Field Safety Notice CoClens Biocide Skin Disinfectant DMK034 (ICN 3212)

NHSSC: 95

Alert:

• CoClens has issued an advisory letter concerning the recent reports of a deviation in the presentation in a sub batch of CoClens 2% Chlorhexidine 2% in 70% Ethanol, 500ml.
• The initial findings have identified the deviation as trace calcium which interacted with the gluconate present in the formulation to form insoluble calcium gluconate, which has eventually crystallised.
• The supplier advises that the particles are not considered as harmful to staff or patients.

Products Affected:

• The affected product is available from NHS Supply Chain:

• Please note only the batch number quoted in the advisory letter is affected.
• All NHS Supply Chain stock has been checked, and future orders will be fulfilled with unaffected stock.
• Please also be aware ICN 2937 was issued 12 May 2025 for this product with different batch numbers affected.
• See our Useful Links section to view ICN 2937.

Next Steps:

• For customers that have received the affected batch please dispose of the product in accordance with your local regulations.
• Please contact CoClens at phil.clifton@co-clens.co.uk who will organise replacement products.

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.