Urgent Device Correction Information
April 23, 2008
ASP would like to inform you of a voluntary corrective action we are
proactively taking to ensure the continued safe and appropriate use of our
products.
Letter
Voluntary device correction notice related to customer reports of STERRAD
Sterilizers emitting a mist due to a premature mechanical failure in its oil
mist filter and/or filter assemblies.
User's Guide Update Excerpt
The STERRAD Systems User's Guide Excerpt that outlines personal safety and
first aid precautions that should be taken in the event that a customer’s
STERRAD System experiences an oil mist filter failure.
We recognize that this information may pose challenges for you in your daily
sterilization practices. We are committed to working with you to minimize any
disruption these developments may have on your work and ensure we merit the
trust you put in us and our products every day. Thank you for your valued
partnership as we work together to safely and effectively prevent infection.
Click
here to view 2007 Product Correction Notices