The Recall Desk

FDA (Devices) recall action 63631

Sentec AG recalled 2 products on 2012-11-28

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2012-11-28
Critical
0
Units
—

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2012-11-28

    SenTec V-Sign Membrane Changer Insert Recalled for Manufacturing Defect

    Sentec AG is recalling SenTec V-Sign Membrane Changer Inserts due to a manufacturing defect that prevents electrolyte presence, potentially degrading PCO2 sensor performance.

    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 ca
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2012-11-28

    SenTec V-Sign Membrane Changer Recalled for Manufacturing Defect

    Sentec AG is recalling 195 boxes of SenTec V-Sign Membrane Changers due to a manufacturing defect that prevents electrolyte presence, potentially degrading PCO2 performance.

    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, oxy
    Category
    Distribution
    1 state