| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00944-1 |
| Product Name/Description |
Scherbak Weights – 400 gr and 800 gr (used with Scherbak vaginal speculum)
Affected part numbers:
Scherbak Weight, 400gr - Art. No. 32-302-10-01
Scherbak Weight, 800gr - Art. No. 32-302-12-01
Full set: Art. No. 32-302-00-01
ARTG number: 177280 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/09/2014 |
| Responsible Entity |
|
| Reason/Issue |
Medical & Optical has been advised by KLS Martin 400gr and 800gr weights, placed in the market place for the Scherbak vaginal speculum, fractures can occur in the laser welded seam between the holding hook and the weight involved. |
| Recall Action |
Recall |
| Recall Action Instructions |
Medical & Optical is recalling the affected stock and a replacement of the affected weights will be provided free of charge. This action has been closed-out on 04/04/2017. |
| Contact Information |
1800 225 065 - Medical + Optical Australia |