HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)
Class I - DangerousWhat Should You Do?
- Check if you have this product: U.S. Model 350P Item Number: 350-STR-US-10 UDI-DI code: 0506016712067 Serial Numbers 23D98002591E23 23D98002593E23 23D98002594E23 23D98002595E23 23D98002597E23 23D98002608E23 23D98002638E23 23D98002668E23 23D98002669E23 23D98002699E23 23D98002734E23 23D98002751E23 23D98002755E23 23D98002756E23 23D98002758E23 23D98002760E23 23D98002761E23 23D98002765E23 23D98002772E23 23D98002773E23 23D98002774E23 23D98002845E23 23D98002852E23 23D98002853E23 23D98002855E23 23D98002856E23 23D98002857E23 23D98002858E23 23D98002859E23 23D98002877E23 23D98002879E23 23D98002885E23 23D98002887E23 23D98002987E23 23D98002989E23 23D98002990E23 23D98003083E23 23D98003092E23 23D98003117I23 23D98003118E23 23D98003459D23 23D98003475D23 23D98008368E23 23D98008390E23 23D98008877E23 23D98011224D23 23D98012987E23 23D98012991E23 23D98012993E23 23D98012994E23 23D98012998E23 23D98012999E23 23D98013490F23 23D98013500F23 23D98016785E23 23D98017244E23 23D98020031C23 23D98020033C23 23D98020036C23 23D98020351C23 23D98020356C23 23D98020386C23 23D98020403C23 23D98020405C23 23D98020406C23 23D98020408C23 23D98020420C23 23D98020592D23 23D98020594D23 23D98020622D23 23D98020623D23 23D98020627D23 23D98020628D23 23D98020629D23 23D98020631D23 23D98020639D23 23D98020640D23 23D98020732D23 23D98023168E23 23D98100628I23 23D98100631I23 23D98100634I23 23D98100648I23 23D98102318K23 23D98104318J23 23D98104432J23 23D98104622J23 23D98104623J23 23D98104624J23 23D98104628J23 23D98104700J23 23D98104737J23 23D98104741J23 23D98104835J23 23D98104867J23 23D98104868J23 23D98104874J23 23D98104889J23 23D98104946J23 23D98104980J23 23D98104985J23 23D98104986J23 23D98104988J23 23D98105086J23 23D98105145J23 23D98105146J23 23D98105147J23 23D98105148J23 23D98105149J23 23D98105150J23 23D98105151J23 23D98105152J23 23D98105153K23 23D98105917J23 23D98105968J23 23D98105980J23 23D98106055J23 23D98108733I23 23D98109510I23 23D98109528I23 23D98109530I23 23D98109536I23 23D98109537I23 23D98109539I23 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24E90020489B24 23E90148518K23 23E90141749K23 24E90018353A24 23E90131752I23 23E90147550K23 23E90147549K23 24E90018363A24 23E90110241H23 23E90131753I23 24E90017316A24 24E90003310B24 23E90135479J23 23E90017678D23 23E90131667I23 23E90103892H23 23E90103894H23 23E90011797D23 23E90107066G23 23E90131427H23 23E90131432H23 23E90006904D23 23E90102226G23 23E90102229G23 23E90131440H23 23E90102659G23 23E90116352H23 23E90148114K23 23E90102210G23 23E90131434H23 23E90148044K23 24E90018361A24 23E90131437H23 23E90137583I23 24E90003983B24 23E90131899I23 23E90006905D23 24E90003492B24 24E90003909B24 23E90102783G23 23E90148066K23 23E90011958D23 23E90145717K23 23E90145714K23 23E90017670D23 23E90131447H23 23E90148035K23 23E90131419H23 23E90017679D23 23E90103889H23 24E90017945A24 23E90147258K23 23E90131413H23 23E90131414H23 23E90103890H23 23E90131900I23 23E90110279H23 23E90131420H23 23E90131896I23 23E90131898I23 23E90131895I23 23E90110826H23 23E90110828H23 23E90110832H23 23E90131438H23 23E90131389H23 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23E90006864D23 23E90006903D23 23E90006891D23 23E90006889D23 23E90006893D23 23E90006972D23 23E90006973D23 23E90006907D23 23E90006868D23 23E90006966D23 23E90006930D23 23E90006969D23 23E90006814D23 23E90006815D23 23E90006817D23 23E90006816D23 23E90006813D23 23E90017627D23 23E90017634D23 23E90017628D23 23E90017632D23 23E90017624D23 23E90017636D23 23E90017631D23 23E90017394D23 23E90017735D23 23E90017677D23 23E90017734D23 23E90017392D23 23E90017637D23 23E90017676D23 23E90017674D23 23E90017672D23 23E90017731D23 23E90017675D23 23E90017393D23 23E90017396D23 23E90017395D23 23E90017381D23 23E90017384D23 23E90017382D23 23E90017383D23 Model 450P Item Number: 450-STR-US-10 UDI-DI code: 0506016712069 Serial Numbers: 23G90001569G23 24G90012089B24 24G90012094B24 24G90012120B24 24G90012118B24 23G90006184D23 23G90009052H23 23G90106476K23 23G90006183D23 23G90106676K23 23G90103796J23 23G90003902H23 23G90105515K23 23G90106520K23 23G90106492K23 24G90011087B24 24G90011095B24 23G90107201J23 23G90112607I23 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23G90000360L23 23G90008043L23 23G90102681L23 23G90102423L23 23G90105198K23 