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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-01155-1
Product Name/Description Nebulisers / Nebuliser Mask Products

Uno multi-angle nebuliser (50) int
Product Code: 1638-00

Uno Multi-angle nebuliser MP T-Piece (50) int
Product Code: 1638-01

Uno Aero Mask AD MA Nebuliser 210cm (50) int
Product Code: 1651-21

Uno Aero Mask Child Multi-Angle Nebuliser 210cm (1x50) int
Product Code: 1654-21

Multiple Lot Numbers affected

ARTG Number:160226
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 27/11/2015
Responsible Entity ConvaTec Australia Pty Ltd
Reason/Issue ConvaTec have determined that specific batches of Nebuliser mask products are not meeting specification. An error in the manufacturing of a component (jet orifice) resulted in this component being unable to produce atomisation or misting of supplied medication, saline or water contained in the nebuliser unit. Therefore the nebuliser mask will not deliver the expected therapy to the patient.
Recall Action Recall
Recall Action Instructions The sponsor ConvaTec is advising users to inspect stock and quarantine the affected units prior to their return to the sponsor/distributor. This action has been closed-out on 26/08/2016.
Contact Information 1800 330 412 - ConvaTec