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U.S. Department of Health and Human Services

Class 2 Device Recall STERRAD NX Sterilizer

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  Class 2 Device Recall STERRAD NX Sterilizer see related information
Date Initiated by Firm December 10, 2008
Date Posted January 11, 2012
Recall Status1 Terminated 3 on December 16, 2011
Recall Number Z-0468-2012
Recall Event ID 51146
510(K)Number K042116  
Product Classification Sterilizer, chemical - Product Code MLR
Product STERRAD NX Sterilizer Hydrogen Peroxide Gas Plasma Sterilizer Product Code 10133.

The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Code Information Product Code 10133; Lot #081032
Recalling Firm/
Manufacturer		 Advanced Sterilization Products
33 Technology Drive
Irvine CA 92618
For Additional Information Contact
949-453-6410
Manufacturer Reason
for Recall		 Advanced Sterilization Products (ASP) has discovered a defect in the barcode labeling of the STERRAD NX System Cassettes 10133, Lot #08I032. This is the only lot number affected by this action. The barcodes for Lot #08I032 were printed improperly and are not capable of being read by the STERRAD unit.
FDA Determined
Cause 2		 Error in labeling
Action Advance Sterilization Products sent an "URGENT: PRODUCT RECALL" letter dated December 10, 2008 to all affected customers. The letter described the product, problem, and the actions to be taken by the customers. The letter instructs customers to examine inventory and return all sealed cassettes, using an enclosed prepaid UPS return label to: Stericycle, 2670 Executive Drive Suite A, Indianapolis, IN 46241. Additionally, a Business Reply Card and packing slip were included with the letter for customers to complete and return. Questions or further assistance was directed to ASP Customer Care Center at 888-783-7723, option 2.
Quantity in Commerce 776 cases
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 and Original Applicant = ADVANCED STERILIZATION PRODUCTS
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