Safety Alert Becton Dickinson ChloraPrep 2% 1ml and ChloraPrep Frepp 2% 1.5ml Applicators (ICN 3355)

NHSSC: 17

Alert:

• The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Class 2 Medicines Recall: EL(26)A/26 regarding Becton Dickinson UK Ltd (BD) ChloraPrep 2% 1ml and ChloraPrep Frepp 2% 1.5ml Applicators.
• See our Useful Links section to view the MHRA Class 2 Medicines Recall notification.
• BD is recalling the affected products due to a potential breach of sterility in the packaging process.
• This defect could increase the risk of the applicator device being contaminated with pathogens, which could lead to increased infection rates for the patients.

Products Affected:

• Two products are affected.
• The two affected products are available from NHS Supply Chain’s stocked route:

• Lots with an expiry date after 02/2028 are not impacted.
• Please see Annex 1 in the alert for more details on the lots affected.
• All NHS Supply Chain stock has been checked and affected products quarantined.
• DMK000 is currently subject to Protect Demand Management.
• DMK000 Is available to order through NHS Supply Chain. However, trusts are allocated a maximum daily quantity or “threshold” to ensure fair supply of available stock across the NHS.
• Potential indirect alternative products are available to order through our online catalogue:
  • MRB306 – Skin Disinfectant Medicinal Product 3ml sterile applicator 2% chlorhexidine gluconate in 70% IPA clear solution
  • MRB494 – Skin Disinfectant Medicinal Product 3ml sterile applicator 2% chlorhexidine gluconate in 70% IPA tinted solution.
• Where potential alternatives are identified, customers are advised to consult your own clinical experts to ensure suitability for your organisation’s use of these products.

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 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 26 June 2026.
• Please be aware that the affected products may appear in procedure packs. We are working with our suppliers and will update with more information, including any affected products, once known.
• We will continue to update this ICN as the situation evolves and more information becomes available.

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.