Field Safety Notice Poly Medicure Fannin Double Chambered Blood Sets (ICN 3217)

NHSSC: 98

Alert:

• Poly Medicure has issued Field Safety Notice LET/QA/2026/007  following customer feedback reporting leakage of the Fannin Double Chambered Blood Set during use.
• Leakage from the Fannin Double Chambered Blood Set (7017DF4X and 7017DF4XMY) during use may result in:
  • Interruption of blood or blood component delivery
  • Exposure risk to clinical staff
  • Air entrainment
  • Delays in patient treatment.
• Poly Medicare advise to date they have received no reports of serious patient harm.

Products Affected:

• There are two products affected.
• The two products affected are available from NHS Supply Chain:

• Please note only the batch numbers quoted on page 5 of the Field Safety Notice are affected.
• All NHS Supply Chain stock has been checked and affected products quarantined.
• Future orders will be fulfilled with unaffected stock

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 batches.
• To arrange collection of the stocked line FSB1884, please contact your NHS Supply Chain Customer Service Adviser with full details of the products for return. Your Customer Service Advisor will arrange collection using Reason Code 7 Suppler recall . All products to be returned no later than Friday 20 February 2026.
• To arrange collection of the eDirect product FBO85002, contact Poly Medicure by emailing: info@polymedicure.com using the Acknowledgement Form on Page 4 of the Field Safety Notice. Giving full details of NPC, batch numbers and quantity.
• Poly Medicure will arrange collection and replacement with unaffected batch numbers.
• Please also inform your NHS Supply Chain Customer Service Advisor full details of the products for collection by Poly Medicure to enable us to offer assistance if required.

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.