Exact FDA event identifier

Event 91506

4 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: January 25, 2023
Product types: Device
Classifications: Class I
Statuses: Ongoing
Recalling firm wording: Baxter Healthcare Corporation

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

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

Z-1139-2023

Recall number: Z-1139-2023
Initiated: January 25, 2023
Classification: Class I
Status: Ongoing
Recalling firm: Baxter Healthcare Corporation
Quantity: 4279 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.

Code information

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, 120340000547, 120340001046, 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120290001093, 120290000545, 120290000531, L2006020-029, 120290000550, L2006020-419, L2006020-286, L2007004-003, L2006020-445, L2006020-573, L2006020-518, L2006020-525, L2006020-126, L2006020-537, L2006020-268, L2006020-515, L2006020-270, L2006020-285, L2006020-256, L2006020-430, L2006020-517, L2006020-135, L2006020-323, 120380001173, L2006020-447, L2006020-574, L2006020-458, L2006020-554, L2006020-503, L2006020-538, L2006020-439, L2006020-407, L2006020-233, L2006020-571, 120470000442, 120470000189, 120450000574, 120450000565, 120470000423, 120460002893, 120460002897, 120430001374, 120450000580, 120500000196, 121010000269, 120460002080, 120400000055, 120390001849, 120500000198, 121010000289, 120400001131, 120400000050, 120390000104, 120380001174, 120390000087, 120470000584, 120470000574, L2005055-986, 120290001103, 120340000311, 120310000687, 120290000631, 120270001449, 120310001138, 120340000309, 120310001018, 120290001095, 120320000116, 120310000707, 120280000859, 120280000245, 120280000975, L2005055-941, 120280000894, 120290000632, 120310000719, L2006020-299, 120380000287, L2006020-443, L2006020-548, L2006020-504, L2006020-596, L2006020-532, L2006020-013, L2006020-217, 120400001754, 120380001319, 120400000022, 120370001976, L2006020-121, 120430000522, 120400000041, 120380001168, 120390000089, L2006020-488, 120390000781, 120390001399, L2006020-298, L2006020-235, L2006020-581, 120390000100, 120380000953, 120390000098, L2006020-163, 120380001320, L2006020-556, L2006020-489, 121010000305, 120400001130, 120460002062, 121010000278, 121010000284, 121010000268, 120460001877, 121010000224, 120390001888, 120390001848, 120390001386, 120390001866, 120470000585, 120470000436, 120390001850, 120390001425, 120470000583, 121010000274, 120390000106, L2001016-015, 120290000607, 120290000651, 120280000991, L2005055-980, L2001016-022, 120280000872, 120280000898, 120300000048, 120290000557, 120290001212, 120290000612, L2001016-001, 120310000656, L2005055-666, L2005055-943, 120320000088, 120340000315, 120340000331, 120310000652, 120310000641, 120310000651, 120390000102, 120390001393, 120390000829, L2006020-423, 120420001814, 120370002003, 120380001332, 120390001390, 120390001396, L2006020-404, L2006020-234, L2006020-087, L2006020-184, 120400000043, L2006020-266, L2006020-258, L2007004-007, 120390000108, 120390000086, 120390000085, L2006020-284, L2006020-203, 120390000084, L2006020-166, L2006020-078, 120390001427, 120470000430, 121010000299, 120400001115, 120390001861, 120390000112, 120420001820, 120430000098, 120450000570, 120430001369, 120450001331, 120380001312, 120470000195, L2006020-460, 121010000221, 120470000433, L2006020-481, 121010000308, 120430000129, 121010000303, 120370002109, L2006020-495, 120380000949, 120510002294, 120510001662, 120270001477, 120370000384, 120370000405, 120370001165, 120380000948, 120380000281, 120360000497, 120370000403, 120300000596, 120290001206, 120380000292, 120380000294, 120310001644, 120310000655, 120290000615, 120310001664, 120320000100, L2005055-938, 120280000855, 120380000301, L2006020-016, 120280000218, 120280000368, 120280000353, 120270001474, 120380001175, 120380001311, L2006020-585, L2006020-306, L2007003-005, 120390001863, 120400001572, 120400001582, 120390000078, L2006020-409, L2005055-922, L2006020-333, L2006020-322, 120390000808, L2006020-406, 120390001851, L2006020-454, 120390001855, 120390001403, L2006020-612, 120400001598, 120400001728, 120360001340, 120430001336, 120510002296, 120510001649, 120450001318, 120450000589, 120430001378, 121010000294, 120430000126, 120430000116, 120430000560, 120430000132, 120420001834, 120400001608, 120400000018, L2006020-156, 120430000568, 120430000123, 120380001176, 120430000121, 120510002291, L2006020-112, 120280000860, 120300000605, 120380000286, L2006020-007, 120370001521, 120370000388, 120280000217, L2005055-912, 120350001699, 120370001537, 120300000606, 120300000639, L2006020-533, 120300000600, L2006020-014, 120380000939, 120300000585, 120370000401, 120390001400, L2006020-257, 120390001864, 120390001853, L2006020-227, 120390001857, L2006020-274, 120400001568, 120390001382, L2006020-543, 120390000101, 120390001405, 120390001391, L2006020-457, 120390001392, 120380001673, 120390000094, 120390001398, 120510001659, 120510001658, 120510002301, 120510001654, 120510001652, 120510001648, 120430001323, 120430001385, 120450001339, 120450000576, 120510002312, 120510001666, 120500001957, 120430000551, 120510002307, 120450001083, 120450000566, 120500001978, 120510001655, 120510001645, 120430000515, 120290000645, 120300000607, 120300000387, 120370001534, 120370000402, 120370000383, L2006020-025, 120370001156, 120380000288, 120300000591, 120370000012, 120380000284, 120300000588, L2006020-030, 120370002111, 120270001457, 120290001195, 120370001175, 120270001446, 120280000364, 120380000942, 120280000243, L2005055-737, L2006020-003, 120310000705, L2006020-546, 120350001725, L2006020-557, L2006020-539, L2006020-374, 120310001574, 120310001658, L2006020-579, L2001042-040, L2006020-141, L2006020-418, L2006020-405, L2006020-085, L2006020-431, L2006020-246, 120390001858, 120390000784, 120390001856, L2006020-467, L2006020-550, 120380000296, 120390001870, 120390001379, 120390000096, 120390001380, 120390000092, 120390000093, 120390001854, 120390001412, 120390001410, L2006020-191, L2006020-116, L2006020-259, L2006020-553, L2006020-095, 120430000099, 120510002290, 120510001665, 121410001194, 121200001994, 121200001998, 121020000155, 121200002003, 120510001664, 120500001977, 120510002302, 120500000212, 120510001643, 120400001615, 120510002295, 120500000201, 120510001657, 120510001661, 120500001954, 121020000145, 121200001996, 121410001196, 121410001200, 121200001992, 120400001127, 121020000395, 120510002299, 120350001685, 120270001456, 120280000978, 120360001336, L2005055-947, 120280000973, 120300000856, L2006020-462, L2006020-411, L2006020-490, L2006020-202, L2006020-380, L2005055-960, 120380000295, 120290000620, 120290001205, 120290000537, 120300000040, 120380000283, 120280000858, 120300000076, 120360001101, L2005055-889, 120360001089, L2006020-560, L2006020-188, L2006020-207, L2006020-463, L2006020-544, L2006020-586, L2006020-562, L2006020-340, L2006020-149, L2006020-153, L2006020-173, L2006020-401, L2006020-093, L2006020-552, L2006020-194, 120340000537, L2005055-894, 120350000959, L2006020-275, 120340000549, 120400001101, 121020000143, 120510001663, 121410000820, 121020000362, 121200002006, 120430001368, 120510001667, 120510001656, 121200001990, 121020000220, 121200001986, 121410000504, 121200002004, 121500001304, 121020000142, 120420001255, 120420001404, 121200001988, 121200001997, 121020000295, 121200001993, 120450000587, 121520000397, 121500000331, 120390001896, 120460001875, 120510002303, 120390000091, 121500001563, 120510002309, 121490000666, 121500001130, 121500000600, 120430000567, 120430000096, 121500000114, 121500000129, 120350001691, 120350001005, L2007002-006, 120370001169, L2006020-469, L2005055-964, L2006020-466, L2007003-010, 120270001470, 120380000935, 120370000389, L2003004-064, L2006020-520, L2006020-060, 120290001214, L2005055-651, L2005055-909, 120370000003, L2006020-329, L2007003-008, 120400001601, 120380001180, 120400001119, 120400001604, 120380001607, 120360001001, 120400001107, 120400001599, 120420001287, 120430000550, 120400001613, 120400001610, 120400001140, 120420001833, 120390000807, 120380000950, 120400001595, 120500001950, 120400001742, 120400001585, 121020000152, 121020000137, 121020000359, 120430001384, 120430001412, 120460001867, 121200001995, 121200001999, 120510002298, 121200002002, 121200001989, 121500001309, 121500001567, 121500001025, 121500001307, 121500001332, 121200002005, 121500000326, 120430001383, 120390001869, 120400000053, 120400001137, 121200002008, 120510001646, 121500000330, 121020000217, 121020000398, 120430001411, 120430001341, 120400001128, 121500001326, 121200002001, 121490000656, 121490000662, 121500001129, 121500001131, 121490000664, 121490000660, 