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Class 3 Device Recall Cidex |
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Date Initiated by Firm |
February 14, 2003 |
Date Posted |
March 29, 2003 |
Recall Status1 |
Terminated 3 on September 27, 2004 |
Recall Number |
Z-0694-03 |
Recall Event ID |
25725 |
510(K)Number |
K922481
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Product Classification |
unknown device name - Product Code 6885
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Product |
Cidex Solution Test Strips
Browne GA Indicators for Cidex Solution Test Strips.
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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 |
Recalling Firm/ Manufacturer |
Advanced Sterilization Products 33 Technology Dr Irvine CA 926182346
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For Additional Information Contact |
Nevine Erian 949-453-6422
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Manufacturer Reason for Recall |
Test strips which are used for QC of sterilant solution fail prematurely due to ingress of moisture.
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FDA Determined Cause 2 |
Other |
Action |
Several 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 Commerce |
22,992 cases (2 bottles per case) |
Distribution |
Nationwide. Australia, Brazil, Canada, Puerto Rico, Colombia, Japan, Korea, South Africa, Thailand, England, Uruguay, Venezuela, Republic of Panama. |
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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.
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510(K) Database |
510(K)s with Product Code = 6885 and Original Applicant = BOARD OF DIRECTORS, ALBERT BROWNE LTD.
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