SenTec V-Sign Membrane Changer — Class II medical device recall Z-0433-2013
Terminated recall by Sentec AG, reported 2012-11-28. A manufacturing defect was observed for the membrane changer insert that does not allow electrolyte to be pres
| Recall number | Z-0433-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sentec AG, Therwil, Baselland, N/A, Switzerland |
| Recall initiated | 2012-11-05 |
| Classified | 2012-11-22 |
| Reported by FDA | 2012-11-28 |
| Terminated | 2012-12-18 |
| Quantity | 195 boxes |
| Lot numbers | 1CF5, 1D21, 1D60, 1DC6, 1DED, 1E0D |
Product
SenTec V-Sign Membrane Changer (VS-MC), 9 pieces. The SenTec V-Sign Membrane Changer is indicated for use with the V-Sign Sensor 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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0433-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.