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SenTec V-Sign Membrane Changer (VS-MC)
- Starting date:
- November 5, 2012
- Posting date:
- February 4, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-17215
Products Recalled
A. SenTec V-Sign Membrane Changer (VS-MC)
Reason
Due to a manufacturing defect that occured for certain inserts, the new electrolyte cannot be expelled due to the fact that the hole for expelling the electrolyte is closed, if a membrane changer with the defective insert was used to change the membrane. As a consequence the sensor will be remembraned without electrolyte. The PC02 Sensor performance will be deteriorated without presence of electrolyte, giving unstable or questionable results.
Affected products
A. SenTec V-Sign Membrane Changer (VS-MC)
Lot or serial number
- 1D58
- 1D80
Model or catalog number
VS-MCI
Companies
- Manufacturer
- Sentec AG