Class 1 Device Recall medtronic

• Date Initiated by Firm: May 10, 2023
• Date Posted: June 16, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1757-2023
• Recall Event ID: 92328
• PMA Number: P010031S550
• Product Classification: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) - Product Code NIK
• Product: CRTD DTMA2D1 CLARIA MRI OUS DF1, Model Number DTMA2D1; Implantable Cardioverter Defibrillators
• Code Information: GTIN 00643169837621, Lot Serial Numbers: RPO604357S, RPO603344S, RPO603999S, RPO603613S, RPO602588S, RPO603485S, RPO603586S, RPO603863S, RPO601733S, RPO603715S, RPO601235S, RPO601389S, RPO601698S, RPO601771S, RPO602006S, RPO602325S, RPO602359S, RPO602456S, RPO602547S, RPO602630S, RPO602667S, RPO602723S, RPO602912S, RPO602956S, RPO603277S, RPO603281S, RPO603474S, RPO603611S, RPO604037S, RPO604118S, RPO604253S, RPO604259S, RPO604282S, RPO604326S, RPO604369S, RPO604405S, RPO604406S, RPO603440S, RPO603702S, RPO603703S, RPO604049S, RPO604050S, RPO604051S, RPO604073S, RPO603075S, RPO601669S, RPO601697S, RPO601763S, RPO602062S, RPO602101S, RPO602494S, RPO602703S, RPO602722S, RPO603071S, RPO603199S, RPO603211S, RPO603337S, RPO603351S, RPO603374S, RPO603645S, RPO603832S, RPO603958S, RPO604249S, RPO604448S, RPO601161S, RPO601166S, RPO601351S, RPO601519S, RPO601648S, RPO601993S, RPO602166S, RPO603371S, RPO603558S, RPO603585S, RPO603608S, RPO603644S, RPO603657S, RPO604149S, RPO604234S, RPO604396S, RPO604415S, RPO601299S, RPO603042S, RPO604021S, RPO601893S, RPO602016S, RPO603962S, RPO604147S, RPO604306S, RPO604347S, RPO601471S, RPO601485S, RPO601591S, RPO601680S, RPO601738S, RPO601973S, RPO602107S, RPO602217S, RPO602241S, RPO602411S, RPO602736S, RPO602831S, RPO602842S, RPO603193S, RPO603306S, RPO603466S, RPO603818S, RPO603960S, RPO603981S, RPO604136S, RPO604183S, RPO604207S, RPO604231S, RPO604404S, RPO604421S, RPO601711S, RPO602582S, RPO601419S, RPO603463S, RPO603992S, RPO604102S, RPO604015S, RPO603163S, RPO603865S, RPO604274S, RPO604340S, RPO604441S, RPO601607S, RPO601737S, RPO602510S, RPO603736S, RPO604250S, RPO603839S, RPO601660S, RPO602292S, RPO602742S, RPO603112S, RPO603192S, RPO603510S, RPO603636S, RPO603802S, RPO603834S, RPO603901S, RPO604424S, RPO601752S, RPO602979S, RPO603424S, RPO603561S, RPO603688S, RPO603931S, RPO601766S, RPO602074S, RPO602123S, RPO602491S, RPO601808S, RPO602213S, RPO602468S, RPO602495S, RPO602801S, RPO602978S, RPO603190S, RPO604018S, RPO601982S, RPO603898S, RPO601765S, RPO603065S, RPO604328S, RPO603814S, RPO604105S, RPO603593S, RPO601787S, RPO602228S, RPO602511S, RPO602799S, RPO603043S, RPO603521S, RPO602188S, RPO602735S, RPO603414S, RPO603876S, RPO603935S, RPO604014S, RPO604337S, RPO602711S, RPO602740S, RPO603877S, RPO601742S, RPO601881S, RPO602778S, RPO604443S, RPO602313S, RPO603126S, RPO603823S, RPO602304S, RPO602307S, RPO603479S, RPO603548S, RPO604011S, RPO602239S, RPO603465S, RPO601967S, RPO603060S, RPO603419S, RPO603438S, RPO601230S, RPO602001S, RPO602367S, RPO602775S, RPO602923S, RPO602973S, RPO603221S, RPO603329S, RPO603475S, RPO603478S, RPO603486S, RPO603648S, RPO603653S, RPO603687S, RPO603781S, RPO603784S, RPO603963S, RPO601426S, RPO601560S, RPO601747S, RPO601748S, RPO601811S, RPO601866S, RPO602500S, RPO602550S, RPO602635S, RPO603278S, RPO603324S, RPO604233S, RPO602270S, RPO601642S, RPO601644S, RPO601882S, RPO601988S, RPO602029S, RPO602059S, RPO602094S, RPO604446S, RPO601474S, RPO601291S, RPO601345S, RPO601677S, RPO601690S, RPO601954S, RPO602061S, RPO602296S, RPO602504S, RPO602719S, RPO602899S, RPO603040S, RPO603499S, RPO603531S, RPO603534S, RPO603542S, RPO603869S, RPO603889S, RPO604041S, RPO604383S, RPO604388S, RPO604447S, RPO601609S, RPO603038S, RPO603747S, RPO603811S, RPO603881S, RPO604024S, RPO604148S, RPO604444S, RPO601544S, RPO601667S, RPO602538S, RPO602892S, RPO604276S, RPO604338S, RPO601412S, RPO601546S, RPO601630S, RPO601693S, RPO601702S, RPO601800S, RPO601879S, RPO602319S, RPO603453S, RPO603562S, RPO603782S, RPO603785S, RPO604101S, RPO604302S, RPO601668S, RPO603751S, RPO604269S, RPO601710S, RPO602928S, RPO602968S, RPO601974S, RPO602766S, RPO603482S, RPO601211S, RPO601218S, RPO601407S, RPO601548S, RPO601603S, RPO601850S, RPO602134S, RPO602244S, RPO603034S, RPO601213S, RPO601337S, RPO601601S, RPO601687S, RPO601984S, RPO602345S, RPO602358S, RPO601614S, RPO602845S, RPO602266S, RPO602268S, RPO601694S, RPO601992S, RPO603342S, RPO603788S, RPO601731S, RPO601773S, RPO602725S, RPO603095S, RPO603544S, RPO604202S, RPO601528S, RPO602914S, RPO601600S, RPO601696S, RPO602305S, RPO601514S, RPO601585S, RPO601777S, RPO601496S, RPO601194S, RPO601342S, RPO601370S, RPO601377S, RPO601483S, RPO601627S, RPO601724S, RPO601823S, RPO601831S, RPO601887S, RPO601965S, RPO601969S, RPO601972S, RPO602269S, RPO602303S, RPO602364S, RPO602761S, RPO602806S, RPO602846S, RPO602915S, RPO602935S, RPO601505S, RPO601384S, RPO601396S, RPO601402S, RPO601466S, RPO601480S, RPO601590S, RPO601594S, RPO601602S, RPO601684S, RPO601707S, RPO601781S, RPO602003S, RPO602133S, RPO602135S, RPO602355S, RPO602662S, RPO602726S, RPO603091S, RPO603580S, RPO603581S, RPO603813S, RPO603857S, RPO604159S, RPO604201S, RPO601920S, RPO601604S, RPO602357S, RPO602739S, RPO602861S, RPO603046S, RPO603135S, RPO603274S, RPO603275S, RPO603380