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U.S. Department of Health and Human Services

Class 2 Device Recall Sterrad CycleSure Biological Indicator

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 Class 2 Recall
Sterrad CycleSure Biological Indicator
see related information
Date Posted October 20, 2009
Recall Status1 Terminated on November 29, 2011
Recall Number Z-0066-2010
Recall Event ID 52632
Premarket Notification
510(K) Numbers
K031226  K994055 
Product Classification Indicator, Biological Sterilization Process - Product Code FRC
Product Sterrad CycleSure Biological Indicator, Product Code 14324. The Sterrad CycleSure Biological Indicator is intended to be used as a standard method for frequent monitoring of the Sterrad Sterilizer cycles.
Code Information All Lots.
Recalling Firm/
Manufacturer
Advanced Sterilization Products
33 Technology Drive
Irvine, California 92618
Manufacturer Reason
for Recall
Biological Indicator indicating a positive result does not maintain yellow color for the entire incubation period and some indicators experience media evaporation prior to the end of the labeled maximum incubation time.
FDA Determined
Cause 2
DESIGN: Device Design
Action An Important Product Labeling Correction - New Instructions for Use dated, June 26, 2009, has been proposed to be sent by the firm for Cyclosure Biological Indicators to consignees. The revised instructions reduce the maximum read time for the indicators to 3 days (72 hours). The letter also states why ASP changed the Instructions. Questions are to be directed to ASP Customer Care Center.
Distribution Worldwide Distribution.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRC and Original Applicant = ADVANCED STERILIZATION PRODUCTS
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