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U.S. Department of Health and Human Services

Class 2 Device Recall STERRAD

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 Class 2 Recall
STERRAD
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Date Posted September 10, 2013
Recall Status1 Terminated on November 27, 2013
Recall Number Z-2174-2013
Recall Event ID 65957
Premarket Notification
510(K) Number
K071385 
Product Classification Sterilizer, Chemical - Product Code MLR
Product STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Code Information Lot/Batch Numbers: 10104001070010*JABIL 10104001070012*JABIL 10104001070037*JABIL 10104001070038*JABIL 10104001070039*JABIL 10104001070040*JABIL 10104001070041*JABIL 10104001080027*JABIL 10104001080020*JABIL 10104001080025*JABIL 10104001080026*JABIL 10104001080028*JABIL 10104001080029*JABIL 10104001080030*JABIL 10104001080031*JABIL 10104001080033*JABIL 10104001080035*JABIL 10104001080034*JABIL 10104001080036*JABIL 10104001080037*JABIL 10104001080095*JABIL 10104001080087*JABIL 10104001080092*JABIL 10104001080090*JABIL 10104001080017*JABIL 10104001080019*JABIL 10104001080088*JABIL 10104001080039*JABIL 10104001080038*JABIL 10104001080041*JABIL 10104001080042*JABIL 10104001080069* 10104001080043*JABIL 10104001080046*JABIL 10104001080085* 10104001080086* 10104001080059* 10104001080060*JABIL 10104001080061* 10104001080063*JABIL 10104001080065*JABIL 10104001080062*JABIL 10104001080048*JABIL 10104001080049*JABIL 10104001080047*JABIL 10104001080050*JABIL 10104001080051*JABIL 10104001080053*JABIL 10104001080052*JABIL 10104001080054*JABIL 10104001080055*JABIL 10104001080056*JABIL 10104001080057*JABIL 10104001080068*JABIL 10104001080058*JABIL 10104001080070*JABIL 10104001080072*JABIL 10104001080073*JABIL 10104001080074*JABIL 10104001080075*JABIL 10104001080076*JABIL 10104001080077*JABIL 10104001080080*JABIL 10104001080081*JABIL 10104001080082*JABIL 10104001080097*JABIL 10104001080084*JABIL 10104001080099*JABIL 10104001080100*JABIL 10104001080098*JABIL 10104001070041*JABIL 10104001070043*JABIL 10104001070042*JABIL 10104001070044*JABIL 10104001070050*JABIL 10104001070053*JABIL 10104001070054*JABIL 10104001070052*JABIL 10104001070051*JABIL 10104001070055*JABIL 10104001070059*JABIL 10104001070058*JABIL 10104001070057*JABIL 10104001070056*JABIL 10104001070061*JABIL 10104001070064*JABIL 10104001070063*JABIL 1041070007*JABIL 1041070015*JABIL 1041070005*JABIL 1041070003*JABIL 1041070006*JABIL 1041070016*JABIL 1041070008*JABIL 1041070017*JABIL 1041070010*JABIL 1041070004*JABIL 1041070011*JABI 1041070018*JABIL 1041070019* 1041080063* 1041080055* 1041080059* 1041080056* 1041080057* 1041070023* 1041070022* 1041080073* 1041080072* 1041080071* 1041080069* 1041080066* 1041080074* 1041080077* 1041080076* 1041080082* 1041080061* 1041080078* 1041080079* 1041080081* 1041080087* 1041080080* 1041080095* 1041080093* 1041080090* 1041080088* 1041080089* 1041080097* 1041080091* 1041080098* 1041080099* 1041080100* 1041080101* 1041080096* 1041080104* 1041080159* 1041080103* 1041080102* 1041080160* 1041080172* 1041080167* 1041080168* 1041080169* 1041070049* 1041080174* 1041070048* 1041080083* 1041080086* 1041080164* 1041080163* 1041080182* 1041080180* 1041080084* 1041080184* 1041080186* 1041080189* 1041080185* 1041080177* 1041080179* 1041080178* 1041080191* 1041080193* 1041080199* 1041080197* 1041080198* 1041080188* 1041080215 1041080194 1041080214 1041080260 1041080206 1041080205 1041080212 1041080204 1041080196 1041080203 1041080259 1041080202 1041080082 1041090269 1041070047 1041080216 1041080220 1041090264 1041070155 1041090263 1041090265 1041070154 1041070156 1041090268 1041090270 1041090275 1041090276 1041090279 1041090277 1041090273 1041080219 1041080207 1041090266 1041090271 1041090343 1041090340 1041090331 1041090300 1041090333 1041090338 1041090322 1041070149 1041070025 1041070147 1041080230 1041090352 1041090350 1041080226 1041080225 1041090272 