Pharmacy Services

Practi-0.9‰ Sodium Chloride Training Intravenous Bags from Wallcur - Voluntary Recall Due to Serious Adverse Events

January 22, 2015

Wallcur is recalling Practi-0.9‰ sodium chloride training intravenous (IV) bags after the products were administered to over 40 patients. Health care facilities, distributors, and FDA are working together to determine how the Wallcur simulation products entered the supply chain. Most health care facilities did not know these products were not for patient administration. It is not known if the current shortage of sodium chloride 0.9% IV injection contributed to the use of the simulation IV solutions. The recalled IV bags were distributed to multiple health care facilities after May 22, 2014. The following Wallcur products are being recalled:

  • Practi-0.9‰ sodium chloride IV bags in 50 mL, 250 mL, 500 mL and 1,000 mL sizes
  • Practi-0.9‰ sodium chloride IV bag with sterile distilled water in 100 mL size

Practi-0.9‰ IV bags are simulation products for training and educational uses. Do not use training IV products in human or animal patients, as these products are not sterile, and serious adverse events including fever, chills, muscle aches, headaches, tremors, hospitalization, and death have been reported. CDC and FDA are testing samples of Wallcur Practi-0.9‰ sodium chloride to determine whether the products contain ingredients that could have caused these adverse events. Providers and patients are encouraged to thoroughly inspect the label of all IV solutions prior to patient administration. Wallcur IV training products may contain the words “for clinical simulation,” “Wallcur,” “Practi-products,” or “Not for use in human or animal patients.”

Inventory should be inspected to ensure simulation products are not distributed for clinical use. If there is concern that simulation products have been mistakenly distributed, immediately contact affected clients, Wallcur, your distributor, and report this to the FDA’s MedWatch program. Health care facilities are advised to quarantine affected products and return them to Wallcur. Wallcur distributors, or those who further distributed or sold these Wallcur products, should immediately notify recipients of this product recall and provide Wallcur with a list of the customers who received recalled products. Customers should also receive a copy of the recall notice and a copy of affected product labels to make product identification easier. Wallcur plans to add enhanced labels to their simulation products that will include the statement “THIS PRODUCT IS FOR TRAINING PURPOSES ONLY. NOT FOR HUMAN OR ANIMAL INJECTION.” Wallcur is requesting that distributors and resellers include the same statement on all electronic or print advertisements for their IV training products.

Call 1-619-702-4333 for questions about this recall. Patients who believe they have received a Wallcur IV injection should contact their health care provider. Patients and health care providers should report any suspected administration or adverse effects associated with Wallcur training IV products to the FDA’s MedWatch Adverse Event Reporting program.

Additional information is available at the following links:

Updated
January 22, 2015; January 13, 2015; University of Utah, Drug Information Service. Copyright 2015, Drug Information Service, University of Utah, Salt Lake City, UT.