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Type of Product	Medical Device
TGA Recall Reference	RC-2024-RN-00165-1
Product Name/Description	AIRFLOW PROPHYLAXIS MASTER or AIRFLOW One WATER Bottle EG-121 Expiry date: 04/2026, 07/2026, 10/2026 NIGHT CLEANER Bottle EG-120 Expiry date: 07/2026, 10/2026 PIEZON Bottle EG-111 Expiry date: 04/2026, 07/2026 ARTG 221348 (EMS Oceania Pty Ltd- Dental abrasive air jet system)
Recall Action Level	Retail
Recall Action Classification	Class II
Recall Action Commencement Date	27/03/2024
Responsible Entity	EMS Oceania Pty Ltd
Reason/Issue	EMS Oceania Pty Ltd has identified batches of bottle components of the AIRFLOW PROPHYLAXIS MASTER or AIRFLOW One Dental abrasive air jet systems that have not been manufactured to quality standards. Root cause of the problem is found to be a weakness of the part above the ultrasound welding of the water bottle. This weakness is due to a higher concentration of black colorant in the bottle lid. 10 incidents have been reported as defective so far (0.092 %) within more than 1 year of use. No injuries were reported. Damage to the ceiling of the dental office were reported.
Recall Action	Recall
Recall Action Instructions	Cease use with immediate effect and return the bottles with the expiry date listed to the distributor. This action has been finalised on 27/6/2024.
Contact Information	1300 469 367 - Ty Vo