23G90105194K23 23G90106070K23 23G90106150L23 24G90011086B24 23G90107671J23 23G90001483I23 23G90110099I23 23G90000399H23 23G90110055I23 23G90101155L23 23G90110039I23 23G90110154I23 23G90110023I23 23G90001478I23 23G90110350I23 23G90109094J23 23G90109081J23 23G90109111J23 23G90105646K23 23G90110224I23 24G90011532B24 23G90105712K23 23G90107398J23 23G90001494I23 23G90109107J23 23G90106142K23 23G90109109J23 23G90008888G23 23G90106253K23 23G90106256K23 23G90001486I23 23G90107482J23 23G90008405G23 23G90106105K23 23G90112606I23 23G90112608I23 23G90107964K23 23G90109261J23 23G90109077J23 23G90109112J23 23G90109046J23 23G90103827J23 23G90108460L23 23G90106799K23 23G90106831K23 23G90105861L23 23G90107346J23 23G90103818J23 23G90009576H23 23G90009590H23 23G90106169K23 23G90107966K23 23G90106117K23 23G90100707K23 23G90105760K23 23G90106273K23 23G90106537K23 24G90011089B24 24G90011091B24 24G90011093B24 23G90004436L23 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23G90101198L23 23G90106381K23 23G90008439L23 23G90100335K23 23G90101211L23 23G90105405K23 23G90008155E23 23G90009078H23 24G90011269B24 23G90105201K23 23G90108629L23 23G90008536G23 23G90109262J23 23G90101189L23 23G90105855L23 24G90011096B24 23G90105740K23 23G90100089L23 23G90105711K23 24G90011090B24 23G90105834L23 23G90006052D23 23G90107950K23 23G90107953K23 23G90107639J23 23G90107632J23 23G90107634J23 23G90107636J23 24G90012297B24 24G90012119B24 23G90008549G23 23G90006064D23 23G90110024I23 23G90004460G23 23G90009532H23 23G90109027J23 23G90109088J23 23G90009573H23 23G90105759K23 23G90106545K23 23G90004012G23 24G90005414B24 24G90005436B24 24G90005443B24 24G90005438B24 23G90109092J23 24G90012920H24 24G90012962H24 23G90008398G23 23G90001489I23 23G90008551G23 23G90106375K23 23G90106204K23 23G90009635H23 23G90003874D23 23G90004218G23 23G90009634H23 23G90006101D23 23G90102989K23 23G90105174K23 23G90105162K23 23G90105168K23 23G90106447K23 23G90004225G23 23G90109086J23 23G90109098J23 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23G90109031J23 23G90107347J23 23G90109091J23 23G90004206G23 23G90106092K23 23G90008502G23 23G90008497G23 23G90005994D23 23G90109242J23 23G90006097D23 23G90110038I23 23G90004039G23 23G90008577G23 23G90106735K23 23G90110126I23 24G90010937B24 23G90107359J23 23G90109026J23 23G90004019G23 23G90106107K23 23G90106199K23 23G90110049I23 23G90109220J23 23G90107338J23 23G90107174J23 23G90101200L23 24G90001566D24 23G90101201L23 23G90106430L23 23G90000956E23 23G90109033J23 23G90008867G23 23G90008868G23 23G90107942K23 23G90106266K23 23G90106262K23 23G90107610J23 23G90100146L23 23G90100164K23 23G90100163K23 23G90100131K23 23G90100162K23 23G90107394J23 23G90107388J23 23G90107396J23 23G90107389J23 23G90107397J23 23G90106473K23 23G90109105J23 23G90106481K23 23G90006042D23 23G90006067D23 23G90112588I23 23G90112609I23 23G90001467I23 23G90100928L23 24G90012889H24 24G90001602D24 23G90008547G23 23G90008544G23 23G90008546G23 23G90001039E23 23G90001040E23 23G90001021E23 23G90001015E23 23G90001051E23 23G90001042E23 23G90001034E23 23G90001043E23 23G90001017E23 23G90001030E23 23G90001022E23 23G90001020E23 23G90001018E23 23G90001031E23 23G90000933E23 23G90000927E23 23G90000938E23 23G90000937E23 23G90000930E23 23G90000940E23 23G90000942E23 23G90000939E23 23G90000941E23 23G90000935E23 23G90000893E23 23G90000853E23 23G90000934E23 23G90000973E23 23G90007499E23 23G90007531E23 23G90007528E23 23G90007534E23 23G90007532E23 23G90008069E23 23G90008071E23 23G90008066E23 23G90008073E23 23G90008070E23 23G90008068E23 23G90008067E23 23G90008095E23 23G90008052E23 23G90008152E23 23G90008097E23 23G90008084E23 23G90008099E23 23G90008088E23 23G90008053E23 23G90001193E23 23G90001195E23 23G90008160E23 23G90008156E23 23G90008055E23 23G90001194E23 23G90008054E23 23G90008077E23 23G90008081E23 23G90001192E23 23G90008056E23 23G90008057E23 23G90001176E23 23G90008157E23 23G90008159E23 23G90008158E23 23G90008085E23 23G90008089E23 23G90008100E23 23G90008090E23 23G90008086E23 23G90008102E23 23G90008092E23 23G90008098E23 23G90008087E23 23G90008154E23 Model 350P Item Number: 350-STR-US-AV UDI-DI Code: 0506016712070 Serial Numbers: 23D98134849H23 23D98134643G23 23D98134836H23 23D98134853H23 23D98134648G23 Model 350P Item Number: 350-STR-US-GW UDI-DI code: 05060167128042 Serial Numbers: 23D98132720G23 