The FDA has recently come under fire from a consumer watchdog group. Public Citizen expressed anger at the FDA for its delay in evaluating the latest problems with Baxter International’s infusion pumps. The pumps are used to deliver intravenous fluids and medicine to patients. Baxter sent a letter to customers in January, warning that its Colleague Infusion pumps could shutdown and overheat. Such problems are potentially fatal. Over six weeks after Baxter issued the warning letter, the FDA classified the announcement as a Class I recall, the agency’s most severe warning. Though it is a serious warning, the Class I recall is not the same as a mandatory device recall, and therefore the Baxter pumps are not being pulled from the market.
According to Public Citizen, Baxter’s Colleague pumps have been linked to 19 deaths, and have been the subject of seven FDA Class I recalls since 2005. Baxter claims that it stopped selling the pumps in the U.S. in 2005, but that 200,000 of the devices are still in use.