Worldwide Recall of Hemodialysis Machines




Worldwide Recall of Hemodialysis Machines

The US Food and Drug Administration (FDA) has issued a worldwide recall of Baxter Healthcare Corporation’s Meridian Hemodialysis Instrument.  The company, located in Deerfield, Illinois is in compliance with the FDA’s request and has notified its customers around the world about the possible serious risks associated with the Meridian Instrument.

The problems associated with the machines include a kinking of tubing that can occur, causing serious health risks such as hemolysis in patients.  Hemolysis is a rare red blood cell breakdown that can overload the kidney and cause anemia, kidney failure, or several other severe health risks.  The faulty machine has already been directly responsible for one death and one very severe injury.

The machines are the Meridian Instruments that have model numbers 5M5576 and 5M5576R.  More than 2,700 machines are being used in various healthcare facilities worldwide, including about 2,100 in the US.    

Both the FDA and Baxter are working closely to ensure that the recall information is properly distributed to all healthcare workers, hospitals, or any patients who have used the product.  In addition to the reports of the serious side effects, the FDA has also concluded a study in which it finds serious risks associated with the machines.

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