Z-1962-2020Class II

Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label...

Name: Z-1962-2020 Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label...
Creator: W. L. Gore & Associates Inc.
Published: 2019-11-18
License: https://open.fda.gov/license/

W. L. Gore & Associates, Inc. / initiated 2019-11-18 / Terminated / root cause: labeling and UDI

FDA source

W. L. Gore & Associates Inc. began a recall of Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ on 2019-11-18. FDA classified it as Class II and gives the reason as "The devices were mislabeled with the incorrect product size resulting in 16Fr devices being labeled as 14Fr devices". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1962-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-18
Posted: 2020-05-11
Terminated: 2020-05-13
Recalling firm: W. L. Gore & Associates, Inc.
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.
Product code: DYB Introducer, Catheter
Reason for recall: The devices were mislabeled with the incorrect product size resulting in 16Fr devices being labeled as 14Fr devices.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
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.
Quantity in commerce: 141 devices
Distribution: 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.
Product codes and lots: Serial numbers 21077298, 21077364, 21077365, 21077366, 21077631, 21077350, 21077351, 21077414, 21060888, 21077339, 21077340, 21077341, 21077417, 21077418, 21061626, 21077286, 21077336, 21077337, 21077211, 21077304, 21077305, 21077307, 21077308, 21077309, 21077640, 21077559, 21077563, 21077564, 21077183, 21077346, 21077347, 21077616, 21077617, 21077618, 21077619, 21077419, 21077596, 21077345, 21077620, 21077635, 21077322, 21077602, 21077362, 21077622, 21077623, 21077624, 21077625, 21077626, 21077627, 21077628, 21077348, 21077349, 21077633, 21077644, 21077363, 21077352, 21077634, 21077621, 21077318, 21077319, 21061622, 21077590, 21077591, 21077629, 21077632, 21060886, 21077593, 21077594, 21077274, 21077282, 21077338, 21077636, 21077637, 21077638, 21077639, 21077642, 21077643, 21061625, 21061627, 21077601, 21077608, 21077284, 21077303, 21077320, 21077321, 21077316, 21077415, 21077416, 21077299, 21077300, 21077301, 21077302, 21077369, 21077342, 21077599, 21077600, 21077197, 21077595, 21061623, 21077641, 21077597, 21061624, 21077285, 21077184, 21077185, 21077609, 21077436, 21077437, 21077592, 21077190, 21077191, 21077192, 21077193, 21077194, 21077195, 21077196, 21077206, 21077207, 21077208, 21077561, 21077562, 21077367, 21077368, 21077188, 21077630, 21077186, 21077187, 21077189, 21077310, 21077317, 21077334, 21077353, 21077605, 21077343, 21077344, 21077177, 21077178, 21077179, 21077180, 21077181, and 21077598.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1962-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1962-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-11

Product code DYB

K160254Class IIGORE DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc. / cleared 2016-05-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)