COVIDIEN LLC recalls 8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826

Recall date

November 5, 2018

Source

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

Recall number

Z-0656-2019

FDA classification

Class II

Brand / firm

COVIDIEN LLC

Sold / distributed

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.

Why it was recalled

The product was released into commercial distribution while subject to importation refusal.

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

What was recalled

8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826