S, RPO603971S, RPO604038S, RPO604303S, RPO601220S, RPO601509S, RPO603064S, RPO602002S, RPO602010S, RPO602438S, RPO603503S, RPO604255S, RPO604335S, RPO604371S, RPO601192S, RPO601226S, RPO601229S, RPO601501S, RPO601999S, RPO602030S, RPO602143S, RPO602523S, RPO602911S, RPO603430S, RPO603738S, RPO601440S, RPO602223S, RPO602230S, RPO602320S, RPO602356S, RPO602426S, RPO602689S, RPO602843S, RPO602984S, RPO603355S, RPO603551S, RPO603870S, RPO602903S, RPO603549S, RPO601237S, RPO603530S, RPO604263S, RPO603583S, RPO603625S, RPO604180S, RPO601952S, RPO602063S, RPO602233S, RPO601688S, RPO601689S, RPO601197S, RPO601417S, RPO601608S, RPO602205S, RPO604170S, RPO601292S, RPO601804S, RPO603819S, RPO604235S, RPO601217S, RPO601379S, RPO601592S, RPO601679S, RPO601198S, RPO601610S, RPO601612S, RPO601436S, RPO601622S, RPO601182S, RPO601520S, RPO603338S, RPO602333S, RPO602499S, RPO603107S, RPO601275S, RPO601277S, RPO601279S, RPO603223S, RPO603224S, RPO603226S, RPO602100S, RPO602175S, RPO602176S, RPO602569S, RPO602616S, RPO603070S, RPO604094S, RPO603768S, RPO604251S, RPO603149S, RPO601577S, RPO603649S, RPO601248S, RPO601257S, RPO603399S, RPO603690S, RPO601352S, RPO601360S, RPO601538S, RPO601753S, RPO601975S, RPO602234S, RPO603200S, RPO603487S, RPO603488S, RPO603698S, RPO603728S, RPO604252S, RPO604327S, RPO604392S, RPO604401S, RPO604435S, RPO604439S, RPO604440S, RPO603902S, RPO603917S, RPO603972S, RPO601664S, RPO603320S, RPO601187S, RPO601433S, RPO602095S, RPO602974S, RPO603737S, RPO602513S, RPO604030S, RPO604121S, RPO603385S, RPO603451S, RPO603495S, RPO603630S, RPO603681S, RPO601164S, RPO602479S, RPO603304S, RPO603096S, RPO603208S, RPO603352S, RPO603359S, RPO603361S, RPO603423S, RPO603462S, RPO603810S, RPO603845S, RPO604036S, RPO604095S, RPO601649S, RPO603159S, RPO604391S, RPO601098S, RPO602206S, RPO601151S, RPO601152S, RPO603787S, RPO601349S, RPO601378S, RPO601451S, RPO601706S, RPO601713S, RPO601947S, RPO602102S, RPO602115S, RPO602121S, RPO602122S, RPO602242S, RPO602321S, RPO602524S, RPO602536S, RPO602701S, RPO602702S, RPO602856S, RPO602857S, RPO602902S, RPO603015S, RPO603076S, RPO603415S, RPO603705S, RPO603807S, RPO602078S, RPO602966S, RPO603418S, RPO603631S, RPO604361S, RPO603896S, RPO603920S, RPO604320S, RPO602254S, RPO603085S, RPO603523S, RPO603773S, RPO603774S, RPO603804S, RPO604119S, RPO602293S, RPO604305S, RPO602764S, RPO602875S, RPO602987S, RPO603470S, RPO604074S, RPO604151S, RPO602906S, RPO602191S, RPO602649S, RPO603078S, RPO603128S, RPO603766S, RPO604022S, RPO604107S, RPO604376S, RPO601100S, RPO601597S, RPO601623S, RPO601650S, RPO601670S, RPO602090S, RPO602156S, RPO602422S, RPO602470S, RPO602732S, RPO603031S, RPO603507S, RPO603587S, RPO603830S, RPO601153S, RPO601227S, RPO601568S, RPO601796S, RPO601799S, RPO602055S, RPO602126S, RPO602200S, RPO602419S, RPO602469S, RPO602907S, RPO603301S, RPO603427S, RPO603518S, RPO603757S, RPO603762S, RPO603772S, RPO604019S, RPO604166S, RPO603933S, RPO601243S, RPO601366S, RPO601368S, RPO601583S, RPO601821S, RPO601854S, RPO602009S, RPO602337S, RPO603079S, RPO603629S, RPO603516S, RPO602081S, RPO604445S, RPO601201S, RPO601435S, RPO602052S, RPO602318S, RPO603110S, RPO603134S, RPO603153S, RPO603677S, RPO601434S, RPO602073S, RPO602276S, RPO602668S, RPO603154S, RPO601147S, RPO601249S, RPO601493S, RPO601553S, RPO602298S, RPO603048S, RPO603171S, RPO603172S, RPO603270S, RPO603356S, RPO603555S, RPO603633S, RPO603744S, RPO604138S, RPO604154S, RPO604256S, RPO604318S, RPO604319S, RPO601491S, RPO601862S, RPO602308S, RPO602480S, RPO603308S, RPO604330S, RPO601270S, RPO601381S, RPO601399S, RPO601446S, RPO601617S, RPO601699S, RPO601792S, RPO601795S, RPO601833S, RPO601991S, RPO602068S, RPO602294S, RPO602476S, RPO602492S, RPO602613S, RPO602625S, RPO602830S, RPO602996S, RPO603133S, RPO603150S, RPO603174S, RPO603307S, RPO603365S, RPO603426S, RPO603448S, RPO603494S, RPO603557S, RPO603833S, RPO603858S, RPO601797S, RPO602192S, RPO602596S, RPO603049S, RPO601307S, RPO602225S, RPO603824S, RPO604033S, RPO601652S, RPO601364S, RPO602014S, RPO602870S, RPO602350S, RPO602825S, RPO604195S, RPO603316S, RPO603899S, RPO602622S, RPO603652S, RPO601632S, RPO601961S, RPO603166S, RPO604173S, RPO602257S, RPO602642S, RPO602643S, RPO602787S, RPO603094S, RPO603322S, RPO603520S, RPO603618S, RPO603620S, RPO603836S, RPO603941S, RPO604072S, RPO604142S, RPO604143S, RPO604416S, RPO604417S, RPO601634S, RPO601849S, RPO603420S, RPO603859S, RPO604358S, RPO601289S, RPO601834S, RPO601838S, RPO601953S, RPO602054S, RPO602437S, RPO603054S, RPO601409S, RPO603864S, RPO604321S, RPO601167S, RPO601169S, RPO601444S, RPO601476S, RPO601550S, RPO603026S, RPO601914S, RPO602077S, RPO603116S, RPO603296S, RPO603509S, RPO604323S, RPO604366S, RPO603641S, RPO604426S, RPO601989S, RPO602611S, RPO602828S, RPO602829S, RPO604048S, RPO601470S, RPO602747S, RPO603098S, RPO603261S, RPO603332S, RPO603903S, RPO602215S, RPO602788S, RPO603883S, RPO604238S, RPO603265S, RPO603671S, RPO604053S, RPO604096S, RPO604205S, RPO604241S, RPO602119S, RPO603480S, RPO603627S, RPO604206S, RPO602558S, RPO602560S, RPO602561S, RPO602563S, RPO602564S, RPO602584S, RPO602585S, RPO602586S, RPO602879S, RPO602880S, RPO602881S, RPO602993S, RPO602994S, RPO602995S, RPO602998S, RPO602999S, RPO603000S, RPO603001S, RPO603004S