Class II — SenTec AG
| Recalling firm | Sentec, Inc. |
|---|---|
| Registered facility | SENTEC, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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.] |
| Quantity | 205 pcs |
| Distribution | Worldwide distribution - US Nationwide in the state of Missouri and countries of Argentina, Australia, Austria, Belgium, Chile, China, Columbia, Costa Rica, Czech Republic, Denmark, Ecuador, Europe, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Indonesia, Israel, Italy, Kuwait, Malaysia, Finland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sri Lanka, Switzerla… |
| Initiated | 2019-05-02 |
| Classified | 2019-08-05 |
| Terminated | 2020-12-16 |
| Recall number | Z-2156-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — SenTec AG (Z-2156-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83115/
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