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U.S. Department of Health and Human Services

Class 3 Device Recall CIDEX OPA Indicator

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 Class 3 Device Recall CIDEX OPA Indicatorsee related information
Date Initiated by FirmSeptember 04, 2003
Date PostedSeptember 21, 2004
Recall Status1 Terminated 3 on January 04, 2005
Recall NumberZ-1481-04
Recall Event ID 27676
510(K)NumberK991709 
Product Classification Indicator, Physical/Chemical Sterilization Process - Product Code JOJ
ProductOrtho-phthaladehyde Concentration Indicator Browne CIDEX OPA Indicator
Code Information CIDEX OPA code 20392, lots: 9272, 9273, 9433, 9434, 9436, 9461, 9512, 9513, 9537, 9538, 9578, 9593, 9664, 9699, 9743, 9744, 9745, 9746, 9814, 9815, 9816, 9854, 9935, 9984, 9985, 10019,  10028, 10036, 10037, 8101, 8144, 8218, 8233, 8321, 8482, 8483, 8510, 8511, 8512, 8513, 8514, 8618, 8630, 8631, 8632, 8636, 8637, 8638, 8792, 8793, 8794, 8795, 8796, 8797, 8798, 8978, 8980, 8981, 9130, 9131, 9133, 9270, 9271, 9272  CIDEX OPA code 20393, lots: 8079, 8102, 8219, 8223, 8421, 8456, 8515, 8550, 8633, 8639, 8970, 8982, 9075, 9260, 9274, 9275, 9536, 9564, 9663, 9796, 9907, 9908, 10000
FEI Number 3003662624
Recalling Firm/
Manufacturer		 Advanced Sterilization Products
33 Technology Dr
Irvine CA 92618-2346
For Additional Information ContactNevine Erian
949-453-6422
Manufacturer Reason
for Recall		Performance failure complaints.
FDA Determined
Cause 2		Other
ActionFirm 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 Commerce95783 cases
DistributionNationwide, Europe, Latin America, Australia, Canada, and Asia Pacific.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JOJ
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