GAMBRO Healthcare of Lakewood, Colo., said Monday that it was recalling three lots containing 9,000 to 15,000 cartridge sets after dozens of patients became sick in Nebraska, Massachusetts, and Maryland.
Dr. William Law of Bon Secours Baltimore Health Systems told CBS News Correspondent Jeffrey Kofman that he was relieved that it is now safe for patients to return to dialysis. He said, "That's the key: Find the cause and move ahead with safe care for patients."
Dr. Tom Safranek, state epidemiologist in Nebraska, said tests of the GAMBRO equipment showed a block where the plastic tubing joins a cartridge - a block that could damage the blood and lead to hemolysis. The sets send blood from the body through a dialysis machine, then back into the body.
They went to 31 dialysis clinics, but the company didn't provide locations. Spokesman Bruce Winsor said GAMBRO did not want to release the information until it had a complete list.
Safranek said he didn't know what other states were involved besides Nebraska, Massachusetts, and Maryland, though he said federal investigators were checking possible links to illnesses in Kentucky and Indiana.
About 20,000 Americans rely on dialysis to remove waste products from their body because their kidneys don't work, mainly because of diabetes, hypertension, or another condition.
The problem first surfaced two weeks ago at a dialysis center in Lincoln, Neb., where 16 patients became ill. Outbreaks also were reported in Baltimore (11 ill and 2 dead); Burlington, Mass. (5 cases); and Indiana (one case).
The defect was discovered Friday night by Nebraska health officials and GAMBRO.
The Lincoln center said GAMBRO officials acknowledged finding an obstruction made by a manufacturing mold at a plant in Mexico. Center officials said the company was working to correct the defect.
Over the Memorial Day weekend, doctors worked with investigators from the Centers for Disease Control and Prevention and the Food and Drug Administration to identify and correct the problem, Kofman reports,
The 33 patients who became ill are all recovering.