| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00490-1 |
| Product Name/Description |
EnCor Probes (used for breast biopsies)
Biopsy Probe – 10g Vertical
End Item Code: ECP0110GV
Lot Numbers: VT14G0223, VT15F0266, VT15G0345, VT15K0439, VT15L0482, VT15M0572
Biopsy Probe – 12g Vertical
End Item Code: ECP0112GV
Lot Number: VT15E0244
ARTG Number: 154530 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
Bard Peripheral Vascular (BPV) has confirmed that the affected lot numbers may be at risk of having an incorrect sample trap assembly. A portion of the affected lots may contain units with incorrect sample trap assemblies affixed to the probe inside the product tray (a lateral assembly instead of an upright assembly). The labelling on the outer product carton and inside packaging tray is correct. Specifically, the issue is that the incorrect sample trap assembly contains shorter vacuum tubing and no clear tray cover.
The potential harm associated with attempting to use this device labelled for Upright use may result in the sample trap assembly being filled with fluid during use and when removing the sample collection tray (basket), the sample(s) may fall out of the collection tray because of the lack of a cover. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Bard is advising users to inspect the affected lots before use to ensure the correct trap assembly is affixed to the probe. This action has been closed-out on 30/01/2017. |
| Contact Information |
02 8875 4039 - Bard Australia |