Recall Z-0966-2026 ยท PHC Infusion Safety Management Software
ICU Medical, Inc.
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
| Date | Dec 19, 2025 (initiated Nov 24, 2025) |
| Status | Open, Classified |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K242117 | LifeShield Infusion Safety Software Suite Icu Medical, Inc., Apr 2, 2025 |