| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00878-1 |
| Product Name/Description |
Mahurkar Acute Lumen Catheters, labelled with Non-DEHP Symbol. (Closed loop, haemaodialysis catheter)
Multiple Product codes
ARTG Numbers: 180135 and 178965 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/09/2012 |
| Responsible Entity |
|
| Reason/Issue |
There is a labelling discrepancy pertaining to certain configurations of the Mahurkar Acute Dual Lumen Catheter. During a review of the product labelling, it was discovered that the devices are labelled as not containing the phthalate Bis (2-ethylhexyl) phthalate (DEHP), when in fact they contain small amounts of DEHP. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Update labelling to include phthalate Bis (2-ethylhexyl) phthalate(DEHP) symbol. |
| Contact Information |
02 9429 3100 - Travis Stephenson |