Field Safety Notice THD Rectoscope 800099 (ICN 2360)

Alert:

• THD has informed us of an issue with an air leak/seal in two accounts with the THD Rectoscopes 800099.
• It has been identified that the issue has occurred during a new design in the moulds resulting in one of the moulds having a 0.0005mm difference in a cavity.
• This means one in every four Rectoscopes on the production line may have the defect.

Products Affected:

• The affected product is available via NHS Supply Chain in two pack sizes:

• The leak issue is not assigned to a particular batch number and is random across the products within the box.
• Only orders received after 1 November 2023 may be affected.
• Future orders will be fulfilled with unaffected stock.

Next Steps:

• The supplier has rectified the issue and has unaffected stock from the new production run which has been fully tested.
• If customers identify the issue, or do not wish to use stock that was delivered after 1 November 2023 due to this issue, please contact your NHS Supply Chain Customer Service Advisor with full details of affected products for return and credit, reason code 7 (before 5 January 2024). Please note your order number, NPC, and quantity stating whether boxes or eaches.

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.