SenTec AG: 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.

Agency Publication Date: August 5, 2019

Affected Products

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 for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.

Lots: 180763, 180834, 180872, 180874, 180876, 180970, 180993, 181011, 181016, 181031, 181034, 181045, 181072, 181087, 181103, 181141, 190080, 190141, 190165, 190203, 190210, and 190264

Product: SenTec Standard Starter Set with and without Service Gas (2 changers each) - 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.

Standard Starter Set Lots: 180932, 180959, 181019, 181082, 190005, 190041, 190093, 190221, and 190282. Standard Starter Set (without Service Gas) Lots:180972 and 190078

Product: SenTec Neonatal Starter Set with and without Service Gas (2 Chargers each) - 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.

Neonatal Starter Set Lots: 181089, 190051 and 190242. Neonatal Starter Set (without Service Gas) Lots: 181068 and 190242

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.

Lots: 180961, 181097, and 190053

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 carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.]

Lots: 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

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83115

Status: Resolved

Manufacturer: SenTec AG

Manufactured In: Switzerland

Units Affected: 5 products (198 pcs.; 22 pcs; 10 pcs; 3 sets; 205 pcs)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Lots: 180763, 180834, 180872, 180874, 180876, 180970, 180993, 181011, 181016, 181031, 181034, 181045, 181072, 181087, 181103, 181141, 190080, 190141, 190165, 190203, 190210, and 190264

Standard Starter Set Lots: 180932, 180959, 181019, 181082, 190005, 190041, 190093, 190221, and 190282. Standard Starter Set (without Service Gas) Lots:180972 and 190078

Neonatal Starter Set Lots: 181089, 190051 and 190242. Neonatal Starter Set (without Service Gas) Lots: 181068 and 190242

Lots: 180961, 181097, and 190053