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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 October 07, 2008
Date Posted December 02, 2008
Recall Status1 Terminated 3 on November 07, 2011
Recall Number Z-0484-2009
Recall Event ID 50071
510(K)Number K042116  
Product Classification Hydrogen Peroxide Gas Plasma Sterilizer - Product Code MLR
Product STERRAD NX Sterilizer, Product Code 10033

Low temperature sterilizers that use hydrogen peroxide gas plasma to inactivate microorganisms on a broad range of medical and surgical instruments.
Code Information Serial Numbers: 0033081006, 0033081007, 0033081016, 0033081017, 0033081019, 0033081020, 0033081022- 0033081029, 0033081036, 0033081039, 0033081048, 0033081059, 0033081080, 0033081082, 0033081086, 0033081088, 0033081089, 0033081091, 0033081095, 10033060892, 10033060379, 100330050671, 10033070576,10033080067,10033050663, and 10033050661.
Recalling Firm/
Manufacturer		 Advanced Sterilization Products
33 Technology Dr
Irvine CA 92618
For Additional Information Contact
949-453-6410
Manufacturer Reason
for Recall		 ASP has discovered a component defect in some of the UV lamp power supplies used in certain STERRAD NX Sterilizers. This defect can potentially cause the Hydrogen Peroxide Monitor to give inaccurate readings.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The Urgent: Product Correction customer notifications, dated October 6, 2008, were hand delivered by field representatives starting October 7, 2008. The letter advises that Advanced Sterilization Products has discovered a component defect in some of the UV lamp power supplies used in certain STERRAD Sterilizers. This defect can potentially cause the Hydrogen Peroxide Monitor to give inaccurate readings. A list of the affected sterilizer serial numbers is included with the letter. The letter advises that the Field Service Engineer has come to their facility to inspect and, if necessary, replace this power supply. Customers are asked to sign the letter acknowledging receipt of this letter upon completion of the work by the Field Service Engineer.
Quantity in Commerce 32 potentially affected systems in the US - 20 installed, 5 uninstalled, 7 potentially affected. There are also 15 units internationally.
Distribution Worldwide Distribution --- USA including states of WV, CA, TN, AZ, WI, NC, MO, NJ, DE, GA, SC, WA, FL, MA, NM, MI, and AL and countries of Ecuador, China, Israel, Japan, Korea, Middle East, Australia, Czech Republic, Spain, Brazil, and Russia.
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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