Our Bad Bug Law Team is investigating the recall of Wallcur intravenous (IV) saline solution bags associated with numerous adverse events. More than 40 people received infusions of simulated saline products that were meant for training purposes, not use on actual patients.
The Wallcur products were not sterile, meaning any number of dangerous pathogens in the IV bags could have caused illness.
Adverse events included fever, chills, tremors and headache. Some patients were hospitalized and one died, although the death is still under investigation. People in 7 states have been harmed: Florida, Georgia, Idaho, Louisiana, North Carolina, New York, and Colorado.
Prompted by these injuries, Wallcur issued a recall of all Practi-0.9% sodium chloride IV bags supplied in 50 mL, 250 mL, 500, mL, and 1000 mL sizes and the Practi-0.9‰ sodium chloride 100 mL IV solution bag with sterile distilled water.This product was shipped to medical clinics, surgical centers and urgent care facilities in a number of states.
All of Wallcur’s products are intended for training, simulation, and educational purposes only. They are not meant for use on humans or animals. But some medical providers used the products on patients.
Product Liability and Medical Malpractice
Most of the medical facilities reported that they were unaware that the IV solution bags were simulation products. However, one clinic did recognized the Wallcur IV bags as a simulation product upon receipt, and returned it to the distributor. This is an interesting twist on the recall that suggests patients injured may have both product liability and medical malpractice claims.
How Should Healthcare Providers Respond to the Recall?
Clinics should take measures to ensure the recalled Wallcur simulation IV bags are not used on patients:
- Visually inspect all IV saline solution bags to ensure none are labeled “Wallcur,” “Practi-products,” “For clinical simulation,” or “Not for use in human or animal patients.”
- Return any suspect IV bags to the distributor.
- Review office procedures and make sure there are procedures in place to visually inspect all future shipments of normal saline products to ensure they are for clinical use and not simulations that are not sterile.
Doctors who think a patient was sickened by a Wallcur IV bag should report that adverse event to the FDA’s MedWatch program.
