Field Safety Notice Hemospray Endoscopic Haemostat (ICN 2151)

Alert:

• This Field Safety Notice is to bring heightened awareness of the potential risks of hemospray powder adhering to the distal end of the endoscope.
• Powder adhesion to the endoscope or adhesion of the endoscope to the GI tissue, especially in the oesophagus or stomach, can result in difficulty, and inability to manoeuvre or to remove the endoscope at the time of the initial hemostasis procedure.
• In some, but not all known instances, this occurred when the powder was sprayed while the endoscope was in a retroflexed position.
• Providers should be prepared to take immediate steps to manage events of adhesion. The specific measures should be guided by facility resources and clinical circumstances.

Products Affected:

•  The four products were available from NHS Supply Chain:

• Please note, FAL12927 and FAL12926 has been superseded by FAL85107 and FAL85106 and are no longer available from NHS Supply Chain

Next Steps:

• Please read and follow the full instructions in the Field Safety Notice and share them with all users of the affected products.
• Complete and return Field Action Customer Reply Form to email FieldAction@cookmedical.com as soon as possible.

Any queries please contact Customer Service for Cook Medical by email uk.orders@cookmedical.com Telephone 0207 365 4183.

Where potential alternatives are identified, customers are advised to consult their 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 Customer Relationship Manager.

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.