Class 2 Device Recall

• Date Initiated by Firm: December 17, 2003
• Date Posted: January 29, 2004
• Recall Status: Terminated on September 10, 2004
• Recall Number: Z-0375-04
• Recall Event ID: 28031
• Product Classification: Indicator, Physical/Chemical Sterilization Process - Product Code JOJ
• Product: Cidex Plus Test Strips
• Code Information: Product code 2924-Lot 010185 Product code 2926-Lot010252
• 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: May not accurately detect minimum effective concentration (MEC)
• FDA Determined Cause: Other
• Action: Recall was made by various emails sent 12/12/2003 to 12/19/2003. Customers are requested to quarantine and return product.
• Quantity in Commerce: 710 cases, 2 bottles per case
• Distribution: Nationwide. Japan, Puerto Rico, Latin America, Caribbean.
• 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.