LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
Reported: December 31, 2025 Initiated: November 24, 2025 #Z-0966-2026
Product Description
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
Reason for Recall
Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery.
Details
- Recalling Firm
- ICU Medical, Inc.
- Units Affected
- 12 customers
- Distribution
- US Nationwide distribution in the states of CA, IA, KY, LA, MD, MS, 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 Product No. 17003-02. Recalled by ICU Medical, Inc.. Units affected: 12 customers.
Why was this product recalled? ▼
Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 31, 2025. Severity: Moderate. Recall number: Z-0966-2026.
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