FDA and the Centers for Disease Control and Prevention (CDC) are continuing to investigate multiple instances of Wallcur’s simulated intravenous (IV) saline products being administered to patients. These products are not sterile and should not be injected in humans or animals.
Wallcur’s simulated IV saline solution, Practi-0.9% sodium chloride solution, was shipped to medical clinics, surgical centers, and urgent care facilities in numerous states.
So far, more than 40 patients have received infusions of the simulated saline products, and there have been many adverse events associated with these incidents including fever, chills, tremors and headache. Some patients were hospitalized, and there is one death associated with the use of these products; it is not known if this death is directly related to the use of the product. Adverse events have been reported in seven states: Florida, Georgia, Idaho, Louisiana, North Carolina, New York, and Colorado.
FDA, in partnership with CDC, has collected samples of Wallcur Practi 0.9% Sodium Chloride from clinics and distributors. These products are being tested to learn if the products may have caused the adverse events in patients.
Wallcur initiated a voluntary recall of Practi-0.9% sodium chloride IV solutions. Most medical facilities reported that they were unaware that the IV solution bags were simulation products. At least one clinic recognized the Wallcur product was a simulation product upon receipt, and returned it to the distributor.
FDA is working with distributors who sold the simulated IV products and clinics that purchased and administered the simulated IV products from Wallcur to determine how these simulation IV solution products entered the supply chain and subsequently were administered to patients.
The FDA recommends that 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.
- Visually inspect all current IV saline solution bags. Ensure none of the bags are labeled “Wallcur,” “Practi-products,” “For clinical simulation,” or “Not for use in human or animal patients.”
- If you have products labeled with any of these words, or you suspect you may have received other products intended for training purposes, separate simulation products from existing inventory and contact your distributor for directions on how to return these products.
- If you have received Wallcur Practi-products by mistake, please contact the distributor, or Wallcur, LLC of San Diego for return instructions.
- Consider reviewing your office procedures and make sure there are procedures in place to visually inspect all future shipments of normal saline products to ensure they are for clinical use.