Field Safety Notice CoClens Biocide Skin Disinfectant DMK034 and DEC85023 (ICN 2937)

• The root cause was identified as trace calcium which interacted with the gluconate present in the formulation to form insoluble calcium gluconate, which crystallised out of solution under storage conditions.
• CoClens advise that measures have now been taken to ensure that traces of calcium can no longer be inadvertently introduced into the production processes and as such they confirm this has been validated by recent production runs.

NHSSC: 05

Alert:

• CoClens has issued an advisory letter following feedback from customers of tiny white salt like deposits seen in the bottles of certain batch numbers of Biocide Skin Disinfectant.
• CoClens advise they have had the samples analysed by an independent laboratory, which has concluded the particles are crystals of calcium salts of gluconic acid.
• This is a known derivative of Chlorhexidine Gluconate and has been assessed to occur at low trace levels in some of the batch examples returned by customers.
• As a precautionary measure in support of the consistency expected by customers in the presentation of the CoClens Skin Disinfection range the company has decided to quarantine the remaining batches.

Products Affected:

• The products affected are available from NHS Supply Chain:

• Please note only the batch numbers quoted in the advisory letter are affected.
• All NHS Supply Chain stock has been checked and future orders will be fulfilled with unaffected stock.

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 the affected lot numbers.
• Contact your local NHS Supply Chain Customer Services Advisor with full details of the affected products in your possession, including NPC, 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 Hospital Care 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.