Advanced Sterilization Products Class II

Company: Advanced Sterilization Products
Date: 6/19/2002
Class: II

PRODUCT
STERRAD 100S Sterilization System. Recall # Z-1082-2.

REASON
Software anomaly allows half cycle run when full cycle displayed.

CODE
Version 3 or lower is subject to upgrade. Newer versions contain software “fix”. Current version is Version 6.

RECALLING FIRM/MANUFACTURER
Advanced Sterilization Products, Irvine, CA, by letters sent March 28, 2002. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1,405

DISTRIBUTION
Nationwide.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.