Field Safety Notice Armstrong Medical Resuscitation Sets with Adjustable Pressure Limiting (APL) Valve (ICN 3281)

NHSSC: 117

• Armstrong Medical has issued an update, Version 2, and provided further Instructions for Use, (IFUs) for their Field Safety Notice CAPA-100 to extend the scope of products affected.
• A further 21 products are affected.
• Two of the additional products affected are available via NHS Supply Chain’s eDirect Service.

• See our Downloads ▼ section to access the updated Field Safety Notice and Instructions for Use relating to the affected products.

NHSSC: 117

Alert:

• Armstrong Medical has issued a Field Safety Notice to inform users of an identified issue associated with the APL valve used in certain Resuscitation Sets.
• In rare cases, the APL valve may stick during opening or closing, which can result in incomplete pressure relief.
• Armstrong Medical determined that the issue is linked to a manufacturing‑related defect affecting components of the APL valve assembly, which may lead to mechanical sticking.
• Use of affected resuscitation sets incorporating the APL valve may, in rare cases, result in partial or complete sticking of the valve during opening or closing. This failure mode can lead to incomplete pressure relief during manual ventilation, with the potential for sustained elevated airway pressures being delivered to the patient.

Products Affected:

• There are 31 products affected.
• Six of the products affected have been supplied via NHS Supply Chain.
• Please see the attached product listing and Field Safety Notice for more information on the products affected.
• Armstrong Medical is implementing a Field Safety Corrective Action to advise users of the information that must be followed within the Instructions for Use (IFU) relating to pre-use checks for the affected product codes, and advise corrective actions are underway to address the identified manufacturing‑related issue and to further strengthen component controls and inspection processes.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Armstrong Medical Limited advises that the device may continue to be used provided that the Instructions on page 2 of the Instructions for Use (IFU) are followed.
• See our Downloads ▼ sectionto access the Field Safety Notice and Instructions for Use relating to the affected 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.