3B Medical, Inc. is recalling two React Health PHOENIX 5L Oxygen Concentrators because they were inadvertently distributed despite failing to meet internal quality specifications. These devices provide supplemental oxygen to patients, and units that do not meet quality standards may fail to deliver the necessary oxygen therapy. No injuries or incidents have been reported, and the affected units were distributed in New York.
The devices may not perform according to their required specifications, which could lead to a failure in providing sufficient oxygen therapy to the user.
Devices did not meet internal quality specifications.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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