SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces. The SenTec V-Sign Membrane Changer Insert is indicated for use
FDA device recall Z-0434-2013 · posted 2012-11-22 · Terminated
Recall details
- Recalling firm
- Sentec AG
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- LKD
- Quantity affected
- 265 boxes (5 per box)
- Distribution
- Distributed only in MO.
- Date initiated
- 2012-11-05
- Date posted
- 2012-11-22
- Date terminated
- 2012-12-18
- Location
- Therwil, Baselland, Switzerland
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE (K101690) | Sentec AG | 2010-12-03 |