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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 Posted December 12, 2012
Recall Status1 Terminated 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 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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