Recall Z-1140-2023 · CBK Ventilator, Continuous, Facility Use
Baxter Healthcare Corporation
Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventilatory support for the care of individuals
| Date | Feb 24, 2023 (initiated Jan 25, 2023) |
| Status | Open, Classified |
| Reason | There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator. |
| Root cause | Under Investigation by firm |
| Action | Baxter issued an URGENT MEDICAL DEVICE CORRECTION notice to its healthcare providers, wholesalers, distributor/reseller, and durable medical equipment providers on 01/25/2023 by USPS First Class Mail. The notice explained the issue and the hazard and requested the following actions be taken by adressee: "Please follow the daily checks and preventive maintenance requirements below to ensure the best oxygen delivery with the Life2000 ventilation system when used with a third-party oxygen concentrator. 1- Daily Checks a) Check the CombO2 hose and Breathe Pillow Interface for kinks, dirt, moistu |
| Quantity | 135 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170037 | Breathe Technologies Life2000 Ventilation System Breathe Technologies, Aug 11, 2017 |