FDA Device recall Z-1139-2023

Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals

FDA Device
Class I
ongoing
Published 2023-03-08

On 2023-03-08 the FDA classified a Class I recall of Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals by Baxter Healthcare, citing there is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1139-2023
Classification	Class I
Status	ongoing
Initiated	2023-01-25
Published	2023-03-08
Last updated	2026-09-13 11:56 UTC
Company	Baxter Healthcare
Distribution	US

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.

Identifiers

code_info	a) REF BT-20-0002, UDI 00887761978089, Serial Numbers: 120370002037, 120370001516, 120370001522, L2005055-910, 12030000… 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

code_info

a) REF BT-20-0002, UDI 00887761978089, Serial Numbers: 120370002037, 120370001516, 120370001522, L2005055-910, 12030000…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1139-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.