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U.S. Department of Health and Human Services

Class 2 Device Recall STERRAD 100NX Cassettes

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 Class 2 Recall
STERRAD 100NX Cassettes
see related information
Date Posted October 22, 2013
Recall Status1 Terminated on January 13, 2014
Recall Number Z-0044-2014
Recall Event ID 66317
Premarket Notification
510(K) Number
K071385 
Product Classification Sterilizer, Chemical - Product Code MLR
Product STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Code Information Lot# 13F050, 13F051, 13F049
Recalling Firm/
Manufacturer
Advanced Sterilization Products
33 Technology Dr
Irvine, California 92618-2346
Manufacturer Reason
for Recall
Advanced Sterilization Products (ASP) is recalling the three lots (13F049, 13F050, 13F051) STERRAD 100NX Cassettes because ASP has determined that the leak indicator on the cassettes is effective for only 12 months of the cassette's labeled 15-month shelf-life.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action Advanced Sterilization Products (ASP) sent an Urgent Medical Device Recall letter on September 18, 2013, to all affected customers. The letter informed the customers of the problems identified and the actions to be taken. Customers were instructed to examine their inventory and return all affected cassettes using the enclosed prepaid UPS return lave to Stericycle. Customers were asked to count their inventory and record the data on the enclosed Business Reply Card and Packing Slip. Customers were asked to provide the notice to anyone in their facility that needs to be informed. Customers were also asked to maintain a copy of the notice with the affected product. Customers with questions or suspected problems were instructed to contact Stericycle directly at 1-877-257-7119. For questions regarding this recall call 949-453-6400.
Quantity in Commerce 2,995 units
Distribution Nationwide Distribution
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.
510(K) Database 510(K)s with Product Code = MLR and Original Applicant = ADVANCED STERILIZATION PRODUCTS
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