| TGA Action ID |
RC-2026-RN-00740-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Ethilon Nylon Suture BLK 45CM 6-0 S/A P-1 PRM
Product code: 697G
Lot:10B3QS |
| ARTG Number |
166222 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Ethicon received complaints for ETHILON Nylon Suture lot 10B3QS regarding distorted/twisted needle defects. An investigation confirmed that some needles in lot 10B3QS are impacted by this defect.
The distortion of needle curvature may be detectable when the needle is grasped with a surgical instrument during normal preparation. However, if used in a procedure exposure to a distorted or twisted needle could result in additional soft tissue or vessel injury, including tearing or bleeding intraoperatively. Additionally, there may be an increased potential for needle breakage during use.
Ethicon has not received any reports of injuries related to this problem to date.
Other products and lots are unaffected. |
| Instructions for Customers/Users |
Customers are to:
- Immediately inspect the device(s) in their possession to determine if their facility has and affected product.
- Quarantine any affected product.
- Contact the sponsor to organise the return any affected product. A refund will be provided. |
| Action Commencement Date |
23/09/2026 |
| Responsible Entity |
|
| Contact Information |
1800 252 194 - Johnson & Johnson Medical Customer Service |