Recall Z-2140-2024 · CBK Ventilator, Continuous, Facility Use
Baxter Healthcare Corporation
Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes BT-20-0002, BT-20-0002A and BT-20-0002AP. The Life2000 ventilation system includes the Life2000 ventilator which has its individual label.
| Date | Jun 26, 2024 (initiated May 29, 2024) |
| Status | Open, Classified |
| Reason | Potential for certain Life2000 ventilator systems to either fail to charge or have intermittent charging behavior due to damage to the battery charger dongle. Damage of the battery charger dongle prevents the ventilator's internal battery from charging. |
| Root cause | Under Investigation by firm |
| Action | Baxter Healthcare began notifying consignees on about 05/29/2024 via " URGENT MEDICAL DEVICE RECALL" letter sent U.S.P.S first class mail. Patients, healthcare providers, wholesalers and distributors were instructed to ensure patients always have an alternate means of ventilator or oxygen therapy available, inspect the battery charger dongle for damage and replace immediately if damaged, and patients may continue to use the ventilator system once they inspect and confirm no damage to the dongle and battery is charging appropriately. Patients were also asked to observe any alarms of the venti |
| Quantity | 2,510 units |
| 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 |