| TGA Action ID |
RC-2026-RN-00828-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Safe-T-Centesis Kits
SAFE-T-CENTESIS KIT 6FR X 16CM
Catalog Number: PIG1260K
Lot Numbers: All lot numbers within expiry
SAFE-T-CENTESIS KIT 8FR X 16CM
Catalog Number: PIG1280K
Lot Numbers: All lot numbers within expiry |
| ARTG Number |
120894 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
BD has identified, through customer complaints, the presence of foreign material within Safe-T-Centesis catheter kits. This action follows on from the April 2026 Product Alert (RC-2026-RN-00193-1) related to this problem.
If the foreign material is not detected before use, patients may be exposed to particulates which may be loose or embedded within the containment board inside the sterile pouch. Exposure to foreign material may cause mechanical irritation or an inflammatory response.
There have been no adverse events reported for this problem in Australia. |
| Instructions for Customers/Users |
Customers are to:
- Discontinue use and immediately dispose of all affected products remaining in their possession in accordance with their facility’s process.
- Complete and return the Customer Response Form to ANZ_Quality@bd.com whether or not they have any remaining product, so that BD may acknowledge the receipt of the notification and subsequently process any required credits. Customers should indicate the product number, lot number and quantity of product that has been disposed of. |
| Action Commencement Date |
21/10/2026 |
| Responsible Entity |
|
| Contact Information |
1800 656 100 - Becton Dickinson |