| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00742-1 |
| Product Name/Description |
Merit Blue Diamond Inflation Devices
Item code: IN7130/C
Lot number H2918431
ARTG 322582
(Merit Medical Australia Pty Ltd - Catheter balloon inflation system, single-use) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/08/2024 |
| Responsible Entity |
|
| Reason/Issue |
Specific lots of Merit Blue Diamond inflation devices are affected by a packaging defect. Specifically, there may be a small hole in the sterile barrier of the device packaging.
Merit has not received any reports of patient harm or injury relating to this defect; however, Merit has received one (1) complaint relating to this problem. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are to:
1.Immediately determine if any of the devices listed are within their facility, quarantine them, and discontinue use and distribution.
2.Immediately return all affected lots in their possession to Merit Medical Australia. |
| Contact Information |
1300 696 374 - customerserviceanz@merit.com - Merit Customer Service |