FDA-Device2021-10-20Class II
Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm, UDI:
W L Gore & Associates, Inc.
Hazard
Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may contain a 9mm x 29 mm x 135 cm device.
Sold states
International distribution to the countries of Italy & Lebanon.
Affected count
2 units
Manufactured in
3750 W Kiltie Ln, N/A, Flagstaff, AZ, United States
Products
Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm, UDI:
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0077-2022Don't want to check this manually?
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