874, 180876, 180970, 180993, 181011, 181016, 181031, 181034, 181045, 181072, 181087, 181103, 181141, 190080, 190141, 190165, 190203, 190210, and 190264. The products were distributed worldwide, including in the United States (specifically Missouri) and numerous international locations. Users should check their lot numbers and contact the manufacturer for instructions on how to proceed.
The recalled product
- Product
- SenTec Membrane Changer (reloadable) [9 pcs] - 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 indicated
- Manufacturer
- SenTec AG
- Affected units
- 198
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 (20)
- Lots: 180763
- 180834
- 180872
- 180874
- 180876
- 180970
- 180993
- 181011
- 181016
- 181031
- 181034
- 181045
- 181072
- 181087
- 181103
- 181141
- 190080
- 190141
- 190165
- 190203
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.
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