FDA Medical devices recall ·
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety… recall
- Recall number
- Z-1763-2025
- Date
- (initiated May 2, 2025)
- Company / brand
- ICU Medical, Inc.
600 N Field Dr, Lake Forest, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 12 US, 3 OUS
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
LifeShield Infusion Safety Software Suite v2.1 and v2.2 UDI-DI 00887709122802
Distribution
Worldwide - US Nationwide distribution in the states of CA, FL, IA, KY, LA, MA, MS, NY, PA, TN, and VA. The country of Philippines.
States: California Florida Iowa Kentucky Louisiana Massachusetts Mississippi New York Pennsylvania Tennessee Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1763-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.