Type of Product |
Medical Device |
TGA Recall Reference |
RC-2013-RN-00541-1 |
Product Name/Description |
ECHELON 60mm Endoscopic Linear Cutter Reloads, Black (Reload cartridge with two 60mm long triple-staggered lines of staples)
Product code: ECR60T Affected products have expiry date 2013-05 to 2014-03 ARTG Number: 125609 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class I |
Recall Action Commencement Date |
29/05/2013 |
Responsible Entity |
|
Reason/Issue |
There is a potential for incomplete staple line formation from the reload damage during the firing sequence. This may result in insufficient tissue apposition that could require surgical intervention to help achieve and maintain anastomotic integrity. |
Recall Action |
Recall |
Recall Action Instructions |
JJM is asking customers to quarantine any affected product in the inventory and return them. |
Contact Information |
1800 252 194 - JJM Customer Service |