Type of Product |
Medical Device |
TGA Recall Reference |
RC-2015-RN-01055-1 |
Product Name/Description |
Ultra-Fine Insulin Syringe for use with U-100 insulin
Catalogue Number: 326725
Lot Number: 5019750
ARTG Number: 125064 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
4/11/2015 |
Responsible Entity |
|
Reason/Issue |
The blister package for some insulin syringes may exhibit an open seal potentially impacting on product sterility. No complaints or adverse events have been reported regarding this issue. |
Recall Action |
Recall |
Recall Action Instructions |
Users are requested to inspect stocks on hand and to quarantine affected units pending collection of the affected stock. A replacement or suitable credit will then be issued. This action has been closed-out on 31/08/2016. |
Contact Information |
1800 656 100 - BD Customer Service |