| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00149-1 |
| Product Name/Description |
Irrigation Handle (20/SP)
Part Number: BD-581012
Catalog Number: 581012
Batch Numbers: 21C0925, 21C0926
ARTG 181817
(Beaver-Visitec International Australia Pty Ltd - Ophthalmic surgical instrument handle, single use) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
26/02/2024 |
| Responsible Entity |
|
| Reason/Issue |
BVI has received a complaint from a customer that shelf pack and pouch label of Catalog#581012 of Irrigation Handle (20/SP) is missing the manufacturing and expiration date.
There is no proximate risk unless, expired lots remain in circulation for 5 years with a potential loss of sterility after the devices’ expiry date which could lead to an indirect patient infection. The expiry of the affected product is 2026. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers should immediately examine their inventory and quarantine product from these lots that are missing the expiry date.
Device Technologies (the distributor) will be in contact with customers who identify affected product (units missing expiry) to arrange return. |
| Contact Information |
0417 419 268 - George Loucas |