Baxter Withdraws Colleague and Syndeo Pumps from U.S. Market
The U.S. Food and Drug Administration (FDA) today announced that Baxter Healthcare Corp. and two of its top corporate executives have signed a consent decree of condemnation and permanent injunction for certain infusion pumps made by the firm. They agreed to stop manufacturing and distributing all models of the Colleague Volumetric Infusion Pump and the Syndeo Patient Controlled Analgesic Syringe Pump in the U.S. until they correct manufacturing deficiencies and until the devices are made in compliance with FDA’s current good manufacturing practice (CGMP) requirements and the Quality System (QS) regulation for devices. Under the consent decree, FDA will allow the firm to continue to provide routine service maintenance, or to replace components, parts, or accessories for the Colleague and Syndeo Infusion Pumps that were already in the hands of customers before October 12, 2005.
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