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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 Device Recall STERRAD CYCLESURE 24 Biological Indicator see related information
Date Initiated by Firm October 03, 2012
Date Posting Updated December 12, 2012
Recall Status1 Terminated 3 on July 19, 2013
Recall Number Z-0520-2013
Recall Event ID 63758
510(K)Number K103222  
Product Classification Indicator, biological sterilization process - Product Code FRC
Product STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324.

Validation kits with Sterrad Cyclesure 24 BI products:

Codes/Serial Numbers, Product Description:

14324 Sterrad Cyclesure 24 Biological Indicator.
14324-02 Sterrad Cyclesure 24 Biological Indicator.
10134 Sterrad 100NX Express Cycle Kit.
10135 Sterrad 100NX Express Cycle Upgrade Kit.
10137 Sterrad 100NX Duo Cycle Upgrade kit.
14325 Cyclesure Challenge Pack Kit.
20103 Sterrad 100NX Test Pack Kit.
20228 Sterrad 100NX Intl Validation Kit.
20229 Sterrad 100NX Validation Kit, USA.
20232 Sterrad 50/100S Validation Kit.
20236 Sterrad 50/100S Validation Kit.
20248 Sterrad 100NX Express Validation Kit.
20253 Sterrad NX Validation Kit.
20254 Sterrad NX Validation Kit Domestic, US.

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 41102 067101 117107 208107, 042101 067107 127107 209107, 042107 068101 131107 210107, 043101 068102 136107 211107, 047101 069101 137107 214107

215107 264107 273107 314107, 216107 265107 277107 315107, 217107 263107 278107 309107, 221108 266107 279107 316107, 223107 267107 280107 318107, 224107 270107 281107 320107, 225107 272107 285107 321107, 228107 273107 286107 181107, 229107 277107 168107 322107, 230107 278107 287107 335107, 231107 279107 288107 340107, 232107 280107 166107 341107, 235107 281107 291107 342107, 236107 285107 169107 343107, 236117 286107 173107 343108, 237107 287107 175107 337107, 238107 288107 176107 345107, 242107 291107 177107 349107, 244107 295107 179107 349108, 245107 300107 295107 350107, 250107 301107 300107 347108, 244108 302107 301107 351107, 250108 303107 303107 354107, 251107 305107 302107 347107, 252107 306107 305107 352107, 254107 307107 306107 361107, 257107 308107 307107 362107, 253107 312107 308107 364107, 255107 313107 312107 003117, 257108 314107 313107 004117

005118 053117 089117 131117 214117, 006117 055117 090117 132117 216117, 010117 045117 094117 133117 217117, 011117 058117 091117 136117 218117, 012117 050117 092117 137117 220117, 013117 054117 095117 138117 221117, 014117 059117 096117 139117 222117, 016117 356107 097117 140117 223117, 187107 060117 098117 141117 224117, 020118 061117 099117 143117 228117, 021117 062117 101117 134117 , 024117 063117 102117 144117 , 025117 065117 103117 145117 , 027117 069117 104117 146117 , 026117 069118 105117 147117 , 031117 070117 106117 151117 , 032117 076117 108117 152117 , 034117 074117 109117 153117 , 036117 075117 110117 154117 , 038117 077117 112117 156117 , 035118 078117 115117 157117 , 039117 080117 116117 159117 , 040117 081117 117117 160117 , 042117 081118 118117 161117 , 041117 082117 123117 172117 , 020117 083117 125117 173117 , 043117 085117 126117 177117 , 047117 084117 121117 175117 , 048117 087117 124117 179117 , 049117 088117 129117 181117



Recalling Firm/
Manufacturer
Advanced Sterilization Products
33 Technology Dr
Irvine CA 92618-2346
For Additional Information Contact
949-453-6400
Manufacturer Reason
for Recall
Advanced Sterilization Products (ASP) is recalling all lots of Sterrad Cyclesure 24 Biological Indicator (BI) manufactured between February 2008 and December 2011 because it may not have adequate data to support the entire duration of the labeled shelf-life.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Advanced Sterilization Products (ASP) sent an "URGENT MEDICAL DEVICE RECALL (REMOVAL) letter dated November 2, 2012 to all customers who received the Sterrad Cyclesure 24 Biological Indicator (BI) product P/N 14324 manufactured between February 2008 and December 2011. The letter informed the customers of the problem identified and the actions to be taken. ASP determined that the 24 BI may not have adequate data to support the entire duration of the labeled shelf life of affected product manufactured during the above timeframe. The letter also informed customers that this is a different recall from the previous July 3, 2012 STERRAD CYCLESURE 24 BI recall. Customers with questions or need additional packing labels are instructed to call Stericycle at (877) 650-7692.
Quantity in Commerce 38,532 units
Distribution Worldwide Distribution-USA (nationwide) and the countries of AR, AU, BE, BR, CA, CL, CN, CO, EC, GT, HK, ID, IN, JP, KR, MX, MY, PA, PE, PH, SG, TH, VE, and RU.
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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