Life2000 Ventilator systems recalled due to battery charging failure risk
The Life2000 Ventilator may fail to charge or experience intermittent charging behavior due to damage to the battery charger dongle. This FDA Class I recall affects approximately 2,510 units distributed nationwide.
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: This is an FDA Class I medical device recall for a life-support ventilator with potential charging failure that could prevent the device from operating. FDA Class I classification warrants a Critical severity rating.
Plain-English summary
Baxter Healthcare Corporation is recalling the Life2000 Ventilator and Life2000 Ventilator System (Product Codes MS-01-0118, BT-20-0002, BT-20-0002A, and BT-20-0002AP) due to a battery charging defect.
The ventilator systems may fail to charge or experience intermittent charging behavior due to damage to the battery charger dongle. When the charger dongle is damaged, it prevents the ventilator's internal battery from charging, which could prevent the device from operating properly.
Approximately 2,510 units have been distributed nationwide. Consumers who own or operate affected Life2000 Ventilator systems should immediately discontinue use if charging issues are detected and contact Baxter Healthcare Corporation or their healthcare provider for guidance on replacement or repair options.
The recalled product
- Product
- Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes BT-20-0002, BT-20-0002A and BT-20-0002AP. The Life2000 ventilation system includes the Life2000 ventilator which has its individual label.
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Ventilator
- Affected units
- 2,510
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)
- Life2000 Ventilator: UDI Number: 00887761978089
- Serial Numbers: 123300001188
- 123300001189
- 123300001190
- 123300001191
- 123300001192
- 123300001193
- 123300001194
- 123300001195
- 123300001196
- 123300001197
- 123300001220
- 123300001221
- 123300001222
- 123300001223
- 123300001224
- 123300001225
- 123300001227
- 123300001292
- 123300001293
Distribution
Distributed nationwide across the United States.
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