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U.S. Department of Health and Human Services

Class 2 Device Recall Tyvek SelfSeal Pouch with STERRAD Chemical Indicator

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  Class 2 Device Recall Tyvek SelfSeal Pouch with STERRAD Chemical Indicator see related information
Date Initiated by Firm June 23, 2010
Date Posted February 22, 2011
Recall Status1 Terminated 3 on March 14, 2012
Recall Number Z-1393-2011
Recall Event ID 56367
510(K)Number K951295  
Product Classification Sterilization Wrap Containers, Trays, Cassettes & Other Accessories - Product Code KCT
Product Tyvek Self-Seal Pouch with STERRAD Chemical Indicator 12332.

Intended to be used to contain medical devices that are being terminally sterilized in STERRAD Sterilization Systems.
Code Information Lot Number: 2020
Recalling Firm/
Manufacturer		 Advanced Sterilization Products
33 Technology Drive
Irvine CA 92618
For Additional Information Contact
949-453-6400
Manufacturer Reason
for Recall		 The recall was initiated after Advanced Sterilization Products (ASP) discovered a non-conforming lot. The misaligned perforations may have caused the seal to be incomplete on some of the pouches, creating a potential breach for pouches being used to store sterilized equipment on shelves.
FDA Determined
Cause 2		 Process control
Action Advanced Sterilization Products (ASP) released Urgent: Product Recall notifications to its consignees identifying the affected product and explaining the reason for recall. The letter also discussed the impact of using this affected product and return instructions. The firm asked customers to examine their inventory, discontinue use of Tyvek Self-Seal Pouch with STERRAD Chemical Indicator 12332 and to return all unused affected products to Stericycle. Customers are to complete the Business Reply Card and return it to Stericycle.
Quantity in Commerce 470
Distribution Worldwide Distribution -- USA, Argentina, Australia, Canada, Chile, Czech Republic, Hong Kong, India, Japan, Panama, Peru and Puerto Rico.
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 = KCT and Original Applicant = ADVANCED STERILIZATION PRODUCTS
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