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FDA Warns Against Use of Simulated IV Solutions From Wallcur

Patients are being injected with nonsterile products

The 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, the agency says.

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 one death is associated with the use of these products; it is not known whether this death is directly related to the product.

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. While there has been a shortage of sodium chloride 0.9% Injection (IV normal saline), the FDA has been working with manufacturers to increase the supply. In addition, the agency is not objecting to the temporary distribution of additional IV normal saline from alternate sources, such as Fresenius Kabi USA, Baxter Healthcare Corp., and B. Braun Medical Inc. Currently, a supply is available from several manufacturers, as posted on the FDA’s website.

The agency encourages clinicians and office staff to take steps to ensure that simulated IV solution products are removed from the office inventory to eliminate the possible injection of Wallcur’s simulated products into patients.

Health care providers should visually inspect all current IV saline solution bags and ensure that none of these bags is labeled “Wallcur,” “Practi-products,” “For clinical simulation,” or “Not for use in human or animal patients.” If providers have products labeled with any of these words, or if they suspect that they may have received other products intended for training purposes, they should separate simulation products from existing inventory and contact their distributors for directions on how to return these products.

If providers have received Wallcur Practi-products by mistake, they should contact the distributor or Wallcur, LLC of San Diego, California, for return instructions.

Providers should also consider reviewing their office procedures and make sure that procedures are in place to visually inspect all future shipments of normal saline products to ensure that they are for clinical use.

On January 7, Wallcur recalled Practi-0.9 sodium chloride IV bags supplied in 50-mL, 250-mL, 500-mL, and 1,000-mL sizes and the Practi-0.9‰ sodium chloride 100-mL IV solution bag with sterile distilled water. All of Wallcur’s products are intended for training, simulation, and educational purposes only. They began shipping the simulated IV products on May 22, 2014.

Sources: FDA; January 14, 2015; and FDA; January 7, 2015.

 

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