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Type of Product Medical Device
TGA Recall Reference RC-2019-RN-00387-1
Product Name/Description enFlow Fluid Warming System

enFlow Disposable Cartridge
Part Number: 980200EU

enFlow Disposable Cartridge with IV Extension Set
Part Number: 980202EU

ARTG: 283586
(Vyaire Medical Pty Ltd - Convection blood/fluid warming set)
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 13/03/2019
Responsible Entity Vyaire Medical Pty Ltd
Reason/Issue Vyaire has initiated a recall based on recently conducted internal testing which has indicated that there is the potential to elude aluminium from the enFlow Disposable Cartridge during intravenous warming therapy with fluid and blood solutions. This recall is being conducted based on the potential patient safety risk associated with aluminium toxicity.

Such toxicity gives rise to a theoretical potential for permanent lessening of a body function (e.g. nerve damage with non-debilitating residual numbness (paraesthesia), OR permanent damage to body structure, OR injury requiring medical or surgical intervention to preclude permanent impairment of a body function OR permanent damage to a body structure.

There have been no complaints related to the signs, symptoms or complications associated with aluminium toxicity during patient use to-date.

Vyaire is recommending that customers discontinue the use of the enFlow Cartridges.
Recall Action Recall
Recall Action Instructions Customers are advised to identify and quarantine all affected products on site.
The sponsor recommends customers destroy all affected stock in accordance with your facility's destruction protocols.
If customers are unable to destroy products on site, please contact the sponsor via the instructions within the customer letter.
All customers are asked to complete and return the customer acknowledgement form, even if no affected stock is on site.

This action has been reviewed and is considered complete in accordance with the requirements of the URPTG.
Contact Information +61 1800 845 141 Customer Service