Z-0434-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 28, 2012
- Initiation Date
- November 5, 2012
- Termination Date
- December 18, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 265 boxes (5 per box)
Product Description
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 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.
Distribution Pattern
Distributed only in MO.
Code Information
Lot numbers: 1D0F, 1D58, 1D80, 1DCA, 1DEA, 1E5F