Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SenTec V-Sign Membrane Changer Insert (VS-MCI) Recalled by Sentec AG Due to A manufacturing defect was observed for the membrane...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Sentec AG directly.
Affected Products
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.
Quantity: 265 boxes (5 per box)
Why Was This 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.
Where Was This Sold?
This product was distributed to 1 state: MO
About Sentec AG
Sentec AG has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report