Welch Allyn Life 2000 Ventilator Battery Charger Defect Causes Inoperability
The Welch Allyn Life 2000 Ventilator has a battery charger defect that could cause an alarm, rendering it inoperable. 187 units nationwide are affected in this FDA Class I recall.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I classification is the criterion for Critical severity under the recall rubric. Class I indicates a reasonable probability the product could cause serious adverse health consequences or death.
Plain-English summary
The Welch Allyn Life 2000 Ventilation System (manufactured by Baxter Healthcare Corporation) is being recalled due to a battery charger defect. The defect could lead to an audible and visual alarm, and if this alarm is engaged, the ventilator becomes inoperable.
This is a Class I recall affecting 187 units that were distributed nationwide in the United States. The affected units can be identified by serial numbers in association with UDI/DI code 00887761978201.
If you own or use an affected Life 2000 Ventilation System, contact Baxter Healthcare Corporation or your healthcare provider immediately for guidance. Do not use a unit if the alarm has engaged or if you believe your unit may be affected.
The recalled product
- Product
- Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- ventilator-malfunction
- battery-charger-defect
- alarm-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI/DI 00887761978201
- Serial Numbers: 124080000663
- 124020000164
- 124020000165
- 124020000166
- 124020000167
- 124020000168
- 124020000169
- 124020000170
- 124020000171
- 124020000172
- 124020000173
- 124020000174
- 124020000175
- 124020000176
- 124080000659
- 124080000661
- 124080000662
- 124080000666
- 124080000667
Distribution
Distributed nationwide across the United States.
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