Field Safety Notice Armstrong Medical Anaesthetic Circuit, AquaVENT® CPAP System, Ventilator Circuit for Non-Invasive Ventilation (ICN 3247)

NHSSC: 109

Alert:

• Armstrong Medical have issued a revision to their Field Safety Notice, CF-1573 Version 4, to inform users this is now a Product Recall for Anaesthetic Circuits, AquaVENT® CPAP Systems and Ventilator Circuits for Non-invasive Ventilation devices.
• This superseded their notification dated 19 December 2025 which was an update to their Instructions for Use (see Product Alert ICN 3214).
• During routine post-market surveillance, Armstrong have received eight customer reports describing holes and tears between the tubing and the purple cuff connector.
• Following internal investigation, Armstrong Medical has determined that the issue is linked to a manufacturing defect, and therefore the affected products must be recalled.

Products Affected:

• 23 products are affected.
• Six products with affected lot numbers have been supplied via our eDirect Service.
• Only lot numbers listed in Table 1, Page 2 to 6 inclusive of the Field Safety Notice are affected.
• Please see the attached product listing and Field Safety Notice for more information and details on the affected products.
• Armstrong Medical confirm unaffected products are now available to order. Please refer to the PDF “Product Update”.

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 all affected products listed in Table 1.
• Cease use immediately.
• Complete the “Response Form,” on page 7 of the Field Safety Notice indicating the quantity of affected product held, whether you will dispose in accordance with your Trust’s local regulations or require collection by Armstrong Medical, and the quantity of replacement products required.
• Return the Response Form to regulatoryaffairs@eakinhealthcare.com. Whether you have affected products or not. Alternatively, contact Armstrong Medical by telephone at +44 (0)28 7035 6029 and request the Sales Department
• Please also contact your NHS Supply Chain Customer Service Advisor with full details of the affected products in your possession to enable us to offer assistance 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.