United StatesLifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 (Product No. 17003-02, UDI‑DI 00887709127227) distributed to 12 customers in CA, IA, KY, LA, MD, MS, NY, PA, TN and VA is being recalled. A software issue limits Concentration Limits to one decimal place (0.1) instead of three (0.001), which may force users to change manufacturer-recommended limits and could result in over‑ or under‑delivery.
What's being recalled
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
Recalling firm: ICU Medical, Inc., Lake Forest, IL, United States.
How to identify it
LifeShield Infusion Safety Software Suite v2.2 UDI-DI 00887709127227
The hazard
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of CA, IA, KY, LA, MD, MS, NY, PA, TN, VA.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada