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Supply Issues Coloplast Ltd Endourology Balloon Catheters (ICN 2811)

Important Customer Notice Supply Issues

Ref: 2025/2811 ICN Number: 2811

Change:

  • The supplier Coloplast Ltd has informed us of a supply issue after issuing a Field Safety Notice withdrawing from use a range of Catheters from their Endourology Portfolio.
  • Eight product codes are affected in total:
    • FAL13280, FAL13281, FAL13282, FAL13283, FAL13284, FAL13655, FAL13656 and FAL13657.
  • A possible sterility issue was detected in Coloplast’s facility on some Coloplast products which has caused supply disruption.
  • See our Useful Links section to view ICN 2768 for full details of the Field Safety Notice.

Impact:          

  • The affected product codes are currently suspended and unavailable to order.
  • Unfortunately, there are no alternatives available. Customers are advised to view the online catalogue for products they deem suitable.
  • See our Downloads ▼ section to access the product listing for further information on the affected product codes.
  • The supply issue is anticipated to be resolved by 31 March 2025.

Next Steps:              

  • Customers are advised to log into our website to view the product listing for further information on the affected products.
  • We will update this ICN when we receive any further information.
  • If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Hospital Care team.

Download our publications ▼

  • 2811 Coloplast Product Listing 23 January 2025

    An Excel file showing the product listing for ICN 2811.
    Login to view the downloads