FDA Device recall Z-0434-2013
SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces
- FDA Device
- Class II
- terminated
- Published 2012-11-28
On 2012-11-28 the FDA classified a Class II recall of SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces by Sentec Ag, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0434-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-05 |
| Published | 2012-11-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Sentec Ag |
| Distribution | MO |
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.
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.
Identifiers
| code_info | Lot numbers: 1D0F, 1D58, 1D80, 1DCA, 1DEA, 1E5F |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0434-2013%22
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