Fresenius Medical Care previously sent a warning memo regarding the dangers of Granuflo and Naturalyte to its company-owned dialysis centers, reports say. However, the company allegedly neglected to send the said memo to other dialysis facilities that are using its products. As a result, the U.S. Food and Drug Administration (FDA) initiated an investigation on the manufacturing company which, in turn, triggered the Class I recall of Granuflo and Naturalyte. In the aftermath of the product recall, numerous Naturalyte and Granuflo lawsuits were filed against Fresenius.
The above mentioned urgent memorandum had been sent by Fresenius in November 2011. It alerted medical practitioners at Fresenius' dialysis centers about the then-discovered dangers of the dialysates. The memo stated that Granuflo and Naturalyte may potentially raise bicarbonate levels in the bloodstream of dialysis patients to dangerous heights. According to the memo, the dosage must be adjusted in order to lower the risk of bicarbonate overdose. Bicarbonate overdose may lead to heart-related complications including heart attack, arrhythmia, stroke, and heart failure.
Unfortunately, physicians who were not informed about the memorandum continued to administer the wrong dosage. As a result, thousands of patients may be at risk of overdosing in sodium bicarbonate. In fact, reports say that 941 dialysis patients had died in 2010 due to complications associated with high levels of bicarbonate.
Despite the urgency of the problem, Fresenius Medical Care allegedly sent the urgent memo to its dialysis centers only. It purportedly failed to inform hundreds of other dialysis clinics and medical centers that also utilize Granuflo and Naturalyte. Thus, patients undergoing dialysis in these clinics were left exposed to the risk of Granuflo and Naturalyte complications for a few months.
Online media reports further reveal that four months after the internal memo was distributed to the dialysis centers of Fresenius, the FDA received a copy of the memo from an anonymous person. Afterward, the agency questioned Fresenius Medical Care regarding the issue. According to the head of compliance for the FDA's medical device division, Steven Silverman, the company's failure to immediately inform all of its customer base regarding this grave issue is a cause for concern.
Fresenius Medical Care was forced to issue a warning to other dialysis centers after being ordered by the FDA. In the end, however, the FDA issued a Class I recall of the dialysis products. Apparently, the dialysis products are too dangerous to be on the market.
After the public found out about the Granuflo recall and the reasons behind it, numerous injured dialysis patients filed a lawsuit against Fresenius Medical Care. Information and updates on these lawsuits involving Granuflo and Naturalyte may be found on the websites of personal injury law firms, including the Rottenstein Law Group's http://www.rotlaw.com.
The above mentioned urgent memorandum had been sent by Fresenius in November 2011. It alerted medical practitioners at Fresenius' dialysis centers about the then-discovered dangers of the dialysates. The memo stated that Granuflo and Naturalyte may potentially raise bicarbonate levels in the bloodstream of dialysis patients to dangerous heights. According to the memo, the dosage must be adjusted in order to lower the risk of bicarbonate overdose. Bicarbonate overdose may lead to heart-related complications including heart attack, arrhythmia, stroke, and heart failure.
Unfortunately, physicians who were not informed about the memorandum continued to administer the wrong dosage. As a result, thousands of patients may be at risk of overdosing in sodium bicarbonate. In fact, reports say that 941 dialysis patients had died in 2010 due to complications associated with high levels of bicarbonate.
Despite the urgency of the problem, Fresenius Medical Care allegedly sent the urgent memo to its dialysis centers only. It purportedly failed to inform hundreds of other dialysis clinics and medical centers that also utilize Granuflo and Naturalyte. Thus, patients undergoing dialysis in these clinics were left exposed to the risk of Granuflo and Naturalyte complications for a few months.
Online media reports further reveal that four months after the internal memo was distributed to the dialysis centers of Fresenius, the FDA received a copy of the memo from an anonymous person. Afterward, the agency questioned Fresenius Medical Care regarding the issue. According to the head of compliance for the FDA's medical device division, Steven Silverman, the company's failure to immediately inform all of its customer base regarding this grave issue is a cause for concern.
Fresenius Medical Care was forced to issue a warning to other dialysis centers after being ordered by the FDA. In the end, however, the FDA issued a Class I recall of the dialysis products. Apparently, the dialysis products are too dangerous to be on the market.
After the public found out about the Granuflo recall and the reasons behind it, numerous injured dialysis patients filed a lawsuit against Fresenius Medical Care. Information and updates on these lawsuits involving Granuflo and Naturalyte may be found on the websites of personal injury law firms, including the Rottenstein Law Group's http://www.rotlaw.com.
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