• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall INOmax DS (Delivery System)

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 1 Device Recall INOmax DS (Delivery System) see related information
Date Initiated by Firm November 30, 2010
Date Posted January 11, 2012
Recall Status1 Terminated 3 on May 29, 2012
Recall Number Z-0583-2012
Recall Event ID 60258
510(K)Number K061901  
Product Classification Apparatus, nitric oxide delivery - Product Code MRN
Product INOmax DS (Delivery System) Model 10003 & 10007.

The INOMAX DS Delivery System delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators. The INOMAX DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.
Code Information Serial Number DS20070005 DS20070006 DS20070007 DS20070008 DS20070009 DS20070010 DS20070011 DS20070012 DS20070013 DS20070014 DS20070015 DS20070016 DS20070017 DS20070018 DS20070019 DS20070020 DS20070021 DS20070022 DS20070023 DS20070024 DS20070025 DS20070026 DS20070027 DS20070028 DS20070029 DS20070030 DS20070031 DS20070032 DS20070033 DS20070034 DS20070035 DS20070036 DS20070037 DS20070038 DS20070039 DS20070040 DS20070041 DS20070042 DS20070043 DS20070044 DS20070045 DS20070046 DS20070047 DS20070048 DS20070049 DS20070050 DS20070051 DS20070052 DS20070053 DS20070054 DS20070055 DS20070056 DS20070057 DS20070058 DS20070059 DS20070060 DS20070061 DS20070062 DS20070063 DS20070064 DS20070065 DS20070066 DS20070067 DS20070068 DS20070069 DS20070070 DS20070071 DS20070072 DS20070073 DS20070074 DS20070075 DS20070076 DS20070077 DS20070078 DS20070079 DS20070080 DS20070081 DS20070082 DS20070083 DS20070084 DS20070085 DS20070086 DS20070087 DS20070091 DS20070092 DS20070093 DS20070094 DS20070095 DS20070096 DS20070097 DS20070098 DS20070099 DS20070100 DS20070101 DS20070102 DS20070103 DS20070104 DS20070105 DS20070106 DS20070107 DS20070108 DS20070109 DS20070110 DS20070111 DS20070112 DS20070113 DS20070114 DS20070115 DS20070116 DS20070117 DS20070118 DS20070119 DS20070120 DS20070121 DS20070122 DS20070123 DS20070124 DS20070125 DS20070126 DS20070127 DS20070128 DS20070129 DS20070130 DS20070131 DS20070132 DS20070133 DS20070134 DS20070135 DS20070136 DS20070137 DS20070138 DS20070139 DS20070140 DS20070141 DS20070142 DS20070143 DS20070144 DS20070145 DS20070146 DS20070147 DS20070148 DS20070149 DS20070150 DS20070151 DS20070152 DS20070153 DS20070154 DS20070155 DS20070156 DS20070157 DS20070158 DS20070159 DS20070160 DS20070161 DS20070162 DS20070163 DS20070164 DS20070165 DS20070166 DS20070167 DS20070168 DS20070169 DS20070170 DS20070171 DS20070172 DS20070173 DS20070174 DS20070175 DS20070176 DS20070177 DS20070178 DS20070179 DS20070180 DS20070181 DS20070182 DS20070183 DS20070184 DS20070185 DS20070186 DS20070187 DS20070188 DS20070189 DS20070190 DS20070191 DS20070192 DS20070193 DS20070194 DS20070195 DS20070196 DS20070197 DS20070198 DS20070200 DS20070201 DS20070202 DS20070203 DS20070204 DS20070205 DS20070206 DS20070207 DS20070208 DS20070209 DS20070210 DS20070211 DS20070212 DS20070213 DS20070214 DS20070215 DS20070216 DS20070217 DS20070218 DS20070219 DS20070220 DS20070221 DS20070222 DS20070223 DS20070224 DS20070225 DS20070226 DS20070227 DS20070229 DS20070230 DS20070231 DS20070232 DS20070233 DS20070234 DS20070235 DS20070236 DS20070237 DS20070238 DS20070239 DS20070240 DS20070241 DS20070242 DS20070243 DS20070244 DS20070245 DS20070247 DS20070248 DS20070249 DS20070250 DS20070251 DS20070252 DS20070253 DS20070254 DS20070255 DS20070256 DS20070257 DS20070258 DS20070259 DS20070260 DS20070261 DS20070262 DS20070263 DS20070264 DS20070265 DS20070266 DS20070267 DS20070268 DS20070269 DS20070270 DS20070271 DS20070272 