| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01108-1 |
| Product Name/Description |
ClinActiv and ClinActiv Plus Therapy Surface (used to provide pressure relief to aid in the prevention and treatment of pressure ulcers)
Model Number: N02050, N02051, P02062, P02063, P02064, P02065
All Serial Numbers affected
ARTG Number: 130272 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
Hill-Rom has become aware of a possible hazardous situation when silicon oil contained in the Vario sensor within the ClinActiv Therapy Surface is accidentally released. When the pocket of silicone oil is subjected to excessive mechanical stress, it may disconnect and leak oil outside the mattress enclosure and onto the floor. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Hill-Rom is providing additional cleaning instructions on cleaning silicon oil from affected surfaces, and advising users to ensure the Vario sensor is replaced every 3 years. This action has been close-out on 11/02/2016. |
| Contact Information |
1800 147 118 - Hill-Rom Technical Support |