| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00966-1 |
| Product Name/Description |
Merit Maestro Microcatheter
Product code: 28MC24150ST/F
Lot Number: H2749681
ARTG 330840
(Merit Medial Australia Pty Ltd - Intravasular microflow catheter) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/11/2023 |
| Responsible Entity |
|
| Reason/Issue |
Merit Medical Australia Pty Ltd, is conducting a recall of specific Merit Maestro Microcatheter lots due to a supplier packaging defect. Specifically, the gold foil pouch holding the catheter may contain a small hole along the pouch seal. This hole may impact the sterility of the device.
Merit has not received any reports of patient harm/injury relating to this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers should:
1. Immediately determine if any of the devices identified in the Customer letter are within their facility.
2. If so quarantine them, and discontinue use and distribution.
3. Ensure that applicable personnel within your organisation are made aware of this field action.
4. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them.
5. Immediately return all affected lots in their possession to Merit Medical Australia, per the instructions in the customer letter. |
| Contact Information |
1300 696 374 - Merit Customer Service |