CHICAGO - March 13, 2019- Vyaire Medical today announced an immediate global recall of the enFlow™ disposable cartridges used with the enFlow™ fluid warming system (part numbers 980200EU, 980202EU). Vyaire is directing customers to suspend use of the enFlow™ system and follow instructions provided by the Company in its recall notice with regard to the affected cartridges.
This recall does not affect the separate enFlow™ Warmer, Controller, and accessories. Customers are encouraged to retain these items as Vyaire is exploring the development of a new cartridge, compatible with the current enFlow™ system, to minimize aluminum exposure.
This decision is based on recently conducted internal testing which indicated that there is the potential to elute aluminum from the enFlow™ disposable cartridge during intravenous warming therapy with fluid and blood solutions. This action was not prompted by adverse incidents or product complaints.
At Vyaire, we put patient safety above all else, and believe that this recall is in the best interests of both our customers and their patients.While we are immediately recalling the affected cartridges from the market now, we intend to actively work with our regulators to explore design or labeling changes that would support the reintroduction of enFlow™ disposable cartridges in the future.
Vyaire's recall of enFlow™ cartridges is consistent with its commitment to ensuring the highest quality standards for its products and the safety of patients worldwide.
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.
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