The US Food and Drug Administration (FDA) is alerting healthcare professionals not to use Wallcur, LLC, simulated intravenous (IV) products in human or animal patients, as the products are for training purposes only.
The FDA has become aware that some Wallcur training IV products have been distributed to healthcare facilities and administered to patients.
There have been reports of serious adverse events associated with some of these products, such as Practi IV Solution Bags.
Before administering IV solutions to patients, healthcare providers should carefully check the labels to ensure that products are not training products.
Wallcur’s training products, which may bear the words “for clinical simulation,” are not to be administered to patients.
If you suspect that any Wallcur training IV products may have been administered to a patient, whether or not the incident has resulted in an adverse event, please report the incident to the FDA’s MedWatch Adverse Event Reporting Program.
The FDA said it will continue to investigate and monitor this issue. The agency is also working with the Centers for Disease Control and Prevention to inform healthcare professionals and state health departments.