Agency classClass IIOur severity:High FDA (Devices)·Z-0433-2013·Announced 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.

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 where a defect leads to deteriorated performance (risk of harm) without reported injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Sentec AG is recalling 195 boxes of SenTec V-Sign Membrane Changers (VS-MC), 9 pieces per box. The affected units are identified by lot numbers 1CF5, 1D21, 1D60, 1DC6, 1DED, and 1E0D. These products were distributed only in Missouri.

The recall is due to a manufacturing defect in the membrane changer insert 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 is indicated for use with the V-Sign Sensor 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 are reported in the source text. Users should stop using the affected membrane changers and contact Sentec AG for instructions on return or replacement.

The recalled product

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…
Manufacturer: Sentec AG
Category: Medical Device — Monitoring Accessories
Hazard: manufacturing-defect
performance-degradation

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: 1CF5
1D21
1D60
1DC6
1DED
1E0D

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 →

Same manufacturer · Sentec AG

See all →

Moderate
Sentec Membrane Changer components recalled for manufacturing defect
FDA (Devices) · 2023-09-27
Moderate
V-Sign Sensor 2 May Experience Out-of-Box Failure Due to Software Configuration
FDA (Devices) · 2023-06-28
High
Transcutaneous monitor attachment rings recalled for weak skin adhesion
FDA (Devices) · 2022-11-09
Moderate
SenTec Digital Monitor Recalled for Missing Isolation Transformer Requirement
FDA (Devices) · 2021-02-24
High
SenTec Membrane Changer Recall Due to Electrolyte Application Defect
FDA (Devices) · 2019-08-14

Same hazard · manufacturing defect