CAIRE FreeStyle Comfort Oxygen Concentrators Recalled for Battery Charging Failure
Caire recalls 739 FreeStyle Comfort portable oxygen concentrators that may fail to recharge their batteries. The devices were distributed in the US, Puerto Rico, Israel, and Peru.
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: This is an FDA Class II recall of a life-sustaining medical device. While no illnesses or injuries have been reported and the hazard is theoretical, oxygen concentrators are risk-of-harm products where device failure could harm patients dependent on supplemental oxygen.
Plain-English summary
Caire, Inc. is recalling 739 units of the FreeStyle Comfort portable oxygen concentrator (model AS200-1) due to a potential failure of the battery charging system in affected units.
The recalled concentrators were distributed worldwide, including throughout the United States, Puerto Rico, Israel, and Peru. For more information about this recall and instructions on device replacement or repair, users should contact the FDA or Caire, Inc.
The recalled product
- Product
- CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.
- Manufacturer
- Caire, Inc.
- Hazard
- battery-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: M766AS20010
- Serial numbers: CBB5224380296
- CBB5224380292
- CBB5224380285
- CBB5224380284
- CBB5224380283
- CBB5224380281
- CBB5224380279
- CBB5224380278
- CBB5224380277
- CBB5224380276
- CBB5224380273
- CBB5224380271
- CBB5224380270
- CBB5224380268
- CBB5224380267
- CBB5224380266
- CBB5224380264
- CBB5224380263
- CBB5224380262
Distribution
Distributed nationwide across the United States.
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