Class II — Sentec AG
| Recalling firm | Sentec, Inc. |
|---|---|
| Registered facility | SENTEC, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | A manufacturing defect was observed for the membrane changer insert that does not allow electrolyte to be present under the new membrane. The PCO2 performance of a sensor without electrolyte will be deteriorated. |
| Product | SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces. The SenTec V-Sign Membrane Changer Insert is indicated for use with the V-Sign Membrane Changer only. The V-sign Sensor is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate are required for adult and pediatric patients. |
| Quantity | 265 boxes (5 per box) |
| Distribution | Distributed only in MO. |
| Initiated | 2012-11-05 |
| Classified | 2012-11-22 |
| Terminated | 2012-12-18 |
| Recall number | Z-0434-2013 |
| 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-0434-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63631/
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