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TGA Action ID	RC-2026-RN-00128-1
Type of Product	Medical Device
Product Name/Description	Comvita Medihoney Antibacterial Wound Gel 25 gram & 50 gram Item codes: 103485 (25g), 103486 (50g) Aggregate codes: 389 (25g), 60060 (50g) Batch numbers: 25g: 2311, 2326, 2328, 2340, 2341, 2345, 2346, 2419, 2433, 2434 50g: 2326, 2332, 2412, 2422, 2434, 2442
ARTG Number	214872
Action Type	Recall
Action Level	Consumer
Hazard Classification	Class II
Reason for the Action	Packaging failures were identified related to the Comvita MediHoney Wound Gel, which could potentially lead to a breach of the sterile barrier. Two potential problems were identified: 1. Inadequate sealing of the foil membrane 2. Tube packaging seal is folded resulting in a channel for product to leak. There is potential risk of infection if the packaging of a sterile product is inadequate and the product is used on an open wound. Additionally, the inability to use the device due to packaging failures may cause inconvenience to the user and delay care. No long-term health consequences are expected due to this problem. To date, no customer complaints have been received by Comvita regarding the integrity of the packaging or due to infection or reaction after use of this product.
Instructions for Customers/Users	Distributors / Retailers are to: - Immediately quarantine the affected stock to prevent further distribution or sale. - Complete and return the customer response form. - Comvita will contact to arrange a credit and advise on returns and appropriate disposal of any quarantined stock. Consumers are to: - Discontinue use of the affected product. - Contact Comvita at hello@comvita.com. - Comvita will contact to arrange a credit and advise on returns and appropriate disposal of any quarantined stock. This action has been finalised on 27/10/2026.
Action Commencement Date	24/02/2026
Responsible Entity	Comvita Australia Pty Ltd
Contact Information	1800 466 392 - Comvita Sales Support Team