VYAIRE MEDICAL enFlow® STATEMENTMar 8, 2019
CHICAGO - March 8, 2019 - Vyaire Medical today issued a Field Safety Notice regarding the enFlow® fluid warming system, recommending that EEA existing customers suspend using the device.
Vyaire's decision to conduct a review of the enFlow® system and initiate this notice is based on recently conducted internal studies which indicate that customers should suspend use of Sterofundin with the enFlow® device at this time.
Discussions with regulatory agencies and the data suggested in a study recently published in the journal Anesthesiadiscussing the potential for aluminum release in coated and un-coated fluid warming devices, including enFlow® , when used with Sterofundin, also factored into the decision to issue this notice.
Vyaire is not aware of a single incident related to enFlow® in a clinical setting where aluminum was observed to have been transmitted to a patient in amounts above scientifically-recognized safe limits, nor have there been any reported adverse events related to aluminum toxicity.
At Vyaire, we put patient safety above all else, and therefore take any data regarding the safety of our products seriously. We are taking active steps to suspend marketing activities globally, including placing the cartridges on ship-hold, while we conduct additional testing with other solutions to confirm their safety with the use of the enFlow® system. We anticipate having results in the very near future and plan to share such data with applicable regulatory bodies and customers. Vyaire is taking these precautionary measures consistent with its commitment to ensuring the safety of its products across a spectrum of solutions.
About Vyaire Medical
Headquartered in Chicago, IL., Vyaire Medical supports and improves the lives of patients with a focus on improving patient outcomes and increasing value for customers. The company was formed in October 2016, to serve healthcare customers with innovative device and service solutions across the respiratory and anesthesia continua of care. Vyaire's legacy brands have a 65-year track record of pioneering, innovating, and advancing respiratory diagnostics, ventilation, and anesthesia delivery & patient monitoring.
From industry-pioneering brands that include Bird, Bear, and Jaeger to respected industry leaders AirLife®, Vital Signs®, Viasys, and many others - Vyaire Medical has nearly 27,000 distinct part numbers recognized, trusted and preferred by specialists in the respiratory therapy and anesthesiology healthcare markets worldwide.
Learn more at www.vyaire.com.