Federal regulators have given medical device maker Baxter International’s recall of its dialysis machines the agency’s most urgent safety warning. The Deerfield, Illinois-based company issued a recall on certain HomeChoice dialysis machines in January after reports of patients overfilling abdominal cavities. The FDA has categorized the action as a Class I recall, its most severe level. The classification applies to problems that can cause “serious adverse health consequences or death.” Baxter says it is still investigating the source of the problems and says it’s working on changes to labeling and software to prevent patient errors. According to the company, the machines can still be used.
Source: Decatur Daily
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