| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00811-1 |
| Product Name/Description |
STERRAD 100NX Cassette (Used to provide hydrogen peroxide sterilant used in the STERRAD NX Steriliser)
Part Number: 10144
Expiration dates before November 1, 2014 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/08/2013 |
| Responsible Entity |
|
| Reason/Issue |
STERRAD 100NX System cassettes are designed with a Leak Indicator on the outer package to provide a visual colour indication in the event Hydrogen Peroxide has leaked from the cassettes. The manufacturer has determined it does not have adequate data to support the effectiveness of the packaging's Leak Indicator for the entire duration of the STERRAD 100NX System cassette's 15 month shelf life. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Johnson & Johnson Medical (JJM) is requesting end users to wear additional safety equipment (protective gloves and eye wear) in the event of handling product with an expired leak indicator as a precautionary measure for devices with an expiration date prior to 1 November 2014. End users are also requested to check for signs of indicator colour change or liquid leakage prior to opening the package. If the white indicator has turned red or a liquid leak is observed, customers are asked to dispose of the cassette immediately. Any indication of leakage should also be notified to JJM. |
| Contact Information |
1800 252 194 - Johnson and Johnson Medical Customer Service |