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Terminated

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.

FDA Recall Z-0484-2009 · Posted 2008-12-02

Recalling FirmAdvanced Sterilization Products
Recall StatusTerminated
Product CodeMLR
Date Initiated2008-10-07
Date Terminated2011-11-07
Product Quantity32 potentially affected systems in the US - 20 installed, 5 uninstalled, 7 potentially affected. There are also 15 units internationally.

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042116STERRAD NX STERILIZERAdvanced Sterilization Products · 2005-04-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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