, RPO603005S, RPO603010S, RPO603011S, RPO603297S, RPO603388S, RPO603389S, RPO603390S, RPO603391S, RPO603393S, RPO603397S, RPO603614S, RPO603697S, RPO603775S, RPO603776S, RPO603777S, RPO603778S, RPO603779S, RPO603828S, RPO603829S, RPO603978S, RPO603984S, RPO604083S, RPO604084S, RPO604400S, RPO601500S, RPO601502S, RPO601503S, RPO601507S, RPO601511S, RPO601513S, RPO601826S, RPO601827S, RPO601829S, RPO601830S, RPO601897S, RPO601902S, RPO601904S, RPO601905S, RPO601907S, RPO602160S, RPO602163S, RPO602164S, RPO602165S, RPO602167S, RPO602168S, RPO602199S, RPO602243S, RPO602245S, RPO602248S, RPO602250S, RPO602261S, RPO602314S, RPO602381S, RPO602383S, RPO602384S, RPO602389S, RPO602390S, RPO602391S, RPO602392S, RPO602393S, RPO602394S, RPO602399S, RPO602519S, RPO602777S, RPO602957S, RPO602958S, RPO603749S, RPO603755S, RPO601646S, RPO604137S, RPO604155S, RPO604381S, RPO601842S, RPO602004S, RPO602741S, RPO602744S, RPO602748S, RPO602754S, RPO603965S, RPO603969S, RPO603970S, RPO603973S, RPO603976S, RPO603616S, RPO604351S, RPO604122S, RPO602921S, RPO601861S, RPO602060S, RPO602282S, RPO602283S, RPO602578S, RPO603018S, RPO603155S, RPO603638S, RPO603953S, RPO604184S, RPO604273S, RPO602515S, RPO603377S, RPO603894S, RPO602342S, RPO602259S, RPO602406S, RPO602409S, RPO602446S, RPO602554S, RPO602556S, RPO603017S, RPO604132S, RPO601464S, RPO603092S, RPO602579S, RPO603809S, RPO603974S, RPO604044S, RPO602171S, RPO602471S, RPO601571S, RPO602413S, RPO602969S, RPO603284S, RPO603319S, RPO603623S, RPO601692S, RPO603115S, RPO603934S, RPO601325S, RPO602692S, RPO603198S, RPO601573S, RPO601714S, RPO603084S, RPO602772S, RPO602889S, RPO602890S, RPO602980S, RPO603471S, RPO601939S, RPO602467S, RPO602496S, RPO602497S, RPO602626S, RPO602666S, RPO602697S, RPO601306S, RPO601490S, RPO601794S, RPO602448S, RPO603073S, RPO603194S, RPO601456S, RPO601655S, RPO602917S, RPO603373S, RPO603750S, RPO602219S, RPO602220S, RPO602221S, RPO603215S, RPO603615S, RPO603921S, RPO603991S, RPO604438S, RPO601580S, RPO601871S, RPO602432S, RPO602826S, RPO603024S, RPO604109S, RPO601909S, RPO601910S, RPO603119S, RPO602209S, RPO602349S, RPO601656S, RPO604135S, RPO601371S, RPO601372S, RPO601915S, RPO602108S, RPO602459S, RPO602527S, RPO602576S, RPO603213S, RPO603459S, RPO603712S, RPO603746S, RPO603800S, RPO602790S, RPO602833S, RPO602847S, RPO603210S, RPO603251S, RPO603554S, RPO603568S, RPO603570S, RPO603571S, RPO603955S, RPO602859S, RPO602860S, RPO603014S, RPO601564S, RPO602017S, RPO602756S, RPO603820S, RPO602737S, RPO601452S, RPO601540S, RPO601936S, RPO602967S, RPO603854S, RPO604291S, RPO604308S, RPO604427S, RPO602836S, RPO602865S, RPO603442S, RPO603446S, RPO603124S, RPO603209S, RPO601837S, RPO602352S, RPO601840S, RPO601946S, RPO603460S, RPO603938S, RPO604068S, RPO603087S, RPO602170S, RPO602982S, RPO601223S, RPO601468S, RPO602424S, RPO602896S, RPO603053S, RPO603932S, RPO601443S, RPO601584S, RPO602549S, RPO604315S, RPO604069S, RPO601572S, RPO602144S, RPO601321S, RPO601576S, RPO602403S, RPO603077S, RPO603111S, RPO603196S, RPO603266S, RPO603312S, RPO603559S, RPO603875S, RPO603910S, RPO604171S, RPO604365S, RPO604386S, RPO602067S, RPO602404S, RPO602989S, RPO603162S, RPO601535S, RPO602396S, RPO602534S, RPO603467S, RPO603501S, RPO601825S, RPO601889S, RPO602131S, RPO603888S, RPO601671S, RPO601672S, RPO601673S, RPO601708S, RPO604066S, RPO601536S, RPO601537S, RPO601363S, RPO602109S, RPO602981S, RPO603502S, RPO603936S, RPO603871S, RPO604419S, RPO601334S, RPO601336S, RPO602262S, RPO603691S, RPO603707S, RPO603792S, RPO604290S, RPO603793S, RPO603879S, RPO601615S, RPO602149S, RPO602371S, RPO602565S, RPO602757S, RPO602844S, RPO603276S, RPO603313S, RPO603315S, RPO603545S, RPO603837S, RPO603867S, RPO604055S, RPO604179S, RPO604409S, RPO604434S, RPO601510S, RPO602235S, RPO602653S, RPO602933S, RPO603985S, RPO604191S, RPO604398S, RPO602759S, RPO603260S, RPO603069S, RPO603765S, RPO603887S, RPO604368S, RPO604418S, RPO601301S, RPO601429S, RPO601323S, RPO601762S, RPO602343S, RPO602770S, RPO603723S, RPO603727S, RPO601188S, RPO602249S, RPO602264S, RPO602762S, RPO601200S, RPO601380S, RPO601428S, RPO601551S, RPO601926S, RPO602146S, RPO602278S, RPO602346S, RPO603431S, RPO603458S, RPO603929S, RPO604012S, RPO604013S, RPO604071S, RPO604085S, RPO604139S, RPO604217S, RPO604257S, RPO604265S, RPO604332S, RPO604380S, RPO604397S, RPO601190S, RPO601339S, RPO602366S, RPO602368S, RPO602463S, RPO602985S, RPO603354S, RPO601189S, RPO602247S, RPO601390S, RPO601870S, RPO602136S, RPO602246S, RPO602141S, RPO602418S, RPO602800S, RPO602964S, RPO601701S, RPO602098S, RPO602324S, RPO602401S, RPO602483S, RPO604108S, RPO601681S, RPO603464S, RPO601482S, RPO601705S, RPO603117S, RPO603491S, RPO602112S, RPO603825S, RPO601873S, RPO602300S, RPO603037S, RPO603387S, RPO603432S, RPO604200S, RPO601703S, RPO601798S, RPO602080S, RPO602369S, RPO602493S, RPO602607S, RPO603055S, RPO603156S, RPO603584S, RPO603647S, RPO604422S, RPO603169S, RPO603336S, RPO601948S, RPO603805S, RPO604243S, RPO601361S, RPO601524S, RPO601525S, RPO601566S, RPO601651S, RPO602196S, RPO604076S, RPO601121S, RPO601253S, RPO601255S, RPO601367S, RPO601463S, RPO601559S, RPO601653S, RPO601654S, RPO601744S, RPO601815S, RPO601820S, RPO601822S, RPO601894S, RPO602076S, RPO602256S, RPO602414S, RPO602416S, RPO602447S, RPO602464S, RPO602677S, RPO601338S, RPO601489S, RPO601547S, RPO602901S, RPO603590S, RPO603874S, RPO604226S, RPO601330S, RPO601575S, RPO601633S, RPO602634S, RPO602690S, RPO602944S, RPO604279S, RPO601461S, RPO602855S, RPO603083S, RPO603441S, RPO603848S, RPO601331S, RPO601662S, RPO602198S, RPO602452S, RPO601209S, RPO601726S, RPO602336S, RPO602738S, RPO603514S, RPO604006S, RPO604007S, RPO604140S, RPO604177S, RPO604232S, RPO601917S, RPO601918S, RPO602018S, RPO602451S, RPO602663S, RPO602781S, RPO603105S, RPO603262S, RPO603662S, RPO603706S, RPO603718S, RPO604394S, RPO602678S, RPO603161S, RPO603682S, RPO604106S, RPO601393S, RPO601421S, RPO601531S, RPO601888S, RPO603057S, RPO601405S, RPO601344S, RPO601640S, RPO601756S, RPO601789S, RPO601859S, RPO602189S, RPO602461S, RPO602520S, RPO602528S, RPO602665S, RPO602695S, RPO602751S, RPO602851S, RPO602886S, RPO602937S, RPO602940S, RPO602965S, RPO602972S, RPO603066S, RPO603346S, RPO603349S, RPO603372S, RPO603384S, RPO603560S, RPO603621S, RPO603640S, RPO603803S, RPO603827S, RPO603904S, RPO603993S, RPO604023S, RPO604099S, RPO604150S, RPO602110S, RPO601515S, RPO601785S, RPO602204S, RPO602858S, RPO603068S, RPO603930S, RPO601631S, RPO602551S, RPO603726S, RPO601309S, RPO601355S, RPO601356S, RPO602153S, RPO601138S, RPO601159S, RPO601174S, RPO601375S, RPO601392S, RPO601853S, RPO601908S, RPO602072S, RPO602338S, RPO602375S, RPO602506S, RPO602508S, RPO603099S, RPO603102S, RPO603634S, RPO603906S, RPO603925S, RPO601196S, RPO601199S, RPO601400S, RPO601404S, RPO601563S, RPO601565S, RPO601749S, RPO601807S, RPO601782S, RPO601783S, RPO601806S, RPO601921S, RPO601922S, RPO601985S, RPO601987S, RPO602000S, RPO602008S, RPO602057S, RPO602092S, RPO602517S, RPO602537S, RPO602559S, RPO602730S, RPO602760S, RPO602883S, RPO603103S, RPO603139S, RPO603140S, RPO603217S, RPO603496S, RPO603624S, RPO603658S, RPO603717S, RPO603729S, RPO603986S, RPO603987S, RPO604004S, RPO604047S, RPO604052S, RPO604063S, RPO602053S, RPO601109S, RPO601171S, RPO601398S, RPO601712S, RPO602193S, RPO602970S, RPO603489S, RPO603508S, RPO603637S, RPO603695S, RPO603975S, RPO604294S, RPO604411S, RPO601101S, RPO601236S, RPO601385S, RPO601599S, RPO601629S, RPO601639S, RPO601757S, RPO601963S, RPO602091S, RPO602157S, RPO602290S, RPO602961S, RPO603429S, RPO603944S, RPO603946S, RPO603994S, RPO603996S, RPO604377S, RPO604378S, RPO602280S, RPO602311S, RPO601106S, RPO601111S, RPO601144S, RPO601172S, RPO601193S, RPO601224S, RPO601234S, RPO601266S, RPO601458S, RPO601467S, RPO601593S, RPO601695S, RPO601754S, RPO601791S, RPO601803S, RPO601805S, RPO601818S, RPO601979S, RPO602033S, RPO602183S, RPO602260S, RPO602400S, RPO602436S, RPO602709S, RPO602724S, RPO603006S, RPO603029S, RPO603056S, RPO603202S, RPO603203S, RPO603271S, RPO603293S, RPO603370S, RPO603567S, RPO603601S, RPO603642S, RPO603654S, RPO603922S, RPO604130S, RPO604153S, RPO604160S, RPO604237S, RPO604245S, RPO604268S, RPO604298S, RPO604341S, RPO601118S, RPO601221S, RPO601442S, RPO602236S, RPO602975S, RPO603129S, RPO603473S, RPO603679S, RPO603914S, RPO604412S, RPO601851S, RPO603916S, RPO601382S, RPO601415S, RPO601545S, RPO601556S, RPO601579S, RPO601659S, RPO601736S, RPO601769S, RPO601868S, RPO601940S, RPO601956S, RPO601957S, RPO601960S, RPO602128S, RPO602159S, RPO602481S, RPO602482S, RPO602535S, RPO602688S, RPO602715S, RPO602971S, RPO603177S, RPO603504S, RPO603609S, RPO603791S, RPO603924S, RPO604185S, RPO604310S, RPO604311S, RPO601285S, RPO601473S, RPO604212S, RPO601231S, RPO601353S, RPO601354S, RPO601362S, RPO601675S, RPO601676S, RPO601729S, RPO601732S, RPO601925S, RPO601951S, RPO602087S, RPO602088S, RPO602201S, RPO602525S, RPO602627S, RPO602629S, RPO602696S, RPO602782S, RPO602783S, RPO603325S, RPO603754S, RPO604111S, RPO604372S, RPO604373S, RPO601185S, RPO601186S, RPO602638S, RPO603074S, RPO601357S, RPO601358S, RPO601359S, RPO601431S, RPO601469S, RPO601581S, RPO601658S, RPO601997S, RPO602037S, RPO602675S, RPO603417S, RPO603434S, RPO603472S, RPO603846S, RPO604060S, RPO602453S, RPO602877S, RPO603826S, RPO604158S, RPO604316S, RPO603412S, RPO602592S, RPO602962S, RPO601450S, RPO601454S, RPO601643S, RPO601784S, RPO602056S, RPO602885S, RPO603197S, RPO603292S, RPO601529S, RPO601549S, RPO601928S, RPO601929S, RPO601930S, RPO601937S, RPO601981S, RPO602331S, RPO602347S, RPO602597S, RPO602869S, RPO603039S, RPO603123S, RPO601286S, RPO601350S, RPO601816S, RPO602340S, RPO602755S, RPO602784S, RPO603362S, RPO603413S, RPO603450S, RPO603528S, RPO603592S, RPO603816S, RPO603851S, RPO603988S, RPO604228S, RPO604307S, RPO602127S, RPO602174S, RPO602190S, RPO602913S, RPO603264S, RPO603579S, RPO603923S, RPO603937S, RPO601700S, RPO601755S, RPO601858S, RPO602317S, RPO602608S, RPO602750S, RPO602791S, RPO602946S, RPO603295S, RPO603511S, RPO603619S, RPO603995S, RPO604045S, RPO604194S, RPO603872S, RPO604344S, RPO604432S, RPO601911S, RPO602991S, RPO603435S, RPO603639S, RPO602212S, RPO601311S, RPO601314S, RPO601318S, RPO601588S, RPO601715S, RPO601768S, RPO601844S, RPO601856S, RPO602058S, RPO602202S, RPO602610S, RPO602786S, RPO602884S, RPO603522S, RPO603838S, RPO603841S, RPO604080S, RPO601561S, RPO602652S, RPO602934S, RPO603578S, RPO603770S, RPO602669S, RPO602749S, RPO602924S, RPO604329S, RPO601465S, RPO601488S, RPO602785S, RPO602824S, RPO