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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2220-2016

The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.

Publicado el 27 de julio de 2016 · Inicio del retiro: 14 de junio de 2016

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

WalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 300000) and Triton FP Infusion Pump (model 400000) Due to Unapproved Changes to the Software and Specifications of the Triton Infusion Pump (model 300000) and Unapproved Changes to the Intended Use of the Triton FP Infusion Pump (model 400000).

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
WalkMed Infusion, LLC
Distribuidor
Nationwide to AL, AZ, CA, FL, IL, KS, MA, MD, MS,NJ, OH, PA, TN, TX, UT, and WA. No foreign/VA/govt/military.
Lote
PCF15045R, PFA13002, PFA13005, PFA13006, PFA13007, PFA13008, PFA13009, PFA13010, PFA13011, PFA13012, PFA13013, PFA13014, PFA13015, PFA13016, PFA13017, PFA13018, PFA13019, PFA13020, PFA13021, PFA13022, PFA13023, PFA13024, PFA13025, PFA13026, PFA13027, PFA13028, PFA13029, PFA13030, PFA13031, PFA13032, PFA13033, PFA13034, PFA13035, PFA13036, PFA13037, PFA13038, PFA13039, PFA13040, PFA13041, PFA13042, PFA13043, PFA13044, PFA13045, PFA13046, PFA13047, PFA13048, PFA13049, PFA13050, PFA14001, PFA14002, PFA14003, PFA14004, PFA14005, PFA14006, PFA14007, PFA14008, PFA14009, PFA14010, PFA14011, PFA14012, PFA14013, PFA14014, PFA14015, PFA14016, PFA14017, PFA14018, PFA14019, PFA14020, PFA14021, PFA14022, PFA14023, PFA14024, PFA14025, PFA14026, PFA14027, PFA14028, PFA14029, PFA14030, PFA14031, PFA14032, PFA14034, PFA14035, PFA14036, PFA14037, PFA14038, PFA14039, PFA14040, PFA14041, PFA14042, PFA14043, PFA14044, PFA14045, PFA14046, PFA14047, PFA14048, PFA14049, PFA14050, PFA14051, PFA14052, PFA14053, PFA14054, PFA14055, PFA14056, PFA14057, PFA14058, PFA14059, PFA14060, PFA15001, PFA15002, PFA15003, PFA15004, PFA15005, PFA15006, PFA15007, PFA15008, PFA15009, PFA15010, PFA15011, PFA15012, PFA15013, PFA15014, PFA15015, PFA15016, PFA15017, PFA15018, PFA15019, PFA15020, PFA15021, PFA15022, PFA15023, PFA15024, PFA15025, PFA15026, PFA15027R, PFA15028, PFA15029, PFA15030, PFA15031, PFA15032, PFA15033, PFA15035, PFA15036, PFA15037, PFA15038, PFA15039, PFA15041, PFA15043, PFA15044, PFA15045, PFA15046, PFA15047, PFA15050R, PFA15051, PFA15052, PFA15053, PFA15054, PFA15055, PFA15056, PFA15057, PFA15058, PFA15059, PFA15060, PFA15061, PFA15062, PFA15063, PFA15064, PFA15065, PFA15066, PFA15067, PFA15068, PFA15069, PFA15070, PFA15071, PFA15072, PFA15073, PFA15074, PFA15075, PFA15076, PFA15077, PFA15078, PFA15079, PFA15080, PFA15081, PFA15082, PFA15083, PFA15084, PFA15085, PFA15086, PFA15087, PFA15088, PFA15089, PFA15090, PFA15091, PFA15092, PFA15093, PFA15094, PFA15095, PFA15096, PFA15097, PFA15098, PFA15099, PFA15100, PFB13001, PFB13002, PFB13003, PFB13004, PFB13005, PFB13006, PFB13007, PFB13008, PFB13009, PFB13010, PFB13011, PFB13012, PFB13013, PFB13014, PFB13015, PFB13016, PFB13017, PFB13018, PFB13019, PFB13020, PFB13021, PFB13022, PFB13023, PFB13024, PFB13025, PFB13026, PFB13027, PFB13028, PFB13029, PFB13030, PFB13031, PFB13032, PFB13033, PFB13034, PFB13035, PFB13036, PFB13037, PFB13038, PFB13039, PFB13040, PFB13041, PFB13042, PFB13043, PFB13044, PFB13045, PFB13046, PFB13047, PFB13048, PFB13049, PFB13050, PFB15001, PFB15002, PFB15003, PFB15004, PFB15005, PFB15006, PFB15007, PFB15008, PFB15009, PFB15010, PFB15011, PFB15012, PFB15013, PFB15014, PFB15015, PFB15016, PFB15017, PFB15018, PFB15019, PFB15020, PFB15021, PFB15022, PFB15023, PFB15024, PFB15025, PFB15026, PFB15027, PFB15028, PFB15029, PFB15030, PFB15031, PFB15032, PFB15033, PFB15034, PFB15035, PFB15036, PFB15037, PFB15038, PFB15039, PFB15040, PFB15041, PFB15042, PFB15043, PFB15044, PFB15045, PFB15046, PFB15047, PFB15048, PFB15049, PFB15050, PFB15051, PFB15052, PFB15053, PFB15054, PFB15055, PFB15056, PFB15057, PFB15058, PFB15059, PFB15060, PFB15061, PFB15065R, PFB15066, PFB15068, PFB15069, PFB15070, PFB15071, PFB15072, PFB15073, PFB15074, PFB15075, PFB15076, PFB15077, PFB15078, PFB15079, PFB15080, PFB15081, PFB15082, PFB15083, PFB15084, PFB15085, PFB15086, PFB15087, PFB15088, PFB15089, PFB15090, PFB15091, PFB15092, PFB15093, PFB15094R, PFB15095, PFB16001, PFB16002, PFB16003, PFB16004, PFB16005, PFB16006, PFB16007, PFB16008, PFB16009, PFB16010, PFB16011, PFB16012, PFB16013, PFB16014, PFB16015, PFB16016, PFB16017, PFB16018, PFB16019, PFB16020, PFB16021, PFB16022, PFB16023, PFB16024, PFB16025, PFB16026, PFB16027, PFB16028, PFB16029, PFB16030, PFB16031, PFB16032, PFB16033, PFB16034, PFB16035, PFB16036, PFB16037, PFB16038, PFB16039, PFB16040, PFB16041, PFB16042, PFB16043, PFB16044, PFB16045, PFB16046, PFB16047, PFB16048, PFB16049, PFB16050, PFB16051, PFB16052, PFB16053, PFB16054, PFB16055, PFB16056, PFB16
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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