Field Safety Notice Insight Health BD ChloraPrep™ Clear 1ml Applicator DMK000 (ICN 2952)

• The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Class 2 Medicines Recall: EL(25)A/36 following Becton Dickinson UK Ltd informing the MHRA of an additional batch of potentially affected products (batch number 4255106) which may exhibit an open seal on the packaging of the applicator.
• See our Useful Links section to view the MHRA’s notice on the gov.uk website.
• NHS Supply Chain has checked all stock for batch 4255106, expiry date 30 September 2027, and can confirm all future deliveries will be of different, unaffected, batch numbers.

Next Steps:

• Read and follow the full instructions in the Class 2 Medicines Recall and share with all users of the affected products.
• Cease use and quarantine the affected batch number 4255106.
• Contact your local NHS Supply Chain Customer Service Advisor with full details of affected products for return using reason code 7 – (Supplier recall).
• All goods to be returned no later than Friday 29 August 2025.

NHSSC: 24

Alert:

• Our supplier Insight Health has informed us of a Field Safety Notice issued by Becton Dickinson (BD) recalling specific batch numbers of BD ChloraPrep 1ml, following customer feedback.
• BD has determined that the affected product may exhibit an open seal on the packaging of the applicator.
• This defect would increase the risk of the applicator device being contaminated with pathogens, which would lead to increased infection rates for the patients.
• The Medicines and Healthcare products Regulatory Agency (MHRA) has been informed, Class 2 Medicine and Healthcare products Regulatory Agencys Recall: BD ChloraPrep Clear – 1mL Applicator, Becton Dickinson UK Ltd, EL(25)A/22 – GOV.UK

Products Affected:

• The product affected is available from NHS Supply Chain:

• Please note only the batch numbers quoted on page 2 of the Field Safety Notice are affected.
• All NHS Supply Chain stock is the process of being checked and affected products quarantined.

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.
• Contact your local NHS Supply Chain Customer Service Advisor with full details of affected products for return using reason code 7 – (Supplier recall). All goods to be returned no later than Friday 6 June 2025.

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