FDAFDA · Food and drugs·Recall number Z-1682-2017
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
Published April 5, 2017 · Recall initiated: December 30, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hospira Inc., A Pfizer Company
- Distributor
- 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
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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