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

Hazard

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

Details from the source

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. Distribution: Nationwide Quantity: 4279 units Lot/code info: 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, 1203

UPC codes

00887761978089, 120370002037, 120370001516, 120370001522, 120300000056, 120370002035, 120370001529, 120370001518, 120370001514, 120370001909, 120370001971, 120360000581, 120370001980, 120370002002, 120380000643, 120370001975, 120370002042, 120370002030, 120370002105, 120370000385, 120380000419, 120370002039, 120380000532, 120370002025, 120370001961, 120370002107, 120370000386, 120370002027, 120370002034, 120350000951, 120370001519, 120370002036, 120370002001, 120370002092, 120380000420, 120370001523, 120380000636, 120380000644, 120370002031, 120340000517

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.