FAKE IV FLUIDS USED AT CLINICS

January 15, 2015

This is a warning for anyone who may receive a saline injection at a medical clinic or hospital in the near future.

On January 14, 2015, the Food and Drug Administration (FDA) announced that bags of fake intravenous (IV) saline solution were shipped to medical clinics, surgical centers, and urgent care facilities in numerous states.

The fake saline, labeled “Practi-0.9% sodium chloride solution” and sold by Wallcur, is not sterile and should not be injected into patients. It is intended as a training tool for health care workers.

The FDA and Centers for Disease Control and Prevention (CDC) have identified more than 40 patients who have received the fake saline, and many have experienced adverse events, including fever, chills, tremors, and headache. Multiple patients who received the fake saline have been hospitalized, and at least one has died, although the FDA does not know whether the fake saline was the cause of this death. In most cases reported so far, signs of fever, chills, muscle aches, and headaches have occurred immediately following injection.

Adverse events have been reported in Florida, Georgia, Idaho, Louisiana, North Carolina, New York, and Colorado.

Read the complete FDA announcement:
http://www.fda.gov/Drugs/DrugSafety/ucm428431.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

IV saline solutions are used daily in hospitals and medical clinics for many purposes, including restoring fluids to patients who have become dehydrated.

The FDA and CDC are investigating how the fake saline entered the medical supply chain. Most medical facilities that received the fake saline reported that they were unaware that the product was intended for training purposes only. Wallcur has now voluntarily recalled its saline training products.

Advice for Patients

If you or a loved one receives care in a hospital or other health care facility, ask your health care provider immediately when you arrive at the facility whether they plan to administer IV saline, and whether they have heard about the recall of Wallcur Practi-0.9% sodium chloride solution.

Before you or a loved one receives a saline injection, check the IV fluid bag to make sure it 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.” If the saline bag contains any of these words, ask your health care provider not to inject the solution.

The FDA advises patients who believe they may have received an injection of Wallcur saline solution to contact their health care provider.

If you suspect that you may have received a Wallcur saline training product, whether or not you experienced an adverse event, please report the incident to FDA’s MedWatch Adverse Event Reporting program by:

• Asking your doctor to help you complete and submit a report of the event online at MedWatch Online Voluntary Reporting Form (https://www.accessdata.fda.gov/scripts/medwatch/), or

• Downloading the form and asking your doctor to help complete the report, (PDF — 1.22MB, at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM349464.pdf), then submitting it via fax at 1-800-FDA-0178.