Recall Z-1763-2025 · PHC Infusion Safety Management Software
ICU Medical, Inc.
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
| Date | May 14, 2025 (initiated May 2, 2025) |
| Status | Open, Classified |
| 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 reaut |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223606 | LifeShield™ Infusion Safety Software Suite Icu Medical, Inc., Aug 24, 2023 |