Terumo Medical Corp recalls Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135

Recall date

April 9, 2018

Source

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

Recall number

Z-2337-2018

FDA classification

Class II

Brand / firm

Terumo Medical Corp

Sold / distributed

Distributed to accounts in AL, CA, FL, IA, IN, MI, MO, NC, NY, SD, TN, and TX.

Why it was recalled

Two lots of product were released for distribution prior to the completion of all required validation and lot acceptance activities. Although sterile, products from these lots may not function as intended and therefore should not be used.

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

What was recalled

Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135