The U.S. Food and Drug Administration (FDA) said last week that more than 40 patients had received intravenous simulated saline that was not sterile and was not intended for human use.
Some patients were hospitalized and at least one death has been linked to use of the product, made by Wallcur LLC, Law360 reports. Wallcur began shipping the simulated saline IV bags in May 2014, the company said. Patients who received the simulated IV saline almost immediately experienced symptoms such as fever and headache, which were recognized and treated promptly in most cases, according to the FDA.The simulated saline IV bags, intended for use only in training, simulation and education, are not sterile and should not be used in humans or animals, according to the FDA. “Clinicians and office staff are encouraged to take steps to ensure IV solution simulation products are removed from office inventory to eliminate the possible injection of Wallcur simulated products into patients,” the FDA said.
In December, the FDA began investigating the use simulated saline solution bags after reports of adverse reactions in Florida, Georgia, Idaho, Louisiana, North Carolina, New York and Colorado, Law360 reports. The solution was sent to medical clinics, surgical centers and urgent care facilities in the states. On January 7, Wallcur recalled all four sizes of its Practi-0.9% sodium chloride IV bags and its Practi-0.9% sodium chloride 100 ml IV solution bag with sterile distilled water, saying that the bags had been administered to patients even though they were intended “for clinical simulation” only.
In its recall letter, Wallcur advised consumers to isolate the simulated saline products and return them to the company. The company provided labels for the IV bags to make them easier to identify and said it planned to add similar labels to the bags before distributing them in future.
The FDA and the Centers for Disease Control and Prevention (CDC) are continuing to investigate the use of the Wallcur products, according to Law360.