Class 3 Device Recall Cidex

• Date Initiated by Firm: February 14, 2003
• Date Posted: March 29, 2003
• Recall Status: Terminated on September 27, 2004
• Recall Number: Z-0695-03
• Recall Event ID: 25725
• 510(K)Number: K981054
• Product Classification: unknown device name - Product Code 6885
• Product: Cidex Plus Solution Test Strips
• Code Information: Cidex Plus, product code 2924, lots: 8423 8560 9229 Cidex Plus, Product code 2926, lots: 8312 8658 9120
• FEI Number: 3003662624
• Recalling Firm/ Manufacturer: Advanced Sterilization Products; 33 Technology Dr; Irvine CA 926182346
• For Additional Information Contact: Nevine Erian; 949-453-6422
• Manufacturer Reason for Recall: Test strips which are used for QC of sterilant solution fail due to ingress of moisture.
• FDA Determined Cause: Other
• Action: Several emails and letters were sent between 2/14/03 and 2/27/03 to customers requesting return of product and also advising them that should return not be a viable option due to availability of replacements, a suggested temporary QC procedure could be used to separate good lots of strips from affected lots.
• Quantity in Commerce: 10,047 cases, (2 bottles per case)
• Distribution: Nationwide. Australia, Brazil, Canada, Puerto Rico, Colombia, Japan, Korea, South Africa, Thailand, England, Uruguay, Venezuela, Republic of Panama.

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 = 6885