ICU Medical Inc recalls Plum 360 Infusion System

Recall date

June 15, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3031-2017

FDA classification

Class II

Brand / firm

ICU Medical Inc

Sold / distributed

Worldwide Distribution - USA (nationwide) Distribution to the states of including Puerto Rico : AL, AR, AZ, CA, FL, GA, HI, IA, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NE, NH, NJ, NM, NY, OH, PA, SD, TN, TX, VA, WA, WI, WY and District of Columbia., and to the countries of : Australia, Cana…

Why it was recalled

Potential for the Connectivity Engine Module of the affected unit to disengage from the main chassis, causing the unit to shut down without an alarm notification. This would delay initiation of therapy or interrupt an infusion.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Plum 360 Infusion System