Cook Medical Hemospray Endoscopic Hemostat Updated Instructions for Use (ICN 1246)

NHSSC: 3

Alert:     

• Cook Medical has issued a Field Safety Notice relating to Hemospray Endoscopic Hemostat, to make customers aware of the updated Instructions for Use.
• The Hemospray Endoscopic Hemostat (HEMO) Instructions for Use (IFU) have been clarified to assist the user in avoiding catheter occlusion.
• These clarifications are anticipated to assist in the reduction of the overall occurrence of the “unable to spray Hemospray powder” malfunction.

Products Affected:

• There are two products available from NHS Supply Chain are:

• There is no product problem with the Hemospray Endoscopic Hemostat and are no new hazards nor new potential adverse effects to the patient as a result of this IFU update.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products. (See our Downloads ▼ section)
• Complete the Customer Response Form and return to European.FieldAction@CookMedical.com.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.