| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01042-1 |
| Product Name/Description |
Ethicon Mersilene Tape (intended for use in circular suture of the cervix)
Product Codes: RS21, RS22, D9212
All unexpired lots
ARTG Number: 165076 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
5/08/2016 |
| Responsible Entity |
|
| Reason/Issue |
Some Mersilene Tape product codes have been supplied with an incorrect Instructions for Use (IFU) insert. The product codes subject to this issue have being supplied with a MERSILENE Suture IFU. The indications for MERSILENE Suture are different from the indications for MERSILENE Tape. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Johnson & Johnson are advising users to examine their inventory immediately to determine if they have affected product, and are providing the correct IFU for MERSILENE Tape.
This action has been closed out on the 12/10/2018. |
| Contact Information |
02 9815 3658 - JJM |