FDA to host stakeholder call tomorrow on recall of simulated IV solution
The Food and Drug Administration will discuss the recent recall of simulated sodium chloride intravenous solutions by Wallcur LLC during a stakeholder call tomorrow at 12 p.m. ET. Speakers will include officials from the FDA and Centers for Disease Control and Prevention. To access the call, dial (888) 282-8356; passcode “FDA.” A replay of the briefing will be available one hour after the call ends until Feb. 16 by dialing 866-515-1602. On Dec. 30, as reported in an AHA Newsflash, FDA alerted health care professionals not to use Wallcur simulated IV products in human or animal patients after learning that some of the products had been distributed to medical clinics, surgical centers and urgent care facilities and administered to patients. The products, which may bear the words “for clinical simulation,” are for training purposes only. According to an FDA update yesterday, more than 40 patients have received infusions of the simulated products and adverse events have been reported in seven states: Florida, Georgia, Idaho, Louisiana, North Carolina, New York and Colorado. For more information, including recommendations to ensure IV solution simulation products are removed from office inventory, see the FDA update.