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Class 3 Device Recall |
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Date Initiated by Firm |
September 04, 2003 |
Date Posted |
September 21, 2004 |
Recall Status1 |
Terminated 3 on January 04, 2005 |
Recall Number |
Z-1479-04 |
Recall Event ID |
27676 |
510(K)Number |
K981054
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Product Classification |
Indicator, Physical/Chemical Sterilization Process - Product Code JOJ
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Product |
Gluteraldehyde Concentration Indicators
''Browne GA Indicator for CIDEX PLUS Products''
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Code Information |
CIDEX PLUS code 2924 lots: 9467, 9514, 9517, 9533 CIDEX PLUS code 2926, lots: 9504, 9518, 9534, 9624, 9655 |
Recalling Firm/ Manufacturer |
Advanced Sterilization Products 33 Technology Dr Irvine CA 92618-2346
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For Additional Information Contact |
Nevine Erian 949-453-6422
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Manufacturer Reason for Recall |
Performance failure complaints.
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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 |
11797 cases |
Distribution |
Nationwide, Europe, Latin America, Australia, Canada, and Asia Pacific. |
Total Product Life Cycle |
TPLC Device Report
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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 = JOJ and Original Applicant = ALBERT BROWNE LTD.
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