Field Safety Notice Integra Lifesciences MediHoney® Barrier and Derma Non-Sterile Creams (ICN 3215)

NHSSC: 97

Alert:

• Integra have issued a Field Safety Notice following customer complaints and subsequent investigation identifying inadequate manufacturing processes related to the production of Non-Sterile Barrier and Derma Creams.
• The supplier advises a total of three (3) complaints have occurred in Europe related to a skin reaction. No serious injury has been reported, and no other complaint has been recorded worldwide.
• Integra Lifesciences advise as per the Health Hazard Evaluation (HHE), if the Medihoney is contaminated and used on a patient it may cause skin inflammation, irritation or an allergic reaction. There are no long-range health consequences.
• If you have already used the products affected by this recall and the product instructions were followed, there is no additional customer follow-up or medical intervention required.

Products Affected:

• Two of the products affected were previously available on the stock route from NHS Supply Chain:

• Please note these products were discontinued by NHS Supply Chain, with the last issued made in October 2025.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Cease use and quarantine all affected products.
• Contact your local NHS Supply Chain Customer Services Advisor with full details of the affected products in your possession, including product code, lot numbers and quantity. Your Customer Services Advisor will give you a unique CMS log number.
• Dispose of the affected products in accordance with your local regulations. Upon written confirmation of disposal in the form of an email, quoting the CMS reference, your Customer Services Advisor will raise the appropriate credit.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Acute team.

Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.