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Recall Observatory FDA recall evidence

Device product

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

Z-0965-2026

November 24, 2025

Class II

Product summary

Firm
ICU Medical, Inc.
Event
Event 98000
Status
Ongoing
Classification
Class II
Quantity
7 customers
Official record key
device-enforcement:Z-0965-2026

Official wording

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.

Code information: 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.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.