React Health oxygen concentrators distributed without meeting quality specifications
React Health is recalling two PHOENIX 5L Oxygen Concentrators that did not meet internal quality specifications but were inadvertently distributed.
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 where devices failing internal quality specifications reached patients, a risk of harm with no injuries reported in the source.
Plain-English summary
React Health is recalling the PHOENIX 5L Oxygen Concentrator. The action covers two units, serial numbers MZJ5S713971 and MZJ5S714009.
Devices which did not meet internal quality specifications were inadvertently distributed. The FDA classified the action as Class II.
Distribution was within the United States, in New York. The concentrators are supplied for patient oxygen therapy.
Users and suppliers should identify affected units using the serial numbers above and follow the instructions issued by React Health. Patients should not stop prescribed oxygen therapy without medical advice.
The recalled product
- Product
- React Health PHOENIX 5L Oxygen Concentrator
- Manufacturer
- 3B Medical, Inc.
- Hazard
- quality-escape
- out-of-specification
- oxygen-therapy
- class-ii
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 (4)
- UDI 06934726614439-250623-MZJ5S713971
- Serial Number MZJ5S713971
- UDI 06934726614439-250623-MZJ5S714009
- Serial Number MZJ5S714009
Distribution
Distributed nationwide across the United States.
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