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.