23D98132737G23 23D98132729G23 23D98132727G23 24D98033686E24 23D98117696G23 23D98117713G23 23D98117710G23 23D98117712G23 Model 360P Item Number: 360-STR-US-GW UDI-DI code: 0506016712806 Serial Numbers: 23E90110301H23 23E90110018H23 Model 450P Item Number: 450-STR-US-GW UDI-DI code: 0506016712808 Serial Numbers: 23G90004884G23 23G90004340G23 Pending O.U.S. Product Information (note information below is both U.S. and O.U.S. information ***************************************** Sales Code / GTIN Code: 350-BAC-BZ-10 0506016712235 Serial Numbers 23D90000147 23D90000149 23D90000151 23D90000152 23D90000153 23D90000154 23D90000171 23D90000172 23D90000173 23D90000174 23D90000175 23D90000176 23D90000177 23D90000178 23D90000182 23D90000019 23D90000020 23D90000021 23D90000022 23D90000023 23D90000024 23D90000025 23D90000026 23D90000035 23D90000036 23D90000037 23D90000038 23D90000039 23D90000040 23D90000041 23D90000042 23D90000043 23D90000044 23D90000050 23D90000052 23D90000123 23D90000124 23D90000125 23D90000126 23D90000127 23D90000128 23D90000129 23D90000130 23D90000129 23D90000177 23D90000182 23D91000026 23D91000027 23D91000028 23D91000011 23D91000012 23D91000013 23D91000014 23D91000015 23D91000024 23D91000025 23D91000008 23D91000009 23D91000010 23D91000016 23D91000017 23D91000018 23D91000019 23D91000020 23D91000021 23D91000022 23D91000023 Sales Code / GTIN Code: 350-BAS-AS-10 / Serial Numbers: 23D98000921L23 23D98003683F23 23D98007722E23 23D98017029F23 23D98017354F23 23D98024610F23 23D98024820F23 23D98133501F23 23D98133502F23 23D98133748F23 23D98133749F23 23D98133750F23 23D98133751F23 23D98133752F23 23D98133753F23 23D98133754F23 23D98133755F23 23D98133756F23 23D98133759F23 23D98133760F23 23D98133761F23 23D98133762F23 23D98133763F23 23D98133764F23 23D98133765F23 23D98133766F23 23D98133767F23 23D98141094B24 23D98141111B24 23D98145914J23 23D98145915J23 23D98145916J23 24D98027738D24 24D98027739D24 24D98027740D24 24D98027741D24 24D98027742D24 24D98027743D24 24D98027744D24 24D98027745D24 24D98027746D24 24D98027747D24 24D98027748D24 24D98027749D24 24D98027750D24 24D98027751D24 24D98027752D24 24D98027753D24 24D98027754D24 24D98027755D24 24D98027756D24 24D98027757D24 24D98027758D24 24D98027759D24 24D98027760D24 24D98027761D24 24D98027762D24 24D98027763D24 24D98027764D24 24D98027765D24 24D98027766D24 24D98027767D24 24D98027768D24 24D98027769D24 24D98027770D24 24D98027771D24 24D98027772D24 24D98027773D24 24D98027774D24 24D98027775D24 24D98027776D24 24D98027777D24 24D98027778D24 24D98027779D24 24D98027780D24 24D98027781D24 24D98027782D24 24D98027783D24 24D98027784D24 24D98027785D24 24D98027786D24 24D98027787D24 24D98027788D24 24D98027789D24 24D98027790D24 24D98027791D24 24D98027792D24 24D98027793D24 24D98027794D24 24D98027795D24 24D98027796D24 24D98027797D24 24D98027798D24 24D98027799D24 24D98029990B24 24D98034126A24 24D98034127A24 24D98034128A24 24D98034129A24 24D98034130A24 24D98034135A24 24D98034137A24 24D98034138A24 24D98034141A24 24D98034143A24 24D98034145A24 24D98034146A24 24D98034147A24 24D98034148A24 24D98034151A24 24D98034153A24 24D98034156A24 24D98034157A24 24D98034158A24 24D98034159A24 24D98034160A24 24D98034176A24 24D98034177A24 24D98034178A24 24D98034226A24 24D98034227A24 24D98034228A24 24D98034230A24 24D98034232A24 24D98034233A24 24D98034234A24 24D98034235A24 24D98034236A24 24D98034237A24 24D98034238A24 24D98034241A24 24D98034242A24 24D98034246A24 24D98034247A24 24D98034248A24 24D98034252A24 24D98034256A24 24D98034258A24 24D98034259A24 24D98034260A24 24D98034261A24 24D98034265A24 24D98034266A24 24D98034267A24 24D98034268A24 24D98034269A24 24D98034270A24 24D98034271A24 24D98034272A24 24D98034273A24 24D98034274A24 24D98034275A24 24D98047291B24 Sales Code / GTIN Code: 350-BAS-AB-10 0506016712473 Sales Code / GTIN Code: 350-BAS-AS-10 0506016712137 Serial Numbers: 23D98000921L23 23D98003683F23 23D98007722E23 23D98017029F23 23D98017354F23 23D98024610F23 23D98024820F23 23D98133501F23 23D98133502F23 23D98133748F23 23D98133749F23 23D98133750F23 23D98133751F23 23D98133752F23 23D98133753F23 23D98133754F23 23D98133755F23 23D98133756F23 23D98133759F23 23D98133760F23 23D98133761F23 23D98133762F23 23D98133763F23 23D98133764F23 23D98133765F23 23D98133766F23 23D98133767F23 23D98141094B24 23D98141111B24 23D98145914J23 23D98145915J23 