Field Safety Procedure Packs ChloraPrep 2% 1ml and ChloraPrep Frepp 2% 1.5ml Applicators (ICN 3359)

NHSSC: 19-21

• The Medicines and Healthcare products Regulatory Agency (MRHA) has issued an updated Class 2 Medicines Recall EL(26) A/34 regarding Becton Dickinson UK Ltd (BD) ChloraPrep 2% 1ml Applicators, extending the scope to include all Lot numbers with an expiry date up to and including 05/2029.
• ICN3355 has been updated with this information.

• As DMK000 is used in a range of Procedure Packs, as detailed in ICN 3359, then we anticipate further impact to those products.
• NHS Supply Chain are contacting relevant Suppliers to obtain details of any impact and will publish an update at the earliest opportunity.

NHSSC: 19-21, 24.

• Unisurge has issued a Field Safety Notice regarding BD ChloraPrep 2% 1ml and ChloraPrep Frepp 2% 1.5ml Applicators contained within their procedure packs.
• 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.
• 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.

Products Affected:

• 9 of the affected Unisurge products are, or have been, available from NHS Supply Chain.
• A total of 68 procedure packs available from NHS Supply Chain are affected.
• See our Downloads▼ section to access the product listing and now four Field Safety Notices for more information on the affected products.

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 products.

eDirect Products – Unisurge:

• Complete the Acknowledgement form on page 5 of the Field Safety Notice whether you have affected products or not and return to Unisurge at sales@unisurge.com
• On receipt of the completed form, Unisurge will contact you to arrange collection of the affected products.
• Contact your local NHS Supply Customer Services Advisor with full details of the affected products collected by B Braun, including product code, Lot numbers and quantity. Your Customer Services Advisor will give you a unique CMS log number and will raise the appropriate credit.

NHSSC: 19-21

Alert:

• B Braun, Kimal and Rocialle have issued Field Safety Notice’s regarding BD ChloraPrep 2% 1mL and ChloraPrep Frepp 2% 1.5mL Applicators contained within their procedure packs.
• BD ChloraPrep Medicines 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.
• See our Useful Links section to view the advice from The Medicines and Healthcare products Regulatory Agency (MHRA) Class 2 Medicines Recall.

Products Affected:

• There are 59 NHS Supply Chain products affected.
• 43 of the affected products are available to order and 16 products are deactivated.
• See our Downloads▼ section to access the product listing and three Field Safety Notices for more information on the affected products and potential alternatives.
• Some of the affected products are trust specific and are not available to everyone.
• Only lot numbers quoted in the Field Safety Notices are affected.
• Lots with an expiry date after February 2028 are not impacted.
• All NHS Supply Chain stock has been checked and affected products quarantined.
• This ICN will be updated with details of any impact on future supply as these become available.

Next Steps:

• Read and follow the full instructions in the three Field Safety Notices and share with all users of the affected products.
• Cease use and quarantine all affected products.

All Stocked Products – as indicated in the product listing.

• 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 10 July 2026.

eDirect Products – B Braun

• Complete the End User Reply Form, Appendix B, page 5 of the Field Safety Notice whether you have affected products or not and return to B Braun by emailing uk@bbraun.com
• On receipt of the completed form, B Braun will contact you to arrange collection of the affected products.
• Contact your local NHS Supply Customer Services Advisor with full details of the affected products collected by B Braun, including NPC, lot numbers and quantity. Your Customer Services Advisor will give you a unique CMS log number and will raise the appropriate credit.

eDirect Products – Kimal

• Complete the Customer Response Form, Appendix 1, page 3 of the Field Safety Notice whether you have affected products or not and return to Kimal at vigilance@kimal.com
• Please note Kimal has requested completed forms are returned by 19 June 2026.
• On receipt of the completed form, Kimal will contact you to arrange collection of the affected products.
• Contact your local NHS Supply Customer Services Advisor with full details of the affected products collected by Kimal including NPC, lot numbers and quantity. Your Customer Services Advisor will give you a unique CMS log number and will raise the appropriate credit.

eDirect Products – Rocialle

• See our Useful Links section to report the quantity of affected Chloraprep being discarded to Rocialle customer complaint portal.
• Alternatively, customer can return the full pack for a full credit, by logging the details to Rocialle customer complaint portal, and Rocialle will arrange the uplift and replacement.

Standalone Products

• See our Useful Links section to view the for information on affected products not contained within procedure packs.
• For customers wishing to utilise their packs, there are four standalone Chloraprep products available from NHS Supply Chain:
  • DMK000 – Skin Disinfectant Medicinal Product 1ml sterile applicator 2% chlorhexidine gluconate in 70% IPA clear solution.
  • MRB303 – Skin Disinfectant Medicinal Product 1.5ml sterile applicator 2% chlorhexidine gluconate in 70% IPA clear solution.
  • 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.
• We will continue to update this ICN as 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.