LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
Summary
The FDA issued a Class II for LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software S by ICU Medical, Inc.. Reason: For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed..
Details
Source
Device Recall
External ID
Z-0965-2026
Action Date
2025-12-31
Status
Ongoing
Category
device
Product Description
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
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.
Quantity Affected: 7 customers
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.
Distribution
US Nationwide distribution in the states of CA, IA, LA, NY, PA, TN, VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-11-24
Company
Lake Forest, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 103 device recalls issued in the same week, part of 413 device-related FDA actions this month.
ICU Medical, Inc. has 95 FDA actions in our database, including 85 recalls and 10 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ICU Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ICU Medical, Inc. have FDA actions?
ICU Medical, Inc. has 95 FDA actions in our database, including 85 recalls and 10 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0965-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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