| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00720-1 |
| Product Name/Description |
METRAN JPAP Travel CPAP Machines
Serial Numbers: P1808E00428 to JP1808E00447
Cancelled ARTG 328181 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/11/2023 |
| Responsible Entity |
|
| Reason/Issue |
There are concerns around the test protocol used for the testing, as the devices were not tested for Particulate Matter and Volatile Organic Compounds (VOCs) according to suitable test protocols. Two VOCs were detected during testing for new and expired devices, but the TGA did not receive appropriate justification as to why these VOCs were not actually emitted from the device. The TGA also does not have information about the concentrations and Margin of Safety for these released VOCs to determine the safety aspects.
This recall does not affect any other CPAP Devices other than the 11 JPAP devices sold by PBMedical in 2020. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers who have the affected device will be contacted and offered a replacement device.
This action has been closed out on 28/02/2024 |
| Contact Information |
1300767279 - Ben Greenaway |