Drug recall
Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP
FDA recall event 95842 · Class I · Baxter Healthcare Corporation
Key facts
| Event ID | 95842 |
|---|---|
| Recall numbers | Z-0884-2025, Z-0885-2025, Z-0886-2025, Z-0887-2025 |
| Recalling firm | Baxter Healthcare Corporation |
| Product type | Devices |
| Products | Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP, Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002, Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A, Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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. |
| Initiation date | Dec 20, 2024 |
| Report date | Jan 22, 2025 |
| City | Deerfield |
| State | IL |
| Country | United States |
| FEI number | 1417572 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: