| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00800-3 |
| Product Name/Description |
PCA Empty Sterile vials with injector. (Intravenous fluid container).
List Number: 060210403
ARTG number: 166111 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/08/2012 |
| Responsible Entity |
|
| Reason/Issue |
There have been reports of leaking injectors on the empty sterile vial. Hospira's investigation concluded that injectors had a manufacturing defect in the promixal 'adhesive well' area due to a weak adhesive bond. The injectors accompanying the empty sterile vials may have an increased risk of leaking, particularly during the filling process. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The sponsor is providing work around instructions to mitigate the risk. |
| Contact Information |
1300 046 774 - Hospira Customer Service |