FDA recall Z-0965-2026

ICU Medical, Inc. · Class II · device

Product

LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02

Reason for recall

For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do so may lead in over delivery, under delivery, or delay in setup on the infusion pump.

Distribution

US Nationwide distribution in the states of CA, IA, LA, NY, PA, TN, VA.

Key facts

Status
Ongoing
Initiation date
2025-11-24
Report date
2025-12-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0965-2026