121500001128, 120430000111, 120430001326, 120430000118, 120430000112, 120430001322, 120360000583, 120270001471, 120300000855, L2006020-283, L2006020-278, 120370000013, L2006020-506, L2005055-963, L2006020-172, L2005055-946, 120300000068, 120300000584, 120300000598, 120370001158, L2006020-598, 120290001100, 120360000582, 120360001172, L2006020-620, 120360001083, 120400000045, 120430000514, 120370002091, 120390001397, 120380001185, 120420001394, 120400001096, 120400001713, 120500001968, 120390000107, 120390000066, 120400001100, 120400001600, 120430000517, 120400000024, 120500000214, 120400001605, 121490000670, 120430001327, 120430000518, 120430000108, 120510002292, 120500000206, 120510002308, 121500001564, 121490000744, 120430000565, 120420001852, 120290000650, 121490000673, 121500001139, 120430000137, 120430000131, 121500001308, 120400001562, 120290000549, L2006020-345, L2006020-510, L2006020-312, 120370002103, 120350001024, 120380000285, 120380000933, L2006020-304, L2005055-940, L2006020-265, L2006020-507, L2006020-264, L2005055-829, 120380000943, 120280000985, 120290001113, 120280000213, 120380000945, 120370001167, L2006020-569, L2005055-932, 120290001098, 120430000507, 121490000669, 120500001961, 120500001953, 121010000246, 121500001329, 121500000163, 120420001854, 120400001753, 121500001132, 121500001023, 121500000131, 120400000017, 120400001738, 120420001858, 121500000334, 121490000754, 121500000328, 120400000015, 120500000215, 121010000267, 120500000197, 121010000276, 120500000204, 120500000202, 121500001134, 120460001873, 121490000667, 120420001839, 120400001722, 121010000272, 121490000755, 120460002444, 121010000281, 121010000222, L2006020-320, 120290001209, 120280000345, 120300000610, L2007003-003, 120270001438, 120350001031, 120350001695, 120370000057, 120370000035, 120280000873, 120290000626, 120300000852, 120300000643, 120340000530, 120370000065, 120350001032, 120370000020, L2006020-531, L2007003-001, L2006020-272, 120360000998, 120350001692, 120280000981, 120360001261, 120360001257, 121010000245, 121500001020, 121500000327, 121010000307, 120470000572, 120460002443, 121500000116, 121500001331, 121500001021, 121490000674, 121500001135, 121500001017, 120420001859, 121500000132, 120350001686, 120280000354, 120360001248, 120290000538, 120370000036, 120370000062, 120400000366, 120370000058, 120280000380, 120290000637, 120280000857, 120360001262, 120370000029, 120350001724, L2005055-811, L2006023-005, 120280000219, 120370000060, 120420001823, 120430000548, 121010000287, 121010000219, 120450001327, 120470000578, 120390000809, 121010000297, 120500000199, 121500001136, 120460002445, 120460002070, 121500001024, 120350000742, 120470000434, 120460002422, 120530000418, 120470000579, 121490000671, 120370000006, 120360001332, 120380000143, 120270001487, 120350001035, 120350001720, 120380000136, 120370000022, L2006020-062, 120350000966, 120370000063, 120350001034, 120350001687, 120280000381, 120380000130, 120360001251, 120370000068, L2006020-355, 120270001491, 120360001093, L2005055-823, 120360001253, 120350001729, 121500000329, 121490000748, 120530000420, 121490000658, 121490000657, 121500001133, 121500001140, 121500000332, 121020000393, 121500001562, 120350001728, 121500001302, 121490000655, 121020000401, 120350000962, 121500001303, 120470000566, 121500001565, 121490000665, 121500001137, 121490000746, 121500001016, 121500001018, 120350000737, 121020000149, 121020000150, 121500001330, 121500000333, 120350000741, 120360000602, 120360001331, 120280000376, 120350001701, L2006020-010, 120280000865, 120280000347, 120290000792, 120370000048, 120360001349, 120350000965, 120370000045, 120370000049, 120360001263, 120280000371, 120360001264, L2006020-180, L2007003-007, L2006020-521, 120280000897, 121500000162, 121020000399, 121500001127, 120350001705, 120530000419, 122010000030, 122010000015, 122010000348, 121520001345, 122010000004, 122010000787, 121520001340, 121520001346, 122010000784, L2005055-500, 120290000547, 120280000361, L2005055-951, L2006020-069, 120350001697, 120370000056, L2006020-356, L2007007-043, 120350001718, 120370000043, 120360001334, 120360001265, 120290000630, 120350000963, 120350001719, L2007003-009, 120290000611, 120370000059, 120370000073, L2002040-089, L2002011-062, L2002011-058, 120210000719, 121410000645, 122010000922, L2002011-056, L1912010-046, L2002011-066, L2006020-001, 