The Recall Desk

FDA (Devices) recall action 83115

SenTec AG recalled 5 products on 2019-08-14

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2019-08-14
Critical
0
Units
438

Why these products were recalled

There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure.

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–5 of 5

  • HighFDA (Devices)··2019-08-14

    SenTec Membrane Changer Set Recalled for Potential Electrolyte Application Failure

    SenTec AG is recalling 3 sets of Membrane Changer Sets because there is a 5% chance of insufficient electrolyte application during sensor changes.

    Product
    SenTec Membrane Changer Set (1 charger plus 1 insert) - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2019-08-14

    SenTec Membrane Changer Insert Recalled for Electrolyte Application Defect

    SenTec AG is recalling Membrane Changer Inserts due to a 5% chance of missing or reduced electrolyte application during sensor changes.

    Product
    SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2019-08-14

    SenTec Membrane Changer Recall Due to Electrolyte Application Defect

    SenTec AG is recalling 198 Membrane Changer units because a defect may result in insufficient electrolyte application during sensor changes.

    Product
    SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2019-08-14

    SenTec Neonatal Starter Set Recalled for Potential Electrolyte Application Defect

    SenTec AG is recalling Neonatal Starter Sets due to a 5% chance of missing or reduced electrolyte application during membrane changes.

    Product
    SenTec Neonatal Starter Set with and without Service Gas (2 Chargers each) - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2019-08-14

    SenTec Standard Starter Set Recalled for Potential Electrolyte Deficiency

    SenTec AG is recalling Standard Starter Sets due to a risk of missing or reduced electrolyte application during the membrane change procedure.

    Product
    SenTec Standard Starter Set with and without Service Gas (2 changers each) - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal…
    Category
    Distribution
    1 state