—#217444

Product

LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02

FDA product code: PHC — Infusion Safety Management Software
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K242117
Affected lot / code info: LifeShield Infusion Safety Software Suite v2.2 UDI-DI 00887709127227

Why it was recalled

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.

Root cause (FDA determination)

Software Design Change

Action the firm took

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.

Recalling firm

Firm: ICU Medical, Inc.
Address: 600 N Field Dr, Lake Forest, Illinois 60045-4835

Distribution

Distribution pattern: US Nationwide distribution in the states of CA, IA, KY, LA, MD, MS, NY, PA, TN, VA.

Timeline

Recall initiated: 2025-11-24
Posted by FDA: 2025-12-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #217444. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.