Class I Recall of GranuFlo® and Naturalyte® Dialysis Medications
GranuFlo®, along with Naturalyte®, is a component of dialysis solution used in cleaning a patient’s blood during dialysis treatment. The drug has been linked to a number of harmful side effects and injuries, including stroke, cardiac arrhythmia, and cardiac arrest. Such dangers led to a Class I Recall of the drug in 2012. As the FDA reports, “[c]lass I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
According to a recent report, a Texas woman went to her local hospital to receive dialysis treatment on February 28, 2011. She was administered GranuFlo® and/or Naturalyte®, which serves as the acid concentrates necessary for the treatment. Shortly after the completion of her dialysis, the plaintiff began to display classic symptoms of stroke, including slurred speech, uncontrollable twitching of the right side of her face, and mental confusion. A MRI and CT scan later confirmed that the plaintiff had indeed suffered a stroke, and as a result, she must now receive continuous medical care to help her overcome the difficulties associated with impaired speech and motor skills.
The plaintiff and her husband claim that her stroke was the direct result of the GranuFlo® and/or Naturalyte® used during her dialysis treatment, and that the manufacturer failed to take adequate measures to ensure the safety of its products before distributing them throughout the market.
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