CAIRE FreeStyle Comfort Portable Oxygen Concentrator Battery Charging Failure
CAIRE FreeStyle Comfort portable oxygen concentrators may fail to recharge their batteries, potentially leaving patients without access to supplemental oxygen. Twenty-three units have been recalled.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a life-sustaining medical device with no reported injuries or illnesses. The potential for battery charging failure creates risk of harm to patients dependent on supplemental oxygen, but injury has not yet been reported, meeting the rubric criterion for High severity.
Plain-English summary
Caire, Inc. is recalling 23 CAIRE FreeStyle Comfort portable oxygen concentrators (model AS200-101) due to potential failure of affected units to recharge their batteries. If the battery fails to recharge, the device may become unusable for patients who depend on it for supplemental oxygen.
The affected units have been distributed worldwide, including throughout the United States, Puerto Rico, Israel, and Peru. Patients and healthcare providers who have received these devices should verify their device serial numbers against the FDA's recall notice.
If you have one of the affected units, contact Caire, Inc. immediately or report any adverse events to the FDA. Do not rely on the device if battery charging is not working properly.
The recalled product
- Product
- CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.
- Manufacturer
- Caire, Inc.
- Hazard
- charging-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: M766AS2001010
- Serial numbers: CBB5224380888
- CBB5224380868
- CBB5224380846
- CBB5224380842
- CBB5224380298
- CBB5224380295
- CBB5224380282
- CBB5224380251
- CBB5224380011
- CBB5224380010
- CBB5224370651
- CBB5224370598
- CBB5224370445
- CBB5224370431
- CBB5224370420
- CBB5224370230
- CBB5224370227
- CBB5224370191
- CBB5224370185
Distribution
Distributed nationwide across the United States.
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