| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00356-1 |
| Product Name/Description |
OxyCap Adult CO2 Sampling Oxygen Mask
Product Code: WL-PB331010
Lot Number: 1206020784
ARTG Number: 133118 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
It has been identified that the tubing was not fitted correctly to the mask during production. This may result in malfunctioning during use, whereby, if the tubing and masks connected by the user is not firm enough, the tubing may come off during usage. |
| Recall Action |
Recall |
| Recall Action Instructions |
Device Technologies / Proact Medical Systems is recalling the affected masks. |
| Contact Information |
02 9975 5755 - Device Technologies |