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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 Actelion Pharmaceuticals Australia Pty Ltd
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