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.
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.”