| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00147-1 |
| Product Name/Description |
Veletri Consumables Kit - Infusion administration set containing B. Braun Water for Injections
Lot Number: 14217404 (B. Braun Water for Injections)
Batch numbers: 0309757 and 0309991 (Veletri Consumables Kit)
Expiry Date: 2017-04
ARTG Number: 219458 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/02/2016 |
| Responsible Entity |
|
| Reason/Issue |
Complaints have been received regarding leakage and under-filling of Ecoflac Plus bottles with cracks at the transition from the container shoulder to the container body. This may result in microbial contamination of the product and pose a risk to patients. |
| Recall Action |
Recall |
| Recall Action Instructions |
The sponsor is advising users to inspect stock and quarantine the affected kits prior to their return. Until replacement kit is received, patients are recommended to use an alternative unaffected water for injection product. If this is not available, patients should check each bottle of water carefully before use to ensure the container and its closure or packaging are undamaged. DO NOT use the bottle if a leak has been noticed. This action has been closed-out on 03/02/2017. |
| Contact Information |
1300 116 441 - Actelion |