Field Safety Notice Cook Medical Hemospray Endoscopic Hemostat Instructions for Use (ICN 3435)

NHSSC: 45

Alert:

• Cook Medical has issued a Field Safety Notice 2026FA0004 to bring heightened awareness to all about upcoming updates to the Hemospray Endoscopic Hemostat Instructions for Use (IFU).
• The updated Hemospray Instructions for Use (IFU) will include new guidance to address two key clinical considerations:
  • Endoscope adherence: Instructions will be added to mitigate the occurrence of powder adhering to the distal end of the endoscope. This condition can cause the endoscope to adhere to tissue, potentially resulting in difficulty manoeuvring or removing the endoscope.
  • Inability to spray powder: Additional instructions will be included for device preparation to reduce situations in which the Hemospray device is unable to dispense powder as intended.
• Please see the Field Safety Notice for more detailed information, including QR codes to access supporting videos.

Products Affected:

• Four products are affected.
• Two of the products affected are available via NHS Supply Chain:

• Cook Medical confirms it has already contacted all affected customers.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Complete Cook Medical’s customer reply form and return to FieldAction@CookMedical.com
• If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Acute 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.