Field Safety Notice Coloplast Urology and Endourology Products (ICN 2768)

NHSSC: 80

Alert:

• Coloplast has issued a Field Safety Notice withdrawing from use a range of catheters, urethral bougies, and drainage devices from their Interventional Urology Portfolio.
• A possible sterility issue was detected in Coloplast’s facility on some Coloplast products.

Products Affected:

• Coloplast have advised that affected lots from 110 NHS Supply Chain products have been distributed.
• Please see the attached Product Listing for more details on the affected products.
• A complete list of all products and lot numbers affected by this notice can be found in Appendix 1.
• Please note only the lot numbers quoted in the Field Safety Notice are affected.
• All NHS Supply Chain stock has been checked and affected products quarantined.
• Future orders will be fulfilled with unaffected stock.
• 42 of the affected products are currently suspended and unavailable to order.
• Please review ICN 1885 for more information on product availability and possible alternatives, for products which fall under the Urology and Bowel Management framework.
• Three of the affected products are deactivated and are no longer available to order:
  • FSS10150
  • FSS1231
  • FSS1351.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Cease use and quarantine all the affected products.
• Complete Appendix 3, Certificate of Destruction, confirming the NPC, MPC, Lot numbers and stating if the quantity is in eaches or unit of issue.
• Return the form to: coreadminsupport@supplychain.nhs.uk.
• Your local NHS Supply Chain Customer Service Advisor will reply by email with a unique CMS log number. Please do not destroy the products until you have received the CMS log number.
• Dispose of the products in accordance with your local regulations and confirm back, quoting the CMS number. On receipt of this confirmation, you will be credited in full by NHS Supply Chain.
• Coloplast have requested completion by 15 January 2025, please ensure you have completed and returned the Certificate of Destruction form before this date where possible.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Hospital Care Team.

Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.