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

FDA device recall Z-0965-2026 · posted 2025-12-19 · Open, Classified

Recall details

Recalling firm

ICU Medical, Inc.

Reason for recall

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.

Action taken

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.

Root cause

Software Design Change

Status

Open, Classified

Product code

PHC

Quantity affected

7 customers

Distribution

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

Date initiated

2025-11-24

Date posted

2025-12-19

Location

Lake Forest, IL

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