Field Safety Notice Altomed Iris Retractors (ICN 2771)

NHSSC: 81

Alert:

• Altomed has issued a Field Safety Notice following a customer advising receipt of a box of Iris Retractors without an expiry date on the outer carton. The internal pouch had the correct expiry date.
• Altomed advise there is no real hazard to the patient at present, the devices manufactured in 2024 have a five-year shelf life.
• Should the product be used after the expiry, the sterility could not be guaranteed.

Products Affected:

• The two products affected are available from NHS Supply Chain:

• Please note only the two lot numbers 1202407009 and 1202403003 as quoted in the Field Safety Notice are affected.
• Altomed advise they immediately quarantined all products with the affected lot numbers and re-labelled, correcting the issue.
• NHS Supply Chain has checked our warehouses for the stock line FGN001, all future issues will be of different, unaffected lot numbers.

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 the affected lot numbers.
• All users are asked to return affected products to Altomed for re-labelling. However, customers can also request replacement labels to re-label themselves if there is a preferable urgent clinical need.
• Please contact the manufacturer for advice if you wish to relabel yourself – returning the devices is advised as the preferable course of action.
• Complete the Customer Response Form and return as soon as possible to: Daniel.lant@altomed.com.
• Please also contact your local NHS Supply Chain Customer Services Advisor with full details of all products returned to enable us to assist you as required.

If you have any further questions, please contact your local NHS Supply Chain Customer Services 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.