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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 Recall
STERRAD NX Sterilizer
see related information
Date Posted December 02, 2008
Recall Status1 Open
Recall Number Z-0484-2009
Recall Event ID 50071
Premarket Notification
510(K) Number
K042116 
Product Classification Sterilizer, Chemical - 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, California 92618
Consumer Instructions Contact the recalling firm for information
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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MLR and Original Applicant = ADVANCED STERILIZATION PRODUCTS
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