—#213581

Product

LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2

FDA product code: PHC — Infusion Safety Management Software
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K223606
Affected lot / code info: LifeShield Infusion Safety Software Suite v2.1 and v2.2 UDI-DI 00887709122802

Why it was recalled

Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values with certain limits, potentially resulting in over-delivery to patient. 2) An unauthorized user may modify and approve a drug library, potentially leading to incorrect program parameters being used for therapy.

Root cause (FDA determination)

Software Design Change

Action the firm took

Firm began notifying consignees on May 2, 2025 via hand delivery of letters titled "Urgent Medical Device Correction." Issue 1: User receives an error if they attempt to define a Percentage Dose Change Increase limit between 60% and 99%. Customers were instructed to ensure all users or potential users of the software are made aware of the notification and proposed mitigations: Use Percentage Dose Change Increase values between 20% and 59% or between 100% and 500%. Pharmacists will not be able to use values from 60% to 99%. Issue 2: It is possible for an unauthorized user to bypass the reauthentication steps required to approve a drug library or delete a medication ruleset. Customers were instructed to ensure all users or potential users are made aware of the notification and proposed mitigation: Communicate with all users the need to log off after finishing a session before leaving the workstation and following cybersecurity best practices. ICU Medical is developing a LifeShield software update to correct both issues.

Recalling firm

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

Distribution

Distribution pattern: Worldwide - US Nationwide distribution in the states of CA, FL, IA, KY, LA, MA, MS, NY, PA, TN, and VA. The country of Philippines.

Timeline

Recall initiated: 2025-05-02
Posted by FDA: 2025-05-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #213581. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.