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

FDA Device Recall #Z-1962-2020 — Class II — November 18, 2019

Recall Summary

Recall Number Z-1962-2020
Classification Class II — Moderate risk
Date Initiated November 18, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm W. L. Gore & Associates Inc.
Location Phoenix, AZ
Product Type Devices
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.

Lot / 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.

Other Recalls from W. L. Gore & Associates Inc.

Recall # Classification Product Date
Z-2340-2021 Class II Gore Molding & Occlusion Balloon Catheter, REF ... Jul 12, 2021
Z-0995-2020 Class II GORE¿ EXCLUDER¿ AAA Endoprosthesis Jan 6, 2020
Z-0996-2020 Class II GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE) Jan 6, 2020

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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