Date Sent: 01/16/2015 03:53 PM EST
Sender: Michigan Health Alert Network
Subject: FDA Investigation and Recall: Wallcur's simulated IV saline solution, Practi-0.9% sodium chloride
Message: Today CDC and FDA asked all 50 State Health Departments to widely distribute information related to their ongoing investigation into the distribution and recall of Wallcur's simulated IV saline solution, Practi-0.9% sodium chloride solution.
This solution was shipped to medical clinics, surgical centers, and urgent care facilities in numerous states and more than 40 patients have received infusions of the simulated saline products. Adverse events associated with these incidents include fever, chills, tremors and headache. Some patients were hospitalized. No events have been reported in Michigan.
CDC and FDA are asking healthcare providers to take the following actions:
Clinicians and office staff are encouraged to take steps to ensure IV solution simulation products are removed from office inventory to eliminate the possible injection of Wallcur simulated products into 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:
More information can be found at:http://www.fda.gov/Drugs/DrugSafety/ucm428431.htm