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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2447-2024

Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description is PLUM 360 Infuser. OUS units marketed with the following descriptions: Bomba de infusi¿n Plum 360 compatible con el software ICU Medical MedNet, Plum 360 Infusion System, PLUM 360, PLUM 360" Infuser, Plum 360 Infuser compatible with ICU Medical MedNet Software, Plum 360 Infuser compatible with ICU Medical MedNet Software Refurb, Plum 360 sistema infusionale compatibile con ICU Medical MedNet Software, Pompe a perfusion Plum 360, compatible avec le logiciel ICU Medical MedNet

Publicado el 21 de agosto de 2024 · Inicio del retiro: 7 de mayo de 2024

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

Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
ICU Medical Inc
Distribuidor
Worldwide Distribution: US (nationwide) and OUS (foreign) countries of: Australia, Canada, France, Guadeloupe, Guatemala, Ireland, Italy, Oman, Paraguay, Qatar, Spain, Saudi Arabia, South Africa, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Uruguay.
Lote
1. Product Code: 300100413. UDI Number (Serial Numbers): +M3353001004131 (43414527, 43414565); +M33530010041311 (43422532, 43511323, 43418697, 43419090, 43429221, 43419323, 43418389, 43418094, 43419257, 43429686, 43429767, 43429677, 43419283, 43429566, 43419102, 43429724, 43429718, 43429710, 43429707, 43429694, 43429692, 43429607, 43429593, 43429592, 43429582, 43429565, 43439515, 43418578, 43418655, 43484008, 43483343, 43483872, 43497023, 43496686, 43497667, 43497529, 43498447, 43496869, 43497174, 43496776, 43497353, 43498271, 43498371, 43496392, 43499242, 43497132, 43499181, 43427768, 43498473, 43496917, 43496871, 43496767, 43496675, 43497038, 43496717, 43498390, 43497559, 43497503, 43496747, 43496674, 43497662, 43497028, 43483719, 43497364, 43418579, 43418548, 43429728, 43418810, 43418646, 43418827, 43429624, 43418530, 43429743, 43429725, 43429563, 43429482, 43499274, 43496535, 43496740, 43483820, 43474669, 43477285, 43479179, 43478327, 43478398, 43497070, 43496861, 43496700, 43497350, 43483721, 43497377, 43497196, 43429558, 43429547, 43429534, 43429497, 43429494, 43429429, 43429399, 43429373, 43429371, 43429220, 43496723, 43429219, 43429067, 43493953, 43452640, 43498262, 43515328, 43496364, 43497508, 43497239, 43497605, 43497276, 43483973, 43484100, 43483749, 43483859, 43483951, 43429285, 43459787, 43429723, 43429679, 43429672, 43429602, 43429600, 43429571, 43429569, 43429560, 43429552, 43429478, 43429685, 43429678, 43497175, 43496779, 43497004, 43496661, 43496537, 43497568, 43429015, 43483722, 43483673, 43483819, 43483904, 43484184, 43483996, 43484136, 43484126, 43484062, 43483351, 43483929, 43495914, 43497555, 43450217, 43456114, 43429568, 43429562, 43429556, 43429555, 43429551, 43429525, 43429640, 43429595, 43429759, 43429758, 43429757, 43419195, 43429557, 43418513, 43429391, 43483901, 43483755, 43484065, 43483966, 43484021, 43483786, 43484034, 43483809, 43484043, 43429359, 43429393, 43429594, 43429733, 43429735, 43445560, 43457063, 43484047, 43483370, 43484038, 43483991, 43484087, 43483979, 43483886, 43483463, 43483967, 43419028, 43419169, 43483775, 30016791, 43476823, 43477643, 43477840, 43470631, 43477880, 43470383, 43470634, 43429333, 43429606, 43429752, 43429668, 43429731, 43429300, 43429580, 43429696, 43429543, 43429739, 43429705, 43429695, 43434798, 43445971, 43442858, 43480611, 43511708, 43458094, 43514602, 43475487, 43475851, 43476582, 43475914, 43476547, 43452416, 43453797, 43497890, 43495745, 43493977, 43466810, 43466861, 43499528, 43495859, 43459172, 43477297, 43475675, 43473381, 43478475, 43476749, 43471754, 43473403, 43473432, 43472746, 43479374, 43508275, 43499564, 43503906, 43477255, 43471276, 43471015, 43475938, 43469896, 43470540, 43470813, 43470906, 43469776, 43476238, 43478709, 43470128, 43477571, 43477247, 43471359, 43477641, 43477017, 43471375, 43499522, 43504108, 43456249, 30014556, 43494868, 43462861, 43467050, 43417069, 43502261, 43423943, 43424356, 43424211, 43417450, 43451631, 43459912, 43433440, 30017436, 43503961, 43490142, 30017827, 43458331, 43435039, 43476461, 43477865, 43479484, 43478395, 43454509, 43434374, 43476939, 43475322, 43476773, 43443855, 43491341, 43477718, 43476784, 43477689, 43477507, 43477026, 43475812, 43476512, 43477739, 43496664, 43496380, 43473890, 43475608, 43475479, 43475755, 43477582, 43477937, 43476747, 43477775, 43477673, 43424958, 43444105, 43466531, 43455873, 43491928, 43419088, 43509982, 43418662, 43419390, 43419337, 43419604, 43419435, 43419365, 43419387, 43419477, 43419382, 43419322, 43419366, 43445665, 43500995, 43428075, 43445371, 43494046, 43427707, 43504233, 43476692, 43477074, 43475700, 43470811, 43476663, 43476785, 43499516, 30016039, 30015138, 30015348, 30015672, 30015993, 30014687, 30015792, 30014884, 30014927, 30014854, 30016124, 43445597, 43453774, 43499719, 43496653, 43499462, 43494786, 43493852, 43495893, 43459272, 43484129, 43483337, 43483823, 43483366, 43483220, 43483338, 43483243, 43483880, 43483856, 43483815, 43499713, 43434862, 43443593, 4349716
Clasificación de riesgo
Class I
Área (FDA)
device
País
United States

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