Field Safety Notice Sterisets Steriflush Syringes With Water FUU85069 and FUU85067 (ICN 3536)

NHSSC: 82

Alert:

• Sterisets Medical Products has issued Field Safety Notice FA2026/003 recalling a range of Steriflush syringes with water following an inspection conducted by INFARMED, I.P., the Portuguese competent authority, at the manufacturing facilities of Sterisets Manufacturing S.A.
• Based on the findings of this inspection, INFARMED, I.P. determined that the medical devices concerned must be recalled from the market.
• The manufacturer advises the Field Safety Notice has not been initiated in response to reported serious incidents or identified product-related adverse events, but is being implemented following the findings of the inspection and in compliance with the mandatory recall decision issued by INFARMED, I.P.
• To date, Sterisets Manufacturing S.A. confirms it has not received any reports of serious incidents or product-related adverse events associated with Steriflush.

Products Affected:

• Six products are affected.
• Two of the products affected are available via NHS Supply Chain’s eDirect route:

• See our Downloads ▼ sections to access the product listing and Field Safety Notice for further information on the affected product codes and potential alternatives, which are currently being linked on our system.
• This ICN will be updated as soon as the manufacturer is able to provide an estimated recovery date.

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.
• Complete the End User Reply Form (Annex A, page 3 of the FSN) even if you no longer have any inventory remaining in your facility and return to as soon as possible to PT@sterisets.com.
• On receipt of the completed form, Sterisets will contact you where appropriate to arrange collection of the affected products in your possession.
• Please also contact your local NHS Supply Chain Customer Service Advisor with full details of affected products to enable us to issue your credit.
• Where potential alternatives are identified, customers are advised to consult their own clinical experts to ensure suitability for their organisation’s use of these 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.