| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00262-1 |
| Product Name/Description |
Weislander Self Retaining Retractor 14cm BL
Part number: ENG-11-2033-00
Lot number: WO382835
ARTG 172560
(Device Technologies Australia Pty Ltd - Retractor) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/04/2024 |
| Responsible Entity |
|
| Reason/Issue |
Device Technologies Australia Pty Ltd (DTA), in conjunction with the manufacturer, Bolton Surgical Ltd, are issuing this Product Defect Correction for the product code and lot number above to the possibility for the retractor teeth to contain metal burrs. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Action Required:
1. Inspect the retractor teeth of Weislander Retractors carrying the affected lot number (the lot number is contained in the barcode).
2. If no burrs are found on the retractor teeth the retractor(s) can continue to be used.
3. If any of the retractor teeth appear to contain burrs, quarantine the affected retractor(s).
4. Take a photo showing the burrs on the retractor and include this with the completed Customer Acknowledgement Form to Device Technologies.
a. Complete a form even if you have no affected devices.
b. Do not dispose of affected devices until Device Technologies confirms to do so.
This action has been finalised on 12/7/2024. |
| Contact Information |
0490 853 258 - Jessica Hill, Product Manager |