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| The United Kingdom: Class 2 Medicines Recall: Becton Dickinson UK Ltd, ChloraPrep 2% 1mL and ChloraPrep Frepp 2% 1.5mL applicators
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Becton Dickinson UK Ltd are recalling batches of ChloraPrep 2% w/v / 70% v/v cutaneous solution 1mL applicators (chlorhexidine gluconate 2%w/v and isopropyl alcohol 70% v/v) and ChloraPrep Frepp 2% w/v / 70% v/v cutaneous solution 1.5 mL applicators (chlorhexidine gluconate 2%w/v and isopropyl alcohol 70% v/v) due to a potential breach of sterility in the packaging process. The recall applies to all batches with an expiry date up to and including 02/2028. Batches with an expiry date after 02/2028 are not impacted. For the full list of impacted batches, please refer to the MHRA website.
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 number of impacted units in each batch is unknown, therefore the batches included in the full list are being recalled as a precautionary measure.
The products are used for disinfection of the skin prior to invasive medical procedures.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-becton-dickinson-uk-ltd-chloraprep-2-percent-1ml-and-chloraprep-frepp-2-percent-1-dot-5ml-applicators-el-26-a-slash-26
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Wednesday, Jun 3, 2026
Issued at HKT 15:15
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