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.
FDA Recall Z-0468-2012 · Posted 2012-01-11
Recalling FirmAdvanced Sterilization Products
Recall StatusTerminated
Product CodeMLR
Date Initiated2008-12-10
Date Terminated2011-12-16
Product Quantity776 cases
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.
Firm 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.
Root Cause
Error in labeling
Distribution Pattern
Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.