Z-0433-2013Class II

SenTec V-Sign Membrane Changer (VS-MC), 9 pieces. The SenTec V-Sign Membrane Changer is indicated for use...

Name: Z-0433-2013 SenTec V-Sign Membrane Changer (VS-MC), 9 pieces. The SenTec V-Sign Membrane Changer is indicated for use...
Creator: Sentec AG
Published: 2012-11-05
License: https://open.fda.gov/license/

Sentec AG / initiated 2012-11-05 / Terminated / root cause: design

FDA source

Sentec AG began a recall of 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... on 2012-11-05. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0433-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-05
Posted: 2012-11-22
Terminated: 2012-12-18
Recalling firm: Sentec AG
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, oxygen saturation, and pulse rate are required for adult and pediatric patients.
Product code: LKD Monitor, Carbon-Dioxide, Cutaneous
Reason for recall: 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.
Root cause tag: design
FDA root cause: Component design/selection
Action: SenTec notified the one US distributor via e-mail on November 5, 2012. The distributor was advised to stop distribution of affected lot numbers. The communication to the distributor described the issue, identified affected product, and stated that SenTec will replace current stock at the end-customer level. The end user can discard the affected products. The distributor is asked to respond back with an e-mail to SenTec that they took appropriate action.
Quantity in commerce: 195 boxes (9 per box)
Distribution: Distributed only in MO.
Product codes and lots: Lot numbers: 1CF5, 1D21, 1D60, 1DC6, 1DED, 1E0D

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0433-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0433-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-22
Z-0434-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-22

Product code LKD

K101690Class IISentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper CableSentec AG / cleared 2010-12-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)