Vyaire Medical—enFlow IV Fluid and Blood Warmers: Cartridges with Aluminum Warming Plates in Fluid Pathway May Lead to IV Infusion with Harmful Concentrations of Aluminum
May 15, 2019 | Risk Management News
ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Device Alerts. For more information contact us at firstname.lastname@example.org.
In an April 29, 2019, Updated Urgent Recall Notification letter submitted by an ECRI Institute member hospital, Vyaire Medical states that its internal testing has demonstrated that when intravenous fluid and blood solutions are warmed with the enFlow disposable cartridges, levels of aluminum extracted from the device may exceed federal guidelines, specifically, those referenced in Title 21, Code of Federal Regulations, part 201.323; "Aluminum in large and small volume parenterals used in total parenteral nutrition." Vyaire Medical also states that the potential patient safety risks associated with this problem include various neurocognitive and bone marrow complications associated with prolonged aluminum exposure. The manufacturer has not confirmed the...