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ICU Medical Inc recalls Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description is
Recalled August 21, 2024 · FDA recall Z-2447-2024 · ICU Medical
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. · FDA Class I
Units
11,961 units
Sold at
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.
Description
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.
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
Manufacturer(s)
ICU Medical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →