| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00310-1 |
| Product Name/Description |
Karl Storz Tissue Morcellation System
All Lot Numbers
ARTG Number: 149346 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/04/2015 |
| Responsible Entity |
|
| Reason/Issue |
Karl Stoz is undertaking update of the KARL STORZ Tissue Morcellation System Instructions For Use (IFU) by adding new ‘Contraindications’ and ‘Warnings’ .
In 2014, The United States Food and Drug Administration issued it’s ‘Immediately in Effect Guidance Document: Product Labelling for Laparoscopic Power Morcellators’. KARL STORZ submitted a morcellator labelling change request and after receiving the FDA’s approval have now implemented the changes. The update to the IFU is in line with the the TGA’s Safety Advisory about the laparoscopic power morcellators on August 4, 2014 which is available at https://www.tga.gov.au/alert/laparoscopic-power-morcellators-update-4-august-2014 . |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Karl Storz is informing the customers of the new ‘Contraindications’ and ‘Warnings’ in the IFU and providing them with a link to the new IFU. This action has been closed-out on 9/08/2016. |
| Contact Information |
1800 996 562 - KARL STORZ Endoscopy Australia Pty Limited |