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