| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00565-1 |
| Product Name/Description |
BioPince, BioPince Ultra and Tru-Core II Automatic Biopsy Instruments
Multiple products and lot numbers
ARTG 223223
(Culpan Medical Pty Ltd - End-cut biopsy gun, single-use) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/07/2024 |
| Responsible Entity |
|
| Reason/Issue |
Holes have been identified in the packaging trays which may compromise the sterile barrier of the device.
Non-sterile product potentially exposes patients to the introduction of micro-organisms into the access site, leading to an infectious process, bacteraemia, or sepsis. There is also a risk of cross contamination if the device is used with another product or on a sterile field. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are to:
- Inspect and quarantine all impacted stock to prevent further use.
- Return affected stock for a replacement. |
| Contact Information |
1800 060 168 - LifeHealth Care |