Unsterile IV Saline Accidentally Given to Over 40 Patients

By Kristin J. Kelley

Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS

The FDA reported on Wednesday that more than 40 patients have received simulated intravenous saline solutions (Practi-0.9% sodium chloride) manufactured by Wallcur and intended for training purposes only. Some patients have been hospitalized and one has died, although the agency can't confirm whether the fatality was directly related to use of the product.

The unsterile, simulated solutions were first shipped to healthcare facilities in multiple states in May 2014. Healthcare providers should monitor patients who've been potentially exposed, and report suspected cases to their state health department and the FDA's MedWatch program. Adverse reactions reported include chills, fever, headache, and tremors.

In a Jan. 7 press release, Wallcur asks distributors to quarantine the saline products and prominently display cautionary language on marketing materials (e.g., "THIS PRODUCT IS FOR TRAINING PURPOSES ONLY. NOT FOR HUMAN OR ANIMAL INJECTION."). The manufacturer plans to use similar language on future IV bags before distributing them.