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RegulatorsMHRAUnited Kingdom

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.

PV Impact Brief

Urgency: HighConfidence: high
Relevant for
Regulatory Intelligence LeadSignal Management Lead
Processes impacted
Signal ManagementLabeling
Action needed

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

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 of ChloraPrep 2% 1mL applicators and ChloraPrep Frepp 2% 1.5 mL applicators due to a potential breach of sterility.

Affected products

  • ChloraPrep 2% 1mL applicator
    Becton Dickinson UK Ltd
  • ChloraPrep Frepp 2% 1.5mL applicator
    Becton Dickinson UK Ltd

PV internal implications

Identify and quarantine all impacted batches and return them to the supplier.

View regulator source

Evidence and confidence

Confidence: highSource updated: Jun 2, 2026

Full briefing

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.

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