Simulated Saline Solution Recalled After Erroneous Patient Infusion

Although the FDA previously warned health care professionals not to inject Wallcur’s Practi-0.9% sodium chloride intravenous solution, given that the non-sterile product was for medical training purposes only, it was mistakenly administered to patients and is now being recalled.

To date, the training products have been infused in more than 40 patients, many of whom are experiencing adverse events such as fever, chills, tremors and headache, and some of whom required hospitalization. One patient death has been associated with the use of the product, though it is currently unknown whether it directly caused the death.

The FDA is now investigating how the non-sterile solution was distributed to medical facilities in Florida, Georgia, Idaho, Louisiana, North Carolina, New York, and Colorado and subsequently administered to patients. Alongside the US Centers for Disease Control and Prevention, the FDA is also testing samples of the recalled product to determine its relation to the serious adverse events experienced by patients.

Those who suspect that a Wallcur training product was administered to a patient should report the incident to FDA’s MedWatch Adverse Event Reporting program by submitting the form online at www.fda.gov/medwatch/report.htm, downloading it at www.fda.gov/MedWatch/getforms.htm, or calling 1-800-332-1088 to request it. Completed paper forms can be returned to the address on the pre-addressed form or faxed to 1-800-FDA-0178.