PV Bulletin

MHRA Class 2 Recall: ChloraPrep 2% applicators (potential sterility breach)

Becton Dickinson UK Ltd is recalling ChloraPrep 2% 1mL and ChloraPrep Frepp 2% 1.5mL applicators due to potential sterility breach.

Primary source: https://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

PV Impact Brief

Urgency: HighConfidence: high

What changed

MHRA published a Class 2 recall for specific batches of ChloraPrep 2% 1mL and ChloraPrep Frepp 2% 1.5mL applicators due to potential loss of sterility.

Why it matters

Use of non-sterile applicators for skin antisepsis prior to injection or catheter insertion could lead to serious infections.

Action needed

Identify and quarantine all impacted batches of ChloraPrep 2% 1mL and Frepp 2% 1.5mL applicators; return to Becton Dickinson UK Ltd.

Relevant for
Regulatory Intelligence LeadSignal Management Lead
Processes impacted
Signal ManagementLabeling
Owner

Regulatory Intelligence Lead

Review cadence

single-event

Regulatory action details

Action type
Class 2 Medicines Recall
Publication date
2026-06-02
Safety issue
Becton Dickinson UK Ltd are recalling batches 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.

Affected products

  • ChloraPrep 2% 1mL applicator
    Becton Dickinson UK Ltd
    All lots with an expiry date up to and including 02/2028. For a full list, see Annex 1.
  • ChloraPrep Frepp 2% 1.5mL applicator
    Becton Dickinson UK Ltd
    All lots with an expiry date up to and including 01/2028. For a full list, see Annex 1.

PV internal implications

Stop supplying the affected batches. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

View regulator source

Evidence and confidence

Confidence: highSource updated: Jun 2, 2026

Full briefing

Practical implication

Identify and quarantine all impacted batches of ChloraPrep 2% 1mL and Frepp 2% 1.5mL applicators; return to Becton Dickinson UK Ltd.

MHRA issued a Class 2 Medicines Recall for Becton Dickinson's ChloraPrep applicators. Users must identify, quarantine, and return impacted batches to the supplier.

What changed: MHRA published a Class 2 recall for specific batches of ChloraPrep 2% 1mL and ChloraPrep Frepp 2% 1.5mL applicators due to potential loss of sterility.

Why it matters: Use of non-sterile applicators for skin antisepsis prior to injection or catheter insertion could lead to serious infections.

Practical implication: Identify and quarantine all impacted batches of ChloraPrep 2% 1mL and Frepp 2% 1.5mL applicators; return to Becton Dickinson UK Ltd.

View original source

Published from the Firecrawl agent regulatory extraction pipeline.

#MHRA#Safety Signals#firecrawl-agent#regulatory-extraction#Class 2 Medicines Recall#Device Vigilance

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