FDA Medical Device Recalls (openFDA)
ICU Medical, Inc.: LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
- Recall number
- Z-1763-2025
- Recalling firm
- ICU Medical, Inc.
- Product
- LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
- Status
- Open, Classified
- Initiated
- 2025-05-02
- Posted
- 2025-05-14
- Terminated
- not on file
- 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.
- Root cause
- Software Design Change
- Action
- 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.
- Quantity
- 12 US, 3 OUS
- 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.
- Lot, serial or model codes
- LifeShield Infusion Safety Software Suite v2.1 and v2.2 UDI-DI 00887709122802
- 510(k) numbers
- ["K223606"]
- PMA numbers
- not on file
- Product code
- PHC
- Firm FEI
- 3013319212
- Firm city
- Lake Forest
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28