| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00383-1 |
| Product Name/Description |
Vaxcel and Xcela PICC with PASV Valve Technology/Kits, BioFlo PICC Triple Lumen with Endexo and PASV Valve Technology/Kits
Multiple models affected
Multiple lot numbers affected
ARTG Numbers: 178780, 203831 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, Navilyst Medical is recalling PICC catheters that contain valve(s) manufactured prior to 15 July 2014. Valves manufactured after this date incorporate a manufacturing specification change that reduces the incidence of haemolysis during blood sampling through the PICC catheter. Use of the PICC catheters that are subject to this recall may have an increased incidence of haemolysed blood samples which may require additional peripheral access or replacement of the PICC catheter.
To date, no patient injuries have been reported to Navilyst Medical as a result of this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Emergo is advising users to inspect stock and return any unused affected product to the distributor. This action has been closed-out on 30/01/2017. |
| Contact Information |
02 9006 1662 - Emergo Australia |