Field Safety Notice Intersurgical Mapleson F Anaesthetic Breathing Systems Containing 0.05L Reservoir Bags with Open Tails (ICN 2520)

Alert:

• Intersurgical has issued a Field Safety Notice having identified a potential safety concern relating to various Mapleson F Anaesthetic Breathing Systems, following receipt of a customer report and ensuing inspection of internal stock.
• Some devices contain a reservoir bag with a closed tail when they should have a reservoir bag with an open tail.
• If the incorrect closed tail reservoir bag is not identified during the routine pre-use check as described in the product instruction for use, it could result in over pressurisation of the system leading to potential barotrauma.

Products Affected:

• Five of the products affected are available via NHS Supply Chain:

• Please note this potentially affects all batch numbers for the above products with expiry dates between April 2024 and March 2029.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Identify any potentially affected products from the affected codes and Lot numbers listed above.
• All users must perform a thorough visual inspection and functional test before use of the products and Lot numbers listed above, to confirm a patent gas pathway exists through the open tail of the reservoir bag to avoid over pressurisation of the system.
• Retain any affected sample(s) identified.
• Contact your local NHS supply Chain Customer Service Advisor with full details of the affected products found e.g., incorrectly closed tail.
• Your Customer Service Advisor will raise a formal product complaint on your behalf.
• Please note Intersurgical confirm this is not a product recall or withdrawal.

If you have any 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.