Field Safety Notice Teleflex Arrow® QuickFlash® Radial Artery Catheterisation Kits and Sets (ICN 2433)

Alert:

• Teleflex has issued a Field Safety Notice for their Arrow® QuickFlash® Radial Artery Catheterisation Kits and Sets & Arrow® QuickFlash® Radial Artery/Arterial Line Catheterisation Kit.
• They are recalling the packs due to reports received indicating a potentially defective component.
• The complaints received by the supplier relate to resistance of the guidewire handle/chamber during use.
• The possible immediate health consequences of the component issue are arterial vasospasm and vessel injury arising from multiple arterial punctures with repeated attempts.

Products Affected:

• Two of the affected products are available from NHS Supply Chain:

• Only the batch numbers listed on Appendix 2 from page 5 of the Field Safety Notice are affected.
• Both products are currently suspended and unavailable to order.
• The supplier has advised they currently do not have a date when these products will become available.
• Unfortunately, there are currently no suitable alternatives for the affected products.
• We will update this ICN when we receive further information from the supplier.

 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 stock that has any batch numbers listed on the Field Safety Notice.
• Complete Appendix 1 on page 4 of the Field Safety Notice and return it by emailing it to uk@Teleflex.com to arrange collection of affected products.
• Contact your NHS Supply Chain Customer Service Advisor with full details of the quantity of affected products in your possession including the serial numbers to enable us to support or raise credit if appropriate.
• If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or your Hospital Care Team.

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 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.