Colleague in a class by itself
This article was originally published in The Gray Sheet
Executive Summary
FDA Feb. 2 applies a Class I designation to an "urgent device correction" letter Baxter sent to Colleague infusion pump customers in December - the fourth Class I recall involving Colleague in 2005. The letter highlighted the potential for battery undercharging and false air detection alarms that Baxter uncovered while investigating previously announced problems. As part of its effort to bring the product back to market, the firm submitted a 510(k) in December for modifications related to problems cited in all four recalls (1"The Gray Sheet" Jan. 30, 2005, p. 17)...
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