ICU Medical Inc: 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 descri

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.

Details from the source

Reason for recall: 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. 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. Quantity: 11,961 units Lot/code info: 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, 4349756

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.