Bacteria Levels Prompt Class I Recall of Fresenius Dialysis Product

Bacteria Levels Prompt Class I Recall of Fresenius Dialysis Product

Posted By The Maher Law Firm || 17-Jun-2014

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The U.S. Food and Drug Administration (FDA) announced May 28 that Fresenius Medical Care North America's voluntary recall of 58 lots of NaturaLyte Liquid Bicarbonate Concentrate 6.4-liter bottles has been classified as a Class I recall due to concerns of potential bacterial contamination.

According to the FDA, a Class I recall is "the most serious type of recall" and reserved for situations in which there is a "reasonable probability" that the recalled product "will cause serious adverse health consequences or death."

In a May 21 press release, Fresenius said it had issued a recall of the NaturaLyte bottles "because they may develop higher bacteria levels than is allowed by the company's internal specifications during their shelf life."

According to the FDA, the agency has received one report of death and two reports of injury "that may be related" to use of the NaturaLyte products.

Fresenius reports that the affected lots were produced at its facility in Montreal, Canada. The lots were manufactured between August 2013 and April 2014 and distributed from August 15, 2013 to April 7, 2014, the FDA states.

Fresenius recalled 49 lots on April 10, 2014 and added nine more lots to the recall on May 1, 2014. The recall initiation date is listed by the FDA as April 4, 2014.

This recall should not be confused with the March 2012 Class I recall of GranuFlo Dry Acid Concentrate and NaturaLyte Liquid Acid Concentrate dialysis products.

Lab Testing Reveals Bacteria

NaturaLyte Liquid Bicarbonate Concentrate is used in the treatment of acute and chronic renal failure during hemodialysis.

It is one of many dialysis products manufactured and distributed across North America by Fresenius Medical Care North America. The company also operates thousands of dialysis clinics in the U.S., including several located in Florida.

The FDA reports that lab testing identified the bacteria at the heart of this recall as being Halomonas (species 1, 2, 3), or a gram negative bacteria typically found in water with a high salt concentration.

The Centers for Disease Control and Prevention describes gram negative bacteria as being "resistant to multiple drugs' and "increasingly resistant to most available antibiotics."

The FDA states that use of a contaminated product could cause sepsis, bacteremia (bacteria entering the bloodstream) and death.

As part of the recall, the FDA has urged customers to examine their stock to determine whether it contains a recalled product, immediately discontinue use, segregate the products in a secure area and perform a "Heat Disinfect" program if the product was placed on a machine prior to patient treatment. Fresenius has asked for the products to be returned.

Drug Recalls Remain an Ongoing Concern

A study published in 2012 in the Archives of Internal Medicine found that drug recalls happen at a rate of about one per month in the U.S.

The study by researchers from Brigham and Women's Hospital in Boston suggested that, even once a recall is issued, the process in place for notifying health care providers of dangerous drugs may not be enough to ensure patient safety, ABC News reported.

If you or a loved one believes they have been treated with a recalled and potentially dangerous drug, it is important to immediately seek medical advice from your doctor as well as legal advice from an attorney with experience in handling defective product cases. The attorney can help you to understand your legal rights and take steps to make sure those rights are protected.

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