DS20070274 DS20070275 DS20070276 DS20070277 DS20070278 DS20070279 DS20070280 DS20070281 DS20070282 DS20070283 DS20080001 DS20080002 DS20080003 DS20080004 DS20080005 DS20080006 DS20080007 DS20080008 DS20080009 DS20080010 DS20080011 DS20080016 DS20080017 DS20080018 DS20080019 DS20080020 DS20080021 DS20080022 DS20080023 DS20080024 DS20080025 DS20080026 DS20080027 DS20080028 DS20080029 DS20080030 DS20080031 DS20080032 DS20080033 DS20080034 DS20080035 DS20080036 DS20080037 DS20080038 DS20080039 DS20080040 DS20080041 DS20080042 DS20080043 DS20080044 DS20080045 DS20080046 DS20080047 DS20080048 DS20080049 DS20080050 DS20080051 DS20080052 DS20080053 DS20080054 DS20080055 DS20080056 DS20080057 DS20080058 DS20080059 DS20080061 DS20080062 DS20080063 DS20080064 DS20080065 DS20080066 DS20080067 DS20080068 DS20080069 DS20080070 DS20080071 DS20080072 DS20080073 DS20080074 DS20080075 DS20080076 DS20080077 DS20080078 DS20080079 DS20080080 DS20080081 DS20080082 DS20080083 DS20080084 DS20080085 DS20080086 DS20080087 DS20080088 DS20080089 DS20080090 DS20080091 DS20080092 DS20080093 DS20080094 DS20080095 DS20080096 DS20080097 DS20080098 DS20080099 DS20080100 DS20080101 DS20080102 DS20080103 DS20080104 DS20080105 DS20080106 DS20080107 DS20080108 DS20080109 DS20080110 DS20080111 DS20080112 DS20080113 DS20080114 DS20080115 DS20080116 DS20080117 DS20080118 DS20080119 DS20080120 DS20080121 DS20080122 DS20080123 DS20080124 DS20080125 DS20080126 DS20080127 DS20080128 DS20080129 DS20080130 DS20080131 DS20080132 DS20080133 DS20080134 DS20080135 DS20080136 DS20080137 DS20080138 DS20080139 DS20080140 DS20080141 DS20080142 DS20080143 DS20080144 DS20080145 DS20080146 DS20080147 DS20080148 DS20080149 DS20080150 DS20080151 DS20080152 DS20080153 DS20080154 DS20080155 DS20080156 DS20080157 DS20080158 DS20080159 DS20080160 DS20080161 DS20080162 DS20080163 DS20080164 DS20080165 DS20080166 DS20080167 DS20080168 DS20080169 DS20080170 DS20080171 DS20080172 DS20080173 DS20080174 DS20080175 DS20080176 DS20080177 DS20080178 DS20080179 DS20080180 DS20080181 DS20080182 DS20080183 DS20080184 DS20080185 DS20080186 DS20080187 DS20080188 DS20080189 DS20080190 DS20080191 DS20080192 DS20080193 DS20080194 DS20080195 DS20080196 DS20080197 DS20080198 DS20080199 DS20080200 DS20080201 DS20080202 DS20080203 DS20080204 DS20080205 DS20080206 DS20080207 DS20080208 DS20080209 DS20080210 DS20080211 DS20080212 DS20080213 DS20080214 DS20080215 DS20080216 DS20080217 DS20080218 DS20080219 DS20080220 DS20080221 DS20080222 DS20080223 DS20080224 DS20080225 DS20080226 DS20080227 DS20080228 DS20080229 DS20080230 DS20080231 DS20080232 DS20080233 DS20080234 DS20080235 DS20080236 DS20080237 DS20080238 DS20080239 DS20080240 DS20080241 DS20080242 DS20080243 DS20080244 DS20080245 DS20080246 DS20080247 DS20080248 DS20080249 DS20080250 DS20080252 DS20080253 DS20080254 DS20080255 DS20080256 DS20080257 DS20080258 DS20080259 DS20080260 DS20080261 DS20080262 DS20080263 DS20080264 DS20080265 DS20080266 DS20080267 DS20080268 DS20080269 DS20080270 DS20080271 DS20080272 DS20080273 DS20080274 DS20080275 DS20080276 DS20080277 DS20080278 DS20080279 DS20080280 DS20080281 DS20080282 DS20080283 DS20080284 DS20080285 DS20080286 DS20080287 DS20080288 DS20080289 DS20080290 DS20080291 DS20080292 DS20080293 DS20080294 DS20080295 DS20080296 DS20080297 DS20080298 DS20080299 DS20080300 DS20080301 DS20080302 DS20080303 DS20080304 DS20080305 DS20080306 DS20080307 DS20080308 DS20080309 DS20080310 DS20080311 DS20080312 DS20080313 DS20080314 DS20080315 DS20080316 DS20080317 DS20080318 DS20080319 DS20080320 DS20080321 DS20080322 DS20080323 