Skip directly to search Skip directly to A to Z list Skip directly to navigation Skip directly to page options Skip directly to site content

COCA Clinical Reminder: February 3, 2015

UPDATE: FDA’s Investigation into Patients being Injected with Simulated IV Fluids Continues


The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are continuing to investigate multiple instances of Wallcur simulated saline solution being administered to patients. To date, we are aware of more than 40 patients who have received infusions of the simulated saline products. Some of the patients experienced adverse events associated with these products including fever, chills, tremors and headache.

FDA and CDC have taken a number of steps to remove the simulated saline products from medical settings, to raise awareness among health care providers, and to provide information to state and local health officials in order to prevent exposure to additional patients.

FDA has been working closely with Wallcur to make several changes to their labeling and marketing practices to prevent this from occurring again.

Wallcur has voluntarily:IV bag closeup

  • Recalled all Practi-0.9% sodium chloride IV bags supplied in 50 mL, 100 mL, 250 mL, 500 mL, and 1000 mL sizes
  • Notified all customers and distributors who received recalled products
  • Added stickers to existing packaging and labeling of Practi-0.9% sodium chloride IV bags to explicitly warn users that the simulated products are not intended for human or animal use and are for training purposes only
  • Continued discussions with FDA concerning labeling recommendations for all simulation products

FDA is reiterating its previous recommendations that ask health care professionals and consumers to do the following:

  • Be vigilant and report any suspected adverse events following use of these products to FDA’s MedWatch program online or at 1-800-332-1088
  • Visually inspect all current IV saline solution bags. Ensure none of the bags are labeled “Wallcur,” “Practi-0.9% saline,” or “For clinical training purposes only”
  • Consider reviewing clinic procedures and make sure there are procedures in place to visually inspect all future shipments of IV products to ensure they are appropriate for clinical use

View the full FDA update.

The CDC and HHS logos are the exclusive property of the Department of Health and Human Services and may not be used for any purpose without prior express written permission. Use of trade names and commercial sources is for identification only and does not imply endorsement by the US Department of Health and Human Services.

Links to non-Federal organizations are provided solely as a service to our users. Links do not constitute an endorsement of any organization by CDC or the Federal Government, and none should be inferred. The CDC is not responsible for the content of the individual organizations.