| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01307-1 |
| Product Name/Description |
Laparascopic inserts with tube, 3.00mm
Item Numbers: RS-003-316, RS-003-325, RS-003-390
Lot Numbers: 13J028#06102952, 13J028#06082301, 06082129/28,08
ARTG Number: 141681 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/12/2013 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has identified a potential risk with the affected laparascopic inserts where during reprocessing, the inner lumen of these laparascopic inserts cannot be flushed out sufficiently with the recommended rising tip. Further investigation showed that all inserts, which cannot be disassembled are affected, and that this it could lead to infection. |
| Recall Action |
Recall |
| Recall Action Instructions |
The affected laparoscopic instruments have not been used and are in their original packaging. Life Healthcare is advising users to return the affected laparoscopic instruments for replacement stock . |
| Contact Information |
02 8114 1551 - Life Healthcare Regulatory Affairs |