Events

Recall of STERRAD CYCLESURE 24 Biological Indicator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Advanced Sterilization Products.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    63758
  • Event Risk Class
    Class 2
  • Event Number
    Z-0520-2013
  • Event Initiated Date
    2012-10-03
  • Event Date Posted
    2012-12-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114717
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Indicator, biological sterilization process - Product Code FRC
  • Reason
    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.
  • 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.

Device

STERRAD CYCLESURE 24 Biological Indicator
  • Model / Serial
    Lot:   225117 337117 295117 334117 227117 338117 296117 326117 227118 264117 300117 327117 230117 265117 301117 330117 233117 266117 302117 331117 235117 267117 310117 331118 235118 268117 311117 332117 237117 269117 312117 335117 239117 270117 313117 341111 241117 273117 314117 343111 242117 275117 315117 348111 243117 277117 316117 350111 244117 278117 317117  245117 280117 318117  246117 281117 319117  249117 282117 321111  253117 283117 321117  255117 284117 322111  257117 285117 322117  259117 287117 323111  261117 289117 323117  263117 291117 324117  333117 292117 325111  334111 294117 325117  336111 357111 333111   04581Z 07781Z 10081Z 14881Z 04681Z 07482Z 10082Z 14981Z 04781Z 07981Z 10381Z 15081Z 04981Z 07881Z 10981Z 15281Z 05081Z 07581Z 10881A 15681Z 05281Z 08181Z 10581Z 15781Z 05181Z 07381Z 10681A 15881Z 05681Z 08481Z 10181Z 15981A 05781Z 08081Z 10281Z 15481Z 05981Z 08281Z 10282A 16381Z 05782Z 08482Z 11281Z 16481Z 06081Z 08581Z 10882Z 16881Z 06181Z 08582Z 11381Z 16181A 06182Z 08681Z 11081A 16581Z 05381Z 08682Z 11082Z 16981Z 05881Z 08781Z 11481Z 17081Z 05982Z 08881A 11681Z 17281A 06381Z 08981Z 12081Z 17581Z 06481Z 07782Z 12181Z 17781A 06482Z 09181Z 12381Z 17981A 06581Z 09281Z 12881Z 17681Z 06681Z 09282Z 13081Z 18281A 06682Z 08782A 13381Z 18581Z 06882Z 09481Z 13581Z 18981Z 06781Z 09381Z 12781Z 19081Z 06881Z 09482Z 13681Z 19181A 07081Z 09581Z 13881Z 19381A 07181Z 09881Z 14081Z 18381Z 07182Z 09981Z 14281Z 19681Z 07481Z 09982Z 14381Z 19781A  19881Z 26081Z 31581Z 02891Z 19981A 26381Z 31681Z 03091Z 20381A 26781Z 31881Z 03491Z 20481A 26881Z 31981Z 03591A 20581A 27081Z 32281Z 03791Z 21381Z 27381Z 32381Z 04091Z 21481A 27481Z 32581Z 04191Z 21881A 27581Z 32981Z 04391Z 21081A 27781Z 33081Z 04491Z 21281A 28181Z 33681Z 04991Z 22081A 28281Z 33781Z 05091Z 20681A 28381Z 33981Z 05191A 22181Z 28481Z 34081Z 05591Z 22481Z 28781A 34381Z 05691Z 22581A 28981Z 35081Z 05891Z 22781Z 29081Z 35181Z 06191Z 22881A 29181Z 35381Z 06291Z 23181A 29481Z 35481Z 06491Z 23381Z 29581Z 35581Z 06891Z 23481Z 29681Z 35781Z 06591Z 23581Z 29781Z 00591Z 06991Z 23981Z 30181Z 00691Z 07191Z 24081A 30281A 00891Z 07291A 24781Z 29881Z 00991Z 07591A 24981Z 30381Z 01219Z 07791A 25281Z 30481Z 01419Z 07891Z 25481Z 30881Z 01691Z 07991Z 25581Z 30981A 01991Z 08391A 25981Z 31081Z 02691Z 08491A 26281Z 31281Z 02791Z 08591A  08991Z 14691Z 26691Z 32091Z 09091A 14791Z 19491Z 32191Z 09291Z 14991A 19891Z 32291Z 09391Z 15291A 26791Z 32391Z 09691A 15491A 19191Z 32491Z 09891A 15591A 19691A 32791A 09991A 15991Z 27191Z 32891Z 10491A 16191Z 27291Z 32991A 10091A 16391Z 27591Z 33491Z 10791Z 16791Z 27891Z 33591Z 11091Z 16891Z 28091Z 33791Z 11191Z 17091Z 28191Z 341091 11391A 17491A 28591Z 342091 11791Z 17691Z 28791Z 343091 11491Z 17791Z 28891Z 344091 11991Z 18191A 29391Z 345091 10591Z 18391A 29491Z 348091 12091A 18791Z 29691A 349091 12191A 18991Z 29991Z 351091 12491A 23191A 30191A 352091 12691Z 23291A 30391Z 355091 12791Z 23391Z 30691Z 356091 12891Z 23691A 30791Z 004101 13191A 23791Z 30891Z 005101 13192A 23891Z 30991Z 007101 13491Z 25491Z 31391Z 008101 13591A 24791Z 31491Z 011101 13991Z 25791Z 31191Z 012101 14091Z 25991Z 31591Z 013101 14291Z 26491Z 31691Z 014101 015101 048101 069102 140107 015107 048107 069107 144107 018101 049101 070101 145107 019101 049102 071101 147107 020117 050101 071102 153107 021101 053101 074101 156107 021107 054101 074102 158107 022101 055101 075101 166107 023101 055102 076101 168107 025107 055107 076107 169107 026101 056101 077101 173107 027101 057101 078101 175107 028101 057102 078102 176107 028107 057107 081101 177107 029101 058101 082101 179107 032101 060101 082102 180107 032107 060102 083101 181107 034101 061101 084101 187107 034107 061117 088101 195107 035101 062102 092107 196107 035117 063101 097107 198107 037101 063107 102107 199107 039101 064101 106107 201107 040101 064102 110107 202107 041101 066117 113107 207107 041102 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
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    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.
  • Manufacturer
    Advanced Sterilization Products

Manufacturer

Advanced Sterilization Products
  • Manufacturer Address
    Advanced Sterilization Products, 33 Technology Dr, Irvine CA 92618-2346
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA