| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00215-1 |
| Product Name/Description |
Inhalo Medical Oxygen with Integrated Pressure Regulator/Flowmeter
BOC Product Code: 400CD
ARTG Number: 187646 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/02/2017 |
| Responsible Entity |
|
| Reason/Issue |
The pressure gauges supplied to BOC as part of the Inhalo device, may in rare circumstances, have a broken pointer. This failure mode may result in the gauge pointer moving independently of actual cylinder pressure. This will result in inaccurate pressure readings being observed. The situation has been observed where, with a cylinder in a vertical position, the pressure gauge pointer can indicate the cylinder is full, when in fact there is reduced content within the cylinder. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Customers are advised to confirm that the stock they are using is not faulty and has sufficient contents to administer therapy i.e., all 400CD Inhalo cylinders will need to be checked prior to use as per the Pressure Gauge Check work instruction provided with the customer letter. If no fault is identified, customers can continue to use the product, there is no need to contact BOC. If a faulty pressure gauge is identified, please contact BOC immediately for a free of charge replacement. BOC has implemented additional product testing prior to release from their filling sites, however there is a remote possibility that a pressure gauge pointer may fail during transit/handling.
This action has been closed out on the 11/10/2018. |
| Contact Information |
1300 363 109 - BOC Limited |