LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Nu
Pending LLM rewrite. Source: FDA_DEVICE Z-0965-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- Product
- LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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