FDAClass IIDecember 31, 2025

LifeShield Drug Library Management recall

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

Why was LifeShield Drug Library Management 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
Recalling firm
ICU Medical, Inc.
Quantity
7 customers
Distribution
US Nationwide distribution in the states of CA, IA, LA, NY, PA, TN, VA.
Recall date
December 31, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls