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Drug & Device News

By ALM Staff | Law Journal Newsletters |

U.S. Marshals Seize Infusion Pumps At FDA's Request

At the request of the FDA, the U.S. District Court for the Northern District of Illinois issued a warrant on Oct. 12 for seizure of three types of infusion pumps manufactured by Baxter Healthcare Corp. Infusion pumps are electronic devices intended to control delivery of solutions and medications to patients. Pump shutdown could result in serious injuries or death to critically ill patients who depend on continuous infusion medications and/or life-sustaining medications. FDA inspections revealed that the firm had continually failed to follow medical device manufacturing requirements. The FDA alleges that none of the seized infusion pumps were manufactured under the proper controls and that the Colleague pumps have a design defect that may cause the pumps to stop and shut down during infusion therapy. The agency also says Baxter failed to inform it of some of the infusion pump failures.

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