Recall Z-0046-2025 · CBK Ventilator, Continuous, Facility Use
Baxter Healthcare Corporation
Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3) BT-20-0002AP, 4) BT-20-0007, 5) BT-20-0011, and 6) RMS010118CP
| Date | Oct 22, 2024 (initiated Sep 12, 2024) |
| Status | Open, Classified |
| Reason | The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas source (Life2000 compressor, oxygen cylinder or wall source) is not supplied to the ventilator before initiating therapy. |
| Root cause | Software Design Change |
| Action | Baxter issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees 09/12/2024 via USPS first class mail. The notice explained the issue with the device, the hazard involved, and requested the following: "Actions to be Taken by Patients 1. Prior to starting therapy, patients should ensure that the Life2000 ventilator is connected to a pressure gas source (Life2000 compressor, oxygen cylinder, or wall source) first and then turned on. The system setup instructions can be found on the Quick Reference Guide, page 11-13. 2. Refer to Attachment A for the website link and QR code for the Qu |
| Quantity | 10,957 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 |