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U.S. Department of Health and Human Services

Class 3 Device Recall CIDEX Activated

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  Class 3 Device Recall CIDEX Activated see related information
Date Initiated by Firm September 04, 2003
Date Posted September 21, 2004
Recall Status1 Terminated 3 on January 04, 2005
Recall Number Z-1480-04
Recall Event ID 27676
510(K)Number K922481  
Product Classification Indicator, Physical/Chemical Sterilization Process - Product Code JOJ
Product Gluteraldehyde Concentration Indicators

''Browne GA Indicator for CIDEX Products''
Code Information CIDEX Activated code 2927, lots: 9520, 9656, 9695, 9804, 9896, 10001  CIDEX Activated Code 2920, lots: 9447, 9522, 9621, 9622, 9661, 9662, 96666, 9764, 9897
Recalling Firm/
Manufacturer		 Advanced Sterilization Products
33 Technology Dr
Irvine CA 92618-2346
For Additional Information Contact Nevine Erian
949-453-6422
Manufacturer Reason
for Recall		 Performance failure complaints.
FDA Determined
Cause 2		 Other
Action Firm issued a Safety Alert to inform users to perform a daily Quality Control check of the test strips to ensure that they are working.
Quantity in Commerce 15,334 cases
Distribution Nationwide, Europe, Latin America, Australia, Canada, and Asia Pacific.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JOJ and Original Applicant = BOARD OF DIRECTORS, ALBERT BROWNE LTD.
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