This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Affected Product
- Product Name: Life2000 Ventilator
- Unique Device Identifier (UDI): 00887761978089
What to Do
- Make sure there is always another way available to provide ventilation or oxygen therapy.
- Inspect the battery charger dongle for damage and make sure the battery is charging appropriately.
- Continue use of the Life2000 ventilator once it is confirmed that there is no damage and the battery is charging as expected.
On May 29, 2024, Baxter sent all affected customers an Urgent Medical Device Recall letter recommending the following actions:
- Immediately contact Baxter Acute Care Customer Service Support at 800-426-4224, option 2, to obtain a replacement if damage is found on the charging dongle or if the Life2000 Ventilator System fails to charge as expected.
- Check that the ventilator battery charge icon is displayed on the touch screen during charging from low battery state to make sure the battery is charging the ventilator.
- Observe any alarms from the Life2000 ventilator system.
- Contact Baxter Acute Care Customer Service Support at 800-426-4224, option 2, for assistance with any alarms.
- Review the system’s Quick Reference Guide for more details about the approximate ventilator battery charge, approximate time remaining, and associated alarms.
- To access the guide online, select Education & Documentation, scroll down to Instructions for Use, then click the down arrow to expand the tab. Select DOWNLOAD under the document: Life2000 Ventilator System Quick Reference Guide.
- Arrange for the return of impacted product by contacting the Baxter Acute Care Customer Service Support, 800-426-4224, option 2, between the hours of 8:00am and 5:00pm Central Time, Monday through Friday.
- Replacements will be provided after starting the process to return impacted product.
- Forward the communication to other facilities or departments in the institution if the product was distributed to them.
- Durable medical equipment (DME) providers must notify patients of the Urgent Medical Device Recall by forwarding the home patient letter attached to the notification.
- Acknowledge receipt of the company’s communication through:
- The customer portal if received directly from Baxter, even if there is no inventory. Log in to the portal using the account number listed in the enclosed reply form instruction sheet.
- The supplier, distributor or wholesaler if the product was purchased through one.
- Dealers, wholesalers, distributors/resellers, or original equipment manufacturers (OEM) must notify customers of this Urgent Medical Device Recall according to customary procedures and check the appropriate box on the customer portal.
Reason for Recall
Baxter is recalling the Life200 Ventilator System due to the potential for failure of the battery charging dongle, which can prevent the system from charging or only allow for intermittent charging.
Use of affected products may cause serious adverse health consequences, including a drop in oxygen levels (desaturation episodes) if the ventilator stops running or only runs intermittently due to a low battery. These desaturation episodes may range from mild to potentially life threatening, or even cause death if the patient is critically ill.
There has been one reported injury. There have been no reports of death.
Device Use
The Life2000 Ventilation System is intended to provide continuous or intermittent breathing (ventilatory) support for people who require mechanical ventilation assistance. The system delivers positive pressure ventilation through a tube inserted into the trachea (endotracheal) or through a mask placed over the face. It can also deliver assist/control ventilation. It is used in both home and health care settings.
Contact Information
Customers in the U.S. with questions about this recall should contact Baxter Acute Care Customer Service Support at 800-426-4224, option 2, between the hours of 8:00 am and 5:00 pm CST, Monday through Friday.
Additional FDA Resources
Additional Company Resources
- Firm Recall/Correction Letter [05/29/2024]
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
