| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00036-1 |
| Product Name/Description |
Xcela PICC with PASV Valve Technology/Kits, BioFlo PICC with Endexo and PASV Valve Technology/Kits
Multiple lot numbers
ARTG numbers: 175080, 178780 & 203831 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/01/2015 |
| Responsible Entity |
|
| Reason/Issue |
Navilyst Medical is recalling PICC catheters that contain valve(s) manufactured prior to October 9, 2013. Use of these PICC catheters may have an increased incidence of hemolyzed blood samples which may require additional peripheral access or replacement of the PICC catheter.
Valves manufactured after this date incorporate a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter and they are not subject to this recall action.
Types of tests affected include Blood Chemistries such as electrolytes and Blood count measurements such as hemoglobin and hematocrit as they can be altered by hemolysis.
To date, no patient injuries have been reported to Navilyst Medical as a result of this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are asked to inspect and quarantine affected stock for return to Navilyst Medical as per the directions in the Customer Letter. This action has been closed-out on 18/07/2016. |
| Contact Information |
02 9006 1662 - Emergo Australia |