| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00755-1 |
| Product Name/Description |
Promed High Concentration Oxygen Masks, Elongated (under chin), Adult Med Concentration
Catalogue Numbers: PMD06001, PMD06002, PMD06003, PMD06009 and PMD06106
Lot Numbers: 100914, 100551, 100550, 100574 and 100581
ARTG Number: 216605 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/06/2017 |
| Responsible Entity |
|
| Reason/Issue |
Convatec has received multiple reports of tubing detaching from the oxygen masks either prior to use (in the packaging) or during use. The detachment of the tubing would result in loss of oxygen to the patient. An investigation determined the failure was caused by an improper solvent bond between the oxygen tubing and the oxygen mask connector. |
| Recall Action |
Recall |
| Recall Action Instructions |
Thermo Fisher is advising users to inspect their stocks and quarantine all units from the affected batch numbers. Thermo Fisher will arrange for stock to be recovered and replacement stock, or a credit note, to be issued.
This action has been closed out on 17/09/2018 |
| Contact Information |
1300 735 292 - Thermo Fisher Scientific Australia Customer Service |