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.
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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