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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 Hill-Rom Pty Ltd
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