| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00266-1 |
| Product Name/Description |
Harris Oxygen Flowmeter
Model Numbers: 86630LOX and 86630LAIR (labelled as “Model 866”)
All Lot Numbers
ARTG No. 140296 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/04/2015 |
| Responsible Entity |
|
| Reason/Issue |
Fisher & Paykel Healthcare Pty Ltd is issuing this recall for product correction on behalf of the Harris Products Group as there have been two reports of confusion due to mislabelled measurement lines on the model 86630LOX flowmeter. The measurement lines are labelled for ArCO2 gas and not Oxygen gas. There have been no reports of injury to date, however there is potential to set up an incorrect flow of Oxygen or Air gas to a patient.
Note: even though there have been no reports involving the air flow meter, it is being included in this recall as it also uses an ArCO2 labelled tube. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Harris Products Group is supplying the correction labels to all affected customers. This label is to be affixed to the flow meter to correctly read the flow of Oxygen or Air gas.
This action has been closed out on 17/09/2019 |
| Contact Information |
03 9879 5022 - Fisher & Paykel Healthcare |