FDAFDA · Food and drugs·Recall number Z-0434-2013
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.
Published November 28, 2012 · Recall initiated: November 5, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sentec AG
- Distributor
- Distributed only in MO.
- Lot
- Lot numbers: 1D0F, 1D58, 1D80, 1DCA, 1DEA, 1E5F
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Switzerland
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