Class I designations, the FDA’s most severe, are used when there is a reasonable probability that product use could cause serious adverse health consequences of death.
The West Whiteland Township, Penn.-based company’s Vial2Bag fluid transfer systems are designed to connect a vial containing medication to an intravenous therapy bag to aid in mixing the medication with the IV fluids, according to an FDA release.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.