Recall Z-0886-2025 · CBK Ventilator, Continuous, Facility Use
Baxter Healthcare Corporation
Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP
| Date | Jan 16, 2025 (initiated Dec 20, 2024) |
| Status | Open, Classified |
| Reason | There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable. |
| Root cause | Process control |
| Action | Baxter issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 12/20/2024 via USPS first class mail. The notice explained the problem with the device, hazard involved, and requested the following actions be taken: 1. Always have an alternate means of ventilation or oxygen therapy available. 2. Patients may continue using the Life2000 ventilator if it is functioning correctly. If the ventilator becomes inoperable, place the patient on an alternate means of ventilation, if necessary, and contact Baxter Advanced Respiratory, Clinical Support team at 800-397-9071. 3. In the inte |
| Quantity | 1 unit |
| Distribution | US, Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170037 | Breathe Technologies Life2000 Ventilation System Breathe Technologies, Aug 11, 2017 |