FDA-Device2024-08-21Class I

Plum 360/A+ spare batteries. Item Number: SUB0000864.

ICU Medical Inc
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.

Sold states
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.
Affected count
130,826 units
Manufactured in
600 N Field Dr, Lake Forest, IL, United States
Products
Plum 360/A+ spare batteries. Item Number: SUB0000864.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2449-2024

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