| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00650-1 |
| Product Name/Description |
NordiPen used with 5mg, 10mg and 15mg Norditropin SimpleXx cartridges
Lot numbers beginning with A, B or C
ARTG Number: 124725 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/07/2013 |
| Responsible Entity |
|
| Reason/Issue |
Internal investigations have concluded that a component supplier change led to a minor change in the shape of the metal thread which joins the mechanical section to the cartridge holder. As a result, the metal thread on the mechanical section is more likely to cut into the plastic thread inside the cartridge holder resulting in increased resistance during assembly. Increased resistance during assembly can result in a patient assuming a pen is correctly assembled when it is not, which could result in under dosing. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Novo Nordisk are providing health care professionals and consumers with clarified instructions for the assembly of the Nordipen. For more details, please see http://www.tga.gov.au/safety/alerts-device-nordipen-130723.htm |
| Contact Information |
1800 632 362 - NordiCare Customer Care Centre |