| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01290-1 |
| Product Name/Description |
Arctic Sun Temperature Management System (used for regulating the temperature and circulation of water to a vest worn by the patient)
Arctic Sun 2000 Temperature Management System (230VAC)
Product Code: 2000-03
Arctic Sun 5000 Temperature Management System (220-240 V Australia)
Product Code: 5000-01-03
ARTG Number: 150422 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/09/2016 |
| Responsible Entity |
|
| Reason/Issue |
An additional warning is to be included in the Operator's Manual with the advice that The Arctic Sun Temperature Management System is not to be used in the operating room environment. This is to address concerns regarding the potential for Non-tuberculous Mycobacterium (NTM) bacterial transmission to a patient based on use of the device in operating rooms and sterile fields under existing labelling. The probability of harm to a patient is considered remote. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Bard is providing customers with operator's manual addendum which contains the additional warning that the Arctic Sun Temperature Management System is not intended for use in the operating room environment. |
| Contact Information |
02 8875 4070 - Bard Australia |