FDA Device Correction – Life2000, March 10, 2023
Posted on March 12, 2023 |
The United States Food and Drug Administration (FDA) has issued a medical device correction for all Baxter International’s Life2000 Ventilation Systems. There is potential for the user’s oxygen saturation to fall to dangerous levels during use while the equipment is attached to an oxygen source. As mentioned in an earlier communication from the FDA, users can continue to use their machines, but they should perform careful daily inspections of the tubing and the equipment in use – both the Life2000 Ventilation System and the oxygen source. Routine cleaning procedures should be performed as described in the Life2000 user manuals.
A device correction is different from a recall because the device may still be used if the user takes the precautions listed on the FDA website. Baxter intends to communicate with the patients using this equipment, but for anyone with further questions, you may call Baxter’s Clinical Support Team at 800-397-9071.
For the full FDA statement and information on how to report adverse events related to this device correction, please visit the FDA website.