Z-0468-2012

STERRAD NX Sterilizer Hydrogen Peroxide Gas Plasma Sterilizer Product Code 10133. The STERRAD Sterilization...

Name: Z-0468-2012 STERRAD NX Sterilizer Hydrogen Peroxide Gas Plasma Sterilizer Product Code 10133. The STERRAD Sterilization...
Creator: Advanced Sterilization Products
Published: 2008-12-10
License: https://open.fda.gov/license/

Advanced Sterilization Products / initiated 2008-12-10 / Terminated / root cause: labeling and UDI

FDA source

Advanced Sterilization Products began a recall of STERRAD NX Sterilizer Hydrogen Peroxide Gas Plasma Sterilizer Product Code 10133. The STERRAD Sterilization System is a low-temperature general-purpose... on 2008-12-10. The reason FDA records is "Advanced Sterilization Products (ASP) has discovered a defect in the barcode labeling of the STERRAD NX System Cassettes 10133, Lot #08I032. This is the only lot number affected by this action. The barcodes for Lot...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0468-2012
Status: Terminated
Initiated: 2008-12-10
Posted: 2012-01-11
Terminated: 2011-12-16
Recalling firm: Advanced Sterilization Products
Product: STERRAD NX Sterilizer Hydrogen Peroxide Gas Plasma Sterilizer Product Code 10133. The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Product code: MLR Sterilizer, Chemical
Reason for recall: Advanced Sterilization Products (ASP) has discovered a defect in the barcode labeling of the STERRAD NX System Cassettes 10133, Lot #08I032. This is the only lot number affected by this action. The barcodes for Lot #08I032 were printed improperly and are not capable of being read by the STERRAD unit.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Advance Sterilization Products sent an "URGENT: PRODUCT RECALL" letter dated December 10, 2008 to all affected customers. The letter described the product, problem, and the actions to be taken by the customers. The letter instructs customers to examine inventory and return all sealed cassettes, using an enclosed prepaid UPS return label to: Stericycle, 2670 Executive Drive Suite A, Indianapolis, IN 46241. Additionally, a Business Reply Card and packing slip were included with the letter for customers to complete and return. Questions or further assistance was directed to ASP Customer Care Center at 888-783-7723, option 2.
Quantity in commerce: 776 cases
Distribution: Nationwide Distribution.
Product codes and lots: Product Code 10133; Lot #081032

Product code MLR

K042116Class IISterrad Nx SterilizerAdvanced Sterilization Products / cleared 2005-04-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)