DS20080324 DS20080325 DS20080326 DS20080327 DS20080328 DS20080329 DS20080330 DS20080331 DS20080332 DS20080333 DS20080334 DS20080335 DS20080336 DS20080337 DS20080338 DS20080339 DS20080340 DS20080341 DS20080342 DS20080343 DS20080344 DS20080345 DS20080346 DS20080347 DS20080348 DS20080349 DS20080350 DS20080351 DS20080352 DS20080356 DS20080357 DS20080358 DS20080359 DS20080360 DS20080361 DS20080362 DS20080363 DS20080364 DS20080365 DS20080366 DS20080367 DS20080368 DS20080369 DS20080370 DS20080371 DS20080372 DS20080373 DS20090001 DS20090002 DS20090003 DS20090004 DS20090005 DS20090006 DS20090007 DS20090008 DS20090009 DS20090010 DS20090011 DS20090012 DS20090013 DS20090014 DS20090015 DS20090016 DS20090017 DS20090018 DS20090019 DS20090020 DS20090021 DS20090022 DS20090023 DS20090024 DS20090025 DS20090026 DS20090027 DS20090028 DS20090029 DS20090030 DS20090031 DS20090032 DS20090033 DS20090034 DS20090035 DS20090036 DS20090037 DS20090038 DS20090039 DS20090040 DS20090041 DS20090042 DS20090043 DS20090044 DS20090045 DS20090046 DS20090047 DS20090048 DS20090049 DS20090050 DS20090051 DS20090052 DS20090053 DS20090054 DS20090055 DS20090056 DS20090057 DS20090058 DS20090059 DS20090060 DS20090061 DS20090062 DS20090063 DS20090064 DS20090065 DS20090066 DS20090067 DS20090068 DS20090069 DS20090070 DS20090071 DS20090072 DS20090073 DS20090074 DS20090075 DS20090076 DS20090077 DS20090078 DS20090079 DS20090080 DS20090081 DS20090082 DS20090083 DS20090084 DS20090085 DS20090086 DS20090087 DS20090088 DS20090089 DS20090090 DS20090091 DS20090092 DS20090093 DS20090094 DS20090095 DS20090096 DS20090097 DS20090098 DS20090099 DS20090100 DS20090101 DS20090102 DS20090103 DS20090104 DS20090105 DS20090106 DS20090107 DS20090108 DS20090109 DS20090110 DS20090111 DS20090112 DS20090113 DS20090114 DS20090115 DS20090116 DS20090117 DS20090118 DS20090119 DS20090120 DS20090121 DS20090122 DS20090123 DS20090124 DS20090125 DS20090126 DS20090127 DS20090128 DS20090129 DS20090130 DS20090131 DS20090132 DS20090133 DS20090134 DS20090135 DS20090136 DS20090137 DS20090138 DS20090139 DS20090140 DS20090141 DS20090142 DS20090143 DS20090144 DS20090145 DS20090146 DS20090147 DS20090148 DS20090149 DS20090150 DS20090151 DS20090152 DS20090153 DS20090154 DS20090155 DS20090156 DS20090157 DS20090158 DS20090159 DS20090160 DS20090161 DS20090162 DS20090163 DS20090164 DS20090165 DS20090166 DS20090167 DS20090168 DS20090169 DS20090170 DS20090171 DS20090172 DS20090173 DS20090174 DS20090175 DS20090176 DS20090177 DS20090178 DS20090179 DS20090180 DS20090181 DS20090182 DS20090183 DS20090184 DS20090185 DS20090186 DS20090187 DS20090188 DS20090189 DS20090190 DS20090191 DS20090192 DS20090193 DS20090194 DS20090195 DS20090196 DS20090197 DS20090198 DS20090199 DS20090200 DS20090201 DS20090202 DS20090203 DS20090204 DS20090205 DS20090206 DS20090207 DS20090208 DS20090209 DS20090210 DS20090211 DS20090212 DS20090213 DS20090214 DS20090215 DS20090216 DS20090217 DS20090218 DS20090219 DS20090220 DS20090221 DS20090222 DS20090223 DS20090224 DS20090225 DS20090226 DS20090227 DS20090228 DS20090229 DS20090230 DS20090231 DS20090232 DS20090233 DS20090234 DS20090235 DS20090236 DS20090237 DS20090238 DS20090239 DS20090240 DS20090241 DS20090242 DS20090243 DS20090244 DS20090245 DS20090246 DS20090247 DS20090248 DS20090249 DS20090250 DS20090251 DS20090252 DS20090253 DS20090254 DS20090255 DS20090256 DS20090257 DS20090258 DS20090259 DS20090260 DS20090261 DS20090262 DS20090263 DS20090264 DS20090265 DS20090266 DS20090267 DS20090268 DS20090269 DS20090270 DS20090271 DS20090272 DS20090273 DS20090274 DS20090275 DS20090276 DS20090277 DS20090278 DS20090279 DS20090280 DS20090281 