Field Safety Notice Bayer Avanta Multi-Patient Administration Tube Sets (ICN 3335)

NHSSC: 11

Alert:

• Bayer has issued a Field Safety Notice SA-2026-RAD-03 regarding specific lots of the Multi-Patient Disposable Set used in conjunction with MEDRAD® Avanta Fluid Management Injection System.
• The Multi-Patient Set is used to administer intravascular radio-opaque contrast compounds and common flushing agents at various volumes and flow rates into humans in diagnostic and interventional angiographic procedures performed in cardiology, radiology, and vascular surgery.
• A recent change to a component of the MPAT Tubing stopcock resulted in a failure of the product to consistently and reliably engage with the Contrast Flow Control Valve (CFCV) snap interface on the Avanta Injection System.
• The Injector Not Available hazard, associated with critical severity harms of Interrupted Procedure and Delay in Procedure for the patient, is indicated for the impacted products.

Products Affected:

• There is one product affected.
• The product affected is available via NHS Supply Chain:

• Please note only the lot numbers quoted in the Field Safety Notice, page 1, are affected.
• Given the impact of the recall and time needed for replenishment, Bayer anticipate an approximately 12-week delay in order shipment, effective immediately.
• Where the affected lot numbers have been supplied by Bayer via NHS Supply Chain’s eDirect Service, these trusts have already been contacted individually by NHS Supply Chain and the supplier.

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 product.
• Bayer has advised they have been in contact with affected trusts to arrange uplift of any affected products.
• Please also contact your local NHS Supply Chain Customer Services Advisor with full details of the affected products in your possession, including product code, lot numbers and quantity. Your Customer Services Advisor will give you a unique CMS log number and arrange credit where appropriate.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Acute 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.