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U.S. Department of Health and Human Services

Class 2 Device Recall STERRAD Cyclesure Biological Indicator (BI),

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  Class 2 Device Recall STERRAD Cyclesure Biological Indicator (BI), see related information
Date Initiated by Firm June 28, 2012
Date Posted July 27, 2012
Recall Status1 Terminated 3 on August 13, 2013
Recall Number Z-2100-2012
Recall Event ID 33854
510(K)Number K103222  
Product Classification Indicator, biological sterilization process - Product Code FRC
Product STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation kits and STERRAD test packs.

The STERRAD CYCLESURE 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
Code Information Lot# 002127, 003127, 005127, 006127, 007127, 008127, 009127, 010127, 011128, 012127, 013127, 014127, 015127, 016127, 018127, 019127, 020127, 021127, 023127, 024127, 025127, 026127, 027127, 028127, 030127, 031127, 032127, 033127, 034127, 035127, 036127, 037127, 038121, 038127 039127, 040127, 041121, 042127, 043127, 044127, 045121, 045127, 046127, 047127, 048127, 049127, 052127, 053121, 053127, 054127, 055121, 056127, 057127, 058127, 059127, 060127, 061127, 062121, 062127, 063127, 064127, 065127, 067127, 068127, 069121, 069127, 070127, 071127, 072127, 073127, 074127, 076121, 077127, 078127, 078128, 079127, 081127, 082127, 084127, 085127, 086121, 086127, 087127, 089127, 090127, 092127, 093121, 094127, 095127, 100121, 100127, 101127, 102127, 104127, 107121, 107127, 107128, 109127, 109128, 110127, 111127, 114121, 114127, 118127, 121121, 121127, 123127, 124127, 125127, 128121, 128127, 129127, 130127, 131127, 132127, 135121, 135127, 136127, 137127, 138127, 139127, 142121, 142127, 143127, 144127, 145127, 146127, 150121, 150127, 151127, 152127, 152128,156127, 157127, 158127, 159127, 160127, 163127, 164127,165127, 339117, 340117, 341117, 342117, 343117, 344117, 345117, 346117, 347117, 348117, 349117, 350117, 351117, 352117, 353117, 354117, 355117, 357117, 360117, 362117, 363117, 364117.
Recalling Firm/
Manufacturer		 Advanced Sterilization Products
33 Technology Dr
Irvine CA 92618-2346
For Additional Information Contact Katie Sweet
949-789-3945
Manufacturer Reason
for Recall		 Advanced Sterilization Products (ASP) is recalling certain lots of the STERRAD CYCLESURE 24 Biological Indicator (BI) product because it does not have adequate data to support the entire duration of the product's labeled shelf-life.
FDA Determined
Cause 2		 Incorrect or no expiration date
Action ASP has posted the STERRAD CYCLESURE Biological Indicator customer letter on their external facing website at: wwww.aspjj.com/us/news/cyclesureletter on July 3, 2012. The letter informed customers who purchased STERRAD CYCLESURE 24 Biological Indicator (BI) product that Advanced Sterilization Products (ASP) is recalling certain lots because ASP has determined that it does not have adequate data to support the entire duration of the product's labeled shelf-life. The letter also provided the customers with what actions are needed for the recall. Customers were instructed to return all unused STERRAD CYCLESURE 24 BI product that exceeds the newly determined expiration dated using the enclosed prepaid UPS return label to Stericycle, 2670 Executive Drive Suite A, Indiapolis, IN 46241. Customers were instructed to count their inventory of product that exceeds the newly determined expiration date and record the data on the enclosed Business Reply Card and packing slip that are included with the customer recall letter. Customers were instructed to complete the requested information on the enclosed postage paid Business Reply Card and return it to Stericycle. Customers were instructed to contact Stericycle at (877) 907-7030 if they need additional packing labels. If customers further distribute the affected products to other locations, then they were instructed to contact Stericycle to arrange for return of the product. Customers were instructed that new shipments of STERRAD CYCLESURE 24 BI product will be shipped on July 9, 2012 that has accurate expiration dates that do not require conversion. Customers wil be able to differentiate between current product and the newly shipped product by the lot number. Current product has a lot number containing 6 characters, eg. 123456. Newly shipped product will have a lot number containing 8 characters, eg. 123456EE. Customers with any additional questions were instructed to contact (877) 907-7030 or contact their A
Quantity in Commerce 38,693 units
Distribution Worldwide Distribution - USA (nationwide)
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FRC and Original Applicant = ADVANCED STERILIZATION PRODUCTS
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