FDA Hits Baxter With Two Warning Letters In Four Weeks
This article was originally published in The Gray Sheet
Executive Summary
The warning letters cite quality system regulation violations related to the firm’s infusion pumps, including inadequate corrective and preventive actions related to complaints of over-infusion and device bladder ruptures.
You may also be interested in...
News Briefs: SGR Reform Bill Progress; CareFusion To Invest In Infusion Pump Firm
House and Senate committees approve long-term physician payment reform bills. CareFusion announces it will invest $100 million in infusion pump maker Caesarea Medical Electronics. More news.
ECRI Highlights Tech Hazards: Alarm Issues, Infusion Pumps Top Its 2014 List
Alarm hazards, infusion pump medication errors and CT radiation exposures in pediatric patients lead ECRI Institute’s 2014 list of the top 10 health technology hazards. Risks from networked devices and robotic surgery also made the list.
News In Brief
Edwards Lifesciences buys BMEYE for $42 mil. Sapien valve sales in Q3 fall below firm’s expectations. Hospira draws FDA warning letter. More news briefs.