LivaNova USA recalls Perfusion Pack, Rx only, Sterile EO

Recall date

November 9, 2018

Source

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

Recall number

Z-0770-2019

FDA classification

Class II

Brand / firm

LivaNova USA

Sold / distributed

Worldwide Distribution - Domestic (US) Consignees: AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, WA, WI, WV, MS; Foreign (OUS) Consignees: Canada

Why it was recalled

4-way stopcocks and stopcock manifold assembled in certain perfusion tubing systems, indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours, may leak or be occluded.

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

What was recalled

Perfusion Pack, Rx only, Sterile EO