| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2019-RN-00671-1 |
| Product Name/Description |
Monoject Standard Hypodermic Needle, 14 G x 1-1/2
Product Code: 8881200011
Lot Number: 906329
ARTG: 186112
(Cardinal Health Australia 503 Pty Ltd - Needle, hypodermic) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/04/2019 |
| Responsible Entity |
|
| Reason/Issue |
Cardinal Health advises that a manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product. The usage of a needle with compromised sterility could result in infection.
To date, Cardinal Health is not aware of any reports of harm in relation to this issue and in this particular case, only veterinary hospitals have been supplied the affected lot number. |
| Recall Action |
Recall |
| Recall Action Instructions |
Whilst this product is included on the ARTG for human use, in this particular case the affected lots have only been supplied to veterinary hospitals.
Therefore, Cardinal Health is advising veterinarians to inspect their stock holdings, then quarantine and return any impacted product.
This action has been closed out on 23/09/2020 |
| Contact Information |
0428 319 989 - Cardinal Health Australia |