The FDA is spotlighting a new medical device correction effort at Baxter over its large-volume Novum IQ infusion pump, following reports of 79 serious injuries and two deaths linked to potential under ...

As predicted, not long after Baxter International issued an urgent safety communication about an issue with some of its Spectrum infusion pumps, it has been upgraded to a full-blown recall complete ...

Two people have died and 79 others have been seriously injured in potential association with a safety issue involving Baxter's Novum IQ large-volume infusion pumps. FDA said it is aware that Deerfield ...

The Syndeo pump could be reintroduced after Baxter fixes its design problems. CDRH has historically been suspicious about the reliability of infusion pumps. Incidents with two pump makers in 2006 have ...

Baxter International issued an urgent device correction Oct. 29 related to all of its Spectrum infusion pumps. The devicemaker said that deviations from specific cleaning methods may impair the pumps’ ...

Baxter recalled over 277,000 infusion pumps due to the risk of the device failing to alarm users of repeated upstream occlusion events. The SIGMA Spectrum Infusion Pump with Master Drug Library ...

DEERFIELD, Ill.--(BUSINESS WIRE)--Baxter International Inc. (NYSE: BAX), a leader in innovative technology for medication delivery, today announced the launch of DeviceVue, a comprehensive asset ...

After a drawn-out approval process, medical equipment company Baxter International received regulatory clearance for a new infusion pump machine that is expected to help the company capture more of ...

CHICAGO, July 13 (Reuters) - The U.S. Food and Drug Administration ordered Baxter International Inc to recall all of its Colleague infusion pumps in use and provide a refund or no-cost replacement to ...

Baxter International Inc. Thursday settled U.S. Justice Department allegations that two of its popular medication delivery pumps were flawed and violated federal law. In a 30-page agreement approved ...

Baxter International (NYSE:BAX) has issued an urgent medical device correction for software installed on certain Spectrum infusion pumps over concerns that they may be emitting false alarms that could ...