| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00798-3 |
| Product Name/Description |
Proximate PPH Hemorrhoidal Circular Stapler and Accessories 33mm, Product code PPH03 and Proximate HCS Hemorrhoidal Circular Stapler and Accessories 33mm, Product code PPH01 (Used for treatment of prolapse and hemorrhoids)
All lot numbers affected
ARTG Number: 99218 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/08/2012 |
| Responsible Entity |
|
| Reason/Issue |
There is difficulty firing the device which may result in an incomplete firing stroke that may result in incomplete staple formation. |
| Recall Action |
Recall |
| Recall Action Instructions |
Quarantine and return affected product to Johnson & Johnson Medical |
| Contact Information |
1800 252 194 - Johnson & Johnson Medical Customer Service |