Conformable Thoracic Stent Graft recalled over labeling errors
- Recall date
- December 17, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- W L Gore & Associates, Inc. recalls Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair…
- Recall number
- Z-2052-2020
- FDA classification
- Class II
- Brand / firm
- W L Gore & Associates, Inc.
- Sold / distributed
- International the country of Japan.
Why it was recalled
The incorrect label was placed on both the primary and secondary package.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.
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