FDA-Device2020-02-19Class II
Niti-S Esophageal Stent, REF ES1806F, ES1808F, ES1810F, ES1815F, ES2006B, ES2010B, ES1612B, ES1615B, ES1810B, ES1812B, ES1815B, ES1610F, ES1612F, ES1615F, ES2006F, ES2008F, ES2010F; Esophageal TTS Stent, REF: EST1806F, EST2012F, EST2012B, EST2015F, EST2008F, EST1808F, EST1814F, EST1810F, EST2010F
Taewoong Medical Co., Ltd.
Hazard
Misprinted IFUs shipped with esophageal stents
Sold states
U.S.: IN
Affected count
178
Manufactured in
14 Gojeong-ro, Wolgot-Myeon,, Gimpo-Si,, Gyeonggi-Do, Korea (the Republic of)
Products
Niti-S Esophageal Stent, REF ES1806F, ES1808F, ES1810F, ES1815F, ES2006B, ES2010B, ES1612B, ES1615B, ES1810B, ES1812B, ES1815B, ES1610F, ES1612F, ES1615F, ES2006F, ES2008F, ES2010F; Esophageal TTS Stent, REF: EST1806F, EST2012F, EST2012B, EST2015F, EST2008F, EST1808F, EST1814F, EST1810F, EST2010F
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1229-2020Don't want to check this manually?
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