120430001787, 120360000593, 120370000030, 120350001704, L2006020-281, L2005055-996, 120370000079, 120350001723, L1810123-009, 120370000016, 120370000021, 120360000053, 120360001097, 120360001080, 120360001185, L2002011-013, 121410000785, 121410001202, 121510000670, L2002011-011, L2001042-042, 120210000742, 120210000730, L2001042-048, 120210000728, 120210000731, L2006022-003, L2002011-016, L2003015-022, 120210000756, 122130000318, 122050001184, 122090001415, 122100001442, 122290000382, 121410000822, 122080000935, 120360000084, 120360000104, 120360001179, 120360001086, 120360000061, 120270001469, 120360001090, 120370000028, 120360000117, 120360000071, 120360001184, 120360000081, 120310000711, 120360001330, 120280000247, 120360000992, 120360000109, 120360001006, 120380001601, 120350001707, 120360000082, 120360000074, 120360000085, 120360000069, 120360001075, 121490000808, 122010001067, 121520000109, 121500000611, 121510000356, 122010001003, 121520000400, L2001044-029, L1904050-003, L2001044-002, 122070000148, 122070000190, 122090001082, 122150000703, 122120000367, 122110001701, 122100000764, 121510000281, 122070000179, 122060002230, 120380000637, 120300000077, 120310001634, 120360000066, 120380000937, 120360001175, 120360001088, 120360001176, 120380001608, 120310000702, 120360001095, 120360000058, 120360000070, 120360000065, 120360000057, 120360001096, 120360000062, 120380001316, 120310000681, 120360000052, 120380000638, 120310001645, 120280000236, 120380000635, 120380001671, 120360001173, 120360000114, 120380001668, 120360000063, 120370000011, 122070000137, 121510000839, 121500000610, 121490000804, 121510000661, 121510000838, 122010001077, 122010001009, 122010000921, 121520000043, 122010000942, 121510000280, 122010000920, 121520000230, 121520000232, 121500000705, 121520000401, 121500000606, 121510000274, 121520000047, 122010000918, 121520000098, 121510000355, 122010001074, 121520000113, 121520000111, 121520000395, 122010001069, 121490000756, 121520000042, 122010001072, 121500001013, 122010001070, 122010001071, 121510000358, 122010000944, 120360000054, 120360000073, 120360000113, 120360000112, 120360000997, 120360001081, 120380001606, 120380000531, 120380001616, 120350001042, 120370000061, 120360000106, 120360001078, 120360000050, 120340000344, 120360001183, 120360001182, 120360001181, 120360001076, 120360001004, 120360000108, 121520000102, 121520000103, 121520000997, 122010000916, 121520000045, 121520000114, 122010001086, 121490000745, 122090001080, 121500000702, 121500000599, 121410000784, 121410000642, 122050000961, 122070000149, 122050000958, 122070000143, 122070000176, 122050000302, 121520000049, 122050000296, 122050000953, 122090001090, 121410000796, 122090001084, 122090001436, 122090001087, 122090001088, 121510000324, 121520000097, 121510000361, 121520000228, 122010000919, 121520000107, 121510000352, 121520000234, 121520000105, 121520000112, 121500000604, 121510000357, 121490000753, 121410000817, 121410001187, 122050000959, 120360000067, 120360001338, 120360001186, 120360000068, 120360000080, 120360000105, 120280000369, 120380000289, 120310001647, 120310000697, L2006020-354, 120310001571, 120360000989, 120340000553, 120340001029, 120310001624, 120340001047, 122010001084, 121520000225, 121520000108, 122090001092, 122050000952, 122070000157, 122090001086, 121520000226, 121520000110, 121520000044, 121510000665, 122010000924, 122050000957, 122070000150, 122090001098, 122080000933, 122070000185, 122070000171, 122050000954, 121510000663, 121410000589, 122010001085, 122090001414, 121500000602, 121510000662, 122070000147, 121510000277, 121520000116, 122050000301, 122050000303, 122080000928, 122050000297, 121410000641, 121520000991, 121510000359, 120390000796, 120370000009, 120360000986, 120390000810, 120380001604, 120380001613, 120360000490, 120340001050, 120360000993, 120350000954, 120370001981, L2005055-973, 120360000487, 120360000988, 120310001038, 120360000996, 120340000525, 120360000480, 120360000478, 120360000495, 120360000483, 120310001659, 120340001020, 120340001058, 120380001623, 122070000146, 122080000934, 122010001080, 122070000175, 122060002087, 122050001201, 122090001435, 122050001198, 122090001097, 122090001412, 121410001193, 122080000927, 122090001094, 122070000144, 121410000585, 122060002252, 122050001188, 122050001202, 122060002090, 1220500011

