| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00186-1 |
| Product Name/Description |
Unimax Medical Systems – Detachable Endo Pouch
DETACHABLE ENDO POUCH 10MM/330ML
Unimax Part Number: UFEP-936115
DTA Part Number: UMS-UFEP-936115
Lot Numbers: 8252304068, 8252304210, 8252305037, 8252305112
DETACHABLE ENDO POUCH 10MM/750ML
Unimax Part Number: UFEP-957115
DTA Part Number: UMS-UFEP-957115
Lot Numbers: 8252304211, 8252305113
ARTG 122824
(Device Technologies Australia Pty Ltd - Bag, tissue extraction) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/03/2024 |
| Responsible Entity |
|
| Reason/Issue |
The device is used to contain and remove specimen removed during laparoscopic surgery. The black tube on the supporting arm was not properly fixed, therefore the tube is left inside the detachable bag and the end of the tube may stretch out after detachment. Although the stretched-out tube is not expected to fall out as it is grasped inside the bag, there is concern the tube may fall off. Also, when observing the partially extended tube, some users may try to grasp the tube out. It potentially leads to the tube falling during the attempt and requires extra time to retrieve the tube, thus prolonging the procedure.
No incidents have been reported in Australia. |
| Recall Action |
Recall |
| Recall Action Instructions |
Locate all affected items at customer's site and isolate from use. Device Technologies Australia will provide replacement products. |
| Contact Information |
1300 338 423 - Device Technologies Australia |