Field Safety Notice Convatec Carboflex™ Dressings 8 x 15cm and 15 x20cm ELV021 and ELV020 (ICN 2459)

Alert:

• Convatec has issued a precautionary Field Safety Corrective Action Notice for specific Lots and dressing sizes of CarboFlex™ due to routine testing not meeting Convatec’s product sterility assurance level of <10-6.
• To date, Convatec advise no complaints or adverse events have been reported related to this issue.
• Convatec advise the associated hazard and potential risk to the end-user would be moderate due to potential infection which could result in medical intervention however, the probability of occurrence is remote.

Products Affected:

•  Two of the products affected have been supplied by NHS Supply Chain:

• Please note only the Lot numbers quoted in the Field Safety Corrective Action Notice, Appendix 2 are affected. Convatec advise NHS Supply Chain only received affected Lot numbers as detailed in the table above.
• These products are currently suspended as Convatec are currently unable to advise when unaffected Lot numbers will be available, this ICN will be updated as soon as we have more information.
• Please refer to the attached product listing for potential alternative products.

Next Steps:

• Read and follow the full instructions in the Field Safety Corrective Action Notice and share with all users of the affected products.
• Cease use and quarantine all affected Lot numbers.
• Contact your local NHS Supply Chain Customer Service Advisor with full details of affected products including, if the quantity is packs of 5 or eaches. Your Customer Service Advisor will confirm details and provide you with a unique CMS reference.
• Dispose of the affected products in accordance with your local regulations.
• On receipt of written confirmation, quoting your unique reference number, credit for the full value of product destroyed will be raised.

Where potential alternatives are identified, Customers are advised to consult your own clinical experts to ensure suitability for your organisation’s use of these products.

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.