Distribution pattern

Nationwide

device · product 2 of 4

Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventilatory support for the care of individuals

Z-1140-2023

Recall number: Z-1140-2023
Initiated: January 25, 2023
Classification: Class I
Status: Ongoing
Recalling firm: Baxter Healthcare Corporation
Quantity: 135 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.

Code information

a) REF BT20007, UDI 00887761978089, Serial Numbers: L191001-005, L191001-003, L191001-004, L191001-002, L191001-001, L191212-022, L191212-023, L191212-021, L191212-024, L191212-025, L200114-011, L200114-004, L200114-008, L1911019-015, L1911019-021, L1911019-023; b) REF BT-20-0007, UDI 00887761978089, Serial Numbers: L1911019-016, L1911019-020, L1911019-022, L2002006-032, L2003004-117, L2003004-085, L2003004-091, L2003004-121, L2002040-026, L2002040-039, L2002040-041, L2002011-033, L2002040-005, L2003004-145, L2003004-130, L2003004-128, L2003004-125, L2003004-123, L2003004-077, L2002040-040, L2002040-042, L2003004-131, L2003004-137, L2003004-144, L2003004-127, L2003004-133, L2003004-129, L2003004-115, L2003004-083, L2003004-087, L2002040-043, L2003004-079, L2003004-073, L2003004-098, L2003004-150, L2003004-181, L2003015-181, L2003015-189, L2003015-188, L2003015-180, L2003015-201, L2003015-205, L2003015-197, L2003015-203, L2003015-185, L2003015-186, L2003015-196, L2003015-198, L2003015-179, L2003015-202, L2003015-204, L2003015-178, L2003015-206, L2003015-309, L2003015-311, L2003015-349, L2003015-276, L2003015-275, L2004002-027, L2004002-015, L2003015-399, L2003015-395, L2003015-393, L2003015-265, L2003015-389, L2003015-391, L2003015-396, L2003015-397, L2003015-398, L2004002-020, L2004002-003, L2003015-384, L2003015-392, L2003015-277, L2003015-273, L2004002-262, L2004002-256, L2004002-263, L2004002-241, L2004002-174, L2004002-246, L2004002-265, L2004002-197, L2004002-170, 120210001615, 120190000718, 120190000711, 120190001264, 120190000088, 120190001269, 120190000078, 120190000089, 120210000884, 120190001266, 120190000092, 120190000730, 120190000075, 120190000706, 120190000737, 120190001275, 120190000728, 120190000093, 120190000707, 120210001613, 120210001608, 120190000077, 120190000091, 120190000074, 120210001614, 120190000714, L2005055-250, 120190000081, L2006020-252, 120190000079, L2005055-873, 120190000090, 120190000076, 120190000722, L2005055-898

Distribution pattern

Nationwide

device · product 3 of 4

Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals

Z-1141-2023

Recall number: Z-1141-2023
Initiated: January 25, 2023
Classification: Class I
Status: Ongoing
Recalling firm: Baxter Healthcare Corporation
Quantity: 8 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.

Code information

a) REF BT200011, UDI 00887761978089, Serial Numbers: L190606-014, L191011-040, L200127-015, L200204-013; b) REF BT-20-0011, UDI 00887761978089, Serial Numbers: L200226-012, L200226-013, L200226-015

Distribution pattern

Nationwide

device · product 4 of 4

Life2000 Ventilator , REF MS-01-0118, ventilatory support for the care of individuals

Z-1142-2023

Recall number: Z-1142-2023
Initiated: January 25, 2023
Classification: Class I
Status: Ongoing
Recalling firm: Baxter Healthcare Corporation
Quantity: 71 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.

Code information

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

Distribution pattern

Nationwide