FDAFDA · Alimentos y medicamentos·N.º oficial Z-2723-2026
ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump
Publicado el 22 de julio de 2026 · Inicio del retiro: 10 de junio de 2026
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- ICU Medical, Inc.
- Distribuidor
- Worldwide distribution - US Nationwide and the country of Canada.
- Lote
- 1) UDI/DI +M335400021, Serial Numbers: 50003704, 50003710, 50004046, 50004072, 50004149, 50004154, 50004156, 50004163, 50004166, 50004168, 50004177, 50004183, 50004205, 50004218, 50004220, 50004249, 50004258, 50004262, 50004263, 50004264, 50004271, 50004300, 50004303, 50004304, 50004305, 50004307, 50004308, 50004310, 50004312, 50004314, 50004316, 50004318, 50004319, 50004323, 50004324, 50004325, 50004326, 50004328, 50004330, 50004331, 50004332, 50004333, 50004334, 50004335, 50004336, 50004338, 50004339, 50004340, 50004341, 50004342, 50004344, 50004345, 50004346, 50004347, 50004348, 50004349, 50004350, 50004351, 50004352, 50004356, 50004358, 50004359, 50004361, 50004363, 50004365, 50004366, 50004370, 50004372, 50004373, 50004374, 50004376, 50004380, 50004382, 50004383, 50004384, 50004385, 50004386, 50004387, 50004389, 50004390, 50004391, 50004392, 50004393, 50004394, 50004395, 50004396, 50004398, 50004399, 50004401, 50004403, 50004405, 50004407, 50004409, 50004410, 50004411, 50004413, 50004415, 50004416, 50004417, 50004424, 50004425, 50004426, 50004428, 50004431, 50004433, 50004435, 50004436, 50004438, 50004439, 50004442, 50004443, 50004444, 50004445, 50004448, 50004449, 50004451, 50004452, 50004455, 50004458, 50004460, 50004461, 50004462, 50004464, 50004465, 50004467, 50004468, 50004469, 50004471, 50004472, 50004473, 50004474, 50004477, 50004481, 50004482, 50004486, 50004487, 50004493, 50004495, 50004499, 50004501, 50004502, 50004506, 50004510, 50004512, 50004513, 50004515, 50004519, 50004521, 50004522, 50004541, 50004552, 50004553, 50004558, 50004559, 50004561, 50004570, 50004571, 50004576, 50004578, 50004579, 50004581, 50004583, 50004586, 50004593, 50004595, 50004599, 50004605, 50004607, 50004608, 50004609, 50004616, 50004631, 50004636, 50004637, 50004642, 50004649, 50004654, 50004655, 50004660, 50004664, 50004665, 50004669, 50004670, 50004671, 50004712, 50004724, 50004756, 50004773, 50004891, 50004907, 50004913, 50004930, 50004939, 50004940, 50005000, 50005001, 50005012, 50005014, 50005018, 50005020, 50005021, 50005027, 50005037, 50005039, 50005040, 50005047, 50005050, 50005057, 50005058, 50005060, 50005065, 50005077, 50005081, 50005096, 50005101, 50005134, 50005184, 50005185, 50005199, 50005205, 50005275, 50005290, 50005328, 50005360, 50005384, 50005425, 50005446, 50005586, 50005594, 50005596, 50005598, 50005599, 50005600, 50005605, 50005607, 50005608, 50005611, 50005615, 50005621, 50005622, 50005623, 50005628, 50005636, 50005637, 50005640, 50005647, 50005648, 50005656, 50005659, 50005660, 50005664, 50005665, 50005666, 50005668, 50005670, 50005671, 50005673, 50005676, 50005683, 50005689, 50005692, 50005695, 50005698, 50005705, 50005706, 50005720, 50005721, 50005722, 50005724, 50005725, 50005726, 50005727, 50005728, 50005735, 50005747, 50005750, 50005752, 50005753, 50005757, 50005758, 50005762, 50005768, 50005770, 50005771, 50005772, 50005775, 50005778, 50005783, 50005785, 50005798, 50005807, 50005808, 50005814, 50005815, 50005823, 50005826, 50005827, 50005829, 50005830, 50005835, 50005843, 50005845, 50005847, 50005848, 50005851, 50005855, 50005856, 50005858, 50005861, 50005863, 50005865, 50005867, 50005868, 50005870, 50005871, 50005879, 50005888, 50005890, 50005891, 50005893, 50005902, 50005910, 50005912, 50005917, 50005920, 50005924, 50005925, 50005927, 50005928, 50005934, 50005935, 50005937, 50005939, 50005941, 50005945, 50005958, 50005962, 50005972, 50005975, 50005977, 50005978, 50005983, 50005987, 50005993, 50006001, 50006006, 50006007, 50006008, 50006010, 50006013, 50006020, 50006031, 50006035, 50006039, 50006045, 50006047, 50006050, 50006060, 50006069, 50006073, 50006083, 50006087, 50006090, 50006108, 50006127, 50006135, 50006149, 50006150, 50006151, 50006159, 50006163, 50006177, 50006183, 50006197, 50006198, 50006205, 50006218, 50006227, 50006230, 50006255, 50006273, 50006288, 50006292, 50006297, 50006303, 50006305, 50006307, 50006311, 50006313, 50006314, 50006315, 50006318, 50006324, 50006335, 50006338, 50006339,
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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