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Sentec AG recalls SenTec V-Sign Membrane Changer (VS-MC), 9 pieces. The SenTec V-Sign Membrane Changer is indicated for use with the V-Si
Recalled November 28, 2012 · FDA recall Z-0433-2013 · Sentec AG
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. · FDA Class II
Units
195 boxes (9 per box)
Sold at
Distributed only in MO.
Description
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 (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.
Manufacturer(s)
Sentec AG
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →