Colleague Pump Status Questionable In ’06 As Baxter Copes With FDA Seizure
This article was originally published in The Gray Sheet
Executive Summary
Baxter is not including any new Colleague infusion pump sales in its 2006 revenue guidance, suggesting a long road ahead in its efforts to repair and replace devices currently on the market
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Baxter’s Colleague Consent Decree Enjoins Sales, Expands Obligations
Baxter signed a consent decree with FDA June 29 forbidding the sale of its widely used but malfunction-prone Colleague intravenous infusion pump until the firm complies with manufacturing quality regulations
Baxter’s Colleague Consent Decree Enjoins Sales, Expands Obligations
Baxter signed a consent decree with FDA June 29 forbidding the sale of its widely used but malfunction-prone Colleague intravenous infusion pump until the firm complies with manufacturing quality regulations
Colleague in a class by itself
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)...