| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00649-1 |
| Product Name/Description |
Unomedical High Concentration Oxygen Masks
Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7') Oxygen Tubing
Product Code: 108MM
Batch Numbers: 106253 and 112025
Non-Rebreather Oxygen Mask, Paediatric High Concentration with 2.1 m (7') Oxygen Tubing
Product Code: 3230MM
Batch Number: 13-20
ARTG Number: 189280 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
26/06/2017 |
| Responsible Entity |
|
| Reason/Issue |
An internal assessment of product reports by ConvaTec has confirmed that specific High Concentration Oxygen Masks have an issue whereby the tubing has been found to disconnect from the oxygen mask, prior to use or during use, causing a disruption in supply of oxygen. |
| Recall Action |
Recall |
| Recall Action Instructions |
ConvaTec is requesting that customers quarantine affected product in their inventory. ConvaTec will organise for product returns and credit.
This action has been closed out on 30/10/2018 |
| Contact Information |
03 9239 2726 - ConvaTec Australia |