Covidien MonaTherm General Purpose Temperature Probe Recall (Class 2)
Immediately quarantine and return unused MonaTherm probes from affected lots; review patient records for potential exposure and adverse events.
2 SOPs may need review
Category
Immediately quarantine and return unused MonaTherm probes from affected lots; review patient records for potential exposure and adverse events.
2 SOPs may need review
Review product inventory for Tawon Liar; report any adverse events to FDA MedWatch; consider adding product to signal monitoring list; ensure labeling compliance checks for similar products.
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
This update requires triage for Label Governance, Signal Validation, Risk Management; confirm local obligations and document follow-up actions.
5 SOPs may need review
Ema update requires triage for Label Governance, Risk Management, AI / GxP Governance; confirm local obligations and document follow-up actions.
5 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
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