Vyaire today announced an immediate global recall of the enFlow® Disposable Cartridges used with the enFlow® fluid warming system (part numbers 980200EU, 980202EU). Vyaire’s decision to initiate an URGENT RECALL NOTIFICATION was based on recently conducted internal testing which has indicated that there is the potential to elude aluminum from the enFlow® Disposable Cartridge during intravenous warming therapy with fluid and blood solutions. This Global Recall is being conducted based on the potential patient safety risk associated with aluminium toxicity. Vyaire has received zero (0) customer complaints to-date related to the signs, symptoms or complications associated with aluminum toxicity subsequent to patient use.
The Quality team at Trudell Medical Marketing Ltd. will immediately begin to action this recall and all customers will be notified with complete details. Should you have any questions, please contact your Trudell Territory Manager or customer service at firstname.lastname@example.org