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IV Solution from San Diego Company Sickened Patients

As product liability lawyers, we are extremely concerned by reports that an intravenous solution made by a San Diego company has sickened 17 patients and potentially killed one. According to the U.S. Food and Drug Administration (FDA), the IV solution is intended for training purposes, but somehow ended up being used to treat patients at more than 22 healthcare facilities across the country.

The FDA has issued a recall for Wallcur LLC’s Practi-0.9‰ sodium chloride IV bags supplied in 50 mL bags. As described in the FDA notice, the products are intended for training, simulation, and educational purposes only. Accordingly, the IV solution is not intended for human or animal administration and is not sterile.

The FDA reports that more than 40 patients have erroneously received infusions of the simulated saline products, which has resulted in adverse events such as fever, chills, tremors, and headache. Some patients were hospitalized, and there is one death linked to the IV solution; however, the FDA emphasized that it is not yet known if this death is directly related to the use of the product.

The FDA is still investigating how the training solution entered the supply chain. In the meantime, the agency is warning healthcare professionals and patients to inspect all IV bags to verify that the bag is not labeled or printed with any of the following: “Wallcur,” “Practi-products,” “For clinical simulation” or “Not for use in human or animal patients.”

In the wake of the patient harm, Wallcur is also working with the FDA to include additional warnings on its products that state: “THIS PRODUCT IS FOR TRAINING PURPOSES ONLY. NOT FOR HUMAN OR ANIMAL INJECTION.”