DS20090282 DS20090283 DS20090284 DS20090285 DS20090286 DS20090287 DS20090288 DS20090289 DS20090290 DS20090291 DS20090292 DS20090293 DS20090294 DS20090295 DS20090296 DS20090297 DS20090298 DS20090299 DS20090300 DS20090301 DS20090302 DS20090303 DS20090304 DS20090305 DS20090306 DS20090307 DS20090308 DS20090309 DS20090310 DS20090311 DS20090312 DS20090313 DS20090314 DS20090315 DS20090316 DS20090317 DS20090318 DS20090319 DS20090320 DS20090321 DS20090322 DS20090323 DS20090324 DS20090325 DS20090326 DS20090327 DS20090328 DS20090329 DS20090330 DS20090331 DS20090332 DS20090333 DS20090334 DS20090335 DS20090336 DS20090337 DS20090338 DS20090339 DS20090340 DS20090341 DS20090342 DS20090343 DS20090344 DS20090345 DS20090346 DS20090347 DS20090348 DS20090349 DS20090350 DS20090351 DS20090352 DS20090353 DS20090354 DS20090355 DS20090356 DS20090357 DS20090358 DS20090359 DS20090360 DS20090361 DS20090362 DS20090363 DS20090364 DS20090365 DS20090366 DS20090367 DS20090368 DS20090369 DS20090370 DS20090371 DS20090372 DS20090373 DS20090374 DS20090375 DS20090376 DS20090377 DS20090378 DS20090379 DS20090380 DS20090381 DS20090382 DS20090383 DS20090384 DS20090385 DS20090386 DS20090387 DS20090388 DS20090389 DS20090390 DS20090391 DS20090392 DS20090393 DS20090394 DS20090395 DS20090396 DS20090397 DS20090398 DS20090399 DS20090400 DS20090401 DS20090402 DS20090403 DS20090404 DS20090405 DS20090406 DS20090407 DS20090408 DS20090409 DS20090410 DS20090411 DS20090412 DS20090413 DS20090414 DS20090415 DS20090416 DS20090417 DS20090418 DS20090419 DS20090420 DS20090421 DS20090422 DS20090423 DS20090424 DS20090425 DS20090426 DS20090427 DS20090428 DS20090429 DS20090430 DS20090431 DS20090432 DS20090433 DS20090434 DS20090435 DS20090436 DS20090437 DS20090438 DS20090439 DS20090440 DS20090441 DS20090442 DS20090443 DS20090444 DS20090445 DS20090446 DS20090447 DS20090448 DS20090449 DS20090450 DS20090451 DS20090452 DS20090453 DS20090454 DS20090455 DS20090456 DS20090457 DS20090458 DS20090459 DS20090460 DS20090461 DS20090462 DS20090463 DS20090464 DS20090465 DS20090466 DS20090467 DS20090468 DS20090469 DS20090470 DS20090471 DS20090472 DS20090473 DS20090474 DS20090475 DS20090476 DS20090477 DS20090478 DS20090479 DS20090480 DS20090481 DS20090482 DS20090483 DS20090484 DS20090485 DS20090486 DS20090487 DS20090488 DS20090489 DS20090490 DS20090491 DS20090492 DS20090493 DS20090494 DS20090495 DS20090496 DS20090497 DS20090498 DS20090499 DS20090500 DS20090501 DS20090502 DS20090503 DS20090504 DS20090505 DS20090506 DS20090507 DS20090508 DS20090509 DS20090510 DS20090511 DS20090512 DS20090513 DS20090514 DS20090515 DS20090516 DS20090517 DS20090518 DS20090519 DS20090520 DS20090521 DS20090522 DS20090523 DS20090524 DS20090525 DS20090526 DS20090527 DS20090528 DS20090529 DS20090530 DS20090531 DS20090532 DS20090533 DS20090534 DS20090535 DS20090536 DS20090537 DS20090538 DS20090539 DS20090540 DS20090541 DS20090542 DS20090543 DS20090544 DS20090545 DS20090546 DS20090547 DS20090548 DS20090549 DS20090550 DS20090551 DS20090552 DS20090553 DS20090554 DS20090555 DS20090556 DS20090557 DS20090558 DS20090559 DS20090560 DS20090561 DS20090562 DS20090563 DS20090564 DS20090565 DS20090566 DS20090567 DS20090568 DS20090569 DS20090570 DS20090571 DS20090572 DS20090573 DS20090574 DS20090575 DS20090576 DS20090577 DS20090578 DS20090579 DS20090580 DS20090581 DS20090582 DS20090583 DS20090584 DS20090585 DS20090586 DS20090587 DS20090588 DS20090589 DS20090590 DS20090591 DS20090592 DS20090593 DS20090594 DS20090595 DS20090596 DS20090597 DS20090598 DS20090599 DS20090600 DS20090601 DS20090602 DS20090603 DS20090604 DS20090605 DS20090606 DS20090607 DS20090608 