Gore DrySeal Flex Introducer Sheath recalled over labeling errors

Recall date

November 18, 2019

Source

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

Official notice title

W. L. Gore & Associates Inc. recalls Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. G…

Recall number

Z-1962-2020

FDA classification

Class II

Brand / firm

W. L. Gore & Associates Inc.

Sold / distributed

All distribution is foreign to the following countries: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Japan, Norway, Spain, Sweden, Switzerland, and the UK.

Why it was recalled

The devices were mislabeled with the incorrect product size resulting in 16Fr devices being labeled as 14Fr devices.

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

What was recalled

Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ.