The FDA and Centers for Disease Control and Preventionwarned Wednesday that more than 40 patients were incorrectly injected with “simulated saline.” One patient died and others were hospitalized with fever, chills, tremors and headaches.
The bags, which look like normal saline, are labeled “for clinical simulation” and are designed to be used on dummies — not people.
Adverse effects were reported in Colorado, Florida, Georgia, Idaho, Louisiana, New York and North Carolina. The FDA said one clinic recognized the product and returned it.
The non-sterile “Practi 0.9% Sodium Chloride solution” saline bags are manufactured by Wallcur of San Diego for training purposes only. The bags were recalled on Jan. 7.
The FDA advised healthcare professionals to check their stock and inspect bags before injecting them into patients. Patients were also encouraged to ask their doctor or nurse to visually inspect the bag.
If the bag says: “Wallcur,” “Practi-products,” “For clinical simulation” or “Not for use in human or animal patients,” then it should not be administered, the FDA said.
There is currently a shortage of sterile saline in the United States. The FDA has authorized for additional saline to be imported from Europe.
Wallcur said it will add “product enhancement labels” to IV bags in the future.
Gavin Stern is a national digital producer for the Scripps National Desk.