| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01408-1 |
| Product Name/Description |
Pressure Care Medical Mattresses and Mattress Covers
NP200 Mattress Cover only
NP200W90E Pressure Care Mattress
NP200W90NE Pressure Care Mattress
Manufactured between 01 June 2014 and 31 January 2016
ARTG Numbers: 261172, 260051 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
31/10/2016 |
| Responsible Entity |
|
| Reason/Issue |
An issue has been identified where defective labels on the printed mattress covers at the foot of the mattress may let liquid through the cover material into the foam mattress and may produce a very low risk of contamination of the mattress. The risk of infection from this defective label to a patient is very small and very unlikely. |
| Recall Action |
Recall |
| Recall Action Instructions |
The Comfort Group is advising customers to quarantine affected stock. Collection of affected products and replacement with unaffected goods will take place as soon as possible.
This action has been closed out on the 26/09/2018.
This action has been closed out on 26/09/2018 |
| Contact Information |
07 3902 8888 - Australian Comfort Group |