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U.S. Department of Health and Human Services

Class 2 Device Recall VSign Membrane Changer

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 Class 2 Recall
VSign Membrane Changer
see related information
Date Posted November 22, 2012
Recall Status1 Terminated on December 18, 2012
Recall Number Z-0434-2013
Recall Event ID 63631
Premarket Notification
510(K) Number
K101690 
Product Classification Monitor, Carbon-Dioxide, Cutaneous - Product Code LKD
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 carbon dioxide tension, oxygen saturation, and pulse rate are required for adult and pediatric patients.
Code Information Lot numbers: 1D0F, 1D58, 1D80, 1DCA, 1DEA, 1E5F
Recalling Firm/
Manufacturer
Sentec AG
Ringstrasse 39
Therwil, Baselland
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: 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 265 boxes (5 per box)
Distribution Distributed only in MO.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LKD and Original Applicant = SENTEC AG
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