Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A

Summary

The FDA issued a Class I for Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A by Baxter Healthcare Corporation. Reason: 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 .

Details

Product Description

Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A

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, 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Quantity Affected: 946 units

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2024-12-20

Company