| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01324-1 |
| Product Name/Description |
Curlin 6000 Painsmart IOD Infusion Pump Power Adapter Accessory
Used with: Moog Curlin 6000 Ambulatory Infusion Pump and Moog Painsmart IOD Infusion Pump
ARTG Number: 225964 (Fresenius Kabi Australia Pty Limited - Infusion pump, analgesic, patient-controlled) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/10/2017 |
| Responsible Entity |
|
| Reason/Issue |
Fresenius Kabi has identified a failure involved with the power adapter. In some cases a spark or short circuit has been reported on the wall socket used to connect the Curlin 6000 and Painsmart pumps. This failure does not affect the pump itself. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Fresenius Kabi is replacing all affected adapters with an improved adapter. In the meantime to mitigate any risk of injury customers are advised to use the device on the battery power and not use the adapter. The adapter is optional and is required only if the pump is to run on AC mains. Hence the pump can be used without the adapter.
This action has been closed out on the 03/12/2018. |
| Contact Information |
02 9391 5559 - Fresenius Kabi Australia |