Device Vigilance

Do not use VCV mode until corrected. Use PCV or PCV-VG mode. Perform Ventilation Screening Test. Return acknowledgement form to GE HealthCare.

Healthcare facilities should implement manufacturer's corrective actions to ensure safe operation.

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

Healthcare facilities must initiate the removal process for affected lots, isolate impacted products, and communicate the recall information to all relevant healthcare professionals. Compliance with the outlined return process is mandatory.

Pharmacies within healthcare establishments must review the safety information and adhere to the guidance issued by ANSM regarding the usage of the device.

Affected healthcare facilities and distributors must immediately check their stock, remove BD ChloraPrep applicators from all kits, apply over-labels indicating the need for component removal, and notify any customers if they have transferred or resold these products.

Affected users must identify, segregate, and quarantine the kits, add warning labels, and ensure the removal of the recalled components prior to use.

All impacted products must be identified, segregated, and quarantined. Users are required to add appropriate warning labels and must exercise extreme caution if using the Manifolds is unavoidable.

Facilities using these devices must immediately cease their use, segregate them from other stock, and return them to Boston Scientific. Relevant personnel must be notified of this recall.

Stakeholders should incorporate the device authorization into labeling and signal management protocols to ensure compliance and effective communication regarding its capabilities.

Companies must implement a strategy to upgrade from Windows 10 to Windows 11 and ensure compliance with essential safety principles, including notifying customers about potential vulnerabilities.

Review impact brief for required actions.