| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00729-1 |
| Product Name/Description |
Arrow International 4Fg Seldinger Conversion Set with Long Sheath
(Peripherally inserted central venous catheter)
Catalogue number: PI-01451-LS
Batch Numbers: 23F14J0437, 23F14K0406, 23F14B0935, 23F14H1535, 23F15A0278, 23F15D0907
ARTG Number: 148783 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/08/2015 |
| Responsible Entity |
|
| Reason/Issue |
The reason for this action is due to the possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter. The component tabs extend past the opening to the sheath, so even if both tabs break, there will be some length of the sheath that would protrude from the skin. Therefore, embolus of the sheath should not occur. The defect is easy to recognise and the clinician would have the choice of either continuing with the split sheath or using a new one. Although the issue does not pose a significant risk to the patient, it may cause a delay of treatment when placing the catheter. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised not to use or distribute any affected stock and immediately quarantine them. Teleflex Medical will arrange collection of any affected stock from affected facilities. This action has been closed-out on 18/08/2016. |
| Contact Information |
1300 360 226 - Teleflex Medical |