United States Marshals Seize Violative Infusion Pumps Made by Baxter Healthcare Corporation

The US District Court for the Northern District of Illinois, at the instance of the FDA, has issued a warrant for seizure of three types of infusion pumps manufactured by Baxter Healthcare Corporation.

Previous FDA inspections revealed that the firm failed to follow medical device manufacturing requirements. FDA alleges that none of the seized infusion pumps were manufactured under the proper controls and the Colleague pumps have a design defect that many cause the pumps to stop and shut down during infusion therapy. FDA had issued Warning letters to Baxter and had given the company an opportunity to correct the violations. However, Baxter failed to take appropriate actions and instead notified the public of the potential heath hazards associated with these products.

The seized products are: SYNDEO PCA Syringe Pumps, Colleague Volumetric Infusion Pumps, and Colleague CX Volumetric Infusion Pumps. Four thousand SYNDEO and Colleague infusion pumps were seized by the US Marshals from a Baxter warehouse, though no products were seized from healthcare facilities or individual users. Health care facilities can continue to use these pumps, with the aid of instructions that Baxter provided previously, but should be aware of the potential problems, especially in when the pump is being used in a life-saving function.

For details on this story, please visit the following link: http://www.fda.gov/bbs/topics/news/2005/new01242.html

If any questions on the report or comments please email us at info@mdiconsultants.com.

Internet Presence, Creation, Design & Maintenance by: Windco.com, Inc