MHRA Class 2 Recall: ChloraPrep 2% applicators (potential sterility breach)
Identify and quarantine all impacted batches of ChloraPrep 2% 1mL and Frepp 2% 1.5mL applicators; return to Becton Dickinson UK Ltd.
2 SOPs may need review
MHRA has published “MHRA Safety Roundup: April 2026” within the GOV.UK alerts/recalls stream. UK device vigilance teams should triage and document relevance.
Mhra update requires triage for Signal Validation, Local Affiliate Compliance, Device Vigilance; confirm local obligations and document follow-up actions.
Local Safety Officer
Review in the next governance cycle and track weekly until closure.
Primary-source confirmation recommended before operational implementation.
MHRA has published “MHRA Safety Roundup: April 2026” within the GOV.UK alerts/recalls stream. UK device vigilance teams should triage and document relevance.
Potential impact spans Signal Validation, Local Affiliate Compliance, Device Vigilance, Regulatory Intelligence Monitoring, Signal Detection, so Local Safety Officer oversight is needed to maintain compliance readiness and evidence traceability.
Mhra update requires triage for Signal Validation, Local Affiliate Compliance, Device Vigilance; confirm local obligations and document follow-up actions.
Identify and quarantine all impacted batches of ChloraPrep 2% 1mL and Frepp 2% 1.5mL applicators; return to Becton Dickinson UK Ltd.
2 SOPs may need review
Identify affected lots and implement recall procedures as per Health Canada guidelines.
2 SOPs may need review
Review adverse event reports for potential links to counterfeit weight loss medicines; check product supply chain for unlicensed sources.
2 SOPs may need review
Marketing authorisation holders should prepare to update their COVID-19 vaccines to target the XFG variant for the upcoming campaign; monitor for further regulatory guidance and prepare for potential strain change submissions.
2 SOPs may need review