Life2000 Ventilation System battery charger defect causes device inoperability
Baxter Healthcare is recalling the Life2000 Ventilation System due to a battery charger defect that can trigger an alarm, rendering the ventilator inoperable and unable to support patients' breathing.
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 a FDA Class I recall of a life-support medical device. The battery charger defect renders the ventilator inoperable, creating a direct threat to patients dependent on the device for breathing support. FDA Class I classification designates Critical severity.
Plain-English summary
Baxter Healthcare Corporation is recalling the Life2000 Ventilation System (Reference BT-20-0002AP), a ventilator distributed nationwide in the United States for providing breathing support to patients.
The ventilator has a defect in the battery charger that can cause an audible and visual alarm to activate. When the alarm is triggered, the ventilator becomes inoperable and cannot provide breathing support.
This is a Class I recall by the FDA, indicating a serious health hazard to patients dependent on the device. Affected units have serial number 122010001081 and UDI/DI codes 00887761978089 or 00815410020537.
Patients using the Life2000 Ventilation System should contact Baxter Healthcare Corporation or their healthcare provider immediately to verify if their device is affected and to discuss alternative breathing support options.
The recalled product
- Product
- Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Ventilator
- Affected units
- 1
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 (2)
- UDI/DI 00887761978089 or 00815410020537
- Serial Numbers: 122010001081
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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