| TGA Action ID |
RC-2026-RN-00909-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Arrow Peripherally Inserted Central Catheter Pressure Injectable (PICC) & Arrowg+ard Blue Advance Pressure Injectable Peripherally Inserted Central Catheter (PICC)
Multiple product descriptions, product codes and batch numbers |
| ARTG Number |
278735, 402570 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
There is a potential quality problem affecting the supplied hydrophilic coated Spring Wire Guide (SWG) components. Teleflex has confirmed the coating may swell inconsistently when hydrated with saline leading to clumping of the coating and potential for detachment.
Detachment of the hydrophilic coating could result in particle release into the blood stream, increasing the risk of emboli. Hydrophilic polymer emboli have been described in literature as having a range of potential adverse health consequences, including inflammation, thrombosis, ischemia, tissue injury, stroke, further intervention, or death.
As of 27 Oct 2026, Teleflex has received 17 complaints associated with the hydrophilic coating on the guidewire. There have been no reports of injury or death. |
| Instructions for Customers/Users |
Customers are to:
- immediately check inventory for affected product, cease use and distribution, and quarantine the affected products.
- Return the customer response form and contact Teleflex customer service. A customer service representative will contact customers with a Return Goods Authorisation (RGA) number and instructions for the return of products.
- Only list batch numbers in scope of the recall notice when completing the response form. Teleflex will issue a credit note upon receipt of the returned affected product. |
| Action Commencement Date |
9/11/2026 |
| Responsible Entity |
|
| Contact Information |
1300 360 226 or recalls.anz@teleflex.com - Teleflex Customer Service |