FDA Medical Device Recalls (openFDA)
ICU Medical, Inc.: LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
- Recall number
- Z-0966-2026
- Recalling firm
- ICU Medical, Inc.
- Product
- LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
- Status
- Open, Classified
- Initiated
- 2025-11-24
- Posted
- 2025-12-19
- Terminated
- not on file
- Reason
- 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
- Software Design Change
- Action
- 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.
- Quantity
- 12 customers
- Distribution
- US Nationwide distribution in the states of CA, IA, KY, LA, MD, MS, NY, PA, TN, VA.
- Lot, serial or model codes
- LifeShield Infusion Safety Software Suite v2.2 UDI-DI 00887709127227
- 510(k) numbers
- ["K242117"]
- 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