Field Safety Notice KCI Medical 3M™ Prevena™ Plus 125 Therapy Unit and System Kits   (ICN 2931)

NHSSC: 02

Alert:

• Solventum (our supplier KCI Medical) has issued a Field Safety Notice regarding 3M™ Prevena™ Plus 125 Therapy Unit and System Kits distributed between 11 March and 18 December 2024.
• The supplier has identified that devices distributed between this period were released with a leak alarm threshold lower than the design specification.
• This results in the therapy unit prematurely alarming although there is no leak within the system and potentially continuing to alarm during therapy although there is no visible leak.

Products Affected:

• There are eight affected products available from our eDirect route.
• Please see the attached product listing and Field Safety Notice for more information on the products affected.
• Please note only the kits distributed between 11 March and 18 December 2024, as noted pages 3 to 5 of the 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.
• Identify and quarantine the affected devices.
• Complete the Field Notice Receipt and Customer Response Form, found on pages 6 and 7 of the notice, and return via email to FSCA-EMEA@solventum.com.
• Solventum will reach out to your facility to help coordinate the return shipment of any affected product.
• Once impacted product has been received by Solventum, they will then authorise a replacement free of charge.

If you have any concerns or 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.