LifeShield Drug Library Management (DLM), LifeShield Infu... (ICU Medical, Inc.) – software issue only allows concentrat... (2025)
Software precision limitations can cause incorrect medication concentration settings.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
Brand
ICU Medical, Inc.
Lot Codes / Batch Numbers
LifeShield Infusion Safety Software Suite v2.2 UDI-DI 00887709127227
Products Sold
LifeShield Infusion Safety Software Suite v2.2 UDI-DI 00887709127227
ICU Medical, Inc. is recalling LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No due to 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). . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On November 24, 2025, the firm notified customers via Urgent Medical Device Correction letters. Consignees were asked to take the following actions: 1. Ensure all users or potential users of LifeShield DLM 2.2.1 are immediately made aware of this notification and proposed mitigations. 2. Until a software update is released, limit any newly created or edited Concentration Limits to one decimal place of precision for limits less than 100. ICU Medical is developing a software update to correct this issue and will notify customers of the timing of the software update.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026