LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
Reported: December 31, 2025 Initiated: November 24, 2025 #Z-0965-2026
Product Description
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
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.
Details
- Recalling Firm
- ICU Medical, Inc.
- Units Affected
- 7 customers
- Distribution
- US Nationwide distribution in the states of CA, IA, LA, NY, PA, TN, VA.
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02. Recalled by ICU Medical, Inc.. Units affected: 7 customers.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 31, 2025. Severity: Moderate. Recall number: Z-0965-2026.
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