Class I

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

ICU Medical Inc · May 7, 2024

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.

States Affected

NATIONWIDE

Quantity Affected

130,826 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2449-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

ICU Medical Inc Medical Device Recall: Plum 360/A+ spare batteries. Item Number: SUB0000864. | SafeCheck