FDA-Device2020-05-20Class II
Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ.
W. L. Gore & Associates Inc.
Hazard
The devices were mislabeled with the incorrect product size resulting in 16Fr devices being labeled as 14Fr devices.
Sold states
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.
Affected count
141 devices
Manufactured in
32360 N North Valley Pkwy, N/A, Phoenix, AZ, United States
Products
Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1962-2020Don't want to check this manually?
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