Field Safety Notice Fresenius Stay Safe Disinfection Cap FHE85316 (ICN 3295)

NHSSC: 119

Alert:

• Fresenius Medical Care has issued an update to a Field Safety Notice dated October 2023 to advise users of the potential side effects of hypothyroidism and hypersensitivity in relation to the use of Stay Safe Disinfection Cap.
• Fresenius advise they are now providing updated labelling information to support effective use of the Stay Safe Disinfection Cap:
  • Side Effects
    • Hypersensitivity to any of the materials in the device. Risk of thyroid dysfunction by uptake of iodine.
  • Medical Warnings and precautions (to prevent side effects):
    • Disinfection cap with povidone-iodine. Risk of thyroid dysfunction by uptake of iodine. Closely monitor thyroid function in patients with small peritoneal fill volume, typically infants and children.
  • Contraindications:
    • Do not use in case of known povidone-iodine allergy.

Products Affected:

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

• Please note this product has only been available via NHS Supply Chain since January 2024 after the original Field Safety Notice was circulated.
• See our Downloads ▼ section to view the original 2023 Feld Safety Notice and the Field Safety Notice Update letter.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Complete and sign the Customer Reply Form and email to Fresenius: VigilanceUK@freseniusmedicalcare.com
• If you have any questions about this letter or require more information, please contact Fresenius Medical Care UK Limited:
  • Telephone: 01623 445 100
  • Email: press.uk@freseniusmedicalcare.com

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.