Field Safety Notice Johnson & Johnson CEREBASE DA Guide Sheath (ICN 2446)

Alert:

• Medos International Sarl (Medos) has issued a Field Safety Notice regarding specific Lots of CEREBASE DA Guide Sheath.
• Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may result in surgical procedural delay, vascular injury, and in extreme rare occasions in may result in embolism.

Product Affected:

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

• See attachment 1 for the full list of Lot numbers affected by the Field Safety Notice.
• Please note these products are currently suspended as Medos are unable to advise Johnson & Johnson when unaffected devices will be available. An update will be issued when this information is received.
• There are currently no alternatives, and we are in the process of identifying suitable products. We will update this ICN with further details when we have further information.

Next Steps:

• Read and follow the full instructions in the Field Safety Corrective Action Notice and share with all users of the affected product.
• Complete the Acknowledgment Form, attachment 3, page 6 of the Field Safety Notice, and return it by emailing: MDFieldactionsUKirl@its.jmk.com
• Johnson & Johnson confirm they have contacted all affected Customers ordering via NHS Supply Chain.
• Please also contact your NHS Supply Chain Customer Service Advisor with full details of the affected products, including quantities and Lot numbers you are returning to Johnson & Johnson, to enable us to manage your credit where appropriate.
• If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or our Hospital Care Team.

Please be aware that in the event of a Field Safety Notice or 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.