| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01314-1 |
| Product Name/Description |
SenoMark UltraCor MRI 14 Gauge Breast Tissue Markers (used for radiographic marking of breast biopsy sites)
Product code: SMUCMRI14GT
Lot number: VT15M0543
ARTG number: 160027 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/10/2016 |
| Responsible Entity |
|
| Reason/Issue |
It has been identified that the product code / lot number combination for a single lot of the device may have an incorrect Instruction for Use (IFU) containing a table in the Description section that misidentifies the wireform and material (Titanium and Stainless Steel). All other product labelling, including outer box and inner packaging, correctly identify the product.The potential exists that a user might inadvertently use a SenoMark UltraCor MRI 14 Gauge Tissue Marker of the wrong material in a patient with known hypersensitivity to titanium. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Bard is providing users with instructions for use that correctly identify the wireform and material. The product can be continued to be used. This action has been closed-out on 17/05/2017. |
| Contact Information |
02 8875 4070 - Bard Australia |