| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00589-1 |
| Product Name/Description |
Polysorb Braided Absorbable Suture and EndoStitch Loading Unit with Polysorb Suture
Multiple Item and Lot Numbers
ARTG Numbers: 180104 and 181255 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/05/2017 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic has identified that there is the potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material. The use of products with this condition may increase the potential for the suture to break. This packaging defect does not impact the sterility of the product. To date, Medtronic have not received any reports of serious injury associated with these issues. |
| Recall Action |
Recall |
| Recall Action Instructions |
Medtronic is advising users to quarantine and discontinue use of the affected item codes. Medtronic will arrange for collection and will issue credit for returned devices.
This action has been closed out on 20/09/2019
This action has been closed out on 20/09/2019 |
| Contact Information |
02 9857 9000 - Medtronic |