| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-01254-1 |
| Product Name/Description |
Syntel Silicone Over the Wire Embolectomy Catheter
Reference numbers: A4E04 and A4E09
Lot numbers: PYT1025, PYT1072 and PYT1051
ARTG 147757
(Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Catheter, embolectomy) |
| Recall Action Level |
Wholesale |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/09/2022 |
| Responsible Entity |
|
| Reason/Issue |
Emergo, on behalf of LeMaitre Vascular, is initiating a recall. A customer reported being confused about the actual size of the catheter. The labelling for the catalog number and corresponding French size was confusing because the OD symbol should be 5F for all models. |
| Recall Action |
Recall |
| Recall Action Instructions |
Emergo has advised that the impacted distributor has discarded all affected stock.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
02 9006 1662 - Emergo Australia |