The Food and Drug Administration yesterday issued an update for health care providers treating patients at risk for sudden cardiac arrest using a Zoll LifeVest 4000 wearable cardioverter defibrillator. In January, FDA alerted patients and providers that the device may fail to deliver a life-saving shock if not replaced soon after displaying a particular “call for service” message code. The update provides additional information regarding the manufacturer’s efforts to remedy the potential hazard as well as recommendations for providers.
 

Related News Articles

Headline
Hospitals spend close to $360 million each year to manage drug shortages, according to a study released this week by Vizient Inc.
Headline
The Centers for Disease Control and Prevention this week announced an anticipated shortage of Aplisol, one of two TB skin tests licensed by the Food and Drug…
Headline
A federal court in Texas yesterday ordered Pharm D Solutions to stop producing or distributing compounded drugs intended to be sterile until the company…
Headline
The Food and Drug Administration Friday issued final guidance clarifying how sponsors may show that a proposed biosimilar product is interchangeable with a…
Headline
The House Judiciary Committee yesterday approved by voice vote the Creating and Restoring Equal Access to Equivalent Samples Act (H.R. 965).
Headline
Civica Rx, the not-for-profit generic drug company, officially opened its headquarters last week in Lehi, Utah.