603030S, RPO603786S, RPO604032S, RPO604065S, RPO603082S, RPO603926S, RPO604399S, RPO601980S, RPO603668S, RPO601788S, RPO602929S, RPO603796S, RPO603843S, RPO601665S, RPO602145S, RPO603106S, RPO603909S, RPO601212S, RPO601691S, RPO604224S, RPO604393S, RPO604355S, RPO601320S, RPO601494S, RPO601625S, RPO601685S, RPO602628S, RPO602767S, RPO603267S, RPO603722S, RPO603860S, RPO604193S, RPO604219S, RPO604230S, RPO604314S, RPO602716S, RPO603347S, RPO601376S, RPO601555S, RPO604213S, RPO603918S, RPO601532S, RPO601533S, RPO602691S, RPO602774S, RPO603207S, RPO603643S, RPO603912S, RPO604077S, RPO604079S, RPO604239S, RPO604370S, RPO604408S, RPO601977S, RPO601406S, RPO601459S, RPO601913S, RPO602374S, RPO602631S, RPO604182S, RPO601203S, RPO601204S, RPO601205S, RPO601206S, RPO601207S, RPO602698S, RPO603452S, RPO603454S, RPO604115S, RPO602539S, RPO601767S, RPO602140S, RPO602425S, RPO602615S, RPO603895S, RPO601497S, RPO601498S, RPO601569S, RPO601919S, RPO601938S, RPO602106S, RPO602178S, RPO602474S, RPO602693S, RPO602694S, RPO602977S, RPO603016S, RPO603515S, RPO603519S, RPO603550S, RPO603632S, RPO603821S, RPO603856S, RPO604192S, RPO604345S, RPO604363S, RPO604390S, RPO601348S, RPO601401S, RPO601526S, RPO601943S, RPO602089S, RPO602322S, RPO602423S, RPO602445S, RPO602501S, RPO602947S, RPO603045S, RPO603477S, RPO603656S, RPO603732S, RPO603794S, RPO604064S, RPO604070S, RPO604112S, RPO604197S, RPO604218S, RPO604271S, RPO604299S, RPO601790S, RPO601878S, RPO602184S, RPO602633S, RPO603604S, RPO603664S, RPO604190S, RPO601709S, RPO602232S, RPO601416S, RPO602323S, RPO601720S, RPO601721S, RPO601949S, RPO603655S, RPO601723S, RPO603959S, RPO601558S, RPO601761S, RPO603062S, RPO604325S, RPO601411S, RPO603742S, RPO603142S, RPO601530S, RPO601793S, RPO601950S, RPO602079S, RPO602120S, RPO602591S, RPO602654S, RPO602789S, RPO602863S, RPO603022S, RPO603676S, RPO603908S, RPO601300S, RPO603041S, RPO603081S, RPO603379S, RPO603445S, RPO601346S, RPO601414S, RPO601425S, RPO601499S, RPO601942S, RPO602712S, RPO601341S, RPO601682S, RPO602218S, RPO602581S, RPO602926S, RPO601574S, RPO604133S, RPO603340S, RPO601154S, RPO601155S, RPO601157S, RPO601886S, RPO602070S, RPO602071S, RPO602203S, RPO602116S, RPO602758S, RPO603552S, RPO604005S, RPO603168S, RPO602348S, RPO603157S, RPO601541S, RPO601543S, RPO601758S, RPO601968S, RPO602096S, RPO602229S, RPO603263S, RPO603341S, RPO601438S, RPO602449S, RPO602822S, RPO604174S, RPO604360S, RPO601424S, RPO601970S, RPO602214S, RPO604164S, RPO602111S, RPO603089S, RPO603437S, RPO603439S, RPO603538S, RPO603539S, RPO601150S, RPO601477S, RPO601481S, RPO602852S, RPO601620S, RPO602151S, RPO602378S, RPO602587S, RPO603483S, RPO603730S, RPO603756S, RPO603891S, RPO604134S, RPO604309S, RPO604059S, RPO601647S, RPO602302S, RPO602583S, RPO602658S, RPO603317S, RPO603318S, RPO604089S, RPO604031S, RPO601251S, RPO601663S, RPO601746S, RPO601941S, RPO602679S, RPO603282S, RPO603529S, RPO601437S, RPO604379S, RPO601191S, RPO601924S, RPO602130S, RPO602439S, RPO602441S, RPO602802S, RPO604346S, RPO602673S, RPO603165S, RPO601280S, RPO601282S, RPO601284S, RPO602211S, RPO603357S, RPO603367S, RPO603368S, RPO603598S, RPO603708S, RPO603710S, RPO601759S, RPO601760S, RPO601846S, RPO602118S, RPO602465S, RPO602466S, RPO602475S, RPO602727S, RPO601268S, RPO601272S, RPO601522S, RPO601523S, RPO601883S, RPO601885S, RPO601931S, RPO601932S, RPO601933S, RPO602075S, RPO602197S, RPO602284S, RPO602285S, RPO602286S, RPO602908S, RPO602939S, RPO603052S, RPO603305S, RPO603481S, RPO603711S, RPO603890S, RPO601210S, RPO601478S, RPO602372S, RPO603855S, RPO603942S, RPO604075S, RPO604275S, RPO604364S, RPO602069S, RPO602258S, RPO602353S, RPO602360S, RPO602704S, RPO602920S, RPO603086S, RPO603588S, RPO603790S, RPO604120S, RPO604178S, RPO601802S, RPO602207S, RPO602208S, RPO603253S, RPO603979S, RPO602900S, RPO601606S, RPO601611S, RPO601613S, RPO601619S, RPO601624S, RPO601626S, RPO601628S, RPO601638S, RPO601641S, RPO602238S, RPO602442S, RPO602443S, RPO602444S, RPO602951S, RPO602954S, RPO602955S, RPO603173S, RPO603175S, RPO603176S, RPO603183S, RPO603394S, RPO603395S, RPO603396S, RPO603574S, RPO603575S, RPO601148S, RPO601397S, RPO601410S, RPO601420S, RPO601439S, RPO601441S, RPO602281S, RPO602484S, RPO602521S, RPO602837S, RPO602838S, RPO602839S, RPO603505S, RPO603506S, RPO601246S, RPO604042S, RPO604043S, RPO601146S, RPO601176S, RPO601183S, RPO601269S, RPO601492S, RPO601562S, RPO601567S, RPO601877S, RPO601994S, RPO602874S, RPO602898S, RPO602976S, RPO603013S, RPO603061S, RPO603254S, RPO603808S, RPO603822S, RPO603847S, RPO604001S, RPO604029S, RPO604082S, RPO604176S, RPO604203S, RPO604246S, RPO604395S, RPO604168S, RPO601971S, RPO601495S, RPO601725S, RPO602104S, RPO603025S, RPO601252S, RPO601635S, RPO602093S, RPO602514S, RPO602655S, RPO602714S, RPO602768S, RPO602878S, RPO603104S, RPO603148S, RPO603484S, RPO604283S, RPO604196S, RPO601261S, RPO601395S, RPO602344S, RPO602575S, RPO603422S, RPO601373S, RPO601403S, RPO601824S, RPO601869S, RPO601874S, RPO601935S, RPO602012S, RPO602405S, RPO602745S, RPO602796S, RPO603097S, RPO603753S, RPO603769S, RPO603957S, RPO604244S, RPO604295S, RPO604304S, RPO604317S, RPO601527S, RPO603147S, RPO601423S, RPO601460S, RPO601876S, RPO603143S, RPO604087S, RPO604090S, RPO604141S, RPO604350S, RPO604