| 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 |
|
| 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 |