DS20090609 DS20090610 DS20090611 DS20090612 DS20090613 DS20090614 DS20090615 DS20090616 DS20090617 DS20090618 DS20090619 DS20090620 DS20090621 DS20090622 DS20090623 DS20090624 DS20090625 DS20090626 DS20090627 DS20090628 DS20090629 DS20090630 DS20090631 DS20090632 DS20090633 DS20090634 DS20090635 DS20090636 DS20090637 DS20090638 DS20090639 DS20090640 DS20090641 DS20090642 DS20090643 DS20090644 DS20090645 DS20090646 DS20090647 DS20090648 DS20090649 DS20090650 DS20090651 DS20090652 DS20090653 DS20090654 DS20090655 DS20090656 DS20090657 DS20090658 DS20090659 DS20090660 DS20090661 DS20090662 DS20090663 DS20090664 DS20090665 DS20090666 DS20090667 DS20090668 DS20090669 DS20090670 DS20090671 DS20090672 DS20090673 DS20090674 DS20090675 DS20090676 DS20090677 DS20090678 DS20090679 DS20090680 DS20090681 DS20090682 DS20090683 DS20090684 DS20090685 DS20090686 DS20090687 DS20090688 DS20090689 DS20090690 DS20090691 DS20090692 DS20090693 DS20090694 DS20090695 DS20090696 DS20090697 DS20090698 DS20090699 DS20090700 DS20090701 DS20090702 DS20090703 DS20090704 DS20090705 DS20090706 DS20090707 DS20090708 DS20090709 DS20090710 DS20090711 DS20090712 DS20090713 DS20090714 DS20090715 DS20090716 DS20090717 DS20090718 DS20090719 DS20090720 DS20090721 DS20090722 DS20090723 DS20090724 DS20090725 DS20090726 DS20090727 DS20090728 DS20090729 DS20090730 DS20090731 DS20090732 DS20090733 DS20090734 DS20090735 DS20090736 DS20090737 DS20090738 DS20090739 DS20090740 DS20090741 DS20090742 DS20090743 DS20090744 DS20090745 DS20090746 DS20090747 DS20090748 DS20090749 DS20090750 DS20090751 DS20090752 DS20090753 DS20090754 DS20090755 DS20090756 DS20090757 DS20090758 DS20090759 DS20090760 DS20090761 DS20090762 DS20090763 DS20090764 DS20090765 DS20090766 DS20090767 DS20090768 DS20090769 DS20090770 DS20090771 DS20090772 DS20090773 DS20090774 DS20090775 DS20090776 DS20090777 DS20090778 DS20090779 DS20090780 DS20090781 DS20090782 DS20090783 DS20090784 DS20090785 DS20090786 DS20090787 DS20090788 DS20090789 DS20090790 DS20090791 DS20090792 DS20090793 DS20090794 DS20090795 DS20090796 DS20090797 DS20090798 DS20090799 DS20090800 DS20090801 DS20090802 DS20090803 DS20090804 DS20090805 DS20090806 DS20090807 DS20090808 DS20090809 DS20090810 DS20090811 DS20090812 DS20090813 DS20090814 DS20090815 DS20090816 DS20090817 DS20090818 DS20090819 DS20090820 DS20090821 DS20090822 DS20090823 DS20090824 DS20090825 DS20090826 DS20090827 DS20090828 DS20090829 DS20090830 DS20090831 DS20090832 DS20090833 DS20090834 DS20090835 DS20090836 DS20090837 DS20090838 DS20090839 DS20090840 DS20090841 DS20090842 DS20090843 DS20090844 DS20090845 DS20090846 DS20090847 DS20090848 DS20090849 DS20090850 DS20090851 DS20090852 DS20090853 DS20090854 DS20090855 DS20090856 DS20090857 DS20090858 DS20090859 DS20090860 DS20090861 DS20090862 DS20090863 DS20090864 DS20090865 DS20090866 DS20090867 DS20090868 DS20090869 DS20090870 DS20090871 DS20090872 DS20090873 DS20090874 DS20090875 DS20090876 DS20090877 DS20090878 DS20090879 DS20090880 DS20090881 DS20090882 DS20090883 DS20090884 DS20090885 DS20090886 DS20090887 DS20090888 DS20090889 DS20090890 DS20090891 DS20090892 DS20090893 DS20090894 DS20090895 DS20090896 DS20090897 DS20090898 DS20090899 DS20090900 DS20090901 DS20090902 DS20090903 DS20090904 DS20090905 DS20090906 DS20090907 DS20090908 DS20090909 DS20090910 DS20090911 DS20090912 DS20090913 DS20090914 DS20090915 DS20090916 DS20090917 DS20090918 DS20090919 DS20090920 DS20090921 DS20090922 DS20090923 DS20090924 DS20090925 DS20090926 DS20090927 DS20090928 DS20090929 DS20090930 DS20090931 DS20090932 DS20090933 DS20090934 DS20090935 