Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ.
- Company
- W. L. Gore & Associates Inc.
- Recall Initiated
- November 18, 2019
- Terminated
- May 13, 2020
- Recall Number
- Z-1962-2020
- Quantity
- 141 devices
- Firm Location
- Phoenix, AZ
Reason for Recall
The devices were mislabeled with the incorrect product size resulting in 16Fr devices being labeled as 14Fr 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.
Lot / Code Info
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.
Root Cause
Labeling Change Control
Action Taken
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.