—#217406

Product

LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02

FDA product code: PHC — Infusion Safety Management Software
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K242117
Affected lot / code info: version 2.2.1 UDI-DI 00887709127227 Issue affects customers who migrated from LifeShield DLM v2.1x to LifeShield DLM v2.2.1 and have any version of a Plum Duo v1.1 drug library that was approved or locked for review before the migration.

Why it was recalled

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 (FDA determination)

Software Design Change

Action the firm took

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 library b) Review drug library reports in CSV or HTML format c) Assess each change within LifeShield DLM to verify the accuracy of the changes (i.e., view impacted medication ruleset hard dose rate limit or view a CCA to verify a maximum rate setting) The firm is developing a software update to correct the issue and will notify customers of the timing of the software update.

Recalling firm

Firm: ICU Medical, Inc.
Address: 600 N Field Dr, Lake Forest, Illinois 60045-4835

Distribution

Distribution pattern: US Nationwide distribution in the states of CA, IA, LA, NY, PA, TN, VA.

Timeline

Recall initiated: 2025-11-24
Posted by FDA: 2025-12-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #217406. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.