DS20090936 DS20090937 DS20090938 DS20090939 DS20090940 DS20090941 DS20090942 DS20090943 DS20090944 DS20090945 DS20090946 DS20100001 DS20100002 DS20100003 DS20100004 DS20100005 DS20100006 DS20100007 DS20100008 DS20100009 DS20100010 DS20100011 DS20100012 DS20100013 DS20100014 DS20100015 DS20100016 DS20100017 DS20100018 DS20100019 DS20100020 DS20100021 DS20100022 DS20100023 DS20100024 DS20100025 DS20100026 DS20100027 DS20100028 DS20100029 DS20100030 DS20100031 DS20100032 DS20100033 DS20100034 DS20100035 DS20100036 DS20100037 DS20100038 DS20100039 DS20100040 DS20100041 DS20100042 DS20100043 DS20100044 DS20100045 DS20100046 DS20100047 DS20100048 DS20100049 DS20100050 DS20100051 DS20100052 DS20100053 DS20100054 DS20100055 DS20100056 DS20100057 DS20100058 DS20100059 DS20100060 DS20100061 DS20100062 DS20100063 DS20100064 DS20100065 DS20100066 DS20100067 DS20100068 DS20100069 DS20100070 DS20100071 DS20100072 DS20100073 DS20100074 DS20100075 DS20100076 DS20100077 DS20100078 DS20100079 DS20100080 DS20100081 DS20100082 DS20100083 DS20100084 DS20100085 DS20100086 DS20100087 DS20100088 DS20100089 DS20100090 DS20100091 DS20100092 DS20100093 DS20100094 DS20100095 DS20100096 DS20100097 DS20100098 DS20100099 DS20100100 DS20100101 DS20100102 DS20100103 DS20100104 DS20100105 DS20100106 DS20100107 DS20100108 DS20100109 DS20100110 DS20100111 DS20100112 DS20100113 DS20100114 DS20100115 DS20100116 DS20100117 DS20100118 DS20100119 DS20100120 DS20100121 DS20100122 DS20100123 DS20100124 DS20100125 DS20100126 DS20100127 DS20100128 DS20100129 DS20100130 DS20100131 DS20100132 DS20100133 DS20100134 DS20100135 DS20100136 DS20100137 DS20100138 DS20100139 DS20100140 DS20100141 DS20100142 DS20100143 DS20100144 DS20100145 DS20100146 DS20100147 DS20100148 DS20100149 DS20100150 DS20100151 DS20100152 DS20100153 DS20100154 DS20100155 DS20100156 DS20100157 DS20100158 DS20100159 DS20100160 DS20100161 DS20100162 DS20100163 DS20100164 DS20100165 DS20100166 DS20100167 DS20100168 DS20100169 DS20100170 DS20100171 DS20100172 DS20100173 DS20100174 DS20100175 DS20100176 DS20100177 DS20100178 DS20100179 DS20100180 DS20100181 DS20100182 DS20100183 DS20100184 DS20100185 DS20100186 DS20100187 DS20100188 DS20100189 DS20100190 DS20100191 DS20100192 DS20100193 DS20100194 DS20100195 DS20100196 DS20100197 DS20100198 DS20100199 DS20100200 DS20100201 DS20100202 DS20100203 DS20100204 DS20100205 DS20100206 DS20100207 DS20100208 DS20100209 DS20100210 DS20100211 DS20100212 DS20100213 DS20100214 DS20100215 DS20100216 DS20100217 DS20100218 DS20100219 DS20100220 DS20100221 DS20100222 DS20100223 DS20100224 DS20100225 DS20100226 DS20100227 DS20100228 DS20100229 DS20100230 DS20100231 DS20100232 DS20100233 DS20100234 DS20100235 DS20100236 DS20100237 DS20100238 DS20100239 DS20100240 DS20100241 DS20100242 DS20100243 DS20100244 DS20100245 DS20100246 DS20100247 DS20100248 DS20100249 DS20100250 DS20100251 DS20100252 DS20100253 DS20100254 DS20100255 DS20100256 DS20100257 DS20100258 DS20100259 DS20100260 DS20100261 DS20100262 DS20100263 DS20100264 DS20100265 DS20100266 DS20100267 DS20100268 DS20100269 DS20100270 DS20100271 DS20100272 DS20100273 DS20100274 DS20100275 DS20100276 DS20100277 DS20100278 DS20100279 DS20100280 DS20100281 DS20100282 DS20100283 DS20100284 DS20100285 DS20100286 DS20100287 DS20100288 DS20100289 DS20100290 DS20100291 DS20100292 DS20100293 DS20100294 DS20100295 DS20100296 DS20100297 DS20100298 DS20100299 DS20100300 DS20100301 DS20100302 DS20100303 DS20100304 DS20100305 DS20100306 DS20100307 DS20100308 DS20100309 DS20100310 DS20100311 DS20100312 DS20100313 DS20100314 DS20100315 DS20100316 DS20100317 