Z-1962-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2020
- Initiation Date
- November 18, 2019
- Termination Date
- May 13, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 141 devices
Product Description
Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ.
Reason for Recall
The devices were mislabeled with the incorrect product size resulting in 16Fr devices being labeled as 14Fr devices.
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.
Code Information
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.