Serious Adverse Events in People Given Wallcur Simulated IV Fluid
FDA Issues Warning to Hospitals
The Wallcur IV fluid is intended as a training aid for healthcare providers to learn how to safely mix and administer IV solutions according to Fierce Pharma Manufacturing.
On December 30, 2014, the FDA warned medical providers to not use the Wallcur simulated IV fluid on people or animals, as these products are not manufactured for this purpose and are for training purposes only.
On January 7, 2015, Wallcur announced a recall for all Practi-0.9% Sodium Chloride IV bags and Practi-0.9% Sodium Chloride IV bag with Distilled Water 100mL.
One Death Associated With Administration of Wallcur Simulated IV Fluid
At least 40 people have been given the unsterile Wallcur IV fluid with many of them becoming sick shortly after being given the fluid, according to the USA Today.
Medscape reports that many of the affected people have had to be hospitalized and that experienced symptoms including:
The FDA and Centers for Disease Control and Prevention, CDC, have obtained samples of the Wallcur simulated IV fluid and are testing the samples to determine what infectious material is present, according to Reuters.
FDA Investigating How Wallcur Practice Fluid Entered Supply Chain
The FDA is investigating how the Wallcur simulated IV fluid ended up being shipped to medical clinics, surgical centers, and urgent care facilities when it is not intended to be injected into people, according to the Institute for Safe Medication Practices.
Wallcur says it started to ship the simulated IV fluids in May 2014 and asks that medical providers check their inventory and return any Practi-0.9% Sodium Chloride IV bags back to the company.
The New Yorks Times reports that cases of humans being injected with the recalled product have occurred in at least 7 states:
- New York
- North Caroline
The production of IV fluid for human use requires sterile conditions, certified materials, strict manufacturing practices, and strict testing for bacteria, fungi, and endotoxins, which were not used for the practice saline, shipped to human health centers, according to Forbes.