Cook Medical Hemospray Endoscopic Hemostat Updated Instructions for Use (ICN 1246)
Important Customer Notice Field Safety Notice
Ref: 2021/1246 ICN Number: 1246
- 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.
- There are two products available from NHS Supply Chain are:
|NPC||Product Description||Supplier Code/MPC|
|FAL12926||Endoscopy haemostasis Heamospray endoscopic haemostatic powder 10 fr/220 cm catheter||HEMO-10-EU|
|FAL12927||Endoscopy haemostasis Heamospray endoscopic haemostatic powder 7 fr/220 cm catheter||HEMO-7-EU|
- 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.
- 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.