FDA recall Z-1565-2023

Product

Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010

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

Key facts

Status

Ongoing

Initiation date

2023-03-22

Report date

2023-05-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1565-2023