Vyaire Medical issued a Class I recall of nearly 3 million enFlow fluid warning system disposable cartridges after it discovered that patients could be exposed to unsafe levels of aluminum.
The recall affects two of the Mettawa, Ill.-based company’s enFlow cartridges, including the 980200EU enFlow – Disposable Cartridge and the 980202EU enFlow – Disposable Cartridge with IV Extension Set.
Vyaire Medical’s enFlow system is designed to warm blood, blood products and intravenous solutions before IV administration to a patient. It is used in hospital and clinical settings to prevent hypothermia. The enFlow disposable cartridge uses an aluminum extrusion to warm blood and IV solutions.
The cartridges are being recalled due to the potential for aluminum to elute from the warmer into the fluids, exposing patients to unsafe levels of aluminum, according to the FDA.
Vyaire Medical issued a field advisory March 13 and sent an updated notice to distributors and end-users April 29. The company recommends users inspect inventories and remove all affected enFlow cartridges from commercial distribution. Vyaire Medical also recommends destroying all affected products in accordance with a facilities destruction protocol, according to the FDA.
There have been no reports of injuries or deaths. Vyaire Medical recommends contacting its technical support department if any adverse reactions have occurred due to the enFlow cartridge device.