Field Safety Notice Steris NEUTRA-FLUSH™ + Endoscope Channel Cleanser (ICN 3354)

NHSSC: 18

Alert:

• Steris has issued a Field Safety Notice following reports of an unusual, sulphur-like odour from four lots of NEUTRA-FLUSH™+.
• Steris advise a thorough investigation was performed, including full review of the manufacturing line where the sachets are filled. Laboratory testing was performed of both the affected product and the filling line. The culture showed no detectable microbiological contamination. No sources of potential contamination were identified, and all measured values were within specification.
• Steris advise the only known risk of the affected product is from the atypical odour itself.

Products Affected:

• Four products are affected.
• The four products affected are available via NHS Supply Chain’s eDirect Service:

• Please note only the lot numbers quoted above and in the Field Safety Notice are affected.

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.
• Dispose of the affected products in accordance with your local regulations.
• Complete Steris Reply Form, page 2 of the Field Safety Notice and return to: Regulatory_Compliance@STERIS.com
• On receipt of the completed form Steris, where appropriate will arrange for replacement products to be supplied to you, free of charge.
• Contact your local NHS Supply Chain Customer Service Advisor with details of all items destroyed to enable us to help if required.

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.