| TGA Action ID |
RC-2026-RN-00710-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Allcare Ultrasound Gel 5L
Lot Number: 20250315
Product Codes: ACGEL5L, ACGEL5L-CARTON
Expiry Date: 14/03/2028 |
| ARTG Number |
435630 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Preservative Efficacy Testing (PET) identified a risk of potential microbial contamination with A. brasiliensis due to failing to meet the preservative efficacy requirements specified in the British Pharmacopoeia.
The use of contaminated ultrasound gel on intact skin poses a low risk of infection in healthy people. However, those who already have a weakened immune system are at a higher risk of infection and can lead to skin irritation and redness at the site of use.
To date, no adverse events have been reported. |
| Instructions for Customers/Users |
Customers are to:
- Immediately inspect stock to identify any affected product on hand.
- Dispose of the affected product immediately.
- Contact Customer Service for a refund or replacement. |
| Action Commencement Date |
21/09/2026 |
| Responsible Entity |
|
| Contact Information |
1300 303 755 - Victor Sports Med Customer Service |