Baxter Healthcare Corporation: Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A

Hazard

There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.

Details from the source

Reason for recall: There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable. Distribution: US, Nationwide Distribution Quantity: 946 units Lot/code info: UDI/DI 00887761981638, Serial Numbers: L1903102-017, L1911019-025, L2001042-007, L2001042-016, L2003015-264, L2005055-916, L2006020-163, L2006020-265, L2006020-455, L2006020-499, L2006020-548, L2007003-009, 120190000085, 120190000090, 120190000707, 120190000713, 120190000714, 120190000730, 120210000714, 120210000719, 120210000740, 120210000744, 120210000756, 120210000759, 120210000760, 120210000884, 120210001610, 120270001439, 120270001446, 120270001452, 120270001453, 120270001455, 120270001469, 120270001478, 120280000212, 120280000218, 120280000241, 120280000248, 120280000341, 120280000347, 120280000349, 120280000354, 120280000356, 120280000360, 120280000364, 120280000368, 120280000369, 120280000376, 120280000380, 120280000850, 120280000851, 120280000864, 120280000873, 120280000880, 120280000975, 120280000977, 120280000978, 120280000979, 120280000989, 120290000531, 120290000536, 120290000550, 120290000607, 120290000615, 120290000629, 120290000630, 120290000650, 120290001090, 120290001096, 120290001098, 120290001109, 120290001113, 120290001195, 120290001199, 120300000033, 120300000036, 120300000038, 120300000041, 120300000043, 120300000051, 120300000056, 120300000058, 120300000060, 120300000064, 120300000065, 120300000071, 120300000073, 120300000075, 120300000077, 120300000387, 120300000588, 120300000593, 120300000598, 120300000607, 120300000609, 120300000612, 120300000613, 120300000614, 120300000641, 120300000645, 120300000646, 120300000847, 120300000848, 120300000851, 12030

UPC codes

00887761981638, 120190000085, 120190000090, 120190000707, 120190000713, 120190000714, 120190000730, 120210000714, 120210000719, 120210000740, 120210000744, 120210000756, 120210000759, 120210000760, 120210000884, 120210001610, 120270001439, 120270001446, 120270001452, 120270001453, 120270001455, 120270001469, 120270001478, 120280000212, 120280000218, 120280000241, 120280000248, 120280000341, 120280000347, 120280000349, 120280000354, 120280000356, 120280000360, 120280000364, 120280000368, 120280000369, 120280000376, 120280000380, 120280000850, 120280000851

Source

Official record: FDA (Device enforcement) ↗

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