| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00915-1 |
| Product Name/Description |
4FR Single Lumen Pressure Injectable Peripherally Inserted Central Catheter (PICC)
Catalogue number: PR-05041-HP
ARTG Number: 148784 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
15/09/2015 |
| Responsible Entity |
|
| Reason/Issue |
There is a labelling inaccuracy in the Instructions for Use (IFU) and injection card. The IFU and the injection card contained within the product states that
PICC testing included 10 pressure injection cycles. This is not correct, it should state that catheter testing included only 5 pressure injection cycles.
If it were to be used for more than five (5) pressure injections, it cannot be ruled out that there is a potential risk that the catheter could rupture during injections 6-10. Catheter rupture can cause catheter or air embolism, bleeding or ineffective treatment and may require the need for radiologic or surgical intervention. No customer complaints have been received for this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Customers are notified not to use the device for more than five pressure injections. Future stock will have the IFU and injection card amended to reflect this change. This action has been closed-out on 26/08/2016. |
| Contact Information |
1300 360 226 - Teleflex Customer Service |