1041090278 1041090280 1041090267 1041080218 1041090287 1041080230 1041080228 1041080221 1041090291 1041090288 1041090292 1041090283 1041090289 1041090284 1041090355 1041090354 1041088875 1041088994 1041089114 1041089234 1041089354 1041089473 1041089593 1041089713 1041089833 1041089952 1041090072 1041090192 1041090312 1041090431 1041090551 1041090671 1041090791 1041090910 1041091030 1041091150 1041091270 1041091389 1041091509 1041091629 1041091749 1041091868 1041091988 1041092108 1041092228 1041092347 1041092467 1041092587 1041092707 1041092826 1041092946 1041093066 1041093186 1041093305 1041093425 1041093545 1041093665 1041093784 1041093904 1041094024 1041094144 1041094263 1041094383 1041094503 1041094623 1041094743 1041094862 1041094982 1041095102 1041095222 1041095341 1041095461 1041095581 1041095701 1041095820 1041095940 1041096060 1041096180 1041096299 1041096419 1041096539 1041096659 1041096778 1041096898 1041097018 1041097138 1041097257 1041097377 1041097497 1041097617 1041097736 1041097856 1041097976 1041098096 1041098215 1041098335 1041098455 1041098575 1041098694 1041098814 1041098934 1041099054 1041099173 1041099293 1041099413 1041099533 1041099652 1041099772 1041099892 1041100012 1041100131 1041100251 1041100371 1041100491 1041100611 1041100730 1041100850 1041100970 1041101090 1041101209 1041101329 1041101449 1041101569 1041101688 1041101808 1041101928 1041102048 1041102167 1041102287 1041102407 1041102527 1041102646 1041102766 1041102886 1041103006 1041103125 1041103245 1041103365 1041103485 1041103604 1041103724 1041103844 1041103964 1041100045 1041100047 1041100050 1041100051 1041100053 1041100052 1041100060 1041100055 1041100057 1041100058 1041100063 1041100054 1041100059 1041100015 1041100064 1041100065 1041100072 1041100069 1041100071 1041100073 1041100075 1041100074 1041100077 1041100081 1041100080 1041100078 1041100083 1041100084 1041100089 1041100088 1041100085 1041100087 1041100086 1041100090 1041100093 1041100114 1041100095 1041100123 1041100121 1041100124 1041100115 1041100116 1041100128 1041100117 1041100119 1041100129 1041100125 1041100130 1041100122 1041100120 1041100118 1041100126 1041100127 1041100137 1041100138 1041100140 1041100142 1041100141 1041100139 1041100149 1041100147 1041100144 1041100150 1041100153 1041100160 1041100166 1041100161 1041100158 1041100164 1041100170 1041100178 1041100176 1041100181 1041100173 1041100186 1041100190 1041100177 1041100192 1041100191 1041100184 1041100196 1041100183 1041100193 1041100197 1041100179 1041100200 1041100201 1041100199 1041100202 1041100208 1041100213 1041100214 1041100215 1041100209 1041100217 1041100204 1041100216 1041100218 1041100210 1041100219 1041100220 1041100227 1041100225 1041100188 1041100221 1041100228 1041100229 1041100231 1041100235 1041100242 1041100244 1041100243 1041100246 1041100245 1041100253 1041100274 1041100261 1041100273 1041100284 1041100288 1041100292 1041100290 1041100291 1041100289 1041100297 1041100294 1041100301 1041100299 1041100310 1041100304 1041100303 1041100306 1041100305 1041100308 1041090486 1041090405 1041100300 1041100315 1041100313 1041100320 1041100311 1041100314 1041100316 1041100312 1041100323 1041100321 1041100322 1041100326 1041100325 1041100327 1041100328 1041100324 1041100319 1041100354 1041100355 1041100358 1041100357 1041110356 1041110357 1041110355 1041110354 1041110003 1041110358 1041110359 1041110004 1041110006 1041110002 1041110008 1041110014 1041110011 1041110015 1041110017 1041110024 1041110030 1041110028 1041110033 1041110032 1041110037 1041110038 1041110035 1041110021 1041110045 1041110036 1041110039 1041110040 1041110046 1041110044 1041110049 1041110052 1041110057 1041110051 1041110059 1041110073 1041110063 1041110060 1041110062 1041110065 1041110064 1041110069 1041110067 1041110072 1041110074 1041110070 1041110076 1041110068 1041110061 1041110071 1041110093 1041110075 1041110091 1041110085 1041110077 1041110080 1041110066 1041110084 1041110086 1041110087 