ICU Medical, Inc.: LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- ICU Medical, Inc.
- Product
- LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
- Reason / hazard
- 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the states of CA, IA, LA, NY, PA, TN, VA.
- Recall initiated
- 2025-11-24
- Code info
- version 2.2.1 UDI-DI 00887709127227 Issue affects customers who migrated from LifeShield DLM v2.1x to LifeShield DLM v2.2.1 and have any version of a Plum Duo v1.1 drug library that was approved or locked for review before the migration.
- Product quantity
- 7 customers
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Lake Forest
- State
- IL
- Country
- United States
- Event id
- 98000
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