Z-0966-2026 Class II Ongoing
FDA device recall Z-0966-2026 was initiated by ICU Medical, Inc. on November 24, 2025 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 12 customers.
Recall Details
- Product Type
- Devices
- Report Date
- December 31, 2025
- Initiation Date
- November 24, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 customers
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.
Distribution Pattern
US Nationwide distribution in the states of CA, IA, KY, LA, MD, MS, NY, PA, TN, VA.
Code Information
LifeShield Infusion Safety Software Suite v2.2 UDI-DI 00887709127227