| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00267-1 |
| Product Name/Description |
Trellis 6 and Trellis 8 Peripheral Infusion System
ARTG Number: 229708 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/03/2015 |
| Responsible Entity |
|
| Reason/Issue |
Covidien (now Medtronic) is conducting a recall of the Trellis 6 and Trellis 8 Peripheral Infusion Systems due to potential for a sterility breach of the outer packaging or pouch material of all lots manufactured.
A breach of the outer pouch may compromise the outside surface sterility of the inner pouch and does not directly affect the sterility of the device components within the inner pouch.
This potential for a sterile breach in the outer pouch material was discovered during standard internal packaging tests. The breach in the pouch barrier is likely not detectable by visual inspection of the product. Covidien has identified possible causes for the pouch damage and has taken actions to prevent distribution of product that may be affected by this issue.
Covidien has received no complaints and is not aware of any patient injury or death related to the issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Covidien is Recalling all affected units from the market and will issue a credit for unused and unexpired devices. This action has been closed-out on 09/08/2016. |
| Contact Information |
02 9429 4364 - Covidien Pty Ltd |