Field Safety Notice Rocialle Healthcare XL Quiver Sterile EVD183 (ICN 2574)

Alert:

• Rocialle Healthcare has issued a Field Safety Notice regarding specific batches of RML228-023 – Bowl 6000ml Blue double wrapped and RML114-003 – XL Quiver Sterile.
• The affected batches have been packed in a sterile barrier system which has not been fully validated. There is a risk, therefore, that the products within the sterile barrier system will not be sterile.

Products Affected:

• One of the affected products is available from NHS Supply Chain Blue Diamond route:

• Please note, only the batch numbers quoted are affected.
• Future orders will be fulfilled with unaffected product.

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 affected batch numbers.
• Contact your local NHS supply Chain Customer Service Advisor with full details of affected products. 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.

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.