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U.S. Department of Health and Human Services

Class 2 Device Recall Sterrad Cyclesure 24 Biological Indicator

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 Class 2 Recall
Sterrad Cyclesure 24 Biological Indicator
see related information
Date Posted June 06, 2012
Recall Status1 Terminated on October 17, 2013
Recall Number Z-1773-2012
Recall Event ID 61954
Premarket Notification
510(K) Number
K103222 
Product Classification Indicator, Biological Sterilization Process - Product Code FRC
Product Sterrad Cyclesure 24 Biological Indicator, P/N: 14324 The STERRAD CYCLESURE 24 Biological Indicator is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
Code Information Lot# 214117, 216117, 217117, 227117, 227118, and 228117.
Recalling Firm/
Manufacturer
Advanced Sterilization Products
33 Technology Dr
Irvine, California 92618-2346
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
The recall was initiated by Advanced Sterilization Products because they recently determined that certain lots of raw materials that were rejected during incoming inspection acceptance test were used for the manufacture of a specific lot range of Sterrad Cyclesure 24 Biological Indicator.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Advanced Sterilization Products a Johnson & Johnson company sent an Urgent Product Recall letter dated March 16, 2012, to all affected customers. The letter provided the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to read the "Details on the Affected Devices/Description of the problem" section in the letter. Customers were instructed to immediately identify and set aside all product listed above in a manner that ensures product will not be used. The lot number and the part number are printed on the label placed around the ampoules. Customers were instructed to return any affected product in accordance with the "Product Return Instructions" section of the letter. Customers were instructed to complete the requested information on the enclosed postage paid business reply card and return it to Stericycle even if they do not have the affected products listed on the letter in stock. Customers with questions were instructed to contact Stericycle at (877) 492-4795. For questions regarding this recall call 949-453-6400.
Quantity in Commerce 2,284 cases (137,040 Biological Indicators)
Distribution Worldwide Distribution - USA (nationwide) and the countries of AR, AU, BE, BR, CA, EC, HK, JP, MX, and PR
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 = FRC and Original Applicant = ADVANCED STERILIZATION PRODUCTS
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