Field Safety Notice B Braun Procedure Packs BD ChloraPrep™ Clear 1ml Applicator (ICN 2960)

NHSSC: 31

Alert:

• B Braun has issued a Field Safety Notice recalling specific batch numbers of Procedure Packs containing BD ChloraPrep™ 1ml.
• The manufacturer and Marketing Authorisation Holder (MAH) of the medicinal product (Becton Dickinson UK Ltd) has identified issues with the packaging seal of the ChloraPrep™ applicator.
• If the seal on the packaging of the applicator is faulty this may lead to the applicator device becoming contaminated, potentially leading to increased risk of infection for the patient.
• This issue also affects Insight Health’s product BD ChloraPrep™ Clear 1ml Applicator, product code DMK000.
• See our Useful Links section to view ICN 2952 for more information.

Products Affected:

• There are 19 products affected available from NHS Supply Chain.
• Please see the attached product listing and Field Safety Notice for more information on the products affected.
• Please note only the batch numbers quoted in Attachment C, page 6 of the notice, are affected.
• Not all of the affected products listed will be visible to every customer using our catalogue.
• There are products available through NHS Supply Chain in the notice, not listed here as B Braun advise the affected batch numbers to have not been supplied to us.
• All NHS Supply Chain stock has been 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 20 June 2025.
• We are working with the supplier to understand the impact this Field Safety Notice has on product availability and will update this ICN with more information once known.
• 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.

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.