FDA recall Z-1567-2023

ICU Medical Inc · Class I · device

Product

ASM Replacement Battery, Component Number SUB0000864

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-1567-2023