| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00697-3 |
| Product Name/Description |
STERRAD 100S System Cassettes (To provide the hydrogen peroxide sterilant used in the STERRAD Steriliser)
Product Number: 10113
Lot Number: 12A070
ARTG Number: 123602 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/07/2012 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has discovered that printed information on the cassette results in the steriliser being unable to properly read the barcode. During the automated process used to print information on STERRAD 100S System cassettes, an additional thirteenth (13th) bar was added to the barcode resulting in an unusable cassette. Because the STERRAD 100S System is designed to accept only properly coded cassettes, the STERRAD 100S will reject all incorrect cassettes and display an error message: “INCORRECT CASSETTE TYPE”. |
| Recall Action |
Recall |
| Recall Action Instructions |
Quarantine and return affected product to Johnson & Johnson Medical. |
| Contact Information |
1800 252 194 - JJM Customer Service |