For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed
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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.
Recall Number
Z-0965-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-11-24
Reported
2025-12-31
Distribution
US Nationwide distribution in the states of CA, IA, LA, NY, PA, TN, VA.
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.
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.