Nearly 2.9 million cartridges used to hold blood and blood products are being recalled, due to a risk that aluminum could melt from the cartridge and enter the patient’s bloodstream, posing a serious risk of injury or death.
The Vyaire Medical enFlow Warming System recall was announced by the U.S. Food and Drug Administration (FDA) on June 27, because unsafe levels of aluminum may melt and enter the fluids being administered to patients. Although no injuries or adverse events have been reported in connection to the problems, the action has been classified as a class 1 recall, which reflects that use of the product poses a risk of severe injury.
The enFlow Disposable Cartridges are designed to be filled with blood, blood products and intravenous solutions and administered to patients through the use of the enFlow Fluid Warming Systems. The warming systems are often used to treat patients with hypothermia.
Officials are warning the enFlow Disposable Cartridges, which are made of aluminum, have the potential to melt and release dangerous amounts of aluminum into the solutions being heated. This could result in unsafe levels of aluminum being intravenously administered into the patients’ bloodstream.
Adverse health effects from aluminum exposure may result in a variety of serious adverse health consequences including muscle weakness, neurocognitive and bone marrow complications, and in severe cases even death.
Approximately 2,899,660 Vyraire Medical enFlow Fluid Warming System Disposable Cartridges with model numbers 980200EU and 980202EU are included in the recall. The products were manufactured Vyaire Medical and distributed to healthcare facilities from January 4, 2016 through March 7, 2019.
Healthcare facilities are being asked to stop using the fluid warming cartridges immediately, unless there are no other alternative fluid warning systems available. Customers with alternative warming systems should quarantine and destroy the cartridges in accordance with the facility’s destruction protocol.
The FDA has categorized this as a Class I recall, indicating it is the most serious of its kind and that the use of the product is likely to result in serious adverse health consequence, including death.
Customers with additional questions or concerns may contact Vyaire’s Technical Support Department at 1-800-231-2466 or email them at GMB-RS-DISP-Complaint-Intake@vyaire.com.