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

Important Customer Notice Field Safety Notice

Ref: 2021/1246 ICN Number: 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:
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.

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.

Downloads ▼

  • 1246 Cook Medical Field Safety Notice

    A PDF of the Field Safety Notice for ICN 1246.
  • 1246 Cook Medical Updated Instructions For Use

    A PDF of the Updated Instructions For Use for ICN 1246.
  • 1246 Customer Response Form

    A PDF of the Customer Response Form for ICN 1246.