Recall archive / FDA device enforcement

Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals — FDA record Z-1139-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jan 25, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals
Reason: There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.
Classification: Class I
Recalling firm: Baxter Healthcare Corporation
Quantity: 4279 units
Agency-reported status: Ongoing
Source record identifier: Z-1139-2023

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	a) REF BT-20-0002, UDI 00887761978089, Serial Numbers: 120370002037, 120370001516, 120370001522, L2005055-910, 120300000056, 120370002035, 120370001529, 120370001518, 120370001514, 120370001909, 120370001971, 120360000581, 120370001980, 120370002002, 120380000643, 120370001975, 120370002042, 120370002030, 120370002105, 120370000385, 120380000419, L1903097-020, L2002011-022, L2002011-007, L2001042-044, 120370002039, 120380000532, 120370002025, 120370001961, 120370002107, 120370000386, 120370002027, 120370002034, 120350000951, 120370001519, 120370002036, 120370002001, 120370002092, 120380000420, 120370001523, 120380000636, 120380000644, 120370002031, 120340000517, 120350000961, 120330000935, 120310001578, 120330000936, 120370001513, L1912025-010, L191025-031, L1904050-005, L1911019-032, L1904050-015, L1912025-041, L1904050-010, L1904038-012, L1904050-007, L1912025-005, L1912025-033, L2001016-048, L2001006-046, L2001044-048, L2001044-043, L1912025-028, L2001006-045, L2001006-032, L2001006-042, 120210000743, L2004034-151, L2004034-142, L1905010-043, L2001042-045, L2005055-715, L2005012-003, L2005055-741, L2003004-081, L2004034-152, 120370002029, L2005055-863, 120340000504, 120370000380, 120310001637, 120350000960, 120370002041, 120370001520, 120370001535, L2006020-362, 120370001524, 120310001642, 120340000333, 120380001660, 120370001979, 120190001262, 120340000546, 120370002024, 120190000713, 120310001668, 120370001525, 120350000947, 120310001015, 120370001530, 120190001263, 120370002033, L2001016-009, L2001016-005, L2001044-038, L2001006-033, L2001006-049, L2001006-012, L2001006-013, L2001006-010, L2001006-026, L2001042-013, L2004034-099, L2003015-100, L2005055-751, L2005055-750, 120210000754, L2002040-058, L2006022-004, L2005055-914, L2005055-962, 120340000524, 120340000535, 120330000931, 120340000542, 120340001031, 120370001536, 120340000539, 120340000533, 120350000967, 120310001131, 120340000303, 120340001022, 120190001272, 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L2006020-584, 120420001849, 120420001246, L2006020-225, 120400001725, 120390001892, 120400001740, 120400000021, 120420001847, 120420001400, 120400001752, 120400001716, 120430000104, 120400000007, 120430000128, 120400001737, 120420001827, 120400001743, 120430000512, 120420001288, 120400000014, 120430000109, 120430000563, 120420001815, 120460002442, 120470000144, 120450001336, 120430001382, 120460001864, 120450000568, 120460001874, 120470000204, 120460002425, 120470000582, 120450000579, 120470000203, 121300001975, 120430000094, 120460001868, 120460002081, 120450000571, 120430000120, L2002006-044, L2004010-112, L2003015-367, L2004010-110, L2003015-087, L1912013-026, L2001006-009, L2001006-023, L2003015-089, L2002006-010, L2002006-007, L2002011-093, L2005055-916, L2005055-944, L2005055-998, L2005055-985, L2006020-056, L2006020-019, L1912025-009, L1912025-012, 120300000047, 120280000861, 120280000248, L2002011-091, 120290000599, L2006020-061, 120280000990, L2005055-936, L2006020-023, 120280000386, L2006020-045, 120300000067, 120280000383, 120280000231, L2002011-085, L2002011-089, 120270001497, L2006020-090, L2006020-414, L2006020-609, L2006020-218, L2006020-057, L2006020-058, L2006020-319, L2006020-363, L2006020-613, L2006020-516, L2006020-232, L2006020-383, L2006020-369, L2006020-359, L2006020-142, L2006020-125, L2006020-545, L2006020-161, L2006020-190, L2006020-415, 120420001285, L2006020-611, 120400001567, 120450001317, 120450000586, 120430001330, 120470000122, 120470000127, 120460002079, 120430000558, 120470000126, 120470000130, 120470000590, 120430000552, 120430001328, 120390001881, 120460002423, 120460002432, 120460002898, 120460002434, L2006020-602, 120390000088, 120430000136, 120460002438, 120470000145, 120470000141, 120430000526, L2001006-022, L2001016-019, L2001016-014, L2003015-375, L2001016-034, L2002006-008, 120210000715, 120210000716, 120280000346, L1912025-013, L1912025-032, L2005055-937, L1911019-018, 120300000064, 120300000862, 120300000038, 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L2006020-336, L2006020-618, 120380001661, L2006020-148, L2006020-075, 120380000473, L2006020-131, L...

Label field

Details supplied by the agency

Lot, code or applicability

a) REF BT-20-0002, UDI 00887761978089, Serial Numbers: 120370002037, 120370001516, 120370001522, L2005055-910, 120300000056, 120370002035, 120370001529, 120370001518, 120370001514, 120370001909, 120370001971, 120360000581, 120370001980, 120370002002, 120380000643, 120370001975, 120370002042, 120370002030, 120370002105, 120370000385, 120380000419, L1903097-020, L2002011-022, L2002011-007, L2001042-044, 120370002039, 120380000532, 120370002025, 120370001961, 120370002107, 120370000386, 120370002027, 120370002034, 120350000951, 120370001519, 120370002036, 120370002001, 120370002092, 120380000420, 120370001523, 120380000636, 120380000644, 120370002031, 120340000517, 120350000961, 120330000935, 120310001578, 120330000936, 120370001513, L1912025-010, L191025-031, L1904050-005, L1911019-032, L1904050-015, L1912025-041, L1904050-010, L1904038-012, L1904050-007, L1912025-005, L1912025-033, L2001016-048, L2001006-046, L2001044-048, L2001044-043, L1912025-028, L2001006-045, L2001006-032, 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The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Nationwide

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Mar 8, 2023
Recall initiation date: Jan 25, 2023
Center classification date: Feb 24, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

Related records