| 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 |
|
| 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 |