Baxter Healthcare Corp., a medical device manufacturer, has recalled its Colleague triple-channel infusion intravenous fluid pumps as a result of 16 serious injuries. This is a “Class I Recall,” the most serious recall classification in which, according to the FDA, “there is a reasonable chance that the product will cause serious health problems or death.”
The recall concerns 4,500 Colleague-brand, triple-channel pumps that were distributed between May 14, 2007 and June 20, 2007. The intravenous fluid pumps can deliver three different intravenous drugs or fluids to patients, however, in certain instances, the pumps may stop delivery of all three fluids.
Baxter began receiving word about pump malfunction at the end of June. The pumps have been removed from use, according to the company.
For more information about this recall visit the FDA Safety Alert.
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