23D98145916J23 24D98027738D24 24D98027739D24 24D98027740D24 24D98027741D24 24D98027742D24 24D98027743D24 24D98027744D24 24D98027745D24 24D98027746D24 24D98027747D24 24D98027748D24 24D98027749D24 24D98027750D24 24D98027751D24 24D98027752D24 24D98027753D24 24D98027754D24 24D98027755D24 24D98027756D24 24D98027757D24 24D98027758D24 24D98027759D24 24D98027760D24 24D98027761D24 24D98027762D24 24D98027763D24 24D98027764D24 24D98027765D24 24D98027766D24 24D98027767D24 24D98027768D24 24D98027769D24 24D98027770D24 24D98027771D24 24D98027772D24 24D98027773D24 24D98027774D24 24D98027775D24 24D98027776D24 24D98027777D24 24D98027778D24 24D98027779D24 24D98027780D24 24D98027781D24 24D98027782D24 24D98027783D24 24D98027784D24 24D98027785D24 24D98027786D24 24D98027787D24 24D98027788D24 24D98027789D24 24D98027790D24 24D98027791D24 24D98027792D24 24D98027793D24 24D98027794D24 24D98027795D24 24D98027796D24 24D98027797D24 24D98027798D24 24D98027799D24 24D98029990B24 24D98034126A24 24D98034127A24 24D98034128A24 24D98034129A24 24D98034130A24 24D98034135A24 24D98034137A24 24D98034138A24 24D98034141A24 24D98034143A24 24D98034145A24 24D98034146A24 24D98034147A24 24D98034148A24 24D98034151A24 24D98034153A24 24D98034156A24 24D98034157A24 24D98034158A24 24D98034159A24 24D98034160A24 24D98034176A24 24D98034177A24 24D98034178A24 24D98034226A24 24D98034227A24 24D98034228A24 24D98034230A24 24D98034232A24 24D98034233A24 24D98034234A24 24D98034235A24 24D98034236A24 24D98034237A24 24D98034238A24 24D98034241A24 24D98034242A24 24D98034246A24 24D98034247A24 24D98034248A24 24D98034252A24 24D98034256A24 24D98034258A24 24D98034259A24 24D98034260A24 24D98034261A24 24D98034265A24 24D98034266A24 24D98034267A24 24D98034268A24 24D98034269A24 24D98034270A24 24D98034271A24 24D98034272A24 24D98034273A24 24D98034274A24 24D98034275A24 24D98047291B24 Sales Code / GTIN Code: 350-BAS-AS-GW 0506016712970 350-BAS-BZ-10 0506016712138 350-BAS-CF-10 0506016712474 Serial Numbers: 23D98010039K23 23D98010260K23 23D98109393I23 23D98113071I23 23D98113491I23 23D98113502I23 23D98117269I23 24D98065981E24 24D98065989E24 Sales Code / GTIN Code: 350-BAS-CN-10 0506016712159 Serial Numbers: 23D98015400J23 23D98016300J23 23D98017373E23 23D98017374E23 23D98017375E23 23D98017376E23 23D98017377E23 23D98017378E23 23D98017379E23 23D98017380E23 23D98017381E23 23D98017382E23 23D98017383E23 23D98017384E23 23D98017385E23 23D98017386E23 23D98017387E23 23D98017389E23 23D98017390E23 23D98017391E23 23D98017392E23 23D98017393E23 23D98017394E23 23D98017395E23 23D98017396E23 23D98017397E23 23D98017398E23 23D98017401E23 23D98017402E23 23D98017403E23 23D98017404E23 23D98017405E23 23D98017406E23 23D98017407E23 23D98017408E23 23D98017409E23 23D98017410E23 23D98019800E23 23D98019801E23 23D98019803E23 23D98019804E23 23D98019805E23 23D98019897E23 23D98021110J23 23D98021134J23 23D98105331J23 23D98105332J23 23D98105333J23 23D98105334J23 23D98105335J23 23D98105336J23 23D98105337J23 23D98105338J23 23D98105339J23 23D98105341J23 23D98105342J23 23D98105343J23 23D98105344J23 23D98105345J23 23D98105346J23 23D98105347J23 23D98105348J23 23D98105349J23 23D98105351J23 23D98105352J23 23D98105353J23 23D98105355J23 23D98105356J23 23D98105357J23 23D98105358J23 23D98105359J23 23D98105360J23 23D98105361J23 23D98105362J23 23D98105363J23 23D98105364J23 23D98105365J23 23D98105366J23 23D98105367J23 23D98105368J23 23D98105369J23 23D98105370J23 23D98105372J23 23D98105373J23 23D98105374J23 23D98105375J23 23D98105376J23 23D98105377J23 23D98105378J23 23D98105429J23 23D98105430J23 23D98105431J23 23D98105432J23 23D98105433J23 23D98105434J23 23D98105435J23 23D98105436J23 23D98105437J23 23D98105438J23 23D98106382J23 23D98106383J23 23D98106384J23 23D98106385J23 23D98106386J23 23D98110557H23 23D98110558H23 23D98110559H23 23D98110560H23 23D98110561H23 23D98110562H23 23D98110563H23 23D98110564H23 23D98110565H23 23D98110566H23 23D98110567H23 23D98110568H23 23D98110569H23 23D98110570H23 23D98110571H23 23D98110572H23 23D98110573H23 23D98110574H23 23D98110575H23 23D98110577H23 23D98110578H23 23D98110579H23 23D98110580H23 23D98110581H23 23D98110582H23 23D98110583H23 23D98110584H23 23D98110585H23 23D98113483H23 23D98117938J23 23D98117939J23 23D98117940J23 23D98117941J23 23D98117942J23 23D98117943J23 23D98117944J23 23D98117945J23 23D98117946J23 23D98117947J23 23D98117948J23 23D98117949J23 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- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- HeartSine Technologies Ltd
