Field Safety Notice Becton Dickinson Update to Catheter Labelling (ICN 3252)

Alert:

• Becton Dickinson has issued a customer letter dated 12 January 2026 to advise customers of an important update to their catheter labelling, implemented as part EU MDR 2017/745 and UK MDR 2002, 618 remediation to comply with ISO 20696 requirements.
• The inflation volume (e.g., 10 mL) has been moved outside the balloon image, with an arrow pointing inward.
• Becton Dickinson advise this change eliminates confusion and clearly indicates the amount of water required to inflate the balloon.
• The adjustment addresses three key points: correct balloon size, correct balloon fill volume and compliance with ISO 20696 and MDR requirements.
• Clarifying Balloon Size vs. Inflation Volume.
• “5 mL” refers to the balloon size only.
• “10 mL” refers to the inflation volume needed to fill the balloon (including the inflation valve, arm,
• and inner lumen).
• Inflating beyond the standard size creates the necessary tension for secure placement.

Products Affected:

• There are 75 product codes affected.
• The 75 products are available via NHS Supply Chain, please see our Downloads ▼ section to access the product listing for further information on the affected product codes.
• Becton Dickinson advise this is a labelling update only; the clinical practice remains unchanged.

Next Steps:

• Read and follow the full information in Becton Dickinson’s letter and share with all users of the affected products.
• Please refer to page 2 of the letter for illustrations of the previous and changed current labels, and page 3 to view the table Becton Dickinson have added to the Instructions for Use (IFUs).

Becton Dickinson advise all inquiries and requests should be directed through your local sales representatives or by contacting BD’s Customer Service by email via BDUK_customerservice@bd.com or telephone on 08009 178 776.

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

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.