429S, RPO601751S, RPO601329S, RPO601324S, RPO601327S, RPO602522S, RPO602827S, RPO603311S, RPO603326S, RPO601475S, RPO603088S, RPO604008S, RPO601408S, RPO602763S, RPO603007S, RPO603610S, RPO603882S, RPO604117S, RPO604198S, RPO604204S, RPO604420S, RPO601666S, RPO604374S, RPO601453S, RPO602148S, RPO604292S, RPO603302S, RPO603546S, RPO603646S, RPO604156S, RPO604331S, RPO601605S, RPO601779S, RPO602186S, RPO602195S, RPO603291S, RPO604002S, RPO604285S, RPO603743S, RPO602351S, RPO602792S, RPO603517S, RPO603675S, RPO604025S, RPO604413S, RPO602636S, RPO602150S, RPO603674S, RPO603835S, RPO604225S, RPO604281S, RPO604208S, RPO603456S, RPO603595S, RPO604322S, RPO602542S, RPO601129S, RPO602161S, RPO601534S, RPO602138S, RPO602139S, RPO602341S, RPO602397S, RPO603002S, RPO603333S, RPO603512S, RPO604264S, RPO602997S, RPO604266S, RPO603401S, RPO604113S, RPO602505S, RPO602887S, RPO603350S, RPO603184S, RPO603513S, RPO601233S, RPO601322S, RPO601413S, RPO601996S, RPO602129S, RPO603072S, RPO603289S, RPO603498S, RPO601326S, RPO601328S, RPO601686S, RPO602457S, RPO604262S, RPO601422S, RPO602299S, RPO602986S, RPO600993S, RPO601202S, RPO601332S, RPO602301S, RPO602365S, RPO601369S, RPO601333S, RPO601813S, RPO602132S, RPO602179S, RPO602498S, RPO602793S, RPO602910S, RPO603290S, RPO603492S, RPO603764S, RPO603840S, RPO604086S, RPO602162S, RPO604092S, RPO604280S, RPO604289S, RPO601978S, RPO603661S, RPO601875S, RPO601962S, RPO601976S, RPO602169S, RPO602177S, RPO601305S, RPO603008S, RPO603100S, RPO601743S, RPO601906S, RPO602142S, RPO603844S, RPO602942S, RPO601340S, RPO601208S, RPO602415S, RPO602417S, RPO602540S, RPO602645S, RPO602646S, RPO602803S, RPO603444S, RPO604088S, RPO604214S, RPO604215S, RPO602099S, RPO601657S, RPO603596S, RPO602866S, RPO601734S, RPO603382S, RPO601912S, RPO601512S, RPO601774S, RPO601776S, RPO602306S, RPO602309S, RPO602637S, RPO602905S, RPO603032S, RPO602765S, RPO603849S, RPO604123S, RPO602943S, RPO603564S, RPO603626S, RPO603950S, RPO604126S, RPO604356S, RPO604359S, RPO604433S, RPO602731S, RPO604091S, RPO604334S, RPO601557S, RPO602114S, RPO603852S, RPO604039S, RPO604229S, RPO601219S, RPO601616S, RPO602158S, RPO603989S, RPO604353S, RPO603553S, RPO604016S, RPO604128S, RPO601884S, RPO602105S, RPO602137S, RPO602251S, RPO602639S, RPO602743S, RPO603919S, RPO604056S, RPO604124S, RPO601986S, RPO602172S, RPO602553S, RPO602862S, RPO604431S, RPO601828S, RPO604127S, RPO604181S, RPO601727S, RPO603497S, RPO604187S, RPO603080S, RPO603348S, RPO601847S, RPO601865S, RPO602718S, RPO603035S, RPO603376S, RPO603457S, RPO601764S, RPO601864S, RPO602117S, RPO601254S, RPO601841S, RPO601843S, RPO601895S, RPO602036S, RPO602049S, RPO602589S, RPO602808S, RPO602941S, RPO603204S, RPO601898S, RPO603219S, RPO603982S, RPO602930S, RPO602038S, RPO602040S, RPO603268S, RPO604017S, RPO603927S, RPO602407S, RPO603663S, RPO603741S, RPO603939S, RPO603239S, RPO603118S, RPO603763S, RPO602289S, RPO603114S, RPO603468S, RPO601168S, RPO601287S, RPO601290S, RPO601294S, RPO603189S, RPO603220S, RPO603257S, RPO601110S, RPO602734S, RPO603760S, RPO603940S, RPO602746S, RPO602813S, RPO601296S, RPO601303S, RPO601304S, RPO601880S, RPO601891S, RPO602315S, RPO602362S, RPO602810S, RPO603003S, RPO603884S, RPO601133S, RPO601137S, RPO601239S, RPO602023S, RPO602026S, RPO602032S, RPO602041S, RPO602330S, RPO602794S, RPO602795S, RPO603635S, RPO603719S, RPO603255S, RPO603556S, RPO603132S, RPO603181S, RPO603229S, RPO602050S, RPO602648S, RPO604300S, RPO602873S, RPO603205S, RPO600992S, RPO601117S, RPO601177S, RPO601283S, RPO602022S, RPO602043S, RPO602312S, RPO602728S, RPO603122S, RPO603701S, RPO603670S, RPO603713S, RPO603569S, RPO602255S, RPO601903S, RPO602152S, RPO602288S, RPO602507S, RPO602809S, RPO603392S, RPO602729S, RPO601107S, RPO602182S, RPO602287S, RPO602361S, RPO602848S, RPO602867S, RPO603141S, RPO604296S, RPO603256S, RPO603673S, RPO603543S, RPO601288S, RPO601298S, RPO602044S, RPO603246S, RPO603212S, RPO601127S, RPO601173S, RPO602020S, RPO602021S, RPO602327S, RPO602590S, RPO602812S, RPO602945S, RPO602953S, RPO603127S, RPO603247S, RPO602363S, RPO602013S, RPO601108S, RPO601247S, RPO601900S, RPO601901S, RPO602185S, RPO602291S, RPO602805S, RPO602891S, RPO603235S, RPO603243S, RPO603272S, RPO603740S, RPO603758S, RPO603725S, RPO602387S, RPO602733S, RPO603547S, RPO604081S, RPO601124S, RPO602047S, RPO602676S, RPO602811S, RPO602820S, RPO602028S, RPO602888S, RPO602035S, RPO602925S, RPO602932S, RPO603225S, RPO600994S, RPO602952S, RPO601839S, RPO602027S, RPO602849S, RPO603120S, RPO601141S, RPO602814S, RPO602854S, RPO603469S, RPO602601S, RPO603145S, RPO601319S, RPO603288S, RPO601134S, RPO603360S, RPO603573S, RPO603660S, RPO603724S, RPO603866S, RPO602042S, RPO603185S, RPO603540S, RPO603892S, RPO601316S, RPO601317S, RPO601112S, RPO601122S, RPO601123S, RPO601899S, RPO602428S, RPO602644S, RPO601128S, RPO601125S, RPO601131S, RPO601135S, RPO601136S, RPO601180S, RPO601896S, RPO602024S, RPO602025S, RPO602039S, RPO602048S, RPO602332S, RPO602377S, RPO602815S, RPO602816S, RPO602872S, RPO602919S, RPO603214S, RPO603249S, RPO603363S, RPO603364S, RPO603997S, RPO604020S, RPO602045S, RPO602382S, RPO602632S, RPO601104S, RPO603206S, RPO602502S, RPO602509S, RPO602532S, RPO602798S, RPO603108S, RPO603187S, RPO601184S, RPO601274S, RPO601892