Recall Z-0965-2026 ยท PHC Infusion Safety Management Software
ICU Medical, Inc.
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
| Date | Dec 19, 2025 (initiated Nov 24, 2025) |
| Status | Open, Classified |
| Reason | For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do so may lead in over delivery, under delivery, or delay in setup on the infusion pump. |
| Root cause | Software Design Change |
| Action | Firm began notifying customers on 11/24/2025 via Urgent Medical Device Correction letters. Customers were instructed to ensure all users or potential users of LifeShield ISSS DLM 2.2.1 with Plum Duo 1.1 drug libraries are made aware of the issue and the following proposed mitigations: Until a software update is released, when performing the first Plum Duo v1.1 drug library review after the migration, the pharmacist is able to review the changes using alternate review mechanisms, as noted in the LifeShield Drug Library Management User Manual: a) Accessing the version history view of the drug |
| Quantity | 7 customers |
| Distribution | US Nationwide distribution in the states of CA, IA, LA, 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 |