| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01488-1 |
| Product Name/Description |
Intro-Flex Automatic Hemostasis Valve Introducer
Model Number: I300F85
Lot Number: 60377828
ARTG Number: 146688 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/12/2017 |
| Responsible Entity |
|
| Reason/Issue |
This recall involves an introducer sheath that was found to be out of specification. If the sheath inner diameter is too small, the clinician may have difficulty inserting the dilator or catheter into the introducer. This will cause a procedural delay as the clinician will need to change out the device over a guidewire with a minimal delay in treatment.
There have been no injuries as a result of this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Edwards is advising users to inspect stock and quarantine any remaining units of the affected lot. Affected units can be returned to Edwards.
This action has been closed out on 15/11/2018 |
| Contact Information |
1800 222 601 - Edwards Customer Service |