S, RPO602398S, RPO602797S, RPO602807S, RPO602918S, RPO603188S, RPO603537S, RPO603603S, RPO602526S, RPO603536S, RPO603600S, RPO601097S, RPO601115S, RPO601126S, RPO602566S, RPO602868S, RPO601139S, RPO601278S, RPO602034S, RPO601120S, RPO601140S, RPO603231S, RPO603345S, RPO601260S, RPO603524S, RPO601132S, RPO602819S, RPO601142S, RPO601302S, RPO603949S, RPO601959S, RPO604227S, RPO603180S, RPO601158S, RPO602216S, RPO603666S, RPO603693S, RPO603244S, RPO602776S, RPO603136S, RPO603589S, RPO604175S, RPO604247S, RPO604270S, RPO604414S, RPO601105S, RPO601143S, RPO601160S, RPO601162S, RPO601245S, RPO601386S, RPO601387S, RPO601448S, RPO601867S, RPO601964S, RPO602046S, RPO602222S, RPO602265S, RPO602485S, RPO603428S, RPO603461S, RPO603170S, RPO602180S, RPO601394S, RPO601432S, RPO601449S, RPO601552S, RPO601570S, RPO601582S, RPO601750S, RPO601778S, RPO601812S, RPO601855S, RPO602277S, RPO602316S, RPO602450S, RPO603378S, RPO601293S, RPO601775S, RPO602297S, RPO602710S, RPO602717S, RPO602753S, RPO603678S, RPO603696S, RPO602706S, RPO602707S, RPO604097S, RPO604129S, RPO604312S, RPO604362S, RPO604402S, RPO604425S, RPO603299S, RPO603476S, RPO603090S, RPO601958S, RPO602011S, RPO602181S, RPO602334S, RPO602385S, RPO603240S, RPO601518S, RPO603665S, RPO603983S, RPO601719S, RPO601103S, RPO602882S, RPO603694S, RPO602005S, RPO601516S, RPO601517S, RPO601945S, RPO602275S, RPO602458S, RPO603020S, RPO603259S, RPO603279S, RPO603280S, RPO603298S, RPO603386S, RPO603525S, RPO603597S, RPO603797S, RPO603886S, RPO604000S, RPO604114S, RPO604145S, RPO604152S, RPO604163S, RPO604199S, RPO604277S, RPO604442S, RPO601716S, RPO602103S, RPO603692S, RPO602395S, RPO603178S, RPO601430S, RPO601455S, RPO602326S, RPO601228S, RPO602420S, RPO603493S, RPO603868S, RPO603443S, RPO602066S, RPO603599S, RPO603216S, RPO602427S, RPO603009S, RPO603201S, RPO603650S, RPO603669S, RPO604093S, RPO604267S, RPO604313S, RPO604254S, RPO604260S, RPO604407S, RPO602604S, RPO602713S, RPO603398S, RPO603628S, RPO604058S, RPO604336S, RPO604403S, RPO601934S, RPO602237S, RPO602927S, RPO603047S, RPO603146S, RPO603842S, RPO603873S, RPO603913S, RPO604010S, RPO603130S, RPO603131S, RPO604046S, RPO603853S, RPO603672S, RPO603659S, RPO604209S, RPO604382S, RPO603328S; GTIN 00763000206284, Lot Serial Numbers: RPO604797S, RPO604458S, RPO605175S, RPO605029S, RPO605292S, RPO605484S, RPO605429S, RPO605149S, RPO604655S, RPO605435S, RPO605406S, RPO605041S, RPO604992S, RPO605281S, RPO605419S, RPO605500S, RPO604288S, RPO604449S, RPO604727S, RPO604772S, RPO604794S, RPO604829S, RPO604831S, RPO605514S, RPO604673S, RPO604999S, RPO605000S, RPO604472S, RPO604572S, RPO604584S, RPO604612S, RPO604654S, RPO604678S, RPO605333S, RPO605482S, RPO604876S, RPO604924S, RPO604862S, RPO604920S, RPO604968S, RPO604986S, RPO604689S, RPO604925S, RPO605021S, RPO605050S, RPO604985S, RPO604885S, RPO604671S, RPO604958S, RPO604852S, RPO604613S, RPO604502S, RPO604510S, RPO604821S, RPO604823S, RPO605065S, RPO604685S, RPO604798S, RPO604720S, RPO604967S, RPO605078S, RPO604485S, RPO605066S, RPO604813S, RPO604487S, RPO604582S, RPO604757S, RPO604775S, RPO604847S, RPO605036S, RPO605375S, RPO605421S, RPO604703S, RPO604849S, RPO604923S, RPO604957S, RPO605048S, RPO604490S, RPO604982S, RPO605040S, RPO605058S, RPO605077S, RPO605119S, RPO605130S, RPO605144S, RPO605145S, RPO605262S, RPO605269S, RPO605303S, RPO605413S, RPO604846S, RPO604936S, RPO604632S, RPO605039S, RPO604754S, RPO605022S, RPO605097S, RPO604867S, RPO604698S, RPO604545S, RPO604596S, RPO604636S, RPO604650S, RPO604750S, RPO604752S, RPO604865S, RPO604931S, RPO605023S, RPO605265S, RPO605294S, RPO604482S, RPO604556S, RPO604571S, RPO604971S, RPO605285S, RPO605295S, RPO604600S, RPO605094S, RPO605026S, RPO604838S, RPO605284S, RPO605074S, RPO605068S, RPO605064S, RPO605263S, RPO604903S, RPO605394S, RPO604759S, RPO604966S, RPO604716S, RPO605313S, RPO604998S, RPO604515S, RPO605003S, RPO604824S, RPO604932S, RPO605259S, RPO604828S, RPO604869S, RPO604883S, RPO604981S, RPO604996S, RPO605010S, RPO605012S, RPO605035S, RPO605206S, RPO605309S, RPO605311S, RPO604468S, RPO604287S, RPO605301S, RPO604723S, RPO604782S, RPO604501S, RPO604888S, RPO604830S, RPO604844S, RPO604866S, RPO605208S, RPO604963S, RPO605279S, RPO604871S, RPO605020S, RPO604523S, RPO604534S, RPO604652S, RPO604529S, RPO604729S, RPO604841S, RPO604956S, RPO604953S, RPO605059S, RPO605210S, RPO605283S, RPO605323S, RPO605391S, RPO604816S, RPO604791S, RPO605063S, RPO604955S, RPO604640S, RPO604697S, RPO604975S, RPO605095S, RPO605114S, RPO604473S, RPO604625S, RPO605033S, RPO604688S, RPO604783S, RPO604848S, RPO604870S, RPO604959S, RPO604694S, RPO604464S, RPO604488S, RPO604493S, RPO604499S, RPO604504S, RPO604505S, RPO604506S, RPO604764S, RPO604805S, RPO604806S, RPO604807S, RPO604820S, RPO604960S, RPO604961S, RPO604962S, RPO605067S, RPO605384S, RPO605385S, RPO605423S, RPO605424S, RPO605425S, RPO605426S, RPO604839S, RPO604558S, RPO604513S, RPO605289S, RPO604872S, RPO604909S, RPO604725S, RPO604734S, RPO604781S, RPO604881S, RPO604776S, RPO605363S, RPO604900S, RPO604901S, RPO604777S, RPO604880S, RPO604952S, RPO605156S, RPO605379S, RPO605397S, RPO604738S, RPO604910S, RPO605389S, RPO604638S, RPO604762S, RPO604803S, RPO604991S, RPO604535S, RPO604945S, RPO605055S, RPO605315S, RPO604