Life2000 Ventilator , REF MS-01-0118, ventilatory support for the care of individuals
Enforcement
- Recall Number
- Z-1142-2023
- Event ID
- 91506
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Baxter Healthcare Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 8, 2023
- Initiation Date
- January 25, 2023
- Classification Date
- February 24, 2023
- Address
- 1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States
Description
Life2000 Ventilator , REF MS-01-0118, ventilatory support for the care of individuals
There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.
UDI 00887761978089, Serial Numbers: L1912010-050, L1905010-081, L1912010-037, L1903102-024, L1912025-024, L1903103-011, L1911019-026, L1912013-045, L1912013-036, L1905010-028, L1903102-028, L1905010-089, L1912013-019, L1903102-010, L1903103-026, L1905010-058, L1903097-007, L1903103-003, L1905010-092, L1903102-019, L1903102-013, L1904038-002, L1905010-051, L1903097-012, L1905010-018, L1904038-001, L1903103-004, L1912013-032, L1904038-003, L1911019-025, L1904050-001, L1905010-059, L1905010-088, L1911019-033, L1903103-001, L1903103-009, L1912013-013, L1903102-025, L1903103-002, L1912013-006, L1911019-010, L1912010-030, L1903097-018, L1912025-021, L1905010-004, L1903103-030, L1911019-027, L1903102-020, L1905010-041, L1912013-031, L1905010-033, L1905010-056, L1912013-041, L1905010-082, L1912010-003, L1912010-035, L1903103-014, L1912013-035, L1912010-034, L1912013-008, L1903103-027, L1903103-007, L1911019-014, L1905010-021, L1912025-019, L1903103-012, L1911019-037, L1912010-002, L1903103-010, L2001042-022, L1912025-007
Nationwide
71 units