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FDA jumping in for defective product causing harm to consumers

It's a sad fact that Texas and other nationwide manufacturers do not take actions regarding a dangerous product until it has already caused harm to consumers. This is usually in the form of a recall. In some cases, the company will issue a voluntary recall of its defective product, which is effective. When it is not effective, the FDA will sometimes jump in to take matters into its own hands and issue its own recall. It appears that this is what has happened with some portable oxygen systems produced by OxySure.

The impacted OxySure portable oxygen system is Model 615. There was an inspection of one of the company's facilities back in September 2014 that didn't meet FDA standards. It was found that the oxygen flow rate was inadequate, which led to a warning letter being issued from the FDA. In June 2015, the company issued a voluntary recall so that consumers could dispose of any product that was defective. Apparently, these defective oxygen systems have a number of malfunctions, including causing bruising, burns, and exposure to chemicals. 

In September 2015, the FDA performed a follow-up inspection to ensure things were back on track following the recall. Unfortunately, the FDA found that the products still did not meet specifications. These products were also still at user sites and available for customers to use. Therefore, the FDA deemed the company's voluntary recalled as ineffective.

Manufacturers are required by law to comply with federal regulations when it comes to consumer safety. This is to ensure that consumers are kept safe and to avoid unnecessary injury from a dangerous or defective product. When manufacturers fail to perform this duty and it results in consumer injury, manufacturers can be held liable via a product liability lawsuit in Texas civil court.

Source:, "Adverse Events Push FDA to Recall Portable Oxygen Systems", Zachary Brennan, March 29, 2016

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