Supply Issues Coloplast Ltd Endourology Balloon Catheters (ICN 2811)

• The supply issue with Endourology Balloon Catheters from Coloplast Ltd is continuing and the supplier is currently unable to advise of a resolution date.
• Eight product codes are affected in total:
• • FAL13280, FAL13281, FAL13282, FAL13283, FAL13284, FAL13655, FAL13656 and FAL13657.
• All affected product codes are now in the process of being delisted from our online catalogue.
• There are no alternatives available. Customers are advised to view the online catalogue for products they deem suitable.
• This ICN is now closed.

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.