| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01400-1 |
| Product Name/Description |
Percuvance Percutaneous Surgical System
Product Code: PCVJG5, PCVMD5, PCVHCA5, PVCGG5, PCVSC5
Multiple Lot Numbers
ARTG number 126369
(Teleflex Medical Australia Pty Ltd - Applier, surgical, clip, haemostatic, single use) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
13/11/2017 |
| Responsible Entity |
|
| Reason/Issue |
Teleflex has identified that the Percuvance Percutanous Surgical System jaws of the tool tip may break, causing a fragment of the tool tip to fall off during use. If breakage occurs during a procedure, additional operating time or enlargement of the incision may be required to retrieve the fragment from the patient. If the fragment cannot be retrieved easily, additional complications could occur.
Teleflex has not received any reports of patient injuries or deaths relating to the recalled products. |
| Recall Action |
Recall |
| Recall Action Instructions |
Teleflex is advising users to quarantine any remaining units of the affected stock for credit.
This action has been closed out on 26/02/2019 |
| Contact Information |
1300 360 226 - Teleflex Medical Australia Customer Service |