Field Safety Notice B Braun Procedure Pack Label Discrepancy (ICN 3459)

NHSSC: 56

Alert:

• B Braun has issued Field Safety Notice RC/26/03 having identified a labelling discrepancy on 10 batches of procedure packs.
• The procedure pack label incorrectly states ChloraPrep 1ml, whereas the procedure pack contains ChloraPrep 1.5ml.
• Braun advise the issue does not affect the quality, safety, intended performance or functionality of the procedure pack or the ChloraPrep product contained within.
• The ChloraPrep supplied within the affected procedure packs is the intended 1.5ml presentation and has not been substituted, altered or otherwise compromised.
• Braun confirms there is no identified impact to product quality, safety or performance, and no patient harm or adverse patient impact has been identified as a result of this discrepancy.

Products Affected:

• Seven products are affected.
• Three of products affected are available via NHS Supply Chain:

• Please note only the batch numbers quoted in Appendix A, page 4 of the Field Safety Notice are affected.
• Braun advise the issue has been communicated to the Medicines and Healthcare products Regulatory Agency (MHRA) – Defective Medicines Report Centre (DMRC). Reference DMRC_PROC-40505255.
• The company is also initiating appropriate corrective and preventive actions within their quality management system to address the root cause of the labelling discrepancy and prevent a recurrence.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Ensure that relevant personnel are made aware of the labelling discrepancy.
• Where applicable, ensure that the discrepancy is considered during use of the affected procedure packs.
• Continue to use the affected procedure packs in accordance with your established procedures, taking into consideration that the correct ChloraPrep presentation contained within the pack is 1.5ml.
• Braun advise no product return, or quarantine is required solely as a result of this labelling discrepancy.
• Complete the Customer Reply Form, page 5 of the field safety notice and return to: uk@bbraun.com no later than 4 September 2026.
• If you identify any additional concerns, discrepancies or patient-related events associated with the affected batches, please submit a product complaint form.
• See our Useful Links section to access our Product Complaint Form.

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.