Z-0884-2025 Class I Ongoing
FDA device recall Z-0884-2025 was initiated by Baxter Healthcare Corporation on December 20, 2024 and is designated Class I. 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. The recall status is ongoing. Affected quantity: 187 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 22, 2025
- Initiation Date
- December 20, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 187 units
Product Description
Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
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 Pattern
US, Nationwide Distribution
Code Information
UDI/DI 00887761978201, Serial Numbers: 124080000663, 124020000164, 124020000165, 124020000166, 124020000167, 124020000168, 124020000169, 124020000170, 124020000171, 124020000172, 124020000173, 124020000174, 124020000175, 124020000176, 124080000659, 124080000661, 124080000662, 124080000666, 124080000667, 124080000668, 124080000669, 123420000499, 123490000931, 124010000910, 124020000163, 124080000670, 124080000672, 124080000673, 124080000675, 124080000677, 124080000678, 124080000679, 124080000715, 124080000716, 124080000718, 124080000733, 124080000735, 124080000772, 124080000784, 124080000854, 124080000855, 124080000856, 124080000857, 124080000863, 124080000865, 124080000919, 124080000920, 124080000921, 124080000922, 124080000923, 124080000924, 124080000925, 124080000926, 124080001290, 124080001367, 124080001388, 124080001409, 124080001594, 124080001596, 124080001601, 124080001602, 124080001603, 124080001604, 124080001605, 124080001606, 124080001608, 124080001609, 124080001610, 124080001612, 124080001614, 124140000062, 124140000063, 124140000065, 124140000067, 124140000068, 124140000069, 124140000070, 124140000123, 124140000125, 124140000126, 124140000127, 124140000401, 124140000402, 124140000403, 124140000404, 124140000405, 124140000636, 124140000637, 124140000638, 124140000668, 124140000671, 124140000672, 124140000675, 124140000677, 124140000679, 124140000681, 124140000683, 124140000684, 124140000686, 124140000687, 124140000688, 124140001005, 124140001014, 124140001187, 124140001191, 124140001195, 124140001201, 124140001203, 124160001584, 124170000747, 124170000749, 124170000804, 124170000828, 124170000832, 124170001158, 124170001159, 124170001161, 124170001162, 124170001163, 124170001166, 124170001171, 124170001172, 124200000070, 124200000071, 124200000072, 124200000073, 124200000074, 124200000076, 124200000077, 124200000078, 124200000079, 124200000080, 124200000081, 124200000083, 124200000084, 124200002473, 124200002474, 124200002475, 124200002476, 124200002478, 124200002479, 124200002480, 124200002481, 124200002482, 124200002485, 124200002486, 124200002489, 124200002490, 124200002491, 124200002492, 124200002493, 124200002494, 124200002495, 124200002496, 124200002497, 124200002498, 124200002499, 124200002500, 124200002501, 124200002502, 124200002503, 124200002504, 124200002505, 124200002506, 124200002507, 124200002508, 124200002509, 124250000491, 124250000492, 124250000493, 124250000494, 124250000495, 124250000496, 124250000497, 124250000498, 124250000499, 124250000500, 124250000533, 124250000534, 124250000535, 124250000536, 124250000537, 124250000538, 124260000558, 124260001171, 124280000585, 124280000741.