Recall Z-1763-2025— ICU Medical, Inc.

Name: FDA recall Z-1763-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-02

Class II · Ongoing

Class II FDA medical device recall by ICU Medical, Inc., initiated 2025-05-02. It names one FDA 510(k) clearance: K223606. Product: LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2. Reason: 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..

Recalling firm: ICU Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-05-02
Firm location: Lake Forest, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K223606 — LifeShield Infusion Safety Software SuiteIcu Medical, Inc.·cleared 2023-08-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.