| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00043-1 |
| Product Name/Description |
Steris Amsco Warming Cabinet
War Cab Pre Glass Dual 24" 230V mobile
Product Code: ST-DJ06014433112
Serial Numbers: 0408215020 and 0408215021
War Cab PTD Glass SGL 18” 230V
Product Code: ST-DJ050144132
Serial Numbers: 0423315089
ARTG Number: 167720 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
12/01/2016 |
| Responsible Entity |
|
| Reason/Issue |
Steris has identified that some information printed on the quick reference magnet is incorrect; specifically, Fahrenheit to Celsius temperature conversions and the default Warming Cabinet temperature. It should be noted that all temperature information in the Warming Cabinet Operator Manual is correct. The risk to patients/users due to the reported issue is negligible. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The sponsor is advising users to discard the existing quick reference magnet and refer to the manual until the replacement quick reference magnet is received. |
| Contact Information |
02 9975 5755 - Device Technologies |