| TGA Action ID |
RC-2026-RN-00915-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Mini-Blades and Lamellar Blades
Beaver Mini-Blade (rounded tip sharp on one side)
SKU: 364820
Beaver Mini-Blade Contains 100 Blades BEAVER6700
SKU: 364822
Beaver Mini-Blade Contains 100 Blades BEAVER6900
SKU: 364823
Beaver Mini-Blade (rounded tip sharp on one side)
SKU: BEAVER6400
Beaver Lamellar Blade, sharp all around
SKU: BEAVER6700
Beaver Mini-Blade
SKU: BEAVER6900
Multiple lot numbers |
| ARTG Number |
181674 |
| Unique Device Identifier (UDI) |
00886158004455, 00886158004479, 00886158004486, 00886158004394, 00886158004417, and 00886158004424 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Beaver-Visitec International (BVI) identified a seal integrity problem affecting certain units. The problem may result in an ‘open seal’ condition, in which sterility cannot be guaranteed.
An open seal compromises the integrity of the sterile barrier and results in loss of product sterility. Use of a product with an open seal may therefore expose the patient to a non-sterile product and may result in an increased risk of infection.
To date, BVI has received one complaint indicating that multiple products had been found with an open seal and has not received any reports of adverse health outcomes related to this problem. |
| Instructions for Customers/Users |
Customers are to:
- Review their existing stock of the affected lots.
- Place under quarantine identified SKUs and lots, to not use or further distribute product subject to this recall notification.
- Indicate in the customer response form how many units have been quarantined.
The sponsor will contact customers with further instructions regarding the product return process. |
| Action Commencement Date |
11/11/2026 |
| Responsible Entity |
|
| Contact Information |
carmen@mcfarlanemedical.com.au - McFarlane Medical |