Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions
Publicado el 5 de abril de 2017 · Inicio del retiro: 30 de diciembre 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
Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy stops, alarms show and sound, pump shuts down after 3 minutes. On AC power, the pump reboots (takes about 25 seconds). Therapy can resume. AC power interruption of 3-7 seconds prompts an incorrect E323 alarm, ongoing therapy stop, and pump reboot. Longer power loss results in battery power operation.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Hospira Inc., A Pfizer Company
- Distribuidor
- Nationwide, Australia, New Zealand, Canada, Mexico, Chile, Philippines, Hong Kong, Greece, Ireland, Jordan, Kuwait, Oman, Poland, Saudi Arabia, Turkey, United Arab Emirates, Italy, France, United Kingdom, Spain
- Lote
- List number 30010; all products with software version 15.02 distributed prior to January 16, 2017. Serial numbers 19985403, 19985406, 19985408, 19985428, 19985439, 19985440, 19985450, 19985464, 19985878, 19985879, 19985880, 19985881, 19985882, 19985883, 19985884, 19985885, 19985886, 19985887, 19985889, 19985890, 19985891, 19985892, 19985893, 19985894, 19985895, 19985896, 19985897, 19985898, 19985899, 19985900, 19985901, 19985902, 19985903, 19985904, 19985905, 19985906, 19985907, 19985908, 19985909, 19985910, 19985911, 19985912, 19985913, 19985914, 19985915, 19985917, 19985918, 19985919, 19985920, 19985921, 19985922, 19985923, 19985924, 19985925, 19985926, 19985927, 19985928, 19985929, 19985930, 19985931, 19985933, 19985934, 19985935, 19985936, 19985937, 19985938, 19985939, 19985940, 19985942, 19985943, 19985944, 19985945, 19985946, 19985947, 19985948, 19985949, 19985950, 19985951, 19985952, 19985953, 19985954, 19985955, 19985956, 19985957, 19985958, 19985959, 19985960, 19985961, 19985962, 19985963, 19985964, 19985966, 19985967, 19985968, 19985969, 19985970, 19985971, 19985972, 19985974, 19985975, 19985976, 19985977, 19985978, 19985979, 19985980, 19985981, 19985982, 19985983, 19985984, 19985985, 19985986, 19985987, 19985988, 19985990, 19985991, 19985993, 19985994, 19985995, 19985996, 19985998, 19985999, 19986000, 19986001, 19986002, 19986003, 19986004, 19986005, 19986006, 19986007, 19986008, 19986009, 19986010, 19986011, 19986012, 19986013, 19986014, 19986015, 19986016, 19986017, 19986018, 19986019, 19986020, 19986021, 19986022, 19986023, 19986024, 19986025, 19986026, 19986027, 19986028, 19986029, 19986030, 19986031, 19986032, 19986033, 19986034, 19986035, 19986038, 19986039, 19986040, 19986041, 19986042, 19986044, 19986045, 19986046, 19986047, 19986048, 19986049, 19986050, 19986051, 19986052, 19986053, 19986054, 19986055, 19986056, 19986057, 19986059, 19986060, 19986061, 19986062, 19986063, 19986064, 19986066, 19986067, 19986068, 19986069, 19986070, 19986071, 19986072, 19986073, 19986074, 19986075, 19986076, 19986077, 19986078, 19986079, 19986080, 19986081, 19986082, 19986083, 19986084, 19986085, 19986086, 19986087, 19986088, 19986090, 19986091, 19986092, 19986093, 19986094, 19986095, 19986096, 19986097, 19986098, 19986099, 19986100, 19986101, 19986102, 19986103, 19986104, 19986106, 19986107, 19986108, 19986109, 19986110, 19986111, 19986112, 19986113, 19986114, 19986116, 19986118, 19986119, 19986120, 19986121, 19986122, 19986123, 19986124, 19986125, 19986126, 19986128, 19986131, 19986133, 19986135, 19986136, 19986137, 19986138, 19986139, 19986141, 19986142, 19986143, 19986145, 19986147, 19986151, 19986152, 19986153, 19986154, 19986155, 19986156, 19986157, 19986158, 19986159, 19986160, 19986161, 19986162, 19986164, 19986165, 19986167, 19986169, 19986171, 19986172, 19986175, 19986177, 19986178, 19986179, 19986180, 19986181, 19986182, 19986183, 19986185, 19986186, 19986187, 19986189, 19986190, 19986191, 19986192, 19986193, 19986194, 19986195, 19986196, 19986197, 19986198, 19986199, 19986202, 19986203, 19986204, 19986205, 19986206, 19986207, 19986208, 19986209, 19986210, 19986211, 19986212, 19986213, 19986214, 19986215, 19986216, 19986217, 19986218, 19986219, 19986220, 19986221, 19986222, 19986223, 19986224, 19986225, 19986226, 19986227, 19986228, 19986229, 19986230, 19986231, 19986232, 19986233, 19986234, 19986235, 19986236, 19986237, 19986239, 19986240, 19986242, 19986243, 19986244, 19986247, 19986249, 19986250, 19986251, 19986254, 19986255, 19986256, 19986257, 19986258, 19986259, 19986260, 19986261, 19986262, 19986263, 19986264, 19986265, 19986266, 19986267, 19986268, 19986269, 19986270, 19986271, 19986272, 19986273, 19986274, 19986276, 19986277, 19986278, 19986279, 19986280, 19986282, 19986283, 19986284, 19986285, 19986286, 19986287, 19986288, 19986289, 19986290, 19986291, 19986292, 19986293, 19986294, 19986295, 19986296, 19986297, 19986298, 19986300, 19986301, 19986302, 19986304, 19986305, 19986306, 19986309, 19986310, 199
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
¿Vendes productos como este?
Recalert vigila todo tu catálogo contra retiros como este, automáticamente.