DS20100318 DS20100319 DS20100320 DS20100321 DS20100322 DS20100323 DS20100324 DS20100325 DS20100326 DS20100327 DS20100328 DS20100329 DS20100330 DS20100331 DS20100332 DS20100333 DS20100334 DS20100335 DS20100336 DS20100337 DS20100338 DS20100339 DS20100340 DS20100341 DS20100342 DS20100343 DS20100344 DS20100345 DS20100346 DS20100347 DS20100348 DS20100349 DS20100350 DS20100351 DS20100352 DS20100353 DS20100354 DS20100355 DS20100356 DS20100357 DS20100358 DS20100359 DS20100360 DS20100361 DS20100362 DS20100363 DS20100364 DS20100365 DS20100366 DS20100367 DS20100368 DS20100369 DS20100370 DS20100371 DS20100372 DS20100373 DS20100374 DS20100375 DS20100376 DS20100377 DS20100378 DS20100379 DS20100380 DS20100381 DS20100382 DS20100383 DS20100384 DS20100385 DS20100386 DS20100387 DS20100388 DS20100389 DS20100390 DS20100391 DS20100392 DS20100393 DS20100394 DS20100395 DS20100396 DS20100397 DS20100398 DS20100399 DS20100400 DS20100401 DS20100402 DS20100403 DS20100404 DS20100405 DS20100406 DS20100407 DS20100408 DS20100409 DS20100410 DS20100411 DS20100412 DS20100413 DS20100414 DS20100415 DS20100416 DS20100417 DS20100418 DS20100419 DS20100420 DS20100421 DS20100422 DS20100423 DS20100424 DS20100425 DS20100426 DS20100427 DS20100428 DS20100429 DS20100430 DS20100431 DS20100432 DS20100433 DS20100434 DS20100435 DS20100436 DS20100437 DS20100438 DS20100439 DS20100440 DS20100441 DS20100442 DS20100443 DS20100444 DS20100445 DS20100446 DS20100447 DS20100448 DS20100449 DS20100450 DS20100451 DS20100452 DS20100453 DS20100454 DS20100455 DS20100456 DS20100457 DS20100458 DS20100459 DS20100460 DS20100461 DS20100462 DS20100463 DS20100464 DS20100465 DS20100466 DS20100467 DS20100468 DS20100469 DS20100470 DS20100471 DS20100472 DS20100473 DS20100474 DS20100475 DS20100476 DS20100477 DS20100478 DS20100479 DS20100480 DS20100481 DS20100482 DS20100483 DS20100484 DS20100485 DS20100486 DS20100487 DS20100488 DS20100489 DS20100490 DS20100491 DS20100492 DS20100493 DS20100494 DS20100495 DS20100496 DS20100497 DS20100498 DS20100499 DS20100500 DS20100501 DS20100502 DS20100503 DS20100504 DS20100505 DS20100506 DS20100507 DS20100508 DS20100509 DS20100510 DS20100511 DS20100512 DS20100513 DS20100514 DS20100515 DS20100516 DS20100517 DS20100518 DS20100519 DS20100520 DS20100521 DS20100522 DS20100523 DS20100524 DS20100525 DS20100526 DS20100527 DS20100528 DS20100529 DS20100530 DS20100531 DS20100532 DS20100533 DS20100534 DS20100535 DS20100536 DS20100537 DS20100538 DS20100539 DS20100540 DS20100541 DS20100542 DS20100543 DS20100544 DS20100545 DS20100546 DS20100547 DS20100548 DS20100549 DS20100550 DS20100551 DS20100552 DS20100553 DS20100554 DS20100555 DS20100556 DS20100557 DS20100558 DS20100559 DS20100560 DS20100561 DS20100562 DS20100563 DS20100564 DS20100565 DS20100566 DS20100567 DS20100568 DS20100569 DS20100570 DS20100571 DS20100572 DS20100573 DS20100574 DS20100575 DS20100576 DS20100577 DS20100578 DS20100579 DS20100580 DS20100581 DS20100582 DS20100583 DS20100584 DS20100585 DS20100586 DS20100587 DS20100588 DS20100589 DS20100590 DS20100591 DS20100592 DS20100593 DS20100594 DS20100595 DS20100596 DS20100597 DS20100598 DS20100599 DS20100600 DS20100601 DS20100602 DS20100603 DS20100604 DS20100605 DS20100606 DS20100607 DS20100608 DS20100609 DS20100610 DS20100611 DS20100612 DS20100613 DS20100614 DS20100615 DS20100616 DS20100617 DS20100618 DS20100619 DS20100620 DS20100621 DS20100622 DS20100623 DS20100624 DS20100625 DS20100626 DS20100627 DS20100628 DS20100629 DS20100630 DS20100631 DS20100632 DS20100633 DS20100634 DS20100635 DS20100636 DS20100637 DS20100638 DS20100639 DS20100640 DS20100641 DS20100642 DS20100643 DS20100644 