| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2019-RN-00683-1 |
| Product Name/Description |
lntroFlex lntroducers
Model Number: 1355BF9
Lot Numbers: 61417169, 61446318, 61446333, 61468596, 61481228, 61481229, 61494718
ARTG 146688
(Edwards Lifesciences Pty Ltd - Catheter introducer) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/05/2019 |
| Responsible Entity |
|
| Reason/Issue |
Edwards Lifesciences have identified a non-conformance with the IntroFlex Introducer in which the nylon disk is out of specification. The nylon disk was too small and therefore the user was unable to pass the dilator through the introducer. The nylon disk being out of specification does not affect leakage as the nylon disk does not act as a barrier to prevent leakage. Therefore, if the dilator was unable to pass through the introducer, the device can be exchanged with a minimal delay in procedure.
All units in the impacted lots are affected by this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Edwards Lifesciences is advising customers to inspect inventory and if affected product is located, call Customer Service to obtain a Returned Good Authorisation number and arrange return.
This action has been closed out on 28/10/2019 |
| Contact Information |
1800 222 601 - Edwards Customer Service |