Class 3 Device Recall

• Date Initiated by Firm: September 04, 2003
• Date Posted: September 21, 2004
• Recall Status: Terminated on January 04, 2005
• Recall Number: Z-1479-04
• Recall Event ID: 27676
• 510(K)Number: K981054
• Product Classification: Indicator, Physical/Chemical Sterilization Process - Product Code JOJ
• Product: Gluteraldehyde Concentration Indicators ''Browne GA Indicator for CIDEX PLUS Products''
• Code Information: CIDEX PLUS code 2924 lots: 9467, 9514, 9517, 9533 CIDEX PLUS code 2926, lots: 9504, 9518, 9534, 9624, 9655
• FEI Number: 3003662624
• Recalling Firm/ Manufacturer: Advanced Sterilization Products; 33 Technology Dr; Irvine CA 92618-2346
• For Additional Information Contact: Nevine Erian; 949-453-6422
• Manufacturer Reason for Recall: Performance failure complaints.
• FDA Determined Cause: 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

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