DS20100645 DS20100646 DS20100647 DS20100648 DS20100649 DS20100650 DS20100651 DS20100652 DS20100653 DS20100654 DS20100655 DS20100656 DS20100657 DS20100658 DS20100659 DS20100660 DS20100661 DS20100662 DS20100663 DS20100664 DS20100665 DS20100666 DS20100667 DS20100668 DS20100669 DS20100670 DS20100671 DS20100672 DS20100673 DS20100674 DS20100675 DS20100676 DS20100677 DS20100678 DS20100679 DS20100680 DS20100681 DS20100682 DS20100683 DS20100684 DS20100685 DS20100686 DS20100687 DS20100688 DS20100689 DS20100690 DS20100691 DS20100692 DS20100693 DS20100694 DS20100695 DS20100696 DS20100697 DS20100698 DS20100699 DS20100700 DS20100701 DS20100702 DS20100703 DS20100704 DS20100705 DS20100706 DS20100707 DS20100708 DS20100709 DS20100710 DS20100711 DS20100712 DS20100713 DS20100714 DS20100715 DS20100716 DS20100717 DS20100718 DS20100719 DS20100720 DS20100721 DS20100722 DS20100723 DS20100724 DS20100725 DS20100726 DS20100727 DS20100728 DS20100729 DS20100730 DS20100731 DS20100732 DS20100733 DS20100734 DS20100735 DS20100736 DS20100737 DS20100738 DS20100739 DS20100740 DS20100741 DS20100742 DS20100743 DS20100744 DS20100745 DS20100746 DS20100747 DS20100749 DS20100750 DS20100751 DS20100752 DS20100753 DS20100754 DS20100755 DS20100756 DS20100757 DS20100758 DS20100759 DS20100760 DS20100761 DS20100762 DS20100763 DS20100764 DS20100765 DS20100766 DS20100767 DS20100768 DS20100769 DS20100770 DS20100771 DS20100772 DS20100773 DS20100774 DS20100775 DS20100776 DS20100777 DS20100778 DS20100779 DS20100780 DS20100781 DS20100782 DS20100783 DS20100784 DS20100785 DS20100786 DS20100787 DS20100788 DS20100789 DS20100790 DS20100791 DS20100792 DS20100793 DS20100794 DS20100795 DS20100796 DS20100797 DS20100798 DS20100799 DS20100800 DS20100801 DS20100802 DS20100803 DS20100804 DS20100805 DS20100806 DS20100807 DS20100808 DS20100809 DS20100810 DS20100811 DS20100812 DS20100813 DS20100814 DS20100815 DS20100816 DS20100817 DS20100818 DS20100819 DS20100820 DS20100821 DS20100822 DS20100823 DS20100824 DS20100825 DS20100826 DS20100827 DS20100828 DS20100829 DS20100830 DS20100831 DS20100832 DS20100833 DS20100834 DS20100835 DS20100836 DS20100837 DS20100838 DS20100839 DS20100840 DS20100841 DS20100842 DS20100843 DS20100844 DS20100845 DS20100846 DS20100847 DS20100848 DS20100849 DS20100850 DS20100851 DS20100852 DS20100853 DS20100854 DS20100855 DS20100856 DS20100857 DS20100858 DS20100859 DS20100860 DS20100861 DS20100862 DS20100863 DS20100864 DS20100865                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
Recalling Firm/
Ino Therapeutics
2902 Dairy Dr
Madison WI 53718-3809
For Additional Information Contact
Manufacturer Reason
for Recall
Through the review and monitoring of its complaint data, Ikaria identified a product anomaly with the INOmax DS Model 1003. Ikaria concluded the anomaly risk to the patient safety was low and non reportable (4/23/10). During a subsequent Level 3 inspection by FDA, it was concluded that the action should have been reported under 21 CFR & 806.10.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Ikaria sent a "RECALL- CUSTOMER PRODUCT REMEDIATION" notice dated December 22, 2011 to all affected customers. The letter describes the product, problem, actions taken by the firm. No action was required by customers. The notice served as correspondence to inform customers of the issue. Customers may direct their questions to Ikaria Customer Care at 1-877-566-9466.
Quantity in Commerce 2446
Distribution Worldwide Distribution-USA (nationwide) and the country of MALAYSIA.
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 = MRN and Original Applicant = INO THERAPEUTICS