Class 2 Device Recall STERRAD 100NX Cassettes

• Date Initiated by Firm: September 18, 2013
• Date Posted: October 22, 2013
• Recall Status: Terminated on January 13, 2014
• Recall Number: Z-0044-2014
• Recall Event ID: 66317
• 510(K)Number: K071385
• Product Classification: Sterilizer, chemical - Product Code MLR
• Product: STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
• Code Information: Lot# 13F050, 13F051, 13F049
• Recalling Firm/ Manufacturer: Advanced Sterilization Products; 33 Technology Dr; Irvine CA 92618-2346
• For Additional Information Contact: 949-453-6400
• Manufacturer Reason for Recall: Advanced Sterilization Products (ASP) is recalling the three lots (13F049, 13F050, 13F051) STERRAD 100NX Cassettes because ASP has determined that the leak indicator on the cassettes is effective for only 12 months of the cassette's labeled 15-month shelf-life.
• FDA Determined Cause: Under Investigation by firm
• Action: Advanced Sterilization Products (ASP) sent an Urgent Medical Device Recall letter on September 18, 2013, to all affected customers. The letter informed the customers of the problems identified and the actions to be taken. Customers were instructed to examine their inventory and return all affected cassettes using the enclosed prepaid UPS return lave to Stericycle. Customers were asked to count their inventory and record the data on the enclosed Business Reply Card and Packing Slip. Customers were asked to provide the notice to anyone in their facility that needs to be informed. Customers were also asked to maintain a copy of the notice with the affected product. Customers with questions or suspected problems were instructed to contact Stericycle directly at 1-877-257-7119. For questions regarding this recall call 949-453-6400.
• Quantity in Commerce: 2,995 units
• Distribution: Nationwide Distribution
• 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 = MLR