[pending] LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product
Pending LLM rewrite. Source: FDA_DEVICE Z-0966-2026.
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
Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery.
The recalled product
- Product
- LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- LifeShield Infusion Safety Software Suite v2.2 UDI-DI 00887709127227
Distribution
Distributed nationwide across the United States.
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