2376 Field Safety Notice Ecolab (ICN 2376)

Alert:

• Ecolab has issued a Field Safety Notice recalling all Lots of their Incidin OxyWipe S and Incidin OxyFoam S.
• Following retesting of the product’s efficacy against C. difficile according to the norm EN 17126. The test result has shown that these products passed the test for clean conditions but failed for dirty conditions.
• Due to the high standard variation observed, Ecolab has also decided to remove the Method 19 claim for Incidin OxyWipe S.

Products Affected:

• One of the affected products is available from NHS Supply Chain via our Stock Route.

• FAL18401 is suspended and currently not available to order.
• Ecolab is currently in the process of updating the product labels and any other accompanying information.
• Products with the new labels are expected to be available approximately February 2024.
• We are unable to offer alternatives on the catalogue as standard due to the complexities around material compatibility and potential damage if the correct product is not reviewed and risk assessed on site.

 Next Steps:

• Read and follow the full instructions in the Field Safety Notice.
• Cease use and quarantine of all products.
• Contact your local NHS Supply Chain Customer Service Advisor with full details of affected products including NPC, Lot numbers, and quantity stating whether Case of 600 or eaches.
• Our Hospital Care team will give you a unique CMS log number and on receipt of written confirmation, will raise the appropriate credit. This must be in the form of an email, quoting the CMS reference and confirming the disposal is in accordance with your local regulations.
• If you have any further questions, please contact your local Hospital Care team.

Please be aware that in the event of a Field Safety Notice or 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.