| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00215-1 |
| Product Name/Description |
Head Positioning Devices
Product code: EVS-PBHP00001
Lot number: 0021351
ARTG Number: 177472 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/03/2014 |
| Responsible Entity |
|
| Reason/Issue |
Envisen have discovered the lot number 0021351 was not aerated for the recommended amount of time after manufacturing, and is emitting an undesirable smell. The smell has been identified as Polyether polyol and Triethylene diamine. Contact with or inhalation of Triethylene diamine can pose a safety risk to patients. |
| Recall Action |
Recall |
| Recall Action Instructions |
Device Technologies are requesting users to isolate affected stock from use. Affected stock can be returned to Device Technologies for credit. |
| Contact Information |
1800 429 551 - Device Technologies Australia Pty Ltd |