Comvita - Medihoney Wound Gel
Comvita Medihoney Wound Gel Recall Summary Comvita MediHoney Wound Gel in 25ml and 50ml sizes from six specific batches (2311, 2340, 2345, 2429, 2433, and 2326) is being recalled because the packaging may not seal properly, potentially compromising sterility. If the sterile barrier is breached, there is a risk of infection when the gel is used on open wounds, and the product may leak or be unusable. This recall affects products distributed to hospitals, pharmacies, and laboratories in New Zealand.
- Recalling firm
- Comvita New Zealand Ltd
- Product
- Comvita - Medihoney Wound Gel. [Device]. Model: COMVITA MEDIHONEY WOUND GEL 25 and COMVITA MEDIHONEY WOUND GEL 50. Affected: Batch number - 2311, 2340, 2345, 2429, 2433 and 2326
- Reason
- 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...
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-02-26
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/92797b69-0e46-41b2-ad55-25ef37fbe3e5