United StatesICU Medical’s LifeShield Drug Library Management (LifeShield Infusion Safety Software Suite v2.2, list 17003-02) version 2.2.1 is affected for customers who migrated from v2.1x and have any Plum Duo v1.1 drug library that was approved or locked for review before migration. The Change Summary review option can stop working for migrated libraries, which may lead to over delivery, under delivery, or delays in infusion pump setup. Affected users must use alternate methods to review changes.
What's being recalled
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
Recalling firm: ICU Medical, Inc., Lake Forest, IL, United States.
How to identify it
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.
The hazard
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.
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, LA, 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