Recall archive / FDA device enforcement

Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description... — FDA record Z-2447-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 7, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: 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
Reason: 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.
Classification: Class I
Recalling firm: ICU Medical Inc
Quantity: 11,961 units
Agency-reported status: Ongoing
Source record identifier: Z-2447-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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, 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43473291, 43476566, 43476913, 43477234, 43475321, 43479417, 43478796, 43476731, 43473521, 43478019, 43473399, 43505676, 43477702, 43477857, 43438784, 43477772, 43477661, 43477921, 43477755, 43475652, 43475463, 43477585, 43456385, 43413789, 43414327, 43414473, 43414486, 43414274, 43414388, 43449148, 43507147, 43509097, 43413688, 43507354, 43506360, 43506051, 43482212, 43460062); +M335300101- (44445922, 46450410, 46450264); No UDI (21802755, 21804527, 21802203, 21802642, 21798957, 21803295, 21804159, 21799375, 21801178, 21803370, 21804323, 21799615, 21804140, 21802626, 21801346, 21800059, 21799659, 21803148, 21803381, 21803503). 2. Product Code: 300100409. UDI Number (Serial Numbers): +M33530010040916 (30007403, 30007387, 30007374, 30007294, 30007292, 30007284, 30007281, 30007263, 30007246, 30007241, 30007222, 30005882, 30011646, 30011622, 30011620, 30011613, 30011605, 30011569, 30011542, 30011525, 30011495, 30011460, 30011457, 30003134, 30010638, 30007167, 3000...

Label field

Details supplied by the agency

Lot, code or applicability

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, 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43473291, 43476566, 43476913, 43477234, 43475321, 43479417, 43478796, 43476731, 43473521, 43478019, 43473399, 43505676, 43477702, 43477857, 43438784, 43477772, 43477661, 43477921, 43477755, 43475652, 43475463, 43477585, 43456385, 43413789, 43414327, 43414473, 43414486, 43414274, 43414388, 43449148, 43507147, 43509097, 43413688, 43507354, 43506360, 43506051, 43482212, 43460062); +M335300101- (44445922, 46450410, 46450264); No UDI (21802755, 21804527, 21802203, 21802642, 21798957, 21803295, 21804159, 21799375, 21801178, 21803370, 21804323, 21799615, 21804140, 21802626, 21801346, 21800059, 21799659, 21803148, 21803381, 21803503). 2. Product Code: 300100409. UDI Number (Serial Numbers): +M33530010040916 (30007403, 30007387, 30007374, 30007294, 30007292, 30007284, 30007281, 30007263, 30007246, 30007241, 30007222, 30005882, 30011646, 30011622, 30011620, 30011613, 30011605, 30011569, 30011542, 30011525, 30011495, 30011460, 30011457, 30003134, 30010638, 30007167, 3000...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Aug 21, 2024
Recall initiation date: May 7, 2024
Center classification date: Aug 9, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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