Fresenius Medical Care is recalling more than 111,000 hemodialysis machines sold throughout the United States, Canada and Mexico. The recall, which affects specific model numbers from the Fresenius 2008 Series hemodialysis machines, was issued due to complaints of the saline bags inappropriately filling during recirculation and setup.
Dialysis machines are designed to cleanse and filter the blood of patients with kidney disease whose kidneys do not function properly. Nearly 400,000 people in the United States undergo this life-saving treatment every day. Fresenius is the world’s largest provider of dialysis products and services, providing dialysis treatments within its own facilities and related products to non-Fresenius-owned clinics.
Last year, Fresenius issued a recall of two of its dialysis products – GranuFlo and NaturaLyte. The products are used to help balance electrolytes in patients undergoing dialysis treatment. The recall was issued because the instructions listed on the packages were confusing and likely contributed to a spike in cardiovascular events, including sudden cardiac arrest, in dialysis patients being treated with the products.
GranuFlo and NaturaLyte contain an ingredient that the body metabolizes into a substance known as bicarbonate. These products, however, contain more of this ingredient than competitor brands. The products’ instructions did not specifically alert health care professionals of this difference, which could lead to higher levels of bicarbonate in the blood. Elevated bicarbonate can increase the risk of cardiovascular events and death.
Several lawsuits have been filed against Fresenius alleging the company did not adequately warn health care professionals and patients that its products could cause serious health risks. The company, which was since ordered by the FDA to recall and re-label containers of GranuFlo and NaturaLyte, has denied any wrongdoing.
Source: Nephrology News