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U.S. Department of Health and Human Services

Class 2 Device Recall CidexPlus Solution Test Strips

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  Class 2 Device Recall CidexPlus Solution Test Strips see related information
Date Initiated by Firm March 16, 2005
Date Posted April 27, 2005
Recall Status1 Terminated 3 on March 20, 2007
Recall Number Z-0779-05
Recall Event ID 31495
510(K)Number K981054  
Product Classification Indicator, Physical/Chemical Sterilization Process - Product Code JOJ
Product Cidexplus Solution Test Strips
Code Information Product Code: 2924 Lot Numbers: 011480, 011483, 011019 Product Code: 2926 Lot Numbers: 011283, 011020
Recalling Firm/
Manufacturer		 Advanced Sterilization Products
33 Technology Dr
Irvine CA 92618-2346
For Additional Information Contact Elizabeth MacAdams
949-581-5799
Manufacturer Reason
for Recall		 CIDEX test strips were found to pass solution below MEC.
FDA Determined
Cause 2		 Other
Action Customers were notified via urgent product recall letter dated March 16, 2005, to return the product for replacement.
Quantity in Commerce 3422 cases (2 bottles per case)
Distribution Nationwide & Puerto Rice
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 = ALBERT BROWNE LTD.
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