| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00963-1 |
| Product Name/Description |
Transfusion Pump Set - Flex Chamber NAS 220cm
Product Code: IV030001
Lot Numbers: 6400623N, 6400723N, 6400823N, 6400923N
ARTG 228375
(Multigate Medical Devices Pty Ltd - Blood transfusion set) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/10/2024 |
| Responsible Entity |
|
| Reason/Issue |
A customer report indicated that the needleless access site (needleless valve) on the transfusion pump set was not engaging and did not allow administration of the drug.
It was confirmed that there was a blockage through the side port/valve. Our investigations following these complaints have identified that the lubricant used during the assembling process occasionally caused the rubber and side port to adhere together, necessitating excessive force to open the connector. |
| Recall Action |
Recall |
| Recall Action Instructions |
All affected customers must immediately identify and quarantine all unused, listed products in their inventory.
Upon receipt of the Customer Confirmation Form, Multigate Medical Devices will organise a credit or replacement of the affected product. |
| Contact Information |
1800 023 321 - Customer Service Team or QA_MDevices@mdevices.com.au |