Type of Product |
Medical Device |
TGA Recall Reference |
RC-2013-RN-00396-1 |
Product Name/Description |
LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier (metal ligating clip applier)
Product Code: ER320
Expiration Date: 2016-11 to 2018-03
Kits containing ER320
Multiple kit product numbers and descriptions
ARTG Number: 122810 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class I |
Recall Action Commencement Date |
1/05/2013 |
Responsible Entity |
|
Reason/Issue |
Johnson & Johnson Pty Ltd has identified potential clip formation and feeding issues, which may result in improper clip formation and insufficient occlusion of the vessel or other structure. |
Recall Action |
Recall |
Recall Action Instructions |
End users are requested to immediately check their inventory to determine if their facility holds any affected units. Affected units must be quarantined until returned to Johnson & Johnson Pty Ltd. |
Contact Information |
1800 252 194 - JJM Customer Service |