19
Jun
2002

Advanced Sterilization Products Class II

0

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.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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