- Reason for Recall:
- Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)
Product Codes/Lot Numbers:
U.S. Model 350P Item Number: 350-STR-US-10 UDI-DI code: 0506016712067 Serial Numbers 23D98002591E23 23D98002593E23 23D98002594E23 23D98002595E23 23D98002597E23 23D98002608E23 23D98002638E23 23D98002668E23 23D98002669E23 23D98002699E23 23D98002734E23 23D98002751E23 23D98002755E23 23D98002756E23 23D98002758E23 23D98002760E23 23D98002761E23 23D98002765E23 23D98002772E23 23D98002773E23 23D98002774E23 23D98002845E23 23D98002852E23 23D98002853E23 23D98002855E23 23D98002856E23 23D98002857E23 23D98002858E23 23D98002859E23 23D98002877E23 23D98002879E23 23D98002885E23 23D98002887E23 23D98002987E23 23D98002989E23 23D98002990E23 23D98003083E23 23D98003092E23 23D98003117I23 23D98003118E23 23D98003459D23 23D98003475D23 23D98008368E23 23D98008390E23 23D98008877E23 23D98011224D23 23D98012987E23 23D98012991E23 23D98012993E23 23D98012994E23 23D98012998E23 23D98012999E23 23D98013490F23 23D98013500F23 23D98016785E23 23D98017244E23 23D98020031C23 23D98020033C23 23D98020036C23 23D98020351C23 23D98020356C23 23D98020386C23 23D98020403C23 23D98020405C23 23D98020406C23 23D98020408C23 23D98020420C23 23D98020592D23 23D98020594D23 23D98020622D23 23D98020623D23 23D98020627D23 23D98020628D23 23D98020629D23 23D98020631D23 23D98020639D23 23D98020640D23 23D98020732D23 23D98023168E23 23D98100628I23 23D98100631I23 23D98100634I23 23D98100648I23 23D98102318K23 23D98104318J23 23D98104432J23 23D98104622J23 23D98104623J23 23D98104624J23 23D98104628J23 23D98104700J23 23D98104737J23 23D98104741J23 23D98104835J23 23D98104867J23 23D98104868J23 23D98104874J23 23D98104889J23 23D98104946J23 23D98104980J23 23D98104985J23 23D98104986J23 23D98104988J23 23D98105086J23 23D98105145J23 23D98105146J23 23D98105147J23 23D98105148J23 23D98105149J23 23D98105150J23 23D98105151J23 23D98105152J23 23D98105153K23 23D98105917J23 23D98105968J23 23D98105980J23 23D98106055J23 23D98108733I23 23D98109510I23 23D98109528I23 23D98109530I23 23D98109536I23 23D98109537I23 23D98109539I23 23D98109540I23 23D98109542I23 23D98109549I23 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23D98148436J23 23D98149738K23 23D98149754K23 23D98149756K23 23D98149760K23 23D98149761K23 23D98149812K23 23D98149813K23 23D98149818K23 23D98149841K23 23D98149856K23 23D98149859K23 24D98029601A24 24D98034886B24 24D98036930A24 24D98037136A24 24D98037137A24 24D98037139A24 24D98037140A24 24D98037188A24 24D98037283A24 24D98037289A24 24D98037294A24 24D98037300A24 24D98037398A24 24D98037415A24 24D98037567A24 24D98037754A24 24D98037757A24 24D98037759A24 24D98037764A24 24D98037766A24 24D98042105A24 24D98042106A24 24D98042108A24 24D98043355A24 24D98046232A24 24D98046233A24 24D98046235A24 24D98046491A24 24D98046493A24 24D98046494A24 24D98046495A24 24D98046496A24 24D98046497A24 24D98046498A24 24D98046499A24 24D98072439A24 24D98072607A24 24D98072696A24 24D98072904A24 24D98072915A24 24D98072933A24 24D98072935A24 Model 360P Item Number: 360-STR-US-10 UDI-DI Code: 0506016712068 Serial Numbers: 23E90148013K23 24E90003928B24 23E90131693I23 23E90148113K23 24E90020489B24 23E90148518K23 23E90141749K23 24E90018353A24 23E90131752I23 23E90147550K23 23E90147549K23 24E90018363A24 23E90110241H23 23E90131753I23 24E90017316A24 24E90003310B24 23E90135479J23 23E90017678D23 23E90131667I23 23E90103892H23 23E90103894H23 23E90011797D23 23E90107066G23 23E90131427H23 23E90131432H23 23E90006904D23 23E90102226G23 23E90102229G23 23E90131440H23 23E90102659G23 23E90116352H23 23E90148114K23 23E90102210G23 23E90131434H23 23E90148044K23 24E90018361A24 23E90131437H23 23E90137583I23 24E90003983B24 23E90131899I23 23E90006905D23 24E90003492B24 24E90003909B24 23E90102783G23 23E90148066K23 23E90011958D23 23E90145717K23 23E90145714K23 23E90017670D23 23E90131447H23 23E90148035K23 23E90131419H23 23E90017679D23 23E90103889H23 24E90017945A24 23E90147258K23 23E90131413H23 23E90131414H23 23E90103890H23 23E90131900I23 23E90110279H23 23E90131420H23 23E90131896I23 23E90131898I23 23E90131895I23 23E90110826H23 23E90110828H23 23E90110832H23 23E90131438H23 23E90131389H23 23E90107138G23 24E90003893B24 