| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01570-1 |
| Product Name/Description |
Medical Mattresses and Mattress Covers
Affected Batches: with printed date of manufacture between 01 June 2014 and 31 January 2016
ARTG Number: 107808 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/12/2016 |
| Responsible Entity |
|
| Reason/Issue |
There is the potential of defective labels on the printed mattress covers at the foot of the mattress. These defective labels 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 |
MacMed is requesting customers to quarantine affected stock which have not been used. Collection of affected products and replacement with unaffected goods will take place as soon as possible. For customers with mattresses already in use, MadMed will visit these customers to inspect if they have affected stock which requires replacing. |
| Contact Information |
1300 308 184 - MacMed Healthcare |