FDA Issues Recall on Meridian Hemodialysis Unit
One death and at least one serious injury blamed on kinked tubing during hemodialysis
THURSDAY, Dec. 15 (HealthDay News) -- The U.S. Food and Drug Administration issued a Class I Recall Wednesday for the Meridian Hemodialysis Instrument (product codes 5M5576 and 5M5576R), a classification that does not require that the instrument be returned. One death and at least one serious injury has been connected with the kinking of blood tubing when it is routed through both channels of the clips mounted on the front of the machine, according to the federal agency.
In a September 28, 2005 letter, Baxter Healthcare Corporation directed clients to route tubing through only one channel of the two channel clips, and take other precautions to reduce kinking. Kinked tubing can result in hemolysis.
"The clinical implication of returning hemolyzed blood to a patient can range from no adverse health consequences up to and including death," according to a company statement. The company will be issuing new clips to help correct the problem.