FDA Investigation and Recall: Wallcur's simulated IV saline solution, Practi-0.9% sodium chloride

Message Details

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.

• Visually inspect all current IV saline solution bags. Ensure none of the bags are labeled "Wallcur," "Practi-products," "For clinical simulation," or "Not for use in human or animal patients."
• If you have products labeled with any of these words, or you suspect you may have received other products intended for training purposes, separate simulation products from existing inventory and contact your distributor for directions on how to return these products.
• If you have received Wallcur Practi-products by mistake, please contact the distributor, or Wallcur, LLC of San Diego for return instructions.
• Consider reviewing your 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.
  

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:

• Evaluate all potentially exposed patients with new, or ongoing symptoms;
• Use appropriate treatment;
• Report suspected cases to the state health department; and
• Report any adverse events following use of these products to FDA's MedWatch program online or at 1-800-332-1088.
  

More information can be found at:http://www.fda.gov/Drugs/DrugSafety/ucm428431.htm