| TGA Action ID |
RC-2026-RN-00027-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Hickman Catheter Kits
Hickman 12 Fr Dual-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff
Catalogue Number: 0600620
Lot Number(s): HUJZ1332, HUJZ1336, HUJZ1339
Hickman 7 Fr Dual-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff
Catalogue Number: 0600570
Lot Number(s): HUKR1342, HUKR1348 |
| ARTG Number |
145469 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
BD has identified via internal inspections that the packaging of some Hickman Catheter kits may have damage present on the outer tray, potentially compromising the sterile barrier. This product features a double-tray packaging structure (outer tray and inner tray). The inner tray, which contains the catheter and accessories, is sealed inside the outer tray along with the instructions for use. For those damaged units, the sterility of the outer surface of the inner tray and the instructions for use may be compromised.
No adverse events have been reported. |
| Instructions for Customers/Users |
Customers are to:
1. Please discontinue use and immediately dispose of all affected product remaining in your possession in accordance with your local facility’s process.
2. Share this notification with all users within your facility network of the product to ensure they are also aware of this recall. If the affected products have been distributed further, please forward this notification to ensure that these entities are contacted and informed of the recall.
3. Report any adverse health consequences or complaints experienced with the use of this product to BD.
Clinical Users are to:
• Not place any of the affected catheters and discard affected product.
• Not remove catheters in situ unless infection is suspected or the device is no longer clinically necessary.
• Inspect insertion sites daily for signs of infection.
This action has been closed out on 21/08/2026 |
| Action Commencement Date |
14/01/2026 |
| Responsible Entity |
|
| Contact Information |
1800 656 100 - BD Australia Customer Service |