Tuesday, June 29, 2010
FDA Warns Baxter On Failures To Properly Report, Investigate Dialysis Device Problems By Jennifer Corbett Dooren
Dow Jones Newswires
The Food and Drug Administration warned a unit of Baxter International (BAX: 41.55, -0.62, -1.47%) about failures to properly report and investigate problems with some of the firm's HomeChoice dialysis devices.
The letter, dated June 3, stemmed from an inspection of Baxter Healthcare's Renal Division that was conducted between Nov. 17, 2009, and Dec. 14, 2009. The warning letter was posted to the FDA's website Tuesday.
In January the company announced a recall of its HomeChoice dialysis systems after receiving reports of serious injuries and at least one death with increased intraperitoneal volume, or overflow of the abdominal cavity.
The company didn't immediately respond to a request for comment.
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