| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00612-1 |
| Product Name/Description |
Threader Monorail and Threader Over the Wire Micro-Dilatation Catheters (used during angioplasty procedures)
Threader Monorail Micro-Dilatation Catheter
Material Number (UPN): H7493926912120
Batch Number:18647602
Threader Over the Wire Micro-Dilatation Catheter
Material Number (UPN): H7493927012120
Batch Numbers: 18647652, 18753516, 18647655
ARTG Numbers: 259153, 259152 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
9/05/2016 |
| Responsible Entity |
|
| Reason/Issue |
Boston Scientific has determined that certain Threader Monorail and Threader Over the Wire Micro-Dilatation Catheters were shipped from the Australia distribution centre with an International Direction for Use (DFU) rather than an Australian DFU. The Australian DFU includes additional warnings and precautions included in the ‘Precaution’ section of the DFU. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Boston Scientific is providing users with the Australian DFU. This action has been closed-out on 17/02/2017. |
| Contact Information |
02 8063 8179 - Boston Scientific |