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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that degrades sensor performance (PCO2 monitoring) without reported injuries, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Sentec AG is recalling 265 boxes of SenTec V-Sign Membrane Changer Inserts (VS-MCI), 5 pieces per box. The affected units are identified by lot numbers 1D0F, 1D58, 1D80, 1DCA, 1DEA, and 1E5F. These products were distributed only in Missouri.
The recall is due to a manufacturing defect that does not allow electrolyte to be present under the new membrane. The source text states that the PCO2 performance of a sensor without electrolyte will be deteriorated. The SenTec V-Sign Membrane Changer Insert is indicated for use with the V-Sign Membrane Changer only, which is used with the SenTec Digital Monitor for continuous non-invasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate in adult and pediatric patients.
No illnesses or injuries have been reported in the source text. Consumers and healthcare facilities should stop using the affected inserts and contact Sentec AG for further instructions.
The recalled product
- 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…
- Manufacturer
- Sentec AG
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot numbers: 1D0F
- 1D58
- 1D80
- 1DCA
- 1DEA
- 1E5F
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Sentec AG under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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