| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01132-1 |
| Product Name/Description |
STERRAD CYCLESURE 24 Biological Indicators (sterilisation process indicator)
Product Number: 14324
Multiple Lot Numbers
Manufactured between February 2008 and December 2011
ARTG Number: 134121 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has determined that it may not have adequate data to support the entire duration of the labelled shelf life of product manufactured from February 2008 to December 2011. |
| Recall Action |
Recall |
| Recall Action Instructions |
Quarantine and return affected product to Johnson & Johnson Medical |
| Contact Information |
1800 252 194 - Johnson & Johnson Medical Customer Service |