Field Safety Notice Intersurgical Guedel Airways (ICN 2989)

NHSSC: 41

Alert:

• Intersurgical has issued a Field Safety Notice regarding specific lots of Guedel Airways.
• The affected devices are potentially contaminated with small plastic burrs inside the Guedel or packaging from the manufacturing process.
• If the burr becomes detached and is inhaled, it could result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.

Products Affected:

• There are four products affected available from NHS Supply Chain:

• Please note only the lot numbers noted in the Field Safety Notice are affected.
• All NHS Supply Chain stock has been checked and affected products quarantined.

Next Steps:

• Read and follow the full instructions in the Customer Notification and share with all users of the affected products.
• Customers are requested to cease use and quarantine all affected products.
• Complete the Customer Reply Form, found page 6 of the notice, and return to priority@intersurgical.co.uk
• Affected products are to be returned for credit.
• eDirect Product FDB404:
  • Please contact the supplier to arrange collection directly from you
  • Please also contact your NHS Supply Chain Customer Service Advisor with full details, including quantities and lot numbers you are returning to the supplier to enable us to manage your credit where appropriate.
• Stocked Products FDB960, FDB316 and FDB317:
  • Contact your local NHS Supply Chain Customer Service Advisor with full details of affected products for return, quoting reason code 7 – (Supplier Recall). All products to be returned no later than Friday 4 July 2025.

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.