STERRAD 100NX Cassette (Used to provide hydrogen peroxide sterilant used in the STERRAD NX Steriliser) 의 리콜

Recall

RC-2013-RN-00811-1

Class II

2013-08-02

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00811-1

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.

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.