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U.S. Department of Health and Human Services

Class 3 Device Recall Cidex

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 Class 3 Device Recall Cidexsee related information
Date Initiated by FirmFebruary 14, 2003
Date PostedMarch 29, 2003
Recall Status1 Terminated 3 on September 27, 2004
Recall NumberZ-0694-03
Recall Event ID 25725
510(K)NumberK922481 
Product Classification unknown device name - Product Code 6885
ProductCidex Solution Test Strips Browne GA Indicators for Cidex Solution Test Strips.
Code Information Cidex Activated, Product Code 2920 lots: 7840 7739 8064 8503 8422 8661 8771 8923 9188 9313 9414  Cidex Plus, Product Code 2924, lots:  Cidex Activated, Product code 2927, lots: 7783 8160 8182 8604 8790 9317 9404 
FEI Number 3003662624
Recalling Firm/
Manufacturer		 Advanced Sterilization Products
33 Technology Dr
Irvine CA 926182346
For Additional Information ContactNevine Erian
949-453-6422
Manufacturer Reason
for Recall		Test strips which are used for QC of sterilant solution fail prematurely due to ingress of moisture.
FDA Determined
Cause 2		Other
ActionSeveral emails and letters were sent between 2/14/03 and 2/27/03 to customers requesting return of product and also advising them that should return not be a viable option due to availability of replacements, a suggested temporary QC procedure could be used to separate good lots of strips from affected lots.
Quantity in Commerce22,992 cases (2 bottles per case)
DistributionNationwide. Australia, Brazil, Canada, Puerto Rico, Colombia, Japan, Korea, South Africa, Thailand, England, Uruguay, Venezuela, Republic of Panama.
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) Database510(K)s with Product Code = 6885
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