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U.S. Department of Health and Human Services

Class 2 Device Recall STERRAD NX Cassettes

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 Class 2 Recall
STERRAD NX Cassettes
see related information
Date Posted January 09, 2013
Recall Status1 Terminated on October 17, 2013
Recall Number Z-0661-2013
Recall Event ID 63877
Product Classification Sterilizer, Chemical - Product Code MLR
Product STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate accessory. The STERRAD NX Cassettes are only used in conjunction with the STERRAD NX Sterilization system.
Code Information Lot # 11J037, 11L038, 11J033
Recalling Firm/
Manufacturer
Advanced Sterilization Products
33 Technology Dr
Irvine, California 92618-2346
Manufacturer Reason
for Recall
Advanced Sterilization Products is recalling three lots of STERRAD NX System Cassettes because it does not have adequate data to support the entire duration of the product's labeled shelf-life.
FDA Determined
Cause 2
DESIGN: Labeling Design
Action Advanced Sterilization Product sent an Urgent Medical Device Recall (Removal) letter dated December 4, 2012, to all affected customers. The letter informed the customers that the Sterrad NX Cassettes do not have adequate data to support the entire duration of the product's labeled shelf-life. Customers are instructed of the problems identifed and the actions to be taken. Customers are instructed to notify their customers if they have further distributed the recalled products and to have them contact Stericycle at (877) 650-7686 to arrange for return of the product. Customers with questions are instructed to call Stericycle at (877) 650-7686 Mon-Fri from 8am to 5pm, ET. For questions regarding this recall call 949-453-6400.
Quantity in Commerce 12,280 units
Distribution Worldwide Distribution - USA (nationwide) and internationally to the following countries: AR, CO, TW, SI, AU, MX, MY, HU, PH, BE, FR, DE, IE, IT, ES, NO, CH, and GB.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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