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In Wake of Lawsuits, New Fresenius Dialysis Recall Issued

Fresenius Medical Care, manufacturer of dialysis equipment and products, has announced a class II recall of some of their hemodialysis machines. The Fresenius dialysis recall applies only to machines in the 2008 Series. A previous recall of Fresenius dialysis products in 2012 led to a still-growing number of product liability lawsuits brought by injured patients against the medical device manufacturer.

Fresenius dialysis recall issued late 2013

According to Nephrology News and Issues, Fresenius issued the recall in cooperation with the FDA on November 12, 2013. The class II recall indicates the products may cause temporary harm to patients. The recall was issued after it was discovered some machines in the 2008 Series included saline bags that failed to fill properly during setup and recirculation. The recall was limited to the 2008 Series, which consisted of more than 111,000 machines in the United States and another 3,600 in Canada and Mexico.

Fresenius has asked clinics with the machines to refrain from using them until they have been thoroughly checked by a qualified service technician. The machines have not been taken off the market at this time, and are expected to continue to be used by medical providers once these checks are completed. The recall also applies to 2008 Series machines currently used in home care as well as clinics.

Previous recall issued on Fresenius products

This is not the first Fresenius dialysis recall in recent history. Less than two years ago, the company issued a recall of Granuflo and Naturalyte, two products used during hemodialysis treatment. Both Granufllo and Naturalyte were used to help cleanse the blood of toxins. However, the unique formulation of these dialysates led to bicarbonate overdoses in hundreds of patients, which raised their risk for stroke, heart attack and sudden death.

During 2010, more than 940 reports of heart attacks related to Granuflo and Naturalyte use were received by Fresenius. The company issued an internal memo in November, 2011, warning Fresenius clinics about the risks associated with these products. However, the warning was not forwarded to external clinics using the Fresenius products or to the FDA.

When the FDA received wind of the memo months later, it launched an investigation into the safety of the products, and into whether Fresenius violated any federal laws when they failed to notify other medical providers and the general public about the problems linked to their dialysis products. The FDA followed up by issuing a class I recall on both Granuflo and Naturalyte. A class I recall is reserved for the most serious types of adverse effects that can cause permanent injury or death.

Lawsuit number now growing against Fresenius

Patients that were injured by Granuflo or Naturalyte prior to the recall may now file lawsuits against Fresenius to pursue compensation for injuries, medical expenses and lost wages. Families who have lost a loved one after use of these products may also file a wrongful death lawsuit.

At this time, more than 400 Granuflo lawsuits have been filed against Fresenius nationwide. Plaintiffs in these complaints allege use of Granuflo and Naturalyte during dialysis treatment has led to heart attack, stroke and sudden death. Plaintiffs also claim Fresenius withheld the risks associated with these products when they marketed them to dialysis clinics and for use in the home.

Many Fresenius lawsuits have now been coordinated into multidistrict litigation in U.S. District Court for the District of Massachusetts. Multidistrict litigation is used to streamline early trial proceedings when a growing number of lawsuits feature similar complaints against the same defendant.

This latest recall by Fresenius may not directly impact the current cases pending in the MDL, but it does raise more questions about the credibility and reliability of the medical supply company.

  1. Nephrology News and Issues, Fresenius Clarifies Recall of Hemodialysis Machines,

  2. FDA, Fresenius Medical Care North America, Naturalyte and Granuflo Acid Concentrate,

  3. United States District Court, District of Massachusetts, MDL No. 2428,

  4. FDA, Enforcement Report : Week of January 15, 2014,