Company: Advanced Sterilization Products
Date of Enforcement Report 11/26/2008
Class:ll

PRODUCT
STERRAD 100S Sterilizer (Product Code 10101). The sterilizer includes software and hardware components. The STERRAD Sterilization System is a low-temperature, general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices, Recall # Z-0340-2009

REASON
1) Inability of the sterilizer to detect when an injection takes place without hydrogen peroxide being transferred to the vaporizer bowl. This situation can result in a cycle completion with the injection of insufficient hydrogen peroxide sterilant and 2) Inability of the sterilizer to detect an obstruction in the door travel path while the door is closing. This situation can result in a hand becoming pinched and bruised while the door is closing.

RECALLING FIRM/MANUFACTURER
Advanced Sterilization Products, Irvine, CA, by letter beginning November 24, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
6,324 units (USA 2,623 units and internationally 3,701 units)

DISTRIBUTION
Nationwide and Internationally