Type of Product |
Medical Device |
TGA Recall Reference |
RC-2014-RN-00189-1 |
Product Name/Description |
Proceed Surgical Mesh
Product Code PCDT1
Lot Number: GGG158
ARTG Number: 117402 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
24/02/2014 |
Responsible Entity |
|
Reason/Issue |
The possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination. Delamination is a separation of the two layers that compose the product. |
Recall Action |
Recall |
Recall Action Instructions |
Customers are requested to quarantine the affected device prior to returning to JJM. |
Contact Information |
1800 241 101 - Johnson & Johnson Medical Customer Service |