Class 2 Device Recall Sterrad Cyclesure 24 Biological Indicator

• Date Initiated by Firm: February 17, 2012
• Date Posted: June 06, 2012
• Recall Status: Terminated on October 17, 2013
• Recall Number: Z-1773-2012
• Recall Event ID: 61954
• 510(K)Number: K103222
• Product Classification: Indicator, biological sterilization process - Product Code FRC
• Product: Sterrad Cyclesure 24 Biological Indicator, P/N: 14324 The STERRAD CYCLESURE 24 Biological Indicator is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
• Code Information: Lot# 214117, 216117, 217117, 227117, 227118, and 228117.
• FEI Number: 3003662624
• Recalling Firm/ Manufacturer: Advanced Sterilization Products; 33 Technology Dr; Irvine CA 92618-2346
• For Additional Information Contact: 949-453-6400
• Manufacturer Reason for Recall: The recall was initiated by Advanced Sterilization Products because they recently determined that certain lots of raw materials that were rejected during incoming inspection acceptance test were used for the manufacture of a specific lot range of Sterrad Cyclesure 24 Biological Indicator.
• FDA Determined Cause: Process control
• Action: Advanced Sterilization Products a Johnson & Johnson company sent an Urgent Product Recall letter dated March 16, 2012, to all affected customers. The letter provided the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to read the "Details on the Affected Devices/Description of the problem" section in the letter. Customers were instructed to immediately identify and set aside all product listed above in a manner that ensures product will not be used. The lot number and the part number are printed on the label placed around the ampoules. Customers were instructed to return any affected product in accordance with the "Product Return Instructions" section of the letter. Customers were instructed to complete the requested information on the enclosed postage paid business reply card and return it to Stericycle even if they do not have the affected products listed on the letter in stock. Customers with questions were instructed to contact Stericycle at (877) 492-4795. For questions regarding this recall call 949-453-6400.
• Quantity in Commerce: 2,284 cases (137,040 Biological Indicators)
• Distribution: Worldwide Distribution - USA (nationwide) and the countries of AR, AU, BE, BR, CA, EC, HK, JP, MX, and PR
• 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 = FRC