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.
FDA Recall Z-0434-2013 · Posted 2012-11-22
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Recalling FirmSentec AG
Recall StatusTerminated
Product CodeLKD
Date Initiated2012-11-05
Date Terminated2012-12-18
Product Quantity265 boxes (5 per box)
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.
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
Distributed only in MO.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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