July 15, 2024
The FDA has issued a Class I recall, its most serious classification, for Baxter’s Life2000 Ventilator system due to a faulty battery charging dongle. This defect may cause the ventilators to shut down unexpectedly, posing a risk of ventilator failure for patients reliant on them for breathing, especially those who are unconscious. While no deaths have been reported, there has been one injury linked to this issue.
Details of the Recall:
- Product: Baxter Life2000 Ventilator system
- Issue: Faulty battery charging dongle causing potential power failures
- UDI: 00887761978089
- Immediate Action: Remove the affected ventilators from patient care settings and distributor warehouses
Next Steps:
- For Providers: Seek alternative breathing treatments for patients. If using the Life2000 system, ensure the battery is fully charged before use and monitor the system frequently for alerts and alarms.
- For Customers: Contact Baxter support at 800-426-4224, option 2, to replace defective dongles. Immediate action is advised if damage is visible or if charging issues are experienced.
- Awareness: Healthcare organizations are requested to post and share the FDA recall notice to enhance visibility and awareness.
Baxter will provide replacement dongles once the process for returning the defective devices is initiated.