Dozens of Patients Given Nonsterile Simulated Saline FDA SaysJan 19, 2015
More than 40 patients received infusions of simulated saline that were not sterile or intended for human use, the U.S. Food and Drug Administration (FDA) said. The simulated saline IV bags were manufactured by Wallcur LLC, according to Law360. Some patients who received intravenous infusions of the product required hospitalization and one patient died.
The FDA said it was uncertain whether the death was a direct result of using the non-sterile simulated saline. Patients who received the products generally experienced fever, chills, tremors and headaches.
The agency stated that the bags are intended for training, simulation and education; they are not sterile and should not be used in humans or animals. "Clinicians and 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 stated.
The FDA said it was investigating the product on Dec. 30 following reports of adverse events associated with them in Florida, Georgia, Idaho, Louisiana, North Carolina, New York and Colorado. Medical clinics, surgical centers and urgent care facilities in these states received the simulated saline solution bags.
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 on Jan. 7. The San Diego-based company said that despite being "for clinical simulation" only, the products were administered to patients. Customers should isolate the products and return them, Wallcur said in its recall letter. Labels were also given to more easily distinguish the bags, and the company said it intended to add similar labels before distributing in the future.
Wallcur began distributing the non-sterile simulated IV bags last May. Patients who received the product almost immediately experienced adverse effects such as fever and headache. The FDA said that in most cases, these symptoms were recognized and treated promptly.