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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 Thermo Fisher Scientific Australia Pty Ltd
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