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.

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email training@softwarecpr.com
to receive discount

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
For info on this course, email training@softwarecpr.com

Corporate Office

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