Healthcare providers must notify patients of potential device performance issues and monitor for any device failure or reduced performance signs.
Identify and quarantine affected ARTIS Icono systems in inventory; contact manufacturer for update guidance.
Healthcare facilities should implement manufacturer's corrective actions to ensure safe operation.
Identify and quarantine affected HeartWare batteries; follow manufacturer's instructions for battery management and replacement; ensure patients and healthcare providers are informed.
Review the specific labeling changes required by the FDA order and update internal safety documents and signal evaluation for ADZYNMA accordingly.
Consumers must stop taking the product immediately and return remaining capsules to a pharmacy for safe disposal.
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.
