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.
This recall has been terminated (originally issued December 2, 2008).
- Company
- Advanced Sterilization Products
- Recall Initiated
- October 7, 2008
- Posted
- December 2, 2008
- Terminated
- November 7, 2011
- Recall Number
- Z-0484-2009
- Quantity
- 32 potentially affected systems in the US - 20 installed, 5 uninstalled, 7 potentially affected. There are also 15 units internationally.
- Firm Location
- Irvine, CA
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
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.
Root Cause
Nonconforming Material/Component
Action Taken
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.