Fresenius NaturaLyte Bicarbonate Concentrate Recalled

GrauFlo and NaturaLyte Recalled by the FDA

In April, the Food and Drug Administration issued a Class I drug recall for additional Fresenius’s dialysis products after a bacterial infection led to a patient death.

The FDA announced the Class I recall after one reported patient death and two patient injuries related to the Fresenius Dialysis product NaturaLyte Bicarbonate Concentrate. Lab testing revealed that the dialysis product contained Halmonas, a bacteria found in water that has a high salt concentration. The bacterium can cause an infection that leads to sepsis, bacteremia, and death.

At least 26 dialysis centers in Tennessee received the product, according to a Fresenius spokesman.

“We have notified all of our affected customers that the recalled product should be removed and are continuing to work with them to carry out the recall,” Jon Stone said.

After learning about the bacterial infection, the FDA issued a recall covering 49 lots of the Fresenius solution on April 10th, with another 9 lots recalled on May 1st.

Fresenius specializes in dialysis products used to treat many levels of kidney disease and failure. Two of its dialysis powders – GranuFlo and NaturaLyte – face thousands of lawsuits from patients across the US who allege that the powders cause heart problems. The Fresenius products fell under a drug recall in 2012 after patient deaths from heart failure were reported after dialysis treatment.

Personal Injury Caused by Fresenius Products GranuFlo and Naturalyte

Multidistrict litigations are special procedures to handle complex litigation, especially relating to product liability lawsuits. MDLs simplify proceedings when injury and liability cases reach the dozens, even the hundreds.

One of the legal accusations against Fresenius is that the company failed to warn the FDA about health problems related to the dialysis powders. In an internal memo from November 2011, Fresenius warned its own doctors and clinics that GranuFlo and Naturalyte increased the risk of cardiopulmonary arrest, and even cardiac death, in certain patients. Despite this belief, the manufacturer did not forward the memo to the FDA, and began to pull the powders only from their own dialysis clinics. Both GranuFlo and Naturalyte were sold to dialysis clinics not affiliated with Fresenius, and were therefore not warned of potential dangers.

In March of 2012, the FDA recalled both the dialysis powders. The regulatory agency is investigating the manufacturer to determine if they violated federal law.

The Strom Law Firm Accepts Cases Against Fresenius for GranuFlo or Naturalyte Injuries

If you or a loved one has had dialysis with GranuFlo or Naturalyte and have since suffered serious heart problems, or if a loved one has received dialysis treatment with either of these drugs and has died from heart complications, you may be entitled to compensation. Defective drugs can cause serious harm, including wrongful death, and drug manufacturers must be held to a high standard regarding their customers’ health. The attorneys at the Strom Law Firm can help. With over 30 years’ experience combined, our lawyers can help you with personal injury lawsuits, including cases against medical manufacturers such as Fresenius, the manufacturer of GranuFlo and Naturalyte. We offer free, confidential consultations to discuss the facts of your case, so do not hesitate to contact us today. 803.252.4800



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