| TGA Action ID |
RC-2026-RN-00685-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Diaguru Ultrasound Gel Blue 250mL
SKU: D-UG250BLCTN, D-UG250BLBX, D-UG250BLEE (for carton, box and bottle pack sizes)
Batch Number: 20240525
Expiry Date: 05/2027 |
| ARTG Number |
449089 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Testing of Diaguru Ultrasound Gel Blue 250mL Batch 20240525 demonstrated inadequate reduction of A. brasiliensis at day 14, failing to meet the preservative efficacy requirements specified in the British Pharmacopoeia. Additionally, there is an error on the product packaging. It should mention to utilise the contents of the bottle within 14 days of opening.
The hazard could lead to reactions to the gel including mild itching and redness at the site of use, and mild infections if not used within 14 days of the bottle opening. A. brasiliensis is a fungus and people with weakened immune systems or lung diseases may be affected by exposure to its spores.
To date, no adverse events have been reported. |
| Instructions for Customers/Users |
Customers are to:
- Immediately identify all affected bottles with batch 20240525 and quarantine on site to prevent further use.
- Wishmed will arrange replacement of all affected products. |
| Action Commencement Date |
21/09/2026 |
| Responsible Entity |
|
| Contact Information |
(02) 8678 6499 - Wishmed Customer Service |