| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01339-1 |
| Product Name/Description |
Trellis 8 Peripheral Infusion System
Model Number: EVT808015V01
Lot Numbers: 9929826, 9930951, 9955126, 9955275 & 9956347
Model Number: EVT808025V01
Lot Numbers: 9954578 & 9955164
Model Number: EVT812015V01
Lot Numbers: 9954559 & 9966680
Model Number: EVT812025V01
Lot Numbers: 9929653, 9953991 & 9954138
ARTG Number: 229708 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
19/12/2014 |
| Responsible Entity |
|
| Reason/Issue |
Covidien is conducting a recall following two customer complaints of the proximal port being located on distal port location and vice versa. This occurred due to a manufacturing error that has resulted in the distal balloon inflation port incorrectly labelled as proximal and the proximal as distal.
Covidien have identified a potential for confusion in the Trellis 8 inflation port identification. A hazard would arise when one of the balloons is deflated out of sequence prior to aspiration. This may allow lytic and thrombus to escape the treatment area if the incorrectly labelled ports are not identified by the physician during prep or when initially inflating the balloon prior to infusing thrombolytic into the treatment area. This may lead to an extended procedure time and/or bleeding and/or potential thrombus in the systemic circulation and/or emboli where a small piece of dislodged thrombus may travel distally and lead to a possible embolism. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
1. Customers are asked to identify and quarantine affected units;
2. Complete and return the supplied response form regardless if any affected stock is on hand; and
3. Follow the directions in the customer letter to obtain replacement stock should that be required.
This action has been closed on the 17/09/2018 |
| Contact Information |
1800 252 467 - Covidien Australia |