569S, RPO604471S, RPO604733S, RPO605138S, RPO604469S, RPO604743S, RPO604581S, RPO604603S, RPO604680S, RPO604784S, RPO604882S, RPO604626S, RPO604875S, RPO605164S, RPO604978S, RPO604591S, RPO604532S, RPO604538S, RPO604563S, RPO605121S, RPO604512S, RPO604527S, RPO605246S, RPO604878S, RPO605009S, RPO604718S, RPO604644S, RPO604840S, RPO604486S, RPO604503S, RPO604509S, RPO604540S, RPO604570S, RPO604579S, RPO604721S, RPO604514S, RPO604970S, RPO604646S, RPO604812S, RPO604674S, RPO604756S, RPO605321S, RPO604592S, RPO605392S, RPO605416S, RPO604926S, RPO604715S, RPO605249S, RPO604491S, RPO604767S, RPO604774S, RPO604788S, RPO604853S, RPO605410S, RPO604633S, RPO604635S, RPO604753S, RPO605030S, RPO604457S, RPO604641S, RPO604666S, RPO604905S, RPO604911S, RPO605014S, RPO604645S, RPO604634S, RPO604850S, RPO604859S, RPO604935S, RPO604977S, RPO605096S, RPO604508S, RPO604561S, RPO604656S, RPO604692S, RPO604751S, RPO604800S, RPO604893S, RPO604939S, RPO604976S, RPO605073S, RPO605272S, RPO605364S, RPO605417S, RPO605437S, RPO605499S, RPO604732S, RPO604605S, RPO604792S, RPO605129S, RPO605486S, RPO604631S, RPO604717S, RPO604790S, RPO604891S, RPO604892S, RPO604904S, RPO605070S, RPO605396S, RPO605445S, RPO604739S, RPO604778S, RPO604787S, RPO604857S, RPO605165S, RPO605205S, RPO604832S, RPO604842S, RPO604681S, RPO604856S, RPO604918S, RPO605013S, RPO604819S, RPO604550S, RPO604466S, RPO604477S, RPO604528S, RPO604599S, RPO604658S, RPO604662S, RPO604604S, RPO604647S, RPO605076S, RPO604679S, RPO604705S, RPO604737S, RPO605253S, RPO605300S, RPO605399S, RPO604522S, RPO604835S, RPO604770S, RPO604811S, RPO604648S, RPO604810S, RPO604980S, RPO604542S, RPO604565S, RPO604536S, RPO604834S, RPO604864S, RPO605008S, RPO605136S, 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RPO605457S, RPO605458S, RPO605461S, RPO605465S, RPO605173S, RPO605174S, RPO605177S, RPO605178S, RPO605180S, RPO605418S, RPO604702S, RPO604707S, RPO604719S, RPO604724S, RPO604730S, RPO604747S, RPO604773S, RPO604845S, RPO604854S, RPO604884S, RPO604887S, RPO604890S, RPO604912S, RPO604916S, RPO604921S, RPO604937S, RPO604951S, RPO604973S, RPO604979S, RPO605031S, RPO605037S, RPO605049S, RPO605135S, RPO605150S, RPO605154S, RPO605157S, RPO605162S, RPO605197S, RPO605209S, RPO605211S, RPO605247S, RPO605268S, RPO605275S, RPO605282S, RPO605291S, RPO605314S, RPO605316S, RPO605324S, RPO605332S, RPO605335S, RPO605337S, RPO605339S, RPO605340S, RPO605358S, RPO605365S, RPO605377S, RPO605381S, RPO605383S, RPO605388S, RPO605400S, RPO605405S, RPO605409S, RPO605412S, RPO605420S, RPO605427S, RPO605430S, RPO605431S, RPO605432S, RPO605433S, RPO605434S, RPO605436S, RPO605464S, RPO605481S, RPO605483S, RPO605496S, RPO605497S, RPO605505S, RPO604699S, RPO604974S, RPO605137S, RPO605254S, RPO605290S, RPO605307S, RPO605308S, RPO605317S, RPO605360S, RPO605390S, RPO605407S, RPO605442S, RPO605491S, RPO605502S, RPO604614S
• Recalling Firm/ Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF); 8200 Coral Sea St Ne; Mounds View MN 55112-4391
• For Additional Information Contact: Technical Services; 800-929-4043
• Manufacturer Reason for Recall: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
• FDA Determined Cause: Under Investigation by firm
• Action: Medtronic issued an URGENT MEDICAL DEVICE CORRECTION NOTICE to its consignees on 05/10/2023 by UPS 2-day delivery or email. Consignees are asked to forward this notification to those who need to be aware within the organization and to any location which the devices have been distributed. The notice explained the problem and the risk and requested the following patient management recommendations: - Prophylactic device replacement is NOT recommended. - Program all HV therapy pathways B>AX in all therapy zones to minimize the risk for this issue. - Prioritize reprogramming patients who have both a history of HV therapy and Rx1 programmed AX>B. - For remaining patients with AX>B programming in any HV therapy sequence, schedule (with appropriate discretion) the next follow-up for in-clinic reprogramming to minimize potential for reduced- or no-energy HV therapies to occur. - Contact Medtronic Technical Services (1-800-929-4043) or your local representative if one of the following is observed as these may be an indication of either a device or lead-related issue: o Reduced- or no-energy HV therapy is displayed in Episode Text (regardless of programmed pathway) o A persistent drop of approximately 50% in RA, RV and LV pacing lead impedance measurements as this may be an indication of increased potential for a future reduced- or no-energy therapy. Update 10/10/2023: Beginning 09/27/2023, Medtronic issued communication via letter to consignees regarding the availability of the revised IFU and SmartSync Software. Consignees are asked to forward this notification to those who need to be aware within the organization and to any location which the devices have been distributed. Consignees are asked to complete and return a confirmation certificate (or equivalent record) confirming they have received the notification.
• Quantity in Commerce: 3570 units
• Distribution: US Nationwide - Worldwide Distribution
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = NIK; PMAs with Product Code = NIK