Field Safety Notice: Bolton Medical RelayPro Thoracic Stent-Graft System (NBS)
Verify inventory of affected RelayPro Thoracic Stent-Graft System lots (model 28-N4-XX-XXX-XXS) and implement actions per the FSN document.
Category
Latest regulatory intelligence and pharmacovigilance briefings with verified source dates and role-specific action guidance.
Verify inventory of affected RelayPro Thoracic Stent-Graft System lots (model 28-N4-XX-XXX-XXS) and implement actions per the FSN document.
Check for affected batches of Mirtazapine 30mg Tablets as described in EL(26)A/28 and implement any necessary quarantining or recall steps.
Identify and remove affected devices from use until corrected; if use is necessary, follow additional precautions provided in the GE HealthCare customer letter.
Confirm child is 24 months or older before administering FluMist; review Product Information; verify patient age against indication.
Identify and quarantine affected products. Return or destroy as instructed. Complete the reply form.
Update product information and guidance for use in elderly populations for Ixchiq; ensure compliance with PRAC recommendations.
Do not use VCV mode until corrected. Use PCV or PCV-VG mode. Perform Ventilation Screening Test. Return acknowledgement form to GE HealthCare.
Immediately stop using the recalled stools, store away from children, and contact Wan Yi (866-677-3889 / customerservice-ca@cosyland.com) to request free repair parts (protective nets, stabilizing feet, instructions).
Manufacturers must verify that their products meet the newly established acceptable intake levels for nitrosamines and implement necessary quality control measures to keep impurities within limits.
Healthcare providers must notify patients of potential device performance issues and monitor for any device failure or reduced performance signs.
Consumers must stop taking the product immediately and return remaining capsules to a pharmacy for safe disposal.
Review the specific labeling changes required by the FDA order and update internal safety documents and signal evaluation for ADZYNMA accordingly.
Healthcare facilities should implement manufacturer's corrective actions to ensure safe operation.
Identify and quarantine affected ARTIS Icono systems in inventory; contact manufacturer for update guidance.
Identify and quarantine affected HeartWare batteries; follow manufacturer's instructions for battery management and replacement; ensure patients and healthcare providers are informed.
Stop using and dispose of Pharmatech MK-677 capsules immediately; consult a healthcare professional if concerned.
Stop using affected batches; return to place of purchase for full refund.
Immediately stop use; visit Wyze Labs website for refund process. Report incidents to Health Canada.
Identify and quarantine products from lots 1725204004 and 1725069002; contact patients who received sensors from these lots; report adverse events if any.
Return recalled products to place of purchase for refund or contact Customer Care for return arrangements.
Identify and quarantine all impacted batches of ChloraPrep 2% 1mL and Frepp 2% 1.5mL applicators; return to Becton Dickinson UK Ltd.
Identify affected lots and implement recall procedures as per Health Canada guidelines.
Review adverse event reports for potential links to counterfeit weight loss medicines; check product supply chain for unlicensed sources.
Immediately quarantine and return unused MonaTherm probes from affected lots; review patient records for potential exposure and adverse events.
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.
This update requires triage for Label Governance, Signal Validation, Risk Management; confirm local obligations and document follow-up actions.
Ema update requires triage for Label Governance, Risk Management, AI / GxP Governance; confirm local obligations and document follow-up actions.
Review the PSUSA documents for calcifediol and ensure alignment with any PRAC recommendations if applicable.
Check stock for the affected batches of Ponlimsi (Denosumab) 60mg solution for injection and follow the instructions in the MHRA notice.
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.
Subscribe to impact-first pharmacovigilance updates. Select every role you want in your digest.
Digest roles: Signal Management Lead. Work email only