1041110089 1041110088 1041110082 1041110090 1041110099 1041110103 1041110100 1041110102 1041110083 1041110105 1041110092 1041110106 1041110107 1041110112 1041110108 1041110111 1041110114 1041110118 1041110124 1041110119 1041110125 1041110120 1041110128 1041110129 1041110132 1041110133 1041110136 1041110126 1041110138 1041110145 1041110147 1041110141 1041110155 1041110144 1041110151 1041110150 1041110148 1041110149 1041110156 1041110187 1041110159 1041110142 1041110163 1041110165 1041110158 1041110162 1041110164 1041110168 1041110169 1041110137 1041110173 1041110171 1041110190 1041110175 1041110167 1041110182 1041110177 1041110179 1041110181 1041110194 1041110191 1041110183 1041110193 1041110196 1041110198 1041110192 1041110200 1041110195 1041110205 1041110199 1041110208 1041110206 1041110212 1041110213 1041110214 1041110215 1041110235 1041110238 1041110232 1041110233 1041110240 1041110247 1041110253 1041110239 1041110243 1041110251 1041110245 1041110254 1041110244 1041110252 1041110250 1041110218 1041110237 1041110256 1041110281 1041110265 1041110270 1041110268 1041110263 1041110283 1041110288 1041110285 1041110295 1041110403 1041110293 1041110287 1041110301 1041110294 1041110409 1041110405 1041110404 1041110406 1041110413 1041110416 1041110411 1041110415 1041110407 1041110419 1041110423 1041110418 1041110414 1041110412 1041110425 1041110422 1041110429 1041110428 1041110430 1041110432 1041110434 1041110437 1041110433 1041110441 1041110439 1041110440 1041110443 1041110438 1041110431 1041110436 1041110435 1041110444 1041110448 1041110449 1041110460 1041110463 1041110461 1041110465 1041110462 1041110472 1041110475 1041110482 1041110473 1041110470 1041110471 1041110479 1041110478 1041110484 1041110485 1041110492 1041110502 1041110481 1041110483 1041110472 1041110487 1041110507 1041110486 1041110510 1041110511 1041110508 1041110495 1041110509 1041110506 1041110496 1041110497 1041110498 1041110499 1041110493 1041110518 1041110514 1041110523 1041110513 1041110524 1041110516 1041110512 1041110525 1041110515 1041110520 1041110521 1041110519 1041110522 1041110491 1041110455 1041110526 1041110517 1041110458 1041110535 1041110529 1041110527 1041110528 1041110538 1041110537 1041110545 1041110534 1041110550 1041110541 1041110544 1041110551 1041110562 1041110552 1041110553 1041110561 1041110554 1041110558 1041110565 1041110564 1041110566 1041110556 1041110560 1041110559 1041110557 1041110563 1041110567 1041110568 1041110272 1041110569 1041110570 1041110571 1041120002 1041110575 1041120003 1041120010 1041120012 1041120017 1041120007 1041120016 1041120019 1041120020 1041120018 1041120013 1041120021 1041120028 1041120009 1041120026 1041120014 1041120025 1041120023 1041120022 1041120011 1041120038 1041120037 1041120039 1041120041 1041120040 1041120045 1041120047 1041120052 1041120046 1041120050 1041120051 1041120049 1041120065 1041120067 1041120068 1041120060 1041120057 1041120056 1041120062 1041120063 1041120069 1041120073 1041120070 1041120071 1041120076 1041120061 1041120075 1041120077 1041120091 1041120099 1041120082 1041120102 1041120103 1041120098 1041120108 1041120105 1041120112 1041120106 1041120111 1041120118 1041120119 1041120133 1041120129 1041120132 1041120140 1041120147 1041120143 1041120152 1041120155 1041120128 1041120153 1041120142 1041120139 1041120113 1041120150 1041120160 1041120168 1041120174 1041120162 1041120157 1041120202 1041120184 1041120170 1041120176 1041120181 1041120172 1041120203 1041120210 1041120211 1041120218 1041120215 1041120216 1041120213 1041120217 1041120230 1041120214 1041120232 1041120237 1041120224 1041120228 1041120244 1041120236 1041120233 1041120246 1041120255 1041120239 1041120253 1041120272 1041120256 1041120238 1041120268 1041120262 1041120266 1041120265 1041120261 1041120257 1041120278 1041120280 1041120320 1041120314 1041120319 1041120318 1041120316 1041120317 1041120231 1041120326 1041120332 1041120289 1041120307 1041120275 1041120309 1041120296 1041120292 