FDAFDA · Food and drugs·Recall number 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
Published August 21, 2024 · Recall initiated: May 7, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ICU Medical Inc
- Distributor
- 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.
- Lot
- 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
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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