Edwards Lifesciences, LLC recalls Intravascular (IV) Administration Sets, Model No. 54IV12, 54IV22, 54IV32, MK2450, 54IV42, MK132, MK2156, MK2270, MK2292…

Recall date

November 13, 2015

Source

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

Recall number

Z-0446-2016

FDA classification

Class II

Brand / firm

Edwards Lifesciences, LLC

Sold / distributed

US

Why it was recalled

Edward Lifesciences is recalling Intravascular (IV) Administration Sets due to the requirement of an additional FDA submission to support commercialization (clearance) of the devices.

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

What was recalled

Intravascular (IV) Administration Sets, Model No. 54IV12, 54IV22, 54IV32, MK2450, 54IV42, MK132, MK2156, MK2270, MK2292, MK2300, MK2374, MK2394, MK2508, MK2227