1041120340 1041120341 1041120357 1041120334 1041120297 1041120302 1041120301 1041120377 1041120369 1041120386 1041120445 1041120367 1041120387 1041120370 1041120446 1041120439 1041120438 1041120441 1041120389 1041120390 1041120449 1041120448 1041120459 1041120463 1041120458 1041120454 1041120464 1041120471 1041120447 1041120469 1041120473 1041120475 1041120474 1041120477 1041120461 1041120466 1041120487 1041120460 1041120481 1041120478 1041120485 1041120482 1041120512 1041120486 1041120483 1041120484 1041120480 1041120476 1041120465 1041120493 1041120490 1041120489 1041120510 1041120496 1041120497 1041120502 1041120488 1041120501 1041120503 1041120498 1041120507 1041120568 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1041130169 1041130161 1041130126 1041130121 1041130184 1041130188 1041130182 1041130187 1041130197 1041130186 1041130195 1041130191 1041130207 1041130193 1041080213 1041080211 1041080200 1041080201 1041080215 1041080217 1041080220 1041090344 1041090346 1041090349 1041090282 1041090323 1041070148 1041070150 1041070151 1041070146 1041070026 1041070152 1041070153 1041080224 1041080229 1041090348 1041090274 1041090285 1041090299 1041090301 1041090302 1041090356 1041090357 1041090362 1041090310 1041090317 1041090326 1041090320 1041090319 1041090325 1041090327 1041090330 1041090335 1041090334 1041090342 1041090395 1041090386 1041090387 1041090391 1041090390 1041090393 1041090404 1041090402 1041090406 1041090399 1041090419 1041090420 1041090421 1041090422 1041090436 1041090412 1041090410 1041090434 1041090415 1041090414 1041090442 1041090438 1041090445 1041090426 1041090437 1041090439 1041090441 1041090444 1041090447 1041090448 1041090435 1041090440 1041090446 1041090450 1041090451 1041090457 1041090455 1041090453 1041090465 1041100011 1041100006 1041100012 1041100013 1041100014 1041100022 1041100023 1041100027 1041100021 1041100030 1041100034 1041100039 1041100044 1041100056 1041100061 1041100062 1041100066 1041100067 1041100068 1041100070 1041100076 1041100082 1041100079 1041100091 1041100094 1041100092 1041100111 1041100112 1041100113 1041100143 1041100145 1041100146 1041100148 1041100151 1041100154 1041100155 1041100156 1041100152 1041100157 1041100167 1041100159 1041100165 1041100172 1041100168 1041100169 1041100171 1041100174 1041100120 1041100175 1041100180 1041100182 1041100185 1041100188 1041100187 1041100189 1041100198 1041100203 1041100207 1041100205 1041100206 1041100226 1041100222 1041100223 1041100230 1041100240 1041100234 1041100232 1041100233 1041100236 1041100241 1041100237 1041100238 1041100239 1041100247 1041100251 1041100252 1041100248 1041100249 1041100259 1041100254 1041100257 1041100260 1041100256 1041100258 1041100272 1041100262 1041100276 1041100277 1041100275 1041100278 1041100279 1041100255 1041100280 1041100281 1041100287 1041100286 1041100293 1041100295 1041100298 1041100296 1041100302 1041100307 1041100309 1041100318 1041100317 1041110005 1041110007 1041110009 1041110010 1041110016 1041110012 1041110013 1041110018 1041110022 1041110026 1041110019 1041110020 1041110029 1041110031 1041110034 1041110027 1041110023 1041110025 1041110047 1041110048 1041110054 1041110058 1041110050 1041110053 1041110056 1041110055 1041110081 1041110101 1041110098 1041110104 1041110109 1041110115 1041110116 1041110130 1041110127 1041110134 1041110117 1041110131 1041110135 1041110140 1041110123 1041110139 1041110143 1041110146 1041110157 1041110161 1041110166 1041110170 1041110178 1041110172 1041110174 1041110176 1041110184 1041110219 1041110207 1041110204 1041110180 1041110197 1041110201 1041110203 1041110209 1041110211 1041110234 1041110210 1041110202 1041110216 1041110217 1041110249 1041110236 1041110248 1041110257 1041110258 1041110255 1041110262 1041110266 1041110267 1041110284 1051110259 1041110269 1041110271 1041110273 1041110279 1041110282 1041110286 1041110289 1041110290 1041110280 1041110291 1041110296 1041110292 1041110297 1041110298 1041110402 1041110410 