| TGA Action ID |
RC-2026-RN-00701-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
CLARITY Blue Ultrasound Gel Water soluble & hypoallergenic Bottle 250mL
Batch Number: 012025
Product Code: CLUSG250BL
Expiry Date: 24/02/2028 |
| ARTG Number |
409391 |
| Unique Device Identifier (UDI) |
9342916050412 - bottle, 9342916050450 - Carton |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
During a routine post market surveillance program undertaken by the TGA, samples of Batch 012025 of Clarity Blue Ultrasound Gel were tested to validate its effectiveness to inhibit specific common microbes (C. albicans, P. aeruginosa, S. aureus and A. brasiliensis).
While the product passed the Microbial limits testing, it failed in reducing the level of the test agent A. brasiliensis to the level as specified in the British Pharmacopeia for Preservative Efficacy.
Patients may have a reaction to the gel resulting in mild itching and redness at the site of use. A. brasiliensis is a fungus and people with weakened immune systems or lung diseases may be affected by exposure to its spores.
No complaints have been received in relation to this problem. |
| Instructions for Customers/Users |
Customers are to:
- Immediately check inventory for any bottles from Batch 012025.
- Quarantine any affected stock on hand to prevent further use.
- Complete the Customer Response form. A representative will be in contact to retrieve and replace the affected stock. |
| Action Commencement Date |
18/09/2026 |
| Responsible Entity |
|
| Contact Information |
1300 778 924 - Jas Virdee, Constar X |