24E90018362A24 24E90017657A24 24E90017483A24 24E90018364A24 23E90110244H23 23E90131748I23 23E90131768I23 23E90011792D23 23E90131904I23 23E90148045K23 23E90107042G23 23E90131448H23 23E90139250I23 24E90018369A24 23E90105485F23 23E90102232G23 23E90107065G23 23E90107068G23 23E90145869K23 23E90145523K23 23E90145475K23 23E90145500K23 23E90102169G23 23E90110286H23 23E90131750I23 23E90131435H23 23E90131431H23 23E90145612K23 23E90147674K23 23E90145484K23 23E90102339G23 23E90130517J23 23E90144000K23 23E90147651K23 23E90145853K23 23E90145852K23 23E90145850K23 24E90017311A24 23E90148014K23 23E90145540K23 23E90006926D23 23E90004982D23 23E90006886D23 23E90006971D23 23E90004978D23 23E90004984D23 23E90006885D23 23E90006964D23 23E90004981D23 23E90006961D23 23E90004983D23 23E90006890D23 23E90006866D23 23E90006910D23 23E90006880D23 23E90004979D23 23E90006970D23 23E90006962D23 23E90006863D23 23E90006968D23 23E90006879D23 23E90006878D23 23E90006884D23 23E90006892D23 23E90006864D23 23E90006903D23 23E90006891D23 23E90006889D23 23E90006893D23 23E90006972D23 23E90006973D23 23E90006907D23 23E90006868D23 23E90006966D23 23E90006930D23 23E90006969D23 23E90006814D23 23E90006815D23 23E90006817D23 23E90006816D23 23E90006813D23 23E90017627D23 23E90017634D23 23E90017628D23 23E90017632D23 23E90017624D23 23E90017636D23 23E90017631D23 23E90017394D23 23E90017735D23 23E90017677D23 23E90017734D23 23E90017392D23 23E90017637D23 23E90017676D23 23E90017674D23 23E90017672D23 23E90017731D23 23E90017675D23 23E90017393D23 23E90017396D23 23E90017395D23 23E90017381D23 23E90017384D23 23E90017382D23 23E90017383D23 Model 450P Item Number: 450-STR-US-10 UDI-DI code: 0506016712069 Serial Numbers: 23G90001569G23 24G90012089B24 24G90012094B24 24G90012120B24 24G90012118B24 23G90006184D23 23G90009052H23 23G90106476K23 23G90006183D23 23G90106676K23 23G90103796J23 23G90003902H23 23G90105515K23 23G90106520K23 23G90106492K23 24G90011087B24 24G90011095B24 23G90107201J23 23G90112607I23 23G90006018D23 23G90105531K23 23G90105573K23 24G90011227B24 23G90110119I23 23G90106011K23 23G90100686K23 23G90106451K23 23G90102992K23 23G90106454K23 23G90106450K23 23G90110201I23 23G90110231I23 23G90100180K23 23G90009404H23 23G90009087H23 23G90009081H23 23G90105399K23 24G90015878A24 23G90008758G23 23G90007502E23 23G90107962K23 23G90102997K23 24G90015874A24 23G90107191J23 23G90107190J23 23G90107195J23 23G90102586J23 23G90107957K23 23G90107393J23 23G90106336K23 23G90008501G23 23G90105667K23 23G90102993K23 23G90106219K23 23G90107945K23 23G90107939K23 23G90112605I23 23G90112599I23 23G90110351I23 23G90110352I23 23G90110348I23 23G90110410I23 23G90112592I23 23G90110127I23 23G90102297K23 24G90016931B24 23G90100548K23 23G90106720K23 24G90015868A24 23G90106449K23 23G90106442K23 23G90106593K23 23G90106591K23 23G90100684K23 23G90106258K23 23G90106261K23 23G90000087H23 23G90000388H23 23G90106033K23 23G90105574K23 23G90110355I23 23G90008634G23 23G90009577H23 23G90109116J23 24G90008247D24 23G90106617K23 23G90106612K23 23G90106619K23 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Item Number: 350-STR-US-AV UDI-DI Code: 0506016712070 Serial Numbers: 23D98134849H23 23D98134643G23 23D98134836H23 23D98134853H23 23D98134648G23 Model 350P Item Number: 350-STR-US-GW UDI-DI code: 05060167128042 Serial Numbers: 23D98132720G23 23D98132737G23 23D98132729G23 23D98132727G23 24D98033686E24 23D98117696G23 23D98117713G23 23D98117710G23 23D98117712G23 Model 360P Item Number: 360-STR-US-GW UDI-DI code: 0506016712806 Serial Numbers: 23E90110301H23 23E90110018H23 Model 450P Item Number: 450-STR-US-GW UDI-DI code: 0506016712808 Serial Numbers: 23G90004884G23 23G90004340G23 Pending O.U.S. Product Information (note information below is both U.S. and O.U.S. information ***************************************** Sales Code / GTIN Code: 350-BAC-BZ-10 0506016712235 Serial Numbers 23D90000147 23D90000149 23D90000151 23D90000152 23D90000153 23D90000154 23D90000171 23D90000172 23D90000173 23D90000174 23D90000175 23D90000176 23D90000177 23D90000178 23D90000182 23D90000019 23D90000020 23D90000021 23D90000022 23D90000023 23D90000024 23D90000025 23D90000026 23D90000035 23D90000036 23D90000037 23D90000038 23D90000039 23D90000040 23D90000041 23D90000042 23D90000043 23D90000044 23D90000050 23D90000052 23D90000123 23D90000124 23D90000125 