FDA Announces Recalls of Health Product Due to 'Serious Injuries'
It's always important to stay informed about recalls, because following recall protocols can ensure you keep your family and friends safe. While it can be annoying to find out that a product you rely on has to be tossed out, it's always better to be safe than sorry, so following recall guidance is crucial.
According to the Food and Drug Administration (FDA), "A recall is a method of removing or correcting products that are in violation of laws administered by the FDA." They add that a "recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective."
Now, the FDA has identified a Class I recall of a health product. A Class I recall is the most serious of all recalls, with the FDA describing it as "a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death."
FDA Classifies Most Serious Recall
The FDA has issued a Class I recall of Draeger SafeStar and TwinStar Filters because of a risk of misleading carbon dioxide readings. This is a serious recall, because having the carbon dioxide readings off could result in deadly consequences.
"The use of affected filters may cause serious adverse health consequences, including airway injury, delayed or incorrect treatment, brain injury and death," the FDA states. They add that there were some serious injuries reported because of the slow increase of CO2 curve when using the sampling port of the filter. The good news is that, so far, there have been no reported deaths due to this issue.
"Draeger is recalling these filters due to the risk of misleading capnography (carbon dioxide) readings," the FDA adds, "which could result in health care providers administering unnecessary or harmful treatments based on incorrect waveform interpretations."
So, health care providers and anyone with these devices should stop using them immediately. The FDA adds to contact your Draeger Consumables Representative for information about alternative filters.
Related: FDA Announces Immediate Recall of Popular Sandwiches