Flexor Check-Flo Introducer Ansel Modification recalled over labeling errors

Recall date

November 12, 2021

Source

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

Official notice title

Cook Inc. recalls Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155 Inte…

Recall number

Z-0388-2022

FDA classification

Class II

Brand / firm

Cook Inc.

Sold / distributed

AL, AZ, CA, FL, GA, KS, MI, MO, MN, NC, NY, OK, TX Foreign: BE, CH, DE, ES, FR, GB,GU, IT, ZA

Why it was recalled

Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa

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

What was recalled

Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.