FDA: Simulated IV Saline Products Distributed to Healthcare Facilities

FDA: Simulated IV Saline Products Distributed to Healthcare Facilities
FDA: Simulated IV Saline Products Distributed to Healthcare Facilities

The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are continuing to investigate multiple instances of Wallcur simulated intravenous (IV) saline products being administered to patients. These products are not sterile and are intended for training purposes only.

The FDA issued an alert in December 2014 to healthcare professionals after the agency became aware that Wallcur's simulated IV saline solution products had been distributed to healthcare facilities and was administered to patients. Over 40 patients received infusions of the simulated saline products; reported adverse events associated with these incidents include fever, chills, tremors, and headache. Some patients were hospitalized and one death has been associated with use of these products, although it is not known if this death is directly related to the use of the product. Adverse events have been reported in Colorado, Florida, Georgia, Idaho, Louisiana, New York, and North Carolina.

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Wallcur has initiated a voluntary recall of Practi-0.9% sodium chloride IV solutions. Clinicians and office staff are encouraged to visually inspect all current IV saline solution bags and ensure that none are labeled “Wallcur,” “Practi-products,” “For clinical simulation,” or “Not for use in human or animal patients.” If clinicians have products labeled with any of these words or suspect they may have received other products intended for training purposes, they should separate simulation products from existing inventory and contact their distributor for directions on how to return these products.

If clinicians suspect that any Wallcur training IV products may have been administered to a patient, whether or not the incident has resulted in an adverse event, they are advised to evaluate all potentially exposed patients with new or ongoing symptoms, use appropriate treatment, report suspected cases to the state health department, and report any adverse events following use of these products to FDA's MedWatch program online.

For more information visit FDA.gov.