23D90000126 23D90000127 23D90000128 23D90000129 23D90000130 23D90000129 23D90000177 23D90000182 23D91000026 23D91000027 23D91000028 23D91000011 23D91000012 23D91000013 23D91000014 23D91000015 23D91000024 23D91000025 23D91000008 23D91000009 23D91000010 23D91000016 23D91000017 23D91000018 23D91000019 23D91000020 23D91000021 23D91000022 23D91000023 Sales Code / GTIN Code: 350-BAS-AS-10 / Serial Numbers: 23D98000921L23 23D98003683F23 23D98007722E23 23D98017029F23 23D98017354F23 23D98024610F23 23D98024820F23 23D98133501F23 23D98133502F23 23D98133748F23 23D98133749F23 23D98133750F23 23D98133751F23 23D98133752F23 23D98133753F23 23D98133754F23 23D98133755F23 23D98133756F23 23D98133759F23 23D98133760F23 23D98133761F23 23D98133762F23 23D98133763F23 23D98133764F23 23D98133765F23 23D98133766F23 23D98133767F23 23D98141094B24 23D98141111B24 23D98145914J23 23D98145915J23 23D98145916J23 24D98027738D24 24D98027739D24 24D98027740D24 24D98027741D24 24D98027742D24 24D98027743D24 24D98027744D24 24D98027745D24 24D98027746D24 24D98027747D24 24D98027748D24 24D98027749D24 24D98027750D24 24D98027751D24 24D98027752D24 24D98027753D24 24D98027754D24 24D98027755D24 24D98027756D24 24D98027757D24 24D98027758D24 24D98027759D24 24D98027760D24 24D98027761D24 24D98027762D24 24D98027763D24 24D98027764D24 24D98027765D24 24D98027766D24 24D98027767D24 24D98027768D24 24D98027769D24 24D98027770D24 24D98027771D24 24D98027772D24 24D98027773D24 24D98027774D24 24D98027775D24 24D98027776D24 24D98027777D24 24D98027778D24 24D98027779D24 24D98027780D24 24D98027781D24 24D98027782D24 24D98027783D24 24D98027784D24 24D98027785D24 24D98027786D24 24D98027787D24 24D98027788D24 24D98027789D24 24D98027790D24 24D98027791D24 24D98027792D24 24D98027793D24 24D98027794D24 24D98027795D24 24D98027796D24 24D98027797D24 24D98027798D24 24D98027799D24 24D98029990B24 24D98034126A24 24D98034127A24 24D98034128A24 24D98034129A24 24D98034130A24 24D98034135A24 24D98034137A24 24D98034138A24 24D98034141A24 24D98034143A24 24D98034145A24 24D98034146A24 24D98034147A24 24D98034148A24 24D98034151A24 24D98034153A24 24D98034156A24 24D98034157A24 24D98034158A24 24D98034159A24 24D98034160A24 24D98034176A24 24D98034177A24 24D98034178A24 24D98034226A24 24D98034227A24 24D98034228A24 24D98034230A24 24D98034232A24 24D98034233A24 24D98034234A24 24D98034235A24 24D98034236A24 24D98034237A24 24D98034238A24 24D98034241A24 24D98034242A24 24D98034246A24 24D98034247A24 24D98034248A24 24D98034252A24 24D98034256A24 24D98034258A24 24D98034259A24 24D98034260A24 24D98034261A24 24D98034265A24 24D98034266A24 24D98034267A24 24D98034268A24 24D98034269A24 24D98034270A24 24D98034271A24 24D98034272A24 24D98034273A24 24D98034274A24 24D98034275A24 24D98047291B24 Sales Code / GTIN Code: 350-BAS-AB-10 0506016712473 Sales Code / GTIN Code: 350-BAS-AS-10 0506016712137 Serial Numbers: 23D98000921L23 23D98003683F23 23D98007722E23 23D98017029F23 23D98017354F23 23D98024610F23 23D98024820F23 23D98133501F23 23D98133502F23 23D98133748F23 23D98133749F23 23D98133750F23 23D98133751F23 23D98133752F23 23D98133753F23 23D98133754F23 23D98133755F23 23D98133756F23 23D98133759F23 23D98133760F23 23D98133761F23 23D98133762F23 23D98133763F23 23D98133764F23 23D98133765F23 23D98133766F23 23D98133767F23 23D98141094B24 23D98141111B24 23D98145914J23 23D98145915J23 23D98145916J23 24D98027738D24 24D98027739D24 24D98027740D24 24D98027741D24 24D98027742D24 24D98027743D24 24D98027744D24 24D98027745D24 24D98027746D24 24D98027747D24 24D98027748D24 24D98027749D24 24D98027750D24 24D98027751D24 24D98027752D24 24D98027753D24 24D98027754D24 24D98027755D24 24D98027756D24 24D98027757D24 24D98027758D24 24D98027759D24 24D98027760D24 24D98027761D24 24D98027762D24 24D98027763D24 24D98027764D24 24D98027765D24 24D98027766D24 24D98027767D24 24D98027768D24 24D98027769D24 24D98027770D24 24D98027771D24 24D98027772D24 24D98027773D24 24D98027774D24 24D98027775D24 24D98027776D24 24D98027777D24 24D98027778D24 24D98027779D24 24D98027780D24 24D98027781D24 24D98027782D24 24D98027783D24 24D98027784D24 24D98027785D24 24D98027786D24 24D98027787D24 24D98027788D24 24D98027789D24 24D98027790D24 24D98027791D24 24D98027792D24 24D98027793D24 24D98027794D24 24D98027795D24 24D98027796D24 24D98027797D24 24D98027798D24 24D98027799D24 24D98029990B24 24D98034126A24 24D98034127A24 24D98034128A24 