FDAJuly 25, 2023device
Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package contains 5 inserts. All are components of the Sentec Digital Monitoring System (SDMS).
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
During rework of components during the manufacturing process, an additional piece of material may have been left in the device, which may result in an impact on measurement performance.
What to do
FDA enforcement status: Ongoing
Brands named
sentec agsentec
UPCs
07640121880933176401218809300764012188008717640121880084276401218800810764012188050617640121880503
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAV-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).2023-05-02
- FDAsentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carbon dioxide and/or oxygen tension monitoring.2022-08-22
- FDASenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of carbon dioxide partial pressure (PCo2), oxygen partial pressure (POs), functional oxygen saturation (PsO2), and pulse rate (PR), using either a single digital s...2020-12-10
- FDASenTec 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 o...2019-05-02
- FDASenTec 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 ...2019-05-02
- FDASenTec 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 ...2019-05-02
- FDASenTec 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 carb...2019-05-02
- FDASenTec 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 dioxid...2019-05-02
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