Abbott Vascular recalls Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 ¿g/cm¿, Nominal Everolimus Cont…

Recall date

March 25, 2020

Source

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

Recall number

Z-2370-2020

FDA classification

Class II

Brand / firm

Abbott Vascular

Sold / distributed

US Nationwide distribution including in the states of NJ, HI, MD, FL, NV, CA, KS and PR. No foreign consignee

Why it was recalled

Incorrect expiration date

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

What was recalled

Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 ¿g/cm¿, Nominal Everolimus Content: 209 ¿g; Lot number 903224A,