Fresenius NaturaLyte Recall Because of Bacterial Contamination Expands

Fresenius recall

The NaturaLyte recall that was originally announced in April has been expanded by Fresenius Medical Care North America, the product’s manufacturer.  As of now, 56 lots of NaturaLyte have been recalled by the company.  In response to this news, the FDA has decided to classify the NaturaLyte recall as a Class I recall.  A Class I recall is the most serious classification used by the FDA.  It’s based on the possibility that using a product may cause severe health problems or even death.  Both the initial recall in April and the most recent recall were announced through letters sent to doctors.

NaturaLyte is an extremely popular bicarbonate product that is used in the course of kidney dialysis.  Basically, a patient who needs kidney dialysis undergoes these treatments because his or her kidneys do not properly expel toxins from the body.  Dialysis treatments handle this process for them, and products such as NaturaLyte are used to help clean a patient’s blood and to neutralize acid buildup in it as the blood passes through the dialysis machine.

NaturaLyte is one of two enormously popular kidney dialysis products sold by Fresenius Medical Care.  NaturaLyte is provided in liquid form and its counterpart, GranuFlo, is provided in powder form.  Thousands of people make use of these products every year in the United States.  It’s obviously critically important for these products to be properly manufactured and maintained, as patients are extremely vulnerable to harm in this context.

Why Was NaturaLyte Recalled?

49 lots of NaturaLyte were recalled in April because bacteria known as Halomonas was discovered as present in this liquid.  Halomonas is commonly found in water with heavy concentrations of salt.  It’s possible that bacteria present in a product such as NaturaLyte could lead to serious harm in patients.  Common reactions to bacterial poisoning can include:

  • Fever
  • Flushing
  • Chills
  • Breathing difficulties
  • Low blood pressure
  • High levels of carbon dioxide in the blood
  • Organ failure
  • Heart attack
  • Death

Clearly, this level of danger has prompted Fresenius Medical Care to aggressively recall this product.  In addition, seven more lots of NaturaLyte were recalled in May for the same reason.

The Legal Problems Faced by Fresenius Medical Care

Unfortunately for many people, this is hardly the first problem that Fresenius Medical Care has encountered with GranuFlo or NaturaLyte.  To date, more than 1,500 Fresenius side effects lawsuits have been filed against the company.  Many of these lawsuits claim that patients suffered sudden cardiac arrest after using one of these products during the course of kidney dialysis.  More than 500 of these Fresenius lawsuits that were filed on the federal level have since been consolidated into one large action.

If you or someone you love has suffered because of problems associated with either NaturaLyte or GranuFlo, you need to make sure that you protect your legal rights.  You can do so by contacting the NaturaLyte side effects lawyers at Parilman & Associates to schedule a free initial consultation.  You can feel free to either email the firm or call 800-800-DRUG.