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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
Recalled May 20, 2020 · FDA recall Z-1962-2020 · W. L. Gore & Associates
Hazard
The devices were mislabeled with the incorrect product size resulting in 16Fr devices being labeled as 14Fr devices. · FDA Class II
Units
141 devices
Sold at
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.
Description
The devices were mislabeled with the incorrect product size resulting in 16Fr devices being labeled as 14Fr devices.
Product
Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ.
Manufacturer(s)
W. L. Gore & Associates Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →