SenTec AG Ringstrasse 39 Therwil Switzerland 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 indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.
Brand
SenTec AG Ringstrasse 39 Therwil Switzerland
Lot Codes / Batch Numbers
Lots: 180961, 181097, and 190053
Products Sold
Lots: 180961, 181097, and 190053
SenTec AG Ringstrasse 39 Therwil Switzerland is recalling SenTec Membrane Changer Set (1 charger plus 1 insert) - Product Usage: is indicated for continuous, due to There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure.
Recommended Action
Per FDA guidance
On May 2, 2019, the firm sent Guidance for SenTec Distributors to their distributors advising them of the issue, requesting them to check their stock and notify their end users via a voluntarily initiated field correction action associated with Membrane Changers and their Inserts which was enclosed with the "recall" letters. The distributors were to report back to SenTec via email.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026