Field Safety Notice Intersurgical Fixed Elbow Mount (ICN 2169)

Alert:

• Intersurgical has issued an Urgent Field Safety Notice following reports of patient elbow disconnecting from the Superset tube in a number of products.
• Whilst the security of connections should be checked during pre-use checks as per the instructions for use provided, if disconnection of the patient’s elbow was to occur in use, ventilation of the patient could be compromised.

Products Affected:

•  The product affected has been supplied by NHS Supply Chain:

• Please note that only the Lot number quoted is affected by this recall.
• NHS Supply Chain’s stock has been checked and all future deliveries will be of different, unaffected Lot numbers.
• Intersurgical confirms the manufacturing process for the catheter mount has been investigated and the problem resolved with no other Lot numbers affected.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share them with all users of the affected products.
• Check your inventory and if Lot 7220483 is found, cease use and quarantine immediately.
• Contact your local NHS Supply Chain Customer Service Advisor with full details of the affected products including NPC, Lot numbers and quantity stating whether boxes or eaches.
• Your Customer Service Advisor will give you a unique CMS log number and on receipt of written confirmation, email quoting the CMS reference, of disposal in accordance with your local regulations will raise the appropriate credit.
• Where potential alternatives are identified, Customers are advised to consult your own clinical experts to ensure suitability for your organisation’s use of these products.
• If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.

Please be aware that in the event of a Field Safety Notice or Product Recall, we may need to provide manufacturers, UK responsible Persons and distributors 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.