The FDA issued updates on recalls of Datascope/Getinge’s Cardiosave Hybrid and Rescue intra-aortic balloon pumps (IABP) and certain Emergent reactive skin decontamination lotion (RSDL) kits, declaring them to be Class 1 recalls because of the “reasonable probability” that use of the devices could cause serious harm or death.
To View This Article:
Subscribe To Device Daily Bulletin Premium
Device Daily Bulletin Premium Subscription
Upgrade to Device Daily Bulletin Premium to get all the articles in the free publication PLUS more in-depth stories on regulatory and industry developments, FDA inspection and enforcement activities and analysis of market trends. It makes sense of everything successful devicemakers must know and do, delivering the news, analysis and interpretation of industry changes you need to stay compliant and thrive. And it’s combined with timely content from FDAnews management reports and webinars. Learn more