Edwards Lifesciences, LLC recalls QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705

Recall date

November 27, 2019

Source

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

Recall number

Z-0800-2020

FDA classification

Class II

Brand / firm

Edwards Lifesciences, LLC

Sold / distributed

U.S.: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV. O.U.S. (Foreign): Brazil, Colombia, Albania, Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Czech Republic, Denmark…

Why it was recalled

If the venous cannula is used in an unintended manner (longer than 6 hours; particularly during extracorporeal membrane oxygenation [ECMO]) there is a risk that separation of the cannula from its connector can occur; which can result in significant blood loss.

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

What was recalled

QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705