| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00228-1 |
| Product Name/Description |
Penumbra System Aspiration Pump - Pump Max, PMX220
Multiple Lot Numbers
ARTG Number: 213819
(Penumbra Neuro Australia - Suction unit, electric powered) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
21/03/2018 |
| Responsible Entity |
|
| Reason/Issue |
The Australian Sponsor address was inadvertently omitted from the Pump Max labelling.
To date, no user complaints have been received regarding this issue. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Penumbra is providing users with a label containing the Australian Sponsor details to affix to devices. Users should refer to the images provided on the Customer Letter for correct location as to where labels should be placed.
This action has been closed out on 05/10/2018 |
| Contact Information |
1300 817 025 - Customer Service Support |