Field Safety Notice GBUK Arterial Cannula Kit 4Fr x 10cm FSQ85014 (ICN 2930)

NHSSC: 9

Alert:

• GBUK has issued a Field Safety Notice regarding specific lots of Arterial Cannula Kit 4Fr x 10cm.
• The needle provided is too narrow so the guidewire will not go down it to complete the Seldinger procedure.
• The inability to perform the Seldinger technique (a medical procedure used to gain safe access to blood vessels or other hollow organs through a needle) may lead to inability to complete the procedure correctly, blood loss, and the need to replace the device with another one.

Products Affected:

• The affected product is available from NHS Supply Chain’s eDirect route:

• The supplier is unable to fulfil future orders with unaffected stock and so FSQ85014 is unavailable to order.
• We are working with the supplier to obtain a date of recovery and will update this ICN once known.
• Potential indirect alternative products are available to order through our online catalogue:
  • FSQ2413 – Arterial Line single lumen polyurethane 18g x 8 cm PEBA straight/straight
  • FSQ2417 – Arterial Line single lumen polyurethane 20g x 12 cm PEBA straight/straight.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Cease use and quarantine all affected products.
• Contact the supplier to arrange collection of the affected products as directed in the notice.
• 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.
• 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 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.