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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
- Affected units
- 187
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.
Part of a larger recall action
This product is one of 4 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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