1041110408 1041110421 1041110417 1041110420 1041110424 1041110426 1041110427 1041110442 1041110445 1041110446 1041110447 1041110454 1041110456 1041110457 1041110459 1041110453 1041110455 1041110458 1041110464 1041110466 1041110467 1041110468 1041110469 1041110474 1041110476 1041110477 1041110480 1041110489 1041110503 1041110788 1041110494 1041110490 1041110504 1041110505 1041110531 1041110539 1041110530 1041110546 1041110547 1041110540 1041110488 1041110536 1041110548 1041110549 1041110555 1041110572 1041110574 1041120004 1041120006 1041120008 1041120015 1041120029 1041120024 1041120027 1041120031 1041120005 1041120030 1041120042 1041120043 1041120044 1041120048 1041120055 1041120058 1041120059 1041120066 1041120054 1041120072 1041120074 1041120078 1041120083 1041120090 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1041120472 1041120462 1041120479 1041120492 1041120504 1041120567 1041120509 1041120569 1041120574 1041120577 1041130002 1041130004 1041130015 1041130022 1041130003 1041130019 1041130021 1041130036 1041130016 1041130008 1041130035 1041130054 1041130028 1041130017 1041130013 1041130024 1041130018 1041130063 1041130069 1041130062 1041130023 1041130079 1041130076 1041130077 1041130078 1041130080 1041130081 1041130071 1041130073 1041130082 1041130087 1041130090 1041130091 1041130092 1041130093 1041130094 1041130095 1041130096 1041130097 1041130098 1041130100 1041130101 1041130102 1041130107 1041130108 1041130133 1041130149 1041130152 1041130162 1041130163 1041130168 1041130119 1041130147 1041130110 1041130117 1041130120 1041130124 1041130137 1041130139 1041130142 1041130160 1041130118 1041130165 1041130020 1041130134 1041130154 1041130167 1041130173 1041130174 1041130183 10104001070020*JABIL 10104001070018*JABIL 10104001070019*JABIL 10104001070021*JABIL 10104001070023*JABIL 10104001070022*JABIL 10104001070025*JABIL 10104001070026*JABIL 10104001070027*JABIL 10104001070032*JABIL 10104001070031*JABIL 10104001070035*JABIL 10104001070036* 10104001080018*JABIL 10104001080032* 10104001080024*JABIL 10104001080089*JABIL 10104001080091*JABIL 10104001080096*JABIL 10104001080064*JABIL 10104001080071*JABIL 10104001080078*JABIL 10104001080079*JABIL 10104001080079*FG 10104001070065*JABIL 10104001070062*JABIL 10104001070060*JABIL 1041070009*JABIL 1041070014*JABIL 1041070013*JABIL 1041080062* 1041070020* 1041070024* 1041070021* 1041080065* 1041080092* 1041070052* 1041080161* 1041080171* 1041080094* 1041080162* 1041080170* 1041080085* 1041070050* 1041080166* 1041080187* 1041080181* 1041080192* 1041080183*
Recalling Firm/
Manufacturer
Advanced Sterilization Products
33 Technology Dr
Irvine, California 92618-2346
Manufacturer Reason
for Recall
The recall of the STERRAD 100NX Cassettes was initiated because Advanced Sterilization Products (ASP) does not have adequate data to support the effectiveness of the packaging's leak indicator for the entire duration of the STERRAD 100 NX System cassette's 15 month shelf life.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action ASP sent an Urgent Medical Device Field Safety Notification letter dated July 25, 2013, to all affected customers. The recall letter informed the customers of the problem identified and the actions to be taken. Customers were instructed to contact Stericycle directly at (866) 562-5937 to report any complaints or suspected problems with their STERRAD 100NX System cassette. For questions regarding this recall call 949-453-6400.
Quantity in Commerce 1,923 units
Distribution Worldwide Distribution - USA (nationwide) and internationally to RU, VE, KW, SA, HU, GB, IT, HK, IL, MX, ZA, PH, GR, AE, IN, CO, KR, AU, IN, ES, SG, MY, TH, TR, TW, SI, BE, PL, EC, CN, JP, PA, DE, VN, CL, and Switzerland, United Kingdom. Israel. Slovenia, Qatar, Panama, Venezuela.
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 = MLR and Original Applicant = ADVANCED STERILIZATION PRODUCTS
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