The accidental use of simulated saline products has led to sickened patients and at least one death nationwide, the FDA and CDC are reporting.
The agencies are warning facilities to examine their saline supplies for IV bags labeled with the words "Wallcur," "Practi-products," "For clinical simulation," or "Not for use in human or animal patients," and to remove those products from circulation.
San Diego-based Wallcur, LLC, a manufacturer of medical simulation products for training and demonstration, has voluntarily recalled the product at issue, Practi-0.9% Sodium Chloride Solution, after several sizes of the non-sterile IV fluid were shipped to clinical consumers and inadvertently administered to more than 40 patients.
Adverse events associated with the injections, including fever, chills, tremors and headaches, have been reported in Colorado, Florida, Georgia, Idaho, Louisiana, New York and North Carolina. These complications have resulted in several patient hospitalizations and possibly 1 death.
The FDA and CDC are investigating how the mock products entered facilities' supply chains. Wallcur has announced plans to boost the visibility of the product warnings on its packaging.