Date Initiated by Firm | November 05, 2012 |
Date Posted | November 22, 2012 |
Recall Status1 |
Terminated 3 on December 18, 2012 |
Recall Number | Z-0433-2013 |
Recall Event ID |
63631 |
510(K)Number | K101690 |
Product Classification |
Monitor, carbon-dioxide, cutaneous - Product Code LKD
|
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. |
Code Information |
Lot numbers: 1CF5, 1D21, 1D60, 1DC6, 1DED, 1E0D |
Recalling Firm/ Manufacturer |
Sentec AG Ringstrasse 39 Therwil, Baselland Switzerland
|
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 | 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. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = LKD
|