[pending] LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Nu
Pending LLM rewrite. Source: FDA_DEVICE Z-0965-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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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