| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01038-1 |
| Product Name/Description |
Aeroneb Pro and Solo Nebuliser Systems - FRIWO power adapter
Product Codes: AG-AS3000-AU and AG-AP1040-AU
ARTG number: 140725 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
25/09/2014 |
| Responsible Entity |
|
| Reason/Issue |
The power adapter could potentially fail, whereby the plastic screw pillars can break and dislodge from the body and the adapter cover can open. If the failure was to occur during use then the internal electrical components of the mains power adapter would become exposed to the user and therefore there is a potential risk of electrical shock. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Covidien is contacting the hospitals and will ship replacement adapters free of charge. Covidien is further requesting the customers to destroy the affected adapters per local disposal processes, when replacement AC mains power adapters are received. This action has been closed-out on 06/07/2016. |
| Contact Information |
1800 350 702 - Covidien Pty Ltd |