SenTec Membrane Changer Insert Recalled for Electrolyte Application Defect
SenTec AG is recalling Membrane Changer Inserts due to a 5% chance of missing or reduced 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 defect involves a risk of harm (inaccurate monitoring) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
SenTec AG is recalling 205 units of SenTec Membrane Changer Inserts (5 pcs) under FDA recall number Z-2156-2019. 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, with specific indications for neonatal patients.
The recall is due to a manufacturing defect where there is 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 defect may affect the accuracy of the monitoring device.
The affected lots include 180759, 180766, 180788, 180814, 180830, 180831, 180837, 180839, 180868, 180869, 180870, 180918, 180933, 180938, 180941, 180984, 180996, 181014, 181027, 181035, 181059, 181070, 181083, 181092, 181100, 181142, 190016, 190028, 190032, 190073, 190088, 190100, 190125, 190143, 190163, 190170, 190215, 190236, 190240, 190262, and 190277. The products were distributed worldwide, including in the United States (specifically Missouri) and numerous international countries. Users should stop using the affected inserts and contact SenTec AG for instructions.
The recalled product
- Product
- SenTec Membrane Changer Insert [5 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 for car
- Manufacturer
- SenTec AG
- Affected units
- 205
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: 180759
- 180766
- 180788
- 180814
- 180830
- 180831
- 180837
- 180839
- 180868
- 180869
- 180870
- 180918
- 180933
- 180938
- 180941
- 180984
- 180996
- 181014
- 181027
- 181035
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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