BrosMed Medical Co.,Ltd. recalls Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to dilate stenoses in the iliac,…

Recall date

December 14, 2018

Source

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

Recall number

Z-0963-2019

FDA classification

Class II

Brand / firm

BrosMed Medical Co.,Ltd.

Sold / distributed

US Distribution to MO.

Why it was recalled

Incorrect (higher) Rated Burst Pressure information printed on label.

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

What was recalled

Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.