| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00993-1 |
| Product Name/Description |
Intravenous Cannula Insertion Pack
Product Code: 061PC09134
Lot Numbers: 23H006, 23J038 and 23J136
Product Code: 061PC09138
Lot Numbers: 23H007, 23H143 and 23J139
ARTG 304720
(ITL Australia Pty Ltd - Intravenous Cannula Insertion Pack - Intravenous start kit) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/11/2023 |
| Responsible Entity |
|
| Reason/Issue |
ITL Australia received a customer complaint indicating that clinicians were having difficulty trying to separate the supporting frame from some of the IV dressings included in an Intravenous Cannula Insertion Pack.
The additional manipulation to separate the IV dressing may lead to cross contamination of the IV dressing which has direct contact with the cannulation site.
There have been no reports of adverse events related to this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are to immediately quarantine the affected lot numbers to prevent further use.
ITL Australia will arrange for the exchange of all affected product and provide customers with a credit note.
This action has been closed out on 27/02/2024 |
| Contact Information |
1300 188 493 - ITL Customer Service |