Class 2 Device Recall CidexPlus Solution Test Strips

• Date Initiated by Firm: March 16, 2005
• Date Posted: April 27, 2005
• Recall Status: Terminated on March 20, 2007
• Recall Number: Z-0779-05
• Recall Event ID: 31495
• 510(K)Number: K981054
• Product Classification: Indicator, Physical/Chemical Sterilization Process - Product Code JOJ
• Product: Cidexplus Solution Test Strips
• Code Information: Product Code: 2924 Lot Numbers: 011480, 011483, 011019 Product Code: 2926 Lot Numbers: 011283, 011020
• FEI Number: 3003662624
• Recalling Firm/ Manufacturer: Advanced Sterilization Products; 33 Technology Dr; Irvine CA 92618-2346
• For Additional Information Contact: Elizabeth MacAdams; 949-581-5799
• Manufacturer Reason for Recall: CIDEX test strips were found to pass solution below MEC.
• FDA Determined Cause: Other
• Action: Customers were notified via urgent product recall letter dated March 16, 2005, to return the product for replacement.
• Quantity in Commerce: 3422 cases (2 bottles per case)
• Distribution: Nationwide & Puerto Rice
• 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