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

Important Customer Notice Field Safety Notice

Ref: 2024/2574 ICN Number: 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:
NPC Product Description Supplier Code / MPC Affected Batches
EVD183 Quivers XL Sterile RML114-003 W543096

W543205

W543487

W543902

W543990

W544082

W544502

  • 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.

Downloads ▼

  • 2574 Rocialle Field Safety Notice 27 June 2024

    A PDF showing the Field Safety Notice for ICN 2574.