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U.S. Department of Health and Human Services

Class 2 Device Recall Tyvek Roll with STERRAD Chemical Indicator

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  Class 2 Device Recall Tyvek Roll with STERRAD Chemical Indicator see related information
Date Initiated by Firm December 24, 2014
Date Posted March 23, 2015
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = ADVANCED STERILIZATION PRODUCTS
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