Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ.
FDA Recall Z-1962-2020 · Posted None
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Recalling FirmW. L. Gore & Associates Inc.
Recall StatusTerminated
Product CodeDYB
Date Initiated2019-11-18
Date Terminated2020-05-13
Product Quantity141 devices
Reason for Recall
The devices were mislabeled with the incorrect product size resulting in 16Fr devices being labeled as 14Fr devices.
Firm Action
The recalling firm issued Field Safety Notices dated 11/19/2019 with FSN Ref and FSCA Ref numbers of #0000000-11152019-001-R titled "Mislabelled 16Fr Introducer Sheaths Labelled as 14FR (3 lots)" issued via email and overnight mail. Return of the devices was requested.
Root Cause
Labeling Change Control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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