STERRAD NX Sterilizer, Product Code 10033 Low temperature sterilizers that use hydrogen peroxide gas plasma to inactivat

FDA device recall Z-0484-2009 · posted 2008-12-02 · Terminated

Recall details

Recalling firm

Advanced Sterilization Products

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.

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MLR

Quantity affected

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,

Date initiated

2008-10-07

Date posted

2008-12-02

Date terminated

2011-11-07

Location

Irvine, CA

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