Product Recall Resuscitation Set – Mapleson C System with APL Valve (ICN 1839)

MHRA TBC

NHS Supply Chain Reference: 54

Alert:

• Armstrong Medical has issued a Field Corrective Action Notice following reports indicating that there are a small number of devices in the field associated with Resuscitation Sets that may contain APL valves that do not function as intended.
• This could lead to indirect patient harm such as a delay in treatment or could possibly lead to a serious deterioration in the health of a patient.
• Each device is expected to be subjected to a “Before use, verify flow patency” test before clinical use. This is to ensure that the APL valve performs as intended in the closed cap and open cap positions of the valve, ensuring that the reservoir bag inflates (cap position closed) and collapses (cap position open). Such a pre-use test is mandated in the Instructions for Use supplied with the device.
• In instances where the device is to be made available to use in emergency situations, Armstrong Medical suggest that all devices are subjected to pre-use tests prior to being made available for use in critical care situations or emergency service vehicles.
• This Field Safety Notice (FSN) is published to facilitate a manufacturing lot specific device recall. See Table 1 for detail of all lots of finished medical devices that are subject to recall under this FSN.

Products Affected:

•  The products affected are available via NHS Supply Chain:

• All devices identified in Table 1 of the FSN can be used safely, provided that the devices are subjected to the pre-use test. Any device which fails the pre-use test should be disposed of or returned to Armstrong Medical. 

Next Steps:

• Read and follow the full instructions in the Field Corrective Notice and share with all users of the affected products.
• Complete the Response Form as appropriate and return to quality@armstrongmedical.net.
• Armstrong Medical will arrange exchange direct with customers for the eDirect product FDD4338.
• Customers with stock of FDC337 should contact their local NHS Supply Chain Customer Service Advisor with full details including if the devices for return are boxes (60) or eaches. Your advisor will arrange collection under reason code 7 “Supplier Recall” for full credit. All goods to be returned no later than Friday 11 November 2022.
• Please reorder replacements as required. Armstrong Medical confirm this recall will not impact on the availability of future supplies.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or Customer Relationship Manager.