Type of Product |
Medical Device |
TGA Recall Reference |
RC-2018-RN-00783-1 |
Product Name/Description |
In-Line Blood Set with Filter
Product Code: MMC2433
Multiple Lot Numbers
ARTG Number: 108533 (Baxter Healthcare - Blood transfusion set) |
Recall Action Level |
Hospital |
Recall Action Classification |
Class I |
Recall Action Commencement Date |
18/06/2018 |
Responsible Entity |
|
Reason/Issue |
Baxter Healthcare have identified the potential for a leak to occur at the tube to cap junction of the In-Line Blood Set with Filter (MMC2433). Preliminary Investigation has shown that this issue is due to the combination of cap dimension variability, especially on lower limit, and insertion depth of the cap into the tube on the lower side. To date, no complaints have been received as a result of this issue. |
Recall Action |
Recall |
Recall Action Instructions |
Baxter is advising customers to identify and quarantine affected product from their facility. Baxter will arrange return of product from impacted users.
This action has been closed out on 26/02/2019 |
Contact Information |
1800 229837 - Baxter Healthcare Customer Service |