24D98034129A24 24D98034130A24 24D98034135A24 24D98034137A24 24D98034138A24 24D98034141A24 24D98034143A24 24D98034145A24 24D98034146A24 24D98034147A24 24D98034148A24 24D98034151A24 24D98034153A24 24D98034156A24 24D98034157A24 24D98034158A24 24D98034159A24 24D98034160A24 24D98034176A24 24D98034177A24 24D98034178A24 24D98034226A24 24D98034227A24 24D98034228A24 24D98034230A24 24D98034232A24 24D98034233A24 24D98034234A24 24D98034235A24 24D98034236A24 24D98034237A24 24D98034238A24 24D98034241A24 24D98034242A24 24D98034246A24 24D98034247A24 24D98034248A24 24D98034252A24 24D98034256A24 24D98034258A24 24D98034259A24 24D98034260A24 24D98034261A24 24D98034265A24 24D98034266A24 24D98034267A24 24D98034268A24 24D98034269A24 24D98034270A24 24D98034271A24 24D98034272A24 24D98034273A24 24D98034274A24 24D98034275A24 24D98047291B24 Sales Code / GTIN Code: 350-BAS-AS-GW 0506016712970 350-BAS-BZ-10 0506016712138 350-BAS-CF-10 0506016712474 Serial Numbers: 23D98010039K23 23D98010260K23 23D98109393I23 23D98113071I23 23D98113491I23 23D98113502I23 23D98117269I23 24D98065981E24 24D98065989E24 Sales Code / GTIN Code: 350-BAS-CN-10 0506016712159 Serial Numbers: 23D98015400J23 23D98016300J23 23D98017373E23 23D98017374E23 23D98017375E23 23D98017376E23 23D98017377E23 23D98017378E23 23D98017379E23 23D98017380E23 23D98017381E23 23D98017382E23 23D98017383E23 23D98017384E23 23D98017385E23 23D98017386E23 23D98017387E23 23D98017389E23 23D98017390E23 23D98017391E23 23D98017392E23 23D98017393E23 23D98017394E23 23D98017395E23 23D98017396E23 23D98017397E23 23D98017398E23 23D98017401E23 23D98017402E23 23D98017403E23 23D98017404E23 23D98017405E23 23D98017406E23 23D98017407E23 23D98017408E23 23D98017409E23 23D98017410E23 23D98019800E23 23D98019801E23 23D98019803E23 23D98019804E23 23D98019805E23 23D98019897E23 23D98021110J23 23D98021134J23 23D98105331J23 23D98105332J23 23D98105333J23 23D98105334J23 23D98105335J23 23D98105336J23 23D98105337J23 23D98105338J23 23D98105339J23 23D98105341J23 23D98105342J23 23D98105343J23 23D98105344J23 23D98105345J23 23D98105346J23 23D98105347J23 23D98105348J23 23D98105349J23 23D98105351J23 23D98105352J23 23D98105353J23 23D98105355J23 23D98105356J23 23D98105357J23 23D98105358J23 23D98105359J23 23D98105360J23 23D98105361J23 23D98105362J23 23D98105363J23 23D98105364J23 23D98105365J23 23D98105366J23 23D98105367J23 23D98105368J23 23D98105369J23 23D98105370J23 23D98105372J23 23D98105373J23 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23D98120281I23 23D98120282I23 23D98120283I23 23D98120284I23 23D98120285I23 23D98120286I23 23D98120287I23 23D98120288I23 23D98120289I23 23D98120290I23 23D98120291I23 23D98120292I23 23D98120293I23 23D98120294I23 23D98120295I23 23D98120296I23 23D98120297I23 23D98120298I23 23D98120299I23 23D98120300I23 23D98120301I23 23D98120316I23 23D98120318I23 23D98120319I23 23D98120320I23 23D98120321I23 23D98120322I23 23D98120323I23 23D98120325I23 23D98120326I23 23D98120327I23 23D98120328I23 23D98120329I23 23D98120330I23 23D98120331I23 23D98120332I23 23D98120333I23 23D98120334I23 23D98120335I23 23D98120336I23 23D98120337I23 23D98120338I23 23D98120339I23 23D98120340I23 23D98120341I23 23D98120342I23 23D98120343I23 23D98120344I23 23D98120345I23 23D98120346I23 23D98120347I23 23D98120348I23 23D98120349I23 23D98120350I23 23D98120351I23 23D98120352I23 23D9812
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2174-2025
Related Recalls
HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J
HeartSine Technologies
Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.
HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
HeartSine Technologies
Automated external defibrillators have a manufacturing issue that could prevent the device from delivering instructional voice prompts to the user during use of the device. Visual instructional icons will still be present, but this issue could potentially lead to no therapy or a delay in therapy.
Automated external defibrillators were shipped in their test configuration so there is a potential to have incorrect language, and CPR duration resulting in the device prompting users to perform CPR for 5-seconds, and it could analyze heart rhythm and instruct users to deliver a shock every 5-seconds if a shockable heart rhythm is detected, potentially leading to no therapy or delayed therapy.