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The Food and Drug Administration (FDA) is alerting healthcare professionals not to use Wallcur, LLC simulated intravenous (IV) products in human or animal patients. These products are for training purposes only.
Before administering IV solutions to patients, healthcare providers should carefully check the labels to ensure that the products are not training products, such as Practi IV Solution Bags marketed by Wallcur. Wallcur’s training products, which may bear the words “for clinical simulation,” are not to be administered to patients.
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 the use of certain of these products – i.e., Practi IV Solution Bags.
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 FDA’s MedWatch Adverse Event Reporting program by:
• Completing and submitting the report online at MedWatch Online Voluntary Reporting Form
• Downloading and completing the form, then submitting it via fax at 1-800-FDA-0178
The FDA 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.
To view the FDA alert, visit: http://www.fda.gov/Drugs/DrugSafety/ucm428431.htm