Class 2 Device Recall Tyvek Roll with STERRAD Chemical Indicator

• Date Initiated by Firm: December 24, 2014
• Date Posted: March 23, 2015
• Recall Status: Terminated on September 04, 2015
• Recall Number: Z-1312-2015
• Recall Event ID: 70216
• 510(K)Number: K141693
• Product Classification: Wrap, sterilization - Product Code FRG
• Product: Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425
• Code Information: Lot No. 68965-1241
• 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 Tyvek Rolls with STERRAD Chemical Indicator because they were shipped to customers after its expiration date of May 18, 2013.
• FDA Determined Cause: Under Investigation by firm
• Action: A customer notification letter was sent on 12/24/14 to all customers who purchased the expired Tyvek Rolls with STERRAD Chemical Indicator. The letter informs the customers of the problems identified and the actions to be taken.
• Quantity in Commerce: 2 units
• Distribution: Saudi Arabia and Portugal
• 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 = FRG